(169 days)
Not Found
No
The description focuses on the material composition and intended use as a surgical mesh, with no mention of AI, ML, image processing, or data-driven analysis.
Yes
The device is used for "reinforcement of soft tissue where weakness exists," which is a therapeutic intervention aimed at improving a health condition.
No
The document states that GraftPatch® is intended for "reinforcement of soft tissue where weakness exists," such as hernia repairs. This describes a therapeutic or repair function, not a diagnostic one.
No
The device description explicitly states it is composed of "heat-laminated layers of crosslinked porcine collagen," indicating it 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 is for "reinforcement of soft tissue where weakness exists" in "general surgical procedures." This describes a device used in vivo (within the body) during surgery.
- Device Description: The description confirms it's a "surgical mesh" composed of "crosslinked porcine collagen" and is used for "hernia repairs." This is a physical implant used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used directly on the patient's tissue during a procedure.
N/A
Intended Use / Indications for Use
The GraftPatch® is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.
Product codes
79 FTM, FTL
Device Description
GraftPatch® is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists, e.g., hernia repairs. The device is composed of heat-laminated layers of crosslinked porcine collagen. GraftPatch® is similar in design, materials, function, and intended use to other surgical meshes which are currently in U.S. commercial distribution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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
Animal implant studies were performed to confirm the functionality of the device. Biocompatibility testing was conducted on the device material in conformance with Tripartite and ISO 10993 recommendations. Results of all testing demonstrated that GraftPatch® Surgical Mesh is both suitable for its intended use and substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
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
510(k) SUMMARY Organogenesis Inc. GraftPatch®
AUG - I 1997
1. DATE PREPARED
January 23, 1997
2. SUBMITTER
Organogenesis Inc. 150 Dan Road Canton, Massachusetts 02021
3. CONTACT
Joel T. Cademartori, P.E. Vice President of Regulatory Affairs, Quality Assurance and Control Organogenesis Inc. 150 Dan Road Canton, Massachusetts 02021
(617) 575-0775 Telephone: (617) 575-0440 Facsimile:
4. DEVICE NAME
GraftPatch®
DEVICE CLASSIFICATION ડ.
Class II (21 CFR 878.3300) Product Code: 79 FTM
1
6. DEVICE DESCRIPTION AND COMPARISON TO PREDICATE PRODUCTS
GraftPatch® is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists, e.g., hernia repairs. The device is composed of heat-laminated layers of crosslinked porcine collagen. GraftPatch® is similar in design, materials, function, and intended use to other surgical meshes which are currently in U.S. commercial distribution. Examples of other surgical meshes which have been cleared for commercial distribution include the Supple Periguard® by Bio-Vascular, Inc. (K923657), and Vicryl surgical mesh by Ethicon, Inc. (K810218).
Determination of substantial equivalence for this product was based on descriptive information about the design, materials, and intended use of the device. Animal implant studies were performed to confirm the functionality of the device. Biocompatibility testing was conducted on the device material in conformance with Tripartite and ISO 10993 recommendations. Results of all testing demonstrated that GraftPatch® Surgical Mesh is both suitable for its intended use and substantially equivalent to the predicate devices.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joel T. Cademartori. P.E. Vice President of Regulatory Affairs Organogenesis Inc ... 150 Dan Road Canton, Massachusetts 02021
- Re: K970561 Trade Name: GraftPatch® Regulatory Class: II Product Code: FTL Dated: June 23, 1997 Received: Jun 25, 1997
AUG - 1 1997
Dear Mr. Cademartori:
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 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 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
3
Page 2 - Mr. Joel T. Cademartori, P.E.
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
- 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,
Celia M. Wilson, Ph.D., M.P.
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
4
510(k) Number (if known):
Device Name: _ GraftPatch®
Indications For Use:
The GraftPatch® is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.
9703
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
colle
(Division Sign-Off) Division of General Restorative Device 510(k) Number
Prescription Use
(Per 2.1 CFR 801.109)
(((
ાર
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Organogenesis Inc. - GraftPatch® 510(k)
1123/97