SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)

K022363 · St. Jude Medical, Inc. · KRH · Sep 19, 2002 · Cardiovascular

Device Facts

• Record ID: K022363
• Device Name: SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)
• Applicant: St. Jude Medical, Inc.
• Product Code: KRH · Cardiovascular
• Decision Date: Sep 19, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SJM® Tailor annuloplasty band is indicated for use in repair of a mitral or tricuspid heart valve that is diseased or damaged due to acquired or congenital processes.

Device Story

SJM Tailor annuloplasty band is a flexible prosthetic device used in cardiac surgery to repair diseased or damaged mitral or tricuspid heart valves. The device consists of a medical-grade silicone rubber core encased in polyester fabric. It is implanted by a surgeon during open-heart procedures to provide structural support to the valve annulus. By reinforcing the annulus, the band helps restore proper valve function and geometry, potentially improving hemodynamic performance and reducing regurgitation. The device is intended for clinical use in hospital settings.

Clinical Evidence

Bench testing only. Physical validation included band end evaluation, gapping, band release, suture retention, and suture pull. Microbiological verification included biocompatibility and sterility assurance evaluations.

Technological Characteristics

Flexible annuloplasty band; medical-grade silicone rubber core; polyester fabric covering. Class II device (21 CFR 870.3800).

Indications for Use

Indicated for patients requiring repair of mitral or tricuspid heart valves diseased or damaged by acquired or congenital processes.

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

• Tailor annuloplasty ring model TARP (K014161)

Submission Summary (Full Text)

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SEP 1 9 2002

K022363

## 510(K) SUMMARY (as Required by 21 CFR § 807.92)

# Submitters Information

A.

| | 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 Specialist<br>St. Jude Medical, Inc.<br>Bus : [phone]<br>Fax : [phone]<br>Email: [e-mail] |
| | Submission Prepared: | July 18, 2002 |
| B. | Device Information | |
| | Proprietary Name: | SJM® Tailor™ annuloplasty band<br>(Tailor band) Model TAB-(size) |
| | Common or Usual Name: | Flexible Annuloplasty band<br>"C" ring |
| | Classification: | Pre-amendment Class II CFR § 870.3800<br>Cardiovascular Prosthetic Devices<br>Annuloplasty Ring |
| | Predicate Device: | St. Jude Medical considers The Tailor<br>annuloplasty band, model TAB to be<br>substantially equivalent to the Tailor<br>annuloplasty ring model TARP. |
| | Device Description | The Tailor band is a flexible band fabricated<br>with a medical grade silicone rubber core,<br>surrounded by polyester fabric. |
| | | |

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Intended Use:

The SJM® Tailor annuloplasty band is indicated for use in repair of a mitral or tricuspid heart valve that is diseased or damaged due to acquired or congenital processes.

### Comparison of Required Technological Characteristics ﻥ

SJM considers the Tailor band, model TAB to be substantially equivalent in configuration, function and intended use to the Tailor ring, model TARP. 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 | Substantially Equivalent |
| d. | Anatomical Sites | Identical |
| e. | Target Population | Identical |
| f. | Performance Testing | Identical |
| g. | Safety Characteristics | Identical |

### Summary of Non-Clinical Tests D.

The testing for the Tailor ring model TARP (predicate) is included in the premarket notification (K014161). The following tests have been performed on the Tailor band model TAB to insure substantial equivalence with the predicate.

#### 1. Physical Validation

- Band end evaluation .
- Gapping ●
- . Band release
- Suture Retention ●
- Suture pull .

### 2. Microbiological Verification

- Biocompatibility evaluation .
- Sterility Assurance evaluation .
- 3. Manufacturing Process Validation

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Image /page/2/Picture/10 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 9 2002

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

Re: K022363 Trade Name: SJM® Tailor™ Annuloplasty Band, Model TAB-(size) Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II (two) Product Code: KRH Dated: September 5, 2002 Received: September 6, 2002

Dear Mr. McKelvey:

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,

K. DeGraw

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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Page 1 of 1

0(k) Number (if known):__

Device Name: SJM® Tailor™ annuloplasty band

Indications for Use:

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

(Please Do Not Write Below This Line-Continue On Another Page If Another Page Is Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K022363

Prescription Use _____________________________________________________________________________________________________________________________________________________________

or

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

(Per 21 CFR 801.109)

003