FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band

K161815 · Genesee Biomedical, Inc. · KRH · Oct 12, 2016 · Cardiovascular

Device Facts

• Record ID: K161815
• Device Name: FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band
• Applicant: Genesee Biomedical, Inc.
• Product Code: KRH · Cardiovascular
• Decision Date: Oct 12, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty Band are indicated for use in patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty rings and bands provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.

Device Story

Fully flexible annuloplasty rings and bands; used to stabilize and reduce mitral or tricuspid valve annulus during surgical repair. Constructed of braided polyester fabric with internal radiopaque marker for visualization. Available in nine sizes (24-40 mm). Surgeon selects ring (complete) or band (partial) based on preference; uses FlexForm Sizers to determine correct size. Implanted during open-heart surgery; provides structural support to annulus; restricts pathological expansion. Benefits patient by facilitating valve repair and preservation.

Clinical Evidence

Bench testing only. Performance testing included tensile strength of ring body materials, tensile strength of construction sutures, and suture pull-out testing to verify design requirements and demonstrate equivalence to predicates.

Technological Characteristics

Braided polyester fabric construction; circumferential flexible radiopaque marker for visualization; nine sizes (24-40 mm); suture markers for trigone and posterior section placement. Sterilized device; non-active, mechanical implant.

Indications for Use

Indicated for patients undergoing mitral or tricuspid valve repair surgery where valve preservation is possible. Provides annular support and restricts expansion.

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

• ATS Simulus Annuloplasty Ring Model 700FF
• ATS Simulus FC Annuloplasty Ring Model 700FC

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 12, 2016

Genesee Biomedical, Inc. Woodrow Mathison President and CEO 700 W. Mississippi Ave Unit D-5 Denver, Colorado 80223-4509

Re: K161815

Trade/Device Name: FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II Product Code: KRH Dated: September 12, 2016 Received: September 13, 2016

Dear Mr. Mathison:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

M.A. Hillebrenner

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) K161815

Device Name

FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty Band

Indications for Use (Describe)

The FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty Band are indicated for use in patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty rings and bands provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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## 510(k) Summary FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty Band

| Applicant | Genesee BioMedical, Inc.<br>700 W Mississippi Ave. Unit D-5<br>Denver, Colorado 80223-4509<br>Toll Free: 1-800-786-4890 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Woodrow G. Mathison, President and CEO<br>700 W Mississippi Ave. Unit D-5<br>Denver, Colorado 80223-4509<br>[e-mail] |
| Date Prepared | October 6, 2016 |
| Trade Name | FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty<br>Band |
| Common or Usual<br>Name: | Annuloplasty Ring or Annuloplasty Band |
| Classification | Class II: Special Controls<br>Regulation Number: 21 CFR 870-3800 |
| Product Code | KRH |
| Review Panel | Cardiovascular |
| Predicate Device | The subject device is substantially equivalent to the ATS Simulus<br>Annuloplasty Ring Model 700FF and the ATS Simulus FC<br>Annuloplasty Ring Model 700FC. |
| Device Description | The FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty<br>Band are fully flexible annular rings and bands designed to reduce and<br>stabilize the valve annulus in patients undergoing mitral or tricuspid<br>repair. |
| | The rings and bands are made of braided polyester fabric. The ring and<br>band contain a circumferential flexible radiopaque marker. The<br>internal radiopaque marker provides radiographic visualization along<br>the entire circumference. |
| | The rings and bands are available in nine sizes: 24 mm; 26 mm; 28<br>mm; 30 mm; 32 mm; 34 mm, 36 mm, 38 mm and 40 mm. The size<br>refers to the inner circumference between the green suture markers |
| nearest the anterior location of the ring and band. FlexForm™ Sizers,<br>Model FRBS, are used to determine the correct size of the ring or<br>band. | |
| The differences between the ring and band are as follows:<br>The FlexForm™ Ring is a complete annular ring. Five markers<br>are provided on the ring; two markers indicate the approximate<br>location of the trigones; three additional markers are provided as<br>an aid to suture placement in the posterior section. | |
| The FlexForm™ Band is a partial ring, without an anterior<br>segment. The key dimensions are the same as the FlexForm<br>Annuloplasty Ring, except for the absence of the anterior<br>segment. Five markers are provided on the band; two markers<br>indicate the approximate location of the trigones; three markers<br>are provided as an aid to suture placement in the posterior<br>section. | |
| The choice of ring or band is based on surgeon preference. | |
| Indication for Use | The FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty<br>Band are indicated for use in patients undergoing surgery of diseased<br>or damaged mitral or tricuspid valves in whom the surgeon determines<br>that the valve can be preserved by employing the appropriate surgical<br>repair. The annuloplasty rings and bands provide support for the mitral<br>or tricuspid annulus and restrict expansion of the annulus. |
| Principle and<br>Mechanism of<br>Operation | The FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty<br>Band provide support for the mitral or tricuspid annulus and restrict<br>expansion of the annulus. |
| Functional and Safety<br>Testing | To verify that device design meets functional and performance<br>requirements, representative samples of the devices underwent testing<br>in accordance with applicable standards and guidance. These data<br>provide an acceptable assurance of the safety and effectiveness of the<br>FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty Band<br>and demonstrate the devices are equivalent to the predicates. |
| Comparative<br>Technology<br>Characteristics | A comparison of the characteristics of the proposed device and the<br>predicate devices shows the FlexForm™ Annuloplasty Ring and<br>FlexForm™ Annuloplasty Band to have the same technological<br>characteristics as the predicate devices that have received 510(k)<br>clearance. |
| Equivalence is based upon intended use, indications for use, principles<br>of operation and fundamental technology. Both devices are intended | |
| | for use in surgical repair of mitral and tricuspid heart valves. |
| | Both devices have similar or identical structure, materials of<br>composition, sterilization method, size range, sizing accessories,<br>packaging and site of application in the body. |
| Non-Clinical Tests<br>Submitted | Performance testing was performed to support substantial<br>equivalence, including: |
| | Tensile strength of ring body materials<br>Tensile strength of construction sutures<br>Suture pull-out testing |
| Conclusion | Genesee BioMedical, Inc. considers the FlexFormTM Annuloplasty<br>Ring and FlexFormTM Annuloplasty Band to be equivalent to the<br>predicate devices. This conclusion is based upon the fact that the<br>devices have an equivalent intended use, and there are no differences<br>that raise new questions of safety and effectiveness. |

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