(161 days)
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
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.
The provided text is a 510(k) summary for the device "Symphony™," a wound dressing. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on material, manufacturing, and performance characteristics, rather than evaluating an AI/ML medical device. Therefore, much of the requested information about acceptance criteria, ground truth, expert adjudication, MRMC studies, and training/test set details for AI/ML models is not present in this document.
However, I can extract the information related to the device's performance and the non-clinical testing performed to establish its substantial equivalence.
Here's an analysis of the provided text, addressing the points where information is available and noting where it is not:
1. A table of acceptance criteria and the reported device performance
The document presents a comparison table between the Symphony™ device (Subject Device) and the predicate device (Endoform® Topical Matrix). This table implicitly shows the acceptance criteria by listing the parameters and the expected range/value for both the subject and predicate devices.
| Parameter | Acceptance Criteria (Predicate / Subject Device) | Reported Device Performance (Symphony™ - Subject Device) |
|---|---|---|
| Indications for Use | Same as predicate | Same as predicate |
| Animal Origin | Ovine | Ovine |
| Tissue Type | Forestomach | Forestomach |
| Presentation - ply's | Predicate: 2-, 3-, 4-, 5-layers of OFM; Subject: 4 layers (OFM, OFM, GAG Foam, OFM) | Device are lugged and comprised of 4 layers as follows: OFM, OFM, GAG Foam, OFM |
| Presentation - sizes | Predicate: 1 cm² to 400 cm²; Subject: 2.5x2.5, 5x5, 10x10, 10x20 cm² | 2.5 cm x 2.5 cm, 5 cm x 5 cm, 10 cm x 10 cm, 10 cm x 20 cm |
| Thickness | Predicate: 1-ply ≥ 0.05mm, 2-ply ≥ 0.20mm, 3-ply ≥ 0.35mm, 4-ply ≥ 0.50mm, 5-ply ≥ 0.65mm; Subject: ≥ 0.35 mm | ≥ 0.35 mm |
| OFM Content (% total mass) | Predicate: 100% w/w; Subject: 55% - 80% w/w | 55% - 80% 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) | Predicate: Not applicable (0%); Subject: 20% - 45% w/w | 20% - 45% w/w |
| 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 | Predicate: Hydrated device does not delaminate after 5 minutes of handling; Subject: Hydrated device maintains laminate integrity after 10 minutes hydration and continuous handling | Hydrated device maintains laminate integrity after 10 minutes hydration and continuous handling |
| Modulus of elasticity | <0.1 GPa | <0.1 GPa |
| Rehydration Time (seconds) | < 5 min (300 seconds) | < 5 min (300 seconds) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Bench testing conducted," "Performance and validation testing executed based on risk analysis of the design changes," and "Results of the testing confirms that the proposed device meets all product specifications." It also lists biocompatibility testing conducted "in accordance with ISO 10993-1."
No specific sample sizes for these tests are provided.
The data provenance (country of origin, retrospective/prospective) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as this document does not describe a study involving expert review for a diagnostic AI/ML device. The "ground truth" for this device's performance relies on various physical, chemical, and biological laboratory tests and measurements, comparing it against established product specifications and the predicate device's characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This document describes non-clinical performance and validation testing of a medical device, not a study evaluating human reader performance or AI output adjudication.
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 is a 510(k) submission for a wound dressing, not an AI/ML diagnostic or assistive device. No human reader studies are described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm. The "standalone performance" of the device itself (Symphony™ wound dressing) was assessed through the non-clinical and biocompatibility tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is defined by:
- Predicate Device Characteristics: Many parameters are compared directly to the predicate device's known characteristics.
- Established Product Specifications: The device met "all product specifications for the intended use." These specifications would be derived from regulatory requirements, industry standards, and the known performance of similar devices.
- ISO 10993-1 Standards: Biocompatibility testing followed this international standard, implying its criteria served as the ground truth for safety.
- Risk Analysis: Performance and validation testing was "executed based on risk analysis of the design changes," meaning criteria were set to mitigate identified risks.
8. The sample size for the training set
Not applicable. This is not an AI/ML device. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML model, there is no ground truth to establish for it in this document.
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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
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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
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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)
| For activities to benefit CFP, NOAA, Science Center |
|---|
| For Cooperative work with CFP, NOAA, Science Center |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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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'BrienDirector of Regulatory AffairsAroa Biosurgery Ltd. |
|---|---|
| Date prepared | 18 February 2020 |
| Contact details | 2 Kingsford Smith PlaceAirport 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
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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 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 inthe management of the followingwounds:• 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-lasersurgery, podiatric, wounddehiscence)• trauma wounds (abrasions,lacerations, second-degree burns,and skin tears)• draining wounds | Endoform® Topical Matrix isindicated for use in themanagement of the followingwounds:• partial and full-thicknesswounds• pressure ulcers• venous ulcers• diabetic ulcers• chronic vascular ulcers• tunnelled / underminedwounds• surgical wounds (donorsites/grafts, post-Moh'ssurgery, post-laser surgerypodiatric, wounddehiscence)• trauma wounds (abrasions,lacerations, second-degreeburns, and skin tears)• draining wounds |
| Animal Origin | Ovine | Ovine |
| Tissue Type | Forestomach | Forestomach |
| Presentation - ply's | Device are lugged and comprised of4 layers as follows:• OFM• OFM• GAG Foam• OFM | Devices are lugged andcomprised of 2-, 3-, 4- and5-layers of OFM (1-layer isfenestrated) |
| Presentation - sizes | Finished devices have the followingsizes• 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 to400 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 (% totalmass) | 55% - 80% w/w | 100% w/w |
| Final device moisturecontent (%w/w) | ≤30% w/w total mass | ≤30% w/w total mass |
| Collagenconcentration of OFM(% total mass) | ≥70% w/w | >70% w/w |
| Onset MeltTemperature of OFM(°C) | 55-70 °C | 55-70 °C |
| Moisture content ofOFM (% 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 Basementmembrane remnants(laminin) | Present | Present |
| OFM Fibronectin | Present | Present |
| DNA concentration ofOFM (mg/g) | <2.1 mg/g | <2.1 mg/g |
| GAG foam (% totalmass) | 20% - 45% w/w | Not applicable - the predicatedevice does not contain GAGfoam (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 laminateintegrity after 10 minutes hydrationand continuous handling | Hydrated device does notdelaminate after 5 minutes ofhandling |
| 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:
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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)
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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.
N/A