(184 days)
Helios Dermal Scaffold is intended for the management of wounds that include:
- Partial- and full- thickness wounds
- Pressure, diabetic, and venous ulcers
- Partial thickness burns
- Surgical wounds – donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence
- Trauma wounds – abrasions, lacerations and skin tears
- Tunneled/undermined wounds
- Draining wounds
Helios Dermal Scaffold is an acellular dermal tissue matrix derived from fetal bovine dermis. The single-use device is supplied sterile and is provided in sheet form in a variety of sizes and configurations, including meshed, solid, and fenestrated designs ranging from 1.5 - 500 cm² to be trimmed by the surgeon to meet the individual patient's needs.
The provided FDA 510(k) clearance letter for the Helios Dermal Scaffold does not contain any information regarding acceptance criteria or the study details typically associated with AI/ML device performance validation.
This document is for a medical device (a dermal scaffold), which is a biological product, not a software or AI/ML-driven diagnostic device. The performance data section refers to physical and biological characteristics of the scaffold, such as:
- Device Characterization Testing: Dimensional verification, color and appearance, suture retention strength, acellularity (histology), collagen denaturation.
- Design Validations: Viral inactivation, sterilization.
- Biocompatibility
- Shelf-life
- Packaging testing
These tests are standard for biological and implantable materials, ensuring their physical integrity, safety, and compatibility with the human body. They do not involve AI/ML algorithms, image analysis, or diagnostic accuracy.
Therefore, it is not possible to extract the requested information (acceptance criteria, sample size, ground truth, expert opinions, MRMC studies, etc.) from this document, as those concepts are not applicable to the type of device described.
To answer your prompt with the requested information, the input document would need to be a 510(k) clearance letter for an AI/ML medical device, typically referencing a clinical study or performance study that evaluates diagnostic accuracy, sensitivity, specificity, or reader agreement.
FDA 510(k) Clearance Letter - Helios Dermal Scaffold
Page 1
August 15, 2025
Helios Biomedical Inc.
℅ Roshana Ahmed
President
Quaras, LLC
2101 Camino Rey
Fullerton, California 92833
Re: K250397
Trade/Device Name: Helios Dermal Scaffold
Regulatory Class: Unclassified
Product Code: KGN
Dated: July 18, 2025
Received: July 18, 2025
Dear Roshana Ahmed:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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K250397 - Roshana Ahmed Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
Page 3
K250397 - Roshana Ahmed Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D.
Assistant Director
DHT4B: Division of Plastic and
Reconstructive Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
Indications for Use
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K250397
Device Name
Helios Dermal Scaffold
Indications for Use (Describe)
Helios Dermal Scaffold is intended for the management of wounds that include:
- Partial- and full- thickness wounds
- Pressure, diabetic, and venous ulcers
- Partial thickness burns
- Surgical wounds – donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence
- Trauma wounds – abrasions, lacerations and skin tears
- Tunneled/undermined wounds
- 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 FDA 3881 (8/23) Page 1 of 1
Page 5
510(k) Summary
K250397
Page 1 of 4
I. Submitter 807.92(a)(1)
Helios Biomedical Inc.
11 Dellbrook Road
Weston MA 02493
Phone: (617) 818-4008
Fax: N/A
Contact Person: Yiannis Monovoukas, President & CEO
II. Device
| Device Proprietary Name: | Helios Dermal Scaffold |
|---|---|
| Common or Usual Name: | Animal-derived, extracellular dermal matrix wound care product |
| Classification Name: | Dressing, Wound, Collagen |
| Regulation Number: | N/A |
| Product Code: | KGN |
| Device Classification | Unclassified |
| Review Panel | General & Plastic Surgery |
III. Predicate Device
Substantial equivalence is claimed to the following device:
- PriMatrix™ Dermal Repair Scaffold ("PriMatrix"), K153690, Integra Lifesciences Corp/TEI Biosciences.
The following devices are cited as reference devices within the submission:
- CardiaMend™ Pericardial and Epicardial Reconstruction Matrix, K210331, Helios Cardio Inc.
- SurgiMend™ Collagen Matrix for Soft Tissue Reconstruction, K071807, Integra Lifesciences Corp/TEI Biosciences.
- Durepair® Dura Regeneration Matrix, K161370, Medtronic Neurosurgery/Integra Lifesciences/TEI Biosciences.
