(89 days)
Sulzer Carbomedics CardioFix™ Pericardium is indicated for the following uses:
• Intracardiac Repair
► Ventricular repair using a reinforced patch technique (i.e., minimum of double thickness).
► Atrial Repair.
• Great vessel repair and suture line buttressing using a reinforced patch technique (i.e., minimum of double thickness) for applications exposed to peak systolic pressure.
• Pericardial Closure.
The Sulzer Carbomedics CardioFix™ Pericardium is prepared from bovine pericardium stabilized using a dye-mediated process referred to as the PhotoFix® process. This photooxidation process creates crosslinks in the bovine tissue. No aldehyde chemistry is used during any phase of manufacturing including the tissue fixation or sterilization processes. The CardioFix™ Pericardium is sterilized by ethylene oxide and is supplied sterile in a sealed container with 22% buffered ethanol solution. The package is designed to facilitate convenient aseptic transfer of the pericardium into the sterile field. Rinsing of the pericardium before implantation is not required. The CardioFix™ Pericardium is available in the following sizes: 1 cm x 1 cm, 4 cm, 6 cm x 8 cm, 8 cm x 14 cm, 10 cm x 16 cm, and 14 cm x 16 cm.
The provided text describes a 510(k) submission for the Sulzer Carbomedics CardioFix™ Pericardium, focusing on its substantial equivalence to predicate devices. However, it does not contain the detailed information typically found in a study report proving a device meets specific acceptance criteria. The document is primarily a summary of the device, its indications for use, and a confirmation of 510(k) clearance by the FDA.
Therefore, I cannot fully answer your request. However, I can extract the information that is present and explain why other sections cannot be completed based on the provided text.
Here's a breakdown of what can and cannot be answered:
1. Table of acceptance criteria and the reported device performance:
The document mentions "Comprehensive in vitro performance testing has been performed for the Sulzer Carbomedics CardioFix™ Pericardium and Bio-Vascular Peri-Guard Pericardium predicate device." It also states, "In vitro performance testing performed for the CardioFix™ Pericardium and predicate device, which included uniaxial tension, suture retention, and suture hole elongation provides evidence that the CardioFix™ Pericardium is substantially equivalent to the predicate devices."
However, the document does not provide the specific acceptance criteria (e.g., numerical thresholds for uniaxial tension, suture retention, or suture hole elongation) or the actual numerical results ("reported device performance") for either the CardioFix™ Pericardium or the predicate device that would allow for a direct comparison against such criteria.
The acceptance criteria for 510(k) submissions are typically framed around demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device that is not subject to premarket approval. The "acceptance criteria" here are implied to be that the CardioFix™ performs comparably to the predicate on these tests. Without the actual data from the testing, a table cannot be completed with specific performance metrics.
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified in the provided text for the in vitro tests.
- Data provenance: For in vitro tests, it's generally retrospective as these are lab tests done on manufactured samples. The country of origin is not specified but implicitly assumed to be from Sulzer Carbomedics Inc. which is in Austin, Texas, USA.
The document also mentions "animal testing demonstrates acceptable in vivo performance for the CardioFix™ Pericardium," and later, in the FDA letter, it states, "You also included results of rat subcutaneous implantation tests assessing calcification potential."
- Sample size for animal test set: Not specified.
- Data provenance for animal study: Animal testing (specifically rat subcutaneous implantation) as described in the text is prospective for the duration of the study, though the reporting within the 510(k) is retrospective. The country of origin is implicitly the location of Sulzer Carbomedics, Inc. (USA) or the location where their research was conducted.
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):
This information is not applicable or not provided in the context of this device and study types.
- For the in vitro performance tests (uniaxial tension, suture retention, suture hole elongation), "ground truth" is established through physical measurement according to validated test methods, not by expert consensus in the typical sense of medical imaging or clinical ground truth.
- For the animal study (rat subcutaneous implantation for calcification), "ground truth" would be established through histological analysis and quantitative assessment of calcification, typically performed by pathologists or histotechnicians, but the number and qualifications of such experts are not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable or not provided for the types of tests described. Adjudication methods are typically used when subjective assessments by multiple experts are involved, such as in clinical trials or image interpretation studies, to resolve discrepancies. The in vitro and animal studies described here are objective measurements or pathological assessments.
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:
This is not applicable. An MRMC study is relevant for AI-powered diagnostic or assistive devices where human readers interpret images or data. The CardioFix™ Pericardium is a medical implant (cardiovascular patch), not a diagnostic or AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The CardioFix™ Pericardium is a medical implant, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For in vitro performance tests: The "ground truth" is derived from physical measurements using established laboratory test methods (e.g., force transducers for tension and retention, calipers or imaging for hole elongation).
- For the animal study (calcification): The "ground truth" for calcification assessment would typically be derived from pathology/histology and potentially quantitative biochemical assays.
8. The sample size for the training set:
This is not applicable. The CardioFix™ Pericardium is a medical implant, not a machine learning model; therefore, there is no "training set."
9. How the ground truth for the training set was established:
This is not applicable for the same reason as point 8.
Summary of what is present in the text related to the "study":
The "study" described is a set of in vitro performance tests and animal testing for the Sulzer Carbomedics CardioFix™ Pericardium, conducted to demonstrate substantial equivalence to a predicate device (Bio-Vascular Peri-Guard Pericardium).
