SJM RIGID SADDLE RING MODEL RSAR-(SIZE)

K042734 · St. Jude Medical, Inc. · KRH · Dec 17, 2004 · Cardiovascular

Device Facts

• Record ID: K042734
• Device Name: SJM RIGID SADDLE RING MODEL RSAR-(SIZE)
• Applicant: St. Jude Medical, Inc.
• Product Code: KRH · Cardiovascular
• Decision Date: Dec 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SJM™ Rigid Saddle Ring is indicated for use to correct annular dilation, increase leaflet coaptation, and prevent further dilatation of the mitral valve annulus caused by liseased states such as degenerative disease, rheumatic disease, ischemia or vascular disease. The combination of prosthetic ring with valvuloplasty may be used in all acquired or congenital mitral insufficiencies with dilation and deformation of the fibrous mitral annulus. For mitral insufficiencies with no subvalvular lesions and normal valvular movements, r of that ring implant alone may be sufficient. However, annuloplasty ring implant along with mitral valvuloplasty repair must be considered for insufficiencies with a prolapsed while mark relongation or rupture of the chordae tendineae and for insufficiencies with valve ado to blongation ements due to fusion of the commissures or chordae tendineae, or chordal hypertrophy.

Device Story

SJM Rigid Saddle Ring is a prosthetic annuloplasty device used in cardiac surgery to repair mitral valve annulus. Device consists of rigid titanium core covered with double velour polyester fabric sewing cuff. Implanted by cardiac surgeons during mitral valve repair procedures to correct annular dilation, increase leaflet coaptation, and prevent further dilation. Sizing (24mm-34mm) determined by inter-commissural distance using ring markers. Device provides structural support to mitral annulus, restoring proper valve geometry and function. Benefits include improved valve competence and reduced regurgitation in patients with diseased mitral valves.

Clinical Evidence

Bench testing only. Performance testing included ring tensile and compressive strength, suture pullout, needle penetration, computational structural analysis, holder evaluation, MR safety, shelf life, biocompatibility, chemical/morphological evaluation, and sterilization validation.

Technological Characteristics

Rigid titanium core; double velour polyester fabric sewing cuff; sizes 24mm-34mm; steam sterilized; dual barrier packaging; mechanical sizing via inter-commissural markers.

Indications for Use

Indicated for patients with mitral valve annular dilation and deformation caused by degenerative, rheumatic, ischemic, or vascular disease. Applicable for acquired or congenital mitral insufficiencies, including cases with chordae tendineae rupture/elongation or commissural fusion.

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

• Edwards Lifesciences GeoForm™ annuloplasty ring model 4200 (Carpentier-McCarthy-Adams |MR-ETlogix annuloplasty ring model 4100) (K032250)

Submission Summary (Full Text)

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K042734

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|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|---------|-----------|
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# 510(K) SUMMARY

(as required by 21 CFR 807.92)

#### Submitters Information A.

| Submitter's Name and Address: | St. Jude Medical, Inc.<br>Cardiac Surgery Division<br>One Lillehei Plaza<br>St. Paul, MN 55117 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name | William McKelvey, RAC<br>Regulatory Affairs Specialist<br>St. Jude Medical, Inc.<br>Bus: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Submission Prepared | September 30, 2004 |

B. **Device Information**

| Proprietary Name: | SJM™ Rigid Saddle ring<br>model RSAR-(size) |
|-------------------|---------------------------------------------|
|-------------------|---------------------------------------------|

Common or Usual Name:

Classification:

Predicate Device:

K032250-Edwards Lifesciences GeoForm™ annuloplasty ring model 4200 (Carpentier-McCarthy-Adams |MR-ETlogix annuloplasty ring model 4100)

Rigid Annuloplasty ring,

Class II per 21 CFR 870.3800,

Mitral Repair Ring

Annuloplasty rings

### Device Description:

The SJM™ Rigid Saddle Ring assembly consists of a rigid core machined from titanium covered with a double velour polyester fabric with a sewing cuff created for suturability. The ring is mounted on a holder and placed in a dual barrier package system. The package system is then steam sterilized. The SJM™ Rigid Saddle Ring is available in sizes 24mm-34mm (even sizes). Sizing is based on the inter-commissural distance as indicated by the commissure markers placed on the ring.

