(140 days)
No.
The description of the device and its testing focuses on its biological and mechanical properties (e.g., self-assembly, biocompatibility, sterility), without any mention of AI, machine learning, or data-driven decision-making.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "intended for the management of wounds," which is a therapeutic function. Additionally, the 'Device Description' explains how it contributes to cellularization and vascularization and provides a moist wound environment, all of which aid in the healing process.
No
This device is intended for the management and treatment of wounds, not for diagnosis. Its description and intended use clearly state its role in providing a scaffold for cellularization and vascularization to facilitate wound healing, which is a therapeutic function.
No
The device description clearly states it is a "wound management device composed of a purified, self-assembling (scaffold-forming) collagen derived from porcine dermis. This two-part device consists of a collagen solution and a self-assembly reagent." This describes a physical, material-based medical device, not a software product. The performance studies also focus on biocompatibility, viral inactivation, sterility, and stability, which are all characteristics of a physical product.
No.
Reasoning: The device is intended for the management of wounds by providing a scaffold for cellularization and vascularization, which is an in-vivo application, not an in-vitro diagnostic test.
N/A
Intended Use / Indications for Use
Collymer Self-Assembling Scaffold is intended for the management of wounds including: 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, second-degree burns, skin tears) and draining wounds.
Product codes
KGN
Device Description
Collymer Self-Assembling Scaffold is a wound management device composed of a purified, self-assembling (scaffold-forming) collagen derived from porcine dermis. This two-part device consists of a collagen solution and a self-assembly reagent. Combining the two solutions initiates collagen self-assembly. The resulting collagen scaffold is suitable for cellularization and vascularization, providing a moist wound environment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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, second-degree burns, skin tears) and draining wounds.)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Non-clinical testing to support substantial equivalence:
- Biocompatibility Assessments (in accordance with ISO 10993-1 and FDA's guidance on the use of ISO 10993-1, including chemical characterization, applicable ISO 10993-1 biocompatibility endpoints, and a toxicological risk assessment). All results met the acceptance criteria and no evidence of adverse biological responses was observed.
- Viral Inactivation (in accordance with ISO 22442-3 and FDA Guidance: "Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)"). Study results demonstrated manufacturing process steps are effective in achieving viral inactivation.
- Sterility Assessment (in accordance with FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," January 2024 and FDA Guidance, "Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice," September 2004). Assessment concluded that process methods and controls consistently produce a sterile final device.
- Shipping Study (in accordance with ASTM D4169). Results demonstrated appropriate packaging design.
- Stability Evaluation (real-time aging study to ensure stability for at least 6 months when stored under refrigerated conditions (5±3°C). Evaluated for chemical, physical, and self-assembling properties, container closure integrity, sterility, and chemical and elemental impurities). Acceptance criteria were met, demonstrating stability for at least 6 months.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K030774, K160136, K222025, K182681
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
FDA 510(k) Clearance Letter - GeniPhys Collymer Self-Assembling Scaffold
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 25, 2025
GeniPhys, Inc.
Sherry Harbin
Chief Technology Officer
7750 Zionsville Road, Suite 200
Indianapolis, Indiana 46268
Re: K250329
Trade/Device Name: GeniPhys Collymer Self-Assembling Scaffold
Regulatory Class: Unclassified
Product Code: KGN
Dated: May 23, 2025
Dear Sherry Harbin:
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" (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).
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K250329 AND K250329 - Sherry Harbin
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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.
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K250329 AND K250329 - Sherry Harbin
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, PhD
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
FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K250329
Device Name: Collymer Self-Assembling Scaffold
Indications for Use (Describe)
Collymer Self-Assembling Scaffold is intended for the management of wounds including: 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, second-degree burns, skin tears) and 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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Page 5
Page 1 of 4
K250329
510(k) Summary
Prepared: June 25, 2025
Submitter: GeniPhys, Inc.
