(76 days)
COROLENE® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular and vascular surgery, in ophthalmic surgery, in plastic surgery and in neurological surgery.
COROLENE® is a monofilament synthetic non-absorbable surgical suture composed of polypropylene. The suture is available undyed or blue dyed with an FDA approved color additive: Phtalocyanine-copper (CI 74160), to enhance visibility. The suture may be provided with or without a standard needle attached.
The provided text describes a 510(k) summary for a new surgical suture called COROLENE®. The submission aims to demonstrate substantial equivalence to a predicate device, PROLENE™.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to USP Monographs for non-absorbable surgical sutures | The device complied with the USP monographs. |
| Conformance to EP Monographs for non-absorbable surgical sutures | The device complied with the EP monographs. |
| Biocompatibility of Polypropylene material | The polypropylene material used for both medical devices is commonly used in surgical applications and has been proven to be biocompatible. |
| Intended Use | COROLENE® has the same intended use as the predicate device PROLENE®. |
| Technological Characteristics | COROLENE® has similar technological characteristics as the predicate device PROLENE® (monofilament synthetic non-absorbable surgical suture, sterile, undyed or blue dyed). |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical or performance testing on a specific sample size of devices, nor does it provide information on data provenance (e.g., country of origin, retrospective/prospective). The performance data cited are related to compliance with established industry standards (USP and EP monographs).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this type of device (surgical suture) is established through adherence to recognized pharmacopoeia standards (USP, EP) rather than expert consensus on a test set in the way one might evaluate an AI diagnostic tool.
4. Adjudication method for the test set
Not applicable, as there isn't a "test set" requiring adjudication by experts.
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 device is a surgical suture, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical suture, not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for this device's performance is its conformance to the specifications and requirements outlined in the United States Pharmacopoeia (USP) Monographs and the European Pharmacopoeia (EP) Monographs for non-absorbable surgical sutures. This includes material properties, sterility, dimensions, tensile strength, and biocompatibility.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set. The "device" is a physical surgical suture.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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K052701/3
Image /page/0/Picture/1 description: The image shows the logo for Peters Surgical. The logo features a stylized ear on the left, followed by the name "Péters" in a handwritten-style font. Below the name, the word "SURGICAL" is written in smaller, block letters. The overall design is simple and professional, likely representing a company specializing in surgical products or services related to the ear.
DEC 1 3 2005
SECTION 10
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
September 12, 2005
510(k) Submitter
PETERS SURGICAL Z.I. Les vignes 42 rue benoit frachon Bobigny, FRANCE 93013
Registration Number: 3004060107 Owner/Operator Number: 9009304 Phone: 33-148-106262 Fax: 33-148-912299
Official Correspondent
Annic LASSERRE Research & Development Manager PETERS SURGICAL Bobigny, FRANCE, 93013 Phone: 33-148-106259
New Device Name
COROLENE® Trade name: Surgical suture, Polypropylene Common/Usual namc: Nonabsorbable Polypropylene Surgical Suture Classification name:
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New Device Classification
Class II in 21 CFR §878.5010 by the General and Plastic Surgery Devices Panel, Nonabsorbable Polypropylene Surgical Suture (GAW).
Predicate Device Name
PROLENETM, Nonabsorbable Polypropylene Surgical Suture (N16374).
Statement of intended use
COROLENE® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular and vascular surgery, in ophthalmic surgery, in plastic surgery and in neurological surgery.
COROLENE® has the same intended use as the predicate device PROLENT®
New Device Description
COROLENE® is a monofilament synthetic non-absorbable surgical suture composed of polypropylene. The suture is available undyed or blue dyed with an FDA approved color additive: Phtalocyanine-copper (CI 74160), to enhance visibility. The suture may be provided with or without a standard needle attached.
Summary of Technological Characteristics of New Device compared to Predicate Device
Our new device COROLENE® has similar technological characteristics as the predicate device PROLENE®. Like currently marketed PROLENF® suture, COROLENE® is a sterile monofilament synthetic non-absorbable surgical suture that conforms to the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures. The polypropylenc material used for both medical devices is commonly used in surgical applications and has been proven to be biocompatible.
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K052701 3/3
Image /page/2/Picture/1 description: The image shows the logo for Péters Surgical. The logo features a stylized eye on the left, with the name "Péters" in a cursive font to the right of the eye. Below "Péters" is the word "SURGICAL" in smaller, block letters.
Performance data
Non-clinical laboratory testing was performed demonstrating that the device complied with the USP Monographs and with the EP Monographs for non-absorbable surgical sutures.
Conclusions
Based on the 510(k) summary (21 CFR 807) and the information provided herein, we conclude that our New Medical Device COROLENE® is substantially equivalent to the Predicate Device PROLENE® under the Federal Food, Drug, and Cosmetic Act.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2005
Annie Lasserre R & D Manager Peters Surgical Z.I Les vignes 42 Rue Benoit Frachon Bobigny, France 93013
Re: K052701
Trade/Device Name: COROLENE® Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable poly-propylene surgical suture Regulatory Class: II Product Code: GAW Dated: September 6, 2005 Received: September 28, 2005
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- Annie Lasserre
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter with anow you to begin manieling your and 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 if you ucate specific daries ion your of your of 15. Also, please note the regulation entitled, Contact the Office of Company of Company of CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your respended its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Roubare Buellun
Mark N. Melkerson Acting 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/5/Picture/0 description: The image shows the logo for Peters Surgical. The logo consists of a stylized ear on the left and the text "Péters" above the word "SURGICAL" on the right. The ear is black and white, and the text is in a handwritten-style font.
K05 270/
SECTION 9
STATEMENT OF INDICATIONS FOR USE
510(k) Number
COROLENE® Device Name
Indications for use
COROLENE® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular and vascular surgery, in ophthalmic surgery, in plastic surgery and in 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)
Harbare BnechD
Division of General, Restorative, and Neurological Devices
510(k) Number K05270)
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.