partial and full-thickness wounds
· pressure ulcers
· venous ulcers
· diabetic ulcers
chronic vascular ulcers
tunnelled / undermined wounds
· surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
· trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
· draining wounds

Device Description

Endoform Topical Matrix is an advanced collagen matrix comprised of natural >70%, non-reconstituted collagen designed to cover, protect, and provide a moist wound environment. The device is supplied in a variety of sizes and thicknesses which can be trimmed by the surgeon to meet the individual patient's needs.

AI/ML Overview

The provided document is a 510(k) summary for the Endoform Topical Matrix. It does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria using performance data. Instead, it argues for substantial equivalence based on similarities to a predicate device and a reference device, along with the device's technological characteristics.

Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth, and expert involvement are not available in this document as it relies on a different pathway for clearance (substantial equivalence to existing devices rather than a de novo performance study against defined acceptance criteria).

However, I can extract the information that is present:

Device: Endoform Topical Matrix

1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria nor reported device performance against those criteria. The clearance is based on substantial equivalence.

2. Sample size used for the test set and the data provenance
Not applicable. Substantial equivalence was not based on a new clinical performance study. The document mentions "literature review" for in vivo use, but does not provide details on specific sample sizes or data provenance for that review.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment activity for a test set is described.

4. Adjudication method for the test set
Not applicable. No test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a medical matrix, not an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used
Not applicable. No specific ground truth methodology for a performance study is described. The basis for clearance is substantial equivalence to a predicate device already on the market.

8. The sample size for the training set
Not applicable. No training set is described as this is not an AI/machine learning device.

9. How the ground truth for the training set was established
Not applicable. No training set is described.

Summary of Information Available in the Document:

Basis for Clearance: Substantial Equivalence to Predicate Device (Endoform Dermal Template, K092096) and Reference Device (Endoform Plastics and Reconstructive Matrix, K162461).

Argument for Equivalence:

Raw Material: Identical (ovine forestomach tissue).
Tissue Processing: Identical.
Intended Use: Identical.
Indications for Use: Identical.
Technological Characteristics: The only difference is the Endoform Topical Matrix is a multi-layer device with a proprietary 'lug lamination' process, which was previously cleared via the reference device (K162461).

Non-Clinical Performance Data:

Warranted Testing: "no additional bench performance testing was warranted" because the subject and predicate devices are made of identical material and the multi-layer design was cleared via the reference device.
Existing Evidence: Mentions that the use of collagen wound dressings is well-established in clinical use and studies, and the collagen matrix used in all Aroa Biosurgery Endoform devices has been previously studied in in vivo models and is in wide-spread clinical use.
In vivo evaluation: "evaluated via a literature review to demonstrate that the subject device is appropriate for the proposed indications based on equivalence to commercially available devices with equivalent composition and indications." (No specific details of the literature review are provided, such as sample size or data provenance).

Clinical Performance Data:

"Substantial equivalence was not based on an assessment of clinical performance data."

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 14, 2017

Aroa Biosurgery Tina O'Brien Director, Regulatory Affairs 2 Kingsford Smith Place Airport Oaks, Auckland 2022, New Zealand

Re: K171231

Trade/Device Name: Endoform Topical Matrix Regulatory Class: Unclassified Product Code: KGN Dated: April 20, 2017 Received: April 27, 2017

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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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 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,

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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Indications for Use

510(k) Number (if known) K171231

Device Name

Endoform Topical Matrix

Indications for Use (Describe)

Endoform Topical Matrix is indicated for the management of the following wounds:

partial and full-thickness wounds
· pressure ulcers
· venous ulcers
· diabetic ulcers
chronic vascular ulcers
tunnelled / undermined wounds
· surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
· trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
· draining wounds

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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5. 510(k) Summary

Contactperson/submitter	Tina O'BrienDirector of Regulatory AffairsAroa Biosurgery
Date prepared	20 April 2017
Contact details	2 Kingsford Smith PlaceAirport Oaks, Auckland2022, New Zealand+64 9 369 3035
Trade name	Endoform Topical Matrix
Product Code	KGN
Common name	Dressing, wound, collagen
Predicate device	Predicate - Endoform Dermal Template (K092096)Reference - Endoform Plastics and Reconstructive Matrix(K162461)

5.1 Device Description

5.2 Intended Use and Indications for Use

5.1.1 Intended Use

Endoform Topical Matrix is a sterile, single use ovine forestomach-derived extracellular matrix intended to cover, protect, and provide a moist wound environment.

5.1.2 Indications for Use

Endoform Topical Matrix is indicated for use in the management of the following wounds:

. partial and full-thickness wounds
. pressure ulcers
. venous ulcers
. diabetic ulcers

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Endoform Topical Matrix - Traditional 510(k)

. chronic vascular ulcers
. tunnelled / undermined wounds
surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser . surgery, podiatric, wound dehiscence)
. trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
. draining wounds

5.3 Technological Characteristics Comparison

The subject Endoform Topical Matrix device is identical to the predicate Endoform Dermal Template with respect to raw material, tissue processing, intended use, and indications for use. The only difference between the subject and predicate devices is the number of layers and use of a different lamination process during manufacturing.

