(353 days)
The surgical patties and surgical strips are indicated for the use including brain and other tissues of the central nervous system, during surgery.
The Codman Surgical Patties and Strips are single use, sterile devices indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
The Surgical Patties are comprised of 3 main components: Cottonoid Material, String and X-ray detectable monofilament.
The Strips are comprised of 2 main parts: Cottonoid Material and X-ray detectable monofilament.
This document describes the acceptance criteria and study results for the Integra LifeSciences Corporation's Codman Surgical Pattie & Strip (K193346).
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual Inspection (Patties) | 1. String and X-ray isolation |
- X-ray weld strength
- X-ray flash
(Demonstrates that proposed patties meet the same performance specification as the predicate device) | All samples passed the acceptance criteria. |
| Visual Inspection (Strips) | 1. X-ray weld strength - X-ray flash
(Demonstrates that proposed strips meet the same specifications as the predicate strips and that the performance of the proposed device with a non-phthalate PVC Resin is substantially equivalent to that of the predicate device) | All samples passed the acceptance criteria. |
| Radiopacity (Patties and Strips) | Qualitative acceptance criteria (as per FDA recognized standard ASTM F640-12).
(Supports that the performance of the proposed device with a non-phthalate PVC Resin is substantially equivalent to that of the predicate device) | All samples passed the qualitative acceptance criteria. |
| Sterilization Validation | Achieve a 10⁻⁶ sterility assurance level (SAL) using the overkill process per FDA recognized standard, ISO 11135:2014, with a reference product load that included "worst case" product, and meet EO/ECH residual and bioburden acceptance criteria.
(Same as predicate device, supporting substantial equivalence) | Test results met the EO/ECH residual and bioburden acceptance criteria and achieved a sterility assurance level of 10⁻⁶. |
| Shelf-Life (2-years) | • X-ray shall not protrude
• Meets ASTM F640
• X-ray shall exhibit adequate adherence
• X-ray shall not overlap string.
(Within the current shelf life claim for the predicate device, does not raise new questions of safety and effectiveness as per FDA recognized standard ASTM F640) | All product tested passed the acceptance criteria. |
| Biocompatibility - Cytotoxicity | Less than or equal to grade 2 reactivity on the 0 to 4 reactivity scale (per ISO 10993-5).
(Demonstrates biocompatibility and substantial equivalence to predicate device) | All product tested passed the acceptance criteria. |
| Biocompatibility - Intracutaneous Study | Difference between test article extract overall mean score and control group score is 1.0 or less (per ISO 10993-10).
(Demonstrates biocompatibility and substantial equivalence to predicate device) | All product tested passed the acceptance criteria. |
| Biocompatibility - USP Rabbit Pyrogen Study | No single animal shows a rise of 0.5 °C above its baseline temperature (per ISO 10993-11).
(Demonstrates biocompatibility and substantial equivalence to predicate device) | All product tested passed the acceptance criteria. |
| Biocompatibility - Acute Systemic Toxicity | No single animal treated with the individual test extract exhibits a significantly greater reaction than the control animals; no more than two animal deaths; no abnormal behavior such as convulsions or prostration occurs in two or more animals; no final body weight loss greater than 10% occurred in three or more animals (per ISO 10993-11).
(Demonstrates biocompatibility and substantial equivalence to predicate device) | All product tested passed the acceptance criteria. |
| Biocompatibility - Guinea Pig Maximization Sensitization Test | A grade of 0 on a patch test reaction scale of 0-3 (per ISO 10993-10).
(Demonstrates biocompatibility and substantial equivalence to predicate device) | All product tested passed the acceptance criteria. |
| Biocompatibility - ASTM Hemolysis Study | Hemolytic index for the test article extract to be 0.1% and non-hemolytic (as per ASTM F756 and ISO 10993-4).
(Demonstrates biocompatibility and substantial equivalence to predicate device) | All product tested passed the acceptance criteria. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the exact sample size for each test. However, it indicates "All samples" passed the acceptance criteria for most tests, suggesting an appropriate number of samples were tested to demonstrate substantial equivalence. The data provenance is derived from bench testing conducted by Integra LifeSciences Corporation, as stated under "Bench Testing" and "Performance Data." This is prospective data generation for the purpose of demonstrating substantial equivalence. The country of origin for the data is not specified, but the submission is to the U.S. FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a physical medical instrument (surgical pattie and strip), not an AI/imaging device requiring expert interpretation for ground truth establishment. The performance evaluation relies on objective physical, chemical, and biological tests.
4. Adjudication method for the test set:
Not applicable. As described in point 3, this is not an AI/imaging device subject to expert adjudication of results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a physical medical instrument and does not involve AI assistance or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical instrument.
7. The type of ground truth used:
The "ground truth" for this device's performance evaluation is established through adherence to recognized industry standards (e.g., ASTM, ISO standards) and meeting predefined objective specifications for physical, chemical, and biological properties. This includes measurements of weld strength, X-ray visibility, sterility assurance levels, and biocompatibility endpoints.
8. The sample size for the training set:
Not applicable. This device is a physical medical instrument and does not involve AI models or training sets.
9. How the ground truth for the training set was established:
Not applicable. As described in point 8, this device does not involve AI models or training sets.
§ 882.4700 Neurosurgical paddie.
(a) A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
(b)
Classification. Class II (performance standards).