(181 days)
No
The summary describes a surgical mesh made from biological material and polypropylene, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a surgical mesh intended to reinforce and/or repair soft tissue where weakness exists, such as in hernias and abdominal wall defects. This directly addresses soft tissue weakness or damage.
No
The device is a surgical mesh used to reinforce and/or repair soft tissue, not to diagnose a condition.
No
The device description clearly states it is a surgical mesh manufactured from layered sheets of ovine forestomach matrix (OFM) and embroidered with polypropylene, indicating it is a physical medical device, not software.
Based on the provided information, 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, specifically for hernias and abdominal wall defects. This is a surgical implant used directly on the patient's body.
- Device Description: The description details a surgical mesh made from biological material (ovine forestomach matrix) and polypropylene, designed for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool and implant used in vivo (within the body) during a surgical procedure.
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
FTL, FTM
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.
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
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.
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 Template - Non-Absorbable in a model of soft tissue reinforcement.
No clinical data was submitted to support the safety and effectiveness of the subject device.
Key Metrics
Not Found
Predicate Device(s)
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/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, representing the department's focus on people and health.
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
1
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
2
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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3
510(k) Summary
Endoform® Reconstructive Template – Non-Absorbable
| 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: | 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.
4
| Device | Endoform
Reconstructive
Template | Ovine Tissue Matrix | Endoform
Reconstructive
Template |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| | 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. |
| Regulation
Number | 878.3300 | 878.3300 | 878.3300 |
| Product Code | FTM | FTM | FTM |
| Intended Use | Intended for use as a
surgical mesh to reinforce
and/or repair soft tissue
where weakness exists. | Intended for use as a
surgical mesh to reinforce
and/or repair soft tissue
where weakness exists. | Intended for use as a
surgical mesh to reinforce
and/or repair soft tissue
where weakness exists. |
| Materials | Ovine derived collagen
and associated
extracellular matrix
components
Collagen I
Collagen III
Polypropylene (PP) | Ovine derived collagen
and associated
extracellular matrix
components
Collagen I
Collagen III
Polypropylene (PP) | Ovine derived collagen
and associated
extracellular matrix
components
Collagen I
Collagen III
Polyglycolic Acid (PGA) |
| Presentation | Lyophilized sheets
provided in a peel pouch | Hydrated sheets provided
in a peel pouch | Lyophilized sheets
provided 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
5
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.