7750 Zionsville Road, Suite 200
Indianapolis, IN 46268
Contact: Sherry L. Harbin, Chief Technical Officer
Proprietary Name: Collymer Self-Assembling Scaffold
Common Name: Wound Dressing with Animal-Derived Material(s)
Classification: Pre-Amendment, Unclassified
Product Code: KGN
Predicate Device: K072113 - Integra Flowable Wound Matrix, Model FWD301
Reference Devices:
- K030774 - Stimulen Collagen
- K160136 - Flowable Wound Matrix
- K222025 - G4Derm / G4Derm Plus Synthetic Wound Matrix
- K182681 - AC5 Topical Gel
Device Description:
Collymer Self-Assembling Scaffold is a wound management device composed of a purified, self-assembling (scaffold-forming) collagen derived from porcine dermis. This two-part device consists of a collagen solution and a self-assembly reagent. Combining the two solutions initiates collagen self-assembly. The resulting collagen scaffold is suitable for cellularization and vascularization, providing a moist wound environment.
Indications For Use:
Collymer Self-Assembling Scaffold is intended for the management of wounds including: 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, second-degree burns, skin tears) and draining wounds.
Summary of Technologies/Substantial Equivalence:
Collymer Self-Assembling Scaffold is substantially equivalent to the predicate device in terms of its indications for use and technological characteristics. Table 1 provides a detailed comparison between the subject and predicate device. Minor differences between the subject device and the predicate device do not raise new types of safety and effectiveness questions. Substantial equivalence was further demonstrated by the non-clinical testing described below.
Table 1. Substantial Equivalence Comparison
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K250329
| Subject Device: Collymer Self-Assembling Scaffold, K250329 | Predicate Device: Integra Flowable Wound Matrix, Model FWD301, K072113 | Reference: Stimulen, K030774 | Reference: Flowable Wound Matrix, K160136 | Reference: G4Derm / G4Derm Plus Synthetic Wound Matrix, K222025 | Reference: AC5 Topical Gel, K182681 | Subject Vs. Predicate Comparison | |
|---|---|---|---|---|---|---|---|
| Indications for Use | Collymer Self-Assembling Scaffold is intended for the management of wounds including: 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, second-degree burns, skin tears) and draining wounds. | Integra Wound Matrix is intended for the management of wounds including: 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, second-degree burns, skin tears) and draining wounds. | Stimulen is intended for the management of wounds including full and partial thickness wounds, pressure ulcers (stage I-IV), venous stasis ulcers, diabetic ulcers, partial thickness burns, acute wounds, abrasions, traumatic wounds healing by secondary intention, donor sites and other surface wounds. | The Flowable Wound Matrix is intended for the management of wounds including: 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, 2nd degree burns, skin tears) and draining wounds. | OTC: May be used for superficial wounds and abrasions and minor burns. Rx: Under the supervision of health care professionals for the local management of partial- and full-thickness wounds including pressure, and diabetic ulcers; lower extremity ulcers including those of venous, arterial, and mixed etiology; surgical wounds; first- degree and partial- thickness burns including management of abrasions and burns associated with dermabrasions and laser resurfacing. | Under the supervision of a health care professional, AC5 Topical Gel is a topical dressing used for management of partial and full-thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers, and surgical wounds. | The subject device has the same indications for use as the predicate device. |
| Product Code | KGN | KGN | KGN | KGN | FRO | FRO | The subject device has the same product code as the predicate device. |
| Composition | Purified, acid-soluble, self-assembling type I collagen derived from porcine dermis | Granulated cross-linked bovine tendon collagen and glycosaminoglycan | Bovine based, purified, soluble modified collagen | Particulate porcine small intestinal submucosa and fructose | Aqueous solution of synthetic peptides | Synthetic self-assembling peptides and sterile water for injection | The subject device, the predicate device, and the reference devices Stimulen (K030774) and Flowable Wound Matrix (K160136) use animal-based collagen sources. Collagen characterization demonstrated that there are no new safety or effectiveness questions. |
| Gel or Scaffold Form | Yes | Yes | Yes | Yes | Yes | Yes | The subject device, the predicate device, and all reference devices form a gel/scaffold material. |
