(73 days)
Not Found
No
The summary describes a physical surgical patch made of polypropylene and polyester, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The PROLENE™ 3D Patch is indicated for the repair of groin hernia defects and acts as a reinforcing material. While it contributes to a surgical repair, it does not directly treat a disease or condition in a therapeutic manner such as drug delivery, pain management, or rehabilitation. It's a surgical implant for structural support.
No
The PROLENE™ 3D Patch is indicated for the repair of groin hernia defects, not for diagnosis. It is a surgical implant designed to reinforce tissue.
No
The device description clearly states it is comprised of nonabsorbable (polypropylene) components and is a physical patch, not software.
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 groin hernia defects that require a reinforcing material to obtain the desired surgical result." This describes a surgical implant used in vivo (within the body) to physically repair a defect.
- Device Description: The description details a physical patch made of polypropylene components, designed to be surgically implanted. It does not mention any components or processes related to testing samples of blood, tissue, or other bodily fluids in vitro (outside the body).
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The PROLENE™ 3D Patch is indicated for the repair of groin hernia defects that require a reinforcing material to obtain the desired surgical result.
Product codes
FTL
Device Description
PROLENE™ 3D Patch is a device comprised of nonabsorbable (polypropylene) components. The polymer of the polypropylene filaments is identical to the material used in PROLENE™ Suture. It consists of a flat mesh onlay patch secured to a formed expandable diamond-shaped mesh patch component. The expandable patch portion of the device is a hollow diamond-shaped component that is deployed through the use of an integrated, looped, polyester thread.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
groin
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)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 26, 2018
Ethicon, Inc. Ms. Melina Escobar Regulatory Affairs Specialist Route 22 West P.O Box 151 Somerville, New Jersey 08876-0151
Re: K181268
Trade/Device Name: PROLENE (Polypropylene) 3D Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: May 10, 2018 Received: May 14, 2018
Dear Ms. Escobar:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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Page 2 - Ms. Melina Escobar
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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) K181268
Device Name PROLENE (Polypropylene) 3D Patch
Indications for Use (Describe)
The PROLENE™ 3D Patch is indicated for the repair of groin hernia defects that require 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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CON a Johns unson company
510(k) Summary
| Submitter: | Ethicon, Inc. a Johnson & Johnson company
P.O. Box 151
Route 22 West
Somerville, NJ 08876-0151 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Melina Escobar
Regulatory Affairs Specialist
Phone: 908-218-2583
Fax: 908-218-2595
Email: mescob14@its.jnj.com |
| Date Prepared: | May 10, 2018 |
| Device Trade Name: | PROLENE™ (Polypropylene) 3D Patch, Nonabsorbable Synthetic
Surgical Mesh |
| Device Common Name: | PROLENE™ 3D Patch |
| Class: | Class II |
| Classification: | 21 CFR 878.3300 – Surgical Mesh |
| Product Code: | FTL |
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| Device | Company | Product Code | 510(k) Number | Predicate for |
|---|---|---|---|---|
| PROLENETM | ||||
| (Polypropylene) | ||||
| 3D Patch | Ethicon, Inc. | FTL | K010722 | Fundamental Scientific |
| Technology, Design, | ||||
| Intended Use, Materials, | ||||
| Construction, Performance | ||||
| Characteristics |
Predicate Device:
Device Description:
PROLENE™ 3D Patch is a device comprised of nonabsorbable (polypropylene) components. The polymer of the polypropylene filaments is identical to the material used in PROLENETM Suture. It consists of a flat mesh onlay patch secured to a formed expandable diamond-shaped mesh patch component. The expandable patch portion of the device is a hollow diamond-shaped component that is deployed through the use of an integrated, looped, polyester thread.
Indications for Use:
The PROLENE™ 3D Patch is indicated for the repair of groin hernia defects that require a reinforcing material to obtain the desired surgical result.
Summary of Technological Characteristics:
PROLENE™ (Polypropylene) 3D Patch is identical to the PROLENE™ (Polypropylene) 3D Patch (K010722) marketed device with respect to technological characteristics. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed device.
The device differs in the labeling (Instructions for Use) which has been reworded/ reformatted to address evolving regulatory expectations and bring the contents of the Instructions for Use up to date.
Substantial Equivalence:
PROLENE™ (Polypropylene) 3D Patch is identical to the PROLENE™ (Polypropylene) 3D Patch, Nonabsorbable Synthetic Surgical Mesh (K010722) marketed mesh with respect to technological characteristics. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed devices. The device differs only in the labeling (Instructions for Use) which has been revised to add a new Contraindication. Additionally,
5
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™ (Polypropylene) 3D Patch is identical to the predicate marketed mesh, PROLENE™ (Polypropylene) 3D Patch, Nonabsorbable Synthetic Surgical Mesh (K010722) with respect to intended use, technological characteristics, material, construction, specification, manufacturing and sterilization. In conclusion, the subject devices are substantially equivalent to the predicate devices.