(76 days)
Not Found
Not Found
No
The device description and performance studies focus on the material properties and mechanical function of a surgical mesh, with no mention of AI or ML technologies.
Yes
The device is described as being used for the "repair of indirect and direct inguinal hernia defects" and is made of a "non-absorbable polypropylene mesh." This indicates its use in the treatment or management of a medical condition, which aligns with the definition of a therapeutic device.
No
Explanation: The device description clearly states it is a "PROLENE Polypropylene Mesh Hernia Device" intended for "repair of indirect and direct inguinal hernia defects," indicating it is a surgical implant for treatment, not diagnosis. There is no mention of diagnostic functions.
No
The device description clearly states it is a physical, three-dimensional mesh device constructed of polypropylene, indicating it is a hardware medical device.
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 inguinal hernia defects. This is a surgical procedure performed in vivo (within the body).
- Device Description: The device is a physical mesh designed to be implanted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests outside of the body on biological samples. This device is a surgical implant used inside the body for structural repair.
N/A
Intended Use / Indications for Use
The PROLENE Polypropylene Mesh Hernia Device is intended to be used for the repair of indirect and direct inguinal hernia defects.
The PROLENE Mesh Hernia Device is indicated for the repair of inguinal hernia defects, both indirect and direct.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
The PROLENE Polypropylene Mesh Hernia Device is a sterile, pre-shaped, three dimensional device constructed of an onlay patch connected by a mesh cylinder to a circular underlay patch. The material is undyed PROLENE* polypropylene mesh constructed of knitted non-absorbable polypropylene filaments identical to that used in PROLENE* polypropylene 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.
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)
ETHICON, Inc has conducted a preclinical study to show that the PROLENE Mesh Hernia Device is effective in repairing inguinal hernias, maintaining its position in the inguinal canal without the aid of sutures. Postoperative tissue ingrowth and functionality were demonstrated.
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.
BARD® Marlex® Mesh PerFix® Plug Nonabsorbable Polypropylene Surgical Mesh Device.
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
SEP 1 0 1997
ﻤﺴﺌ
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. |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NEW DEVICE NAME: ETHICON PROLENE* Polypropylene Mesh
Hernia Device Nonabsorbable Synthetic Surgical Mesh Implant. |
| | PREDICATE DEVICE NAME: BARD® Marlex® Mesh PerFix® Plug
Nonabsorbable Polypropylene Surgical Mesh Device. |
| | 510(k) SUMMARY |
| Device Description | The PROLENE Polypropylene Mesh Hernia Device is a sterile,
pre-shaped, three dimensional device constructed of an onlay
patch connected by a mesh cylinder to a circular underlay patch.
The material is undyed PROLENE* polypropylene mesh
constructed of knitted non-absorbable polypropylene filaments
identical to that used in PROLENE* polypropylene
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. |
| Intended Use | The PROLENE Mesh Hernia Device is intended to be used for
the repair of indirect and direct inguinal hernia defects.. |
| Indications Statement | The PROLENE Mesh Hernia Device is indicated for the repair
of inguinal hernia defects, both indirect and direct. |
| Technological
Characteristics | The modified device has comparable technological characteristics
to the predicate device. Both devices are pre-shaped, three
dimensional devices constructed of knitted polypropylene
monofilaments. |
| | When compared to the predicate device, the PROLENE Mesh
Hernia Device is a single device which requires no sutures to
secure into place. The PerFix Plug is available as two separate
pieces in which the fluted mesh must be sutured into place. |
| Performance Data | ETHICON, Inc has conducted a preclinical study to show that
the PROLENE Mesh Hernia Device is effective in repairing
inguinal hernias, maintaining its position in the inguinal canal
without the aid of sutures. Postoperative tissue ingrowth and
functionality were demonstrated. |
| 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
Device under the Federal Food, Drug, and Cosmetic Act. |
PROLENE Polypropylene Mesh Hernia Device ETHICON, Inc.
・・・・・
1
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
510(k) SUMMARY, Continued
Continued on next page
- Trademark
PROLENE Polypropylene Mesh Hernia Device ETHICON, Inc.
.
・
:
2
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
Contact
Gregory R. Jones Director, Regulatory Affairs ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151
Date
June 25, 1997
PROLENE Polypropylene Mesh Hernia Device ETHICON, Inc.
21 . . . .
. :
・.
3
Image /page/3/Picture/11 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, with its wings spread. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 1997
Mr. Gregory R. Jones Director, Regulatory Affairs ETHICON, Inc. PO Box 151 Somerville, New Jersey 08876-0151
Re: K972412
Trade Name: PROLENE Polypropylene Mesh Hernia Device Regulatory Class: II Product Code: FTL Dated: June 25, 1997 Received: June 26, 1997
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 requirements , as set forth in the Quality System Regulation (OS) 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) 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.
tsoblef
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
5
and the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contributi
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
A. A. M.
Indications for Use:
PROLENE Polypropylene Mesh Hernia Device_ The PROLENE Polypropylene Mesh Hernia Device is indicated
for the repair of indirect and direct inguinal hernia defects.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K97241 |
| Prescription Use (Per 21 CFR 801.109) | X | OR | Over-The Counter Use |
|---|---|---|---|
| --------------------------------------- | --- | ---- | ---------------------- |
(Optional Format 1-2-9G)