(57 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of an implantable annuloplasty ring, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for the correction of mitral valvular insufficiency, and is implanted in patients to reduce and stabilize the valve annulus, which are direct interventions for a medical condition.
No
Explanation: The device is an implantable annuloplasty ring used for the correction of mitral valvular insufficiency by reducing and stabilizing the valve annulus during surgical repair. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is an implantable annuloplasty ring made of titanium alloy, silicone, and polyester, indicating it is a physical hardware device, not software.
Based on the provided information, the TruForm™ Sievers Annuloplasty Ring is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the TruForm™ Sievers Annuloplasty Ring is an implantable annuloplasty ring designed to be surgically placed within the body to repair the mitral valve annulus. It is a physical device used in a surgical procedure, not a test performed on a sample outside the body.
Therefore, the TruForm™ Sievers Annuloplasty Ring falls under the category of an implantable medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
KRH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mitral valvular insufficiency / valve annulus / mitral heart valves
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional and Safety Testing: To verify that device design meets functional and performance requirements, representative samples of the devices underwent testing in accordance with applicable standards and guidance. These data demonstrate the device is equivalent to the predicate and/or reference device.
Non-Clinical Tests Submitted: Testing was performed to support substantial equivalence, including:
Biocompatibility
Sterilization
Computational Finite Element Analysis (FEA)
Tensile strength of ring materials
Suture pull-out testing
MRI Compatibility
Packaging
Shelf-life
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 D5
Denver, Colorado 80223-4509 |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Woodrow G. Mathison, President and CEO
wmathison@geneseebiomedical.com
Phone: 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 Controls
Regulation 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 Ring
K905175 - Sculptor Annuloplasty Ring
K072655 - Simulus Annuloplasty Ring |
| Device Description | 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. |
| Indications for Use: | The TruForm™™ Sievers Annuloplasty Ring is indicated for the
correction of mitral valvular insufficiency where the lesions are
not so severe as to require total valve replacement. |
| Principle and Mechanism
of Operation | The TruForm Sievers Annuloplasty Ring provides support for
the mitral valve and restricts expansion of the annulus. |
| Functional and Safety
Testing | To verify that device design meets functional and performance
requirements, representative samples of the devices underwent
testing in accordance with applicable standards and guidance.
These data demonstrate the device is equivalent to the predicate
and/or reference device. |
| Comparative Technology
Characteristics | A comparison of the characteristics of the proposed device and
the predicate and/or reference device show the TruForm™™
Sievers Annuloplasty Ring to have the same technological
characteristics 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. Both
devices are intended for use in surgical repair of mitral heart
valves. |
| | The subject and predicate device have similar or identical
materials of composition, size range, sizing accessories and site
of application in the body. |
| | Changes between the device and predicate include minor
modifications to the shape and the addition of six (6) ring sizes. |
| Non-Clinical Tests
Submitted | Testing was performed to support substantial equivalence,
including: |
| | Biocompatibility
Sterilization
Computational Finite Element Analysis (FEA)
Tensile strength of ring materials
Suture pull-out testing
MRI Compatibility
Packaging
Shelf-life |
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5
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.