(27 days)
The SJM® Tailor™ annuloplasty ring is indicated for use in the repair of a mitral or tricuspid valve that is diseased or damaged due to acquired or congenital processes.
The Tailor ring is a flexible ring fabricated with a medical grade silicone rubber core, surrounded by polyester fabric. The full ring may be cut to form a partial or "C" ring.
The provided text is a 510(k) summary for the SJM® Tailor™ annuloplasty ring, model TARP. This document primarily focuses on establishing substantial equivalence to a predicate device (Tailor ring, model TARN) rather than presenting a standalone study with specific acceptance criteria and detailed device performance metrics in the way one might expect for a new AI/software device.
Therefore, the requested information, particularly regarding acceptance criteria and a study that proves the device meets those criteria (in terms of performance metrics like sensitivity, specificity, etc.), sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for test and training sets, and training set sample sizes, is not present in the provided document.
The document is about a physical medical device (annuloplasty ring) and its substantial equivalence based on physical, non-clinical, and safety characteristics. It is not about a software or AI device that would typically have the kind of performance study details requested.
However, I can extract the information that is present regarding the comparison and testing:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide "acceptance criteria" in terms of performance metrics (like accuracy, sensitivity, etc.) or specific numerical thresholds. Instead, it demonstrates substantial equivalence to a predicate device based on characteristics and non-clinical testing.
| Characteristic | Equivalency Claim | Testing/Rationale |
|---|---|---|
| Product Labeling | Substantially Equivalent | Implied by submission for marketing based on predicate. |
| Intended Use | Identical | "repair of diseased or damaged mitral or tricuspid heart valves". |
| Physical Characteristics | Different (Holder and Handle only) | Non-Clinical Tests Performed: Holder to Handle connection, Holder assembly, Ring assembly to holder. (No specific numerical results reported in this summary). |
| Anatomical Sites | Identical | Mitral or tricuspid heart valves. |
| Target Population | Identical | Patients with diseased or damaged mitral or tricuspid heart valves determined to be repairable. |
| Performance Testing | Substantially Equivalent | Refers to predicate device (K000119) and testing for new holder/handle. (No specific numerical results reported in this summary). |
| Safety Characteristics | Substantially Equivalent | Non-Clinical Tests Performed: Microbiological Testing (Biocompatibility, Sterility Assurance), Manufacturing Process Validation. (No specific numerical results reported in this summary). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes non-clinical engineering and biological testing, not a clinical study on patient data with a "test set."
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 not a study requiring expert-established ground truth on a test set.
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 or software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests conducted (e.g., physical testing, microbiological testing), the "ground truth" would be established by standard engineering specifications, material properties, and biological testing protocols relevant to medical devices, not by expert consensus on clinical cases or pathology.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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JAN 1 5 2002
510(K) SUMMARY (as Required by 21 CFR § 807.92)
Submitters Information A.
B.
| 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 17, 2001 |
| Device Information | |
| Proprietary Name: | SJM® Tailor™ annuloplasty ring(Tailor ring) |
| Common or Usual Name: | Flexible Annuloplasty Ring"C" ring |
| Classification: | Pre-amendment Class II CFR § 870.3800Cardiovascular Prosthetic Devices,Annuloplasty Ring (revised April 10, 2001) |
| Predicate Device: | St. Jude Medical considers The Tailor ring,model TARP to be substantially equivalentto the Tailor ring model TARN. |
| Device Description | The Tailor ring is a flexible ring fabricatedwith a medical grade silicone rubber core,surrounded by polyester fabric. The fullring may be cut to form a partial or "C" ring. |
Special 510(k) — Tailor Annuloplasty Ring
Section 7 - 510(k) Summary
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Intended Use:
The Tailor ring is indicated for use in repair of diseased or damaged mitral or tricuspid heart valves that are determined by the physician to be repairable and do not require replacement.
C. Comparison of Required Technological Characteristics
SJM considers the Tailor ring, model TARP to be substantially equivalent in configuration, function and intended use to the Tailor ring, model TARN. 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 |
D. Summary of Non-Clinical Tests
The testing for the Tailor ring model TARN (predicate) is included in the premarket notification (K000119). The following tests have been performed on the Tailor ring model TARP to insure substantial equivalence with the predicate.
New Holder/Handle Configuration
- Physical Testing 1.
- Holder to Handle connection .
- Holder assembly .
- Ring assembly to holder .
-
- Microbiological Testing
- . Biocompatibility
- · Sterility Assurance
- ന് Manufacturing Process Validation
Special 510(k) - Tailor Annuloplasty Ring Section 7 - 510(k) Summary
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2002
Mr. William McKelvey Regulatory Affairs Coordinator St. Jude Medical, Inc. One Lillehei Plaza St. Paul, MN 55117
Re: K014161
Trade Name: SJM® Tailor™ Annuloplasty Ring, Model TARP-(size) Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II (two) Product Code: KRH Dated: December 17, 2001 Received: December 19, 2001
Dear Mr. McKelvey:
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.
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
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Page 2 - Mr. William McKelvey
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
s (21) CFR (2000) (2006) (2006) (21) CFR 1000-1050, forth in the quality systems (QS) regulation (21 -51 Fur o 20) -542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR
This letter will allow you to begin marketing your device as described in your Section 510(k)
the same of the supportune of a list of a legical carticle squirelevice to Aleg This letter will allow you to begin marketing your advice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivaleand thus, premarket notification. The PDA Inding of subsantal equive and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific advice for your do vites diagnostic devices), please contact the Office of
additionally 21 CFR Part 809.10 for in the sitted diagnostic devices the and additionally 21 CFR Part 809.10 for questions on the promotion and advertising of
Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising Compliance at (301) 594-4380. Additionally, for quot (301) 594-4639. Also, please note the your device, please contact the Office of Compination in (1CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket motifications the regulation entitled, "Misbranding by reichers to premanter Act may be obtaincol from the Other general information on your responsional and Consumer Assistance at its toll-free number Division of Oman (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours
Bram 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
510(k) Number (if known):__
Device Name: SJM® Tailor™ annuloplasty ring
Indications for Use:
The SJM® Tailor™ annuloplasty ring is indicated for use in the repair of a mitral or tricuspid 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: | K01416 |
Prescription Use X
or
Over-The-Counter Use
Per 21 CFR 801.109)
Optional Format 1-2-96)
Special 510(k) - Tailor Annuloplasty Ring Indications For Use
003
§ 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.”