K Number
K180829
Device Name
PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh
Manufacturer
Date Cleared
2018-06-28

(90 days)

Product Code
Regulation Number
878.3300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
PROLENE™ 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. The PROLENE™ Hernia System is indicated for the repair of abdominal wall hernia defects, including inguinal (direct & indirect).
Device Description
PROLENE™ Mesh is a sterile, nonabsorbable synthetic surgical mesh designed for the repair of abdominal wall hernias and abdominal wall deficiencies. The implant device 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, LLC). This material, when used as a suture, has been reported to be non-reactive and to retain its strength indefinitely in clinical use. PROLENE™ 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 fiber junctions are not subject to the same work fatigue exhibited by more rigid metallic meshes. This bi-directional, elastic property allows adaptation to various stresses encountered in the body. PROLENE™ Hernia System is a sterile, pre-shaped, three-dimensional device designed for the repair of abdominal wall hernia defects, including inguinal (direct & indirect). It is constructed of an onlay patch connected by a mesh cylinder to a circular or oblong underlay patch. The material is undyed PROLENE™ (Polypropylene) Mesh constructed of knitted nonabsorbable polypropylene filaments.
More Information

Not Found

No
The device description focuses on the material properties and physical construction of surgical mesh and a hernia system, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Yes.
The device is used for the repair of abdominal wall hernias and deficiencies, which are medical conditions, and aims to provide a therapeutic benefit by reinforcing the affected area.

No

The device description clearly states that PROLENE™ Mesh is a "surgical mesh designed for the repair of abdominal wall hernias and abdominal wall deficiencies," and the PROLENE™ Hernia System is indicated for the "repair of abdominal wall hernia defects." These are therapeutic, not diagnostic, uses.

No

The device description clearly indicates it is a physical surgical mesh and hernia system made of polypropylene, 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 abdominal wall hernias and deficiencies. This is a surgical intervention performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
  • Device Description: The device is a surgical mesh made of polypropylene. It is a physical implant used to reinforce tissue. This is consistent with a surgical device, not a diagnostic test.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

N/A

Intended Use / Indications for Use

PROLENE™ 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.

The PROLENE™ Hernia System is indicated for the repair of abdominal wall hernia defects, including inguinal (direct & indirect).

Product codes (comma separated list FDA assigned to the subject device)

FTL

Device Description

PROLENE™ Mesh is a sterile, nonabsorbable synthetic surgical mesh designed for the repair of abdominal wall hernias and abdominal wall deficiencies. The implant device 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, LLC). This material, when used as a suture, has been reported to be non-reactive and to retain its strength indefinitely in clinical use.

PROLENE™ 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 fiber junctions are not subject to the same work fatigue exhibited by more rigid metallic meshes. This bi-directional, elastic property allows adaptation to various stresses encountered in the body.

PROLENE™ Hernia System is a sterile, pre-shaped, three-dimensional device designed for the repair of abdominal wall hernia defects, including inguinal (direct & indirect). It is constructed of an onlay patch connected by a mesh cylinder to a circular or oblong underlay patch. The material is undyed PROLENE™ (Polypropylene) Mesh constructed of knitted nonabsorbable polypropylene filaments.

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.

K962530, K984220

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.

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June 28, 2018

Ethicon, Inc % Ms. Stephanie Saati Senior Regulatory Affairs Program Lead Route 22 West, P.O. Box 151 Somerville, New Jersey 08876

Re: K180829

Trade/Device Name: PROLENE™ Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE™ (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh Regulation Number: 21 CFR 878.3300

Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: March 29, 2018 Received: March 30, 2018

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 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);

1

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

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Indications for Use

510(k) Number (if known) K180829

Device Name

PROLENE™ Mesh Polypropylene Non-Absorbable Synthetic Surgical Mesh

PROLENE™ (Polypropylene) Hernia System, Nonabsorbable Synthetic Surgical Mesh

Indications for Use (Describe)

PROLENE™ 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.

The PROLENE™ Hernia System is indicated for the repair of abdominal wall hernia defects, including inguinal (direct & indirect).

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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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 Program Lead
Phone: 908-218-3318
Fax: 908-218-2595
Email: SSaati@its.jnj.com |
| Date Prepared: | March 28, 2018 |
| Device Trade Name: | PROLENE™ Polypropylene Mesh Non-Absorbable
Synthetic Surgical Mesh |
| | PROLENE™ (Polypropylene) Hernia System,
Nonabsorbable Synthetic Surgical Mesh |
| Device Common Name: | PROLENE™ Mesh |
| | PROLENE™ Hernia System |
| Class: | Class II |
| Classification: | 21 CFR 878.3300 – Surgical Mesh |
| Product Code: | FTL |

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Predicate Devices:

PROLENE™ Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh

DeviceCompanyProduct Code510(k) NumberPredicate for
PROLENE™
Polypropylene
Mesh
Nonabsorbable
Synthetic
Surgical MeshEthicon,
Inc.FTLK962530Fundamental Scientific
Technology, Design,
Intended Use, Materials,
Construction,
Performance
Characteristics

PROLENE™ (Polypropylene) Hernia System, Nonabsorbable Synthetic Surgical Mesh

DeviceCompanyProduct Code510(k) NumberPredicate for
Modification of
PROLENETM
(Polypropylene)
Hernia System,
Nonabsorbable
Synthetic
Surgical MeshEthicon,
Inc.FTLK984220Fundamental Scientific
Technology, Design,
Intended Use, Materials,
Construction,
Performance
Characteristics

Device Description:

PROLENE™ Mesh is a sterile, nonabsorbable synthetic surgical mesh designed for the repair of abdominal wall hernias and abdominal wall deficiencies. The implant device 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, LLC). This material, when used as a suture, has been reported to be non-reactive and to retain its strength indefinitely in clinical use.

