(126 days)
Coated VICRYL* (Polyglactin 910) Synthetic Absorbable Suture
Not Found
No
The 510(k) summary describes a surgical suture and its material composition. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The device is a surgical suture used for tissue approximation and ligation, which are mechanical functions, not therapeutic. Therapeutic devices are typically defined by their ability to treat, diagnose, cure, or mitigate disease, or to affect the structure or any function of the body through pharmacological, immunological, or metabolic means.
No
The device is a surgical suture used for approximation and/or ligation of soft tissues, which is a treatment modality, not a diagnostic one.
No
The device description clearly states it is a surgical suture composed of physical materials (copolymer, coating, antimicrobial agent), indicating it is a physical 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 about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that this is a surgical suture used for "general soft tissue approximation and/or ligation." This is a device used within the body during a surgical procedure, not for testing specimens outside the body.
- Intended Use: The intended use is for surgical procedures, not for diagnostic testing.
- Lack of Diagnostic Information: The description does not mention any diagnostic purpose or the analysis of biological samples.
Therefore, based on the provided information, this Modified Coated VICRYL* suture is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Modified Coated VICRYL* suture is intended for use in general soft tissue approximation and/or ligation, except for use in ophthalmic, cardiovascular and neurological tissues.
Modified Coated VICRYL* Plus Antimicrobial suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues.
Modified Coated VICRYL* (Polyglactin 910) Synthetic Absorbable Suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues.
Product codes
GAM
Device Description
Modified Coated VICRYL* (Polyglactin 910) suture is a synthetic absorbable sterile surgical suture composed of a copolymer made from 90% glycolide and 10% L-lactide. Modified Coated VICRYL* suture is coated with a mixture composed of equal parts of a copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate and a small amount of an antimicrobial agent, Irgacare MP (triclosan).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues.
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)
Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP Monograph for absorbable surgical sutures. Additionally, in-vivo/in-vitro testing was provided showing that the device performed as intended and as claimed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Coated VICRYL* (Polyglactin 910) Synthetic Absorbable Suture
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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K022715 page 1/2
SECTION 8
SUMMARY OF SAFETY AND EFFECTIVENESS DEC 1 9 2002
| 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.
MODIFIED DEVICE NAME: Modified VICRYL* (Polyglactin
910) Synthetic Absorbable Suture
PREDICATE DEVICES NAME: Coated VICRYL* (Polyglactin
910) Synthetic Absorbable Suture. |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | Modified Coated VICRYL* (Polyglactin 910) suture is a synthetic
absorbable sterile surgical suture composed of a copolymer made
from 90% glycolide and 10% L-lactide. Modified Coated
VICRYL* suture is coated with a mixture composed of equal parts
of a copolymer of glycolide and lactide (Polyglactin 370) and
calcium stearate and a small amount of an antimicrobial agent,
Irgacare MP (triclosan). |
| Intended Use | Modified Coated VICRYL* suture is intended for use in general
soft tissue approximation and/or ligation, except for use in
ophthalmic, cardiovascular and neurological tissues. |
| Indications Statement | Modified Coated VICRYL* Plus Antimicrobial suture is indicated
for use in general soft tissue approximation and/or ligation, except
for ophthalmic, cardiovascular and neurological tissues. |
| Technological
Characteristics | The modified device has similar technological characteristics as the
predicate devices. Like the currently marketed Coated VICRYL
suture device, it is a sterile, braided synthetic absorbable suture
that conforms to the USP Monograph for absorbable surgical
sutures, except for diameter. Like several previously cleared
devices, the modified device contains the antimicrobial agent,
triclosan. |
| Performance Data | Non-clinical laboratory testing was performed demonstrating that
the device conformed to the USP Monograph for absorbable
surgical sutures. Additionally, in-vivo/in-vitro testing was
provided showing that the device performed as intended and as
claimed. |
| Conclusions | Based on the 510(k) summaries and 510(k) statements (21 CFR
807) and the information provided herein, we conclude that the
modified device is substantially equivalent to the Predicate
Devices under the Federal Food, Drug, and Cosmetic Act. |
| Contact | Rey Librojo
Senior Project Manager, Regulatory Affairs
ETHICON Products
ETHICON, Inc.
Rt. #22, West
Somerville, NJ 08876-0151 |
| Date | August 14, 2002 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Rey Librojo Senior Project Manager Ethicon, Inc. Division of Johnson & Johnson Medical P.O. Box 151 Somerville, New Jersey 08876-0151
Re: K022715
Trade/Device Name: Coated VICRYL™ Antimicrobial (Polyglactin 910) Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(glycolide/L-lactide) Surgical Suture Regulatory Class: II Product Code: GAM Dated: November 19, 2002 Received: November 20, 2002
Dear Mr. Librojo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 - Mr. Rey Librojo
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Miriam C Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Indications for Use:
KO22715
Modified Coated VICRYL* (Polyglactin 910) Synthetic Absorbable Suture
Modified Coated VICRYL* suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 CFR 801.109)
OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-9G)
Muriam C. Provost
nston Sun-OR) ision of General, Restorative I Neurologic of Levices
KO 22715
- Trademark
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