(88 days)
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.
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.
This document is a 510(k) premarket notification for a medical device called the "Endoform® Reconstructive Template" (ERT), which is a surgical mesh. The purpose of this notification is to declare that a modified version of the ERT is substantially equivalent to a previously cleared predicate device. The only change proposed is an increase in the maximum device size.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Parameter) | Reported Device Performance (Goal) | Study Finding |
|---|---|---|
| Bench Testing | "meets all product specifications" | |
| Mechanical Strength | Adequate for intended use | Ensured through bench testing |
| Endotoxin | Within acceptable limits | Ensured through bench testing |
| Dimensional Verification | Accurate dimensions | Ensured through bench testing |
| Validation Testing | "meets all product specifications" | |
| Manufacturing Process Validation | Robust and consistent | Achieved |
| Labeling Validation | Accurate and compliant | Achieved |
| Packaging Transportation Validation | Maintains integrity during transit | Achieved |
| Sterilization (SAL) | 10⁻⁶ | Achieved |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state specific numerical sample sizes for each test set (e.g., how many devices were tested for mechanical strength, endotoxin, etc.). It only broadly refers to "bench testing and validation testing."
- Test Set Sample Size: Not explicitly stated (e.g., number of units tested per bench test).
- Data Provenance: The studies were conducted by Aroa Biosurgery, Limited, which is based in New Zealand. The studies appear to be prospective for the modified device based on the phrase "Performance and validation testing executed based on risk analysis of the proposed change supports the substantial equivalence..."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable in this context. The "acceptance criteria" here refer to engineering and manufacturing specifications (e.g., mechanical strength, sterility, dimensions) for a physical medical device. Ground truth, in the context of expert consensus, is typically relevant for diagnostic devices or those requiring human interpretation of results. For this surgical mesh, the "ground truth" is defined by the established engineering standards and specifications.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple human readers or experts when establishing a ground truth, often for image interpretation or clinical diagnosis. Since the "acceptance criteria" for this device are based on objective physical and chemical measurements (bench testing, sterility), there is no human interpretation or adjudication involved in meeting these criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical data was submitted to support the safety and effectiveness of the modified Endoform Reconstructive Template." MRMC studies inherently involve human readers and clinical outcomes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. A "standalone" performance typically refers to the performance of an algorithm or AI system without human intervention. The Endoform Reconstructive Template is a physical surgical mesh, not an algorithm or AI-powered device.
7. The Type of Ground Truth Used
The "ground truth" (or basis for acceptance) for this device's performance is based on established product specifications, engineering standards, and regulatory requirements. This includes:
- Pre-defined mechanical strength targets.
- Specified endotoxin limits.
- Dimensional tolerances.
- Sterility Assurance Level (SAL) of 10⁻⁶.
- Biocompatibility as demonstrated by the predicate device.
8. The Sample Size for the Training Set
This information is not applicable. The concept of a "training set" is relevant for machine learning or AI models. The Endoform Reconstructive Template is a physical medical device. Its development and testing involve manufacturing processes, material science, and engineering validation, not an AI training paradigm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8. There is no "training set" in the context of this device's development.
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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
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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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Special 510(k) Summary
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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
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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.
§ 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.