(89 days)
Not Found
No
The device description and performance studies focus on the material properties and biological performance of a bovine pericardium patch, with no mention of AI or ML technologies.
Yes
The device is described as a pericardial patch used for intracardiac repair, great vessel repair, and pericardial closure, which are medical interventions aimed at treating a health problem.
No
The device is a medical implant (pericardium) used for surgical repair, not for diagnosing conditions.
No
The device description clearly states it is a physical product made from bovine pericardium, stabilized and sterilized, and available in various sizes. It is a biological tissue patch, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to surgical repair and reconstruction within the body (intracardiac repair, great vessel repair, pericardial closure). IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The device is a patch made from bovine pericardium intended for implantation. This is a surgical implant, not a diagnostic tool used to analyze samples.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any biological markers or substances to diagnose a condition.
Therefore, the Sulzer Carbomedics CardioFix™ Pericardium is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DXZ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracardiac, Great vessel, Pericardial
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Bio-Vascular Peri-Guard Pericardium
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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. Newton |
| Regulatory Affairs Manager | |
| 1300 E. Anderson Lane, Austin, TX 78752 | |
| Phone: (512) 435-3407 Fax: (512) 435-3350 | |
| Submission Submitted on: | September 30, 1999 |
1
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
2
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 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 |
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)