(225 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of the annuloplasty ring, with no mention of AI or ML technologies.
Yes.
The device is indicated for use in patients undergoing surgery for diseased or damaged mitral valves, providing support and restricting expansion of the mitral annulus. This directly addresses a medical condition, which is the definition of a therapeutic device.
No
The device is an implantable annuloplasty ring used to support and restrict the expansion of the mitral annulus. It is a therapy device, not a diagnostic one.
No
The device description clearly describes a physical, implantable annuloplasty ring made of materials like MP35N alloy, silicone, and polyester fabric. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "patients undergoing surgery for diseased or damaged mitral valves" and the device "provides support for and restricts expansion of the mitral annulus." This describes a surgical implant used directly on a patient's anatomy.
- Device Description: The description details a physical implantable ring made of specific materials (MP35N alloy, silicone core, braided polyester fabric) designed to be surgically placed.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition. IVDs are typically reagents, instruments, or systems used for testing samples.
The device described is a surgical implant used for mitral valve repair, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
TransForm McCarthy Mitral Annuloplasty Ring is indicated for use in patients undergoing surgery for diseased or damaged mitral valves. The ring provides support for and restricts expansion of the mitral annulus.
Product codes
KRH
Device Description
The TransForm™ McCarthy Mitral Annuloplasty Ring is an implantable, semi-rigid annuloplasty ring for mitral valve repair with the stiffened portions at the anterior and posterior segments. The ring is flexible at the commissure regions to allow physiological movement of the annulus. Stiffener placement allows the ring to maintain its "D" saddle shape during systole and a flastole. The stiffeners consist of MP35N 0.71 mm diameter (polished and formed) alloy. An elastic silicone core and braided polyester fabric form the ring body. The TransForm Annuloplasty Ring has four green radial markers at the left and right trigones and two markers at the mid-anterior and mid-posterior. The natural mitral annulus throughout the cardiac cycle. The interrupted stiffeners within the silcone core provide semi-rigid elastic flexibility. Elasticity of the "D" to "O" or circular transformation, accommodates remodeling of the annulus, while creating inward forces to maintain circular annular qeometry aqainst physical expansion. The size range of TransForm is from 24mm with 2mm increments. Size refers to the internal CC diameter of the ring. Rings are intended to be implanted on the patient's mitral annulus to reduce and stabilize the annulus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mitral annulus
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)
The following non-clinical and/or clinical tests were completed on the TransForm McCarthy Mitral Annuloplasty Ring:
Computational Structural Analysis Braid tensile strength Radial Seam tensile test Suture pull out/tensile strength Sterilization validation Cytotoxicity Pyrogenicity
Non-clinical testing demonstrates that the construction braid tensile strength exceeds the passffail criteria, that the worst catific stiffener size have higher safety factors than the absolute worst case used for evaluation in this FEA, and that the braid material used to construct the TransForm McCarthy Mitral Annuloplasty Ring provides a suture pullout strength that exceeds the minimum pass/fail criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 9, 2024
Genesee Biomedical Inc Woodrow Mathison President and CEO 700 W. Mississippi Ave Unit D-5 Denver, Colorado 80223
Re: K232599
Trade/Device Name: TransForm McCarthy Mitral Annuloplasty Ring (TF) Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II Product Code: KRH Dated: March 6, 2024 Received: March 7, 2024
Dear Woodrow 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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-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 Advice (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 -S
Jaime Raben, PhD Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K232599
Device Name
TransForm McCarthy Mitral Annuloplasty Ring
Indications for Use (Describe)
TransForm McCarthy Mitral Annuloplasty Ring is indicated for use in patients undergoing surgery for diseased or damaged mitral valves. The ring provides support for and restricts expansion of the mitral annulus.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| 510(k) #: | 510(k) Summary | Prepared on: 2024-04-09 | |
