DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE

K032810 · Medtronic Heart Valves · KRH · Dec 5, 2003 · Cardiovascular

Device Facts

• Record ID: K032810
• Device Name: DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE
• Applicant: Medtronic Heart Valves
• Product Code: KRH · Cardiovascular
• Decision Date: Dec 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Duran Band (Model H607H), Duran Ring and Band (Models 610R and 610B), the Duran AnCore Ring and Band (Models 620R and 620B) and the Duran AnCore Ring and Band with Chordal Guide (Models 620R and 620B) are indicated for the reconstruction and/or remodeling of pathological mitral and tricuspid valves. Note: The Chordal Guide feature of the Duran AnCore Ring/Band with Chordal Guide (Models 620R and 620B) is indicated only for chordal replacement surgery of pathological mitral valves.

Device Story

Permanent, implantable, flexible annuloplasty rings/bands; polyester fabric construction with 3-mm cross-section; silicone marker impregnated with barium sulfate for radiographic visualization. Used in cardiac surgery for mitral and tricuspid valve reconstruction/remodeling. Provided on holder to facilitate implantation; includes sizers for size assessment and handle for positioning. Sizes range 23mm to 35mm. Implanted by cardiac surgeons in clinical settings. Benefits include structural support for valve repair; Chordal Guide feature assists in chordal replacement surgery.

Clinical Evidence

Bench testing only. Biocompatibility established via historical use of materials (polyester fabric, polyester suture, barium-impregnated silicone) since 1978. Suture pull-out testing performed on polyester fabric (avg 26.90 lbs) and individual fibers (avg 2.61 lbs). Sterilization validated to SAL 10^-6 per ISO 10993-7.

Technological Characteristics

Flexible annuloplasty rings/bands; polyester fabric; silicone marker with barium sulfate; 3-mm cross-section; sizes 23-35mm. Sterilization: 100% ethylene oxide. No software or electronic components.

Indications for Use

Indicated for reconstruction and/or remodeling of pathological mitral and tricuspid valves. Chordal Guide feature indicated only for chordal replacement surgery of pathological mitral valves.

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

• Duran Ring (H608H) (K980534)

Reference Devices

• Duran Ring (H601H) (K893678)
• Posterior Band (607) (K960356)
• CG Future Band (638B) (K011395)

Submission Summary (Full Text)

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K032810

# DEC = 5 2003

## 510(k) SUMMARY

# DURAN PRODUCT FAMIL Y

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

#### SUBMITTER INFORMATION I

| Company Name: | Medtronic Heart Valves (Medtronic) |
|--------------------------------------|---------------------------------------------------|
| Company Address: | 8299 Central Avenue N.E.<br>Minneapolis, MN 55432 |
| Company Phone:<br>Company Facsimile: | [phone]<br>[phone] |
| Contact Person: | Julie Sherman<br>Regulatory Affairs Manager |
| Date Summary Prepared: | September 8, 2003 |

#### II DEVICE IDENTIFICATION

Trade/Proprietary Name:

Duran Band (Model H607H) Duran Ring and Band (Models 610R and 610B) Duran AnCore Ring and Band (Models 620R and 620B) Duran AnCore Ring and Band with Chordal Guide (Models 620R and 620B)

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 # | 510(k) Number |
|------------|---------|---------------|
| Duran Ring | H608H | K980534 |

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### The 510(k) also includes references to the following marketed devices:

| Device | Model # | 510(k) Number |
|----------------|---------|---------------|
| Duran Ring | H601H | K893678 |
| Posterior Band | 607 | K960356 |
| CG Future Band | 638B | K011395 |

#### IV DEVICE DESCRIPTION

The Duran product family (including the Duran products listed in Section II -DEVICE IDENTIFICATION), consist of permanent, implantable, flexible annuloplasty rings or bands made of polyester fabric with a 3-mm cross-section. A silicone marker, impregnated with barium sulfate enables radiographic visualization. The individual ring and band sizes range from 23mm to 35mm, in two-millimeter increments.

The Duran products are used with associated accessories that include a holder, handle and sizers. The ring or band is provided on a holder to facilitate implantation of the device. The sizers are used to assess appropriate ring or band size and the handle interfaces with the holder to allow for proper positioning of the ring or band.

#### V DESCRIPTION OF INDICATIONS FOR USE

The devices in the Duran product family (including the Duran products listed in Section II) are indicated for the reconstruction and/or remodeling of pathological mitral and tricuspid valves.

Note: The Chordal Guide feature of the Duran AnCore Ring and Band with Chordal Guide (Models 620R and 620B) is indicated only for chordal replacement surgery of pathological mitral valves.

#### VI SUBSTANTIAL EQUIVALENCE

The Duran products listed in Section II are substantially equivalent to the predicate, Duran Ring (Model H608H). The implantable portion of the devices (the annuloplasty ring or band) are identical to the previously cleared Duran Ring (Model H608H), only the packaging and accessories (including holder, handle and sizers) have changed. An additional ring and band size (23mm) was added for the Duran AnCore Ring and Band and the Duran AnCore Ring and Band with Chordal Guide (Models 620R and 620B), however this size is dimensionally the same as the smallest sized CG Future Band (Model 638B)(K011395) previously cleared by FDA.

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The devices have the same indications for use, repair of mitral and tricuspid valves. (Note: The Chordal Guide feature of the Duran AnCore Ring and Band with Chordal Guide (Models 620R and 620B) is indicated only for chordal replacement surgery of mitral valves.)

