(93 days)
No K/DEN number provided within the document for the predicate
Not Found
No
The summary describes a biological tissue graft (xenograft pericardium) used for soft tissue reinforcement. There is no mention of any computational or algorithmic components, let alone AI/ML. The performance studies focus on material properties and biocompatibility.
No.
The device acts as a non-resorbable scaffold to reinforce soft tissue during surgical repair and does not involve therapeutic action or treatment of a disease.
No
The device is described as a non-resorbable scaffold for soft tissue reinforcement during surgical procedures, not as a tool for diagnosis.
No
The device description clearly states it is a "cross-linked Xenograft pericardium," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "reinforcement of soft tissue where weakness exists" and to "act as a non resorbable scaffold to assist with a soft tissue repair." This describes a device used in vivo (within the body) during surgery to physically support and reinforce tissue.
- Device Description: The description details a "cross-linked Xenograft pericardium" provided sterile for surgical use. This is a biological implant material, not a reagent or instrument used to test samples in vitro.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) outside of the body to provide diagnostic information. The purpose is structural support during surgery.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The EnCuff does not fit this description.
N/A
Intended Use / Indications for Use
The Shelhigh EnCuff patch is intended for the surgical repair of soft tissue deficiencies and/or to reinforce soft tissues where weakness exists and in rotator cuff repair surgery.
The EnCuff is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The device is intended to act as a non resorbable scaffold to assist with a soft tissue repair. The device is also intended for reinforcement of the soft tissues which are repaired by suture or suture anchors, to the supraspinatus, during rotator cuff repair surgery.
Product codes (comma separated list FDA assigned to the subject device)
79 FTM, FTL
Device Description
The Shelhigh EnCuff is a cross-linked Xenograft pericardium, rinsed with No-React® anticalcification process. The device is provided sterile in 2% benzyl alcohol solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, rotator cuff, supraspinatus
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The Shelhigh EnCuff Patch is Identical to the Shelhigh No-React® pericardial patches currently manufactured by Shelhigh Inc. (No K/DEN number provided within the document for the predicate)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
DEC 1 9 2003
KO32893
Page 1 of 1
December 5, 2003
Summary of safety and efficacy Shelhigh EnCuff Patch
Applicant: Shelhigh Inc. 650 Liberty Ave, Union, NJ 07083
Contact person: Shlomo Gabbay, MD Tel: 908-206-8906 Fax 908-206-8725
l. Proprietary and Common Name:
Shelhigh No-React® EnCuff Patch Trade name: Common name : Surgical Mesh Classification: 878.3300 - Surgical Mesh Product Code: 79 FTM
ll. Predicate Devices:
The Shelhigh EnCuff Patch is Identical to the Shelhigh No-React® pericardial patches currently manufactured by Shelhigh Inc.
Intended Use
The Shelhigh EnCuff patch is intended for the surgical repair of soft tissue deficiencies and/or to reinforce soft tissues where weakness exists and in rotator cuff repair surgery.
IV. Product Description
The Shelhigh EnCuff is a cross-linked Xenograft pericardium, rinsed with No-React® anticalcification process. The device is provided sterile in 2% benzyl alcohol solution.
VI. Substantial Equivalence
It is substantially equivalent to the predicate devices, having the same intended use and technological characteristics.
- VII Shelhigh EnCuff material exhibits good tensile strength, shrink temperature and suture retention. The material reapproximates well around suture holes. It is soft and pliable. The material exhibits excellent biocompatibility, and passed the requirements 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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three overlapping shapes that resemble birds in flight, rendered in black.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2003
Shlomo Gabbay, M.D. Medical Director Shelhigh, Inc. 650 Liberty Avenue Union, New Jersey 07083
Re: K032893
Trade/Device Name: Shelhigh No-React ® EnCuff Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Polymeric surgical mesh Regulatory Class: II Product Code: FTL Dated: September 16, 2003 Received: September 30, 2003
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.
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Shlomo Gabbay, M.D.
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) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
The EnCuff is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The device is intended to act as a non resorbable scaffold to assist with a soft tissue repair. The device is also intended for reinforcement of the soft tissues which are repaired by suture or suture anchors, to the supraspinatus, during rotator cuff repair surgery.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
KO32823
Meriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number .
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