(184 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the material properties, mechanical characteristics, and biological response of a surgical mesh. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a prosthesis, made from polypropylene mesh, to reinforce soft tissue where weakness exists, such as in the repair of inguinal hernias thereby providing therapy.
No
Explanation: The device is a surgical mesh intended for the reinforcement of soft tissue, primarily for hernia repair. Its purpose is to physically support and strengthen tissue, not to diagnose a condition or disease.
No
The device description clearly indicates it is a physical mesh prosthesis made from polypropylene and PDO monofilament, intended for surgical implantation. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "reinforcement of soft tissue where weakness exists, such as in the repair of inguinal hernias." This describes a surgical implant used directly in the body to provide structural support.
- Device Description: The description details a physical mesh made of polypropylene and PDO, designed for surgical implantation. It discusses its physical properties, shape, and components for positioning and fixation.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on biological samples.
The information provided clearly indicates this is a surgical mesh intended for direct implantation in the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Modified ONFLEX Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, such as in the repair of inguinal hernias.
Product codes
FTL
Device Description
The proposed Modified ONFLEX™ Mesh is a self-expanding, non-absorbable, sterile (Ethylene Oxide) prosthesis, made from monofilament polypropylene mesh and has a lightweight large pore design. This construction allows a prompt fibroblastic response through the interstices of the mesh as observed in a preclinical model, which may not correlate to performance in humans. The Modified ONFLEX™ Mesh has an anatomical shape designed to cover potential defect areas.
The Modified ONFLEX™ Mesh also contains two pockets to facilitate insertion and positioning of the device. The positioning pockets are located on the larger medical apex of the mesh and the lateral apex of the mesh. In addition to the pocket, the mesh also contains straps to facilitate positioning and fixation of the device. The Modified ONFLEX™ Mesh comes packaged with an onlay which is available in one size and is optional based on surgeon preference.
The proposed device contains SorbaFlex™ Memory Technology comprised of an absorbable PDO monofilament which forms an interrupted ring. SorbaFlex™ Memory Technology provides memory and stability to the device, facilitating ease of initial insertion and proper placement of the device. The PDO monofilament is folded and welded onto itself at the ends. The interrupted ring provides memory and stability to the device, facilitating ease of initial insertion and proper placement of the device. The PDO monofilament fully degrades by means of hydrolysis in vivo in 6 - 8 months. The PDO monofilament is dyed violet by adding D & C Violet No. 2. The interrupted ring is placed within a mesh tube constructed from a knitted polypropylene monofilament. The purpose of the mesh tube is to contain the interrupted recoil ring during the degradation process. The interrupted ring, contained in the mesh tube, is sewn between two layers of mesh with polytetrafluoroethylene (PTFE) monofilament.
The Modified ONFLEX™ Mesh is offered in two sizes: medium (0115610) and large (0115611). The proposed Modified ONFLEX™ Mesh is considered a tissue contacting permanent implant according to Blue Book Memorandum issued on May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, inguinal hernias, inguinal canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Mechanical testing was performed consistent with FDA Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh, issued March 2, 1999, to verify that the Modified ONFLEX™ Mesh's performance characteristics are similar to that of the predicate devices. Testing was performed in accordance per "FDA Guidance for the Preparation of Premarket Notification for a Surgical Mesh."
Biocompatibility testing was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. Tests include Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Subchronic toxicity, Genotoxicity, and Implantation.
Mechanical Testing: Physical and performance characteristics measured include Mesh weave characteristics, Mesh thickness, Mesh pore size, Mesh density, Mesh stiffness, Ball burst strength, Suture pullout strength, Tear strength, PDO monofilament tensile strength, Strap Attachment Strength, and Simulated deployment test.
Animal Study: In vivo and in vitro resorption studies were performed to characterize the mechanical strength and resorption of the PDO monofilament in the SorbaFlex™ Memory Technology and originally were provided in support of the Ventrio™ Hernia Patch via K081777. These studies were adopted in support of this submission.
The test results provided in this submission demonstrate that the Modified ONFLEX™ Mesh is substantially equivalent to the predicates.
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.
K091659, K081777, K100229, K963141
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.
No reference devices were used in this submission.
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the heads, resembling hair or ribbons.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2015
Davol Incorporated. Subsidiary of C. R. Bard Incorporated Ms. Mariya Buharin Regulatory Affairs Specialist 100 Crossings Boulevard Warwick, Rhode Island 02886
Re: K142706
Trade/Device Name: Modified ONFLEX Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: February 4, 2015 Received: February 5, 2015
Dear Ms. Buharin:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
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" (21CFR 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 yours.
