CARDIOFLON, CARDIOXYL

K060163 · Peters Surgical · GAT · Oct 11, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060163
• Device Name: CARDIOFLON, CARDIOXYL
• Applicant: Peters Surgical
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Oct 11, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

CARDIOFLON® and CARDIOXYL® are sterile, nonabsorbable synthetic surgical sutures; composed of braided polyester [poly(ethylene terephtalate)]; available with or without pledgets. CARDIOFLON® features PTFE coating; CARDIOXYL® features polysiloxane coating. Sutures are green-dyed or white to facilitate visibility. Used by surgeons in clinical settings for soft tissue approximation and ligation. Device provides mechanical closure of tissues; benefits include biocompatibility and compliance with USP/EP standards for nonabsorbable sutures.

Clinical Evidence

Bench testing only. Compliance with USP and EP monographs for nonabsorbable surgical sutures demonstrated via non-clinical laboratory testing.

Technological Characteristics

Braided polyester [poly(ethylene terephtalate)] suture; CARDIOFLON® coated with PTFE; CARDIOXYL® coated with polysiloxane. Sterile; nonabsorbable. Complies with USP and EP requirements. Green (D&C green nº6 CI 61565) or white.

Indications for Use

Indicated for general soft tissue approximation and/or ligation in patients undergoing cardiovascular, ophthalmic, or neurological surgery.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• PETERS CARDIOFLON® SUTURE (K913101)
• TI-CRON TM (K930591)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

### Official Correspondent

Annie LASSERRE Research & Development Manager PETERS SURGICAL Bobigny, FRANCE, 93013 Phone: [phone]

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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.

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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.

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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

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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 [phone]. 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 [phone] or [phone] 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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K060163

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