(50 days)
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No
The device description and performance studies focus on the physical properties and biocompatibility of surgical sutures, with no mention of AI or ML.
No.
A therapeutic device is used to treat a disease or condition. This device is a surgical suture used for approximation and/or ligation, which is a tool used during a medical procedure, not a treatment in itself.
No
The device, a surgical suture, is used for soft tissue approximation and ligation, which are therapeutic and restorative actions, not diagnostic procedures.
No
The device description clearly states it is a physical surgical suture made of polyglycolic acid, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general soft tissue approximation and/or ligation," which are surgical procedures performed on the body, not with samples taken from the body.
- Device Description: The device is a surgical suture, a physical material used to close wounds or tie off blood vessels during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, or tissue) to diagnose, monitor, or screen for diseases or conditions.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens for diagnostic purposes. This device is clearly intended for in vivo (within the body) use during surgery.
N/A
Intended Use / Indications for Use
The intended use of the device is in general soft tissue approximation and/or ligation including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
Product codes
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Device Description
Lukens® · PGA (polyglycolic acid), synthetic absorbable surgical sutures, coated, braided USP manufactured by Lukens Medical Corporation are equivalent to Dexon II polyglycolic acid, synthetic, absorbable surgical sutures USP with polycaprolate coating system manufactured by Davis & Geck. Lukens - PGA (polyglycolic acid), synthetic absorbable surgical sutures USP are dyed with D&C Violet No. 2 and are coated with E-Caprolactone.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
general soft tissue, ophthalmic
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Testing of suture diameter, suture length, knot-pull tensile and needle attachment strength according to methods outlined in USP XXIII demonstrates that Lukens - PGA (polyglycolic acid), synthetic absorbable surgical sutures meet or exceed USP requirements and are equivalent to Dexon II polyglycolic acid surgical sutures in terms of the above parameters.
Biocompatibility testing showed no evidence of toxicity of Lukens - PGA (polyglycolic acid), synthetic absorbable surgical sutures, USP.
Implantation studies in animals indicate that Lukens - PGA retains approximately 50% of its original tensile strength at two week post implantation, with approximately 20% remaining at three weeks. Absorption of Lukens - PGA absorbable synthetic suture is essentially complete between 60 and 90 days.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.
0
Image /page/0/Picture/0 description: The image shows the logo for LUKENS MEDICAL CORPORATION. The logo is in black and white. The word "LUKENS" is in large, bold letters, and the words "MEDICAL CORPORATION" are in smaller letters below. There is a registered trademark symbol next to the "S" in "LUKENS".
- 342-9638 (800) 631-0076
3820 ACADEMY PARKWAY NORTH NE ALBUQUERQUE, NM. 87109-4
FEB 1 2 1997
Fax (505) 342-9735
510(K) SUMMARY
"This summary of 510(k) Safety and Effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92." "The assigned 510(k) number is _
| Applicant | Lukens ® Medical Corporation
3820 Academy Parkway North NE
Albuquerque, NM 87109
Tel: (505) 342-9638
Fax: (505) 342-9735 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Mr. Scott Henderson, C.Mfg.E.
Vice President, Development and Engineering |
| Date | December 16, 1996 |
| Name of Device | |
| Proprietary Name: | Lukens ® - PGA (Polyglycolic Acid)
Synthetic Absorbable Surgical
Suture, Coated, Braided U.S.P. |
| Common or Usual Name: | Polyglycolic Acid Synthetic,
Absorbable Surgical Suture,
Coated, Braided U.S.P. |
| Classification Name: | Suture, Absorbable, Synthetic,
Polyglycolic Acid |
Lukens® · PGA (polyglycolic acid), synthetic absorbable surgical sutures, coated, braided USP manufactured by Lukens Medical Corporation are equivalent to Dexon II polyglycolic acid, synthetic, absorbable surgical sutures USP with polycaprolate coating system manufactured by Davis & Geck. Lukens - PGA (polyglycolic acid), synthetic absorbable surgical sutures USP are dyed with D&C Violet No. 2 and are coated with E-Caprolactone.
1
Testing of suture diameter, suture length, knot-pull tensile and needle attachment strength according to methods outlined in USP XXIII demonstrates that Lukens - PGA (polyglycolic acid), synthetic absorbable surgical sutures meet or exceed USP requirements and are equivalent to Dexon II polyglycolic acid surgical sutures in terms of the above parameters.
Biocompatibility testing showed no evidence of toxicity of Lukens - PGA (polyglycolic acid), synthetic absorbable surgical sutures, USP.
Implantation studies in animals indicate that Lukens - PGA retains approximately 50% of its original tensile strength at two week post implantation, with approximately 20% remaining at three weeks. Absorption of Lukens - PGA absorbable synthetic suture is essentially complete between 60 and 90 days.
The intended use of the device is in general soft tissue approximation and/or ligation including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
12-16-96
Date
Scott Henderson
Scott Henderson, C.Mfg.E. Vice President, Development and Engineering
SH-510K