(109 days)
No
The device description and performance studies focus on the material properties and physical characteristics of a collagen matrix for soft tissue repair. There is no mention of AI or ML in the intended use, device description, or performance evaluation sections.
Yes
The device is implanted to reinforce soft tissue where weakness exists, which directly addresses a medical condition to improve patient health, thus acting as a therapeutic device.
No
The device is an implantable matrix designed to reinforce soft tissue, not to diagnose a condition.
No
The device is a physical collagen matrix intended for surgical implantation, not a software product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device 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 device used within the body for structural support during surgery.
- Device Description: The description details a "collagen matrix" that is "surgically implanted" and "fixed, via sutures, staples or tacks to the surrounding tissue." This further confirms its use as an implantable surgical material.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device does not perform any such testing on specimens.
The information provided consistently describes a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Endoform® Plastics and Reconstructive Matrix 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
Device Description
Endoform® Plastics and Reconstructive Matrix is an advanced collagen matrix comprised of natural >70%, non-reconstituted collagen. Endoform® Plastics and Reconstructive Matrix is designed to be fixed, via sutures, staples or tacks to the surrounding tissue, at the discretion of the attending physician for applications in plastic and reconstructive surgery. For example, the device can be surgically implanted to reinforce damaged or ruptured soft tissue membranes and reinforce muscle flaps. The device is supplied sterile and dry in a variety of sizes and thicknesses, which can be trimmed by surgeons to meet the individual patient's needs.
Endoform® Plastics and Reconstructive Matrix is laminated via a proprietary process termed 'lug lamination', which is a physical means of fabricating the devices, such that the individual sheets of the device are physically bonded to one another as opposed to using embroidery to sew the laminate of collagen matrix sheets.
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
attending physician
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 was conducted on the Endoform® Plastics and Reconstructive Matrix to support the substantial equivalence of the proposed device to the predicate device, as detailed below:
- tensile strength ●
- suture retention ●
- biochemical composition ●
- endotoxin
- dimensional verification ●
- ball burst
- modulus of elasticity ●
- delamination evaluation
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.
Biocompatibility of the proposed device has been assessed via ISO 10993-1 and has been concluded that the device is biocompatible based on the established safety of the reference device.
As the proposed predicate and reference devices are technologically equivalent, safety and performance of the proposed device is based on the in vivo performance of the predicate and reference devices.
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.
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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of an eagle with three human profiles incorporated into its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2016
Aroa Biosurgery c/o Gordon MacFarlane, Ph.D., RAC ICON PLC 62 Forest Street, Suite 300 Marlborough, MA 01752
Re: K162461
Trade/Device Name: Endoform Plastics and Reconstructive Matrix Regulation Number: 21 CFR §878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM Dated: November 17, 2015 Received: November 21, 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 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
1
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
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director
Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162461
Device Name
Endoform® Plastics and Reconstructive Matrix
Indications for Use (Describe)
Endoform® Plastics and Reconstructive Matrix 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.
| 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
Image /page/3/Picture/2 description: The image contains a logo with an abstract design on the left and the text "AROA" on the right. The abstract design consists of a cluster of orange ovals arranged in a circular pattern, resembling a stylized sun or flower. The text "AROA" is in a bold, sans-serif font, with each letter evenly spaced and aligned horizontally.
510(k) Summary for the Aroa Biosurgery Endoform® Plastics and Reconstructive Matrix (per 21CFR 807.92)
1. SUBMITTER/510(K) HOLDER
Aroa Biosurgery, Limited 2 Kingsford Smith Place Auckland 2022 New Zealand
| Contact Person: | Tina O'Brien |
|---|---|
| Director, Regulatory Affairs | |
| tina.obrien@aroabio.com | |
| Telephone: | +64 9 8693035 |
| Date Prepared: | August 19, 2016 |
2. DEVICE NAME
| Proprietary Name: | Endoform® Plastics and Reconstructive Matrix |
|---|---|
| Common/Usual Name: | EndoGraft |
| Device Class: | Surgical Mesh |
| Product Code: | FTM |
3. PREDICATE / REFERENCE DEVICES
Predicate Device:
- · SIS Plastic Surgery Matrix (Cook Biotech) (K034039)
- · Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug (K161221)
Reference Devices:
4. DEVICE DESCRIPTION
Endoform® Plastics and Reconstructive Matrix is an advanced collagen matrix comprised of natural >70%, non-reconstituted collagen. Endoform® Plastics and Reconstructive Matrix is designed to be fixed, via sutures, staples or tacks to the surrounding tissue, at the discretion of the attending physician for applications in plastic and reconstructive surgery.
4
For example, the device can be surgically implanted to reinforce damaged or ruptured soft tissue membranes and reinforce muscle flaps. The device is supplied sterile and dry in a variety of sizes and thicknesses, which can be trimmed by surgeons to meet the individual patient's needs.
Endoform® Plastics and Reconstructive Matrix is laminated via a proprietary process termed 'lug lamination', which is a physical means of fabricating the devices, such that the individual sheets of the device are physically bonded to one another as opposed to using embroidery to sew the laminate of collagen matrix sheets.
