← Product Code KGN · K200413 # Symphony (K200413) _Aroa Biosurgery , Ltd. · KGN · Jul 29, 2020 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K200413 ## Device Facts - **Applicant:** Aroa Biosurgery , Ltd. - **Product Code:** KGN - **Decision Date:** Jul 29, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use Symphony™ is intended to cover, protect, and provide a moist wound environment. ## Device Story Symphony is a sterile, single-use wound dressing composed of a 4-ply laminate structure: three layers of ovine forestomach-derived extracellular collagen matrix (OFM) sandwiching a layer of glycosaminoglycan (GAG) foam. The device is applied by a clinician to the wound site to cover, protect, and maintain a moist wound environment. It functions as a physical barrier and scaffold for wound management. The device is available in various rectangular sizes up to 200 cm². It is intended for use in clinical settings for a wide range of chronic and acute wounds. The device is provided sterile and is intended for single use. ## Clinical Evidence Bench testing only. No clinical data provided. Testing included GAG foam characteristics, physical specifications, mechanical strength, endotoxin levels, and dimensional verification. Biocompatibility testing was performed per ISO 10993-1 for permanent contact with breached or compromised surfaces, including cytotoxicity, sensitization, irritation, implantation, and toxicological risk assessment. ## Technological Characteristics 4-ply laminate wound dressing; materials: ovine forestomach-derived extracellular collagen matrix (OFM) and glycosaminoglycan (GAG) foam. OFM content 55-80% w/w; GAG foam 20-45% w/w. Thickness ≥ 0.35 mm. Suture retention ≥ 1.5 N. Modulus of elasticity < 0.1 GPa. Sterilization method not specified. Biocompatibility per ISO 10993-1. ## Predicate Devices - Endoform® Topical Matrix ([K171231](/device/K171231.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/2 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 29, 2020 Aroa Biosurgery Ltd. Tina O'Brien Director, Regulatory Affairs 2 Kingsford Smith Place Airport Oaks, Auckland 2022 New Zealand Re: K200413 Trade/Device Name: Symphony Regulatory Class: Unclassified Product Code: KGN Dated: June 24, 2020 Received: June 29, 2020 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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see {1}------------------------------------------------ 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, For Anjana Jain, 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K200413 Device Name Symphony™ Indications for Use (Describe) Symphony™ 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 Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------| | | X | 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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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/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 word "AROA" in a bold, black sans-serif font. #### 510(k) Summary 5 | Contact person/submitter | Tina O'Brien
Director of Regulatory Affairs
Aroa Biosurgery Ltd. | |--------------------------|-------------------------------------------------------------------------------------------------| | Date prepared | 18 February 2020 | | Contact details | 2 Kingsford Smith Place
Airport Oaks, Auckland 2022, New Zealand
+64 9 369 3035, ext. 214 | | Trade name | Symphony™ | | Common name | Wound dressing | | Classification | Unclassified | | Classification name | Dressing, Wound, Collagen | | Product Code | KGN | | Predicate device | Endoform® Topical Matrix (K171231) | #### Device Description 5.1 Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of glycosaminoglycans between sheets of ovine forestomach-derived extracellular collagen matrix. The 4-ply rectangular devices are available in sizes up to 200 cm². #### 5.2 Intended Use Symphony™ is intended to cover, protect, and provide a moist wound environment. #### 5.3 Indications for Use Symphony™ 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 {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 smaller orange circles. To the right of the design is the word "AROA" in a simple, sans-serif font. #### 5.4 Technological Characteristics Comparison Symphony™ devices are