CG FUTURE ANNULOPLASTY BAND

K052860 · Medtronic Heart Valves · KRH · Nov 10, 2005 · Cardiovascular

Device Facts

• Record ID: K052860
• Device Name: CG FUTURE ANNULOPLASTY BAND
• Applicant: Medtronic Heart Valves
• Product Code: KRH · Cardiovascular
• Decision Date: Nov 10, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CG Future® Annuloplasty Band is 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

The CG Future Annuloplasty Band is a single-use, permanent, semi-rigid implantable device for mitral valve repair. It consists of a polyester fabric-covered MP35N metallic wire stiffener, over-molded with LSR silicone. The band features eyelets at both ends and green-colored suture markers at the trigone and center locations. It is implanted in the mitral position by a surgeon. The device is used with a disposable holder, reusable sizers, and a reusable handle to facilitate sizing and anchoring into the trigones. By providing structural support to the mitral annulus, the band enables annular remodeling, which helps correct valvular insufficiency and stenosis, potentially improving valve function and patient outcomes.

Clinical Evidence

Bench testing only. Verification and validation studies were performed to demonstrate that modifications to the predicate device did not affect performance or intended use. No new biocompatibility testing was required.

Technological Characteristics

Semi-rigid implantable band; materials include polyester fabric, MP35N metallic wire, and LSR silicone. Dimensions range from 26mm to 38mm. Non-electronic, mechanical device. Sterilization processes are consistent with the predicate device.

Indications for Use

Indicated for patients requiring reconstruction or remodeling of pathological mitral valves to correct valvular insufficiency and/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® Annuloplasty Band (K011395)

Submission Summary (Full Text)

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K 052 860
CG FUTURE™ Annuloplasty Band

Special 510(k): Device Modification

NOV 1 0 2005

# SUMMARY OF SAFETY AND EFFECTIVENESS

## CG Future® Annuloplasty Band

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA and CFR 807.92.

#### I SUBMITTER INFORMATION

| Company Name: | Medtronic Heart Valves (Medtronic |
|------------------------|---------------------------------------------------|
| Company Address: | 8299 Central Avenue N.E.<br>Minneapolis, MN 55432 |
| Company Phone: | [phone] |
| Company Facsimile: | [phone] |
| Contact Person: | Julie Sherman<br>Regulatory Affairs Manager |
| Date Summary Prepared: | October 10, 2005 |

#### II DEVICE IDENTIFICATION

| Trade/Proprietary Name: | CG Future® Annuloplasty Band<br>[Model 638B] |
|-------------------------|----------------------------------------------|
| 21 CFR Reference: | 870.3800 |
| 21 CFR Common Name: | Ring, Annuloplasty |
| Classification: | Class II |
| Panel: | CV (74) KRH |

#### III IDENTIFICATION OF PREDICATE DEVICE

| Device | Model # | FDA Clearance |
|------------------------------|---------|------------------------|
| CG Future® Annuloplasty Band | 638B | K011395, July 12, 2001 |

#### IV DEVICE DESCRIPTION

The CG FUTURE Band is a single use, permanent, semi-rigid, implantable device intended for the repair of a patient's mitral valve. The CG FUTURE Band consists of a partial band of polyester fabric covering a formed, metallic (MP35N) wire stiffener material with eyelets formed at both ends. The stiffener element is over-molded with LSR silicone. The band is marked at three locations (the two trigone locations and the center) with green-colored suture.

Image /page/0/Picture/13 description: The image shows the Medtronic logo and the word "Confidential" underneath it. The Medtronic logo is a stylized image of a person with outstretched arms. The text is in a bold, sans-serif font. The image is likely from a document or presentation that is confidential and intended for internal use only.

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Two trigone markers identify the eyelets in the stiffener to facilitate anchoring of the stiffener into the trigones by the surgeon with sutures. The individual band size (26, 28, 30, 32, 34, 36, and 38mm) represents the widest, straight-line distance as measured at the inside of the fabric-covered band. The band is designed for implantation in the mitral position only.

The CG FUTURE Band is used with associated accessories that include a holder, sizers and a handle. Implantation of the band is aided with the disposable band holder. The band is released from the holder by cutting suture at two points. The CG FUTURE Band sizer set is used to assess appropriate band size. The sizers cover all seven sizes of the CG FUTURE Band and are marked with the band size and the trigone locations. The sizers are reusable and are provided non-sterile. The reuseable annuloplasty handle, which is available in two lengths, interfaces with both the holder and the sizers.

#### V DESCRIPTION OF INTENDED USE

The CG Future® Annuloplasty Band is 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.

#### SUBSTANTIAL EQUIVALENCE VI

The CG FUTURE Band and the modified CG FUTURE Band are manufactured using the same raw materials, manufacturing, packaging and sterilization processes. Both products have the same indications for use.

#### VII PERFORMANCE DATA

.

The CG FUTURE Band was subjected to verification and validation studies. The verification/validation studies demonstrate that the modifications to the predicated device are appropriate and do not affect the intended use or performance of the device.

No changes have been made to the manufacturing or sterilization of this device to warrant new or additional biocompatibility testing of the device components.

Image /page/1/Picture/10 description: The image shows the Medtronic logo with the word "Medtronic" in bold, black letters. Below the logo, the word "Confidential" is written in a smaller, black font. The Medtronic logo is a circular design with abstract shapes inside.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 2005

Medtronic Cardiac Surgery c/o Ms. Julie Sherman Regulatory Affairs Manager 8299 Central Avenue NE Minneapolis, MN 55432-3576

Re: K052860 CG Future® Annuloplasty Band Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II (Two) Product Code: KRH Dated: October 10, 2005 Received: October 11, 2005

Dear Ms. Sherman:

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 - Ms. Julie Sherman

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Dmna R. Vachner

Image /page/3/Picture/5 description: The image shows a signature. The signature is composed of a few curved lines and a horizontal line. The signature is in black ink and is on a white background.

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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### 510(k) Number (if known): K05 ھے ھاے ے کے ے

Device Name: CG Future Annuloplasty Band [Model 638B]

### Indications for Use:

The CG Future Annuloplasty Band is 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ X Per 21 CFR 801.109

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Dr. Anna R. Lochner

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_k 0.5 28 0

Image /page/4/Picture/14 description: The image shows the Medtronic logo and the word "Confidential" in bold black font. The Medtronic logo is on the left side of the image and consists of a circle with a stylized design inside. The word "Medtronic" is on the right side of the logo, and the word "Confidential" is below the word "Medtronic".