(33 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of an implantable annuloplasty ring, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used to repair diseased or damaged mitral valves by providing support and restricting expansion of the mitral annulus, which directly treats a medical condition.
No
The device is an implantable annuloplasty ring used to support and restrict the expansion of the mitral annulus during surgical repair; it does not diagnose a condition.
No
The device description clearly states it is an implantable, Semi-Rigid, annular ring made of physical materials (Polyester, MP35N wire, MP35N spring, MP35N coupler). It is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "use in those patients undergoing surgery of diseased or damaged mitral valves". This describes a surgical implant used in vivo (within the body) to repair a structural issue.
- Device Description: The description details an "implantable, Semi-Rigid, annular ring" made of materials like Polyester and MP35N wire. This is consistent with a surgical implant, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such testing on specimens.
The ATS SIMULUS™ Semi-Rigid Mitral Annuloplasty Rings Model 800SR is a surgical implant.
N/A
Intended Use / Indications for Use
The ATS SIMULUS™ Semi-Rigid Mitral Annuloplasty Rings Model 800SR are for use in those patients undergoing surgery of diseased or damaged mitral 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 annulus and restrict expansion of the annulus.
Product codes
KRH
Device Description
The ATS SIMULUS™ Semi-Rigid Mitral Annuloplasty Rings Model 800SR 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 closecoiled MP35N spring, the two ends of which are joined together by a miniature MP35N coupler in the mid-anterior segment. The entire circumferential of the annuloplasty ring is radiopaque. The rings are available in the following six sizes: 24mm, 26mm, 28mm, 30mm, 32mm, 36mm, 36mm and 40mm. The size refers to the lateral diameter of the stiffener band.
The ATS SIMULUSTM Semi-Rigid Mitral 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mitral valve / atrioventricular annulus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon / Patients undergoing surgery
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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007 23 2007
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510(k) S
. Information
Summary 1 | | Party of the program and the program of the first of the first of the first of the first of the first of the first of the first of the first of the first of the first of the
Genesee Biomedical. In.
me | |
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| Contraction of the comments of
一个官兵使用
Premarket Notification.
Section 510(k) | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 -
2002
SPPT MRER | |
Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory Authority:
-
- Device Name:
Trade Name: ATS SIMULUS™ Semi-Rigid Mitral Annuloplasty Ring Model 800SR
- Device Name:
Common Name(s): Annuloplasty Ring
Classification Name(s): Ring, Annuloplasty
2. Establishment Name & Registration Number:
Genesee Biomedical, Inc. Name: Number: 1723241
3. Classification(s):
Class II Device Class: Classification Panel: Cardiovascular Devices Panel Product Code(s): KRH
4. Equivalent Predicate Device:
Genesee Biomedical Inc's. Sculptor® Semi-Rigid Mitral Annuloplasty Ring Model 605M (K905175). Equivalence can be seen in the design, material composition, surgical technique and intended use.
5. Device Description:
The ATS SIMULUS™ Semi-Rigid Mitral Annuloplasty Rings Model 800SR 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 closecoiled MP35N spring, the two ends of which are joined together by a miniature MP35N coupler in the mid-anterior segment. The entire circumferential of the annuloplasty ring is radiopaque. The rings are available in the following six sizes: 24mm, 26mm, 28mm, 30mm, 32mm, 36mm, 36mm and 40mm. The size refers to the lateral diameter of the stiffener band.
1
6. Packaging:
The ATS SIMULUSTM Semi-Rigid Mitral 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 SIMULUS™ Semi-Rigid Mitral Annuloplasty Rings are for use in those patients undergoing surgery of diseased or damaged mitral 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 natural 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
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 3 2007
Genesee Biomedical, Inc c/o John T. M. Wright Ph.D Chief Executive Officer 1308 S. Jason Street Denver, CO 80223-3408
Re: K072655
ATS Simulus TM Semi-Rigid Mitral Annuloplasty Ring Model 800SR Regulation Number: 21 CFR 870.3800 Regulation Name: Ring, Annuloplasty Regulatory Class: Class II (two) Product Code: KRH Dated: September 12, 2007 Received: September 24, 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 (OS) 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
R. bochner
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Kon2655 510(k) Number :_
ATS SIMULUS™ Semi-Rigid Mitral Annuloplasty Ring Model 800SR Device Name(s):
Indications For Use:
The ATS SIMULUS™ Semi-Rigid Mitral Annuloplasty Rings Model 800SR are for use in those patients undergoing surgery of diseased or damaged mitral 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 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)
(Per 21 CFR 801.109)
(Optional format 1-2-96)
una D. Verdennes
(Division Si - Off) Division of Cardiovascular Devices
510(K) Number_K072655