(121 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a surgical mesh, with no mention of AI or ML technologies.
Yes
The device is described as a "sterile, nonabsorbable synthetic surgical mesh designed for the repair of hernias and other fascial defects," which are medical conditions that require treatment, thus qualifying it as a therapeutic device.
No
Explanation: The device is a surgical mesh used for the repair of hernias and fascial defects, which is a treatment rather than a diagnostic function.
No
The device description explicitly states it is a "sterile, nonabsorbable synthetic surgical mesh" composed of "knitted filaments of extruded polypropylene," which are physical materials, not software. The performance studies also focus on material properties and sterilization, not software validation.
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 other fascial defects. This is a surgical implant used in vivo (within the body).
- Device Description: The description details a surgical mesh made of polypropylene, designed to be implanted.
- 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 about a physiological state, health, or disease.
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
Prolene Soft Polypropylene Mesh may be 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.
Product codes
FTL
Device Description
PROLENE Soft Mesh is a sterile, nonabsorbable synthetic surgical mesh designed for the repair of hernias and other fascial defects. The implant device is composed of knitted filaments of extruded polypropylene. Blue PROLENE™ monofilaments have been integrated to produce contrast striping in the mesh.
PROLENE Soft 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.). Blue PROLENE monofilaments have been incorporated to produce contrast striping in the mesh. The mesh is constructed of 3.5 mil diameter monofilament fibers, knitted into a unique design that results in a mesh that is approximately 50 percent more flexible than standard PROLENE Mesh. Polypropylene 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 is designed to allow 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)
The following performance data were provided in support of the substantial equivalence determination:
- Biocompatibility: PROLENE Soft Mesh is a permanent (>30 days) implant device contacting tissue. The biocompatibility for PROLENE Soft Mesh 50 cm x 50 cm has been evaluated in accordance with ISO 10993-1:2009 "Biological Evaluation of Medical Devices - Evaluation and Testing", and ANSI/AAMI ST72:2011 "Bacterial endotoxins -Test methods, routine monitoring, and alternatives to batch testing." Endotoxin testing was performed in accordance with ANSI/AAMI ST72:2011 and met criteria of
§ 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
Image /page/0/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" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 11, 2017
Ethicon, Inc. Ms. Debbie Fazen Senior Regulatory Affairs Program Lead Route 22 West, P.O. Box 151 Somerville, New Jersey 08876
Re: K163152
Trade/Device Name: Prolene Soft Polypropylene Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: February 10, 2017 Received: February 13, 2017
Dear Ms. Fazen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163152
Device Name Prolene Soft Polypropylene Mesh
Indications for Use (Describe)
Prolene Soft Polypropylene Mesh may be 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.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------- |
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| Submitter: | Ethicon, Inc. a Johnson & Johnson company
P.O. Box 151
Route 22 West
Somerville, NJ 08876-0151 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Debbie Fazen
Senior Regulatory Affairs Program Lead
Ph: (908) 218-3196
Fax: (908) 218-2595
Email: Dfazen@its.jnj.com |
| 510(k) Number: | K163152 |
| Date Prepared: | March 10, 2017 |
| Device Trade Name: | PROLENE® Soft Polypropylene Mesh |
| Device Common Name: | PROLENE Soft Mesh |
| Class: | Class II |
| Classification: | 21 CFR 878.3300 – Surgical Mesh |
| Product Code: | FTL |
| Predicate Device: | |
| 510(k) Summary |
|---|
| In accordance with 21 CFR 807.87(h) and 21 CFR 807.92 |
| Device | Company | Product Code | 510(k) Number | Predicate for |
|---|---|---|---|---|
| PROLENE® Soft | ||||
| Polypropylene | ||||
| Mesh | Ethicon, Inc. | FTL | K001122 | Fundamental |
| Scientific | ||||
| Technology, Design, | ||||
| Intended Use, | ||||
| Materials, | ||||
| Construction, | ||||
| Performance | ||||
| Characteristics |
4
Device Description
PROLENE Soft Mesh is a sterile, nonabsorbable synthetic surgical mesh designed for the repair of hernias and other fascial defects. The implant device is composed of knitted filaments of extruded polypropylene. Blue PROLENE™ monofilaments have been integrated to produce contrast striping in the mesh.
PROLENE Soft 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.). Blue PROLENE monofilaments have been incorporated to produce contrast striping in the mesh. The mesh is constructed of 3.5 mil diameter monofilament fibers, knitted into a unique design that results in a mesh that is approximately 50 percent more flexible than standard PROLENE Mesh. Polypropylene 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 is designed to allow adaption to various stresses encountered in the body.
Indications for Use
The PROLENE Soft Polypropylene Mesh may be 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. The Indications for Use on the Prolene Soft Mesh 50 cm x 50 cm subject device is identical to the predicate device.
Summary of Technological Characteristics
The predicate and subject devices function in the same manner. They are designed as prosthetic material for the repair of hernias and other fascial deficiencies by providing reinforcement or acting as bridging materials. The technological characteristics of the subject device are different as compared to the predicate device. Both predicate and subject PROLENE Soft Mesh devices are composed of a macro porous non-absorbable synthetic surgical mesh. The additional size (50 cm x 50 cm) of the subject device has been developed to satisfy customer needs.
The safety and effectiveness and substantial equivalence of the predicate device and subject device has been demonstrated via data collected during design validation and design verification. The results of these tests provide reasonable assurance that the subject device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing. All materials used in the proposed device are the same as the predicate device and meet the requirements of ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and Testing within a risk management process.
5
Performance Data
The following performance data were provided in support of the substantial equivalence determination:
- Biocompatibility PROLENE Soft Mesh is a permanent (>30 days) implant device 1. contacting tissue. The biocompatibility for PROLENE Soft Mesh 50 cm x 50 cm has been evaluated in accordance with ISO 10993-1:2009 "Biological Evaluation of Medical Devices - Evaluation and Testing", and ANSI/AAMI ST72:2011 "Bacterial endotoxins -Test methods, routine monitoring, and alternatives to batch testing." Endotoxin testing was performed in accordance with ANSI/AAMI ST72:2011 and met criteria of