(172 days)
The AnnuloFlo™ System is intended for use in the repair of the human cardiac mitral valve. The AnnuloFlo™ annuloplasty ring is indicated as a reinforcement for repair of the human cardiac mitral valve damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.
The AnnuloFlo™ System consists of an annuloplasty ring, and a complete set of instrumentation provided in a tray to properly size the annulus and implant the annuloplasty ring. The annuloplasty ring is designed to reinforce the native annulus while revailing the native appratus.
This document describes the "AnnuloFlo™ System" (K970375), an annuloplasty ring for human cardiac mitral valve repair. The provided text is a 510(k) summary and the FDA's clearance letter, which focuses on regulatory approval and substantial equivalence rather than a detailed scientific study with specific acceptance criteria and performance metrics.
Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, sample sizes for test and training sets, expert qualifications, and ground truth establishment is not available in the provided text. The document is a regulatory submission summary, not the full study report.
Here's what can be extracted and what is explicitly not available based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-toxic, non-hemolytic, non-pyrogenic | "Material biocompatibility testing has been completed and supports these materials are non-toxic, non-hemolytic, and non-pyrogenic." (Reference to materials common to C.PHV) |
| Mechanical Performance | Suture retention strength comparable to other vascular prostheses fabrics | "suture retention testing to demonstrate that the [fabric] is comparable to fabrics used in other vascular prostheses." |
| Packaging & Sterilization | Five-year shelf life; same sterilization cycle as CPHV | "Package integrity testing to validate a five year shelf life has been conducted on this package. ... is sterilized in the same sterilizer, the same sterilization cycle as the CPHV." |
| MRI Compatibility | Non-ferrous, does not present a significant risk during MRI | "All materials are non-ferrous, have extensive history in implants and do not present a significant risk during Magnetic Resonance Imaging (MRI)." |
| Substantial Equivalence | Device is substantially equivalent to a predicate device (Carpentier-Edwards Classic™ Annuloplasty Ring) | FDA determination: "we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not available. The document summarizes testing but does not provide details on sample sizes for specific mechanical or biocompatibility tests, nor does it describe a "test set" in the context of, for example, clinical performance or image analysis. The data provenance is also not specified.
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 / Not available. This device is a physical medical implant, not an AI/diagnostic software. "Ground truth" in this context would relate to the validity of material properties or mechanical performance, which are evaluated through standardized tests, not expert consensus in the way a diagnostic AI would be. No information about expert involvement in establishing "ground truth" for the tests mentioned is provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Not available. As above, this pertains more to diagnostic accuracy studies involving human interpretation or complex data, not the material and mechanical testing described for this device.
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
- No, not done. This is an implantable medical device, not an AI or diagnostic tool. MRMC studies are not relevant for this type of product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, not applicable. This is an implantable medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For biocompatibility: Established biological safety standards and in-vitro testing criteria (implied by "non-toxic, non-hemolytic, non-pyrogenic").
- For mechanical performance: Standardized ASTM test methods (e.g., for suture retention strength) and comparison to established predicate device performance or industry standards.
- For shelf life: Accelerated aging studies and package integrity tests (implied).
- For MRI compatibility: Material properties (non-ferrous) and potentially specialized testing for interaction with MRI fields (implied).
8. The sample size for the training set
- Not applicable / Not available. The device is not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable / Not available. No training set exists.
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Image /page/0/Picture/0 description: The image shows a handwritten alphanumeric string. The string appears to be "K970375". The characters are written in a cursive style, with some connections between the numbers. The writing is in black ink on a white background.
SULZERMEDICA
510(k) Summary per SMDA 1990 and 21 CFR 807.92 AnnuloFlo™ System
JUL 2 5 1997
Sulzer Carbomodios Ino.
1300 East Anderson Lane Austin, Texas 78752-17
Phone (512) 435-3200
FAX (512) 435-3350
WATS (800) 648-1579 (US and Canada)
Submitter: Sulzer Carbomedics, Inc. 1300 East Anderson Lane Austin, Texas 78752 U.S.A.
Contact: Michael C. Morton, Manager, Regulatory Affairs Telephone: (512) 435-3373 Facsmile: (512) 435-3350
Date of Summary: May 2, 1997
Classification Name: Annuloplasty Ring
Common Name: Annuloplasty Ring
.
Proprietary Name: AnnuloFlo™ System
Predicate Device: Carpentier-Edwards Classic™ Annuloplasty King
Statement of Intended Use: 7be AnnuloFlo™ System is intended for use in the repair of the human cardian valve.
Statement of Indications for Use: The AnnuloFlord annuloplasty ring is indicated as a reinforcement for repair of the human cardiac miral valve damaged by acquired or congeniual disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where viewal inspection confirms that the valve is repairable and does not require replacement.
Description of Device: The AnnuloFloTh System consists of an annuloplasty ring, and a complete set of instrumentation provided in a tray to properly size the annulus and implant the annuloplasty ring. The annuloplasty ring is designed to reinforce the native annulus while revailing the native appratus.
