(107 days)
Not Found
No
The document describes a physical mesh device for hernia repair and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a hernia mesh intended for the repair of abdominal wall hernias and deficiencies, which falls under the definition of a therapeutic device designed to treat a medical condition.
No
This device is a surgical mesh intended for the repair of hernias and abdominal wall deficiencies, providing mechanical support. It does not perform any diagnostic functions.
No
The device description clearly states it is a "sterile prosthesis" composed of "knitted filaments of extruded polypropylene," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Exogenesis Hernia Mesh Function: The description clearly states the Exogenesis Hernia Mesh is a "sterile prosthesis designed to provide mechanical support for reconstruction of soft tissue deficiencies." It is surgically implanted into the body to repair hernias and other fascial defects.
- Lack of Diagnostic Testing: The device does not perform any tests on bodily samples to diagnose a condition or provide information about a patient's health status. Its function is purely structural and mechanical.
The information provided describes a surgical implant, not a diagnostic test performed in a laboratory setting.
N/A
Intended Use / Indications for Use
The Exogenesis Hernia Mesh is indicated for the repar of abdominal wall hernias and abdominal wall deficiencies that require the addition of reinforcing material to obtain the desired surgical result. The Exogenesis Hernia Mesh is indicated for the repair of abdominal wall hernia defects, including inguinal (direct & indirect). The Exogenesis Hernia Mesh is not indicated for transvaginal pelvic organ prolapse repair.
The Exogenesis Hernia Mesh is intended for single patient one-time use only.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
The Exogenesis Hernia Mesh is a sterile prosthesis designed to provide mechanical support for reconstruction of soft tissue deficiencies. The device is intended for the repair of hernias and other fascial deficiencies requiring the addition of reinforcing or bridging material to obtain the desired surgical result. The Exogenesis Hernia Mesh is composed of knitted filaments of extruded polypropylene, and knitted to provide elasticity in both directions. This construction permits the mesh to be cut into any desired shape or size without unraveling. The Exogenesis Hernia Mesh is treated with a proprietary technology to modify the surface of the mesh to increase surface area of the filaments on a microscopic level.
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)
Biocompatibility testing has been performed on the final version of the Exogenesis Hernia Mesh which supports the substantial equivalence of the material including the processing. Performance testing is provided which compares the physical characteristics of the Exogenesis Hernia Mesh in both its untreated state and with processing as well as compared to the predicate device. There were no significant differences between the Exogenesis untreated Hernia Mesh and the Exogenesis processed Hernia Mesh in physical or mechanical parameters. These results confirm that the processing has no measurable impact on the structure and function of the polypropylene mesh and supports substantial equivalence.
In addition, there were no significant differences between the Exogenesis Hernia Mesh and the Prolene predicate device with respect to mesh thickness and single-fiber thickness. However, the pore size for the Exogenesis Hernia Mesh was greater than that of the predicate device. In performance testing, there were no differences between the Exogenesis Hernia Mesh and the Prolene predicate device in tear resistance. Given that Prolene is a stiffer mesh, it demonstrated higher tensile, suture pull-out and burst strength than the Exogenesis Hernia Mesh. However, published results for the Prolite Ultra showed that the Exogenesis mesh was higher than the ProLite Ultra. In addition, all meshes reported higher burst strength than that of abdominal muscle. The results of this testing confirm that the Exogenesis Hernia Mesh is substantially equivalent to the predicate device.
Additionally, animal testing was performed which assessed the localized tissue interaction and the mechanical properties of the untreated Exogenesis Hernia Mesh compared to the processed Exogenesis Hernia Mesh. Results at Day 90 and Day 180 showed that both versions of the Exogenesis Hernia Mesh were comparable in burst strength, and both were much greater in burst strength as compared to the native abdominal wall.
Therefore, biocompatibility testing and bench and animal testing support substantial equivalence.
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, Inc. Prolene Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh – K180829
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal for the Department of Health & Human Services - USA. To the right of the seal, there is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
September 26, 2019
Exogenesis Corporation % Maureen O'Connell President O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, Massachusetts 02180
Re: K191545
Trade/Device Name: Exogenesis Hernia Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: June 10, 2019 Received: June 11, 2019
Dear Ms. O'Connell:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191545
Device Name Exogenesis Hernia Mesh
Indications for Use (Describe)
The Exogenesis Hernia Mesh is indicated for the repar of abdominal wall hernias and abdominal wall deficiencies that require the addition of reinforcing material to obtain the desired surgical result. The Exogenesis Hernia Mesh is indicated for the repair of abdominal wall hernia defects, including inguinal (direct & indirect). The Exogenesis Hernia Mesh is not indicated for transvaginal pelvic organ prolapse repair.
The Exogenesis Hernia Mesh is intended for single patient one-time use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
a
Exogenesis Hernia Mesh Premarket Notification: Traditional 510(k)
510(k) Summary
Exogenesis Hernia Mesh
| Submitter: | Exogenesis Corporation
20 Fortune Drive
Billerica, MA 01821
978-439-0120 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maureen O'Connell
O'Connell Regulatory Consultants, Inc.