SJM® IAR annuloplasty ring - 510(k) Summary

01

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## Intended Use:

The SJM™ Rigid Saddle Ring is indicated for use to correct annular dilation, increase leaflet coaptation, and prevent further dilatation of the mitral valve annulus caused by liseased states such as degenerative disease, rheumatic disease, ischemia or vascular disease. The combination of prosthetic ring with valvuloplasty may be used in all acquired or congenital mitral insufficiencies with dilation and deformation of the fibrous mitral annulus.

For mitral insufficiencies with no subvalvular lesions and normal valvular movements, r of that ring implant alone may be sufficient. However, annuloplasty ring implant along with mitral valvuloplasty repair must be considered for insufficiencies with a prolapsed while mark relongation or rupture of the chordae tendineae and for insufficiencies with valve ado to blongation ements due to fusion of the commissures or chordae tendineae, or chordal hypertrophy.

#### Comparison of Required Technological Characteristics C.

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

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

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

The following performance testing was conducted;

- Ring Tensile Strength .
- Ring compressive Strength .
- Suture Pullout Test .
- Needle Penetration Test .

SJM® IAR annuloplasty ring ~ 510(k) Summary

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- Computational Structural Analysis
- Holder Evaluation .
- Assembled Ring/Holder Evaluation .
- MR Safety .
- Package Shelf Life Evaluation .
- Manufacturing Process validation .
- Biocompatibility Evaluation .
- Chemical and Morphological Evaluation .
- Sterilization Validation .
- Bioburden .
- Pyrogenicity .

### Conclusion

SJM has demonstrated that the SJM™ Rigid Saddle Ring is safe and effective for the intended use. The SJM™ Rigid Saddle Ring is, with respect to intended use and technological characteristics, substantially equivalent to the predicate device.

### SJM® IAR annuloplasty ring - 510(k) Summary

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2004

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

K042734 Re:

SJMTM Rigid Saddle Ring Model RSAR-(size) Regulation Number: 21 CFR 870.3800 Regulation Name: Rigid Annuloplasty Ring Regulatory Class: Class II (two) Product Code: KRH Dated: September 30, 2004 Received: October 1, 2004

Dear Mr. McKelvey:

We have reviewed your Section 510(k) premarket notification of intent to market the device in diedi we nave reviewed your becaon 910(t) promotion is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in intersuate for tose stated in the clebosity to regally manation to the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Ford, Frys commerce prior to May 20, 1976, are encordance with the provisions of the Federal Food, Drug, devices that have been recuired in accession in accessor and of a premarket approval application (PMA). and Cosment Act (Act) that do not require approvial controls provisions of the Act. The You may, uteretore, market me device, books of the months for annual registration, listing of general controls provisions of the rest 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 If your device is classified (500 a00 v) ols. Existing major regulations affecting your device can may be subject to such additional controliations, 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 or any I vith 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 OFF Part 877) its extens (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. product radiall of own 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 promation hotel in "Tresults 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]. 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 (2017) 97 + 1055 - 1055 Part 807.97) you may obtain. 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,

Duma R. Lechner

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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U.S. Food and Drug Administration - Center for Devices and Radiological Health

Page 1 of 1 -

510(k) Number (if known): K042734

SJM™ Rigid Saddle Ring _______________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________

### Indications For Use

The SJM™ Rigid Saddle ring is indicated for use to correct annular dilation, increase The Ouw - Right Cadele Heather dilatation of the mitral valve annulus caused by diseased states such as degenerative disease, rheumatic disease, Ischemia or vascular disease. The combination of prosthetic ring with valvuloplasty may be used in all discuse. "The ochibitation insufficiencies with dilation and deformation of the fibrous mitral annulus.

For mitral insufficiencies with no subvalvular lesions and normal valvular movements, r of thirds including may be sufficient. However, annuloplasty ring implant prostred img million valvuloplasty repair must be considered for insufficiencies with a along with intral value of elongation or rupture of the chordae tendineae and for insufficiencies with limitation of valvular movements due to fusion of the commisures or chordae tendineae, or chordal hypertrophy.

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

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dwane D. Schurch

(Division Sign-Off) (Division Orgin Sign Scular Devices

510(k) Number_K642734