(133 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological interactions of a surgical mesh, with no mention of AI or ML technologies.
Yes
The device is a surgical mesh used to repair hernias and other fascial deficiencies, which falls under the definition of a therapeutic device as it is intended to treat a medical condition.
No
This device is a surgical mesh used for the repair of hernias and fascial deficiencies, acting as a reinforcing or bridging material. It is a therapeutic device, not one that identifies or diagnoses a condition.
No
The device description clearly states it is a "sterile, partially absorbable skirted mesh device" composed of physical materials (polypropylene, polydioxanone, poliglecaprone 25 film), indicating it is a physical medical device, 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 surgical repair of hernias and fascial deficiencies by providing a reinforcing or bridging material. This is a surgical implant used directly in the body, not a test performed on samples outside the body.
- Device Description: The description details a sterile, partially absorbable mesh device designed for surgical implantation. This aligns with a surgical device, not an IVD.
- Performance Studies: The performance studies described involve biocompatibility testing, bench testing of physical characteristics, and pre-clinical efficacy studies in animal models. These are typical evaluations for surgical implants, not IVDs which would involve analytical and clinical performance studies related to diagnostic accuracy.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
In summary, the ETHICON PHYSIOMESH™ Open is a surgical mesh intended for implantation during hernia repair, which is a therapeutic procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
ETHICON PHYSIOMESH™ Open may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
ETHICON PHYSIOMESH™ Open Flexible Composite Mesh Device is a sterile, partially absorbable skirted mesh device designed for the repair of hernias and other fascial defects. The implant device is composed of a macroporous mesh, knitted from polypropylene and polydioxanone fibers, laminated to an absorbable poliglecaprone 25 film that is intended to physically separate the mesh from underlying tissue and organ surfaces thereby reducing unintended tissue attachment to the mesh. The perimeter edges are prefolded to create the fixation skirt that facilitates manual placement and positioning against the intra-abdominal wall, while allowing for the use of mechanical fixation devices.
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)
ETHICON PHYSIOMESH™ Open Device underwent an extensive safety and performance testing program. including bench and animal testing, to demonstrate that the device meets the requirements as defined in user specifications, performs as intended, and is substantially equivalent to the predicate devices. The tests conducted include:
- Biocompatibility testing in accordance to the tests recommended in the ISO 10993-1 standard was conducted. The results indicate that the device is biocompatible per this standard.
- Bench top testing was performed to assess the physical/performance characteristics of the new device. In accordance with FDA's "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh" (March 2, 1999), the bench top testing evaluated physical characteristics of mesh including mesh knitting pattern, mesh pore size/porosity, mesh density, mesh thickness, and mesh stiffness as well as mesh performance testing including mesh burst strength and suture pullout strength.
- Pre-clinical efficacy studies were performed including a 14-day rabbit sidewall model study designed to evaluate potential for adhesion formation and a 91-day swine two-stage incisional hernia model study designed to evaluate tissue integration and reaction as well as mesh compression.
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.
ETHICON PHYSIOMESH™ Flexible Composite Mesh - (K093932), BARD Ventrio™ ST Hernia Patch - (K101920), Parietex™ Optimized Composite Mesh (PCO) - (K110816)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting community and connection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2014
Ethicon Incorporated Ms. Susan Lin, RAC Manager, Regulatory Affairs P.O. Box 151, Route 22 West Somerville, New Jersey 08876
Re: K141560
Trade/Device Name: ETHICON PHYSIOMESH™ Open Flexible Composite Mesh Device Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: September 17, 2014 Received: September 19, 2014
Dear Ms. Lin:
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
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Page 2 - Ms. Susan Lin
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 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/Resourcesfor You/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,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4 _INDICATIONS FOR USE STATEMENT
| 510(k) No (if known): | |
|---|---|
| Device Name: | ETHICON PHYSIOMESH™ Open Flexible Composite Mesh Device |
| Indications for Use: | ETHICON PHYSIOMESH™ Open may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result. |
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510(K) Summary
| Applicant: | Ethicon Inc.
P.O. Box 151
Route 22 West
Somerville, NJ 08876
USA
Phone: +1-908-218-2256
Fax: +1-908-218-2595 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | October 23, 2014 |
| Contact Person: | Susan Lin |
| Proprietary Device Name: | ETHICON PHYSIOMESH™ Open Flexible Composite Mesh
Device |
| Common Device Name: | Surgical Mesh |
| Classification: | Class II
21 CFR 878.3300 – Surgical Mesh, polymeric;
Product Code: FTL |
| Predicate Devices: | ETHICON PHYSIOMESH™ Flexible Composite Mesh -
(K093932)
BARD Ventrio™ ST Hernia Patch - (K101920)
Parietex™ Optimized Composite Mesh (PCO) - (K110816) |
| Manufacturer: | Johnson & Johnson MEDICAL GmbH
Robert-Koch-Strasse 1
22851 Norderstedt
Germany |
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5.1 Description of the Device Subject to Premarket Notification:
ETHICON PHYSIOMESH™ Open Flexible Composite Mesh Device is a sterile, partially absorbable skirted mesh device designed for the repair of hernias and other fascial defects. The implant device is composed of a macroporous mesh, knitted from polypropylene and polydioxanone fibers, laminated to an absorbable poliglecaprone 25 film that is intended to physically separate the mesh from underlying tissue and organ surfaces thereby reducing unintended tissue attachment to the mesh. The perimeter edges are prefolded to create the fixation skirt that facilitates manual placement and positioning against the intra-abdominal wall, while allowing for the use of mechanical fixation devices.
5.2 Indications for Use:
ETHICON PHYSIOMESH™ Open may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Summary of Characteristics of new Device to Predicate Devices: 5.3
The principle of operation and fundamental scientific technology of the new device are equivalent to the predicate devices. The ETHICON PHYSIOMESHTM Open Device and the predicate 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 new device are similar to the predicate devices. Similar to ETHICON PHYSIOMESH™, the new device is composed of a macroporous mesh coated with an absorbable tissue separation film. Similar to BARD Ventrio™ ST Hernia Patch and Parietex™ Optimized Composite Mesh (PCO), ETHICON PHYSIOMESH™ Open Device has a fixation skirt that facilitates manual placement and positioning against the intra-abdominal wall, while allowing for the use of mechanical fixation devices.
5.4 Performance Data:
ETHICON PHYSIOMESH™ Open Device underwent an extensive safety and performance testing program. including bench and animal testing, to demonstrate that the device meets the requirements as defined in user specifications, performs as intended, and is substantially equivalent to the predicate devices. The tests conducted include:
- Biocompatibility testing in accordance to the tests recommended in the ISO 10993-1 standard was conducted. The results indicate that the device is biocompatible per this standard.
- Bench top testing was performed to assess the physical/performance characteristics of the new device. In accordance with FDA's "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh" (March 2, 1999), the bench top testing evaluated physical characteristics of mesh including mesh knitting pattern, mesh pore size/porosity, mesh density, mesh thickness, and mesh stiffness as well as mesh performance testing including mesh burst strength and suture pullout strength.
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- Pre-clinical efficacy studies were performed including a 14-day rabbit sidewall model ● study designed to evaluate potential for adhesion formation and a 91-day swine two-stage incisional hernia model study designed to evaluate tissue integration and reaction as well as mesh compression.
ર.ર Conclusion
The ETHICON PHYSIOMESH™ Open Flexible Composite Mesh Device has the same intended use and fundamental scientific technology as its predicate devices. Performance data demonstrates that the device is as safe and as effective as the predicate devices for the intended use. Thus we conclude that the proposed device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act.
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Ethicon Inc.
June 2014