(181 days)
Endoform® Reconstructive Template is intended for use as a surgical mesh to reinforce and/ or 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.
Endoform Reconstructive Template - Non-Absorbable is a surgical mesh manufactured by layering sheets of ovine forestomach matrix (OFM) to create 1- through 10- ply embroidered devices for soft tissue reconstruction. The device design includes thicknesses from 1- through 10- ply to give a range of strengths as required for a particular implant procedure. The construction of Endoform™ Reconstructive Template - Non-Absorbable devices includes lyophilization of single sheets of OFM followed by embroidery with polypropylene. Devices are terminally sterilized by ethylene oxide (EO) sterilization.
This document is an FDA 510(k) premarket notification decision letter for a surgical mesh device, Endoform® Reconstructive Template - Non-Absorbable. It does not describe an AI medical device or a study involving AI. Therefore, it is impossible to answer the questions about acceptance criteria and study proving an AI device meets those criteria based on the provided text.
The document discusses the substantial equivalence of the surgical mesh to a predicate device based on:
- Biocompatibility Data: Additional cytotoxicity testing, toxicological assessment, and viral inactivation assessment were performed.
- Performance Data: Biomechanical testing (uniaxial tensile strength, ball burst strength, suture retention strength) and an in-vivo study in a soft tissue reinforcement model.
- Clinical Data: No clinical data was submitted.
The provided text pertains to a physical medical device (surgical mesh) and its substantial equivalence determination, not an AI/ML medical device. Therefore, the questions about acceptance criteria for an AI device, sample sizes for AI test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models are not applicable to the content of this document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 16, 2016
Aroa Biosurgery Limited c/o Gordon MacFarlane, Ph.D., RAC ICON Clinical Research LLC 62 Forest Street Marlborough, MA 01752
Re: K153632
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, FTM Dated: May 16, 2016 Received: May 17, 2016
Dear Dr. MacFarlane:
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 - Gordon MacFarlane, Ph.D.
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
- 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) K153632
Device Name
Endoform® Reconstructive Template - Non Absorbable
Indications for Use (Describe)
Endoform® Reconstructive Template is intended for use as a surgical mesh to reinforce and/ or 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
Endoform® Reconstructive Template – Non-Absorbable
| Submitted By: | Aroa Biosurgery, Limited2 Kingsford Smith PlaceAuckland 2022New Zealand |
|---|---|
| Contact Person: | Brian R. WardChief Executive OfficerBrian.ward@aroabio.comP: +64 9 8693035 |
| Date Prepared: | 16 June 2016 |
Device Information:
| Trade Name: | Endoform® Reconstructive Template – Non-Absorbable |
|---|---|
| Common or Usual Name: | Surgical Mesh |
| Classification Name: | Mesh, Surgical (21 CFR §878.3300) |
| Product Code: | FTL |
| FTM |
| Predicate Device: | Ovine Tissue Matrix (K141053) |
|---|---|
| Reference Device: | Endoform Reconstructive Template (K130547, K153633) |
Device Description:
Endoform Reconstructive Template - Non-Absorbable is a surgical mesh manufactured by layering sheets of ovine forestomach matrix (OFM) to create 1- through 10- ply embroidered devices for soft tissue reconstruction. The device design includes thicknesses from 1- through 10- ply to give a range of strengths as required for a particular implant procedure. The construction of Endoform™ Reconstructive Template - Non-Absorbable devices includes lyophilization of single sheets of OFM followed by embroidery with polypropylene. Devices are terminally sterilized by ethylene oxide (EO) sterilization.
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 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.
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| Device | EndoformReconstructiveTemplate | Ovine Tissue Matrix | EndoformReconstructiveTemplate |
|---|---|---|---|
| Non-Absorbable(Subject Device) | OTM(Predicate Device) | ERT(Reference Device) | |
| 510(k) Number | K153632 | K141053 | K130547/K153633 |
| Manufacturer | Aroa Biosurgery, Ltd. | TELA Bio, Inc. | Aroa Biosurgery, Ltd. |
| RegulationNumber | 878.3300 | 878.3300 | 878.3300 |
| Product Code | FTM | FTM | FTM |
| Intended Use | Intended for use as asurgical mesh to reinforceand/or repair soft tissuewhere weakness exists. | Intended for use as asurgical mesh to reinforceand/or repair soft tissuewhere weakness exists. | Intended for use as asurgical mesh to reinforceand/or repair soft tissuewhere weakness exists. |
| Materials | Ovine derived collagenand associatedextracellular matrixcomponentsCollagen ICollagen IIIPolypropylene (PP) | Ovine derived collagenand associatedextracellular matrixcomponentsCollagen ICollagen IIIPolypropylene (PP) | Ovine derived collagenand associatedextracellular matrixcomponentsCollagen ICollagen IIIPolyglycolic Acid (PGA) |
| Presentation | Lyophilized sheetsprovided in a peel pouch | Hydrated sheets providedin a peel pouch | Lyophilized sheetsprovided in a peel pouch |
| Design | Terminally sterilized | Terminally sterilized | Terminally sterilized |
| Size | Up to 20 x 20 cm, 400 cm² | Up to 25 x 40 cm, 1000 cm² | Up to 20 x 20 cm, 200 cm² |
| Thickness | Approx. 0.15-1.5 mm | Approx. 0.15-1.2 mm | Approx. 0.15-1.2 mm |
Summary of Technological Characteristics:
Biocompatibility Data:
Biocompatibility, biomechanical bench, and in vivo performance testing have been conducted to evaluate the safety and performance characteristics of Endoform Reconstructive Template – Non-Absorbable.
Additional cytotoxicity testing, a toxicological assessment, and a viral inactivation assessment were performed to evaluate the safety of the modified ERT device. Results indicate that the device biocompatibility profile is acceptable.
Performance Data:
Biomechanical testing included uniaxial tensile strength (modulus of elasticity), ball burst strength, and suture retention strength. Results indicate that Endoform Reconstructive Template - Non-Absorbable is equivalent to the predicate device and meets the requirements for the intended use.
An in vivo study demonstrated the safety and effectiveness of Endoform Reconstructive
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Template - Non-Absorbable in a model of soft tissue reinforcement.
Clinical Data:
No clinical data was submitted to support the safety and effectiveness of the subject device.
Conclusion:
Endoform Reconstructive Template - Non-Absorbable is substantially equivalent to TELA Bio's Ovine Tissue Matrix (K141053), which has been cleared by FDA for the same intended use and indications. In addition, Endoform Reconstructive Template - Non-Absorbable has similar technological characteristics and principle of operation as the predicate device.
The minor technological differences between Endoform Reconstructive Template - Non-Absorbable and the predicate device do not raise new questions of safety and effectiveness. Performance and preclinical data demonstrate that Endoform Reconstructive Template -Non-Absorbable is as safe and effective as 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.