(76 days)
N16374
Not Found
No
The description focuses on the material and intended use of a surgical suture, with no mention of AI or ML capabilities.
No.
The device, a surgical suture, is used for approximating and ligating tissues, which is a supportive rather than a therapeutic function. It aids in the healing process but does not directly treat a disease or condition.
No
Explanation: The device, COROLENE® sutures, is a surgical suture used for tissue approximation and ligation. Its purpose is to repair or join tissues, not to diagnose a condition or disease.
No
The device is a surgical suture, which is a physical medical device made of polypropylene, not software.
No, 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. They are used outside of the body (in vitro).
- COROLENE® Suture Function: COROLENE® sutures are surgical devices used within the body to approximate and ligate tissues during surgery. They are a physical tool used for repair, not for diagnostic testing of samples.
The provided information clearly describes a surgical suture, not a diagnostic test.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GAW
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.
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 non-absorbable surgical sutures.
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.
PROLENETM, Nonabsorbable Polypropylene Surgical Suture (N16374).
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
§ 878.5010 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.
0
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:
1
Kosa>Ul$_{2/3}$
Image /page/1/Picture/1 description: The image shows the logo for "Peters Surgical". The logo consists of a stylized ear on the left, followed by the name "Peters" in a cursive font. Below "Peters" is the word "Surgical" in smaller, block letters. The logo is simple and professional, likely representing a company specializing in surgical products or services related to the ear.
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.
2
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.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol featuring a staff with two snakes entwined around it. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement around the caduceus. The text is in all capital letters.
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.
4
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
5
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)