(46 days)
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Not Found
No
The 510(k) summary describes a surgical suture, a physical medical device, and makes no mention of AI or ML technology in its description, intended use, or performance studies.
No
The device is a surgical suture used for tissue approximation and ligation, which is a supportive role in a medical procedure, not a treatment in itself.
No
Explanation: The device is a surgical suture used for tissue approximation and/or ligation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "synthetic braided absorbable surgical suture prepared from a copolymer of lactide and glycolide," which is a physical, hardware-based medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this is a surgical suture intended for use in general soft tissue approximation and/or ligation. This is a device used within the body during a surgical procedure, not for testing samples outside the body.
The information provided describes a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed is intended for use in general soft tissue approximation and/or ligation as is the predicate device Coated VICRYL* (Polyglactin 910) suture.
ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed is indicated for soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular, or neurological tissue.
Product codes
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Device Description
Synthetic ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed is a synthetic braided absorbable surgical suture prepared from a copolymer of lactide and glycolide. The suture is coated with a copolymer of caprolactone and glycolide.
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
soft tissue
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical laboratory testing was performed to determine breaking strength retention. Biocompatibility and Functionality testing was conducted to assess the safety and effectiveness of ETHICON Absorbable poly(L-lactide/glycolide) Surgical Surgical Surgical Suture, Undyed. Results indicated that the device was highly biocompatable and was functional within its indicated uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
VICRYL* (Polyglactin Suture)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predicate device Johnson & Johnson Absorbable Tendon Suture and Coated VICRYL* II (Polyglactin 910) suture.
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.
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SECTION 7 DEC 16 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) Summary of Safety and Effectiveness
Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule " ... 510(k) Summaries and 510(k) Statements ... " (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
NEW DEVICE NAME: ETHICON Absorbable poly(Llactide/glycolide) Surgical Suture, Undyed
PREDICATE DEVICE: VICRYL* (Polyglactin Suture)
REFERENCE DEVICE NAMES: Predicate device Johnson & Johnson Absorbable Tendon Suture and Coated VICRYL* II (Polyglactin 910) suture.
510(k) SUMMARY
Device Description
Synthetic ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed is a synthetic braided absorbable surgical suture prepared from a copolymer of lactide and glycolide. The suture is coated with a copolymer of caprolactone and glycolide.
Intended Use
ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed is intended for use in general soft tissue approximation and/or ligation as is the predicate device Coated VICRYL* (Polyglactin 910) suture.
Continued on next page
ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed ETHICON, Inc.
1
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
510(k) SUMMARY, Continued Indications Statement ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed is indicated for soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular, or neurological tissue. Technological The new device has similar technological characteristics as Characteristics the predicate device Coated VICRYL (Polyglactin 910) suture. The new device has the same chemical composition as the reference device, Absorbable Tendon Suture. When compared to the predicate devices, ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed, Undyed, Undyed increased breaking strength retention (BSR) and absorption profile. Performance Data Nonclinical laboratory testing was performed to determine breaking strength retention. Biocompatibility and Functionality testing was conducted to assess the safety and effectiveness of ETHICON Absorbable poly(L-lactide/glycolide) Surgical Surgical Surgical Suture, Undyed. Results indicated that the device was highly biocompatable and was functional within its indicated uses. Conclusions Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Devices under the Federal Food, Drug, and Cosmetic Act. Contact John D. Paulson, Ph.D. Vice President, Regulatory Affairs ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151
Date
October 31, 1996
ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed ETHICON, Inc.