Jennifer R. Stevenson -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) K142706
Device Name Modified ONFLEX Mesh
Indications for Use (Describe)
The Modified ONFLEX Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, such as in the repair of inguinal hernias.
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
This 510(k) Summary is provided per the requirements of section 21 CFR 807.92.
I. Submitter
| Submitter's Name: | Davol, Inc., Subsidiary of C. R. Bard, Inc. |
|---|---|
| Contact Person: | Mariya Buharin |
| Regulatory Affairs Specialist | |
| Address: | 100 Crossings Boulevard |
| Warwick, RI 02886 | |
| Telephone: | (401) 825-8729 |
| Fax: | (401) 825-8765 |
| Email: | marie.buharin@crbard.com |
| Date prepared: | March 19th, 2015 |
| Trade Name: | Modified ONFLEXT™ Mesh |
|---|---|
| Common/Usual Name: | - Surgical Mesh |
| Classification Name: | - Mesh, Surgical, Polymeric (21 CFR § 878.3300) |
| Regulatory Class: | - Class II |
| Product Code: | - FTL |
III. Predicate Devices
- . Bard® 3DMax™ Light Mesh
- o K091659 (Davol, Inc.), FDA cleared on 08/08/2009
- Bard® Ventrio™ Hernia Patch, ●
No reference devices were used in this submission.
IV. Device Description
.
The proposed Modified ONFLEX™ Mesh is a self-expanding, non-absorbable, sterile (Ethylene Oxide) prosthesis, made from monofilament polypropylene mesh and has a lightweight large pore design. This construction allows a prompt fibroblastic response through the interstices of the mesh as observed in a preclinical model, which may not correlate to performance in humans. The Modified ONFLEX™ Mesh has an anatomical shape designed to cover potential defect areas.
The Modified ONFLEX™ Mesh also contains two pockets to facilitate insertion and positioning of the device. The positioning pockets are located on the larger medical apex of the mesh and the lateral apex of the mesh. In addition to the pocket, the mesh also contains straps to facilitate
PREMARKET NOTIFICATION FOR THE MODIFIED ONFLEX™ MESH
SECTION 6
4
positioning and fixation of the device. The Modified ONFLEX™ Mesh comes packaged with an onlay which is available in one size and is optional based on surgeon preference.
The proposed device contains SorbaFlex™ Memory Technology comprised of an absorbable PDO monofilament which forms an interrupted ring. SorbaFlex™ Memory Technology provides memory and stability to the device, facilitating ease of initial insertion and proper placement of the device. The PDO monofilament is folded and welded onto itself at the ends. The interrupted ring provides memory and stability to the device, facilitating ease of initial insertion and proper placement of the device. The PDO monofilament fully degrades by means of hydrolysis in vivo in 6 - 8 months. The PDO monofilament is dyed violet by adding D & C Violet No. 2. The interrupted ring is placed within a mesh tube constructed from a knitted polypropylene monofilament. The purpose of the mesh tube is to contain the interrupted recoil ring during the degradation process. The interrupted ring, contained in the mesh tube, is sewn between two layers of mesh with polytetrafluoroethylene (PTFE) monofilament.
The Modified ONFLEX™ Mesh is offered in two sizes: medium (0115610) and large (0115611). The proposed Modified ONFLEX™ Mesh is considered a tissue contacting permanent implant according to Blue Book Memorandum issued on May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing".
v. Indications for Use
The Modified ONFLEX™ Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, such as in the repair of inguinal hernias.
VI. Comparison of Technological Characteristics with the Predicate Devices
The Modified ONFLEX™ Mesh has the same intended use and similar technological characteristics, as the currently marketed predicates 3DMax™ Light Mesh (K091659), VentrioTM Hernia Patch (K081777/ K100229), and Modified Kugel™ Hernia Patch (K963141). The Modified ONFLEX™ Mesh and predicates 3DMax™ Light Mesh, Modified Kugel™ Hernia Patch and Ventrio™ Hernia Patch are intended for use in the reinforcement of soft tissue where weakness exists. The Modified ONFLEXTM Mesh combines the large pore knit construction, and anatomical shape of 3DMax™ Light Mesh, the strap and onlay features of Modified Kugel™ Hernia Patch and the SorbaFlex™ Memory Technology, mesh tube and pocket features of Ventrio™ Hernia Patch.