| Form and Presentation | Acidified collagen solution that when mixed with a phosphate-based buffer and applied topically using a dual syringe/luer connector system forms a collagen scaffold | Crosslinked collagen and glycosaminoglycan particulate rehydrated to a gel-like consistency using saline in a dual syringe/luer connector system and then applied topically | Collagen powder that when applied topically dissolves in wound exudate and forms a collagen gel; other product formats represent a flowable gel or a pre-formed sheet | Particulate small intestinal submucosa and fructose rehydrated to a gel-like consistency using saline in a dual syringe/luer connector system and then applied topically | Aqueous solution of synthetic peptides (shear-thinning) that when applied topically using a syringe/applicator system forms a gel | Lyophilized self-assembling synthetic peptide that is reconstituted in water to create an acidic peptide solution; when applied topically using a syringe/ applicator system, the peptide solution interacts with endogenous ions in wounds and self-assembles to form a scaffold | The subject device, the predicate device, and all reference devices are applied topically and result in a gel or scaffold form. |
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K250329
Non-Clinical Testing:
Collymer Self-Assembling Scaffold underwent non-clinical testing and analyses to support a determination of substantial equivalence to the predicate device. The following were completed:
Biocompatibility Assessments
The biocompatibility assessment of the Collymer Self-Assembling Scaffold was conducted in accordance with ISO 10993-1 and FDA's guidance on the use of ISO 10993-1. The testing included chemical characterization, applicable ISO 10993-1 biocompatibility endpoints, and a toxicological risk assessment. All results met the acceptance criteria. No evidence of adverse biological responses was observed, and the device is deemed safe and suitable for its intended use.
Viral Inactivation
A viral inactivation study was completed to confirm compliance to ISO 22442-3 and FDA Guidance: "Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)." The study results demonstrated that the manufacturing process steps evaluated are effective in achieving viral inactivation, ensuring the safety of the device under the conditions tested.
Sterility Assessment
A sterility assessment was conducted in accordance with FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," January 2024 and FDA Guidance, "Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice," September 2004. The assessment concluded that the process methods and controls consistently produce a sterile final Collymer Self-Assembling Scaffold device.
| Subject Device: Collymer Self-Assembling Scaffold, K250329 | Predicate Device: Integra Flowable Wound Matrix, Model FWD301, K072113 | Reference: Stimulen, K030774 | Reference: Flowable Wound Matrix, K160136 | Reference: G4Derm / G4Derm Plus Synthetic Wound Matrix, K222025 | Reference: AC5 Topical Gel, K182681 | Subject Vs. Predicate Comparison | |
|---|---|---|---|---|---|---|---|
| Biocompatible | Yes | Yes | Yes | Yes | Yes | Yes | The subject device, the predicate device, and all reference devices are all biocompatible. |
| Sterile Formulation | Yes | Yes | Yes | Yes | Yes | Yes | The subject device, the predicate device, and all reference devices are all supplied sterile. |
| Single Use | Yes | Yes | Yes | Yes | Yes | Yes | The subject device, the predicate device, and all reference devices are all single use. |
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K250329
Shipping Study
A shipping study was completed in accordance with ASTM D4169. The results demonstrated that the packaging design is appropriate for its intended use.
Stability Evaluation
A stability (real-time aging) study was completed on Collymer Self-Assembling Scaffold to ensure the device materials and associated primary packaging remain stable for at least 6 months when stored under refrigerated conditions (5±3°C). The product was evaluated for chemical, physical, and self-assembling properties, container closure integrity, sterility, and chemical and elemental impurities. The acceptance criteria were met, demonstrating stability of the device for at least 6 months at 5±3°C.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of Collymer Self-Assembling Scaffold to the predicate device.
Conclusion:
A comparison of the subject and predicate device, including comparison of the intended use and technological characteristics has demonstrated that the subject device is as safe and effective as the predicate device. Thus, the subject device is substantially equivalent to the predicate device.