(46 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 any technology related to AI or ML.
Yes
The device is indicated for the repair of hernia or other fascial defects, which are therapeutic interventions.
No
The device description clearly states it is a "PROLENE Soft (Polypropylene) Mesh" indicated for the "repair of hernia or other fascial defects," serving as a "reinforcing or bridging material." This describes a therapeutic, implantable material, not a device used to identify or analyze a condition.
No
The device description clearly states it is a knitted mesh constructed of 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the PROLENE Soft Mesh is a surgical mesh intended for the repair of hernias and other fascial defects. It is a physical implant used in vivo (within the body) during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the PROLENE Soft Mesh falls under the category of a surgical implant or device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
This 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.
The PROLENE Soft (Polypropylene) 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
FTL
Device Description
PROLENE Soft* polypropylene mesh is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE* Polypropylene Suture, Nonabsorbable Surgical Sutures, U.S.P. (ETHICON, INC.). The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue ingrowth. Blue PROLENE monofilaments have been incorporated to produce contrast striping in the mesh. The mesh is constructed of reduced diameter monofilament fibers, knitted into a unique design that results in a mesh that is approximately 50 percent more flexible than standard PROLENE mesh. This material, when used as a suture, has been reported to be non-reactive and to retain its strength indefinitely in clinical use.
PROLENE Soft mesh is knitted by a process which interlinks each fiber junction and which 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 adaption 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)
Nonclinical laboratory testing was not performed as there is no change to the clinical intended use as compared to the two predicate devices. Sufficient bench testing was conducted in accordance with the FDA guidance document ""Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
KDW1122
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: PROLENE Soft* (Polypropylene)
Mesh |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | PREDICATE DEVICE NAME: PROLENE* (Polypropylene)
Mesh and MERSILENE* Mesh |
| | 510(k) SUMMARY |
| Device Description | PROLENE Soft* polypropylene mesh is constructed of knitted
filaments of extruded polypropylene identical in composition to
that used in PROLENE* Polypropylene Suture, Nonabsorbable
Surgical Sutures, U.S.P. (ETHICON, INC.). The mesh affords
excellent strength, durability and surgical adaptability, with
sufficient porosity for necessary tissue ingrowth. Blue PROLENE
monofilaments have been incorporated to produce contrast striping
in the mesh. The mesh is constructed of reduced diameter
monofilament fibers, knitted into a unique design that results in a
mesh that is approximately 50 percent more flexible than standard
PROLENE mesh. This material, when used as a suture, has been
reported to be non-reactive and to retain its strength indefinitely in
clinical use. |
Continued on next page
PROLENE* Soft (Polypropylene) Mesh ETHICON, Inc.
1
K ΨΨ1122
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
510(k) SUMMARY, Continued
| Description (continued) | PROLENE Soft mesh is knitted by a process which interlinks each
fiber junction and which 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 adaption to various stresses encountered in the body. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | This 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. |
| Indications Statement | This mesh is used 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. |
| Technological
Characteristics | For technological characteristics, the values established for
PROLENE Soft mesh are less than those of PROLENE mesh, but
greater than those of MERSILENE mesh. Both PROLENE Soft
mesh and PROLENE mesh are constructed of polypropylene
fibers. PROLENE Soft mesh offers a 50% more flexible
monofilament mesh. |
| Performance Data | Nonclinical laboratory testing was not performed as there is no
change to the clinical intended use as compared to the two
predicate devices. Sufficient bench testing was conducted in
accordance with the FDA guidance document ""Guidance for the
Preparation of a Premarket Notification Application for a Surgical
Mesh." |
.
2
K$\phi\psi1122
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
| Conclusions | Based on the 510(k) summaries and 510(k) statements (21 CFR
807) and the information 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 | April 6, 2000 |
3
Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human profile with three lines extending from the head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2000
Mr. Gregory R. Jones Director, Regulatory Affairs Ethicon, Inc. Route 22 Somerville, New Jersey 08876
Re: K001122 Trade Name: PROLENE Soft (Polypropylene) Mesh Regulatory Class: II Product Code: FTL Dated: April 6, 2000 Received: April 7, 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 (OS) 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,
Dinna R. Lechner.
OCelia 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): | K001132 |
|---|---|
| --------------------------- | --------- |
Device Name:
Indications for Use:
PROLENE Soft* (Polypropylene) Mesh.
The PROLENE Soft (Polypropylene) 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)
OR
(Division Sign-Off) Division of General Restorative Devices 510(k) Number_Kool | 2 乙
Over-The Counter Use
(Optional Format 1-2-9G)