(397 days)
No
The document describes a wound care product made from ovine collagen and focuses on its physical properties, biocompatibility, and equivalence to a predicate device. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes.
The device is used for the management of various wounds, which falls under the definition of a therapeutic purpose.
No
The text describes Myriad™ Particles as being indicated for use in the "management" of various wounds, such as pressure ulcers and surgical wounds. It is an extracellular matrix product. There is no mention of it being used to diagnose conditions, process information to provide a diagnosis, or output diagnostic information. Its role is in treatment/management, not diagnosis.
No
The device description explicitly states it is derived from an extracellular matrix and supplied as a sterile particulate, indicating a physical, non-software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Myriad™ Particles is used for the management of various types of wounds. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as an extracellular matrix derived from ovine collagen, supplied as a sterile particulate. This is a material applied directly to a wound, not a reagent or instrument used to analyze a biological sample.
- Performance Studies: The performance studies focus on bench testing (physical specifications, biocompatibility) and comparison to a predicate device based on substantial equivalence, not on the accuracy or performance of a diagnostic test.
The information provided strongly indicates that Myriad™ Particles is a wound care product intended for therapeutic use, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Myriad™ Particles 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 .
- . tunneled/undermined wounds
- Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, . wound dehiscence)
- . trauma wounds (abrasions, lacerations, partial-thickness burns, and skin tears)
- · draining wounds
Product codes (comma separated list FDA assigned to the subject device)
KGN
Device Description
Myriad™ Particles is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.
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)
Bench testing included physical specifications, packaging, EO residuals, bioburden, and endotoxin testing. Results of the testing confirms that the proposed device meets all product specifications for the intended use and demonstrates substantial equivalence to the predicate device.
The following biocompatibility testing was conducted in accordance with ISO 10993-1 based on the device's classification as 'breached or compromised surface' contact for a 'permanent' duration:
- Cytotoxicity (MEM Elution)
- Delayed Type Hypersensitivity (Sensitization)
- Irritation (intracutaneous reactivity)
- Implantation
- Toxicological risk assessment
- Heavy metal testing
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.
Endoform™ Dermal Template (K092096)
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.
Cook® ECM Powder (K152033)
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
0
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March 31, 2021
Aroa Biosurgery Ltd. Tina O'Brien Director, Regulatory Affairs 2 Kingsford Smith Place Airport Oaks, Auckland 2022 New Zealand
Re: K200502
Trade/Device Name: Myriad Particles Regulatory Class: Unclassified Product Code: KGN Dated: February 25, 2021 Received: March 1, 2021
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 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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lixin Liu, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Myriad™ Particles
Indications for Use (Describe)
Myriad™ Particles 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 .
- . tunneled/undermined wounds
- Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, . wound dehiscence)
- . trauma wounds (abrasions, lacerations, partial-thickness 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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510(k) Summary 5
| Contact person/submitter | Tina O'Brien
Director of Requlatory Affairs
Aroa Biosurgery Ltd. |
|--------------------------|-------------------------------------------------------------------------------------------------|
| Last Updated | 30 March 2021 |
| Contact details | 2 Kingsford Smith Place
Airport Oaks, Auckland 2022, New Zealand
+64 9 369 3035, ext. 214 |
| Trade name | Myriad™ Particles |
| Common name | Wound dressing |
| Classification | Unclassified |
| Classification name | Dressing, Wound, Collagen |
| Product code | KGN |
| Predicate device | Endoform™ Dermal Template (K092096) |
| Reference device | Cook® ECM Powder (K152033) |
5.1 Device Description
Myriad™ Particles is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.
5.2 Intended Use
Myriad™ Particles is intended to cover, protect, and provide a moist wound environment.
5.3 Indications for Use
Myriad™ Particles 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
- tunneled/undermined wounds
- . Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
- . trauma wounds (abrasions, lacerations, partial-thickness bums, and skin tears)
- . draining wounds
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Image /page/4/Picture/0 description: The image shows the logo for AROA. On the left side of the logo is an orange circular design made up of many smaller orange oval shapes. To the right of the design is the text "AROA" in a simple, sans-serif font.
5.4 Technological Characteristics Comparison
The primary difference between the subject and predicate devices is the device presentation (powder vs. sheet format). An additional inner tray has been implemented to facilitate dispensing of the new device presentation.
The subject Myriad™ Particles® device is identical to the predicate Endoform™ Dermal Template with respect to raw material, tissue processing (with the exception of the steps to convert the ECM material from a sheet to a particulate), terminal sterilization, intended use, and indications for use.
Cook Biotech's ECM Powder (K152033) is noted as a reference device to highlight a similar design modification to a 510(k) cleared animal-derived collagen dressing sheet format to a powdered form, both intended for use in wound care.
| Device | Subject Device
Myriad™ Particles
(K200502) | Predicate Device
Endoform™ Dermal Template
(K092096) |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Aroa Biosurgery Ltd. | Aroa Biosurgery Ltd. |
| Classification Name | dressing, wound, collagen (KGN)
Unclassified | dressing, wound, collagen (KGN)
Unclassified |
| Intended
Use | Myriad™ Particles is 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 woundspressure ulcersvenous ulcersdiabetic ulcerschronic vascular ulcerstunnelled / undermined woundssurgical 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 |
| Indications for Use | Myriad™ Particles is indicated for use
in the management of the following
wounds:
partial and full-thickness woundspressure ulcersvenous ulcersdiabetic ulcerschronic vascular ulcerstunneled/undermined woundsSurgical wounds (donor sites/grafts, post-Moh's surgery | Endoform™ Dermal Template is
supplied sterile and is intended for
single use in the treatment of the
following wounds:
partial and full-thickness woundspressure ulcersvenous ulcersdiabetic ulcerschronic vascular ulcerstunnelled / undermined wounds |
| Device | Subject Device
Myriad™ Particles
(K200502) | Predicate Device
Endoform™ Dermal Template
(K092096) |
| | post-laser surgery, podiatric, wound dehiscence) trauma wounds (abrasions, lacerations, partial-thickness bums, and skin tears) draining 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 |
| Animal Tissue | Ovine Forestomach | Ovine Forestomach |
| Nominal sizes | Particles ranging from 0.25 mm -2.00 mm | Fenestrated or non-fenestrated sheets ranging in size up to 400 cm² |
| Components | Ovine derived collagen and associated ECM components
-collagen I
-collagen III | Ovine derived collagen and associated ECM components
-collagen I
-collagen III |
| Bioburden
(CFU/device) | 70% | 80-90 % |
| DNA (mg/g) | 0.05 mg/g | >0.05 mg/g |
| Laminin | Present | Present |
| Moisture content
(% totalmass) | 0 | Permeability Index >0 |
| Process chemical
residues(g/kg) | EDTA