(125 days)
No
The summary describes a surgical mesh made of biological and synthetic materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as reinforcing soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. This describes a treatment for a medical condition.
No
Explanation: The device, Endoform Restella, is a surgical mesh intended for implantation to reinforce soft tissue, not for diagnosis. Its description and intended use clearly state it is a reconstructive product, and there is no mention of diagnostic functions, image processing, or AI/ML.
No
The device description clearly states it is a surgical mesh manufactured from physical materials (ovine forestomach matrix, PGA, PP suture) and is intended for implantation. This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery." This describes a surgical implant used directly on the patient's body for structural support.
- Device Description: The device is a "surgical mesh manufactured by layering sheets of ovine forestomach matrix... for use in plastic and reconstructive surgery." This further confirms it's a physical implant.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, or tissue samples) to provide information for diagnosis, monitoring, or screening. The description of Endoform Restella does not involve any such testing of specimens.
Therefore, Endoform Restella is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
Endoform Restella is intended for use in the reinforcement of soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastics and reconstructive surgery.
Endoform Restella is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
Product codes
FTM, FTL
Device Description
Endoform Restella is a surgical mesh manufactured by layering sheets of ovine forestomach matrix to create multi-layer configurations of devices laminated with absorbable polyglycolic acid (PGA) and non-absorbable polypropylene (PP) suture material for use in plastic and reconstructive surgery. The 3-ply devices are available in sizes up to 400 cm² in arced rectangle, contour, and oval shapes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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
The bench testing and validation conducted on Restella devices demonstrates 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 Restella 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
Not Found
Predicate Device(s)
Endoform® Plastics & Reconstruction Matrix (K162461)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 11, 2019
Aroa Biosurgery Ltd. Tina O'brien Director, Regulatory Affairs 2 Kingsford Smith Place Airport Oaks, 2022 Nz
Re: K183398
Trade/Device Name: Endoform Restella Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM, FTL Dated: December 6, 2018 Received: December 7, 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 may, 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 aware 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.htm); 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.
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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5. 510(k) Summary
| Contact person/submitter | Tina O'Brien |
|---|---|
| Director of Regulatory Affairs | |
| Aroa Biosurgery Ltd. | |
| Date prepared | 6 December 2018 |
| Contact details | 2 Kingsford Smith Place |
| Airport Oaks, Auckland 2022, New Zealand | |
| +64 9 369 3035, ext. 214 | |
| Trade name | Endoform® Restella - Absorbable and Non-Absorbable |
| Common name | Surgical mesh |
| Classification name | Mesh, Surgical; Mesh, Surgical Polymeric |
| Predicate device | Endoform® Plastics & Reconstruction Matrix (K162461) |
Device Description 5.1
Endoform Restella is a surgical mesh manufactured by layering sheets of ovine forestomach matrix to create multi-layer configurations of devices laminated with absorbable polyglycolic acid (PGA) and non-absorbable polypropylene (PP) suture material for use in plastic and reconstructive surgery. The 3-ply devices are available in sizes up to 400 cm² in arced rectangle, contour, and oval shapes.
5.2 Intended Use and Indications for Use
5.2.1 Intended Use
Endoform Restella is intended for use in the reinforcement of soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastics and reconstructive surgery.
5.2.2 Indications for Use
Endoform Restella is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for onetime use.
3
Endoform Restella - Traditional 510(k)_- K183398
5.3 Technological Characteristics Comparison
Endoform Restella devices are a line extension to Endoform Reconstructive Template devices embroidered with either absorbable polyglycolic acid (K130547) or non-absorbable polypropylene suture (K153632) to introduce new configurations for use in plastic and reconstructive surgery.
Endoform Restella maintains the same fundamental technological characteristics as the predicate device, Endoform® Plastics & Reconstruction Matrix (K162461) with respect to material composition, biocompatibility, sterilization, and packaging materials and processes. The primary difference is the lamination method in that the subject device is embroidered with either polyglycolic acid and polypropylene suture material, while the predicate contains no suture material and is laminated using a proprietary lugging method.
Performance and validation testing executed based on risk analysis of the design changes supports substantial equivalence of the subject device. The primary characteristic specifications for the ovine forestomach matrix have not changed as a result of the modification. However, the Restella device may not have sufficient strength to support stresses encountered in some ventral hernias or large-area, body-wall repairs
5.4 Non-Clinical Performance Data
The bench testing and validation conducted on Restella devices demonstrates 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 Restella based on the equivalence of the material composition of the proposed device to the predicate.
5.5 Clinical Performance Data
Substantial equivalence was not based on an assessment of clinical performance data.
5.6 Conclusions
The technological characteristics and materials of the subject device are equivalent to 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
4
Indications for Use
510(k) Number (if known)
Device Name
Endoform Restella
Indications for Use (Describe)
Endoform Restella is for implantation to reinforce soft tissue where weakness exists in patients repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|
| -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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