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.

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.

AI/ML Overview

The provided text (K014037) describes a 510(k) premarket notification for the SJM® Seguin annuloplasty ring, focusing on its substantial equivalence to a predicate device (Seguin ring, model SAR). This submission is for a medical device (an annuloplasty ring) and not an AI/ML software device. Therefore, many of the requested categories related to AI/ML device testing (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set sample size) are not applicable or described in this document.

The acceptance criteria and study information provided in this document are primarily focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than detailed performance metrics against specific acceptance criteria for a novel AI algorithm.

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

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Product Labeling: Substantially Equivalent to predicate	Substantially Equivalent
Intended Use: Identical to predicate	Identical
Physical Characteristics: Substantially Equivalent (with noted differences in holder/handle)	Different (Holder and Handle only) but overall function maintained
Anatomical Sites: Identical to predicate	Identical
Target Population: Identical to predicate	Identical
Performance Testing: Substantially Equivalent to predicate (prior testing on predicate)	Substantially Equivalent
Safety Characteristics: Substantially Equivalent to predicate	Substantially Equivalent
New Holder/Handle Configuration: Function as intended	Physical Testing performed: Holder to Handle connection, Holder assembly, Ring assembly to holder. (No specific performance metrics are reported, but successful testing is implied for substantial equivalence).
Biocompatibility: As per predicate	Biocompatibility testing performed.
Sterility Assurance: As per predicate	Sterility Assurance testing performed.
EtO Residual Evaluation: As per predicate	EtO Residual Evaluation performed.
Manufacturing Process Validation: As per predicate	Manufacturing Process Validation performed.

The document states that the SJM® Seguin annuloplasty ring, model SARP, is considered "substantially equivalent" to its predicate device, the Seguin ring, model SAR. The performance criteria are implicitly met by demonstrating this substantial equivalence through comparison of characteristics and specific non-clinical tests.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The study is a non-clinical evaluation comparing a new device iteration to a predicate, not a clinical study with patient data or a test set in the context of AI/ML.

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 is a medical device submission based on substantial equivalence, not an AI/ML algorithm requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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 is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the performance and safety established for the predicate device (Seguin ring, model SAR), which was previously cleared by the FDA (K961246). The new device (model SARP) is demonstrated to be substantially equivalent to this established "truth" through comparative non-clinical testing.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary

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K014037

JAN 0 4 2002

510(K) SUMMARY

(as Required by 21 CFR § 807.92)

Submitters Information A.

Submitter's Name:	St. Jude Medical, IncCardiac Surgery Division
Address:	St. Jude Medical, Inc.One Lillehei PlazaSt. Paul, MN 55117
Contact Name	William McKelveyRegulatory Affairs CoordinatorSt. Jude Medical, Inc.Bus : (651) 415-7029Fax : (651) 766-3049Email: 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 RingValvulplasty RingMitral Valve Support Ring
Classification:	Pre-amendment Class II CFR § 870.3800Devices,CardiovascularAnnuloplasty Ring (revised April 10, 2001)
Predicate Device:	St. Jude Medical considers The Seguinring, model SARP to be substantiallyequivalent to the Sequin ring model SAR.
Device Description	The Seguin ring is a semi-rigid ringfabricated from an untra-high molecularweight polyethylene (PE) core surroundedby a polyester sewing ring. providing ameans for attaching the ring to the heartannulus as well as a suitable surface fortissue ingrowth.

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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 .
1. Manufacturing Process Validation

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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.

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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

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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

Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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.”