part of the Endoform® Dermal Template family of devices to introduce new configurations that include a layer of glycosaminoglycans. Symphony™ maintains the same fundamental technological characteristics as the predicate device with respect to ovine forestomach material, sterilization method, packaging materials, and tissue processing. The Symphony™ device differs from the predicate only with respect to the addition of a layer of glycosaminoglycans. The devices are available in a variety of sizes. Performance and validation testing executed based on risk analysis of the design changes supports substantial equivalence of the subject device. | Parameter | Subject Device - Symphony ™ | Predicate Device-
Endoform® Topical Matrix | |---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | Symphony™ 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® 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 | | Animal Origin | Ovine | Ovine | | Tissue Type | Forestomach | Forestomach | | Presentation - ply's | Device are lugged and comprised of
4 layers as follows:
• OFM
• OFM
• GAG Foam
• OFM | Devices are lugged and
comprised of 2-, 3-, 4- and
5-layers of OFM (1-layer is
fenestrated) | | Presentation - sizes | Finished devices have the following
sizes
• 2.5 cm x 2.5 cm
• 5 cm x 5 cm
• 10 cm x 10 cm
• 10 cm x 20 cm | Sizes ranging from 1 cm² to
400 cm² | | Thickness | $\ge$ 0.35 mm | 1-ply $\ge$ 0.05mm | | Parameter | Subject Device - Symphony ™ | Predicate Device-
Endoform® Topical Matrix | | | | 2-ply ≥ 0.20mm;
3-ply ≥ 0.35mm;
4-ply ≥ 0.50mm;
5-ply ≥ 0.65mm | | OFM Content (% total
mass) | 55% - 80% w/w | 100% w/w | | Final device moisture
content (%w/w) | ≤30% w/w total mass | ≤30% w/w total mass | | Collagen
concentration of OFM
(% total mass) | ≥70% w/w | >70% w/w | | Onset Melt
Temperature of OFM
(°C) | 55-70 °C | 55-70 °C | | Moisture content of
OFM (% total mass) | <30% w/w | <30% w/w | | Total Sulphated GAGs'
concentration of OFM
(mg/g) | >0.05 mg/g | >0.05 mg/g | | OFM Basement
membrane remnants
(laminin) | Present | Present | | OFM Fibronectin | Present | Present | | DNA concentration of
OFM (mg/g) | <2.1 mg/g | <2.1 mg/g | | GAG foam (% total
mass) | 20% - 45% w/w | Not applicable - the predicate
device does not contain GAG
foam (0%) | | Permeability
(permeability Index,
PI) | PI>0 | PI>0 | | Suture Retention | ≥1.5 N | ≥1.5 N | | Endotoxin | <20 EU/device | <20 EU/device | | EDTA Residuals
(mg/kg) | <11000 mg/kg | <11000 mg/kg | | TX-100 Residuals
(mg/kg) | <15700 mg/kg | <15700 mg/kg | | Bioburden | <1000 CFU/device | <1000 CFU/device | | Laminate Stability | Hydrated device maintains laminate
integrity after 10 minutes hydration
and continuous handling | Hydrated device does not
delaminate after 5 minutes of
handling | | Modulus of elasticity | <0.1 GPa | <0.1 GPa | | Rehydration Time
(seconds) | < 5 min (300 seconds) | < 5 min (300 seconds) | The table below summarizes the similarities and differences: {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for AROA. The logo consists of an orange circular design made up of small oval shapes on the left side of the image. To the right of the design is the text "AROA" in a simple, sans-serif font. # Symphony™ – Traditional 510(k) {6}------------------------------------------------ Image /page/6/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 shapes. To the right of the design is the text "AROA" in a simple, sans-serif font. ## K200413 ## Symphony™ – Traditional 510(k) #### 5.5 Non-Clinical Performance Data Bench testing conducted included GAG foam characteristics, physical specifications, mechanical strength, endotoxin, and dimensional verification 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 #### Conclusions 5.6 The technological characteristics of the proposed device are similar to the predicate. Performance of the device is not impacted by the addition of GAGs or the layer configuration. Based on the results of verification and validation testing it can be concluded that the proposed device is substantially equivalent to the predicate device and does not raise new questions of safety or effectiveness. --- **Source:** [https://fda.innolitics.com/device/K200413](https://fda.innolitics.com/device/K200413) **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