(88 days)
FILAMIDE is intended for use as non-absorbable sutures in general soft tissue approximation including skin tissue closure and/or ligation in cardiac, vascular and ophthalmic procedures.
FILAPROP sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
FILASILK is intended for use as non-absorbable sutures in general soft tissue approximation and/or ligation including use in cardiac, vascular and ophthalmic procedures.
MERICRON XL suture is intended for use in general soft tissue approximation and/or ligation including cardiovascular surgery, neurosurgery and ophthalmic procedures.
FILASILK™ silk suture is a non-absorbable, sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. FILASILK™ sutures are processed to remove the natural waxes and gums. FILASILK™ suture is available undyed or dyed black with Logwood extract and coated with bees wax. FILASILK™ suture meets requirements established by the United States Pharmacopoeia (U.S.P.) for non-absorbable surgical suture.
FILAMIDE™ suture is a non-absorbable, sterile, synthetic, monofilament surgical suture composed of polyamide 6 [(NH-CO-(CH2)s]n and Polyamide 6,6 (NH(CH2)g-NH-CO-(CH2)4-CO)n. FILAMIDE™ sutures are dyed with Logwood extract. Available in a broad range of suture sizes and lengths, FILAMIDE'M is either non-needled or attached to standard stainless steel needles of varying types and sizes.
MERICRON XL™ suture is a coated, braided, non-absorbable sterile surgical suture composed of poly (ethylene terephthalate). The empirical molecular formula of the polymer is (C10HoO4),. The suture is coated with bees wax which acts as a lubricant to mechanically improve the ease of passage through tissue and the overall handling quality of the suture. MERICRON XL™ is available undyed or dyed green with D & C Green No.6. MERICRON XL™ is available in a range of gauge sizes and lengths, or attached to standard stainless steel needles of various types and sizes.
FILAPROP™ suture is a monofilament, synthetic non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The molecular formula of polypropylene is (C3Hs)n, FILAPROP™ sutures are dyed with phthalocyanine blue. FILAPROP™ is available in a range of gauge sizes and lengths attached to standard stainless steel needles of various types and sizes.
Here's the breakdown of the acceptance criteria and study information for the Meril Endo Surgery Private Limited sutures, based on the provided document:
This document, a 510(k) Premarket Notification from the FDA, focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report of novel performance criteria for a new type of device. Therefore, the "acceptance criteria" discussed are primarily regulatory and harmonized standards (USP requirements) that the device must meet to show it is as safe and effective as existing legally marketed devices.
1. Table of Acceptance Criteria and Reported Device Performance
Device: Filasilk, Filamide, Mericron XL, Filaprop (All are different types of non-absorbable surgical sutures)
| Acceptance Criteria (USP Requirements) | Reported Device Performance (Compliance) | Notes |
|---|---|---|
| Diameter USP | Complies | FILAMIDE™ & FILAPROP™ may be slightly oversize in diameter to U.S.P. requirement for some suture sizes. |
| Tensile strength USP | Complies | Includes knot pull tensile strength. |
| Needle attachment USP | Complies | Includes suture-needle attachment. |
| Suture Length | Complies | |
| Biocompatibility (various tests) | Evaluated (Implied compliance for substantial equivalence) | Tests include: In Vitro Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Sub Chronic Toxicity, Intramuscular Implantation, Bacterial Reverse Mutation, Mammalian Erythrocyte Micronucleus, In Vitro Hemolysis, Pyrogen Test. |
| Extractable Color | Complies | Colorants used (Logwood extract, D&C Green No. 6, Phthalocyanine blue) are in accordance with 21 CFR sections. |
| Sterility | Complies | |
| Material Composition | Same as predicate devices | Made from organic protein (Filasilk), polyamide (Filamide), polyester (Mericron XL), polypropylene (Filaprop). |
| Design | Similar to predicate devices | |
| Intended Use | Similar to predicate devices | |
| Suture Size | Similar to predicate devices | |
| Colorant Used Dye / Un-dyed | Similar to predicate devices | |
| Suture Coating | Similar to predicate devices | |
| Single Use | Similar to predicate devices | |
| Sterilization Method | Similar to predicate devices | |
| Packaging | Similar to predicate devices | |
| Label Claim | Similar to predicate devices | |
| Labeling and Instructions for Use (IFU) | Similar to predicate devices |
Conclusion (from document): "Performance testing of the Meril sutures complies the USP requirements i.e. suture diameter, suture length, knot pull tensile strength, extractable color, suture-needle attachment and sterility. However, FILAMIDE™ & FILAPROP™ may be slightly oversize in diameter to U.S.P. requirement for some suture sizes."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of sutures tested) for the performance criteria. It only states that "The Surgical Suture was subjected to the performance testing as per USP requirements."
The data provenance is not explicitly stated as country of origin, but the submitting company is Meril Endo Surgery Private Limited, located in Vapi, Gujarat, India. The testing was conducted to meet United States Pharmacopoeia (U.S.P.) standards, implying internationally recognized quality and testing protocols for medical devices. The data is retrospective in the sense that it was generated for the 510(k) submission, not as part of a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of submission. This document pertains to physical and chemical performance standards of surgical sutures, not diagnostic or interpretive tasks requiring expert ground truth establishment (like image analysis by radiologists). The "ground truth" here is defined by objective, measurable USP physical and chemical property standards.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the assessment is against objective physical/chemical standards, not interpretive judgments that would require adjudication.
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 surgical suture, not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating the performance of diagnostic systems, often involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical suture, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation is based on established, objective, and quantitative specifications outlined in the United States Pharmacopoeia (USP) for non-absorbable surgical sutures. This includes:
- USP for diameter
- USP for tensile strength
- USP for needle attachment
- General USP requirements for suture length, biocompatibility, sterility, and colorant compliance (e.g., 21 CFR references for dyes).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device; there is no training set in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an algorithm, there is no ground truth established for such a purpose. The "ground truth" for demonstrating substantial equivalence is adherence to recognized industry standards (USP).
§ 878.5030 Natural nonabsorbable silk surgical suture.
(a)
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.(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.