Materials: The AnnuloFlo™ annuloplasty ring employs materials with a long and saisfactory history of use in candiovascular applications, including materials used in the CaboMedics® Prostbetic IIeart Valve (CPIN). All materials are non-ferrous, have extensive history in implants and do not present a significant risk during Magnetic Resonance Imaging (MRI). The annuloplasty ring consists of an ASTM (Ti-GAI-4V) titanium stiffener ring enclosed in a sewing ring of silicone elastomer tubing purchased from a major U.S. manufacturer, and lanited polyester fabric (VP1200) manufactured by Sulzer Vascurek Ltd. The sewing ing is coated with Biolite® carbon, manufactured by Sulzer Carbomedics Inc.
Design: The mitral AnnuloFlory annuloplasty ring is kidney shaped. The curved posterior segment of the ring corresponds to the native posterior leafler. The open segment of the ring corresponds to the anterior leafler
Testing: The AnnuloFlom annuloplasty ring uses materials common to the C.PHV, including titanium, polyester fabric, polyester suture, and Biolite® Carbon coating, Material biocompandility tessing has been coupleted Upd supports these materials are non-toxic, aon-hemolyge, and non pyrogenie. Mechanical testing, for the AnnuloFloral annuloplasty ring includes suture retention testing to demonstrate that the is comparable to fabrics used in other vascular prositieses. The AmuloFlores annuloplasty ring shares the same packaging as the CPHV, and is sterlized in the same sterilizes the same sterlization cycle as the CPHV. Package integrity testing to validate a tive year shelf lite has been conducted on this package.
Technological Comparison: The AnnuloFloThe annuloplasty ring intended use, design, function, and composition are similar to the Classic™ Annuloplasty Rung with the addition of Biolitely, a low temperature isoropic carbon couling, on the sewing ring of the AnuloFlix annuloplasty ring. Diolite® has a long and successful history of use in cardiovascular applications, including the CPHV.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three wavy lines, resembling a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael C. Morton Manager, Requlatory Affairs Sulzer Carbomedics, Inc. 1300 East Anderson Lane Austin, Texas 78752-1793
Jul 25 1997
Re: K970375 AnnuloFlo™ System, Mitral Model AR700 Regulatory Class: III (Three) Product Code: KRH Dated: January 31, 1997 Received: February 3, 1997
Dear Mr. Morton:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (act). The general controls provisions of the act include requirements for registration, listing of devices, good manufacturing practices, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 A substantially equivalent determination assumes compliance to 895. with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulation.
Under Section 522(a) of the act, manufacturers of certain types of devices identified by the Act or designated by FDA are required to conduct postmarket surveillance studies. FDA has identified under Section 522(a)(1)(A) the device cleared for marketing by this letter as requiring postmarket surveillance.
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Page 2 - Mr. Michael C. Morton
Within thirty (30) days of first introduction or delivery for introduction of this device into interstate commerce you are required to submit to FDA certification of the date of introduction into interstate commerce, a detailed protocol which describes the postmarket surveillance study, and a detailed profile of the study's principal investigator that clearly establishes the qualifications and experience of the individual to conduct the proposed study. For your information, general guidance on preparing a protocol for a postmarket surveillance study is encloseed.
Submit five (5) copies to:
Center for Devices and Radiological Health Postmarket Surveillance Studies Document Center Room 3083 (HFZ-544) 1350 Piccard Drive Rockville, Maryland 20850
Within sixty (60) days of receipt of your protocol, FDA will either approve or disapprove it and notify you of the Agency's action in writing. You should not begin your postmarket surveillance study of this device until the protocol has been approved. Data generated under an unapproved protocol may not satisfy your obliqation under section 522. Please note that you must continue to collect and report data needed to maintain compliance with Medical Device Reporting regulations (21 CFR 803).
Failure to certify accurately the date of initial introduction of your device into interstate commerce, to submit timely an acceptable protocol, or to undertake and complete and FDA approved postmarket surveillance study consistent with the protocol will be considered violations of section 522. In accordance with the Medical Device Amendments of 1992, failure of a manufacturer to meet its obligations i under section 522 is a prohibited act under section 301(q)(1) (C) of the Act (21 U.S.C. 331 (q) (1) (C) . Further, under section 502 (t) (3) of the act (21 U.S.C. 352(t)(3)), a device is misbranded if there is a failure or refusal to comply with any requirement under section 522 of Violations of sections 301 or 502 may lead to requlatory the act. actions including seizure of your product, injunction, prosecution, or civil money penalties.
If you have questions specifically concerning postmarket surveillance study requirements, contact the Postmarket Surveillance Studies Branch at (301) 594-0639.
In addition, on August 16, 1993, the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific
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Page 3 - Mr. Michael C. Morton
requirement of the requlation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
DAspoh
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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"INDICATIONS FOR USE" STATEMENT
510(K) Number: Unknown
AnnuloFlo™ System Device Name:
The AnnuloFlo™ annuloplasty ring is indicated as a reinforcement for Indications for Use: repair of the human cardiac mitral valve damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) √
Over-The-Counter Use
(Optional Format 1-2-96)
Lisa Kenail in Bu
OR
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K914373
§ 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.”