(203 days)
No
The device description and intended use focus on a biomaterial implant for soft tissue reinforcement, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as an implant for reinforcement of soft tissue, not for providing therapy.
No
The device is a soft tissue implant intended for reinforcement, not for diagnosing conditions.
No
The device description clearly states it is a physical implant made from porcine small intestine submucosa (SIS), which is a biomaterial. It is 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 it's for "reinforcement of soft tissue where weakness exists" and specifically for "reinforcement of the soft tissues which are repaired by suture or suture anchors limited to the supraspinatus during rotator cuff repair surgery." This describes a surgical implant used in vivo (within the body) to support tissue.
- Device Description: The description details a "round device, manufactured from 10 plys of Small Intestine Submucosa, (SIS)." This is a physical implant material.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with patient specimens.
Therefore, the DePuy Restore Orthobiologic Soft Tissue Implant is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The DePuy Restore Orthobiologic Soft Tissue Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. In addition, the implant is intended for use in the specific application of reinforcement of the soft tissues which are repaired by suture or suture anchors limited to the supraspinatus during rotator cuff repair surgery.
Product codes
FTM
Device Description
The Restore Orthobiologic Soft Tissue Implant is a round device, manufactured from 10 plys of Small Intestine Submucosa, (SIS). SIS is a biomaterial derived from porcine small intestine. SIS is composed predominately of water and collagen. This material is identical to the material approved K982330 for use in general surgical procedures for reinforcement of soft tissue where weakness exists.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, 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)
K980431, K973170, K993948, K992159, K983162, K992159, K970561, K974540
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 2 7 2000
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string appears to be "K001738". The characters are written in black ink on a white background. The handwriting is somewhat stylized, with the characters having a slightly rounded appearance.
SUMMARY OF SAFETY AND EFFECTIVEN
NAME OF SPONSOR:
DePuy, Inc. P.O. Box 988 Warsaw, Indiana 46581-0988
510(k) CONTACT:
Marcia J. Arentz Senior Regulatory Associate
TRADE NAME:
DePuy Restore® Orthobiologic Soft Tissue Implant
COMMON NAME: CLASSIFICATION: DEVICE PRODUCT CODE: Surgical Mesh 878.3300 - Surgical Mesh 79 FTM
SUBSTANTIALLY EQUIVALENT DEVICES:
- · Cook Biotech Inc. Surgisis Surgical Mesh (K980431)
- · Cook Biotech Inc. SIS Wound Dressing (K973170)
- · Cook Biotech Inc. SIS Wound Dressing II (K993948)
-
- Cook Biotech Inc. Surgisis Sling (K992159)
- · Bio-Vascular Peri-guard (K983162)
- · Bio-Vascular Peri-Strips (K992159)
- · Organogenesis Graft Patch (K970561)
- · Sentron SIS Hernia Repair Device (K974540)
DEVICE DESCRIPTION AND INTENDED USE:
The Restore Orthobiologic Soft Tissue Implant is a round device, manufactured from 10 plys of Small Intestine Submucosa, (SIS). SIS is a biomaterial derived from porcine small intestine. SIS is composed predominately of water and collagen. This material is identical to the material approved K982330 for use in general surgical procedures for reinforcement of soft tissue where weakness exists.
The Restore Orthobiologic Soft Tissue Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The device is intended to act as a resorbable scaffold that initially has sufficient strength to assist with a soft tissue repair, but then resorbs and is replaced by the patient's own tissue. The device is also intended for reinforcement of the soft tissues which are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy Restore Orthobiologic Soft Tissue Implant is substantially equivalent to the above listed devices in that it is manufactured from the same material (SIS, porcine small intestine submucosa) as the Sentron SIS Hernia Repair Device and the Cook Biotech Inc. SIS Wound Dressing and SIS Surgical Mesh and Sling. The material is very similar to that of the Organogenesis Graft Patch (cross-linked porcine collagen). It has the same general intended use as the Organogenesis Graft Patch, the Bio-Vascular Supple Peri-guard, and the SIS Surgical Mesh and it has a similar design to all of these soft tissue patches. It has the additional specific intended use for reinforcement of the soft tissues which are repaired by suture or suture anchors during rotator cuff repair surgery which is substantially equivalent to the pre-amendment use of surgical mesh in rotator cuff repair.
1
Image /page/1/Picture/2 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized depiction of three wavy lines, which are arranged in a way that resembles a stylized human figure. The text "DEPARTMENT OF HEALTH & HL" is arranged around the logo.
DEC 2 7 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marcia J. Arentz Senior Regulatory Associate Depuy Orthopaedics, Inc. P.O. Box 988 Warsaw, Indiana 46581
K001738 Re:
Trade Name: Restore® Orthobiologic Soft Tissue Implant Regulatory Class: II Product Code: FTM Dated: October 20, 2000 Received: October 23, 2000
Dear Ms. Arentz:
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, 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.
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 with the current Good Manufacturing Practice requirement, 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 regulatory 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 regulations.
2
Page 2 - Ms. Marcia J. Arentz
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) 594-4595. 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/dsmamain.html".
Sincerely yours,
Sincerely yours,
Mark H. Milliken
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
001138
510(k) Number (if known)
Device Name Restore orthobiologic Soft Tissue Implant
Indications for Use:
The DePuy Restore Orthobiologic Soft Tissue Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. In addition, the implant is intended for use in the specific application of reinforcement of the soft tissues which are repaired by suture or suture anchors limited to the supraspinatus during rotator cuff repair surgery.
Concurrence of CDRH, Office of Device Evaluation
Prescription Use OR Over-The-Counter Use
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K001738