UNIRING - ANNULOPLASTY RING WITH SIZERS

K071281 · Peters Surgical · KRH · Aug 3, 2007 · Cardiovascular

Device Facts

• Record ID: K071281
• Device Name: UNIRING - ANNULOPLASTY RING WITH SIZERS
• Applicant: Peters Surgical
• Product Code: KRH · Cardiovascular
• Decision Date: Aug 3, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UNIRING® is indicated as reinforcement for repair of the human cardiac mitral and tricuspid valves damaged by acquired or congenital disease, or as a replacement for a previously implanted vannuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.

Device Story

UNIRING is a flexible annuloplasty ring designed for surgical implantation in the mitral or tricuspid position to reinforce valve repair. The device is provided with a holder assembly and a separate set of sizers to assist the surgeon in determining the appropriate annulus size. Used by cardiac surgeons in an operating room setting, the device provides structural support to the valve annulus. The surgeon assesses the valve visually to confirm repairability before implantation. The device benefits patients by restoring or maintaining valve function in cases of acquired or congenital disease, or by replacing failed prior annuloplasty rings.

Clinical Evidence

Bench testing only. Biocompatibility testing confirmed materials are non-toxic, non-hemolytic, and non-pyrogenic per 21 CFR Part 58. Mechanical integrity testing, specifically suture retention force, demonstrated performance equivalent to predicate devices. Compliance with USP and EP monographs for absorbable surgical sutures was verified.

Technological Characteristics

Flexible annuloplasty ring; implantable as partial or complete ring. Materials are non-toxic, non-hemolytic, and non-pyrogenic. Mechanical design includes suture retention features. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients requiring reinforcement for repair of human cardiac mitral and tricuspid valves damaged by acquired or congenital disease, or replacement of a previously implanted annuloplasty ring. Contraindicated if visual inspection confirms the valve is not repairable and requires replacement.

Regulatory Classification

Identification

An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”

Predicate Devices

• Northrup Universal Annuloplasty System (K033685)
• CarboMedics AnnuloFlex Annuloplasty System (K992056)
• Edwards Lifesciences Cosgrove-Edwards Annuloplasty System (K923367)
• Baxter Carpentier-Edwards Physio Annuloplasty Ring (K926138)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Peters Surgical. The logo consists of a stylized, abstract graphic on the left, resembling a partial circle or organic shape made up of smaller elements. To the right of the graphic, the text "Péters" is displayed in a stylized, handwritten-like font, with an acute accent over the "e". Below "Péters", the word "SURGICAL" is written in smaller, blocky capital letters.

Image /page/0/Picture/1 description: The image shows a handwritten sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by the number '0', then '71281'. The handwriting is somewhat rough, but the characters are generally legible.

# SECTION 11

AUG - 3 2007

## 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 | April 27, 2007 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter | PETERS SURGICAL<br>Z.I. Les vignes<br>42 rue Benoît Frachon<br>Bobigny, FRANCE 93013<br>Registration Number: 3004060107<br>Owner/Operator Number: 9009304<br>Phone: [phone]<br>Fax: [phone] |
| Official Correspondent | Robert RENAULT<br>Quality Director<br>PETERS SURGICAL Bobigny, FRANCE, 93013<br>Phone: [phone] |
| New Device Name | UNIRING® - Annuloplasty ring with sizers<br>Trade name:<br>Common/Usual name: Annuloplasty Ring<br>Classification name: Ring, Annuloplasty |
| New Device Classification | Class II in 21 CFR §870.3800 by the Cardiovascular Device<br>Classification Panel, Annuloplasty Ring (KRH). |
| Predicate Device Name | Northrup Universal Annuloplasty System - K033685<br>CarboMedics AnnuloFlex Annuloplasty System - K992056<br>Edwards Lifesciences Cosgrove-Edwards Annuloplasty System - K923367<br>Baxter Carpentier-Edwards Physio Annuloplasty Ring - K926138 |

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Image /page/1/Picture/0 description: The image shows the logo for Peters Surgical. The logo features a stylized eye-like design on the left, followed by the name "Peters" in a handwritten-style font. Below "Peters" is the word "SURGICAL" in smaller, block letters.

#### Statement of intended use

The UNIRING® is indicated as reinforcement for repair of the human cardiac mitral and tricuspid valves damaged by acquired or congenital disease, or as a replacement for a previously implanted vannuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.

#### New Device Description

The UNIRING® consists of an annuloplasty ring mounted on a holder assembly for implantation in the mitral or tricuspid position. A complete set of instrumentation is available scparately to properly size the annulus.

# Summary of Technological Characteristics of New Device compared to Predicate Device(s)

The UNIRING® is a flexible annuloplasty ring that can be implanted either as a partial or complete ring, according to the surgeon's preference and/or patient condition. For purposes of this submission, the UNIRING® was compared to the following predicate device(s):

- Northrup Universal Annuloplasty System K033685 .
- CarboMedics AnnuloFlex Annuloplasty System K992056 .
- can be implanted cither as a partial or complete ring with identical function as the Northrup Universal Annuloplasty System
- Edwards Lifesciences Cosgrove-Edwards Annuloplasty System K923367 .
- Baxter Carpentier-Edwards Physio Annuloplasty Ring K926138 .

#### 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.

The results of biocompatibility testing support that the materials used in the manufacture of the UNIRING® are non-toxic, non-hemolytic, and non-pyrogenic. All testing was conducted under Good Laboratory Practices per 21 CFR Part 58. Mechanical Integrity testing for the UNIRING® includes suture retention testing which demonstrated that the design provided for a more than adequate sure reterior force as compared to the predicate device. Testing demonstrated that the UNIRING® is substantially equivalent to the predicate device for repair of the mitrial or tricuspid valve.

#### Conclusions

Based on the 510(k) summary (21 CFR 807) and the information provided herein, we conclude that our Medical Device UNIRING® is substantially equivalent to the Predicate devices 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

AUG - 3 2007

Peters Surgical c/o Mr. Robert Renault Quality Director Z.I. Les Vignes 42 Rue Benoit Franchon Bobigny, France 93013

Re: K071281

> UNIRING - Annuloplasty Ring with Sizers Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty ring Regulatory Class: Class II (two) Product Code: KRH Dated: May 7, 2007 Received: May 7, 2007

Dear Mr. Renault:

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.

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Page 2 – Mr. Robert Renault

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. 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/cdrh/industry/support/index.html.

Sincerely yours.

R. lochner

A Bram D. Zuckerman, M.D. - Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image contains the logo for Péters Surgical. The logo features a stylized eye-like graphic on the left, with the name "Péters" in a handwritten-style font to the right. Below the name, the word "SURGICAL" is written in smaller, block letters. The overall design is simple and professional, likely representing a company in the medical or surgical field.

### SECTION 10

## STATEMENT OF INDICATIONS FOR USE

14071281 510(k) Number

Device Name UNIRING® Annuloplasty Ring with sizers

#### Indications for use

The UNIRING® is indicated as reinforcement for repair of the human cardiac mitral and tricuspid valves damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.

Prescription Use × × AND/OR (Part 21 CFR 801 Subpart D)

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)

sumner R. bchums

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number k071281

UNIRING/ Traditional 510(K)/ 2007