(138 days)
Endoform Reconstructive Template – Non-Absorbable is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists.
Endoform Reconstructive Template – Non-Absorbable is indicated for use in the repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome.
Endoform Reconstructive Template - Non-Absorbable is a surgical mesh manufactured by layering sheets of ovine forestomach matrix to create multi-layer configurations of devices laminated with non-resorbable polypropylene (PP) suture material in a variety of sizes for use in soft tissue reconstruction. Devices up to 400 cm² are available in thicknesses from 1- through 10- ply, and larger devices up to 1000cm2 are available in 4-, 6-, and 8-ply presentations.
This document describes the Endoform Reconstructive Template - Non-Absorbable, a surgical mesh. The submission (K181935) is a 510(k) premarket notification for a line extension to increase the maximum device size.
Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Specifications) | Reported Device Performance |
|---|---|
| Material composition | Remains the same as predicate |
| Biocompatibility | Remains the same as predicate |
| Sterilization | Remains the same as predicate |
| Packaging materials and processes | Remains the same as predicate |
| Mechanical Strength | Meets all product specifications for the intended use |
| Endotoxin levels | Meets all product specifications for the intended use |
| Dimensional verification | Meets all product specifications for the intended use |
| Performance (general) | Performance specifications have not changed and are met |
The document states that the performance specifications for the device have not changed and that the device meets these specifications. The specific quantitative values of these specifications are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size for test set: Not explicitly stated. The document refers to "Bench testing and validation" and "results of verification and validation testing" without providing specific sample numbers for each test.
- Data provenance: Not explicitly stated, but the company is Aroa Biosurgery Ltd. located in New Zealand. These would be non-clinical, laboratory-based tests.
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)
Not applicable. This device is a surgical mesh, and the testing described is non-clinical (bench testing) for physical properties, not a clinical study involving radiologists or medical image interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for clinical studies involving multiple reviewers/experts, which is not the case here.
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
Not applicable. This is not an AI/software device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (surgical mesh), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance data, the "ground truth" would be established by:
- Engineering specifications and standards for mechanical strength and dimensional properties.
- Validated laboratory assays for endotoxin levels and biocompatibility (as carried over from the predicate device).
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of physical device testing.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
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December 4, 2018
Aroa Biosurgery Ltd. Tina O'Brien Director, Regulatory Affairs 2 Kingsford Smith Place Airport Oaks, Auckland 2022 New Zealand
Re: K181935
Trade/Device Name: Endoform Reconstructive Template - Non Absorbable Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL, FTL, FTM Dated: September 3, 2018 Received: September 5, 2018
Dear Tina O'Brien:
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 mav, 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 avare 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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.
Cynthia Chang -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) K181935
Device Name
Endoform Reconstructive Template - Non-Absorbable
Indications for Use (Describe)
Endoform Reconstructive Template - Non-Absorbable is intended for use as a surgical mesh to repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome.
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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510(k) Summary
| Contact person/submitter | Tina O'Brien |
|---|---|
| Director of Regulatory Affairs | |
| Aroa Biosurgery Ltd. | |
| Date prepared | 3 December 2018 |
| Contact details | 2 Kingsford Smith Place |
| Airport Oaks, Auckland 2022, New Zealand | |
| +64 9 369 3035, ext. 214 | |
| Trade name | Endoform® Reconstructive Template - Non-Absorbable |
| Common name | Surgical mesh |
| Classification name | Mesh, Surgical; Mesh, Surgical Polymeric |
| Predicate device | Endoform® Reconstructive Template (K153632) |
Device Description
Endoform Reconstructive Template - Non-Absorbable is a surgical mesh manufactured by layering sheets of ovine forestomach matrix to create multi-layer configurations of devices laminated with non-resorbable polypropylene (PP) suture material in a variety of sizes for use in soft tissue reconstruction. Devices up to 400 cm² are available in thicknesses from 1- through 10- ply, and larger devices up to 1000cm2 are available in 4-, 6-, and 8-ply presentations.
Intended Use and Indications for Use
Intended Use
Endoform Reconstructive Template – Non-Absorbable is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists.
Indications for Use
Endoform Reconstructive Template – Non-Absorbable is indicated for use in the repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome.
Technological Characteristics Comparison
The proposed change to the Endoform Reconstructive Template device is a line extension to devices embroidered with non-resorbable polypropylene suture (K153632) to increase the maximum device size to 1000cm² for presentations comprised of 4, 6, and 8 layers of tissue. The modified Endoform Reconstructive Template maintains the same intended use and fundamental technological characteristics as the predicate device with polypropylene suture with respect to material composition, biocompatibility, sterilization, and packaging materials and processes.
The modified device is comprised of three (3) pieces of embroidered material, which are joined together creating 2 seams. The pieces used for fabrication have a
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different embroidery pattern around the perimeter than commercial devices to facilitate the joining process. With the exception of the seaming overlaps, the modified device has the same thickness as the predicate device.
The modified device differs only in the maximum device size available by area from 400cm² to 1000cm². Performance and validation testing executed based on risk analysis of the proposed change supports substantial equivalence of the proposed device for the intended use. The performance specifications for the device have not changed as a result of the modification.
Non-Clinical Performance Data
Bench testing and validation was conducted on the larger size Endoform Reconstructive Template Non-Resorbable devices to demonstrate substantial equivalence to the predicate device. Bench testing included mechanical strength, endotoxin, and dimensional verification testing. Results of the testing confirms that the proposed device meets all product specifications for the intended use.
Previous biocompatibility testing performed for the product presented in K153632 remains applicable to the larger Endoform Reconstructive Template - Non-Absorbable product based on the equivalence of the material composition of the proposed device to the predicate.
Clinical Performance Data
Substantial equivalence was not based on an assessment of clinical performance data.
Conclusions
The technological characteristics of the proposed device are equivalent to the predicate. Performance of the device is not dependent on size, and size is the only change between the proposed device and the predicate. Based on the results of verification and validation testing it can be concluded that the proposed device is substantially equivalent to the predicate device.
§ 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.