(53 days)
Not Found
No
The summary describes a surgical suture and its physical and biological properties. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
Yes
The device, a surgical suture, is used for short-term wound support in soft tissue approximation, which directly aids in the healing and restoration of bodily function, fitting the definition of a therapeutic device.
No
Explanation: The device is a surgical suture used for tissue approximation, not for diagnosing medical conditions. Its purpose is to physically close wounds, which is a treatment, not a diagnostic function.
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:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The description clearly states that this is a surgical suture used for "superficial general soft tissue approximation of the skin and mucosa." This is a device used within the body during a surgical procedure.
- Lack of IVD Characteristics: The document does not mention any testing of samples, analysis of biological markers, or any other activities typically associated with IVD devices.
Therefore, the Sharpoint® Coated FAST ABSORBING™ PolyGlycolic Acid suture is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Coated FAST ABSORBING PolyGlycolic Acid 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 FAST ABSORBING PolyGlycolic Acid suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures. Sharpoint® Coated Fast Absorbing™ PolyGlycolic Acid 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 Fast Absorbing™ PolyGlycolic Acid Suture is not intended for use in ligation, ophthalmic cardiovascular or neurological procedures.
Product codes (comma separated list FDA assigned to the subject device)
GAM
Device Description
Suture is a synthetic absorbable braided, sterile, surgical suture composed of a homopolymer of Glycolic Acid. The suture material is coated with a copolymer of Polycaprolactone and PolyGlycolic Acid. The substances contained in the coating and suture are noncollagenous and nonantigenic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
superficial general 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)
Physical testing was conducted on the Coated FAST ABSORBING PolyGlycolic Acid suture to USP 24, including Sutures - Diameter, Sutures- Needle Attachment, and Tensile Strength. Animal testing was performed for conformance to ISO 10993 for biocompatibility and implant studies in animals to demonstrate rates of tensile strength and mass loss.
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.
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.
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JAN 2 8 2002
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS SUBSTANTIAL EQUIVALENCY
Surgical Specialties Corporation Submitter: Address: 100 Dennis Drive Reading, PA 19606 610 404 1000, ext. 2231 Telephone: Elizabeth Lazaro Contact Person: Regulatory Affairs Specialist December 3, 2001 Date Prepared: Sharpoint® Coated FAST ABSORBINGTM Name of Device: PolyGlycolic Acid braided, synthetic absorbable suture, undyed. Common / Usual Suture, Absorbable, Synthetic, PolyGlycolic Acid Classification Name: Predicate Device: Ethicon, Inc. Coated VICRYL RAPIDE (polyglactin 910) braided synthetic absorbable, suture, undyed. Coated FAST ABSORBING PolyGlycolic Acid Device Description Suture is a synthetic absorbable braided, sterile, surgical suture composed of a homopolymer of Glycolic Acid. The suture material is coated with a copolymer of Polycaprolactone and PolyGlycolic Acid. The substances contained in the coating and suture are noncollagenous and nonantigenic.
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Coated FAST ABSORBING PolyGlycolic Acid suture, undyed Surgical Specialties Corporation
/
1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
| Intended Use: | Coated FAST ABSORBING PolyGlycolic Acid
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 FAST ABSORBING PolyGlycolic Acid
suture is not intended for use in ligation,
ophthalmic, cardiovascular or neurological
procedures. |
| | The coated FAST ABSORBING PolyGlycolic Acid
suture, undyed has the same intended use as the
predicate device. |
| Technological Characteristics: | Coated FAST ABSORBING PolyGlycolic Acid
suture, undyed is composed of 100% PolyGlycolic
Acid, a material equivalent to the material
comprising the predicate VICRYL Rapide device.
The suture has the same design as the VICRYL
Rapide predicate devices, being a sterile, flexible
suture available in a coated braided multifilament
form. |
| Performance Data: | Physical testing was conducted on the Coated
FAST ABSORBING PolyGlycolic Acid suture to
USP 24, including Sutures - Diameter,
Sutures- Needle Attachment, and
Tensile Strength. Animal testing was performed for
conformance to ISO 10993 for biocompatibility and
implant studies in animals to demonstrate rates of
tensile strength and mass loss. |
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Coated FAST ABSORBING PolyGlycolic Acid suture, undyed Surgical Specialties Corporation
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The FAST ABSORBING PolyGlycolic Acid Synthetic Absorbable surgical suture is similar in intended use, materials, design, and performance characteristics to the Ethicon VICRYL Rapide Synthetic Absorbable Surgical Suture (K944110).
The determination of substantial equivalence for this device was based on a detailed device description, physical testing (U.S.P. 24) and animal testing for conformance with performance standards e.g. ISO 10993-1 Biological Evaluation of Medical Devices and the FDA Guidance Document for Surgical Suture 510(k)s issued on August 10, 2000.
Based on the 510(k) summaries (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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2002
Ms. Elizabeth Lazaro Regulatory Affairs Specialist Surgical Specialties Corporation 100 Dennis Drive Reading, Pennsylvania 19606
Re: K014021
Trade/Device Name: Sharpoint® Coated FAST ABSORBING™ Polyglycolic Acid Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(glycolide/L-lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: December 05, 2001 Received: December 06, 2001
Dear Ms. Lazaro:
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.
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Page 2 - Ms. Elizabeth Lazaro
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" (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 yours,
Miriam C. Provost
Of 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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Page 1 of 1_
6
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Sharpoint® Coated FAST ABSORBING™ PolyGlycolic Acid Device Name: Synthetic
Absorbable Surgical Suture
Indications for Use:
Sharpoint® Coated Fast Absorbing™ PolyGlycolic Acid 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 Fast Absorbing™ PolyGlycolic Acid Suture is not intended for use in ligation, ophthalmic cardiovascular or neurological procedures.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Muriam C. Provost
(Division Sign-Off) Division of Coneral, Rostorative and Neurological Devices
510(k) Number KO1 402