(107 days)
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.
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.
The provided text describes a medical device, the "Exogenesis Hernia Mesh," and its substantial equivalence to a predicate device, the "Prolene Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh." This document is a 510(k) summary, which focuses on demonstrating substantial equivalence rather than reporting a study with specific acceptance criteria for performance measurements in the context of device performance metrics like sensitivity/specificity for algorithms.
Therefore, the information requested, which is typically relevant for AI/ML-based device studies, is largely not present in this document. The device in question is a surgical mesh, not a software algorithm, so many of the questions regarding AI/ML study design (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable.
However, I can extract the available information related to performance and testing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't define explicit acceptance criteria in a quantitative sense as might be seen for an algorithm (e.g., "sensitivity must be > X%"). Instead, it focuses on demonstrating comparability to the predicate device. The "acceptance criteria" are implied by the demonstration of "no significant differences" or "comparable" results, or exceeding a basic biological benchmark (like abdominal muscle strength).
| Characteristic | Acceptance Criteria (Implied) | Exogenesis Hernia Mesh Performance (Reported) | Predicate Device (K180829) Performance (Reported) |
|---|---|---|---|
| Indications for Use | Same as predicate | Matches predicate (with minor wording differences) | Repair of abdominal wall hernias/deficiencies |
| Device Composition | Same as predicate (Polypropylene, non-resorbable) | Polypropylene (non-resorbable) | Polypropylene (non-resorbable) |
| Construction | Same as predicate (Knitted filaments of extruded polypropylene) | Knitted filaments of extruded polypropylene | Knitted filaments of extruded polypropylene |
| Bench Testing for Hernia Mesh | Pass/Comparable to predicate | Pass | Pass |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible |
| Sterile | Yes | Yes | Yes |
| Single Use | Yes | Yes | Yes |
| Processing Impact | No measurable impact on structure/function of mesh | No significant differences (Exogenesis untreated vs processed) in physical/mechanical parameters | N/A (Predicate doesn't have this processing step) |
| Mesh Thickness | No significant differences compared to predicate | No significant differences | Same as Exogenesis |
| Single-Fiber Thickness | No significant differences compared to predicate | No significant differences | Same as Exogenesis |
| Pore Size | Comparable to predicate | Greater than predicate device | Smaller than Exogenesis |
| Tear Resistance | No differences compared to predicate | No differences | Same as Exogenesis |
| Tensile Strength | Comparable to predicate (or adequate for intended use) | Lower than Prolene, but higher than ProLite Ultra | Higher than Exogenesis (Prolene stiffer) |
| Suture Pull-out Strength | Comparable to predicate (or adequate for intended use) | Lower than Prolene | Higher than Exogenesis |
| Burst Strength | Comparable to predicate (or adequate for intended use & > abdominal muscle) | Lower than Prolene, but all meshes > abdominal muscle. Animal data: Exogenesis processed/untreated comparable and > native abdominal wall. | Higher than Exogenesis (Prolene stiffer); all meshes > abdominal muscle. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "Performance Testing," "Biocompatibility testing," and "animal testing," but does not specify sample sizes for these tests, nor the data provenance (country, retrospective/prospective). These are typically proprietary details submitted to the FDA separately.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the device is a surgical mesh, not an AI/ML algorithm requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reason as above.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable as the device is a surgical mesh, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a surgical mesh, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the mechanical and physical property testing, the "ground truth" would be the measured physical properties themselves (e.g., burst strength, tensile strength) obtained through standardized testing methods, and for biocompatibility, it would be the results of the specific biological tests. For the animal study, the "ground truth" would be the in vivo measurements and observations of burst strength and localized tissue interaction. These are not "expert consensus" or "pathology" in the diagnostic sense, but rather objective measurements from laboratory and animal models.
8. The sample size for the training set
This is not applicable as the device is a physical product (surgical mesh), not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the document):
The "study" presented here is a demonstration of Substantial Equivalence to a legally marketed predicate device (Ethicon, Inc. Prolene Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh – K180829) rather than meeting a set of independent performance criteria.
