The ATS SIMULUS 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.

Device Description

The ATS SIMULUS Annuloplasty Rings are implantable, fully flexible, annular rings (Figure 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 braided Polyester. The ring contains a circumferential flexible radiopaque marker. The entire circumference of the ring is radiopaque. The annuloplasty rings and accessories are designed as an integrated system to ease implantation. Malleable stems connects the double ended sizers to their handle. The rings are available in the following sizes: 23 mm, 27 mm, 31 mm, 31 mm, 33 mm and 35 mm. The size refers to the inner diameter of the ring. Green trigone markers are spaced at 120° from the radial seam, which is located midpoint of the posterior segment.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called the ATS SIMULUS Annuloplasty Ring. It describes the device, its intended use, and indicates that testing was performed. However, this document does not contain the specific details about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or detailed performance studies.

The section "8. Testing Summary:" on page 1 states: "Testing included LAL, Sterility Validation, Class IV Biocompatibility tests on the predicate device. Mechanical testing was carried out on complete modified rings and ring components. All test results were satisfactory."

This statement confirms that testing was done and that the results were "satisfactory," but it lacks the granular information required to complete the table and answer the specific questions about acceptance criteria and study methodology.

Therefore, I cannot provide a detailed response to your request based solely on the provided text. The document is primarily focused on demonstrating substantial equivalence to a predicate device for regulatory clearance rather than providing a detailed performance study report.

Here's what can be inferred and what information is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the provided text. For LAL, Sterility Validation, Biocompatibility, and Mechanical Testing, there would be specific regulatory or internal acceptance criteria (e.g., LAL endotoxin levels below a certain threshold, sterility assurance level (SAL) of 10^-6, specific cytotoxicity or sensitization limits, certain force/stress limits for mechanical tests). These are not published here.
Reported Device Performance: The text generically states, "All test results were satisfactory." This is not a quantitative or specific performance report.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified for any of the tests mentioned (LAL, Sterility, Biocompatibility, Mechanical).
Data Provenance: Not explicitly stated. Given it's a 510(k) submission, the testing would have been conducted by or for the applicant (Genesee Biomedical, Inc.) likely in the US, but this is an inference, not stated fact for the data origin. It would be retrospective for the submission, based on tests performed prior to filing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, clinical assessments). The tests mentioned (LAL, Sterility, Biocompatibility, Mechanical) are laboratory-based and generally do not involve "expert consensus" for ground truth in the way clinical studies do. Standards and validated methods define the "ground truth" for these types of tests.

4. Adjudication method for the test set

Not applicable for the types of tests described (LAL, Sterility, Biocompatibility, Mechanical).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, the document does not mention any MRMC comparative effectiveness study. These are typically for diagnostic devices where human readers interpret results.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an implantable annuloplasty ring, not an algorithm.

7. The type of ground truth used

For LAL, Sterility, Biocompatibility, and Mechanical testing, the ground truth is established by validated laboratory methods and regulatory standards. For example, sterility is determined by absence of microbial growth in culture, LAL by an enzymatic reaction, biocompatibility by absence of adverse biological responses in standardized tests (e.g., ISO 10993 series), and mechanical performance by meeting engineering specifications under controlled conditions. It's not "expert consensus," "pathology," or "outcomes data" in the clinical sense for these specific tests.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set. The "predicate device" is mentioned for some tests, but that's for demonstrating equivalence, not for training a model.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows a sequence of handwritten characters, which appear to be alphanumeric. The sequence reads 'K0S2565'. The characters are written in a bold, somewhat stylized font, with some connections between the letters and numbers. The overall impression is that of a code or identifier written by hand.

NOV 1 7 2005

Ps 1 of 2

510(k) Summary InformationPremarket Notification, Section 510(k)	Genesee Biomedical, Inc.JUNE 27, 2005
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Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

1. Device Name:

Trade Name: ATS SIMULUS Annuloplasty Ring Model 700FF

Common Name(s): Annuloplasty Ring

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:

K905175, PTI Annuloplasty Ring (Sterile), Now called the Genesee BioMedical, Inc. Sculptor® Annuloplasty Ring.

Equivalence can be seen in the design, material composition, surgical technique and intended use.

5. Device Description:

The annuloplasty rings and accessories are designed as an integrated system to ease implantation. Malleable stems connects the double ended sizers to their handle

The rings are available in the following sizes: 23 mm, 27 mm, 31 mm, 31 mm, 33 mm and 35 mm. The size refers to the inner diameter of the ring. Green trigone markers are spaced at 120° from the radial seam, which is located midpoint of the posterior segment.

6. Packaging:

The ATS SIMULUS Annuloplasty Rings are supplied STERILE (sterilized by gamma radiation) and nonpyrogenic, packaged in inner and outer blister trays with peelable lids. Each ring is mounted on a disposable holder. The rings will remain sterile until at least the expiration date provided the package is unnened and undamaged.

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K052565

B 2 or 2

7. Indications for Use:

8. Testing Summary:

Testing included LAL, Sterility Validation, Class IV Biocompatibility tests on the predicate device. Mechanical testing was carried out on complete modified rings and ring components. All test results were satisfactory.

Applicant Name & Address: 9.

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 jwright@geneseebiomedical com

1. Registration Number:
  1723241

Company Contact: 11.

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 and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written around the circumference of the circle.

NOV 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Genesee BioMedical. Inc. c/o John T. M. Wright, Ph.D. Chief Executive Officer 1308 S. Jason Street Denver, CO 80223-3408

Re: K052565

ATS SIMULUS Annuloplasty Ring Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II (Two) Product Code: KRH Dated: November 14, 2005 Received: November 15, 2005

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. Iisting 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 - John T. M. Wright, Ph.D.

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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Donna R. Vichner

GA 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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Page 1

510(k) Number : K052565

ATS SIMULUS Annuloplasty Ring Device Name(s):

Indications For Use:

Prescription Use ________X Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Donna Lachner

(Division Sign-Off) (Division Olgh-div)
Division of Cardiovascular Devices

510(k) Number k 152565

(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.”