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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the ATS SIMULUS Adjustable Flexible Annuloplasty Ring Model 735AF. It describes the device, its intended use, and states that certain tests were conducted. However, it does not contain details about specific acceptance criteria or a study proving the device meets those criteria in the way typically expected for a software or AI-driven device performance study.

The document states:

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."

This indicates that the testing performed was primarily related to the physical properties, sterility, and biocompatibility of the annuloplasty ring as a medical implant, rather than a performance study involving diagnostic accuracy or similar metrics.

Therefore, many of the requested details cannot be extracted from this document, as they pertain to a different type of device evaluation (e.g., for AI/software).

Here's a breakdown of what can and cannot be answered based on the input:

Section	Information from Provided Text
1. Table of Acceptance Criteria and Reported Device Performance	Cannot be provided in the requested format. The document states "All test results were satisfactory" for LAL, Sterility Validation, Class VI Biocompatibility, and mechanical testing. However, it does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic device) or numerical performance metrics for these tests. It simply confirms satisfactory completion.
2. Sample size used for the test set and data provenance	Not applicable/Not provided. This device is a physical implant, not a data-driven system requiring a test set of data. The "tests" mentioned are physical and biological evaluations of the device itself.
3. Number of experts used to establish ground truth and qualifications	Not applicable/Not provided. Ground truth, in the context of diagnostics, would typically be established by experts reviewing images, pathology, or clinical outcomes. For a physical implant, "ground truth" relates to its material properties and performance under stress, which are assessed through engineering and biological assays, not expert review of data.
4. Adjudication method for the test set	Not applicable/Not provided.
5. Multi-reader multi-case (MRMC) comparative effectiveness study	Not applicable/Not provided. This is relevant for diagnostic devices (especially imaging AI), not for an annuloplasty ring.
6. Standalone (algorithm only without human-in-the-loop) performance	Not applicable/Not provided. This device does not have an algorithm.
7. Type of ground truth used	Not explicitly stated as "ground truth" but implied for physical testing: Material specifications, known biological responses (for biocompatibility), engineering standards for mechanical strength, and sterility parameters.
8. Sample size for the training set	Not applicable/Not provided. This device does not use a training set as it's not a machine learning model.
9. How ground truth for the training set was established	Not applicable/Not provided.

In summary, the provided K071214 document is a 510(k) summary for a physical medical device (an annuloplasty ring), not a diagnostic or AI-driven device. As such, the testing described focuses on the device's physical and biological integrity, sterility, and safety, rather than performance metrics related to data analysis or diagnostic accuracy. The document states that all conducted tests were "satisfactory," which is the equivalent of meeting acceptance criteria for this type of submission, but it doesn't provide the detailed quantitative criteria or results typical of a performance study for software/AI.

Summary

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K071214

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:

1. Device Name:
  Trade Name: ATS SIMULUS Adjustable Flexible Annuloplasty Ring Model 735 AF

Common Annuloplasty Ring Name(s):

Classification Name(s): Ring, Annuloplasty

1. Establishment Name & Registration Number:
  Name: Genesee Biomedical, Inc. Number: 1723241
1. Classification(s):
  Device Class: Class II Classification Panel: Cardiovascular Devices Panel Product Code(s): KRH

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 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.

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. 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.

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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.

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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

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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)

Regulation Number and Section

§ 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.”