(205 days)
The ATS TRI-AD™ Semi-Flexible Tricuspid Annuloplasty Rings Model 900SFC are for use in those patients undergoing surgery of diseased or damaged 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 tricuspid annulus and restrict expansion of the annulus.
The ATS TRI-AD™ Semi-Flexible Tricuspid Annuloplasty Rings Model 900SFC are implantable, semi-rigid, annular Rings. The Rings reduce and stabilize the atrioventricular annulus in patients undergoing mitral valve repair. The body of the ring is made of flat braided Polyester. The ring contains an MP35N wire stiffener in the lateral and posterior segments. The wire stiffener is contained within a close-coiled MP35N spring. The two ends of the stiffener wire are fitted with miniature MP35N end caps at each trigone. These caps prevent the stiffener wire from poking through the end seam of the ring. The entire circumferential of the annuloplasty ring is radiopaque between trigones. The Rings are available in the following six sizes: 26mm, 28mm, 30mm, 32mm, 34mm, 36mm. The size refers to the inner major diameter of the ring.
This submission describes a medical device, the ATS TRI-AD™ Semi-Flexible Tricuspid Annuloplasty Ring Model 900SFC, and its equivalence to a predicate device. The document does not describe an AI/ML powered device, nor does it present any studies proving the device meets acceptance criteria related to AI/ML performance.
Instead, this 510(k) summary focuses on demonstrating substantial equivalence to a previously cleared device (ATS SIMULUS® Semi-Flexible Tricuspid Annuloplasty Ring Model 800SR) based on design, material composition, surgical technique, and intended use.
Here's an analysis of the provided text in relation to your request, highlighting the absence of AI/ML or related performance studies:
1. A table of acceptance criteria and the reported device performance
The document lists several mechanical tests, but these are for the annuloplasty ring's physical properties, not for any AI/ML performance. It states "All test results were satisfactory" without providing specific numerical acceptance criteria or detailed performance data.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Integrity: | |
| Tensile strength of flat Polyester tubular braid. | Satisfactory |
| 4-0 Suture tensile test | Satisfactory |
| Stiffener wire tensile strength. | Satisfactory |
| Body implant suture pull out strength. | Satisfactory |
| Stiffener retention seam penetration strength. | Satisfactory |
| Stress Levels: | |
| Finite Element Analysis (FEA) of the stress levels of stiffeners | Satisfactory |
| Biocompatibility: | |
| LAL (Limulus Amebocyte Lysate) | Previously carried out on predicate device |
| Sterility Validation | Previously carried out on predicate device |
| Class VI Biocompatibility | Previously carried out on predicate device |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for the mechanical tests performed. Data provenance is not mentioned. As these are mechanical tests performed on components or complete bands, "country of origin of the data" and "retrospective or prospective" are not applicable in the typical sense for clinical or AI/ML studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This document is about a physical medical device (annuloplasty ring) and its mechanical properties, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, which are not described here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an annuloplasty ring, not an AI/ML system, and no MRMC studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the mechanical tests would be the measured physical properties or successful completion of a test according to a predefined standard, not based on expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
Not applicable. There is no AI/ML algorithm, and therefore no training set.
9. How the ground truth for the training set was established
Not applicable. As there is no AI/ML algorithm or training set, this question is irrelevant to the provided document.
In summary, the provided document is a 510(k) summary for a physical medical device (an annuloplasty ring) and focuses on demonstrating substantial equivalence to a predicate device through mechanical testing, sterility, and biocompatibility. It does not involve any AI/ML components or related performance studies.
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1093903
| 510(k) Summary InformationPremarket Notification, Section 510(k) | Genesee Biomedical, Inc.DECEMBER 12, 2007 |
|---|
Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory Authority:
-
- Device Name:
Trade Name: ATS TRI-AD™ Semi-Flexible Tricuspid Annuloplasty Ring Model 900SFC
- Device Name:
Common Annuloplasty Ring Name(s):
JUL 1 5 2010
Classification Name(s): Ring, Annuloplasty
2. Establishment Name & Registration Number:
Name: Genesee Biomedical, Inc. Number: 1723241
-
- 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. ATS SIMULUS® Semi-Flexible Tricuspid Annuloplasty Ring Model 800SR (K072655). Equivalence can be seen in the design, material composition, surgical technique and intended use.
5. Device Description:
The ATS TRI-AD™ Semi-Flexible Tricuspid Annuloplasty Rings Model 900SFC are implantable, semi-rigid, annular Rings. The Rings reduce and stabilize the atrioventricular annulus in patients undergoing mitral valve repair. The body of the ring is made of flat braided Polyester. The ring contains an MP35N wire stiffener in the lateral and posterior segments. The wire stiffener is contained within a close-coiled MP35N spring. The two ends of the stiffener wire are fitted with miniature MP35N end caps at each trigone. These caps prevent the stiffener wire from poking through the end seam of the ring. The entire circumferential of the annuloplasty ring is radiopaque between The Rings are available in the following six sizes: 26mm, 28mm, trigones. 32mm. 34mm. 36mm. The size refers to the inner major diameter of the ring.
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6. Packaging:
The ATS TRI-ADTM Semi-Flexible Tricuspid Annuloplasty Ring is supplied STERILE (sterilized by gamma radiation) and non-pyrogenic, mounted on a disposable holder, packaged in inner and outer Chevron style Tyvek/Polymylar peel pouches. The ring will remain sterile until at least the expiration date provided the package is unopened and undamaged.
7. Indications for Use:
The ATS TRI-ADTM Semi-Flexible Tricuspid Annuloplasty Bands are for use in those patients undergoing surgery of diseased or damaged mitral valves in which the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty bands provide support for the natural annulus and restrict expansion of the annulus
8. Testing Summary:
Testing included LAL, Sterility Validation, and Class VI Biocompatibility had previously been carried out on a predicate device. The following mechanical tests were carried out on complete modified bands and ring components.
- Tensile strength of flat Polyester tubular braid. 1.
- 4-0 Suture tensile test 2.
- Stiffener wire tensile strength. 3.
- Body implant suture pull out strength. 4.
- Stiffener retention seam penetration strength. 5.
- Finite Element Analysis (FEA) of the stress levels of stiffeners 6.
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 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/0 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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure with three curved lines representing its wings or feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 1 5 2010
Genesee Biomedical. Inc. c/o John T. M. Wright, Ph.D. Chief Executive Officer 1308 S. Jason Street Denver, CO 80223
Re: K093903
Trade Name: ATS TRI-AD™ Semi-Flexible Tricuspid Annuloplasty Ring Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty ring Regulatory Class: Class II Product Code: KRH Dated: June 14, 2010 Received: June 15, 2010
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.
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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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
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
K093903 510(k) Number (if known)
Device Name: ATS TRI-AD Semi-Flexible Tricuspid Annulopfasty Ring Model 900SFC
Indications For Use:
The ATS TRI-AD™ Semi-Flexible Tricuspid Annuloplasty Rings Model 900SFC are for use in those patients undergoing surgery of diseased or damaged tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical The annuloplasty Rings provide support for the tricuspid annulus and restrict repair. 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) | |
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| Page 1 of 1 | |
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K093903 |
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§ 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.”