(77 days)
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No
The description focuses on the physical characteristics and function of an implantable medical device (annuloplasty bands) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is described as an annuloplasty band that provides support for the mitral or tricuspid annulus and restricts its expansion, which is a therapeutic action aimed at preserving diseased or damaged heart valves.
No
Explanation: The device is an implantable annuloplasty band used to support and restrict the expansion of the mitral or tricuspid annulus during valve repair surgery. It is a therapeutic device, not a diagnostic one, as it does not diagnose, monitor, or detect medical conditions.
No
The device description clearly states that the device is an implantable, adjustable flexible, annular band made of tubular braided Polyester with radiopaque markers. This is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in patients undergoing surgery to repair diseased or damaged mitral or tricuspid valves. It is an implantable device used in vivo (within the body) to support and restrict the heart valve annulus.
- Device Description: The description details an implantable band made of Polyester with radiopaque markers. This is a surgical implant, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is mechanical support and stabilization within the body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The ATS SIMULUS® Adjustable Flexible Annuloplasty Bands Model 735AC are for use in those 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 bands provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.
Product codes (comma separated list FDA assigned to the subject device)
KRH
Device Description
The ATS SIMULUS® Adjustable Flexible Annuloplasty Bands Model 735AC are implantable, adjustable flexible, annular bands (Figure II.1). The bands reduce and stabilize the atrioventricular annulus in patients undergoing mitral or tricuspid valve repair. The body of the band is made of tubular braided Polyester. The band contains circumferential flexible radiopaque markers. The entire circumference of the band is radiopaque.
The bands are available in the following six sizes: 25 mm, 27 mm, 29 mm, 31 mm, 33 mm, 35 mm, 37mm and 39mm. The size refers to the equivalent inner circumference of the band, trigone to trigone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
mitral or tricuspid valves, mitral or tricuspid annulus
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing included LAL, Sterility Validation, and Class VI Biocompatibility tests on the predicate device. Mechanical testing was carried out on complete modified rings and ring components. All test results were satisfactory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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| 510(k) Summary Information
Premarket Notification, Section 510(k) | | | | | Genesee Biomedical, Inc.
APRIL 30, 2007 |
|----------------------------------------------------------------------|--|------------------------------------------------------------------------------------------------------|--------------|--|--------------------------------------------|
| Regulatory Authority: | | Safe Medical Devices Act of 1990, 21 CFR 807.92 | | | |
| 1. Device Name: | | | | | |
| Trade Name: | | ATS SIMULUS® Adjustable Flexible Annuloplasty Band
Model 735 AC | | | |
| Common Name(s): | | Annuloplasty Ring | MAY - 7 2009 | | |
| Classification Name(s): | | Ring, Annuloplasty | | | |
| 2. Establishment Name & Registration Number: | | | | | |
| Name: | | Genesee Biomedical, Inc. | | | |
| Number: | | 1723241 | | | |
| 3. Classification(s): | | | | | |
| Device Class: | | Class II | | | |
| Classification Panel: | | Cardiovascular Devices Panel | | | |
| Product Code(s): | | KRH | | | |
| 4. Equivalent Predicate Device: | | | | | |
| | | Genesee Biomedical Inc's. SIMULUS® Adjustable Flexible Annuloplasty Ring Model
735AF | | | |
| | | Equivalence can be seen in the design, material composition, surgical technique and
intended use. | | | |
5. Device Description:
The ATS SIMULUS® Adjustable Flexible Annuloplasty Bands Model 735AC are implantable, adjustable flexible, annular bands (Figure II.1). The bands reduce and stabilize the atrioventricular annulus in patients undergoing mitral or tricuspid valve repair. The body of the band is made of tubular braided Polyester. The band contains circumferential flexible radiopaque markers. The entire circumference of the band is radiopaque.
The bands are available in the following six sizes: 25 mm, 27 mm, 29 mm, 31 mm, 33 mm, 35 mm, 37mm and 39mm. The size refers to the equivalent inner circumference of the band, trigone to trigone.
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6. Packaging:
The ATS SIMULUS® Annuloplasty Bands are supplied STERILE (sterilized by gamma radiation) and non-pyrogenic, packaged in inner and outer Chevron style Tyvek/Polymylar peel pouches. The rings will remain sterile until at least the expiration date provided the package is unopened and undamaged.
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7. Indications for Use:
The ATS SIMULUS® Adjustable Flexible Annuloplasty Bands are for use in those 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 bands provide support for the mitral or tricuspid annulus and restrict expansion of the annulus
8. Testing Summary:
Testing included LAL, Sterility Validation, and Class VI Biocompatibility tests on the predicate device. Mechanical testing was carried out on complete modified rings and ring components. All test results were satisfactory.
9. Applicant Name & Address:
John T. M. Wright, Ph.D. Genesee Biomedical, Inc. 1308 So Jason Street, Denver, CO 80223 Phone (303) 777-3000 extension 111 Fax (303) 777-8866 Email intight a geneseebiomedical.com
10. Registration Number:
1723241
11. Company Contact:
John Wright, Ph.D. Genesee Biomedical, Inc.
12. Submission Correspondent:
John T. M. Wright, Ph D. Chief Executive Officer Genesee Biomedical, Inc.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Public Health Service
MAY - 7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Genesee Biomedical, Inc. John T.M. Wright, Ph.D., CEO 1308 S Jason Street Denver CO 80223
Re: K090428
Trade/Device Name: ATS SIMULUS® Adjustable Flexible Annuloplasty Band Model 735AC
Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II Product Code: KRH Dated: April 30, 2009 Received: May 1, 2009
Dear Dr. Wright:
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.
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
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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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): K090428
Device Name:_ ATS SIMULUS® Adjustable Flexible Annuloplasty Band Model 735AC
Indications For Use:
The ATS SIMULUS® Adjustable Flexible Annuloplasty Bands Model 735AC are for use in those 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 bands provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.
Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
eonell
Division Sian-Off) Division of Cardiovascular Devices 510(k) Number K090428
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