Who is the manufacturer of PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH?

ETHICON, Inc. filed the 510(k) submission for PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH (K001122).

What is the FDA product code for PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH?

FTL. It is classified under 21 CFR 878.3300 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH?

PROLENE (Polypropylene) Mesh; MERSILENE Mesh.

Who can help prepare an FDA 510(k) submission like PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH

K001122 · ETHICON, Inc. · FTL · May 23, 2000 · General, Plastic Surgery

Device Facts

Record ID	K001122
Device Name	PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
Applicant	ETHICON, Inc.
Product Code	FTL · General, Plastic Surgery
Decision Date	May 23, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.3300
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

PROLENE Soft Mesh is a knitted polypropylene surgical mesh; constructed of reduced-diameter monofilament fibers; features blue monofilament contrast striping. Device provides reinforcement or bridging for hernia and fascial defect repair. Knitted design interlinks fiber junctions; provides bi-directional elasticity; allows cutting to desired size without unraveling. Approximately 50% more flexible than standard PROLENE mesh. Used by surgeons in clinical settings to provide strength and durability while allowing tissue ingrowth. Material is non-reactive and retains strength indefinitely in vivo.

Clinical Evidence

No clinical data. Bench testing conducted in accordance with FDA guidance document 'Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh'.

Technological Characteristics

Knitted polypropylene monofilament mesh. Features reduced fiber diameter compared to standard PROLENE mesh. Bi-directional elasticity. Non-absorbable. Sterilized.

Indications for Use

Indicated for the repair of hernia or other fascial defects requiring reinforcing or bridging material.

Regulatory Classification

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.

Predicate Devices

PROLENE (Polypropylene) Mesh
MERSILENE Mesh

Related Devices

K163152 — PROLENE Soft Polypropylene Mesh · ETHICON, Inc. · Mar 11, 2017
K172089 — PROLENE Soft Polypropylene Mesh · ETHICON, Inc. · Oct 5, 2017
K013718 — GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR · Gynecare, A Div. of Ethicon, Inc. · Jan 8, 2002
K962530 — PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH · ETHICON, Inc. · Aug 9, 1996
K070018 — UNIVERSAL SURGICAL MESH, MODEL 100 · Generic Medical Device, Inc. · Apr 27, 2007

Submission Summary (Full Text)

{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)