SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE)

K014037 · St. Jude Medical, Inc. · KRH · Jan 4, 2002 · Cardiovascular

Device Facts

• Record ID: K014037
• Device Name: SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE)
• Applicant: St. Jude Medical, Inc.
• Product Code: KRH · Cardiovascular
• Decision Date: Jan 4, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SJM® Seguin annuloplasty ring is indicated for use in the repair of a mitral valve that is diseased or damaged due to acquired or congenital processes.

Device Story

SJM Seguin annuloplasty ring (model SARP) is a semi-rigid implantable device used in mitral valve repair surgery. It consists of an ultra-high molecular weight polyethylene (PE) core encased in a polyester sewing ring, which facilitates attachment to the heart annulus and promotes tissue ingrowth. The device is implanted by a cardiac surgeon during open-heart procedures. The primary function is to provide structural support to the mitral valve annulus, restoring proper valve geometry and function. The SARP model introduces a modified holder and handle configuration compared to the predicate device to assist in surgical delivery. The device is provided sterile for single use.

Clinical Evidence

Bench testing only. Testing included physical performance evaluation of the holder-to-handle connection, holder assembly, and ring-to-holder assembly, alongside biocompatibility, sterility assurance, and EtO residual evaluation.

Technological Characteristics

Semi-rigid annuloplasty ring. Materials: Ultra-high molecular weight polyethylene (PE) core, polyester sewing ring. Sterilization: Ethylene oxide (EtO). Configuration: Implantable ring with modified holder/handle delivery system.

Indications for Use

Indicated for patients requiring repair of diseased or damaged mitral heart valves (acquired or congenital) determined by a physician to be repairable and not requiring 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

• Seguin ring model SAR (K961246)

Submission Summary (Full Text)

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K014037

# JAN 0 4 2002

# 510(K) SUMMARY

(as Required by 21 CFR § 807.92)

#### Submitters Information A.

B.

| Submitter's Name: | St. Jude Medical, Inc<br>Cardiac Surgery Division |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | St. Jude Medical, Inc.<br>One Lillehei Plaza<br>St. Paul, MN 55117 |
| Contact Name | William McKelvey<br>Regulatory Affairs Coordinator<br>St. Jude Medical, Inc.<br>Bus : [phone]<br>Fax : [phone]<br>Email: [e-mail] |
| Submission Prepared: | December 6, 2001 |
| Device Information | |
| Proprietary Name: | SJM® Seguin annuloplasty ring<br>(Seguin ring) model SARP-(size) |
| Common or Usual Name: | Annuloplasty Ring<br>Valvulplasty Ring<br>Mitral Valve Support Ring |
| Classification: | Pre-amendment Class II CFR § 870.3800<br>Devices,<br>Cardiovascular<br>Annuloplasty Ring (revised April 10, 2001) |
| Predicate Device: | St. Jude Medical considers The Seguin<br>ring, model SARP to be substantially<br>equivalent to the Sequin ring model SAR. |
| Device Description | The Seguin ring is a semi-rigid ring<br>fabricated from an untra-high molecular<br>weight polyethylene (PE) core surrounded<br>by a polyester sewing ring. providing a<br>means for attaching the ring to the heart<br>annulus as well as a suitable surface for<br>tissue ingrowth. |

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Intended Use:

The Sequin ring is indicated for use in repair of diseased or damaged mitral heart valves that are determined by the physician to be repairable and do not require replacement.

#### Comparison of Required Technological Characteristics ﻥ

SJM considers the Seguin ring, model SARP to be substantially equivalent in configuration, function and intended use to the Seguin ring, model SAR. The table below is a comparison of the equivalency characteristics between the two devices.

| | Characteristic | Equivalency |
|----|--------------------------|------------------------------------|
| a. | Product Labeling | Substantially Equivalent |
| b. | Intended Use | Identical |
| c. | Physical Characteristics | Different (Holder and Handle only) |
| d. | Anatomical Sites | Identical |
| e. | Target Population | Identical |
| f. | Performance Testing | Substantially Equivalent |
| g. | Safety Characteristics | Substantially Equivalent |

#### Summary of Non-Clinical Tests D.

The testing for the Seguin ring model SAR (predicate) is included in the premarket notification (K961246). The following tests have been performed on the Seguin ring model SARP to insure substantial equivalence with the predicate.

# New Holder/Handle Configuration

- Physical Testing 1.
- Holder to Handle connection ●
- Holder assembly .
- Ring assembly to holder .

#### 2. Microbiological Testing

- Biocompatibility ●
- Additional Evaluation of Routine Testing .
- Sterility Assurance ●
- EtO Residual Evaluation .
- 3. Manufacturing Process Validation

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines beneath them, resembling a stylized caduceus or a representation of people receiving care.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 1 9 2002

Mr. William McKelvey Regulatory Affairs Coordinator St. Jude Medical, Inc. One Lillehei Plaza St. Paul, MN 55117

Re: K014037

> Trade Name: SJM® Seguin Annuloplasty Ring, Model SARP(size) Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II (two) Product Code: KRH Dated: December 6, 2001 Received: December 7, 2001

Dear Mr. McKelvey:

This letter corrects our substantially equivalent letter regarding the SJM® Seguin Annuloplasty Ring dated January 4, 2002. Our letter incorrectly referred to your Model name as SAR-M. This is an error. The Model name has been corrected to SARP.

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. William McKelvey

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

ram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

6014037 510(k) Number (if known):_

Device Name: SJM® Seguin annuloplasty ring

Indications for Use:

The SJM® Seguin annuloplasty ring is indicated for use in the repair of a mitral valve that is diseased or damaged due to acquired or congenital processes.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFANOTHER PAGE IS NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K014034

Prescription Use X

or

Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Optional Format 1-2-96)