The devices are manufactured and sterilized (100% ethylene oxide) using the same process as cleared for the Duran Ring (Model H608H). The packaging is identical to that previously cleared for use with other devices in the Duran product family. The labeling is equivalent to the labeling previously cleared for use with the Duran Ring (Model H608H).

#### TECHNOLOGICAL CHARACTERISTICS VII

The Duran product family (including the Duran products listed in Section II), consist of permanent, implantable, flexible annuloplasty rings or bands made of polyester fabric with a 3-mm cross-section. A silicone marker, impregnated with barium sulfate enables radiographic visualization. The individual ring and band sizes range from 23mm to 35mm in two-millimeter increments.

Like the predicate device, Duran Ring (Model H608H), the products are indicated for the reconstruction and/or remodeling of pathological mitral and tricuspid valves. (Note: The Chordal Guide feature of the Duran AnCore Ring and Band with Chordal Guide (Models 620R and 620B) is indicated only for chordal replacement surgery of mitral valves.)

#### VIII PERFORMANCE DATA

The materials used in the manufacture of the Duran products listed in Section II are identical to those used in the predicate device, Duran Ring (Model H608H). The materials include polyester fabric, polyester suture and a silicone marker, impregnated with barium sulfate. These materials have been used to manufacture the Duran products since 1978 with no indication of biocompatibility issues. No changes have been made to the manufacturing or sterilization of this device to warrant new or additional biocompatibility testing of these components. The accessories are made from materials commonly used for medical devices and have been shown to be biocompatible.

Suture pull-out testing was previously conducted on the polyester fabric by looping a 0.009 inch diameter stainless steel wire through the fabric of a Duran Ring, then pulling the wire in a tensile test apparatus until failure. The average pull-out force was 26.90 lbs. Suture pull-out testing was also conducted on an individual fiber. The test consisted of looping only one coarse of the fabric with a 4-0 suture and performing a pull test in a tensile test apparatus. The average pullout force for this test was 2.61 lbs. No changes were made to the fabric, so this test was not repeated.

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The Duran products listed in Section II are sterilized using the same 100% ethylene oxide sterilization process previously qualified for the predicate, Duran Ring (Model H608H). As the result of changes to the packaging and accessories, Medtronic requalified the sterilization cycle for each of the products listed in Section II. The sterilization cycle provides an SAL (Sterility Assurance Level) of 10 6. Sterilant residual levels were tested and meet the requirements of ISO 10993-7 (1995), Biological evaluation of Medical Devices part 7: Ethylene Oxide Sterilization Residuals. Medtronic completes reverification of the Duran products sterilization qualification process on an annual basis.

Biological testing (including bioburden and pyrogen) and manufacturing process controls have been established for the Duran products listed in Section II. The testing and methods used are based on processes established for the predicate device, Duran Ring (Model H608H).

The Duran products are constructed from materials that have already been qualified through Medtronic product shelf-life validation testing. The packaging is identical to packaging previously qualified and cleared by FDA for other Duran products. Therefore, no additional shelf-life testing is required for the devices listed in Section II.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 5 2003

Medtronic Heart Valves c/o Mr. Phillip Nuerurer 8299 Central Avenue, N.E. Minneapolis, MN 55432-3576

Re: K032810

Duran Band (Model H607H) Duran Ring (Model 610R) Duran Band (Model 610B) Duran AnCore Ring (Model 620R) Duran AnCore Band (Model 620B) Duran AnCore Ring with Chordal Guide (Model 620R) Duran AnCore Band with Chordal Guide (Model 620B) Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II (two) Product Code: KRH Dated: September 8, 2003 Received: September 9, 2003

Dear Mr. Nuerurer:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your bocurer 310(s) person is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manative possible in the Medical Device A mendments, or to commence prior to May 20, 1970, the enastance 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 I ou may, mercedes, manot and not include requirements for annual registration, listing of general controls provisions of use ice, labeling, and prohibitions against misbranding and adulteration.

Image /page/4/Picture/9 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

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# Page 2 - Mr. Phillip Nuerurer

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 a0070) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations a be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Court of Feants concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least oc advised that I Drive bean that your device complies with other requirements of the Act that I DA has Inado a deceminations administered by other Federal agencies. You must or any I catal suatues and registanents, including, but not limited to: registration and listing (21 Comply with an the rice or equirements of the manufacturing practice requirements as set CFK Fart 607), adoling (21 CFR Part 820); and if applicable, the electronic form in the quality by events (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro neviews (2 veting your device as described in your Section 510(k) I mis icher will anow you to organ maing of substantial equivalence of your device to a legally prematics notification: "The Presults 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 If you desire specific advice for your act [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 other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address.

Sincerely yours,

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): K03 2 8 1 . O

Device Name:

Duran Band (Model H607H) Duran Ring (Model 610R) Duran Band (Model 610B) Duran AnCore Ring (Model 620R) Duran AnCore Band (Model 620B) Duran AnCore Ring with Chordal Guide (Model 620R) Duran AnCore Band with Chordal Guide (Model 620B)

### Indications for Use:

The Duran Band (Model H607H), Duran Ring and Band (Models 610R and 610B), the Duran AnCore Ring and Band (Models 620R and 620B) and the Duran AnCore Ring and Band with Chordal Guide (Models 620R and 620B) are indicated for the reconstruction and/or remodeling of pathological mitral and tricuspid valves.

Note: The Chordal Guide feature of the Duran AnCore Ring/Band with Chordal Guide (Models 620R and 620B) is indicated only for chordal replacement surgery of pathological mitral valves.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR 801.109

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Elia Malli

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

510(k) Number_ K632810