(49 days)
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 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.
The provided document is a 510(k) premarket notification for a medical device (surgical sutures) and does not contain information regarding studies with acceptance criteria, device performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
Instead, it focuses on demonstrating substantial equivalence to a predicate device (Coated VICRYL™ (POLYGLACTIN 910) Suture) through non-clinical laboratory testing.
Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The device's performance was evaluated against the requirements of the United States Pharmacopoeia (USP) Monographs and the European Pharmacopoeia (EP) Monographs for Absorbable surgical sutures.
- Reported Device Performance: The document states, "Non-clinical laboratory testing was performed demonstrating that the device complied with the USP Monographs and with the EP Monographs for Absorbable surgical sutures."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| USP Monographs for Absorbable surgical sutures | Device complied with USP Monographs for Absorbable surgical sutures |
| EP Monographs for Absorbable surgical sutures | Device complied with EP Monographs for Absorbable surgical sutures |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "non-clinical laboratory testing" without detailing the number of units tested.
- Data Provenance: Not explicitly stated beyond "non-clinical laboratory testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. Ground truth in this context would likely refer to established pharmacopoeia standards, not human expert consensus.
4. Adjudication method for the test set:
- Not applicable/Not provided. Compliance with pharmacopoeia standards typically involves laboratory testing against defined physical and chemical properties, not human adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This document is for a physical medical device (sutures), not an AI/software device involving human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document is for a physical medical device (sutures), not an AI/software algorithm.
7. The type of ground truth used:
- Ground Truth: Pharmacopoeia standards (United States Pharmacopoeia (USP) Monographs and European Pharmacopoeia (EP) Monographs for Absorbable surgical sutures).
8. The sample size for the training set:
- Not applicable. This is not an AI/software device that requires a training set. The "new device" is compared to a "predicate device" and its performance against pharmacopoeia standards is established through non-clinical testing.
9. How the ground truth for the training set was established:
- Not applicable. As above, this is not an AI/software device.
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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 PlasticSurgery 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.
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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
§ 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.