MEMO 3D SEMIRIGID ANNULOPLASTY RING

K071327 · Sorin Biomedica Cardio S.R.L. · KRH · Aug 10, 2007 · Cardiovascular

Device Facts

• Record ID: K071327
• Device Name: MEMO 3D SEMIRIGID ANNULOPLASTY RING
• Applicant: Sorin Biomedica Cardio S.R.L.
• Product Code: KRH · Cardiovascular
• Decision Date: Aug 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MEMO 3D™ device is intended for correction of mitral insufficiencies or steno-insufficiences. The use of the MEMO 3D™ device is indicated for correction of congenital or acquired mitral insufficiencies with dilatation and deformation of the mitral annulus. Type I insufficiencies, with no manifest lesions in the subvalvular apparatus, can be treated with the device on its own. For type II insufficiencies, characterized by valve prolapse sustained by elongation/breakage of the chordae tendineae and papillary muscles, and type III insufficiencies, characterized by partially immobilized leaflets due to the fusion/hypertrophy of the chordae tendineae, the device implantation must be accompanied by corrective valvuloplasty.

Device Story

MEMO 3D™ Semirigid Annuloplasty Ring; surgical implant for mitral valve repair. Device consists of metallic inner core embedded in medical-grade silicone, encased in tubular knitted fabric coated with Carbofilm™ (turbostratic carbon). Supplied pre-mounted on disposable holder to maintain shape and assist in measured plications of mitral annulus during implantation. Available in 24mm-38mm sizes. Used by cardiac surgeons in OR to restore mitral valve function; device provides structural support to annulus. Benefits include correction of mitral insufficiency/steno-insufficiency; stabilization of annulus geometry. Implantation may require concurrent valvuloplasty for Type II or Type III insufficiencies.

Clinical Evidence

Bench testing only. No clinical data presented. Non-clinical testing included ultimate tensile strength, suture pull-out, rigidity determination, computational stress analysis, fatigue and durability testing, corrosion resistance, biocompatibility, sterilization validation, pyrogenicity, and shelf-life.

Technological Characteristics

Semirigid annuloplasty ring; metallic inner core; medical-grade silicone sheath; tubular knitted fabric coated with Carbofilm™ (turbostratic carbon); Carbofilm™ coated polyester thread. Sizes 24mm-38mm. Non-ferromagnetic. Sterile, non-pyrogenic. Disposable holder included for implantation.

Indications for Use

Indicated for patients with congenital or acquired mitral insufficiency or steno-insufficiency involving mitral annulus dilatation and deformation. Contraindicated in patients with severe organic lesions with chordae tendineae retraction, congenital malformations with limited valvular tissue, extensive valve leaflet calcification, or evolving bacterial endocarditis.

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

• Baxter Healthcare Corporation Carpentier-Edwards Physio Annuloplasty Ring (K926138)
• Carbomedics AnnuloFlo™ System (K970375 and K021051)
• Carbomedics AnnuloFlex™ Annuloplasty System (K023185)

Submission Summary (Full Text)

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K07/327

| 510(k) Summarv of Safety and Effectiveness | |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| Submitter | Sorin Biomedica Cardio S.r.l.<br>I-13040 Saluggia (VC) Italy<br>Via Crescentino<br>+39.0161.4871 [voice] |
| Contact | Heather Crawford, RAC<br>Regulatory Affairs Project Manager<br>CarboMedics, Inc.<br>1300 East Anderson Lane<br>Austin, Texas 78752<br>512.435.3266 [voice] |
| | 512.435.3350 [facsimile]<br>[e-mail] [email] |
| Date | May 10, 2007 |
| Device | Trade Name: MEMO 3D™ Semirigid Annuloplasty Ring 21 CFR 870.3800: Annuloplasty Ring Product Code: KRH - Class II - Special Controls Medical Specialty: Cardiovascular |
| Predicate<br>Devices | K926138: Baxter Healthcare Corporation Carpentier-Edwards Physio Annuloplasty Ring K970375 and K021051: Carbomedics AnnuloFlo™ System K023185: Carbomedics AnnuloFlex™ Annuloplasty System |

AUG 1 0 2007

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MEMO 3D and Carbofilm are trademarks of Sorin Biomedica Cardio.
Carpentier-Edwards and Carpentier-Edwards Physio are registered trademarks of Edwards Lifesciences.