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K250397
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IV. Device Description
Helios Dermal Scaffold is an acellular dermal tissue matrix derived from fetal bovine dermis. The single-use device is supplied sterile and is provided in sheet form in a variety of sizes and configurations, including meshed, solid, and fenestrated designs ranging from 1.5 - 500 cm² to be trimmed by the surgeon to meet the individual patient's needs.
V. Indications for Use
Helios Dermal Scaffold is intended for the management of wounds that include:
- Partial and full thickness wounds
- Pressure, diabetic, and venous ulcers
- Partial thickness burns
- Surgical wounds – donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence
- Trauma wounds – abrasions, lacerations and skin tears
- Tunneled/undermined wounds
- Draining wounds
VI. Technological Characteristics
Helios Dermal Scaffold is substantially equivalent to the predicate device, PriMatrix™ Dermal Repair Scaffold (K153690) with respect to intended use and technological characteristics. A comparison of the two devices is provided in the table below.
| Helios Dermal Scaffold | PriMatrix™ Dermal Repair Scaffold (K153690) | Analysis | |
|---|---|---|---|
| Indications for Use | Intended for the management of wounds that include:• Partial and full thickness wounds• Pressure, diabetic, and venous ulcers• Partial thickness burns• Surgical wounds – donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, | Intended for the management of wounds that include:• Partial and full thickness wounds• Pressure, diabetic, and venous ulcers• Second-degree burns• Surgical wounds – donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, | Identical |
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K250397
Page 3 of 4
| Helios Dermal Scaffold | PriMatrix™ Dermal Repair Scaffold (K153690) | Analysis | |
|---|---|---|---|
| wound dehiscence• Trauma wounds – abrasions, lacerations and skin tears• Tunneled/undermined wounds• Draining wounds | wound dehiscence• Trauma wounds – abrasions, lacerations and skin tears• Tunneled/undermined wounds• Draining wounds | ||
| Reusable or single use | Single-Use | Single-Use | Identical |
| Material | Collagen, extracellular matrix | Collagen, extracellular matrix | Identical |
| Animal Tissue Source | Fetal bovine dermis | Fetal bovine dermis | Identical |
| Fundamental Technology | Acellular dermal matrix for the management of wounds | Acellular dermal matrix for the management of wounds | Identical |
| Form | Disc, square, or rectangle | Disc, square, or rectangle | Identical |
| Design | Solid, fenestrated, or meshed sheet | Solid, fenestrated, or meshed sheet | Identical |
| Size | 1.5 - 500 cm² | 1.5 - 500 cm² | Identical |
| Number of Layers | Single-ply | Single-ply | Identical |
| Sterilization | Ethylene oxide; SAL 10⁻⁶ | Ethylene oxide; SAL 10⁻⁶ | Identical |
| Storage | Store dry, at room temperature (15 ℃ - 30 ℃) | Store dry, at room temperature (15 ℃ - 30 ℃) | Identical |
| Shelf Life | Three (3) years from the date of lyophilization | Five (5) years from the date of lyophilization | Substantially equivalent |
Helios Dermal Scaffold is identical to the predicate device in terms of fundamental technology, indications for use, materials, form, design, size, sterilization, storage, and biocompatibility, and is substantially equivalent in terms of shelf life.
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K250397
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Substantial equivalence to the predicate device is demonstrated through performance test and biocompatibility.
VII. Performance Data
Helios Dermal Scaffold is identical to the reference devices CardiaMend™ Pericardial and Epicardial Reconstruction Matrix (K210331) and/or SurgiMend™ Collagen Matrix for Soft Tissue Reconstruction (K071807) with respect to fundamental technology, materials, manufacturing process, sterilization, storage, biocompatibility, and shelf life; therefore, existing data from CardiaMend™ Pericardial and Epicardial Reconstruction Matrix and/or SurgiMend™ Collagen Matrix for Soft Tissue Reconstruction was leveraged in support of the substantial equivalence determination:
- Device Characterization Testing
- Dimensional verification
- Color and appearance
- Suture Retention Strength
- Acellularity (Histology)
- Collagen Denaturation
- Design Validations
- Viral Inactivation
- Sterilization
- Biocompatibility
- Shelf-life
- Packaging testing
Device characterization testing was also undertaken on the fenestrated and meshed variants.
VIII. Conclusion
Helios Dermal Scaffold is substantially equivalent to the specified predicate device based on comparisons of device functionality, material, technological characteristics, and indications for use.
N/A