(127 days)
Non Absorbable Surgical Nylon Suture is indicated for use in general soft tissue approximation and/or ligation, the device can be left in place for a maximum of 7 days.
The proposed device is a nonabsorbable monofilament surgical suture which is supplied sterile. The proposed device will be offered in diameters ranging from USP size 6-0 through 2 and available in length varying from 45cm to 150cm with or without needles attached. The proposed device is dyed blue. The color additive is FD&C BLUE NO. 2, the weight percentage for color additive is less than 0.1%.
The document provided describes a 510(k) summary for a medical device called "Non Absorbable Surgical Nylon Suture." It details the device's characteristics, its comparison to a predicate device, and the results of non-clinical tests conducted to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document provides a comparative table (Table 1: Comparison of Technology Characteristics) that implicitly lists acceptance criteria by showing the proposed device's performance against established standards or in comparison to the predicate device.
| Acceptance Criteria (Standard/Predicate) | Reported Device Performance (Proposed Device) | Remark/Compliance |
|---|---|---|
| Product Code: GAR | GAR | Same |
| Regulation Number: 21CFR 878.5020 | 21CFR 878.5020 | Same |
| Class: II | II | Same |
| Indication for Use: General soft tissue approximation and/or ligation (predicate also includes cardiovascular, ophthalmic, microsurgery, neurological procedures) | General soft tissue approximation and/or ligation, can be left in place for a maximum of 7 days. | Similar (proposed device's indication is a subset of the predicate's) |
| Structure: Monofilament | Monofilament | Same |
| Length: 3cm to 250cm (Predicate) | 45cm to 150cm | Different (within predicate's range) |
| Diameter: 11-0 through 5 (Predicate) | 6-0 through 2 | Different (within predicate's range) |
| Needle: With or without needles attached | With or without needles attached | Same |
| Duration of use: Permanent (Predicate) | Up to 7 days | Different |
| Performance Test - Diameter: Comply with USP | Comply with USP | Same |
| Performance Test - Needle Attachment: Comply with USP | Comply with USP | Same |
| Performance Test - Tensile Strength: Comply with USP | Comply with USP | Same |
| Performance Test - Length: Unknown (Predicate) | Not less than 95.0% of the length stated on the label | Different (specific criterion provided for proposed device) |
| Material: Polyamide (PA 6/66) & Stainless Steel Wires | Polyamide (PA 6/66) & Stainless Steel Wires | Same (Predicate specified Polyamide 6 and/or polyamide 6,6; 300 or 400 series stainless steel) |
| Dyed, Un-dyed: Dyed and Un-dyed (Predicate) | Dyed | Different |
| Colorant: [Phthalocyaninato(2-)] copper or logwood extract (Predicate) | Blue, FD&C BLUE NO. 2, weight percentage less than 0.1% | Different |
| Sterile: Gamma Irradiation or Ethylene Oxide (EO) (Predicate) | Ethylene Oxide (EO) | Different (but EO is a predicate sterilization method) |
| Biocompatibility - Cytotoxicity: Viability not reduced to less than 70% | The viability is not reduced to less than 70% | Same |
| Biocompatibility - Sensitization: Comply with ISO 10993 (Predicate) | The Magnusson and Kligman grades is less than 1. | Same (specific criterion provided for proposed device) |
| Biocompatibility - Irritation: The irritation score is less than 1.0 (Implies compliance with ISO 10993) | The erythema and edema grades is less than 1.0; The irritation score is less than 1.0 | Same |
| Biocompatibility - Implantation: No lesion at the implantation site (Implies compliance with ISO 10993 for Implantation (4 week)) | No lesion at the implantation site | Same |
| Biocompatibility - Systemic Toxicity: No animal died or abnormal behavior occurred, weight loss not exceeding 10% (Implies compliance with ISO 10993-11) | No animal died or abnormal behavior occurred. The weight loss not exceed 10% | Same |
| Biocompatibility - Pyrogen: Temperature raise less than 0.5°C (Implies compliance with USP ) | Temperature raise less than 0.5°C | Same |
| Biocompatibility - Subacute Systemic Toxicity: No behavioral change or sign of toxicity; clinical pathology parameter within reference range; no macroscopic changes in viscera at necropsy; histopathology within normal histomorphological limits (Implies compliance with ISO 10993-11) | No behavioral change or sign of toxicity was observed. | |
| Clinical pathology parameter within the reference range. | ||
| No macroscopic changes in the viscera at necropsy. | ||