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## 510(k) Summary of Safety and Effectiveness, Continued

| <b>Indications<br/>for Use</b> | The MEMO 3D™ device is intended for correction of mitral insufficiencies<br>or steno-insufficiences. <p>The use of the MEMO 3D™ device is indicated for correction of congenital or acquired mitral insufficiencies with dilatation and deformation of the mitral annulus. Type I insufficiencies, with no manifest lesions in the subvalvular apparatus, can be treated with the device on its own. For type II insufficiencies, characterized by valve prolapse sustained by elongation/breakage of the chordae tendineae and papillary muscles, and type III insufficiencies, characterized by partially immobilized leaflets due to the fusion/hypertrophy of the chordae tendineae, the device implantation must be accompanied by corrective valvuloplasty.</p> |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Contra-<br/>indications</b> | The annuloplasty rings should not be used in the case of: <ul><li>Severe organic lesions with retraction of chordae tendinae</li><li>Congenital malformations with limited valvular tissue</li><li>Extensive calcification of valve leaflets</li><li>Evolving bacterial endocarditis</li></ul> |
| <b>Device<br/>Description</b> | The MEMO 3D™ Semirigid Annuloplasty Ring is supplied as a sterile, non- pyrogenic, non-ferromagnetic ring pre-mounted on a disposable holder. The annuloplasty ring is manufactured by embedding a metallic inner core with medical grade silicone. The resulting silicone sheath, around the metallic core, is then encased within a tubular knitted fabric coated with Carbofilm™, which is a thin layer of turbostratic carbon. The fabric is then sewn along its length with Carbofilm™ coated polyester thread. <p>The annuloplasty ring is attached to the disposable holder to maintain the shape of the ring during implantation and allow for measured plications of the mitral annulus. Suture guides are present on the holder to aid the surgeon during ring placement.</p> <p>The MEMO 3D™ annuloplasty ring is available in sizes 24mm through 38mm in two millimeter increments. A complete set of accessory instrumentation is to be available separately to properly size the annulus and implant the annuloplasty ring.</p> |
| | <i>Continued on next page</i> |
| | K071327 |

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MEMO 3D and Carbofilm are trademarks of Sorin Biomedica Cardio. Carpentier-Edwards and Carpentier-Edwards Physio are registered trademarks of Edwards Lifesciences.

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## 510(k) Summary of Safety and Effectiveness, Continued

The MEMO 3D™ Semirigid Annuloplasty Ring is considered to be Technological Characteristics substantially equivalent in technological characteristics and intended use to the predicate devices. Equivalency is supported by multiple characteristics, including:

- Intended use 。一
- Anatomical site for implantation -
- Product labeling -
- Physical characteristics -
- Target population -
- Performance testing -
- Safety characteristics -

Non-Clinical Testing demonstrated that the MEMO 3D™ Semirigid Annuloplasty Ring is Testing substantially equivalent to the predicate devices for repair of the mitral valve. Non-clinical testing included: ultimate tensile strength, suture pull-out, rigidity determination, computational stress analysis, fatigue and durability testing, corrosion resistance, biocompatibility, sterilization validation, pyrogenicity, and shelf-life.

- Conclusion The MEMO 3D™ Semirigid Annuloplasty Ring has been demonstrated as safe and effective for its intended use. With respect to intended use and technological characteristics, the MEMO 3DTM Semirigid Annuloplasty Ring is substantially equivalent to the legally marketed predicate devices.
071327

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MEMO 3D and Carbofilm are trademarks of Sorin Biomedica Cardio. Carpentier-Edwards and Carpentier-Edwards Physio are registered trademarks of Edwards Lifesciences.

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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 features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized depiction of an eagle or bird-like figure, with three curved lines representing its wings or body.

AUG 1 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sorin Biomedica Cardio S.R.L. C/O Heather Crawford, RAC Project Manager, Regulatory Affairs Carbomedics, Inc. 1300 East Anderson Lane Austin, TX 78752-1793

Re: K071327

Trade/Device Name: MEMO 3D™ Semirigid Annuloplasty Ring Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II Product Code: KRH Dated: May 10, 2007 Received: May 11, 2007

Dear Ms Crawford:

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.

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

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## Page 2 - Ms. Crawford

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 Biometric's (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,

Blyminmar for

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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## Indications for Use

510(k) Number (if known):

07/327

Device Name: MEMO 3D™ Semirigid Annuloplasty Ring

Indications for Use:

MEMO 3D™ device is intended for correction of mitral insufficiencies or stenoinsufficiencies.

The use of the MEMO 3D™ device is indicated for correction of congenital or acquired mitral insufficiencies with dilatation and deformation of the mitral annulus. Type I insufficiencies, with no manifest lesions in the subvalvular apparatus, can be treated with the device on its own. For type II insufficiencies, characterized by valve prolapse sustained by elongation/breakage of the chordae tendineae and papillary muscles, and type III insufficiencies, characterized by partially immobilized leaflets due to the fusion/hypertrophy of the chordae tendineae. the device implantation must be accompanied by corrective valvuloplasty.

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)

B. Hemmerm

Division Sign-Off Division of Cardlovascular Devices 510(k) Number

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