(57 days)
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.
The TruForm™ Sievers Annuloplasty Ring, Model TRH is a semi-flexible implantable annuloplasty ring designed to reduce and stabilize the valve annulus in patients undergoing mitral repair. The inner core of the ring is made of a titanium alloy. Silicone covers the inner core and a sewing cuff made of braided polyester encompasses the ring. Three points of the ring are marked with polyester suture to aid in suture placement for implantation. The ring is available in ten (10) sizes: 24 mm; 26 mm; 28 mm; 30 mm; 32 mm; 34 mm; 36 mm; 38 mm; 40 mm; and 42 mm.
The provided text describes the regulatory clearance for a medical device called the TruForm™ Sievers Annuloplasty Ring, Model TRH. It is a 510(k) premarket notification, which means the device is being declared substantially equivalent to existing, legally marketed predicate devices.
However, the document does not describe a study involving an algorithm or AI, nor does it present acceptance criteria for an AI device. The TruForm™ Sievers Annuloplasty Ring is a physical medical implant used for cardiac surgery.
Therefore, I cannot extract the information requested about acceptance criteria and studies proving the device meets them in the context of an AI device. The document focuses on the equivalence of a physical annuloplasty ring to its predicates through non-clinical testing and shared characteristics.
If there was a misunderstanding and the request was for a physical device, the acceptance criteria are generally met by demonstrating substantial equivalence to a predicate device through:
- Same intended use and indications for use.
- Similar technological characteristics.
- Addressing any differences that could raise new questions of safety and effectiveness through testing.
The non-clinical tests performed for this physical device to support substantial equivalence include:
- Biocompatibility
- Sterilization
- Computational Finite Element Analysis (FEA)
- Tensile strength of ring materials
- Suture pull-out testing
- MRI Compatibility
- Packaging
- Shelf-life
These tests demonstrate that the device is equivalent to the predicate and/or reference devices, implying it meets the safety and performance requirements for its intended use.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------------------------------------------------- |
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510(k) Summary TruForm™ Sievers Annuloplasty Ring
| Applicant | Genesee BioMedical, Inc.700 W Mississippi Ave. Unit D5Denver, Colorado 80223-4509 |
|---|---|
| Contact Person | Woodrow G. Mathison, President and CEOwmathison@geneseebiomedical.comPhone: 303-777-3000 Fax: 303-777-8866 |
| Date Prepared | October 1, 2020 |
| Trade Name | TruForm™ Sievers Annuloplasty Ring Model TRH |
| Common or Usual Name | Annuloplasty Ring |
| Classification | Class II Special ControlsRegulation Number: 21 CFR 870.3800 |
| Product Code | KRH |
| Review Panel | Cardiovascular |
| Predicate Device | The subject device is substantially equivalent to the NeoForm™Annuloplasty Ring, Model 4200 (K190506) |
| Reference Devices | K161815 - FlexForm Annuloplasty RingK905175 - Sculptor Annuloplasty RingK072655 - Simulus Annuloplasty Ring |
| Device Description | The TruForm™ Sievers Annuloplasty Ring, Model TRH is asemi-flexible implantable annuloplasty ring designed to reduceand stabilize the valve annulus in patients undergoing mitralrepair.The inner core of the ring is made of a titanium alloy. Siliconecovers the inner core and a sewing cuff made of braidedpolyester encompasses the ring. Three points of the ring aremarked with polyester suture to aid in suture placement forimplantation.The ring is available in ten (10) sizes: 24 mm; 26 mm; 28 mm;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 thecorrection of mitral valvular insufficiency where the lesions arenot so severe as to require total valve replacement. |
| Principle and Mechanismof Operation | The TruForm Sievers Annuloplasty Ring provides support forthe mitral valve and restricts expansion of the annulus. |
| Functional and SafetyTesting | To verify that device design meets functional and performancerequirements, representative samples of the devices underwenttesting in accordance with applicable standards and guidance.These data demonstrate the device is equivalent to the predicateand/or reference device. |
| Comparative TechnologyCharacteristics | A comparison of the characteristics of the proposed device andthe predicate and/or reference device show the TruForm™™Sievers Annuloplasty Ring to have the same technologicalcharacteristics as the predicate device that has received 510(k)clearance. |
| Equivalence is based upon intended use, indications for use,principles of operation and fundamental technology. Bothdevices are intended for use in surgical repair of mitral heartvalves. | |
| The subject and predicate device have similar or identicalmaterials of composition, size range, sizing accessories and siteof application in the body. | |
| Changes between the device and predicate include minormodifications to the shape and the addition of six (6) ring sizes. | |
| Non-Clinical TestsSubmitted | Testing was performed to support substantial equivalence,including: |
| BiocompatibilitySterilizationComputational Finite Element Analysis (FEA)Tensile strength of ring materialsSuture pull-out testingMRI CompatibilityPackagingShelf-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.
§ 870.3800 Annuloplasty ring.
(a)
Identification. An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”