- In vitro tests included: Uniaxial tension, suture retention, and suture hole elongation.
- Animal testing: Rat subcutaneous implantation tests assessing calcification potential. The FDA noted that "calcification development is delayed in the CardioFix™ compared to the control device," but also cautioned that the rat model is not validated for human correlation.
This document serves as a 510(k) summary, which typically provides an overview rather than the detailed methodology and results of such studies. For the specific numerical data and detailed test protocols, one would normally refer to the full 510(k) submission or supporting technical documentation, which is not provided here.
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Image /page/0/Picture/1 description: The image shows the words "SULZER MEDICA" in bold, black font. The words are all capitalized and are arranged horizontally. The word "SULZER" is larger than the word "MEDICA". The font appears to be sans-serif.
DEC 2 9 1999
Sulzer Carbomedics Inc.
1300 East Anderson Lane Austin. Texas 78752-1793
Phone (512) 435-3200 FAX (512) 435-3350 WATS (800) 648-1579 (US and Canada)
510(k) SUMMARY SULZER CARBOMEDICS CARDIOFIX™ PERICARDIUM
The Sulzer Carbomedics CardioFix™ Pericardium is prepared from bovine pericardium stabilized using a dye-mediated process referred to as the PhotoFix® process. This photooxidation process creates crosslinks in the bovine tissue. No aldehyde chemistry is used during any phase of manufacturing including the tissue fixation or sterilization processes.
The CardioFix™ Pericardium is sterilized by ethylene oxide and is supplied sterile in a sealed container with 22% buffered ethanol solution. The package is designed to facilitate convenient aseptic transfer of the pericardium into the sterile field. Rinsing of the pericardium before implantation is not required. The CardioFix™ Pericardium is available in the following sizes: 1 cm x 1 cm, 4 cm, 6 cm x 8 cm, 8 cm x 14 cm, 10 cm x 16 cm, and 14 cm x 16 cm.
The CardioFix™ Pericardium is indicated for use in (1) intracardiac repair (ventricular repair using a reinforced patch technique (i.e., minimum of double thickness) and atrial repair], (2) great vessel repair and suture line buttressing using a reinforced patch technique (i.e., minimum of double thickness) for applications exposed to peak systolic pressure, and (3) pericardial closure.
Comprehensive in vitro performance testing has been performed for the Sulzer Carbomedics CardioFix™ Pericardium and Bio-Vascular Peri-Guard Pericardium predicate device. In vitro performance testing performed for the CardioFix™ Pericardium and predicate device, which included uniaxial tension, suture retention, and suture hole elongation provides evidence that the CardioFix™ Pericardium is substantially equivalent to the predicate devices. In addition, animal testing demonstrates acceptable in vivo performance for the CardioFix™ Pericardium.
Sulzer Carbomedics considers the CardioFix™ Pericardium to be substantially equivalent to the currently marketed predicate devices.
| Common name of the Device: | Cardiovascular Patch |
|---|---|
| Trade Name or Proprietary Name: | Sulzer Carbomedics CardioFix™ Pericardium |
| Submitter and Contact Person: | Edward E. NewtonRegulatory Affairs Manager1300 E. Anderson Lane, Austin, TX 78752Phone: (512) 435-3407 Fax: (512) 435-3350 |
| Submission Submitted on: | September 30, 1999 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. In the center of the seal is an eagle-like symbol with three lines representing the body and wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 9 1999
Mr. Edward E. Newton Requlatory Affairs Manager Sulzer Carbomedics, Inc. 1300 East Anderson Lane Austin, Texas 78752-1793
K993288 Re: Sulzer Carbomedics CardioFix™ Pericardium Trade Name: Regulatory Class: II Product Code: DXZ Dated: September 30, 1999 Received: October 1, 1999
Dear Mr. Newton:
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 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). 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.
We note that you have provided an article hypothesizing that aldehyde fixation is a potential precursor for calcification. You also included results of rat subcutaneous implantation tests assessing calcification potential. The results suggest that calcification development is delayed in the CardioFix™ compared to the control device. Since the rat model has not been validated to correlate with the human response regarding calcification, your promotional materials must not imply, even by juxtapositioning of verbiage, that the results of the rat studies are predictive of the human response. Any reference to the rat study must include a caveat that long-term human data are not available, and may not correlate with the results of the rat study.
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 to 895. A substantially equivalent determination assumes compliance
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Page 2 - Mr. Edward E. Newton
with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, 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 sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). 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/dsma/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT
| 510(K) Number (if known): | Unknown |
|---|---|
| Device Name: | Sulzer Carbomedics CardioFix™ Pericardium |
| Indications for Use: | Sulzer Carbomedics CardioFix™ Pericardium is indicatedfor the following uses: |
| • Intracardiac Repair► Ventricular repair using a reinforced patchtechnique (i.e., minimum of double thickness).► Atrial Repair. | |
| • Great vessel repair and suture line buttressing using areinforced patch technique (i.e., minimum of doublethickness) for applications exposed to peak systolic |
Pericardial Closure. ●
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
pressure.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bota R. Campbell
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number k 993288
Prescription Use
OR
Over-the-Counter Use
(Optional Format 1-2-96)
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).