PROLENE™ Mesh is knitted by a process which interlinks each fiber junction and which provides for elasticity in both directions. This construction permits the mesh

5

to be cut into any desired shape or size without unraveling. The fiber junctions are not subject to the same work fatigue exhibited by more rigid metallic meshes. This bi-directional, elastic property allows adaptation to various stresses encountered in the body.

PROLENE™ Hernia System is a sterile, pre-shaped, three-dimensional device designed for the repair of abdominal wall hernia defects, including inguinal (direct & indirect). It is constructed of an onlay patch connected by a mesh cylinder to a circular or oblong underlay patch. The material is undyed PROLENE™ (Polypropylene) Mesh constructed of knitted nonabsorbable polypropylene filaments.

Indications for Use:

PROLENE™ 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.

The PROLENE™ Hernia System is indicated for the repair of abdominal wall hernia defects, including inguinal (direct & indirect).

Summary of Technological Characteristics:

PROLENETM Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh is substantially equivalent to the PROLENE™ Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh (K962530) predicate device with respect to technological characteristics. Both the subject and predicate devices are constructed of knitted filaments of extruded polypropylene. The devices function in the same manner and are designed to provide reinforcement to repair abdominal wall hernias and abdominal wall deficiencies. The subject mesh is manufactured within the existing manufacturing processes for the predicate device. There are no changes to the manufacturing, packaging, sterilization processes, or shelf life of the currently marketed device.

PROLENE™ (Polypropylene) Hernia System. Nonabsorbable Synthetic Surgical Mesh is substantially equivalent to the PROLENE™ (Polypropylene) Hernia

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System, Nonabsorbable Synthetic Surgical Mesh (K984220) predicate device with respect to technological characteristics. Both the subject and predicate devices are sterile, pre-shaped, three-dimensional devices constructed of an onlay patch connected by a mesh cylinder to a circular or oblong underlay patch. The material used in both devices is undyed PROLENE™ (Polypropylene) mesh constructed of knitted nonabsorbable polypropylene filaments. Both the subject and predicate devices function in the same manner and are designed for the repair of abdominal wall hernia defects, including inguinal (direct & indirect). There are no changes to the manufacturing, packaging, and sterilization processes, or shelf life of the currently marketed device.

The subject PROLENETM Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh and PROLENE™ (Polypropylene) Hernia System, Nonabsorbable Synthetic Surgical Mesh, for which this 510(k) Premarket Notification- Change being Effected is being submitted, differs from the currently marketed devices, K962530 and K984220, in the labeling (Instructions for Use). The Instructions for Use has been revised to add a new Contraindication. Additionally, several other sections of the Instructions for Use of the subject devices 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™ Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh is substantially equivalent to the PROLENE™ Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh (K962530) predicate device. Both the subject and predicate devices are constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE™ Polypropylene Suture, nonabsorbable surgical sutures. The principle of operation of the subject PROLENE™ Mesh, which is to provide reinforcement to repair abdominal wall hernias and abdominal wall deficiencies, is equivalent to that of the predicate device. The subject device is manufactured within the existing manufacturing processes for the predicate device. There are no changes to the packaging, sterilization processes, or shelf life of the currently marketed device.

PROLENE™ (Polypropylene) Hernia System, Nonabsorbable Synthetic Surgical Mesh is substantially equivalent to the PROLENE™ (Polypropylene) Hernia

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System, Nonabsorbable Synthetic Surgical Mesh (K984220) predicate device. Both the subject and predicate devices are sterile, pre-shaped, three-dimensional devices constructed of an onlay patch connected by a mesh cylinder to a circular or oblong underlay patch. The material is undyed PROLENE™ (Polypropylene) mesh constructed of knitted nonabsorbable polypropylene filaments. The principle of operation of the subject PROLENE™ (Polypropylene) Hernia System, which is to provide reinforcement to repair abdominal wall hernia defects, including inguinal (direct & indirect) hernias, is equivalent to that of the predicate device. There are no changes to the manufacturing, packaging, and sterilization processes, or shelf life of the currently marketed device.

The subject PROLENE™ Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh and PROLENE™ (Polypropylene) Hernia System, Nonabsorbable Synthetic Surgical Mesh differ from their respective predicate devices, K962530 and K984220, in the labeling (Instructions for Use). The Instructions for Use has been revised to add a new Contraindication. Additionally, several other sections of the Instructions for Use of the subject devices 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 devices has been modified to add clarity and does not introduce any new indications or expand patient population of the predicate device.

Conclusion:

Based on the intended use, fundamental scientific technology and, technological characteristics, the subject devices PROLENE™ Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh and PROLENE™ (Polypropylene) Hernia System, Nonabsorbable Synthetic Surgical Mesh are considered to be substantially equivalent to their predicate devices, K962530 and K984220 respectively.