(37 days)
Not Found
Not Found
No
The summary describes a surgical suture and its material properties. There is no mention of AI, ML, image processing, or any computational analysis of data.
No.
Explanation: The device is a surgical suture used for short-term wound support of the skin and mucosa, which is a restorative function rather than a therapeutic one. It facilitates healing but does not treat a disease or condition.
No
The device, a surgical suture, is used for wound closure and support, not for identifying the nature or cause of a medical condition.
No
The device description clearly describes a physical suture made from a copolymer, 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 clearly states the device is for "superficial general soft tissue approximation of the skin and mucosa." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "sterile suture," which is a material used to close wounds or surgical incisions.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not involve testing samples outside the body.
The information provided describes a surgical suture, which is a medical device used in vivo (within the living body), not in vitro (in glass or outside the body).
N/A
Intended Use / Indications for Use
6-0 undyed VICRYL RAPIDE suture is intended for use in 0-0 undyed VICK I a tissue approximation where only short term wound support is required.
Size 6-0 Coated VICRYL RAPIDE suture, undyed has the same intended use as the predicate device.
6-0 undyed Coated VICRYL RAPIDE suture is indicated only for use in superficial general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. Coated VICRYL RAPIDE suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
6-0 Coated VICRYL RAPIDE (polyglactin 910) suture, undyed 0-0 Coated VICK Project multifilament strand prepared from a Is a sterne suture, nexiolo slide and lactide. The coating for 6-0 Coporyiner made from gift is prepared with a mixture of undyed VICK FD NH ID IJ plactide and calcium stearate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
superficial general soft tissue approximation of the skin and mucosa
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Benchtop testing was performed to assess knot tensile strength and nonclinical laboratory testing was performed to determine breaking strength retention. Biocompatibility and clinical was deemed unnecessary to support this modification.
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.
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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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
SECTION 7
AUG - 2 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) Summary of safety and Effectiveness Information supporting claims of substantial equivalence, nnormation supporting caral Food, Drug and Cosmetic Act, as defined ander and effectiveness is summarized below. For respecting safety and offeesiewer, this summary is formatted in the convenience of alogency's final rule " ... 510(k) Summaries and 510(k) Statements ... " (21 CFR 807) and can be used to and JTO(K) Statements: ... (-------------------------------------------------------------------------------------------------------------------------------------------------it from the Agency.
MODIFIED DEVICE NAME: Additional size of Coated VICRYL MODIFILD DEVICE Nine braided synthetic absorbable suture, undyed, Size 6-0.
PREDICATE DEVICE NAME: Coated VICRYL RAPIDE (polyglactin 910) braided synthetic absorbable suture, undyed.
510(k) SUMMARY
Device Description
Intended Use
6-0 Coated VICRYL RAPIDE (polyglactin 910) suture, undyed 0-0 Coated VICK Project multifilament strand prepared from a Is a sterne suture, nexiolo slide and lactide. The coating for 6-0 Coporyiner made from gift is prepared with a mixture of undyed VICK FD NH ID IJ plactide and calcium stearate.
6-0 undyed VICRYL RAPIDE suture is intended for use in 0-0 undyed VICK I a tissue approximation where only short term wound support is required.
Size 6-0 Coated VICRYL RAPIDE suture, undyed has the same intended use as the predicate device.
Continued on next page
Coated VICRYL RAPIDE (polyglactin 910) suture, Undyed - Size 6-0 ETHICON, Inc.
1
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
510(k) SUMMARY, Continued
| Indications Statement | 6-0 undyed Coated VICRYL RAPIDE suture is indicated only
for use in superficial general soft tissue approximation of the
skin and mucosa, where only short term wound support (7-10
days) is required. Coated VICRYL RAPIDE suture is not
intended for use in ligation, ophthalmic, cardiovascular or
neurological procedures. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | 6-0 Coated VICRYL RAPIDE suture, undyed has the same
technological characteristic as the predicate device. There is no
change in chemistry, material or composition. |
| Performance Data | Benchtop testing was performed to assess knot tensile strength
and nonclinical laboratory testing was performed to determine
breaking strength retention. Biocompatibility and clinical was
deemed unnecessary to support this modification. |
| 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 Device
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
June 24, 1996
Coated VICRYL RAPIDE (polyglactin 910) suture, Undyed - Size 6-0 ETHICON, Inc.