MICARDIA ANNULOPLASTY BAND DR

K070488 · Micardia Corporation · KRH · Sep 4, 2008 · Cardiovascular

Device Facts

• Record ID: K070488
• Device Name: MICARDIA ANNULOPLASTY BAND DR
• Applicant: Micardia Corporation
• Product Code: KRH · Cardiovascular
• Decision Date: Sep 4, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Annuloplasty Band DR and Annuloplasty Ring DR are indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.

Device Story

Annuloplasty Band DR (RNG6) and Ring DR (RNG7) provide annular support for mitral valve repair; fabricated from nickel titanium support ring, silicone, and polyester fabric. Used during open-heart bypass surgery; implanted via sutures. Includes reusable sizers (SZR1) and handle (HNDL) to measure mitral valve commissures, anterior leaflet length, and surface area. Device reduces mitral annulus opening, increasing coaptation depth between anterior and posterior leaflets to resolve mitral regurgitation. Operated by surgeons in clinical/OR settings.

Clinical Evidence

Bench testing only. Testing included biocompatibility, computational structural analysis, ring tensile strength, suture pull-out strength, sterilization validation, bioburden/pyrogen testing, packaging/shelf-life analysis, corrosion testing, and MRI analysis.

Technological Characteristics

Nickel titanium support ring, silicone, polyester fabric covering. Sizes: 28-36 mm. Implanted via sutures. Non-active, mechanical device. Sterilized.

Indications for Use

Indicated for patients requiring reconstruction or remodeling of pathological mitral valves to correct valvular insufficiency or stenosis.

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

• CG Future® (K011395/K052860)

Submission Summary (Full Text)

{0}------------------------------------------------

K070488

SEP - 2008

## 510(k) Summary (as required by 21 CFR 807.92)

#### 1. Submitter Information

| Company Name: | MiCardia Corporation |
|--------------------------------------|------------------------------------------------------------|
| Company Address: | 30 Hughes - Suite 206<br>Irvine, CA 92618 |
| Company Phone:<br>Company Facsimile: | 949-951-4888<br>949-951-4812 |
| Contact Person: | Jeffrey P. DuMontelle<br>Director of RA, QA and Compliance |
| Date Summary Prepared: | February 16, 2007 |

### 2. Device Identification

Trade or Proprietary Name:

Annuloplasty Band DR™ (Model RNG6) Annuloplasty Ring DR™ (Model RNG7)

| Common Name: | Ring, Annuloplasty |
|--------------------|--------------------|
| Classification: | Class II |
| Regulation Number: | 21 CFR 870.3800 |
| Product Code: | (74) KRH |

### 3. Identification of Predicate Device

| Device | Model # | FDA Clearance |
|------------|-----------|-----------------|
| CG Future® | 638B/638R | K011395/K052860 |

### 4. General Description

MiCardia's Annuloplasty Band DR™ (Model RNG6) and Annuloplasty Ring DR™ (Model RNG7) function as annular support for the mitral annulus only. The devices are fabricated from a nickel titanium support ring surrounded by silicone with a polyester fabric covering. The devices are mounted on holders, packaged in a barrier packaging system and governa sterilized. The devices are available in sizes 28 mm, 30 mm, 32 mm, 34 mm, and 36 mm. The size of the device is based on the inter-commissural markers placed on the ring. The devices are permanently implanted using sutures and typical techniques for mitral valve repair using open-heart bypass.

The Annuloplasty Band DR™ and Annuloplasty Ring DR™ are used with associated accessories that include a holder, and reusable sizers (Model SZR1) and reusable handle (Model HNDL). The handle may be attached to either the sizers or the holders to aid in sizing or implantation. The diseased mitral valve annulus is measured with the appropriate MiCardia sizer. The sizers are provided in five (5) sizes; 28 mm, 30 mm, 32 mm, 34 mm, and 36 mm. The sizers are used to evaluate the distance between the patient's mitral valve commissures, anterior leaflet length and surface area, in order to select the approvial esize of annuloplasty band or ring for the repair. The appropriately sized band or ring is implanted using a series of sutures, typically 2-0 or 3-0, placed approximately 4 mm apart. The band or

{1}------------------------------------------------

ring is used to reduce the mitral annulus opening thereby causing a closer approximation of the anterior and posterior leaflets. This typically creates an increase in the depth of coaptation between the anterior and posterior leaflets when they are closed and resolves the pathological mitral valve (e.g. mitral regurgitation),

### న్. Intended Use

The Annuloplasty Band DR and Annuloplasty Ring DR devices are indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.

### 6. Comparison of Required Technological Characteristics

MiCardia Corporation considers the Annuloplasty Band DR and Annuloplasty Ring DR to be substantially equivalent in technological characteristics (e.g. design and materials) and intended use to the predicate devices. Table 6.1 below is a comparison of the equivalency characteristics between the MiCardia Annuloplasty Band DR/Annuloplasty Ring DR and the predicate devices.

| Characteristic | Equivalency |
|-----------------------------|--------------------------|
| 1. Product Labeling | Substantially equivalent |
| 2. Intended Use | Identical |
| 3. Physical Characteristics | Substantially equivalent |
| 4. Anatomical Sites | Identical |
| 5. Target Population | Substantially equivalent |
| 6. Performance Testing | Substantially equivalent |
| 7. Safety Characteristics | Substantially equivalent |

## Table 6.1

## Characteristic Comparison of Annuloplasty Band DR/Ring DR to Predicate Devices

### 7. Summary of Non-Clinical Tests

The following was conducted:

- Biocompatibility Testing a.
- b. Computational Structural Analysis
- Ring Tensile Strength C.
- d. Suture Pull-out Strength
- e. Sterilization Validation
- f. Bioburden and Pyrogen
- g. Packaging and Shelf Life Analysis
- Corrosion h.
- Magnetic Resonance Imaging Analysis i.

### 7. Conclusion

MiCardia Corporation has demonstrated that the Annuloplasty Band DR™ and Annuloplasty Ring DRTM are safe and effective for the intended use. The Annuloplasty Band Annuloplasty Band DR and Annuloplasty Ring DR are substantially equivalent to the predicate devices with respect to their intended use and technological characteristics.

## END OF 510(k) SUMMARY

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three bars above its head, representing the department's commitment to health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 4 2008

MiCardia Corporation c/o Mr. Jeffrey DuMontelle Director of RA, QA and Compliance 30 Hughes Suite 206 Irvine CA 92618

Re: K070488 Trade/Device Name: MiCardia's Annuloplasty Band DR™ (Model RNG6) and Annuloplasty Ring DR™ (Model RNG7) Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II Product Code: KRH Dated: May 22, 2008 Received: May 23, 2008

Dear Mr. DuMontelle:

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 indirlotions 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 Amendrants, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, or otvices ma Act (Act) that do not require approval of a premarket approval application (PMA). You most. therefore, market the device, subject to the general controls provisions of the Act. Too may, controls provisions of the Act include requirements for annual registration listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulterstion.

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.

{3}------------------------------------------------

## Page 2 - Mr. Jeffrey DuMontelle

Please be advised that FDA's issuance of a substantial equivalence detcrmination 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Dma R. Vochner

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

Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known): K070488

Device Name: _________________________________________________________________________________________________________________________________________________________________

### Indications for Use:

The Annuloplasty Band DR and Annuloplasty Ring DR are indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be correct d by appropriate repair and annular remodeling.

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page |_ of _ |

Duna D. Lames

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K070488

(Posted November 13, 2003)