(88 days)
"Cutalon" Nonabsorbable Polyamide Surgical Sutures are provided sterile and are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
"Cutalon" Nonabsorbable Polyamide Surgical Sutures are composed of the long-chain aliphatic polymers extruded Nylon (Nylon 6) sutures which conform to the United States Code of Federal Regulations, 21 CFR Part, 878.5020. "Cutalon" is a wet-packed, extruded, nylon monofilament suture. The base polymer material is Nylon 6. (As required in CFR 878.5020) The nylon suture material is foilpackaged "wet" in a solution containing isopropyl alcohol, water and other components. The purpose of the "wet" packaging is to provide a nylon suture that is supple (easier to twist and tie) straight from the package due to the water absorption into the nylon. Genzyme "Cutalon" Surgical Suture are available in USP sizes 6-0 through 0 (metric sizes 0.7 through 3.5).
This document describes the Genzyme "Cutalon" Nonabsorbable Polyamide Surgical Suture, focusing on its substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the typical sense of a novel device evaluation.
Below is an analysis structured to address your points, acknowledging that much of the information requested (like detailed performance studies, expert involvement, and statistical sample sizes for training/test sets) is not applicable or present for a 510(k) submission based on substantial equivalence to an already marketed device.
Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria
The "Cutalon" Nonabsorbable Polyamide Surgical Suture does not present a novel technology requiring de novo performance studies against specific acceptance criteria. Instead, its acceptance is based on demonstrating substantial equivalence to a predicate device (Genzyme's existing Nylon Suture) that has already met regulatory requirements. The key "acceptance criteria" here are aligning with existing standards and demonstrating no new questions of safety or effectiveness.
The "study" proving the device meets these criteria is primarily a comparison analysis and biocompatibility testing, rather than a clinical trial or performance study against quantitative metrics like accuracy, sensitivity, or specificity.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (based on Substantial Equivalence) | Reported Device Performance (as per submission) |
|---|---|
| Intended Use Equivalence: | "Cutalon" Nonabsorbable Polyamide Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. This is identical to the predicate Nylon Suture. |
| Material Equivalence: | Composed of the long-chain aliphatic polymer extruded Nylon (Nylon 6), conforming to 21 CFR Part 878.5020. This is identical to the predicate Nylon Suture. The submission specifies "Nylon 6 or 6.6" in the comparison table, aligning with the predicate. |
| Manufacturing Process Equivalence: | Identical to the predicate Nylon Suture, with the exception of the packaging method. The base suture (extruded Nylon monofilament) is the same. |
| Function Equivalence: | The "Cutalon" Suture is identical in function to the predicate device. The wet packaging is described as enhancing suppleness, making it "easier to twist and tie," which is presented as an improvement in handling without altering the fundamental function. |
| Sterilization Equivalence: | Uses Gamma Irradiation (Cobalt 60), validated according to AAMI/ANSI/ISO 11137 with a Sterility Assurance Level (SAL) of $10^{-6}$. The predicate also uses Gamma Irradiation (or ETO). |
| Biocompatibility: | Demonstrated to be non-cytotoxic, non-hemolytic, non-allergenic, non-mutagenic, non-irritant, meeting requirements for systemic toxicity, implant requirements (USP Muscle Implant 1 week & 90 days), and USP physico-chemical. Meets requirements for long-chain aliphatic polymer Nylon 6. This aligns with safety expectations for an equivalent device and is based on specific testing (listed below). |
| Compliance with USP Requirements: | Genzyme "Cutalon" Sutures meet all requirements established by the United States Pharmacopeia (USP) for nonabsorbable sutures except for diameter (the meaning of this exception is unclear without further context, but it's noted). The predicate also "Meets USP Requirement" for Suture Tensile Strength. |
| Packaging (Difference Acknowledged): | "Wet Packaged" (sterile) vs. "Dry Packaged" (sterile) for the predicate. This is the primary differentiating feature, intended to make the suture more supple. The safety and sterility of this new packaging method are addressed through validation of the packaging process and sterility. The FDA letter specifically notes the need for maintaining documentation regarding vendor certification for raw or semiprocessed source material, all manufacturing and quality control release procedures, and validation of sterilization procedures. |
| Tensile Strength: | Meets USP Requirement (consistent with predicate). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
For substantial equivalence submissions like this, dedicated "test sets" with statistically determined sample sizes for performance evaluation (e.g., accuracy against a gold standard) are not typically required or provided.
- Biocompatibility Testing: The specific sample sizes for tests like USP Muscle Implant, Sensitization, Acute Systemic Toxicity, Hemocompatibility, Cytotoxicity, and Genotoxicity are not explicitly stated in the summary. These tests typically involve animal models or in-vitro cultures. The provenance would be the testing laboratories, likely in the US, following recognized standards (ISO 10993-1). These are prospective tests performed on the "Cutalon" device.
- Comparison to Predicate: The "test set" in this context is the predicate device itself and its historical performance, which has been marketed since December 1976.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. No "ground truth" in the clinical sense (e.g., disease diagnosis) needed to be established by experts for comparing performance. The "ground truth" for this submission revolves around:
- USP standards: These are established by pharmacopeial experts.
- Biocompatibility standards (ISO 10993-1): These are established international standards by experts in toxicology and materials.
- Predicate device characteristics: These were established during the original market approval (PMA N85-060 in 1976 and subsequent 510(k) K930738 in 1994) and are accepted as given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no "adjudication" of performance data from a test set in this context. The FDA's review process itself involves regulatory experts evaluating the submission against established regulations and guidance documents.
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 is a medical device (suture), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI-assisted performance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) submission is primarily derived from:
- Regulatory Standards: United States Code of Federal Regulations (21 CFR Part 878.5020 for Nylon sutures).
- Pharmacopeial Standards: United States Pharmacopeia (USP) requirements for nonabsorbable sutures.
- International Biocompatibility Standards: ISO 10993-1 Biological Evaluation of Medical Devices.
- Predicate Device Data: The established safety and effectiveness profile of Genzyme's existing Nylon Suture that has been on the market since 1976, which served as the benchmark for substantial equivalence.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires training data.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.