← Product Code KGN · K200502 # Myriad Particles (K200502) _Aroa Biosurgery , Ltd. · KGN · Mar 31, 2021 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K200502 ## Device Facts - **Applicant:** Aroa Biosurgery , Ltd. - **Product Code:** KGN - **Decision Date:** Mar 31, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Indications for Use Myriad™ Particles is intended to cover, protect, and provide a moist wound environment. ## Device Story Myriad™ Particles is a sterile, ovine-derived extracellular matrix (ECM) wound dressing supplied as particulates. Derived from ovine forestomach, it contains collagen I, collagen III, fibronectin, and glycosaminoglycans. The device is applied to wounds to cover, protect, and maintain a moist environment, facilitating healing. It is intended for use by healthcare professionals in clinical settings for various wound types, including chronic and surgical wounds. The device is a physical dressing; it does not involve active electronic components, software, or automated analysis. It functions as a scaffold for tissue repair. The primary difference from the predicate Endoform™ Dermal Template is the physical presentation (particulate vs. sheet), which allows for easier application to complex or irregular wound geometries. ## Clinical Evidence No clinical data. Substantial equivalence is based on bench testing, including physical specifications, packaging, EO residuals, bioburden, endotoxin testing, and biocompatibility testing (cytotoxicity, sensitization, irritation, implantation, toxicological risk assessment, and heavy metal testing) per ISO 10993-1. ## Technological Characteristics Ovine-derived ECM (collagen I, collagen III, fibronectin, glycosaminoglycans). Particulate form (0.25-2.00 mm). Sterilized via ethylene oxide (SAL 10^-6). Biocompatibility per ISO 10993-1. Particle size verified via ISO 3310-1 sieve. Moisture content <30% w/w. Onset melt temperature 55-70 °C. ## Predicate Devices - Endoform™ Dermal Template ([K092096](/device/K092096.md)) ## Reference Devices - Cook® ECM Powder ([K152033](/device/K152033.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 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 {2}------------------------------------------------ ## 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for AROA. On the left side of the image is an orange circular design that is made up of many smaller oval shapes. To the right of the design is the word "AROA" in a sans-serif font. #### 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 {4}------------------------------------------------ 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) | <1000 CFU/device | <1000 CFU/device | | Collagen (% total
mass) | >70% | 80-90 % | | DNA (mg/g) | <2.1 mg/g | <2.1 mg/g | | Endotoxin
(EU/device) | <20 EU/device | <20 EU/device | | Ethylene oxide
residues(mg/device) | EO <4 mg /device
ECH <9 mg/device | EO <0.2 mg/device
ECH <0.45 mg/ device | | Fibronectin | Present | Present | | Glycosaminoglycans
(mg/g) | >0.05 mg/g | >0.05 mg/g | | Laminin | Present | Present | | Moisture content
(% totalmass) | < 30% w/w | < 30% w/w | | Onset Melt
Temperature | 55-70 °C | 55-70 °C | | Particle size | Particles must be able to pass through a 3.15 mm aperture calibrated sieve (ISO 3310-1) whenvibratory sieved. | N/A | | Permeability | Permeability Index >0 | Permeability Index >0 | | Process chemical
residues(g/kg) | EDTA <11 g/kg
TX-100 <15.7 g/kg | EDTA <425 g/kg
TX-100 <610 g/kg | | Process heavy metal
residues (mg/kg) | Cr <650 mg/kg
Fe <1,150 mg/kg
Ni <150 mg/kg | N/A | | Rehydration Time | < 1 min | < 1 min | | Sterility Assurance
Level(SAL) | 10-6 | 10-6 | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for AROA. On the left is an orange circular design made up of many smaller orange ovals. To the right of the design is the text "AROA" in a bold, sans-serif font. # Myriad™ Particles – Traditional 510(k) K200502 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for AROA. The logo consists of an orange circular design on the left and the word "AROA" in black font on the right. The circular design is made up of several smaller orange oval shapes arranged in a circular pattern. The word "AROA" is written in a simple, sans-serif font. #### 5.5 Non-Clinical Performance Data 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 ● #### 5.6 Clinical Performance Data Substantial equivalence was not based on an assessment of clinical performance data. #### 5.7 Conclusions Myriad™ Particles is as safe and effective and has the same intended uses, indications, and principles of operation as Endoform™ Dermal Template. The minor differences between the Myriad™ Particles presentation and the predicate device do not raise different questions of safety or effectiveness. Performance data demonstrate that Myriad™ Particles is as safe and effective as the predicate device. --- **Source:** [https://fda.innolitics.com/device/K200502](https://fda.innolitics.com/device/K200502) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com