| Histopathology within normal histomorphological limits | Same | |
| Biocompatibility - Bacterial Reverse Mutation: No statistical significance for number of revertant colonies between test and control groups; no statistically significant dose-effect relationship (Implies compliance with ISO 10993-3) | No statistical significance for the number of revertant colonies between the test group and control group. | |
| No statistically significant dose-effect relationship was observed | Same | |
| Biocompatibility - Gene Mutation: No concentration-related increase of mutant frequency (Implies compliance with ISO 10993-3) | No concentration-related increase of mutant frequency. | Same |
| Biocompatibility - Chromosome Aberration: No significant difference in percentage of cells with structural aberrations between test and control groups (Implies compliance with ISO 10993-3) | No significant difference in the percentage of cells with structural aberrations between the test group and control group. | Same |
| Biocompatibility - Hemolysis: Hemolytic index less than 2% (Implies compliance with ASTM F756) | Hemolytic index is less than 2% | Same |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the sample sizes used for each specific non-clinical test. It lists the standards and states "The test results demonstrated that the proposed device complies with the following standards." For biological evaluations (e.g., cytotoxicity, irritation, systemic toxicity), these studies typically involve in vitro tests and animal models, governed by the respective ISO 10993 standards and USP monographs. The number of samples/animals would be specified within those standard protocols, but are not detailed in this 510(k) summary.
- Data Provenance: The tests were "non clinical tests" and involved compliance with ASTM, ISO, and USP standards. This indicates laboratory testing, likely performed by or for the manufacturer. The country of origin of the data is not specified beyond the manufacturer being in China. The data would be considered prospective for the purpose of this submission (i.e., new tests were conducted for this device clearance).
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 information is typically not included in a 510(k) summary for non-clinical testing of a surgical suture. The "ground truth" for these tests are the established thresholds and methodologies defined within the cited international and national standards (ASTM, ISO, USP). Compliance is determined by whether the device's performance falls within the acceptable ranges or meets the pass/fail criteria outlined in these published standards. These standards are developed and updated by expert committees in relevant fields, but individual expert assessment for a specific test set, as might be done for clinical image analysis, is not applicable here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving human interpretation (e.g., radiology reads) where there can be inter-reader variability. For non-clinical tests against defined standards, results are typically objective measurements or observations that either meet or fail the established criteria.
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 510(k) submission for a surgical suture, which is a physical medical device, not an AI-assisted diagnostic tool. No MRMC studies or AI assistance were involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI device. The tests were performed on the physical suture device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the non-clinical tests is based on established scientific and engineering standards and methodologies. These include:
- ASTM International Standards: For material testing (e.g., seal strength, seal leaks).
- ISO 10993 Series of Standards: For biological evaluation of medical devices (e.g., cytotoxicity, sensitization, irritation, implantation, systemic toxicity, genotoxicity, ethylene oxide residuals, hemolysis).
- United States Pharmacopeia (USP) Monographs: For physical characteristics of sutures (e.g., diameter, tensile strength, needle attachment, pyrogen, bacterial endotoxins).
The tests determine if the device meets quantitatively defined thresholds or qualitative observations specified by these authoritative standards, rather than expert consensus on individual cases or clinical outcomes data.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning or AI algorithm that requires a training set. The tests performed are to evaluate the physical and biological characteristics of the manufactured suture.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this 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.