(59 days)
No
The summary describes a physical medical device (an annuloplasty band) and its materials and testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is indicated for use in the "repair of a mitral or tricuspid valve that is diseased or damaged," which directly addresses and corrects a medical condition.
No
The device, an annuloplasty band, is indicated for the repair of a heart valve, not for diagnosing a condition.
No
The device description clearly states it is a "flexible band fabricated with a medical grade silicone rubber core, surrounded by polyester fabric," indicating it is a physical hardware device.
Based on the provided information, the SJM® Tailor™ annuloplasty band is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the repair of a mitral or tricuspid valve within the body. IVDs are used to examine specimens outside the body (in vitro) to provide information about a patient's health.
- Device Description: The device is a physical implant designed to be surgically placed. IVDs are typically reagents, instruments, or systems used for testing biological samples.
- Lack of IVD-related information: The description does not mention any components or processes related to analyzing biological samples or providing diagnostic information based on such analysis.
The SJM® Tailor™ annuloplasty band is a surgical implant used for the mechanical repair of heart valves.
N/A
Intended Use / 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.
Product codes
KRH
Device Description
The Tailor band is a flexible band fabricated with a medical grade silicone rubber core, surrounded by polyester fabric.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mitral or tricuspid heart valve
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 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.
- Physical Validation
- Band end evaluation .
- Gapping ●
- . Band release
- Suture Retention ●
- Suture pull .
- Microbiological Verification
- Biocompatibility evaluation .
- Sterility Assurance 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
SEP 1 9 2002
510(K) SUMMARY (as Required by 21 CFR § 807.92)
Submitters Information
A.
| | 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 Specialist
St. Jude Medical, Inc.
Bus : (651) 415-7029
Fax : (651) 766-3049
Email: 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 § 870.3800
Cardiovascular Prosthetic Devices
Annuloplasty Ring |
| | Predicate Device: | St. Jude Medical considers The Tailor
annuloplasty band, model TAB to be
substantially equivalent to the Tailor
annuloplasty ring model TARP. |
| | Device Description | The Tailor band is a flexible band fabricated
with a medical grade silicone rubber core,
surrounded by polyester fabric. |
| | | |
1
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
2
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.
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,
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