(91 days)
Not Found
No
The document describes a physical implantable device (annuloplasty ring) and its materials, sizes, and testing. There is no mention of software, algorithms, image processing, AI, ML, or data sets, which are typically associated with AI/ML medical devices.
Yes
The device is used in surgery to repair diseased or damaged heart valves by providing support and restricting the expansion of the mitral or tricuspid annulus, directly treating a medical condition.
No
Explanation: The ATS SIMULUS™ Adjustable Flexible Annuloplasty Rings are implantable medical devices designed to support and restrict the expansion of the mitral or tricuspid annulus during valve repair surgery. They are therapeutic devices, not diagnostic.
No
The device description clearly states that the device is an implantable, adjustable flexible, annular ring made of tubular braided Polyester with radiopaque markers. This describes a physical, hardware medical device, not a software-only device.
Based on the provided information, the ATS SIMULUS™ Adjustable Flexible Annuloplasty Rings Model 735AF is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for surgical implantation to support and restrict the expansion of the mitral or tricuspid annulus during valve repair surgery. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is an implantable ring made of polyester with radiopaque markers. This is a physical medical device designed for surgical placement.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The description of the ATS SIMULUS™ ring does not involve any such testing of specimens.
In summary, the ATS SIMULUS™ Adjustable Flexible Annuloplasty Rings are a surgical implant, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ATS SIMULUS™ Adjustable Flexible Annuloplasty Rings 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 rings 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 Rings Model 735AF are implantable, adjustable flexible, annular rings (Figure II.1). The rings reduce and stabilize the atrioventricular annulus in patients undergoing mitral or tricuspid valve repair. The body of the ring is made of tubular braided Polyester. The ring contains circumferential flexible radiopaque markers. The entire circumference of the ring is radiopaque.
The rings are available in the following six sizes: 25 mm, 27 mm, 31 mm, 33 mm and 35 mm. The size refers to the inner circumference of the ring, trigone to trigone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
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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.
K052565, K905175, K801876, K821258
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.
Not Found
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.”
0
JUL 3 1 2007
| 510(k) Summary Information | Genesee Biomedical, Inc. |
|---|---|
| Premarket Notification, Section 510(k) | APRIL 30, 2007 |
Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory Authority:
-
- Device Name:
Trade Name: ATS SIMULUS Adjustable Flexible Annuloplasty Ring Model 735 AF
- Device Name:
Common Annuloplasty Ring Name(s):
Classification Name(s): Ring, Annuloplasty
-
- Establishment Name & Registration Number:
Name: Genesee Biomedical, Inc. Number: 1723241
- Establishment Name & Registration Number:
-
- Classification(s):
Device Class: Class II Classification Panel: Cardiovascular Devices Panel Product Code(s): KRH
- Classification(s):
4. Equivalent Predicate Device:
Genesee Biomedical Inc's. SIMULUS™ Fully Flexible Annuloplasty Ring Model 700FF (K052565) and Genesee Biomedical Inc's. Sculptor Adjustable Annuloplasty Ring Model 605M, & Tricuspid Annuloplasty Ring Models 605T (K905175). The device is also equivalent to the Puig Massana-Shiley Annuloplasty Ring (K801876 and K821258).
Equivalence can be seen in the design, material composition, surgical technique and intended use.
5. Device Description:
The ATS SIMULUS™ Adjustable Flexible Annuloplasty Rings Model 735AF are implantable, adjustable flexible, annular rings (Figure II.1). The rings reduce and stabilize the atrioventricular annulus in patients undergoing mitral or tricuspid valve repair. The body of the ring is made of tubular braided Polyester. The ring contains circumferential flexible radiopaque markers. The entire circumference of the ring is radiopaque.
The rings are available in the following six sizes: 25 mm, 27 mm, 31 mm, 33 mm and 35 mm. The size refers to the inner circumference of the ring, trigone to trigone.
1
. 6. Packaging:
The ATS SIMULUS Annuloplasty Rings 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.
7. Indications for Use:
The ATS SIMULUS™ Adjustable Flexible Annuloplasty Rings 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 rings 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 (303) 777-8866 Fax Email jwright@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.
2
Image /page/2/Picture/2 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 1 2007
Genesee BioMedical, Inc. c/o John T. M. Wright, Ph. D. Chief Executive Officer 1308 South Jason St. Denver, CO 80223
K071214 Re:
Trade/Device Name: ATS SIMULUS Adjustable Flexible Annuloplasty Ring Model 735AF Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II Product Code: KRH Dated: June 28, 2007 Received: June 29, 2007
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 such 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.
3
Page 2 - Dr. John T. M. Wright
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Dina R. Lachner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number :
ATS SIMULUS Adjustable Flexible Annuloplasty Ring Model 735AF Device Name(s):
Indications For Use:
The ATS SIMULUS Adjustable Flexible Annuloplasty Rings Model 735AF 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 rings provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR Over-The-Counter Use _ PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)
suma P. bohner
Division Sign-Off) Division of Cardiovascular Devices
510(K) Number_K0712|4
(Per 21 CFR 801.109)
(Optional format 1-2-96)