(60 days)
Not Found
Not Found
No
The device description and intended use are solely focused on the material composition and physical properties of a surgical suture, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a surgical suture used for tissue approximation and ligation, which is a supportive role in a medical procedure, not a therapeutic intervention itself.
No
Explanation: The device is a surgical suture used for tissue approximation and ligation, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical surgical suture made of synthetic absorbable material, 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 "general soft tissue approximation and/or ligation" and "ophthalmic procedures." This describes a surgical device used in vivo (within a living organism) for physical repair or joining of tissues.
- Device Description: The description details the material composition of a surgical suture, which is a physical implant or tool used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside of a living organism) to provide information about a physiological state, health, disease, or congenital abnormality. IVDs typically involve analyzing samples like blood, urine, or tissue.
Therefore, this device is a surgical suture, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Modified Coated VICRYL* suture is intended for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.
Coated VICRYL* suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in 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, which is prepared by coating VICRYL* suture material with a copolymer of 90% caprolactone and 10% glycolide and subsequently with a mixture composed of equal parts of a copolymer of glycolide and lactide (Polyglactin 370) with calcium stearate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue
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 testing was provided showing that the device performed as intended.
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.
0
Age 1/2
SEP 1 3 2002
SECTION 8
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. | |||
| MODIFIED DEVICE NAME: Coated VICRYL* (Polyglactin |
- Synthetic Absorbable Suture | | |
| | PREDICATE DEVICES NAME: Coated VICRYL* (Polyglactin - 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, which is prepared by coating VICRYL* suture
material with a copolymer of 90% caprolactone and 10% glycolide
and subsequently with a mixture composed of equal parts of a
copolymer of glycolide and lactide (Polyglactin 370) with calcium
stearate. | | |
| Intended Use | Modified Coated VICRYL* suture is intended for use in general
soft tissue approximation and/or ligation, including use in
ophthalmic procedures, but not for use in cardiovascular and
neurological tissues. | | |
| | Modified Coated VICRYL* suture has the same intended use as
the predicate device, current Coated VICRYL* suture. | | |
1
KO22269 Page 2/3
Section 8 – Summary of Safety and Effectiveness, Continued
Indications Statement Modified Coated VICRYL* suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues. Technological Characteristics The new device has similar technological characteristics as the predicate devices. Like the predicate device, it is a sterile, braided synthetic absorbable suture that conforms to the USP Monograph for absorbable surgical sutures, except for diameter. Performance Data Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP Monograph for absorbable surgical sutures. Additionally, in-vivo testing was provided showing that the device performed as intended. 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 Lea Ann Conway Director, Regulatory Affairs and Quality Assurance Ethicon Products ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151 July 10, 2002 Date
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
SFP 1 3 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ethicon. Inc Lea Ann Conway Director, Regulatory Affairs and Quality Assurance Route 22. West Somerville, New Jersey 08876
Re: K022269
Trade/Device Name: Coated VICRYL* (Polyglactin 910) Synthetic Absorbable Suture Regulation Number: 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: July 10, 2002 Received: July 15, 2002
Dear Ms. Conway:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If vour 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.
3
Page 2 – Ms. Lea Ann Conway
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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" (21 CFR 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 yours,
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
4
INDICATIONS FOR USE
022269
510(k) Number (if known):
,
Device Name:
Indications for Use:
Coated VICRYL* (Polyglactin 910) Synthetic Absorbable Suture
Coated VICRYL* suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in 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 | OR | Over-The Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) |
| (Division Sign-Off) | (Optional Format 1-2-9G) | |
|---|---|---|
| Division of General, Restorative and Neurological Devices |
| 510(k) Number | K022269 |
|---|---|
| --------------- | --------- |