(28 days)
No
The device description and performance studies focus on the physical properties and testing of a semi-rigid annuloplasty ring, with no mention of AI or ML technologies.
Yes
The device is an annuloplasty ring used to repair a diseased or damaged mitral valve, which is a therapeutic intervention.
No
The device description indicates it is an annuloplasty ring used to repair a mitral valve, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a physical ring fabricated from polyethylene and polyester, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the repair of a mitral valve, which is a surgical procedure performed in vivo (within the living body). IVDs are used to examine specimens in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a physical implant (an annuloplasty ring) designed to be surgically placed in the heart. This is not the nature of an IVD.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
Therefore, the SJM® Seguin annuloplasty ring is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SJM® Seguin annuloplasty ring is indicated for use in the repair of a mitral valve that is diseased or damaged due to acquired or congenital processes.
Product codes
KRH
Device Description
The Seguin ring is a semi-rigid ring fabricated from an untra-high molecular weight polyethylene (PE) core surrounded by a polyester sewing ring. providing a means for attaching the ring to the heart annulus as well as a suitable surface for tissue ingrowth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mitral heart valves, heart 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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The testing for the Seguin ring model SAR (predicate) is included in the premarket notification (K961246). The following tests have been performed on the Seguin ring model SARP to insure substantial equivalence with the predicate.
New Holder/Handle Configuration
- Physical Testing
- Holder to Handle connection
- Holder assembly
- Ring assembly to holder.
- Microbiological Testing
- Biocompatibility
- Additional Evaluation of Routine Testing
- Sterility Assurance
- EtO Residual Evaluation
- Manufacturing Process Validation
Key Metrics
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.”
0
JAN 0 4 2002
510(K) SUMMARY
(as Required by 21 CFR § 807.92)
Submitters Information A.
B.
| Submitter's Name: | St. Jude Medical, Inc
Cardiac Surgery Division |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | St. Jude Medical, Inc.
One Lillehei Plaza
St. Paul, MN 55117 |
| Contact Name | William McKelvey
Regulatory Affairs Coordinator
St. Jude Medical, Inc.
Bus : (651) 415-7029
Fax : (651) 766-3049
Email: wmckelvey@sjm.com |
| Submission Prepared: | December 6, 2001 |
| Device Information | |
| Proprietary Name: | SJM® Seguin annuloplasty ring
(Seguin ring) model SARP-(size) |
| Common or Usual Name: | Annuloplasty Ring
Valvulplasty Ring
Mitral Valve Support Ring |
| Classification: | Pre-amendment Class II CFR § 870.3800
Devices,
Cardiovascular
Annuloplasty Ring (revised April 10, 2001) |
| Predicate Device: | St. Jude Medical considers The Seguin
ring, model SARP to be substantially
equivalent to the Sequin ring model SAR. |
| Device Description | The Seguin ring is a semi-rigid ring
fabricated from an untra-high molecular
weight polyethylene (PE) core surrounded
by a polyester sewing ring. providing a
means for attaching the ring to the heart
annulus as well as a suitable surface for
tissue ingrowth. |
1
Intended Use:
The Sequin ring is indicated for use in repair of diseased or damaged mitral heart valves that are determined by the physician to be repairable and do not require replacement.
Comparison of Required Technological Characteristics ﻥ
SJM considers the Seguin ring, model SARP to be substantially equivalent in configuration, function and intended use to the Seguin ring, model SAR. The table below is a comparison of the equivalency characteristics between the two devices.
| Characteristic | Equivalency | |
|---|---|---|
| a. | Product Labeling | Substantially Equivalent |
| b. | Intended Use | Identical |
| c. | Physical Characteristics | Different (Holder and Handle only) |
| d. | Anatomical Sites | Identical |
| e. | Target Population | Identical |
| f. | Performance Testing | Substantially Equivalent |
| g. | Safety Characteristics | Substantially Equivalent |
Summary of Non-Clinical Tests D.
The testing for the Seguin ring model SAR (predicate) is included in the premarket notification (K961246). The following tests have been performed on the Seguin ring model SARP to insure substantial equivalence with the predicate.
New Holder/Handle Configuration
- Physical Testing 1.
- Holder to Handle connection ●
- Holder assembly .
- Ring assembly to holder .
2. Microbiological Testing
- Biocompatibility ●
- Additional Evaluation of Routine Testing .
- Sterility Assurance ●
- EtO Residual Evaluation .
-
- Manufacturing Process Validation
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines beneath them, resembling a stylized caduceus or a representation of people receiving care.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 2002
Mr. William McKelvey Regulatory Affairs Coordinator St. Jude Medical, Inc. One Lillehei Plaza St. Paul, MN 55117
Re: K014037
Trade Name: SJM® Seguin Annuloplasty Ring, Model SARP(size) Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II (two) Product Code: KRH Dated: December 6, 2001 Received: December 7, 2001
Dear Mr. McKelvey:
This letter corrects our substantially equivalent letter regarding the SJM® Seguin Annuloplasty Ring dated January 4, 2002. Our letter incorrectly referred to your Model name as SAR-M. This is an error. The Model name has been corrected to SARP.
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 - Mr. William McKelvey
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
ram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
6014037 510(k) Number (if known):_
Device Name: SJM® Seguin annuloplasty ring
Indications for Use:
The SJM® Seguin annuloplasty ring is indicated for use in the repair of a mitral valve that is diseased or damaged due to acquired or congenital processes.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFANOTHER PAGE IS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K014034
Prescription Use X
or
Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Optional Format 1-2-96)