TruForm Sievers Annuloplasty Ring

K202253 · Genesee Biomedical, Inc. · KRH · Oct 6, 2020 · Cardiovascular

Device Facts

• Record ID: K202253
• Device Name: TruForm Sievers Annuloplasty Ring
• Applicant: Genesee Biomedical, Inc.
• Product Code: KRH · Cardiovascular
• Decision Date: Oct 6, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TruForm Sievers Annuloplasty Ring is indicated for the correction of mittal valvular insufficiency where the lessions are not so severe as to require total valve replacement.

Device Story

TruForm Sievers Annuloplasty Ring (Model TRH) is a semi-flexible implantable device for mitral valve repair; reduces and stabilizes valve annulus. Device consists of titanium alloy inner core, silicone covering, and braided polyester sewing cuff. Implanted by cardiac surgeons during open-heart surgery. Provides structural support to mitral valve; restricts annular expansion. Output is physical stabilization of valve tissue. Benefits patient by correcting valvular insufficiency, potentially avoiding total valve replacement.

Clinical Evidence

Bench testing only. No clinical data presented. Non-clinical testing included biocompatibility, sterilization, computational finite element analysis (FEA), tensile strength of materials, suture pull-out testing, MRI compatibility, packaging, and shelf-life validation.

Technological Characteristics

Semi-flexible annuloplasty ring. Materials: titanium alloy core, silicone cover, braided polyester sewing cuff. Sizes: 24 mm to 42 mm (10 sizes). Principle: mechanical support/annular restriction. Implantable device.

Indications for Use

Indicated for patients with mitral valvular insufficiency requiring surgical repair where lesions are not severe enough to necessitate total valve replacement.

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

• NeoForm™ Annuloplasty Ring, Model 4200 (K190506)

Reference Devices

• FlexForm Annuloplasty Ring (K161815)
• Sculptor Annuloplasty Ring (K905175)
• Simulus Annuloplasty Ring (K072655)

Submission Summary (Full Text)

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October 6, 2020

Genesee BioMedical, Inc Woodrow Mathison President and CEO 700 W Mississippi Ave, Unit D5 Denver, Colorado 80223-4509

Re: K202253

Trade/Device Name: TruForm™ Sievers Annuloplasty Ring, Model TRH Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty ring Regulatory Class: Class II Product Code: KRH Dated: August 10, 2020 Received: August 11, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jaime Raben Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K202253

Device Name

TruForm Sievers Annuloplasty Ring, Model TRH

Indications for Use (Describe)

The TruForm Sievers Annuloplasty Ring is indicated for the correction of mittal valvular insufficiency where the lessions are not so severe as to require total valve replacement.

| Type of Use (Select one or both, as applicable) |
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| <div style="display:flex; align-items:center;"><span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
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## 510(k) Summary TruForm™ Sievers Annuloplasty Ring

| Applicant | Genesee BioMedical, Inc.<br>700 W Mississippi Ave. Unit D5<br>Denver, Colorado 80223-4509 |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Woodrow G. Mathison, President and CEO<br>[e-mail]<br>Phone: [phone] Fax: [phone] |
| Date Prepared | October 1, 2020 |
| Trade Name | TruForm™ Sievers Annuloplasty Ring Model TRH |
| Common or Usual Name | Annuloplasty Ring |
| 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 NeoForm™<br>Annuloplasty Ring, Model 4200 (K190506) |
| Reference Devices | K161815 - FlexForm Annuloplasty Ring<br>K905175 - Sculptor Annuloplasty Ring<br>K072655 - Simulus Annuloplasty Ring |
| Device Description | The TruForm™ Sievers Annuloplasty Ring, Model TRH is a<br>semi-flexible implantable annuloplasty ring designed to reduce<br>and stabilize the valve annulus in patients undergoing mitral<br>repair.<br>The inner core of the ring is made of a titanium alloy. Silicone<br>covers the inner core and a sewing cuff made of braided<br>polyester encompasses the ring. Three points of the ring are<br>marked with polyester suture to aid in suture placement for<br>implantation.<br>The ring is available in ten (10) sizes: 24 mm; 26 mm; 28 mm;<br>30 mm; 32 mm; 34 mm; 36 mm; 38 mm; 40 mm; and 42 mm. |
| Indications for Use: | The TruForm™™ Sievers Annuloplasty Ring is indicated for the<br>correction of mitral valvular insufficiency where the lesions are<br>not so severe as to require total valve replacement. |
| Principle and Mechanism<br>of Operation | The TruForm Sievers Annuloplasty Ring provides support for<br>the mitral valve and restricts 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<br>testing in accordance with applicable standards and guidance.<br>These data demonstrate the device is equivalent to the predicate<br>and/or reference device. |
| Comparative Technology<br>Characteristics | A comparison of the characteristics of the proposed device and<br>the predicate and/or reference device show the TruForm™™<br>Sievers Annuloplasty Ring to have the same technological<br>characteristics as the predicate device that has received 510(k)<br>clearance. |
| | Equivalence is based upon intended use, indications for use,<br>principles of operation and fundamental technology. Both<br>devices are intended for use in surgical repair of mitral heart<br>valves. |
| | The subject and predicate device have similar or identical<br>materials of composition, size range, sizing accessories and site<br>of application in the body. |
| | Changes between the device and predicate include minor<br>modifications to the shape and the addition of six (6) ring sizes. |
| Non-Clinical Tests<br>Submitted | Testing was performed to support substantial equivalence,<br>including: |
| | Biocompatibility<br>Sterilization<br>Computational Finite Element Analysis (FEA)<br>Tensile strength of ring materials<br>Suture pull-out testing<br>MRI Compatibility<br>Packaging<br>Shelf-life |

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## Conclusion

Genesee BioMedical, Inc. considers the TruForm™ Sievers Annuloplasty Ring to be equivalent to the predicate device. This conclusion is based upon the fact that the devices have an equivalent intended use, and there are no differences that raise different questions of safety and effectiveness.