(86 days)
Not Found
No
The device description and performance studies focus on the material properties and surgical application of a mesh, with no mention of AI or ML technologies.
Yes
The device is described as a surgical mesh used for the repair of hernias and other fascial deficiencies, which are medical treatments.
No
The device description indicates it is a surgical mesh for hernia repair, and the "Summary of Performance Studies" describes non-clinical and in-vivo testing related to its function as a reinforcing material, not for diagnosis.
No
The device description explicitly states it is a "sterile mesh" with physical components (polypropylene mesh, ORC fabric, polydioxanone polymer film), indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the repair of hernias and other fascial deficiencies, which is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical mesh, a physical implant used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body 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 for structural repair within the body.
N/A
Intended Use / Indications for Use
PROCEED Mesh may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
PROCEED* Surgical Mesh is a sterile mesh designed for the repair of hernias and other fascial deficiencies. The mesh product has separate layers comprising of PROLENE* Soft Mesh, a nonabsorbable polypropylene mesh, a fabric of oxidized regenerated cellulose (ORC) and a polydioxanone polymer film.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-clinical laboratory testing was performed demonstrating that the device is comparable to standard surgical mesh devices that are indicated for hernia repair and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain that desired surgical result. Additionally, in-vivo testing was provided showing that the device performed as intended and as claimed.
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.
PROLENE Soft Polypropylene Mesh.
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.
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
KO31925 (1. 1982)
SECTION 8
SUMMARY OF SAFETY AND EFFECTIVENESS
| 510(k) Summary | Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
NEW DEVICE NAME: PROCEED* Surgical Mesh
PREDICATE DEVICES NAME: PROLENE Soft Polypropylene Mesh. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | PROCEED* Surgical Mesh is a sterile mesh designed for the repair of hernias and other fascial deficiencies. The mesh product has separate layers comprising of PROLENE* Soft Mesh, a nonabsorbable polypropylene mesh, a fabric of oxidized regenerated cellulose (ORC) and a polydioxanone polymer film. |
| Intended Use | PROCEED Mesh may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result. |
| Indications Statement | PROCEED Mesh may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result. |
| Technological
Characteristics | PROCEED has similar technological characteristics as the
predicate devices. The addition of another layer to the
standard base surgical mesh material is common to the
W.L. GORE & Associates, Inc. DualMesh** Biomaterial
(K963619), the Genzyme Corp. Sepramesh** Biosurgical
Composite (K994328) and the Bard Composix** Mesh
(510K K971745) with a performance characteristic of
minimizing tissue attachment to the base mesh material.
With the addition of the ORC layer to minimize tissue
attachment to the base PROLENE Soft Mesh, the
PROCEED Mesh continues to meet the functional
requirements of a surgical mesh |
| Performance Data | Non-clinical laboratory testing was performed
demonstrating that the device is comparable to standard
surgical mesh devices that are indicated for hernia repair
and other fascial deficiencies that require the addition of a
reinforcing or bridging material to obtain that desired
surgical result. Additionally, in-vivo testing was provided
showing that the device performed as intended and as
claimed. |
| Conclusions | Based on the 510(k) summaries and 510(k) statements (21
CFR 807) and the information provided herein, we
conclude that the modified device is substantially
equivalent to the Predicate Devices under the Federal Food,
Drug, and Cosmetic Act. |
| Contact | Rey Librojo
Senior Project Manager, Regulatory Affairs
ETHICON Products
ETHICON, Inc.
Rt. #22, West
Somerville, NJ 08876-0151 |
| Date | September 3, 2003 |
1
ψ31925 (P. 20A2)
2
Image /page/2/Picture/1 description: The image shows a stylized drawing of three birds in flight, arranged closely together. The birds are depicted with simple, curved lines, giving them a sense of movement. A dotted circle partially surrounds the birds, adding a sense of enclosure or focus to the composition. The drawing is in black and white, with a minimalist aesthetic.
food and Drug 200 Corporate Boute Rockville MD 20050
SEP 1 7 2003
Mr. Rev Librojo Senior Project Manager, Regulatory Affairs Ethicon, Inc. Rt. #22 West Somerville, New Jersey 08876-0151
Re: K031925
Trade/Device Name: PROCEED* Trilaminate Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Polymeric surgical mesh Regulatory Class: II Product Code: FTL Dated: June 20, 2003 Received: June 27, 2003
Dear Mr. Librojo:
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.
3
Page 2 - Mr. Rey Librojo
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,
Miriam 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
4
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Indications for Use:
PROCEED* Trilaminate Surgical Mesh
PROCEED Mesh may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 CFR 801.109)
OR
, i
Over-The Counter Use
(Optional Format 1-2-9G)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
K031925 510(k) Number_
Page iii