44 Oak Street
Stoneham, MA 02180
Phone: 978-207-1245 |
| Date Prepared: | September 18, 2019 |
| Trade Name: | Exogenesis Hernia Mesh |
| Classification Name: | Surgical Mesh |
| Regulation Number: | 21 CFR 878.3300 |
| Product Code: | FTL |
| Predicate Device: | Ethicon, Inc. Prolene Polypropylene Mesh Non-Absorbable
Synthetic Surgical Mesh – K180829 |
| Device Description: | The Exogenesis Hernia Mesh is a sterile prosthesis designed to
provide mechanical support for reconstruction of soft tissue
deficiencies. The device is intended for the repair of hernias and
other fascial deficiencies requiring the addition of reinforcing or
bridging material to obtain the desired surgical result. The
Exogenesis Hernia Mesh is composed of knitted filaments of
extruded polypropylene, and knitted to provide elasticity in both
directions. This construction permits the mesh to be cut into any
desired shape or size without unraveling. The Exogenesis Hernia
Mesh is treated with a proprietary technology to modify the surface
of the mesh to increase surface area of the filaments on a
microscopic level. |
4
Indications for Use: The Exogenesis Hernia Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of reinforcing material to obtain the desired surgical result. The Exogenesis Hernia Mesh is indicated for the repair of abdominal wall hernia defects, including inguinal (direct & indirect). The Exogenesis Hernia Mesh is not indicated for transvaginal pelvic organ prolapse repair.
The Exogenesis Hernia Mesh is intended for single patient one-time use only.
Summary of Technological
Characteristics: The Exogenesis Hernia Mesh is constructed of polypropylene fibers warp knitted together to form the mesh. The knitting process creates a device with large pores and minimum density and thickness similar to the light weight meshes currently on the market. The result is an implant which allows tissue ingrowth that reinforces the tissue defect, while minimizing the inflammatory response and fibrous encapsulation related to implant mass. The mesh possesses the mechanical and physical properties necessary for long term tissue support. The Exogenesis Hernia Mesh is surface treated using a proprietary process to increase surface area of the filaments on a microscopic level.
Substantial Equivalence
Discussion:
Exogenesis Corporation believes that the Exogenesis Hernia Mesh described in this notification and for use under the conditions of the proposed labeling is substantially equivalent to a legally marketed predicate device that is a Class II medical device. The following table presents the Exogenesis Hernia Mesh compared with the predicate device which is the Ethicon, Inc. Prolene Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh cleared in K180829.
5
| Characteristic | Exogenesis Hernia Mesh | Prolene Polypropylene Mesh Non-
Absorbable Synthetic Surgical Mesh |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Exogenesis Corporation | Ethicon Inc. |
| 510(k) Number | TBD | K180829 |
| Class | II | II |
| Device Classification
Name | Mesh, Surgical, Polymeric | Mesh, Surgical, Polymeric |
| Regulation Number | 878.3300 | 878.3300 |
| Product Code | FTL | FTL |
| Use | Prescription | Prescription |
| Indications for Use | ... is indicated for the repair of abdominal wall
hernias and abdominal wall deficiencies that
require the addition of reinforcing material to
obtain the desired surgical result. The
Exogenesis Hernia Mesh is indicated for the
repair of abdominal wall hernia defects,
including inguinal (direct & indirect). The
Exogenesis Hernia Mesh is not indicated for
transvaginal pelvic organ prolapse repair.
...is intended for single patient one-time use
only. | ...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 Composition | Polypropylene (non-resorbable) | Polypropylene (non-resorbable) |
| Construction | Knitted filaments of extruded polypropylene | Knitted filaments of extruded
polypropylene |
| Bench Testing for
Hernia Mesh | Pass | Pass |
| Animal Data | Yes | No |
| Biocompatibility | Biocompatible | Biocompatible |
| Sterile | Yes | Yes |
| Characteristic | Exogenesis Hernia Mesh | Prolene Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh |
| Single Use | Yes | Yes |
Substantial Equivalence Comparison
6
The intended use of both the Exogenesis Hernia Mesh and the Prolene predicate device is as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue. The Exogenesis Hernia Mesh and the Prolene predicate device are both mesh devices composed of polypropylene which is non-resorbable. Both devices are made from knitted filaments of extruded polypropylene. Both devices are provided sterile and are for single use only. The Exogenesis Hernia Mesh has an additional processing step compared to the Prolene, which is Accelerated Neutral Atom Beam (ANAB) processing. This step does not add any new materials of construction and does not change the chemical composition of the product
Performance Testing
Biocompatibility testing has been performed on the final version of the Exogenesis Hernia Mesh which supports the substantial equivalence of the material including the processing. Performance testing is provided which compares the physical characteristics of the Exogenesis Hernia Mesh in both its untreated state and with processing as well as compared to the predicate device. There were no significant differences between the Exogenesis untreated Hernia Mesh and the Exogenesis processed Hernia Mesh in physical or mechanical parameters. These results confirm that the processing has no measurable impact on the structure and function of the polypropylene mesh and supports substantial equivalence.
In addition, there were no significant differences between the Exogenesis Hernia Mesh and the Prolene predicate device with respect to mesh thickness and single-fiber thickness. However, the pore size for the Exogenesis Hernia Mesh was greater than that of the predicate device. In performance testing, there were no differences between the Exogenesis Hernia Mesh and the Prolene predicate device in tear resistance. Given that Prolene is a stiffer mesh, it demonstrated higher tensile, suture pull-out and burst strength than the Exogenesis Hernia Mesh. However, published results for the Prolite Ultra showed that the Exogenesis mesh was higher than the ProLite Ultra. In addition, all meshes reported higher burst strength than that of abdominal muscle. The results of this testing confirm that the Exogenesis Hernia Mesh is substantially equivalent to the predicate device.
Additionally, animal testing was performed which assessed the localized tissue interaction and the mechanical properties of the untreated Exogenesis Hernia Mesh compared to the processed Exogenesis Hernia Mesh. Results at Day 90 and Day 180 showed that both versions of the Exogenesis Hernia Mesh were comparable in burst strength, and both were much greater in burst strength as compared to the native abdominal wall.
Therefore, biocompatibility testing and bench and animal testing support substantial equivalence.
7
Therefore, in summary, the new device has the same intended use and similar technological characteristics to the predicate device and is therefore, substantially equivalent. Performance data support substantial equivalence of the different technological characteristics.