(103 days)
The FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty Band are indicated for use in patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty rings and bands provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.
The FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty Band are fully flexible annular rings and bands designed to reduce and stabilize the valve annulus in patients undergoing mitral or tricuspid repair.
The rings and bands are made of braided polyester fabric. The ring and band contain a circumferential flexible radiopaque marker. The internal radiopaque marker provides radiographic visualization along the entire circumference.
The rings and bands are available in nine sizes: 24 mm; 26 mm; 28 mm; 30 mm; 32 mm; 34 mm, 36 mm, 38 mm and 40 mm. The size refers to the inner circumference between the green suture markers nearest the anterior location of the ring and band. FlexForm™ Sizers, Model FRBS, are used to determine the correct size of the ring or band.
The differences between the ring and band are as follows: The FlexForm™ Ring is a complete annular ring. Five markers are provided on the ring; two markers indicate the approximate location of the trigones; three additional markers are provided as an aid to suture placement in the posterior section.
The FlexForm™ Band is a partial ring, without an anterior segment. The key dimensions are the same as the FlexForm Annuloplasty Ring, except for the absence of the anterior segment. Five markers are provided on the band; two markers indicate the approximate location of the trigones; three markers are provided as an aid to suture placement in the posterior section.
The choice of ring or band is based on surgeon preference.
The provided text is a 510(k) summary for a medical device (FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty Band). This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving that a new device meets specific acceptance criteria through a clinical study.
Therefore, the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details is not typically found in a 510(k) summary like this one.
510(k) submissions primarily focus on:
- Comparison to a Predicate Device: Demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to an already cleared device.
- Non-Clinical Testing: Typically involves bench testing (e.g., tensile strength, fatigue, sterilization validation, biocompatibility) to show the device meets engineering specifications and standards, but not direct clinical outcomes or diagnostic performance.
Based on the provided text, here's what can be extracted, and what cannot be:
Information Available:
-
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied): The device passed various performance tests to ensure it meets functional and performance requirements. The specific numerical acceptance criteria are not provided.
- Reported Device Performance (as listed in "Non-Clinical Tests"):
- Tensile strength of ring body materials
- Tensile strength of construction sutures
- Suture pull-out testing
- (NOTE: The actual numerical results of these tests and how they compare to specific acceptance criteria are not included in this summary.)
-
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A: This device is a physical annuloplasty ring/band, not an AI algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. The device underwent "Functional and Safety Testing" which are non-clinical hardware tests.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests (tensile strength, suture pull-out), the "ground truth" would be the engineering specifications and established test methodologies for material properties. This is implicitly linked to industry standards and regulatory guidance for medical devices, rather than expert consensus on clinical data or pathology. Specific details are not provided.
-
8. The sample size for the training set:
- N/A: This is a physical medical device, not an AI algorithm that requires a training set. The "samples" referred to are representative physical samples of the manufactured device used for non-clinical testing.
-
9. How the ground truth for the training set was established:
- N/A: Not applicable for a physical device.
Information NOT Available in this Document:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "representative samples" for testing, but does not specify the number of samples for each test, nor the "data provenance" as this refers to clinical data, which was not used for this type of submission.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A: No clinical study involving expert ground truth for a test set is described here. The "ground truth" for the non-clinical tests would be the predetermined engineering specifications, not expert clinical consensus.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A: No clinical study or expert review of a test set is described.
- 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
- N/A: This is a physical device, not an AI diagnostic tool, so MRMC studies and "human readers" improving with AI are not relevant.
In summary, as this is a 510(k) summary for a physical medical device, it relies on demonstrating substantial equivalence through non-clinical performance and material characterization, rather than clinical studies with human "readers" or algorithms that would involve the extensive details requested in your prompt.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 12, 2016
Genesee Biomedical, Inc. Woodrow Mathison President and CEO 700 W. Mississippi Ave Unit D-5 Denver, Colorado 80223-4509
Re: K161815
Trade/Device Name: FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II Product Code: KRH Dated: September 12, 2016 Received: September 13, 2016
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. 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 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 (reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
M.A. Hillebrenner
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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Indications for Use
510(k) Number (if known) K161815
Device Name
FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty Band
Indications for Use (Describe)
The FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty Band are indicated for use in patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty rings and bands provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.