|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | ||
| Applicant Name | Genesee Biomedical Inc | ||
| Applicant Address | 700 W. Mississippi Ave Unit D-5 Denver CO 80223 United States | ||
| Applicant Contact Telephone | 303-777-3000 | ||
| Applicant Contact | Mr. Woodrow Mathison | ||
| Applicant Contact Email | wmathison@geneseebiomedical.com | ||
| Device Name | 21 CFR 807.92(a)(2) | ||
| Device Trade Name | TransForm McCarthy Mitral Annuloplasty Ring (TF) | ||
| Common Name | Annuloplasty ring | ||
| Classification Name | Ring, Annuloplasty | ||
| Regulation Number | 870.3800 | ||
| Product Code | KRH | ||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K161815 | FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band | KRH | |
| K072655 | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, M | KRH |
Device Description Summary
The TransForm™ McCarthy Mitral Annuloplasty Ring is an implantable, semi-rigid annuloplasty ring for mitral valve repair with the stiffened portions at the anterior and posterior segments. The ring is flexible at the commissure regions to allow physiological movement of the annulus. Stiffener placement allows the ring to maintain its "D" saddle shape during systole and a flastole. The stiffeners consist of MP35N 0.71 mm diameter (polished and formed) alloy. An elastic silicone core and braided polyester fabric form the ring body. The TransForm Annuloplasty Ring has four green radial markers at the left and right trigones and two markers at the mid-anterior and mid-posterior. The natural mitral annulus throughout the cardiac cycle. The interrupted stiffeners within the silcone core provide semi-rigid elastic flexibility. Elasticity of the "D" to "O" or circular transformation, accommodates remodeling of the annulus, while creating inward forces to maintain circular annular qeometry aqainst physical expansion. The size range of TransForm is from 24mm with 2mm increments. Size refers to the internal CC diameter of the ring. Rings are intended to be implanted on the patient's mitral annulus to reduce and stabilize the annulus.
21 CFR 807.92(a)(4)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
Intended Use/Indications for Use
TransForm McCarthy Mitral Annuloplasty Ring is in patients undergoing surgery for diseased or damaged mitral valves. The ring provides support for and restricts expansion of the mitral annulus.
Indications for Use Comparison
A comparison of the characteristics of the proposed device and/or reference device show that there are no differences between the subject device and the predicate device with respects indications and intended use. Both devices have the
4
same principle and mechanism of operation.
Technological Comparison
21 CFR 807.92(a)(6)
Technological aspects were assessed for substantial equivalence. The subject devices have similar size, shape, and material composition. The subject device, the TransForm McCarthy Annuloplasty Ring, contains and silicone elastic core that provide a semi-riaid flexibility that conforms to the mitral annulus and accommodates the remodeling of the annulus which differs from the predicate's fill; me only core. The silicone core of the subject device is also manufactured with 20% barium sulfate which with the MP35N stiffeners are radiopague. This differs from the predicate with 55% barium sulfate and 6% tungsten. The subject is made from the same polysulfone as the predicate but also contains two PEEK inserts to maintain the "D" saddle shape of the ring implantation. The subject device, the TransForm McCarthy Annuloplasty Ring, will be manufactured under equivalent conditions as the predicate device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following non-clinical and/or clinical tests were completed on the TransForm McCarthy Mitral Annuloplasty Ring:
Computational Structural Analysis Braid tensile strength Radial Seam tensile test Suture pull out/tensile strength Sterilization validation Cytotoxicity Pyrogenicity
Genesee BioMedical, Inc. considers the TransForm™ Mitral Annuloplasty Ring to be substantially equivalent to the predicate device. This conclusion is based upon the devices have an equivalent intended use and that there are no clinical, or biological differences in performance testing that raise new questions of safety and effectiveness. Non-clinical testing demonstrates that the construction braid tensile strength exceeds the passffail criteria, that the worst catific stiffener size have higher safety factors than the absolute worst case used for evaluation in this FEA, and that the braid material used to construct the TransForm McCarthy Mitral Annuloplasty Ring provides a suture pullout strength that exceeds the minimum pass/fail criteria.