(59 days)
The SJM® Tailor™ annuloplasty band 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 band is a flexible band fabricated with a medical grade silicone rubber core, surrounded by polyester fabric.
The provided document is a 510(k) summary for a medical device, the SJM® Tailor™ annuloplasty band. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies to establish acceptance criteria and performance. Therefore, most of the requested information regarding acceptance criteria, study details, and human-AI comparative effectiveness is not applicable to this document.
Here's a breakdown of the parts that can be addressed based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in a quantitative sense for performance metrics like sensitivity, specificity, or accuracy. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device through various non-clinical tests.
| Characteristic | 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 to predicate | Substantially Equivalent |
| Anatomical Sites | Identical to predicate | Identical |
| Target Population | Identical to predicate | Identical |
| Performance Testing | Identical to predicate | Identical |
| Safety Characteristics | Identical to predicate | Identical |
| Band end evaluation | Demonstrated satisfactory performance in comparison to predicate | Performed |
| Gapping | Demonstrated satisfactory performance in comparison to predicate | Performed |
| Band release | Demonstrated satisfactory performance in comparison to predicate | Performed |
| Suture Retention | Demonstrated satisfactory performance in comparison to predicate | Performed |
| Suture pull | Demonstrated satisfactory performance in comparison to predicate | Performed |
| Biocompatibility evaluation | Demonstrated satisfactory performance | Performed |
| Sterility Assurance evaluation | Demonstrated satisfactory performance | Performed |
| Manufacturing Process Validation | Demonstrated satisfactory performance | Performed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not applicable. This submission relies on non-clinical testing and comparison to a predicate device, not a patient-based test set in the context of AI or diagnostic performance. The tests mentioned are for material and mechanical properties, not clinical assessment on patients.
- Data provenance: Not applicable. The tests performed are laboratory-based and do not involve patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no "ground truth" establishment by experts in the context of image interpretation or diagnosis for this device's non-clinical testing. The tests are physical and microbiological validations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "adjudication method" in the context of clinical interpretation or expert review for this type of non-clinical testing.
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 a medical device for heart valve repair (an annuloplasty band), not an AI diagnostic or assistance tool that would undergo MRMC studies involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles for material integrity, mechanical strength, and biocompatibility, as well as validated testing methods. It's not a clinical "ground truth" derived from patient-specific data.
8. The sample size for the training set
Not applicable. This is not an AI or machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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SEP 1 9 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 SpecialistSt. Jude Medical, Inc.Bus : (651) 415-7029Fax : (651) 766-3049Email: wmckelvey@sjm.com | |
| Submission Prepared: | July 18, 2002 | |
| B. | Device Information | |
| Proprietary Name: | SJM® Tailor™ annuloplasty band(Tailor band) Model TAB-(size) | |
| Common or Usual Name: | Flexible Annuloplasty band"C" ring | |
| Classification: | Pre-amendment Class II CFR § 870.3800Cardiovascular Prosthetic DevicesAnnuloplasty Ring | |
| Predicate Device: | St. Jude Medical considers The Tailorannuloplasty band, model TAB to besubstantially equivalent to the Tailorannuloplasty ring model TARP. | |
| Device Description | The Tailor band is a flexible band fabricatedwith a medical grade silicone rubber core,surrounded by polyester fabric. | |
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Intended Use:
The SJM® Tailor annuloplasty band is indicated for use in repair of a mitral or tricuspid heart valve that is diseased or damaged due to acquired or congenital processes.
Comparison of Required Technological Characteristics ﻥ
SJM considers the Tailor band, model TAB to be substantially equivalent in configuration, function and intended use to the Tailor ring, model TARP. 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 | Substantially Equivalent |
| d. | Anatomical Sites | Identical |
| e. | Target Population | Identical |
| f. | Performance Testing | Identical |
| g. | Safety Characteristics | Identical |
Summary of Non-Clinical Tests D.
The testing for the Tailor ring model TARP (predicate) is included in the premarket notification (K014161). The following tests have been performed on the Tailor band model TAB to insure substantial equivalence with the predicate.
1. Physical Validation
- Band end evaluation .
- Gapping ●
- . Band release
- Suture Retention ●
- Suture pull .
2. Microbiological Verification
- Biocompatibility evaluation .
- Sterility Assurance evaluation .
-
- Manufacturing Process Validation
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Image /page/2/Picture/10 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 9 2002
St. Jude Medical, Inc. c/o Mr. William McKelvey Regulatory Affairs Coordinator One Lillehei Plaza St. Paul, MN 55117
Re: K022363 Trade Name: SJM® Tailor™ Annuloplasty Band, Model TAB-(size) Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II (two) Product Code: KRH Dated: September 5, 2002 Received: September 6, 2002
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.
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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,
K. DeGraw
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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Page 1 of 1
0(k) Number (if known):__
Device Name: SJM® Tailor™ annuloplasty band
Indications for Use:
The SJM® Tailor™ annuloplasty band 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 If Another Page Is Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K022363
Prescription Use _____________________________________________________________________________________________________________________________________________________________
or
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
(Per 21 CFR 801.109)
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.”