(86 days)
Not Found
No
The device description focuses solely on the material composition and physical properties of a surgical mesh, with no mention of software, algorithms, or data processing.
No
The device is a nonabsorbable synthetic surgical mesh used for the repair of abdominal wall deficiencies, acting as a reinforcing material. While it aids in a surgical repair, it does not directly treat a disease or condition; rather, it provides structural support as part of a physical repair.
No
The device, PROLENE™ Soft Mesh, is described as a surgical mesh for repairing abdominal wall deficiencies, not for diagnosing conditions.
No
The device description clearly states it is a sterile, nonabsorbable synthetic surgical mesh composed of knitted filaments of extruded polypropylene, which is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes.
- PROLENE™ Soft Mesh Function: The description clearly states that PROLENE™ Soft Mesh is a surgical mesh intended for the repair of abdominal wall deficiencies. It is an implantable device used directly in the body during surgery.
- No Specimen Examination: The device does not involve the examination of any specimens (like blood, urine, tissue, etc.) outside of the body.
Therefore, based on the provided information, PROLENE™ Soft Mesh is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PROLENE™ Soft Mesh is indicated for the repair of abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
PROLENE™ Soft Mesh is a sterile, nonabsorbable synthetic surgical mesh designed for the repair of abdominal wall hernias and abdominal wall deficiencies. 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 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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal wall
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)
Not Found
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.
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 5, 2017
Ethicon Incorporated Ms. Stephanie Saati Senior Regulatory Affairs Specialist Route 22 West, P.O. Box 151 Somerville, New Jersey 08876-0151
Re: K172089
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: July 10, 2017 Received: July 11, 2017
Dear Ms. Saati:
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 (DICE) 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 (DICE) 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
2
Indications for Use
510(k) Number (if known) K172089
Device Name PROLENE™ Soft Polypropylene Mesh
Indications for Use (Describe)
PROLENE™ Soft Mesh is indicated for the repair of abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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100540783 | Rev. 1 K172089 page 1 of 3
HICON a John huson company
510(k) Summary
| Submitter: | Ethicon, Inc. a Johnson & Johnson company
P.O. Box 151
Route 22 West
Somerville, NJ 08876-0151 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephanie Saati
Senior Regulatory Affairs Specialist
Phone: 908-218-3318
Fax: 908-218-2595
Email: SSaati@its.jnj.com |
| Date Prepared: | June 30, 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: | FTI |
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| Device | Company | Product Code | 510(k) Number | Predicate for |
|---|---|---|---|---|
| PROLENE™ Soft | ||||
| Polypropylene | ||||
| Mesh | ||||
| Product Code: | ||||
| SPM3XL | Ethicon, Inc. | FTL | K163152 | Fundamental Scientific |
| Technology, Design, | ||||
| Intended Use, Materials, | ||||
| Construction, Performance | ||||
| Characteristics | ||||
| PROLENE™ Soft | ||||
| (Polypropylene), | ||||
| Nonabsorbabale | ||||
| Synthetic | ||||
| Surgical Mesh | ||||
| Product Codes: | ||||
| SPMH | ||||
| SPMII | ||||
| SPMLI | ||||
| SPMS | ||||
| SPMXS | ||||
| SPMXXL | Ethicon, Inc. | FTL | K001122 | Fundamental Scientific |
| Technology, Design, | ||||
| Intended Use, Materials, | ||||
| Construction, Performance | ||||
| Characteristics |
Predicate Device:
Device Description:
PROLENE™ Soft Mesh is a sterile, nonabsorbable synthetic surgical mesh designed for the repair of abdominal wall hernias and abdominal wall deficiencies. 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 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. 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.
5
Indications for Use:
PROLENE™ Soft Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.
Summary of Technological Characteristics:
PROLENE™ Soft Polypropylene Mesh is identical to the PROLENE™ Soft Polypropylene Mesh (K163152) and PROLENE™ Soft (Polypropylene). Nonabsorbabale Synthetic Surgical Mesh (K001122) marketed mesh with respect to technological characteristics. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed devices differ only in the labeling (Instructions for Use) which has been revised to add a new Contraindication. Additionally, several other sections of the Instructions for Use of the subject device have been reworded reformatted for clarity to address evolving regulatory expectations and bring the contents of the Instructions for Use up to date.
Substantial Equivalence:
PROLENE™ Soft Polypropylene Mesh is identical to the PROLENE™ Soft Polypropylene Mesh (K163152) and PROLENE™ Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh (K001122) marketed mesh with respect to technological characteristics. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed devices differ only in the labeling (Instructions for Use) which has been revised to add a new Contraindication. Additionally, several other sections of the Instructions for Use of the subject device have been reworded reformatted for clarity to address evolving regulatory expectations and bring the contents of the Instructions for Use up to date. The Indication statement of the subject mesh has been modified to add clarity. The Indication of the subject device does not introduce any new indications or expand patient population of the predicate mesh.
Conclusion:
The subject mesh, PROLENE™ Soft Polypropylene Mesh is identical to the two predicate marketed meshes, PROLENE™ Soft Polypropylene Mesh (K163152) and PROLENE™ Soft (Polypropylene). Nonabsorbabale Synthetic Surgical Mesh (K001122) with respect to intended use, technological characteristics, material, construction, specification, manufacturing and sterilization. In conclusion, the subject PROLENE™ Soft Polypropylene Mesh is substantially equivalent to the two predicate meshes.