(103 days)
Not Found
No
The device description and performance studies focus on the physical properties and structural integrity of the annuloplasty rings and bands, with no mention of AI or ML technologies.
Yes
The device is indicated for use in patients undergoing surgery to repair diseased or damaged mitral or tricuspid valves, providing support and restricting expansion of the annulus, which are direct therapeutic interventions.
No
The device is an annuloplasty ring and band intended to support and restrict expansion of the mitral or tricuspid annulus during valve repair. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states that the device is a physical annuloplasty ring and band made of braided polyester fabric with a radiopaque marker. It is a physical implant used in surgery, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The FlexForm™ Annuloplasty Ring and Band are implantable devices used during surgery to repair damaged heart valves. They are physically placed within the patient's body to provide structural support.
- Lack of Specimen Testing: The description does not mention any testing of biological specimens. The device's function is mechanical support, not diagnostic analysis of bodily fluids or tissues.
Therefore, based on the provided information, the FlexForm™ Annuloplasty Ring and Band are surgical implants, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes
KRH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mitral or tricuspid valves, mitral or tricuspid 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
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 provide an acceptable assurance of the safety and effectiveness of the FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty Band and demonstrate the devices are equivalent to the predicates.
Non-Clinical Tests Submitted: Performance testing was performed to support substantial equivalence, including:
Tensile strength of ring body materials
Tensile strength of construction sutures
Suture pull-out testing
Key Metrics
Not Found
Predicate Device(s)
The subject device is substantially equivalent to the ATS Simulus Annuloplasty Ring Model 700FF and the ATS Simulus FC Annuloplasty Ring Model 700FC.
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.”
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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-5
Denver, Colorado 80223-4509
Toll Free: 1-800-786-4890 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Woodrow G. Mathison, President and CEO
700 W Mississippi Ave. Unit D-5
Denver, Colorado 80223-4509
wmathison@geneseebiomedical.com |
| Date Prepared | October 6, 2016 |
| Trade Name | FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty
Band |
| Common or Usual
Name: | Annuloplasty Ring or Annuloplasty Band |
| 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 ATS Simulus
Annuloplasty Ring Model 700FF and the ATS Simulus FC
Annuloplasty Ring Model 700FC. |
| Device Description | 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. | |
| Indication for Use | 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. |
| Principle and
Mechanism of
Operation | The FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty
Band provide support for the mitral or tricuspid annulus and restrict
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
provide an acceptable assurance of the safety and effectiveness of the
FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty Band
and demonstrate the devices are equivalent to the predicates. |
| Comparative
Technology
Characteristics | A comparison of the characteristics of the proposed device and the
predicate devices shows the FlexForm™ Annuloplasty Ring and
FlexForm™ Annuloplasty Band to have the same technological
characteristics as the predicate devices that have 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 and tricuspid heart valves. |
| | Both devices have similar or identical structure, materials of
composition, sterilization method, size range, sizing accessories,
packaging and site of application in the body. |
| Non-Clinical Tests
Submitted | Performance testing was performed to support substantial
equivalence, including: |
| | Tensile strength of ring body materials
Tensile strength of construction sutures
Suture pull-out testing |
| Conclusion | Genesee BioMedical, Inc. considers the FlexFormTM Annuloplasty
Ring and FlexFormTM Annuloplasty Band to be equivalent to the
predicate devices. This conclusion is based upon the fact that the
devices have an equivalent intended use, and there are no differences
that raise new questions of safety and effectiveness. |
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