The Modified ONFLEX™ Mesh and the predicates, 3DMax™ Light Mesh, Ventrio™ Hernia Patch, and Modified Kugel™ Hernia Patch are constructed from polypropylene monofilament. The Modified ONFLEX™ Mesh has a similar large pore knit construction and anatomical shape as the predicate 3DMax™ Light Mesh. The perimeter of the polypropylene mesh on the Modified ONFLEX™ Mesh is heat sealed to form a smooth edge, similar to the predicate 3DMax Light Mesh.
The Modified ONFLEX™ Mesh utilizes a PDO monofilament ring mechanism similar to the Ventrio™ Hernia Patch. The Modified ONFLEX™ Mesh's ring is interrupted and folded to form a loop on each end whereas Ventrio™ Hernia Patch has an uninterrupted ring that is ultrasonically welded together. The Modified ONFLEX™ Mesh uses the same mesh tube to encompass the ring mechanism as the predicate Ventrio™ Hernia Patch. This mesh tube is the same material composition, polypropylene, as the mesh that is used to construct the other mesh
PREMARKET NOTIFICATION FOR THE MODIFIED ONFLEX™ MESH
SECTION 6
5
layers of the Modified ONFLEX™ Mesh. The PDO monofilament in the mesh tube is sewn between two layers of mesh with PTFE monofilament in both the Modified ONFLEX™ Mesh and the predicate Ventrio Hernia Patch. Additionally, Ventrio™ Hernia Patch contains a layer of expanded polytetrafluoroethylene (ePTFE) which contacts bowel or viscera when used for soft tissue repair in ventral hernia, to minimize tissue attachment to the mesh. The proposed Modified ONFLEX™ Mesh is designed to be used primarily in soft tissue repair in the inguinal canal, and thus does not contain such a design feature.
The Modified ONFLEX™ Mesh has two positioning pockets similar to the Modified Kugel™ Hernia Patch and predicate Ventrio™ Hernia Patch. The Modified ONFLEX™ Mesh has two pockets, on the larger medial apex of the mesh and the lateral apex of the mesh formed by the top layer of mesh. The Ventrio™ Hernia Patch has two positioning pockets formed by a slit in the top layer of the mesh. The Modified Kugel™ Hernia Patch has two pockets formed by a hole on the top layer of the mesh. Additionally, the Modified ONFLEX™ Mesh has two positioning straps and is packaged with an optional onlay similar to the Modified Kugel™ Hernia Patch.
Mechanical testing was performed consistent with FDA Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh, issued March 2, 1999, to verify that the Modified ONFLEX™ Mesh's performance characteristics are similar to that of the predicate devices.
VII. Performance Data
The following performance data are provided in support of the substantial equivalence determination. Testing was performed in accordance per "FDA Guidance for the Preparation of Premarket Notification for a Surgical Mesh."
Biocompatibility Testing
Biocompatibility testing was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
Modified ONFLEX™ Mesh is considered a tissue contacting permanent implant. Therefore, the following tests are required and were leveraged from the predicate devices in support of this premarket notification:
- . Cytotoxicity
- Sensitization
- Intracutaneous reactivity
- Acute systemic toxicity ●
- . Subchronic toxicity
- Genotoxicity .
- . Implantation
Electrical safety and electromagnetic compatibility (EMC)
There are no electrical or metal components in the Modified ONFLEX™ Mesh; therefore the proposed device does not require EMC and Electrical Safety evaluation.
PREMARKET NOTIFICATION FOR THE MODIFIED ONFLEX™ MESH
SECTION 6
6
Software Verification and Validation Testing
The proposed Modified ONFLEX Mesh™ does not contain software.
Mechanical Testing
The following physical and performance characteristics were measured to compare the proposed Modified ONFLEX™ Mesh to the predicates 3DMax™ Light Mesh, Modified Kugel™ Hernia Patch and Ventrio Hernia Patch:
- Mesh weave characteristics
- . Mesh thickness
- . Mesh pore size
- . Mesh density
- Mesh stiffness
- . Ball burst strength
- Suture pullout strength
- . Tear strength
- PDO monofilament tensile strength ●
- Strap Attachment Strength ●
- Simulated deployment test
Animal Study
In vivo and in vitro resorption studies were performed to characterize the mechanical strength and resorption of the PDO monofilament in the SorbaFlex™ Memory Technology and originally were provided in support of the Ventrio™ Hernia Patch via K081777. Since Modified ONFLEX™ Mesh contains the same PDO monofilament as the predicate Ventrio™ Hernia Patch these resorption studies have been adopted and provided in support of this Modified ONFLEX™ Mesh submission.
VIII. Conclusions
The test results provided in this submission demonstrate that the Modified ONFLEX™ Mesh is substantially equivalent to the predicates.