The demonstration of substantial equivalence involved:
- Comparison of Technological Characteristics: Showing the Exogenesis Hernia Mesh has the same intended use, similar material composition (polypropylene), similar construction (knitted filaments), and is also sterile and single-use, compared to the predicate.
- Performance Testing (Bench Testing):
- Biocompatibility testing: Performed on the final version of the Exogenesis Hernia Mesh to support the material's equivalence even with the proprietary surface treatment.
- Physical Characteristics Comparison: Compared the Exogenesis Hernia Mesh (both untreated and with proprietary processing) to the predicate device.
- Results showed "no significant differences" between the untreated and processed Exogenesis mesh in physical/mechanical parameters, indicating the processing does not alter fundamental structure and function.
- Results showed "no significant differences" between Exogenesis Hernia Mesh and predicate in mesh thickness and single-fiber thickness.
- Exogenesis Hernia Mesh had "greater" pore size than the predicate.
- "No differences" in tear resistance between Exogenesis and predicate.
- Prolene (predicate) demonstrated "higher tensile, suture pull-out and burst strength" than Exogenesis, which is attributed to Prolene being a "stiffer mesh." However, the Exogenesis mesh was reported to be higher than another published mesh (Prolite Ultra) in tensile strength, and importantly, "all meshes reported higher burst strength than that of abdominal muscle," indicating adequate strength for the intended use.
- Animal Testing:
- Assessed localized tissue interaction and mechanical properties (burst strength) of untreated vs. processed Exogenesis Hernia Mesh.
- Results at Day 90 and Day 180 showed 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."
The conclusion drawn is that the biocompatibility testing, bench testing, and animal testing collectively "support substantial equivalence" to the predicate device, thus demonstrating the device meets the regulatory requirements for market clearance via the 510(k) pathway.
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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
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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
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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) |
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a
Exogenesis Hernia Mesh Premarket Notification: Traditional 510(k)
510(k) Summary
Exogenesis Hernia Mesh
| Submitter: | Exogenesis Corporation20 Fortune DriveBillerica, MA 01821978-439-0120 |
|---|---|
| Contact Person: | Maureen O'ConnellO'Connell Regulatory Consultants, Inc.44 Oak StreetStoneham, MA 02180Phone: 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-AbsorbableSynthetic Surgical Mesh – K180829 |
| Device Description: | The Exogenesis Hernia Mesh is a sterile prosthesis designed toprovide mechanical support for reconstruction of soft tissuedeficiencies. The device is intended for the repair of hernias andother fascial deficiencies requiring the addition of reinforcing orbridging material to obtain the desired surgical result. TheExogenesis Hernia Mesh is composed of knitted filaments ofextruded polypropylene, and knitted to provide elasticity in bothdirections. This construction permits the mesh to be cut into anydesired shape or size without unraveling. The Exogenesis HerniaMesh is treated with a proprietary technology to modify the surfaceof the mesh to increase surface area of the filaments on amicroscopic level. |
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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.
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| 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 ClassificationName | 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 wallhernias and abdominal wall deficiencies thatrequire the addition of reinforcing material toobtain the desired surgical result. TheExogenesis Hernia Mesh is indicated for therepair of abdominal wall hernia defects,including inguinal (direct & indirect). TheExogenesis Hernia Mesh is not indicated fortransvaginal pelvic organ prolapse repair....is intended for single patient one-time useonly. | ...is indicated for the repair of abdominalwall hernias and abdominal walldeficiencies that require the addition of areinforcing material to obtain the desiredsurgical result. The PROLENE™ HerniaSystem is indicated for the repair ofabdominal wall hernia defects, includinginguinal (direct & indirect). |
| Device Composition | Polypropylene (non-resorbable) | Polypropylene (non-resorbable) |
| Construction | Knitted filaments of extruded polypropylene | Knitted filaments of extrudedpolypropylene |
| Bench Testing forHernia 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
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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.
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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.
§ 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.