(167 days)
VYPRO Mesh, PROLENE Polypropylene Mesh, MERSILENE Mesh
Not Found
No
The summary describes a physical surgical mesh material and its intended use, with no mention of software, algorithms, or any technology that would suggest AI/ML.
No
The device is a surgical mesh used to repair hernias and abdominal fascia deficiencies, providing structural support rather than delivering therapy.
No
The device is a mesh used as a reinforcing or bridging material for surgical repair, not for diagnosis.
No
The device description explicitly states it is a "sterile partially absorbable composite mesh manufactured from approximately equal parts of absorbable poliglecaprone-25 monofilament fiber and non absorbable polypropylene monofilament fiber," indicating it is a physical hardware device, 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 the "repair of hemias and other abdominal fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result." This describes a surgical implant used directly on the patient's body during a procedure.
- Device Description: The device is a "sterile partially absorbable composite mesh" made of fibers. This is a physical material intended for implantation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not perform any such diagnostic testing on specimens.
Therefore, this device falls under the category of a surgical implant or medical device used for structural support and repair within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ULTRAPRO Mesh may be used for the repair of hernias and other abdominal fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Is for the "repair of hemias and other abdominal fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result."
Product codes
FTL
Device Description
ULTRAPRO* Mesh is a sterile partially absorbable composite mesh designed for the repair of hernias and other abdominal fascia deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
ULTRAPRO Mesh is manufactured from approximately equal parts of absorbable poliglecaprone-25 monofilament fiber and non absorbable polypropylene monofilament fiber.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal fascia
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, animal testing demonstrated that ULTRAPRO would achieve good tissue ingrowth.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
VYPRO Mesh, PROLENE Polypropylene Mesh, MERSILENE Mesh
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
K03337
SECTION 8
SUMMARY OF SAFETY AND EFFECTIVENESS
| 510(k) Summary of Safety and Effectiveness | 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: ULTRAPRO* Mesh
PREDICATE DEVICES NAME: VYPRO Mesh, PROLENE Polypropylene Mesh, MERSILENE Mesh | |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | ULTRAPRO* Mesh is a sterile partially absorbable composite mesh designed for the repair of hernias and other abdominal fascia deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
ULTRAPRO Mesh is manufactured from approximately equal parts of absorbable poliglecaprone-25 monofilament fiber and non absorbable polypropylene monofilament fiber. | |
| Intended Use | ULTRAPRO Mesh may be used for the repair of hernias and other abdominal fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result. | |
| Indications Statement | ULTRAPRO Mesh may be used for the repair of hernias and other abdominal fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result. | |
| Technological
Characteristics | | ULTRAPRO has similar technological characteristics as the
predicate devices. The characteristics evaluated include thickness,
burst strength, flexural rigidity, tear strength, tensile strength,
porosity, and suture pull-out strength. Comparison to other
commercialized surgical meshes indicates equivalency in clinical
performance. |
| 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, animal testing
demonstrated that ULTRAPRO would achieve good tissue
ingrowth. |
| 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 | | October 14, 2003 |
Trademark ULTRAPRO Mesh ETHICON, Inc.
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- Trademark ULTRAPRO Mesh ETHICON, Inc.
K03337
ace
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with three curved lines representing the human form. The logo is rendered in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR = 1 2004
Mr. Ray Librojo Senior Project Manager Ethicon. Inc. Rt. #22, West Somerville, New Jersey 08876-0151
Re: K033337
Trade/Device Name: ULTRAPRO Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: January 8, 2004 Received: January 13, 2004
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.
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Page 2 - Mr. Ray 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 vour 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
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510(k) Number (if known): K033337
Device Name: ULTRAPRO Mesh
Indications For Use. Is for the "repair of hemias and other abdominal fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result."
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)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number_K633337