(48 days)
The NeoForm™ Annuloplasty Ring is indicated for the correction of mitral valvular insufficiency where the lesions are not so severe as to require total valve replacement.
The NeoForm™ Annuloplasty Ring, Model 4200 is a rigid 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 polyester fabric 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 four sizes: 26 mm; 28 mm; 30 mm; and 32 mm.
This document describes the 510(k) summary for the NeoForm™ Annuloplasty Ring, Model 4200. This is a medical device and the submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing performance metrics against specific acceptance criteria for an AI/algorithm-based device.
Therefore, many of the requested points, such as specific acceptance criteria related to AI performance, sample sizes for test sets in an AI context, expert qualifications for ground truth in AI, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this type of medical device submission.
Here's a breakdown of the relevant information from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present quantitative acceptance criteria for the performance of the annuloplasty ring in a numerical or statistical sense as one would expect for an AI algorithm. Instead, the "acceptance " is based on demonstrating substantial equivalence to a predicate device through functional and safety testing. The reported "performance" is that the device met these requirements and is equivalent to the predicate.
| Acceptance Criteria Category | Reported Device Performance and Equivalence |
|---|---|
| Functional and Performance Requirements | Device design meets functional and performance requirements. Data demonstrates equivalence to the predicate and/or reference device. |
| Technological Characteristics | Same technological characteristics as the predicate device (GeoForm™ Annuloplasty Ring, Model 4200 (K032250)). |
| Intended Use | Equivalent to the predicate device. |
| Indications for Use | Equivalent to the predicate device. |
| Principles of Operation | Equivalent to the predicate device. |
| Fundamental Technology | Equivalent to the predicate device. |
| Materials of Composition | Similar or identical to the predicate device. |
| Size Range | Similar or identical to the predicate device. |
| Sizing Accessories | Similar or identical to the predicate device. |
| Site of Application in the Body | Similar or identical to the predicate device. |
| Biocompatibility | Tested to support substantial equivalence. |
| Sterilization | Tested to support substantial equivalence. (Minor modification from predicate). |
| Computational Finite Element Analysis (FEA) | Performed to support substantial equivalence. |
| Tensile strength of ring materials | Tested to support substantial equivalence. |
| Suture pull-out testing | Tested to support substantial equivalence. |
| MRI Compatibility | Tested to support substantial equivalence. |
| Packaging | Tested to support substantial equivalence. (Minor modification from predicate). |
| Shelf-life | Tested to support substantial equivalence. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document states "representative samples of the devices underwent testing" for functional and safety tests. Specific sample sizes for each test are not provided.
- Data Provenance: The data provenance (e.g., country of origin, retrospective/prospective) is not specified in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as this is not an AI/algorithm-based device and does not involve establishing ground truth from expert readings in that context. The "truth" for the device's functional and safety performance is based on engineering and materials science standards and testing.
4. Adjudication method for the test set
This is not applicable as there is no expert reading or interpretation requiring adjudication in the context of an AI/algorithm.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This device is an annuloplasty ring, not an AI-assisted diagnostic or treatment tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical medical implant, not an algorithm.
7. The type of ground truth used
The "ground truth" for this medical device is established by:
- Engineering specifications and design requirements: The device's physical properties, materials, and mechanical behavior.
- Performance against established standards: Biocompatibility standards, sterilization efficacy, material strength standards, etc.
- Comparison to a legally marketed predicate device: Demonstrating that the new device performs similarly or equivalently to a device already deemed safe and effective.
8. The sample size for the training set
This is not applicable as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established
This is not applicable as this is not an AI/algorithm-based device.
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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 18, 2019
Genesee BioMedical, Inc Mr. Woodrow Mathison President and CEO 700 W Mississippi Ave, Unit D5 Denver, Colorado 80223-4509
Re: K190506
Trade/Device Name: NeoForm™ Annuloplasty Ring Model 4200 Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty ring Regulatory Class: Class II Product Code: KRH Dated: February 28, 2019 Received: March 1, 2019
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 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
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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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510(k) Summary NeoForm™ 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 | April 15, 2019 |
| Trade Name | NeoForm™ Annuloplasty Ring Model 4200 |
| 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 GeoForm™Annuloplasty Ring, Model 4200 (K032250). |
| Reference Device | ATS Simulus™ Semi-Rigid Annuloplasty Ring, Model 800SR(K072655). |
| Device Description | The NeoForm™ Annuloplasty Ring, Model 4200 is a rigidimplantable annuloplasty ring designed to reduce and stabilizethe valve annulus in patients undergoing mitral repair.The inner core of the ring is made of a titanium alloy. Siliconecovers the inner core and a sewing cuff made of polyester fabricencompasses the ring. Three points of the ring are marked withpolyester suture to aid in suture placement for implantation.The ring is available in four sizes: 26 mm; 28 mm; 30 mm; and32 mm. |
| Indications for Use: | The NeoForm™ 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 NeoForm™ Annuloplasty Ring provides support for themitral annulus 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 NeoForm™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 structure, the sterilization method, andpackaging. | |
| 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 | |
| Conclusion | Genesee BioMedical, Inc. considers the NeoForm™Annuloplasty Ring to be equivalent to the predicate device. Thisconclusion is based upon the fact that the devices have anequivalent intended use, and there are no differences that raisedifferent questions of safety and effectiveness. |
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§ 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.”