| 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 FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty Band
| Applicant | Genesee BioMedical, Inc.700 W Mississippi Ave. Unit D-5Denver, Colorado 80223-4509Toll Free: 1-800-786-4890 |
|---|---|
| Contact Person | Woodrow G. Mathison, President and CEO700 W Mississippi Ave. Unit D-5Denver, Colorado 80223-4509wmathison@geneseebiomedical.com |
| Date Prepared | October 6, 2016 |
| Trade Name | FlexForm™ Annuloplasty Ring and FlexForm™ AnnuloplastyBand |
| Common or UsualName: | Annuloplasty Ring or Annuloplasty Band |
| 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 ATS SimulusAnnuloplasty Ring Model 700FF and the ATS Simulus FCAnnuloplasty Ring Model 700FC. |
| Device Description | The FlexForm™ Annuloplasty Ring and FlexForm™ AnnuloplastyBand are fully flexible annular rings and bands designed to reduce andstabilize the valve annulus in patients undergoing mitral or tricuspidrepair. |
| The rings and bands are made of braided polyester fabric. The ring andband contain a circumferential flexible radiopaque marker. Theinternal radiopaque marker provides radiographic visualization alongthe entire circumference. | |
| The rings and bands are available in nine sizes: 24 mm; 26 mm; 28mm; 30 mm; 32 mm; 34 mm, 36 mm, 38 mm and 40 mm. The sizerefers to the inner circumference between the green suture markers | |
| nearest the anterior location of the ring and band. FlexForm™ Sizers,Model FRBS, are used to determine the correct size of the ring orband. | |
| The differences between the ring and band are as follows:The FlexForm™ Ring is a complete annular ring. Five markersare provided on the ring; two markers indicate the approximatelocation of the trigones; three additional markers are provided asan aid to suture placement in the posterior section. | |
| The FlexForm™ Band is a partial ring, without an anteriorsegment. The key dimensions are the same as the FlexFormAnnuloplasty Ring, except for the absence of the anteriorsegment. Five markers are provided on the band; two markersindicate the approximate location of the trigones; three markersare provided as an aid to suture placement in the posteriorsection. | |
| The choice of ring or band is based on surgeon preference. | |
| Indication for Use | The FlexForm™ Annuloplasty Ring and FlexForm™ AnnuloplastyBand are indicated for use in patients undergoing surgery of diseasedor damaged mitral or tricuspid valves in whom the surgeon determinesthat the valve can be preserved by employing the appropriate surgicalrepair. The annuloplasty rings and bands provide support for the mitralor tricuspid annulus and restrict expansion of the annulus. |
| Principle andMechanism ofOperation | The FlexForm™ Annuloplasty Ring and FlexForm™ AnnuloplastyBand provide support for the mitral or tricuspid annulus and restrictexpansion of the annulus. |
| Functional and SafetyTesting | To verify that device design meets functional and performancerequirements, representative samples of the devices underwent testingin accordance with applicable standards and guidance. These dataprovide an acceptable assurance of the safety and effectiveness of theFlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty Bandand demonstrate the devices are equivalent to the predicates. |
| ComparativeTechnologyCharacteristics | A comparison of the characteristics of the proposed device and thepredicate devices shows the FlexForm™ Annuloplasty Ring andFlexForm™ Annuloplasty Band to have the same technologicalcharacteristics as the predicate devices that have received 510(k)clearance. |
| Equivalence is based upon intended use, indications for use, principlesof operation and fundamental technology. Both devices are intended | |
| for use in surgical repair of mitral and tricuspid heart valves. | |
| Both devices have similar or identical structure, materials ofcomposition, sterilization method, size range, sizing accessories,packaging and site of application in the body. | |
| Non-Clinical TestsSubmitted | Performance testing was performed to support substantialequivalence, including: |
| Tensile strength of ring body materialsTensile strength of construction suturesSuture pull-out testing | |
| Conclusion | Genesee BioMedical, Inc. considers the FlexFormTM AnnuloplastyRing and FlexFormTM Annuloplasty Band to be equivalent to thepredicate devices. This conclusion is based upon the fact that thedevices have an equivalent intended use, and there are no differencesthat raise new 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.”