(114 days)
Not Found
No
The device description focuses on the material properties and construction of a surgical mesh, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is a surgical mesh for repairing anatomical defects, falling into the category of medical implants rather than devices that provide therapy (e.g., drug delivery, stimulation, or rehabilitation).
No
Explanation: The "Intended Use" states that the device is "intended for the repair of hernia or other fascial defects," indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly states it is a surgical mesh constructed of knitted polypropylene filaments, 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 the "repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result." This describes a surgical implant used in vivo (within the body) during a surgical procedure.
- Device Description: The description details the material and construction of a surgical mesh, again indicating an implantable device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo as a surgical implant.
N/A
Intended Use / Indications for Use
The Universal Surgical Mesh is intended for the repair of hernia or other fascial defects 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
Universal Surgical Mesh is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh (ETHICON, INC). The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue in-growth.
Universal Surgical Mesh in knitted by a process that interlinks each fiber junction and provides for elasticity in both directions. This construction permits the mesh to be cut into any desired shape or size without unraveling. The bi-directional elastic property allows adaptation to various stresses encountered in the body.
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)
The company did not conduct, nor depend on, clinical studies or non-clinical laboratory studies in order to establish substantial equivalence as there is no change to the clinical intended use as compared to the two predicate devices.
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.
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
APR 2 7 2007
510(K) Summary
Introduction
This 510(k) summary documentation is intended to comply with requirements of 21 CFR § 807.92. FDA may make this summary available to the public within 30 days following a finding of substantial equivalence.
510K Submitted By
Generic Medical Device, Inc. 2201-34th Ave NW Gig Harbor, WA 98335
USA Contact Person
Monica R. Montanez, RAC, CQA Consultant Tel: 713-523-9630 / Fax: 713-521-2770
Date Prepared
December 28, 2006
Trade Name of Device
Universal Surgical Mesh
Proprietary Name:
Universal Surgical Mesh Common Name:
Surgical Mesh
Classification Name:
Surgical Mesh Class II: General & Plastic Surgery 21 CFR 878.3300, Product Code FTL.
Predicate Devices: K962530- PROLENE Polypropylene Mesh Nonabsorbable Synthetic Manufactured by: Ethicon, Inc. Somerville, New Jersey 08876-0151
510(k) Classification Class II
1
Device Description
Universal Surgical Mesh is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh (ETHICON, INC). The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue in-growth.
Universal Surgical Mesh in knitted by a process that interlinks each fiber junction and provides for elasticity in both directions. This construction permits the mesh to be cut into any desired shape or size without unraveling. The bi-directional elastic property allows adaptation to various stresses encountered in the body.
Intended Use
The Universal Surgical Mesh is intended for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Comparison to Predicate Devices
Universal Surgical Mesh has the same intended use and same technological characteristics as the predicate device PROLENE Polypropylene Mesh Nonabsorbable Synthetic.
Clinical/Non-Clinical Studies
The company did not conduct, nor depend on, clinical studies or non-clinical laboratory studies in order to establish substantial equivalence as there is no change to the clinical intended use as compared to the two predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Generic Medical Device, Inc. % General Medical Device Company Ms. Monica R. Montanez, RAC, CQA Consultant 3906 Roseland Street Houston, Texas 77006
APR 2 7 2007
Re: K070018
Trade/Device Name: Universal Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: April 14, 2007 Received: April 17, 2007
Dear Ms. Montanez:
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
3
Page 2 - Ms. Monica R. Montanez, RAC, CQA
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. 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Universal Surgical Mesh
510(k) Number (if known):
Device Name: Universal Surgical Mesh
Indications For Use: The Universal Surgical Mesh is indicated for the repair of hemia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Prescription Use X (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)
Opl
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number 1000718