(91 days)
Nonabsorbable Silk Suture with Needle is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular , ophthalmic and neurological procedures.
Nonabsorbable Polypropylene Suture with Needle is indicated for use in soft tissue approximation and/or ligation including use in general cardiovascular, ophthalmic and neurological procedures.
Nonabsorbable Polyester Suture with Needle is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
Nonabsorbable Polyamide suture with needle is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures.
The applicant devices of nonabsorbable silk suture with needle consist of a silk surgical suture made of natural silk and a stainless steel needle. It is EO sterilized, and prygon-free. Nonabsorbable silk suture is braided.
The applicant devices of nonabsorbable polypropylene suture with needle consist of a silk surgical suture made of polypropylene and a stainless steel needle. It is EO sterilized, and prygon-free.
The applicant devices of nonabsorbable polyester suture with needle consist of a polyester surgical suture made of polyester and a stainless steel needle. It is EO sterilized, and prygon-free.
The applicant devices of nonabsorbable polyamide suture with needle consist of a polyamide surgical suture made of long-chain, aliphatic polymers nylon and a stainless steel needle. It is EO sterilized, and prygon-free.
The provided 510(k) summary does not contain information about acceptance criteria or a study proving that the device meets those criteria. This document is a submission for a medical device (surgical sutures) seeking substantial equivalence to predicate devices, not reporting performance against specific acceptance criteria.
The information primarily focuses on:
- Manufacturer and Contact Information: Foosin Medical Supplies Inc., Ltd.
- Device Identification: Nonabsorbable Silk Suture with Needle, Nonabsorbable Polypropylene Suture with Needle, Nonabsorbable Polyester Suture with Needle, and Nonabsorbable Polyamide Suture with Needle.
- Device Description: Composition (natural silk, polypropylene, polyester, polyamide, stainless steel needle), sterilization method (EO sterilized), and braided/not braided.
- Intended Use: General soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.
- Predicate Devices: Citing K-numbers (K041514, K070243, K060165, K0060471).
- Substantial Equivalence Determination: A claim that the applicant devices are substantially equivalent to their respective predicate devices.
- FDA Correspondence: A letter from the FDA confirming the substantial equivalence determination and outlining regulatory requirements.
- Indications for Use Forms: Standard FDA forms specifying the intended use for each suture type.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies based on the provided text, as it is not present in this document. Such information would typically be found in a separate section detailing performance testing (e.g., tensile strength, knot security, biocompatibility, sterility assurance level) within a more comprehensive regulatory submission.
§ 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.