(49 days)
Not Found
No
The device description and performance studies focus on the material properties and physical performance of surgical sutures, with no mention of AI or ML.
No
The device is a surgical suture used for tissue approximation and ligation, which is a supportive role in surgery, not a direct therapeutic intervention.
No
Explanation: The provided text describes surgical sutures, which are used for "soft tissue approximation and/or ligation." There is no mention of the device being used to identify, diagnose, or monitor a medical condition.
No
The device description clearly states it is a physical surgical suture made of synthetic materials, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the sutures are for "general soft tissue approximation and/or ligation" during surgery. This is a direct surgical intervention on a patient's body.
- Device Description: The description details the physical composition and form of surgical sutures, which are used in vivo (within a living organism).
- 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) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside of the body) to analyze samples and provide diagnostic information. This device is a surgical tool used in vivo.
N/A
Intended Use / Indications for Use
The synthetic absorbable surgical sutures OPTIME® and SINUSORB® PGA are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery; but not for use in cardiovascular and neurological surgery.
Product codes
GAM
Device Description
OPTIME® and SINUSORB® PGA are synthetic absorbable braids composed of homopolymer of glycolic acid and coated with epsilon-caprolactone and calcium stearate or a mixture composed of polycaprolacton, calcium stearate and fatty acid ester. These surgical sutures are available undyed or violet dyed with an FDA approved color additive: D&C violet nº2, CI 60725. The suture may be provided with or without a standard needle attached.
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 complied with the USP Monographs and with the EP Monographs for Absorbable surgical sutures.
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
Image /page/0/Picture/0 description: The image shows the logo for Peters Surgical. The logo features a stylized eye on the left, with a pattern of small circles forming the iris and pupil. To the right of the eye, the text "Péters" is written in a bold, slightly italicized font, with the accent mark over the "e". Below "Péters", the word "SURGICAL" is written in smaller, sans-serif capital letters.
K062366
Page 1 of 2
SECTION 11
OCT = 2 2006
510(k) SUMMARY
[As Required by 21 CFR 807.92(c)]
Information supporting claims of substantial equivalence, as defined under the Federal Food, drug and Cosmetic Act, respecting safety and effectiveness is summarized below.
510(k) Summary Date prepared August 8, 2006
510(k) Submitter
PETERS SURGICAL Z.I. Les vignes 42 rue Benoît Frachon Bobigny, FRANCE 93013
Registration Number: 3004060107 Owner/Operator Number: 9009304 Phone: 33-148-106262 Fax: 33-148-912299
Official Correspondent
Annie LASSERRE Research & Development Manager PETERS SURGICAL Bobigny, FRANCE, 93013 Phone: 33-148-106259
New Device Name
| Trade name: | OPTIME® and SINUSORB® PGA |
|---|---|
| Common/Usual name: | Synthetic Absorbable Suture, PGA Suture |
| Classification name: | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| New Device Classification | Class II in 21 CFR §878.4493 by the General and Plastic |
| Surgery Devices Panel, Absorbable poly(glycolide/l- | |
| lactide) surgical suture (GAM). | |
| Predicate Device Name | Coated VICRYL™ (POLYGLACTIN 910) Suture, |
| ETHICON INC., K022269 |
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Image /page/1/Picture/0 description: The image shows the logo for Peters Surgical. The logo consists of a stylized image of an eye on the left, and the text "Peters" above the word "Surgical" on the right. The eye is made up of many small dots, and the text is in a simple, sans-serif font.
K 062366
page 2 of 2
Statement of intended use
The synthetic absorbable surgical sutures OPTIME® and SINUSORB® PGA are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery; but not for use in cardiovascular and neurological surgery.
OPTIME® and SINUSORB® PGA have the same intended use as the predicate device Coated VICRYL 100 (Polyglactin 910) Suture.
New Device Description
OPTIME® and SINUSORB® PGA are synthetic absorbable braids composed of homopolymer of glycolic acid and coated with epsilon-caprolactone and calcium stearate or a mixture composed of polycaprolacton, calcium stearate and fatty acid ester. These surgical sutures are available undyed or violet dyed with an FDA approved color additive: D&C violet nº2, CI 60725. The suture may be provided with or without a standard needle attached.
Summary of Technological Characteristics of New Device compared to Predicate Device
OPTIME® and SINUSORB® PGA sutures have similar technological characteristics as the predicate device Coated VICRYL™ (Polyglactin 910) Suture. Like the predicate device, OPTIME® and SINUSORB® PGA are sterile, braided synthetic absorbable surgical sutures that conform to the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for Absorbable surgical sutures. The polyglycolic acid material used for both "new" and "predicate" medical devices is commonly used in surgical applications and has been proven to be biocompatible.
Performance data
Non-clinical laboratory testing was performed demonstrating that the device complied with the USP Monographs and with the EP Monographs for Absorbable surgical sutures.
Conclusions
Based on the 510(k) summary (21 CFR 807) and the information provided herein, we conclude that our New Medical Devices OPTIME® and SINUSORB® PGA are substantially equivalent to the Predicate device Coated VICRYL™ Suture under the Federal Food, Druing, and Cosmetic Act.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three lines forming its wings. The eagle is positioned above a wavy line, which may represent water. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the central image.
OCT - 2 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Peters Surgical % Ms. Annie Lasserre Research and Development Manager Z.I. Les vignes 42 Rue Benoît Frachon Bobigny, France 93013
Re: K062366
Trade/Device Name: OPTIME®, SINUSORB® PGA Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly (glycolide/L-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: August 8, 2006 Received: August 14, 2006
Dear Ms. Lasserre:
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.
3
Page 2 - Ms. Annie Lasserre
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 logally 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Dep. Director
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Peters Surgical. The logo features a stylized image of an eye on the left, with the company name "Péters SURGICAL" on the right. The word "Péters" is in a larger, stylized font, while "SURGICAL" is in smaller, block letters below it.
SECTION 10
STATEMENT OF INDICATIONS FOR USE
510(k) Number K062366
Device Name OPTIME®, SINUSORB® PGA
Indications for use
The synthetic absorbable surgical sutures OPTIME® and SINUSORB® PGA are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmio surgery, but not for use in cardiovascular and neurological surgery.
Prescription Use x_ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| (Division Sign-Off) |
| Division of General, Restorative, |
| and Neurological Devices |
510(k