(48 days)
No
The device description and performance studies focus on the material composition and established clinical use of collagen matrices, with no mention of AI or ML technologies.
Yes
The device is indicated for the management of various types of wounds, including pressure ulcers, diabetic ulcers, surgical wounds, and trauma wounds, which are conditions that require therapeutic intervention.
No
The device description and intended use indicate that Endoform Topical Matrix is a wound dressing designed to cover and protect wounds and provide a moist wound environment. It is used for management and treatment, not for diagnosing conditions.
No
The device description clearly states it is a "collagen matrix comprised of natural >70%, non-reconstituted collagen," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a topical matrix for managing various types of wounds. This is a direct application to the body for therapeutic purposes, not for testing samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a collagen matrix designed to cover, protect, and provide a moist wound environment. This aligns with a wound dressing or matrix, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on equivalence to existing wound dressings and literature review of clinical use, not on diagnostic accuracy metrics like sensitivity, specificity, or AUC.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to directly manage and support the healing of wounds on the body.
N/A
Intended Use / Indications for Use
Endoform Topical Matrix is a sterile, single use ovine forestomach-derived extracellular matrix intended to cover, protect, and provide a moist wound environment.
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
- 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
Product codes (comma separated list FDA assigned to the subject device)
KGN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence was not based on an assessment of 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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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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
1
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
| Contact
person/submitter | Tina O'Brien
Director of Regulatory Affairs
Aroa Biosurgery |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------|
| Date prepared | 20 April 2017 |
| Contact details | 2 Kingsford Smith Place
Airport Oaks, Auckland
2022, 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
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.
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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Image /page/4/Picture/1 description: The image shows the logo for AROA. The logo consists of an orange circular design made up of smaller orange circles, resembling a sun or a burst of energy. To the right of the circular design is the word "AROA" in bold, black, sans-serif font.
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 Device
Endoform Topical Matrix | Predicate Device
Endoform Dermal Template
(K092096) | Reference Device
Endoform 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 |
| Classification
Name | dressing, wound, collagen
(KGN)
Unclassified | dressing, wound, collagen
(KGN)
Unclassified | surgical mesh (FTL)
21 CFR 878.3300
Class II |
| 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 | Endoform Dermal Template
is supplied sterile and is
intended for single use in
the
treatment 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 | 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. |
| Device Status | Subject Device
Endoform Topical Matrix | Predicate Device
Endoform Dermal Template
(K092096) | Reference Device
Endoform Plastics &
Reconstruction Matrix
(K162461) |
| | | surgery, post-laser surgery,
podiatric,
wound dehiscence) - trauma wounds
(abrasions, lacerations,
second-degree burns, and
skin tears) - draining wounds | |
| 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
- 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 | Endoform Dermal Template
is supplied sterile and is
intended for single use in
the treatment 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 | 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. |
| Animal origin | Ovine | Ovine | Ovine |
| Tissue type | Forestomach | Forestomach | Forestomach |
| Nominal sizes | Sizes ranging from 1 cm²
to 400 cm², lugged | Fenestrated or non-
fenestrated sheets
ranging in size up to 400
cm² | Sizes ranging from 1 cm² to
400 cm², lugged |
| Thickness | 0.15 - 1.50 mm | 0.25 mm | 0.15 – 1.50 mm |
| Presentation | Sterile, lyophilized, multi-
laminate lugged sheets in
peel pouch | Sterile, lyophilized single
sheets in peel pouch | Sterile, lyophilized, multi-
laminate lugged sheets in
peel pouch |
| Components | Ovine derived collagen
and associated ECM
components
-collagen I
-collagen III | Ovine derived collagen and
associated ECM
components
-collagen I
-collagen III | Ovine derived collagen and
associated ECM
components
-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.