(138 days)
Not Found
No
The description focuses on the material composition and physical properties of a surgical mesh, with no mention of AI or ML capabilities.
No.
The device is a surgical mesh used to reinforce and/or repair soft tissue, not to treat a disease or medical condition in a therapeutic manner.
No
The device is described as a surgical mesh intended for reinforcing and/or repairing soft tissue, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a surgical mesh manufactured from physical materials (ovine forestomach matrix and polypropylene suture material), 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 as a surgical mesh to reinforce and/or repair soft tissue, specifically for hernias and abdominal wall defects. This is a surgical implant used directly on the patient's body.
- Device Description: The device is a surgical mesh made from biological material and polypropylene suture. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for conditions. This device is a therapeutic implant used during surgery.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FTL, FTL, FTM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, hernias and/or abdominal wall defects
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)
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.
Substantial equivalence was not based on an assessment of clinical performance data.
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.
Endoform® Reconstructive Template (K153632)
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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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) |
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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.