SEGUIN ANNULOPLASTY RING

K092310 · St Jude Medical · KRH · Aug 27, 2009 · Cardiovascular

Device Facts

• Record ID: K092310
• Device Name: SEGUIN ANNULOPLASTY RING
• Applicant: St Jude Medical
• Product Code: KRH · Cardiovascular
• Decision Date: Aug 27, 2009
• 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 mitral valves that are diseased or damaged due to acquired or congenital processes.

Device Story

The SJM Seguin Annuloplasty Ring is a semi-rigid device used for mitral valve repair. It consists of an ultra-high molecular weight polyethylene core encased in a polyester sewing cuff. The cuff facilitates surgical attachment to the mitral annulus and promotes tissue ingrowth. The device is implanted by a surgeon during cardiac procedures to restore valve function in patients where repair is preferred over replacement. It functions as a structural support for the mitral annulus. The device is provided sterile and is intended for prescription use.

Clinical Evidence

Bench testing only. Performance characteristics evaluated include ring tensile strength, ring compression strength, suture pullout, MR safety, manufacturing process validation, biological evaluation, and sterilization parameter evaluation.

Technological Characteristics

Semi-rigid annuloplasty ring. Materials: ultra-high molecular weight polyethylene core, polyester sewing cuff. Form factor: ring, sizes 24 mm-40 mm. Sterilization: method not specified but identical to predicate.

Indications for Use

Indicated for patients requiring repair of diseased or damaged mitral heart valves due to acquired or congenital processes, as determined by a physician.

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

• SJM Seguin Ring model SARP-(size) (K014037)

Submission Summary (Full Text)

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16092310

## SECTION 7 - 510(K) SUMMARY

#### Applicant Information

Submitter's Name and Address:

Contact Name

#### Submission Prepared

Device Information

Proprietary Name:

Common or Usual Name:

Classification:

#### Predicate Device:

SJM Seguin Ring model SARP-(size)

510(k) No. K014037 - cleared January 4, 2002

#### Device Description:

The SJM Seguin Ring is a semi-rigid ring fabricated from an ultra-high molecular weight polyethylene core surrounded by a polyester sewing cuff, which provides a means for attaching the ring to the mitral annulus as well as a suitable surface for tissue ingrowth.

### Intended Use:

The SJMM Seguin annuloplasty ring is intended to be used for repair of diseased or damaged mitral heart valves that are determined by the physician to be repairable and do not require replacement.

St. Jude Medical Seguin Ring - Special 510(k)

# AUG 2 7 2009

St. Jude Medical 177 County Road B. East St. Paul, MN 55117

Thomas Rademacher Regulatory Affairs Specialist St. Jude Medical 177 County Road B, East St. Paul, MN 55117 Bus: [phone] Fax: [phone] Email: [e-mail]

July 24, 2009

SJM Seguin Annuloplasty Ring

Semi-rigid annuloplasty ring Mitral repair ring

Class II per 21 CFR 870.3800, Annuloplasty rings

Confidential

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#### Comparison of Required Technological Characteristics

SJM considers the SJM Seguin Annuloplasty ring to be substantially equivalent in technological characteristics (e.g. design and materials) and intended use to the predicate device. The table below is a comparison of the equivalency characteristics between the SJM Seguin Annuloplasty Ring and the predicate device.

| Item | Equivalency |
|--------------------------|--------------------------|
| Principles of Operation | Identical |
| Product Labeling | Substantially Equivalent |
| Indications for Use | Identical |
| Physical Characteristics | Substantially Equivalent |
| Anatomical Sites | Identical |
| Target Population | Identical |
| Performance Testing | Substantially Equivalent |
| Safety Characteristics | Substantially Equivalent |
| Packaging | Identical |
| Sterilization | Identical |
| Shelf-Life | Identical |

### Summary of Non-Clinical Tests

The following performance characteristics were evaluated:

- Ring Tensile Strength .
- Ring Compression Strength .
- Suture Pullout Test .
- . MR Safety Evaluation
- Manufacturing Process validation .
- Biological Evaluation
- Sterilization Parameter Evaluation .

### Conclusion

St. Jude Medical has demonstrated that the SJM Seguin Annuloplasty ring is safe and effective for the The Seguin Ring is, with respect to intended use and technological characteristics, intended use. substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains an image of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the edge of the circle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

## AUG 2 7 2009

St. Jude Medical c/o Mr. Thomas Rademacher Regulatory Affairs Specialist 177 County Road B, East St. Paul, MN 55117

Re: K092310

> Seguin Annuloplasty Ring Model SARP-(size), Sizes 24 mm-40 mm (even sizes) Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty ring Regulatory Class: Class II (two) Product Code: KRH Dated: July 24, 2009 Received: July 29, 2009

Dear Mr. Rademacher:

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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 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. Thomas Rademacher

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Duna R. Vorhmer

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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## Attachment 2

Indications for Use Statement

## Indications for Use

510(k) Number (if known): K092310 Device Name: SJM Seguin Annuloplasty Ring Indications For Use:

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

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

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anna R. de Sinner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K092310

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