Medical Devices · Oct 31, 2023

Acrostak Schweiz AG

3 extracted findings · 5 model-assigned issue types

FDA source excerpt, selected passage

the MCATH Flexy Microcatheter, was introduced in 2021 without 510(k) clearance as a new design to your firm’s cleared device covered under K171176.

Complaints & adverse event reporting Design controls Production & process controls Records & data integrity Registration, listing & premarket

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Registration, listing & premarket21 CFR 807.81(a)(3)

The M-CATH Flexy Microcatheter was introduced without 510(k) clearance despite significant design changes.

Supporting FDA text

Source excerpt · automated text-match check
the MCATH Flexy Microcatheter, was introduced in 2021 without 510(k) clearance as a new design to your firm’s cleared device covered under K171176.

Production & process controls21 CFR 820.75(b)(2)

The firm failed to monitor and control process parameters for validated processes, including cleanroom particle counts.

Supporting FDA text

Source excerpt · automated text-match check
your firm has never monitored particle counts in this environment to demonstrate that the environment is adequately controlled

Records & data integrity21 CFR 820.75(b)(2)

The firm failed to establish procedures for documenting process monitoring data.

Supporting FDA text

Source excerpt · automated text-match check
procedures for documenting process monitoring data have not been adequately established.

Design controls21 CFR 820.30(g)

The firm's risk assessment table failed to identify and calculate the risk of embolism from tip separation.

Supporting FDA text

Source excerpt · automated text-match check
The risk table does not identify nor calculate the risk of embolism resulting from catheter tip separation.

Design controls21 CFR 820.30(g)

The firm's risk assessment underestimated the probability and severity of tip separation risks.

Supporting FDA text

Source excerpt · automated text-match check
the current risk assessment table does not appear to address all potential risks associated with tip separation; it underestimates the potential risk probability and severity

Design controls21 CFR 820.30(g)

The design validation report lacked acceptance criteria to demonstrate user needs and intended uses were met.

Supporting FDA text

Source excerpt · automated text-match check
your firm’s design validation report for M-CATH and M-CATH Flexy microcatheters, REP-00130: Design Validation Report – Microcatheters (Rev. 1, approved 2022-08-19), also does not contain acceptance criteria.

Production & process controls21 CFR 820.90(b)(2)

The firm failed to establish procedures defining responsibility for rework and retesting of nonconforming product.

Supporting FDA text

Source excerpt · automated text-match check
Failure to establish and maintain procedures that define the responsibility for rework, to include retesting and reevaluation of the nonconforming product after rework

Complaints & adverse event reporting21 CFR 803.17(a)(1)

The MDR procedure omitted the definition of 'serious injury', potentially leading to incorrect reportability decisions.

Supporting FDA text

Source excerpt · automated text-match check
the procedure omits the definition of the term “serious injury” from 21 CFR Part 803.3.

Findings extracted from the letter

Selected FDA passages, not the complete letter.

Failure to maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met as required by 21 CFR 820.75(b)(2) – Process Validation. More specifically, the environmental control validation activities should be monitored and controlled per the established procedures to ensure that specific requirements continue to be met.

21 CFR 820.75(b)(2)

Failure to establish and maintain design validation procedures to ensure that devices conform to defined user needs and intended uses; to ensure proper risk analysis is completed; and to ensure the results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation are documented in the design history file, as required by 21 CFR 820.30(g).

21 CFR 820.30(g)

Failure to establish and maintain procedures that define the responsibility for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications per 21 CFR 820.90 (b)(2). For example, your firm manufacturing work instruction for M-CATH microcatheters (WI 158-1, Rev. F; approved 28 September 2022) **(b)(4)**.

21 CFR 820.90

What FDA requested

Model-assisted summary. Consult the letter for complete requests and conditions.

Provide completed clean room validations under normal operating conditions.
Provide finalized updates to procedures and forms for processes with variable parameter settings.
Provide updated risk table reflecting tip separation risks, mitigations, severity, and occurrences.
Provide updated design validation protocols with acceptance criteria.
Provide updated rework procedures and device history record forms with rework description fields.

Sections and clauses cited

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 807.81(a)(3)21 CFR 803.17(a)(1)21 CFR 803.3 21 CFR 807.81(b)21 CFR 820.75(b)(2)21 CFR 820.30(g)21 CFR 820.90 21 CFR 803.50(a)

Acrostak Schweiz AG

Findings and supporting evidence

The M-CATH Flexy Microcatheter was introduced without 510(k) clearance despite significant design changes.

The firm failed to monitor and control process parameters for validated processes, including cleanroom particle counts.

The firm failed to establish procedures for documenting process monitoring data.

The firm's risk assessment table failed to identify and calculate the risk of embolism from tip separation.

The firm's risk assessment underestimated the probability and severity of tip separation risks.

The design validation report lacked acceptance criteria to demonstrate user needs and intended uses were met.

The firm failed to establish procedures defining responsibility for rework and retesting of nonconforming product.

The MDR procedure omitted the definition of 'serious injury', potentially leading to incorrect reportability decisions.

Findings extracted from the letter

What FDA requested

Sections and clauses cited

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FDA Warning Letter Alerts

Findings and supporting evidence

The M-CATH Flexy Microcatheter was introduced without 510(k) clearance despite significant design changes.

The firm failed to monitor and control process parameters for validated processes, including cleanroom particle counts.

The firm failed to establish procedures for documenting process monitoring data.

The firm's risk assessment table failed to identify and calculate the risk of embolism from tip separation.

The firm's risk assessment underestimated the probability and severity of tip separation risks.

The design validation report lacked acceptance criteria to demonstrate user needs and intended uses were met.

The firm failed to establish procedures defining responsibility for rework and retesting of nonconforming product.

The MDR procedure omitted the definition of 'serious injury', potentially leading to incorrect reportability decisions.

Findings extracted from the letter

What FDA requested

Sections and clauses cited

More medical-device letters

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Put this kind of reading towork on your own records.

Put this kind of reading to
work on your own records.