5. INDICATIONS FOR USE
Endoform® Plastics and Reconstructive Matrix 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.
6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICES
The predicate and reference devices are listed in the table below. The predicate and reference devices serve to support substantial equivalence for the technological characteristics. The technological characteristics of Endoform® Plastics and Reconstructive Matrix and SIS Plastic Surgery Matrix are equivalent in that they are both primarily composed of mammalian collagens and are indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.
| Device Status | Proposed Device | Predicate | Predicate | Reference Predicate |
|---|---|---|---|---|
| Manufacturer | Aroa | Cook Biotech | Cook Biotech | Aroa |
| 510K Number | Proposed | K034039 | K161221 | K130547/K153633 |
| Device name | Endoform® Plastics & Reconstruction Matrix | SIS Plastic Surgery Matrix | Biodesign Plastic Surgery Matrix | Endoform® Reconstructive Template |
| Classification Name | Surgical mesh (FTM) | |||
| 21 CFR 878.3300 | ||||
| Class II | Surgical mesh (FTM) | |||
| 21 CFR 878.3300 | ||||
| Class II | Surgical mesh (FTM) | |||
| 21 CFR 878.3300 | ||||
| Class II | Surgical mesh (FTL/FTM) | |||
| 21 CFR 878.3300 | ||||
| Class II | ||||
| Intended use | Endoform® Plastics and Reconstructive Matrix is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in | The SIS Plastic Surgery Matrix is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. | For implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. | 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, but are not limited to the |
Side-by-Side Comparison of the Proposed Device and the Predicate and Reference Devices
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| Device Status | Proposed Device | Predicate | Predicate | Reference Predicate |
|---|---|---|---|---|
| Manufacturer | Aroa | Cook Biotech | Cook Biotech | Aroa |
| plastic and | ||||
| reconstructive surgery. | ||||
| The device is supplied | ||||
| sterile and is intended | ||||
| for one-time use. | The device is supplied | |||
| sterile and is intended | ||||
| for one-time use. | following procedures; | |||
| hernioplasty and repair | ||||
| of body wall defects. | ||||
| The device allows | ||||
| reinforcement or | ||||
| bridging of a deficit to | ||||
| obtain the desired | ||||
| surgical outcome. | ||||
| Endoform® | ||||
| Reconstructive | ||||
| Template is intended | ||||
| for single use only. | ||||
| Animal origin | Ovine | Porcine | Porcine | Ovine |
| Tissue type | Forestomach | Small intestinal | ||
| submucosa | Small intestinal | |||
| submucosa | Forestomach | |||
| Nominal sizes | Sizes ranging from 1 | |||
| cm² to 400 cm², | ||||
| lugged | 2 to 70 mm width | |||
| up to 200 mm length | 2 to 70 mm width | |||
| up to 200 mm length | Sizes ranging up to | |||
| 400 cm² | ||||
| Thickness | 0.15 – 1.5 mm | 0.1 – 1.5 mm | 100 to 1500 µm thick | Approximately 0.15 – |
| 1.20 mm | ||||
| Presentation | Sterile, lyophilized, | |||
| multi-laminate lugged | ||||
| sheets in a peel pouch | The device is supplied | |||
| sterile in double pouch | ||||
| system. | The device is supplied | |||
| sterile in double pouch | ||||
| system. | Sterile, lyophilized | |||
| sheets in peel pouch | ||||
| Components | Ovine derived | |||
| collagen | Porcine derived | |||
| collagen | Porcine derived | |||
| collagen an | Ovine derived | |||
| collagen and | ||||
| polyglycolic acid | ||||
| (PGA) suture material |
The technological characteristics of Endoform® Plastics and Reconstructive Matrix and the reference device Endoform® Reconstructive Template are equivalent in that they are both primarily composed on ovine ('sheep') collagen and indicated for implantation for soft tissue repair or reinforcement in plastic and reconstructive surgery. Both surgical mesh devices are manufactured from the same ovine source material using an identical manufacturing process.
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7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
Bench testing was conducted on the Endoform® Plastics and Reconstructive Matrix to support the substantial equivalence of the proposed device to the predicate device, as detailed below:
- tensile strength ●
- suture retention ●
- biochemical composition ●
- endotoxin
- dimensional verification ●
- ball burst
- modulus of elasticity ●
- delamination evaluation
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.
Biocompatibility of the proposed device has been assessed via ISO 10993-1 and has been concluded that the device is biocompatible based on the established safety of the reference device.
As the proposed predicate and reference devices are technologically equivalent, safety and performance of the proposed device is based on the in vivo performance of the predicate and reference devices.
8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
There was no clinical testing required to support the indications for use as they are equivalent to the predicate device.
9. SUMMARY OF OTHER INFORMATION
No additional information was provided.
10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
Based on the non-clinical and animal testing completed, and the comparisons with the predicate and reference devices, Endoform® Plastics and Reconstructive Matrix does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.