(17 days)
Not Found
Not Found
No
The document describes a surgical suture and its material composition, with no mention of AI or ML technology.
Yes
The device is a surgical suture used for soft tissue approximation, which directly aids in the healing and restoration of bodily function, thus serving a therapeutic purpose.
No
The device is a surgical suture used for wound approximation, not for diagnosing medical conditions.
No
The device description clearly states it is a surgical suture, which is a physical medical device, 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 "superficial soft tissue approximation of the skin and mucosa." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "synthetic absorbable sterile surgical suture." This is a physical material used to close wounds.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVDs are devices used outside the body to analyze biological samples. This device is used inside or on the body during a surgical procedure.
N/A
Intended Use / Indications for Use
Indicated only for use in superficial 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
GAM
Device Description
Modified Coated VICRYL* Rapide (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* Rapide suture is first coated (inner coating) with a copolymer of 90/10% w/w caprolactone / glycolide and subsequently coated with a mixture composed of equal parts of Polyglactin 370 (copolymer of glycolide and L-lactide) and vegetable-based calcium stearate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, 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)
Results of verification testing indicates that the product meets the established performance requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
K033746 P9
page 1/2
DEC 1 8 2003
| Statement | 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 Coated VICRYL* Rapide
(Polyglactin 910) Suture |
| | PREDICATE DEVICE NAME: Coated VICRYL* Rapide
(Polyglactin 910) Suture. |
| Device Description | Modified Coated VICRYL* Rapide (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* Rapide suture is first coated (inner coating) with
a copolymer of 90/10% w/w caprolactone / glycolide and
subsequently coated with a mixture composed of equal parts of
Polyglactin 370 (copolymer of glycolide and L-lactide) and
vegetable-based calcium stearate. |
| Intended Use | Indicated only for use in superficial 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. |
| Indications Statement | Indicated only for use in superficial 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 | |
| | The modified device has similar technological characteristics as the
predicate devices. Like the currently marketed VICRYL* Rapide
suture device, it is a sterile, braided synthetic absorbable suture
which is also coated. |
| Performance Data | Results of verification testing indicates that the product meets the
established performance requirements. |
| 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 | November 25, 2003 |
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K033746 page 21
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2003
Mr. Rey Librojo Senior Project Manager Ethicon. Inc. Route 22 West Somerville, New Jersey 08876-0151
Re: K033746
K033740
Trade/Device Name: Modified Coated VICRYL* Rapide (Polyglactin 910) Synthetic Absorbable Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: November 24, 2003 Received: December 1, 2003
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 sct 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 - Mr. Rey Librojo
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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Muriam C. Provost
a 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
510(k) Number (if known):
Device Name:
Indications for Use:
Modified Coated VICRYL* Rapide (Polyglactin 910) Synthetic Absorbahle Suture
INDICATIONS FOR USE
(033-
Modified Coated VICRYL* Rapide synthetic absorbable suture is indicated only for use in superficial 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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8033746
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
. ...
30(k) Number_
- Trademark
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