The subject device is a multi-layer device that 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. The following table details the similarities and differences of the subject, predicate, and reference devices:

Device Status	Subject DeviceEndoform Topical Matrix	Predicate DeviceEndoform Dermal Template(K092096)	Reference DeviceEndoform Plastics &Reconstruction Matrix(K162461)
Manufacturer	Aroa	Aroa	Aroa
510K Number	K171231	K092096	K162461
Device name	Endoform Topical Matrix	Endoform Dermal Template	Endoform Plastics &Reconstruction Matrix
ClassificationName	dressing, wound, collagen(KGN)Unclassified	dressing, wound, collagen(KGN)Unclassified	surgical mesh (FTL)21 CFR 878.3300Class II
Intended use	Endoform Topical Matrix isa sterile, single use ovineforestomach-derivedextracellular matrixintended to cover, protect,and provide a moistwound environment	Endoform Dermal Templateis supplied sterile and isintended for single use inthetreatment of the followingwounds:* partial and full-thicknesswounds* pressure ulcers* venous ulcers* diabetic ulcers* chronic vascular ulcers* tunnelled / underminedwounds* surgical wounds (donorsites/grafts, post-Moh's	Endoform Plastics andReconstructive Matrix is forimplantation to reinforcesoft tissue where weaknessexists in patients requiringsoft tissue repair orreinforcement in plastic andreconstructive surgery. Thedevice is supplied sterileand is intended for one-timeuse.
Device Status	Subject DeviceEndoform Topical Matrix	Predicate DeviceEndoform Dermal Template(K092096)	Reference DeviceEndoform Plastics &Reconstruction Matrix(K162461)
		surgery, post-laser surgery,podiatric,wound dehiscence)* trauma wounds(abrasions, lacerations,second-degree burns, andskin tears)* draining wounds
Indications for Use	Endoform Topical Matrix isindicated for use in themanagement of thefollowing wounds:* partial and full-thicknesswounds* pressure ulcers* venous ulcers* diabetic ulcers* chronic vascular ulcers* tunnelled / underminedwounds* surgical wounds (donorsites/grafts, post-Moh'ssurgery, post-lasersurgery, podiatric,wound dehiscence)* trauma wounds(abrasions, lacerations,second-degree burns,and skin tears)* draining wounds	Endoform Dermal Templateis supplied sterile and isintended for single use inthe treatment of thefollowing wounds:* partial and full-thicknesswounds* pressure ulcers* venous ulcers* diabetic ulcers* chronic vascular ulcers* tunnelled / underminedwounds* surgical wounds (donorsites/grafts, post-Moh'ssurgery, post-laser surgery,podiatric,wound dehiscence)* trauma wounds(abrasions, lacerations,second-degree burns, andskin tears)* draining wounds	Endoform Plastics andReconstructive Matrix is forimplantation to reinforcesoft tissue where weaknessexists in patients requiringsoft tissue repair orreinforcement in plastic andreconstructive surgery. Thedevice is supplied sterileand is intended for one-timeuse.
Animal origin	Ovine	Ovine	Ovine
Tissue type	Forestomach	Forestomach	Forestomach
Nominal sizes	Sizes ranging from 1 cm²to 400 cm², lugged	Fenestrated or non-fenestrated sheetsranging in size up to 400cm²	Sizes ranging from 1 cm² to400 cm², lugged
Thickness	0.15 - 1.50 mm	0.25 mm	0.15 – 1.50 mm
Presentation	Sterile, lyophilized, multi-laminate lugged sheets inpeel pouch	Sterile, lyophilized singlesheets in peel pouch	Sterile, lyophilized, multi-laminate lugged sheets inpeel pouch
Components	Ovine derived collagenand associated ECMcomponents-collagen I-collagen III	Ovine derived collagen andassociated ECMcomponents-collagen I-collagen III	Ovine derived collagen andassociated ECMcomponents-collagen I-collagen III

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Endoform Topical Matrix – Traditional 510(k)

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5.4 Non-Clinical Performance Data

As the subject and predicate devices are made of identical material (ovine forestomach tissue) and the multi-layer design and manufacture has been cleared via the reference device, no additional bench performance testing was warranted.

The use of collagen wound dressings is well-established in clinical use and studies in various animal models of dermal injury. Additionally, the collagen matrix used in all Aroa Biosurgery Endoform devices has been previously studied in in vivo models of dermal injury and is currently in wide-spread clinical use for the management of acute and chronic wounds.

In vivo use of the subject Endoform Topical Matrix was evaluated via a literature review to demonstrate that the subject device is appropriate for the proposed indications based on equivalence to commercially available devices with equivalent composition and indications.

5.5 Clinical Performance Data

Substantial equivalence was not based on an assessment of clinical performance data.

5.6 Conclusions

Based on the subject, predicate, and reference devices being completely identical in raw material and tissue processing steps, as well as the published data supporting use of the collagen matrix for the proposed indications, the introduction of Endoform Topical Matrix does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.

Regulation Number and Section

N/A