(78 days)
Not Found
No
The device description and the "Mentions AI, DNN, or ML" section explicitly state that AI/ML is not found. The device is a physical tissue patch and associated accessories.
No
The device is a patch for cardiac reconstruction and repair, which is an implantable medical device, not a therapeutic device in the sense of delivering therapy. Its function is structural repair.
No
The device is described as an intracardiac patch for structural repair and reconstruction, not for identifying or assessing medical conditions.
No
The device description clearly states it is a physical tissue patch made from bovine pericardium, which is a hardware component.
Based on the provided information, the CorRestore patch is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as an intracardiac patch for cardiac reconstruction and repair." This describes a device that is implanted directly into the body to repair tissue, not a device used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition.
- Device Description: The description details a physical patch made from bovine pericardium intended for surgical implantation. It doesn't mention any components or processes related to analyzing biological samples.
- Anatomical Site: The anatomical site is "Intracardiac," which is inside the body. IVDs are used to test samples from the body, but the testing itself happens in vitro (in glass, or outside the body).
In summary, the CorRestore patch is a medical device used for surgical repair within the heart, not a diagnostic tool used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
The CorRestore™ patch is intended for use as an intracardiac patch for cardiac reconstruction and repair.
Product codes
DXZ
Device Description
The CorRestore Patch is an oval tissue patch made from glutaraldehyde fixed bovine pericardium. It is intended to be used as an intracardiac patch for cardiac reconstruction and repair. It is identical to other marketed bovine pericardium patches except that it incorporates an integral suture bolster (also made of fixed bovine pericardium) in the shape of an oval ring and is packaged with accessories needed for cardiac repair and reconstruction. The CorRestore Patch comes as a kit including a patch and suture strip (1.4 x 16 cm), both manufactured from processed bovine pericardium. Optionally included is a set of various sutures needed for implantation. To assist the surgeon in determining the appropriate size, a separate disposable sizer kit is offered.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracardiac
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
AUG - 7 2003
Appendix D
CorRestore™ Patch System, new suture supplier Trade Name: Intracardiac Patch or Pledget Common Name: Establishment Information: Somanetics Corporation 1653 East Maple Road Troy, MI 48083 Phone: (248) 689-3050 (248) 689-4272 Fax: Contact Person: Ronald A. Widman, Vice President of Medical Affairs Class II, Panel 74 DXZ Classification:
Product Description:
The CorRestore Patch is an oval tissue patch made from glutaraldehyde fixed bovine pericardium. It is intended to be used as an intracardiac patch for cardiac reconstruction and repair. It is identical to other marketed bovine pericardium patches except that it incorporates an integral suture bolster (also made of fixed bovine pericardium) in the shape of an oval ring and is packaged with accessories needed for cardiac repair and reconstruction. The CorRestore Patch comes as a kit including a patch and suture strip (1.4 x 16 cm), both manufactured from processed bovine pericardium. Optionally included is a set of various sutures needed for implantation. To assist the surgeon in determining the appropriate size, a separate disposable sizer kit is offered.
| Without
Sutures | W/ Ethicon
Sutures | W/ Genzyme
Sutures | Product |
|--------------------|-----------------------|-----------------------|------------------------------|
| 1.5P2 | 1.5P2S | 1.5P2SG | 1.5 x 2 cm* CorRestore Patch |
| 2P3 | 2P3S | 2P3SG | 2 x 3 cm* CorRestore Patch |
| 3P4 | 3P4S | 3P4SG | 3 x 4 cm* CorRestore Patch |
Accessory:
CRPS
CorRestore Patch Sizer Set
Substantial Equivalence:
The CorRestore patch is equivalent in indications for use, size, shape, material, manufacturing processes, sterilization, packaging, instructions and intended use to the predicate CorRestore Patch System, K011487. The only change is the addition of a new suture supplier, Genzyme. Sutures are packaged in the same way with labeling appropriate for their premarket notification status, the same as the predicate. The packaging prevents liquid sterilant from contacting the sutures. The CorRestore Patch is substantially equivalent to the predicate device.
0(k) Summary
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 7 2003
Mr. Ronald A. Widman Vice President of Medical Affairs Samanetics Corporation 1653 East Maple Road Troy, MI 48083
Re: K031586
Trade Name: CoreRestore™ Patch System Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac Patch or Pledget Regulatory Class: Class II (two) Product Code: DXZ Dated: May 19, 2003 Received: May 21, 2003
Dear Mr. Widman:
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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 additional controls. Existing major regulations affecting your device can be
2
Page 2 - Mr. Ronald A. Widman
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.
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 (21 CFR Part 807); 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 the labeling regulation, please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97), You may obtain other general information on your responsibilities under the Act 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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
KO31586 510(k) Number (if known) _
Device Name: CorRestore™ Patch System Processed Bovine Pericardial Patch
Indications For Use:
The CorRestore patch is intended for use as an intracardiac patch for cardiac reconstruction and repair.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K. Oesterle
n of Cardiovascular Devices
510(k) Number K031586
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)