(261 days)
Not Found
No
The device description and performance studies focus on the material composition and physical properties of surgical sutures, with no mention of AI or ML.
No.
A therapeutic device is one that treats a disease or condition. This device, a surgical suture, is used to approximate tissue during surgery, which is a supportive role to the surgical procedure, not a direct therapeutic action on a disease. While it aids in healing and recovery, it does not exert a therapeutic effect itself on a disease state.
No
The devices described are surgical sutures, which are used for "general soft tissue approximation and/or ligation." Their purpose is to close wounds or tie off vessels, not to diagnose conditions.
No
The device description clearly states it is a surgical suture made of polyester braids, 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:
- Intended Use: The intended use clearly states that the sutures are for "general soft tissue approximation and/or ligation" in surgical procedures. This involves physically joining tissues within the body.
- Device Description: The description details the composition and characteristics of surgical sutures, which are physical implants or devices used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. Surgical sutures, like the ones described, are used in vivo (within the body) during surgical procedures.
N/A
Intended Use / Indications for Use
The CARDIOFLON® and CARDIOXYL® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, in ophthalmic surgery and in neurological surgery.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
The synthetic non-absorbable surgical sutures CARDIOFLON® and CARDIOXYL® are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOFLON® braids are coated with a polymer of tetrafluorethylene (PTFE) and CARDIOXYL® braids are coated with polysiloxane.
CARDIOFLON® and CARDIOXYL® sutures are green dyed (D&C green nº6 CI 61565) and white (undyed). Some packs are composed of green and white II is to facilitate location during use.
CARDIOFLON® and CARDIOXYL® sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for nonabsorbable surgical sutures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue, cardiovascular, ophthalmic, neurological
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 devices 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.
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
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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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060163 1/3
Image /page/0/Picture/1 description: The image shows the logo for "Péters Surgical". The logo consists of a stylized ear on the left, followed by the name "Péters" in a cursive font. Below "Péters" is the word "SURGICAL" in smaller, block letters. The overall design is simple and professional, likely representing a company specializing in surgical products related to the ear.
Attachment 12
OCT 1 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
January 09, 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
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K06163 2/3
Image /page/1/Picture/1 description: The image shows the logo for Peters Surgical. The logo features a stylized ear shape in black on the left. To the right of the ear shape, the text "Peters" is written in a stylized font, with the accent mark over the "e". Below "Peters", the word "SURGICAL" is written in smaller, sans-serif capital letters.
New Device Name
Trade name: CARDIOFLON®, CARDIOXYL® Common/Usual name: Sterile Polyester Suture Classification name: Polyester Nonabsorbable Synthetic Suture
New Device Classification
Class II by the General and Plastic Surgery Devices Panel, Nonabsorbable Polyester Surgical Suture (GAS).
Predicate Device Name
PETERS CARDIOFLON® SUTURE, Nonabsorbable Polyester Synthetic Suture (K913101).
TI-CRON TM, Nonabsorbable Polyethylene Surgical Suture (K930591).
Statement of intended use
CARDIOFLON® and CARDIOXYL® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, in ophthalmic surgery, in plastic surgery and in neurological surgery.
New Device Description
The synthetic non-absorbable surgical sutures CARDIOFLON® and CARDIOXYL® are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOFLON® braids are coated with a polymer of tetrafluorethylene (PTFE) and CARDIOXYL® braids are coated with polysiloxane.
CARDIOFLON® and CARDIOXYL® sutures are green dyed (D&C green nº6 CI 61565) and white (undyed). Some packs are composed of green and white II is to facilitate location during use.
CARDIOFLON® and CARDIOXYL® sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for nonabsorbable surgical sutures.
2
Image /page/2/Picture/0 description: The image shows the logo for "Peters Surgical". The logo consists of a stylized ear on the left and the text "Peters" above the word "Surgical" on the right. The word "Peters" is in a larger, italicized font, while "Surgical" is in a smaller, non-italicized font.
Summary of Technological Characteristics of New Device to Predicate Device
CARDIOFLON® and CARDIOXYL® sutures sutures similar technological Characteristics as the predicate devices and TI-CRON™ Like our previously cleared Polyester sutures PETERS CARDIOFLON® SUTURE and the currently marketed TI-CRON™ sutures, CARDIOFLON® and CARDIOXYL® are sterile synthetic nonabsorbable surgical sutures that conform to the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures. The polyester [poly(ethylene terephtalate)] material used for these 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 devices 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 CARDIOFLON® and CARDIOXYL® are substantially equivalent to the predicate devices PETERS CARDIOFLON® SUTURE and TI•CRON™ under the Federal Food, drug, and Cosmetic Act.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other, and connected by flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 1 2006
Peters Surgical % Ms. Annie Lasserre Research & Development Manager Z.I. Les vignes 42 rue Benoît Frachon Bobigny, France 93013
Re: K060163
Trade/Device Name: CARDIOFLON®, CARDIOXYL® Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: August 29, 2006 Received: September 11, 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
4
Page 2 - Ms. Annie Lasserre
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.
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), 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/cdrb/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson 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/1 description: The image shows a logo for a company called "Péters Surgical". The logo features a stylized eye on the left side, with the company name written in a handwritten-style font to the right of the eye. The word "Surgical" is written in smaller letters below the name "Péters".
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Attachment 10
Indications for Use Statement
| 510(k) Number (if known) | K060163 |
|---|---|
| Device Name | CARDIOFLON®, CARDIOXYL® |
| Indications for Use | The CARDIOFLON® and CARDIOXYL® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, in ophthalmic surgery and in neurological surgery. |
| Prescription Use (Per 21 CFR 801. 109) | X |
| OR Over-The-Counter Use |
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
PETERS CARDIOFLON SUTURE/Special 510(k)/January 2006 510(k) Number K060167