(90 days)
Not Found
No
The device description and intended use are focused on the material properties and surgical application of a suture, with no mention of AI or ML.
No
The device, Dexon® "R" Polyglycolic Acid Suture, is a surgical suture used for wound closure and support, which is not considered a therapeutic device. It helps in the healing process but does not treat a disease or medical condition itself.
No
This device is a surgical suture used for wound closure, not for diagnosing conditions or diseases. Its purpose is to provide short-term wound support.
No
The device described is a surgical suture, which is a physical medical device made of absorbable material. It is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "surgical closure of skin and mucosa". This is a surgical device used directly on a patient's body for wound closure.
- Device Description: The description details a surgical suture material.
- 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.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside or on the body) for a surgical procedure.
N/A
Intended Use / Indications for Use
The Dexon® "R" Sutures are indicated for use in the surgical closure of skin and mucosa where short-term wound support is required and where rapid degradation of the suture material is considered desirable. It is not intended for use in ligation, ophthalmic, cardiovascular or neural tissue.
Product codes
73GAM
Device Description
The Dexon® "R" Polyglycolic Acid Suture is an Absorbable Suture composed of a homopolymer of glycolic acid and coated with Polycaprolate, a copolymer of glycolide and epsilon-caprolactone. The polycaprolate coating system is inert, noncollagenous, nonantigenic and nonpyrogenic. The Dexon "R" sutures are sterile, inert, noncollagenous, nonantigenic and nonpyrogenic and are available in various colors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
The following battery of tests were performed in accordance to respective guidelines and deemed acceptable: Cytoxicity (elution test), Systemic Injection, Pyrogenicity, Intracutaneous Injection and Strength Retention.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
MAY 1 8 1998
510k SUMMARY OF SAFETY AND EFFECTIVENESS
DEXON® "R" Polyglycolic Acid, Synthetic Absorbable Surgical Suture
Sherwood-Davis & Geck Submitted by: 444 McDonnell Blvd. Hazelwood, MO 63042-2516
Vanada Johnson Contact: Sr. Regulatory Affairs Specialist
February 12, 1998 Date of Summary:
The Dexon® "R" Polyglycolic Acid Suture is an Absorbable Suture composed of a homopolymer of glycolic acid and coated with Polycaprolate, a copolymer of glycolide and epsilon-caprolactone. The Dexon "R" Suture is a Class II device, per 21 CFR Section 878,4493. Product code 73GAM. Performance standards have not been pulmogated for this device, as of this date ..
The polycaprolate coating system is inert, noncollagenous, nonantigenic and nonpyrogenic. The Dexon "R" sutures are sterile, inert, noncollagenous, nonantigenic and nonpyrogenic and are available in various colors.
The Dexon® "R" Sutures are indicated for use in the surgical closure of skin and mucosa where short-term wound support is required and where rapid degradation of the suture material is considered desirable. It is not intended for use in ligation, ophthalmic, cardiovascular or neural tissue.
The following battery of tests were performed in accordance to respective guidelines and deemed acceptable: Cytoxicity (elution test), Systemic Injection, Pyrogenicity, Intracutaneous Injection and Strength Retention.
Dexon® "R" Polyglycolic Acid. Synthetic Absorbable Surgical Suture is substantially equivalent in design and composition to Vicryl Rapide (Ethicon, Inc.). Both are synthetic polyglycolic acid absorbable sutures. The intended use for Dexon "R" and Vicryl Rapide are very similar. Both are available sterile, undyed and in various lengths, diameters and quantities w/surgical needles. Sherwood-Davis & Geck considers the DEXON® "R" Polyglycolic Acid, Synthetic Absorbable Surgical Suture to be substantially equivalent to the DEXON family of predicate devices: DEXON II covered under 510(k) K900198, DEXON Violet covered under 510(k) K972566, Vicryl Rapide Suture covered under 510(k) K944110.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY | 8 |998
Ms. Vanada Johnson Senior Regulatory Affairs Specialist Sherwood Davis and Geck 444 McDonnell Boulevard Hazelwood, Missouri 63042-2516
Re: K980610 Dexon R® Polyglycolic Acid Synthetic Absorbable Suture Regulatory Class: II Product Code: GAM Dated: February 12, 1998 Received: February 17, 1998
Dear Ms. Johnson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices that were regulated as transitional devices and that have been reclassified into class II. Notice of this reclassification was published in the Federal Register on Tuesday, October 26, 1993 (Vol. 58, No. 205, Pages 57557 and 57558). A copy of this Federal Register can be obtained by calling the Division of Small Manufacturers Assistance (DSMA) at (800) 638-2041 or (301) 443-6597. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
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- The Dexon R® Polyglycolic Acid Synthetic Absorbable Suture is indicated for use in the surgical closure of skin and mucosa where only short-term wound support is required and where rapid degradation of the suture material is considered desirable. It is not intended for use in ligation, ophthalmic, cardiovascular, or neural tissues.
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- This device may not be manufactured from any material other than homopolymers and copolymers glycolide and/or L-lactide. In addition, you must maintain documentation at your premises regarding vendor certification for raw or semiprocessed source material, all manufacturing and quality control release procedures, and validation of sterilization procedures used in the manufacture of the Dexon R® Polyglycolic Acid Synthetic Absorbable Suture. Any deviation of the source material or processing as described in this 510(k) notification requires submission of a new premarket notification and Food and Drug Administration (FDA) clearance prior to commercial distribution of the modified device.
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Page 2 - Ms. Johnson
The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibition against misbranding and adulteration.
Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, The Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control Provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4595. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597, or at its internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours.
'oeele
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known)_ K980610
Device Name: Sherwood-Davis & Geck DEXON® Rapid Polyglycolic Acid, Synthetic Absorbable Surgical Suture
DEXON® Rapid (DEXON "R") sutures are indicated for use in the Indications for Use: surgical closure of skin and mucosa where only short-term wound support is required and where rapid degradation of the suture material is considered desirable. It is not intended for use in ligation, ophthalmic, cardiovascular or neural tissue.
(PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrenc of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-the-Counter Use ... . . . (Per 21 CFR 801.109) 3 (Division Sign-off)
510(k) Number _ K9 806/0
Sherwood-Davis & Geck DEXON® Rapid Polyglycolic Acid, Synthetic Absorbable Surgical Suture Premarket Notification