(190 days)
The Shelhigh BioRing™ is intended for use in the repair of the human cardiac mitral valve.
The Shelhigh BioRing™ is indicated as a reinforcement for repair of the human cardiac mitral valve damaged by acquired or congenital disease, or a replacement for a previously implanted annuloplasty ring.
The Shelhigh BioRing™ consists of circular rings made of Polyester material and covered with No-React processed pericardium.
This document is a 510(k) summary for the Shelhigh BioRing and describes its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the way typically expected for an AI/ML device.
Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and sample sizes for a performance study evaluating an AI/ML component is not applicable to this document.
However, I can extract the information that is present and indicate where the requested details are not available.
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria for device performance based on a study, nor does it report specific performance metrics in that context. The "acceptance criteria" here are related to demonstrating substantial equivalence to predicate devices, focusing on materials, intended use, and technological characteristics.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Intended Use | Same as predicate devices (repair of human cardiac mitral valve) |
| Technological Characteristics | Similar to predicate devices (circular rings, polyester material, No-React processed pericardium) |
| Material Properties | Good tensile strength, good suture retention |
| Biocompatibility | Non-toxic, non-hemolytic, non-pyrogenic; Passed all required biocompatibility tests |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This document does not describe a performance study with a test set. The evaluation is based on a comparison to predicate devices and material testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. No test set or ground truth establishment by experts is described in this context.
4. Adjudication Method for the Test Set
Not applicable. No test set or adjudication method is described.
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 device is an annuloplasty ring, not an AI/ML device. Therefore, no MRMC study involving AI assistance was conducted or would be relevant to this product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
Not applicable. For this type of medical device (physical implant), "ground truth" would relate to factors like material specifications, biocompatibility test results, and clinical outcomes for the predicate devices, rather than an expert-adjudicated dataset. The document states that the materials "passed the requirements of all tests," implying a comparison to established standards for safety and performance (biocompatibility, tensile strength, suture retention).
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML component, thus no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI/ML component, thus no training set or its associated ground truth.
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JUN - 4 2003
510(K) Summary Class Shelhigh BioRing
Proprietary and Common Name:
Shelhigh BioRing™ Trade name: Common name : Annuloplasty Ring
Predicate Devices
AnnuloFlex, Duran Flexiable Ring,and Shelhigh No-React pericardial Patch.
Intended Use
The Shelhigh BioRing™ is intended for use in the repair of the human cardiac mitral valve.
Product Description
The Shelhigh BioRing™ consists of circular rings made of Polyester material and covered with No-React processed pericardium.
Substantial Equivalence
It is substantially equivalent to the predicate devices, having the same intended use and technological characteristics
Shelhigh BioRing™ material exhibits good tensile strength, and suture retention. The materials used in the manufacture of the BioRing™ are non-toxic, non-hemolytic, and non-pyrogenic. The materials exhibit excellent biocompatibility, and passed the requirments of all tests.
Conclusions: This device is, in respect to intended use and technological characteristics, substantially equivalent to the predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 2003
Shelhigh, Inc c/o Shlomo Gabbay, M.D. Chief Scientific Advisor P.O. Box 884 Millburn, NJ 07041
Re: K023940
Trade Name: Shelhigh BioRingTM Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II (two) Product Code: 74 KRH Dated: November 6, 2003 Received: November 26, 2002
Dear Dr. Gabbay:
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 - Shlomo Gabbay, M.D.
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 (OS) 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), please contact the Office of Compliance at (301) 594-4646. 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.
N. Dale Tuttle
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
510(k) Number (if known):
Device Name: Shelhigh BioRing™ Indications For Use:
The Shelhigh BioRing™ is indicated as a reinforcement for repair of the human cardiac mitral valve damaged by acquired or congenital disease, or a replacement for a previously implanted annuloplasty ring.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
Ov
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
N.Oelam
510(k) Number
§ 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.”