(86 days)
Not Found
Not Found
No
The device description focuses on the material composition and physical properties of a surgical mesh, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device, VYPRO Mesh, is indicated for the repair of hernia or other fascial defects, which are medical conditions, and its function involves reinforcing or bridging material to achieve a surgical result. This aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
This device, VYPRO Mesh, is a surgical mesh designed for the repair of hernias and other fascial defects. Its purpose is to reinforce or bridge tissue, not to diagnose medical conditions.
No
The device description clearly states it is a mesh constructed from physical materials (polyglactin and polypropylene fibers) intended for surgical implantation. It is a physical medical 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 surgical repair of hernias and fascial defects by providing reinforcement or bridging material. This is a surgical implant used in vivo (within the body).
- Device Description: The description details the materials and construction of a surgical mesh designed to be implanted in the body.
- 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 in the body for structural support.
N/A
Intended Use / Indications for Use
VYPRO Mesh is indicated 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
VYPRO Mesh is constructed from approximately equal parts of absorbable polyglactin 910 multifilament fiber and non-absorbable polypropylene multifilament fiber. The purpose of the absorbable polyglactin component is to add firmness to the polypropylene structure and thus make intraoperative handling of the mesh easier. The mesh affords excellent strength, durability and surgical adaptability, with a porous structure to enable mesh incorporation into surrounding tissues. The polymer of the polypropylene fiber is identical to that used in PROLENE* Polypropylene Suture, Nonabsorbable Surgical Sutures, U.S.P. (ETHICON, INC.). This material, when used as a suture, has been reported to be nonreactive and to retain its strength indefinitely in clinical use.
The polyglactin fiber consists of a copolymer containing 90% grycolide and 10% lactide. This copolymer is identical in synthetic composition to that which has been found to be nonantigenic, nonpyrogene and to elicit only a mild tissue reaction during absorption. The poryglacem component is absorbed within 56 to 70 days, leaving the polypropylene mesh structure that allows strong integration into the physiological stresses to which the abdominal wall is subject.
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 technological characteristics that were evaluated for VYPRO Mesh include: thickness, burst strength, flexural rigidity, tear strength, suture pull-out and tensile strength. The values for VYPRO Mesh are less than those for PROLENE Mesh, but greater than MERSILENE Mesh. VYPRO Mesh has a greater compliance and thickness than PROLENE Mesh, larger pore size, and higher burst strength than MERSILENE Mesh. Nonclinical laboratory testing was not performed as there is no analogous to the clinical intended use as compared to the predicate devices. Sufficient bench testing was conducted in accordance with the guidance document "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh."
The results of a clinical study compared the use of VYPRO Mesh with MARLEX and ATRIUM Meshes. This study has found VYPRO Mesh to be acceptable with regard to mechanical and clinical characteristics including some advantages in bench testing and clinical trials.
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.
Not Found
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
NOV 2 2 2000
SECTION 7
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.
MODIFIED DEVICE NAME: VYPRO* Mesh
PREDICATE DEVICE NAME: PROLENE* (Polypropylene) Mesh and VICRYL* (Polyglactin 910) Mesh for materials and indications and MERSILENE* Polyester Mesh for Indications For Use.
510(k) SUMMARY
...
Device Description
VYPRO Mesh is constructed from approximately equal parts of absorbable polyglactin 910 multifilament fiber and non-absorbable polypropylene multifilament fiber. The purpose of the absorbable polyglactin component is to add firmness to the polypropylene structure and thus make intraoperative handling of the mesh easier. The mesh affords excellent strength, durability and surgical adaptability, with a porous structure to enable mesh incorporation into surrounding tissues. The polymer of the polypropylene fiber is identical to that used in PROLENE* Polypropylene Suture, Nonabsorbable Surgical Sutures, U.S.P. (ETHICON, INC.). This material, when used as a suture, has been reported to be nonreactive and to retain its strength indefinitely in clinical use.
Continued on next page
VYPRO* Mesh ETHICON, Inc.
23
1
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
...
510(k) SUMMARY, Continued
Description (continued)
Intended Use
Indications Statement
Technological Characteristics
Performance Data
The polyglactin fiber consists of a copolymer containing 90% The polygiaoun 10% lactide. This copolymer is identical in gryconde and 107at used in VICRYL* (polyglactin 910) synthetic composition to that which has been found to be nonantigenic, absorbacts batand to elicit only a mild tissue reaction during nonpyrogeme and to enortial component is absorbed within 56 to absorption. The poryglacem on polypropylene mesh structure that 70 days, leaving the physiological stresses to which the abdominal wall is subject.
This mesh is intended for the repair of hernia or other fascial 1 mo most require the addition of a reinforcing or bridging material to obtain the desired surgical result.
This mesh is used for the repair of hernia or other fascial defects 1 mis mosil is aboution of a reinforcing or bridging material to obtain the desired surgical result.
The technological characteristics that were evaluated for VYPRO Mesh include: thickness, burst strength, flexural rigidity, tear strength, suture pull-out and tensile strength. The values strongin, sutters proPRO Mesh are less than those for PROLENE Mesh, but greater than MERSILENE Mesh. VYPRO Mesh has a NICSII, but grouter than ility and thickness than PROLENE Mesh, iarger porce bize, frigher burst strength than MERSILENE Mesh.
Nonclinical laboratory testing was not performed as there is no Nonemarous the clinical intended use as compared to the predicate devices. Sufficient bench testing was conducted in accordance with devices: Suitting document ""Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh."
Continued on next page
VYPRO* Mesh ETHICON, Inc.
24
2
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
Performance Data (continued)
The results of a clinical study compared the use of VYPRO Mesh with MARLEX and ATRIUM Meshes. This study has found WYPRO Mesh to be acceptable with regard to mechanical and v ITTC Mosil to stics including some advantages in bench testing and clinical trials.
Conclusions
Based on the 510(k) summaries and 510(k) statements (21 CFR Dasod on the orrormation provided herein, we conclude that the new device is substantially equivalent to the Predicate Device under the Federal Food, Drug, and Cosmetic Act.
Contact
Gregory R. Jones Director, Regulatory Affairs ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151
Date
August 25, 2000
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 2 2000
Mr. Gregory R. Jones Director, Regulatory Affairs Ethicon, Inc. Route 22 West P.O. Box 151 Somerville, New Jersey 08876
K002672 Re:
Trade Name: VYPRO Mesh VICRYL-PROLENE Partially Absorbable Synthetic Surgical Mesh
Regulatory Class: II Product Code: FTL Dated: August 25, 2000 Received: August 28, 2000
Dear Mr. Jones:
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.
4
Page 2 - Mr. Gregory R. Jones
This letter will allow you to begin marketing your device as described in your 510(k) rins letter will anow yourse obgan finding of substantial equivalence of your device to a premaince notification. - In 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 and additionally 60911594-4595. Additionally, for questions on the promotion and Compliance at (301) vice, please contact the Office of Compliance at (301) 594-4639. advortibing or your aregulation entitled, "Misbranding by reference to premarket Also, prease flore the regal 97). Other general information on your responsibilities under the nother (21) OF IC or 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 McMullan
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
5
INDICATION FOR USE
510(k) Number (if known):
. , :
Device Name:
Indications for Use:
VYPRO* Mesh VICRYL*-PROLENE* Partially Absorbable Synthetic Surgical Mesh
VYPRO Mesh is indicated 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.
(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) | X |
|---|---|
| OR | |
| Over-The Counter Use | |
| for Mark N Millhiser | |
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K002672 (Optional Format 1-2-9G) |
VYPRO* Mesh ETHICON, Inc.