(88 days)
Not Found
No
The summary describes a surgical mesh made from biological material and embroidery, with no mention of AI or ML in its function, design, or testing.
Yes
The device is described as a surgical mesh intended to reinforce and/or repair soft tissue where weakness exists, specifically for hernias and abdominal wall defects, which are therapeutic actions.
No
This device is a surgical mesh intended to reinforce and/or repair soft tissue; it does not diagnose any condition.
No
The device description clearly states it is a surgical mesh manufactured from layered ovine forestomach matrix, embroidered with polyglycolic acid, and terminally sterilized. This describes a physical, implantable medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "surgical mesh to reinforce and/or repair soft tissue where weakness exists," specifically for "hernias and/or abdominal wall defects." This describes a device used in vivo (within the body) during surgery.
- Device Description: The description details a "surgical mesh manufactured by layering sheets of ovine forestomach matrix (OFM)" for "implant applications." This further confirms its use as an implantable surgical device.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This device does not perform any such tests on samples.
The information provided consistently describes a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FTM
Device Description
The Aroa Endoform Reconstructive Template ("ERT") is a surgical mesh manufactured by layering sheets of ovine forestomach matrix (OFM) to create 1- through 10- ply embroidered devices for implant applications as part of soft tissue reconstruction. The device design includes a range of thicknesses from 1- through 10- ply to give a range of strengths as required for a particular implant procedure. The construction of ERT devices includes lyophilization of single sheets of OFM followed by embroidery with polyglycolic acid (PGA). Devices are terminally sterilized by ethylene oxide (EO) sterilization. The device has received FDA clearance (K130547) for sizes up to 200cm2.
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 testing was performed on the Endoform Reconstructive Template to support the substantial equivalence of the proposed device to the predicate device. Bench testing included mechanical strength, endotoxin, and dimensional verification testing. All bench testing was conducted under Design Control procedures. In addition to bench testing, validation of the manufacturing process, labeling, packaging transportation, and sterilization to achieve a sterility assurance level (SAL) of 10-6 were performed. Results of the testing demonstrate that the proposed device meets all product specifications for the intended use.
Previous biocompatibility testing performed for the product presented in K130547 is applicable to the proposed Endoform Reconstructive Template product based on the equivalence of the material composition of the proposed device to the predicate.
No clinical data was submitted to support the safety and effectiveness of the modified Endoform Reconstructive Template.
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.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 15, 2016
Aroa Biosurgery Ltd. c/o Dr. Gordon MacFarlane ICON plc 62 Forest Street Marlborough, MA 01752
Re: K153633
Trade/Device Name: Endoform Reconstructive Template Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM Dated: February 16, 2016 Received: February 18, 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
1
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K153633
Device Name Endofonn Reconstructive Template
Indications for Use (Describe)
Endoform Reconstructive Template is intended for usc 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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."
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Special 510(k) Summary
Image /page/4/Picture/1 description: The image contains a logo with an orange circular design on the left and the word "AROA" in black letters on the right. The circular design is composed of several smaller orange circles arranged in a symmetrical pattern. The word "AROA" is written in a simple, sans-serif font, with each letter evenly spaced. The overall design is clean and modern.
510(K) NUMBER: K153663
PAGE 1 OF 2
Special 510(k) Summary for the Endoform® Reconstructive Template
- Submitted By: Aroa Biosurgery, Limited 2 Kingsford Smith Place Auckland 2022 New Zealand
- Contact Person: Brian R. Ward Chief Executive Officer Brian.ward@aroabio.com P. +64.9.8693035
- Date Prepared: March 14, 2016
Device Information:
| Trade Name: | Endoform® Reconstructive Template (ERT) |
|---|---|
| Common or Usual Name: | Surgical Mesh |
| Classification Name: | Mesh, Surgical (21 CFR §878.3300, Product Code FTM) |
Predicate Device: Endoform Reconstructive Template (K130547)
Device Description:
The Aroa Endoform Reconstructive Template ("ERT") is a surgical mesh manufactured by layering sheets of ovine forestomach matrix (OFM) to create 1- through 10- ply embroidered devices for implant applications as part of soft tissue reconstruction. The device design includes a range of thicknesses from 1- through 10- ply to give a range of strengths as required for a particular implant procedure. The construction of ERT devices includes lyophilization of single sheets of OFM followed by embroidery with polyglycolic acid (PGA). Devices are terminally sterilized by ethylene oxide (EO) sterilization. The device has received FDA clearance (K130547) for sizes up to 200cm2.
Intended Use:
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
5
abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome.
Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use:
The proposed change to the Endoform Reconstructive Template device is a line extension to increase the maximum device size to 400cm2. The Endoform Reconstructive Template maintains the same intended use and fundamental technological characteristics as the predicate device including material composition, biocompatibility, sterilization, and packaging materials and processes.
The proposed device will differ only in the maximum device size available by area from 200cm to 400cm². Performance and validation testing executed based on risk analysis of the proposed change supports the substantial equivalence of the proposed device for the intended use. The product specifications for the device have not changed as a result of the modification.
Performance Data:
Bench testing and validation testing was performed on the Endoform Reconstructive Template to support the substantial equivalence of the proposed device to the predicate device. Bench testing included mechanical strength, endotoxin, and dimensional verification testing. All bench testing was conducted under Design Control procedures. In addition to bench testing, validation of the manufacturing process, labeling, packaging transportation, and sterilization to achieve a sterility assurance level (SAL) of 10° were performed. Results of the testing demonstrate that the proposed device meets all product specifications for the intended use.
Previous biocompatibility testing performed for the product presented in K130547 is applicable to the proposed Endoform Reconstructive Template product based on the equivalence of the material composition of the proposed device to the predicate.
Clinical Data:
No clinical data was submitted to support the safety and effectiveness of the modified Endoform Reconstructive Template.
Other Information:
No other information was submitted.
Conclusion:
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 and does not raise new questions of safety or effectiveness.