FastSkin Patch
Device Facts
| Record ID | BK251174 |
|---|---|
| Device Name | FastSkin Patch |
| Applicant | MimiX Biotherapeutics, Ltd |
| Product Code | PMQ · Hematology |
| Decision Date | Nov 7, 2025 |
| Decision | SESE |
| Regulation | 21 CFR 864.9245 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Fast Skin Patch is intended to be used at point-of-care for the safe and rapid preparation of Whole Blood Clot (WBC) from a small sample of a patient's own peripheral blood. Under the supervision of a healthcare professional, the WBC produced by the FastSkin Patch is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, diabetic ulcers, and mechanically or surgically-debrided wounds.
Device Story
Convenience kit for point-of-care preparation of autologous whole blood clot (WBC) for wound management. Input: 20 mL patient peripheral blood collected via phlebotomy into ACD-A vacuum tubes. Process: Citrated blood mixed with calcium gluconate and kaolin; mixture added to sterile coagulation cartridge; 8-minute coagulation period. Output: Whole blood clot transferred to non-adherent dressing for topical application to wounds. Operated by healthcare professionals in clinical settings. Benefits: Provides autologous wound matrix for management of chronic/exuding wounds; facilitates wound closure.
Clinical Evidence
Multi-center, open-label, controlled clinical study (n=20) in patients with chronic diabetic foot ulcers (1-25 cm²). Comparison: FastSkin Patch + SOC vs. SOC alone. Primary endpoint: complete wound closure at 12 weeks. Results: 60% closure rate (6/10) in treatment group vs. 10% (1/10) in control group. No treatment-related adverse events reported.
Technological Characteristics
Kit components: PETG coagulation cartridge, kaolin initiator, ACD-A anticoagulant. Materials: PETG, Tyvek, OPA-PE. Sterilization: (b)(4) for cartridge and initiator. Biocompatibility: ISO 10993-1 compliant (cytotoxicity, sensitization, systemic toxicity, pyrogenicity). Shelf life: 24 months. Standalone, non-electronic, single-use convenience kit.
Indications for Use
Indicated for patients with exuding cutaneous wounds, including leg ulcers, pressure ulcers, diabetic ulcers, and mechanically or surgically-debrided wounds, requiring topical application of autologous whole blood clot.
Regulatory Classification
Identification
An automated blood cell separator is a device that uses a centrifugal or filtration separation principle to automatically withdraw whole blood from a donor, separate the whole blood into blood components, collect one or more of the blood components, and return to the donor the remainder of the whole blood and blood components. The automated blood cell separator device is intended for routine collection of blood and blood components for transfusion or further manufacturing use.
Special Controls
*Classification.* Class II (special controls). The special control for this device is a guidance for industry and FDA staff entitled “Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle.”
Predicate Devices
- ActiGraft® RD2 Ver.02 System (BK210570)
Submission Summary (Full Text)
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510(k) #:
# 510(k) Summary
Prepared on: 2025-11-06 (2)
## Contact Details
21 CFR 807.92(a)(1)
Applicant Name
MimiX Biotherapeutics, Ltd
Applicant Address
Aarbergstrasse 46, CH-2503 Biel
Benne
Switzerland
Biel/Bienne Switzerland
Applicant Contact Telephone
(b) (6)
Applicant Contact
Dr. Tanya Rhodes
Applicant Contact Email
tanya.rhodes@mimixbio.com
## Device Name
21 CFR 807.92(a)(2)
Device Trade Name
FastSkin Patch
Common Name
Peripheral Blood Processing Device for Wound Management.
Classification Name
Automated Blood Cell Separator
Regulation Number
864.9245 (Regulatory Class II)
Product Code(s)
PMQ
## Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
Predicate #
Predicate Trade Name (Primary Predicate is listed first)
Product Code
BK210570
ActiGraft® RD2 Ver.02 System
PMQ
## Device Description Summary
21 CFR 807.92(a)(4)
The FastSkin® Patch is a "convenience kit" that contains the following components for drawing and handling autologous whole blood and allowing it to clot in a controlled manner in order to form a wound matrix/dressing:
The FastSkin® Patch includes:
- Blood Management Kit
- Coagulation Cartridge
- Coagulation Initiator
- Patient Labels
- Instruction of Use
The Blood Management Kit includes a blood collection set which is used to collect and store the patient's blood prior to preparation of the whole blood clot.(WBC).
The following additional accessories (not included in the kit) are required for the use of the FastSkin® Patch:
- Calcium gluconate 100 mg mL Preservative-free single-dose bottle 10 mL (Rx)
- Sterile gloves, Nitrile Powder-Free
- Sterile alcohol pad
- Sterile Non-adherent dressing / Gauze pad
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To use the kit, 20 mL of blood from the patient is drawn into two sterile vacuum tubes containing ACD-A anticoagulant. Calcium gluconate solution is injected into the kaolin vial and mixed. This suspension and the citrated blood are then gently mixed and added to the sterile coagulation cartridge to coagulate for 8 minutes. The whole blood clot that is formed is then transferred to a non-adherent dressing and applied to the patient's wound. All FastSkin Patch kit elements and reagents are disposed of after a single use of the kit. The procedure may be repeated with a new FastSkin Patch kit after a few days.
Off-the-shelf component packages are individually sterile. The coagulation cartridge is sterilized via (b) (4) and the coagulation initiator vial is sterilized via (b) (4) and packed in a non-sterile pouch bag. All components are then packed in a non-sterile cardboard carton as the final kit.
# Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The Fast Skin Patch is intended to be used at point-of-care for the safe and rapid preparation of Whole Blood Clot (WBC) from a small sample of a patient's own peripheral blood. Under the supervision of a healthcare professional, the WBC produced by the FastSkin Patch is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, diabetic ulcers, and mechanically or surgically-debrided wounds.
The intended use of the device is the same as that of the predicate.
# Technological Comparison
21 CFR 807.92(a)(6)
The FastSkin Patch and ActiGraft RD2 Ver.02 System are both designed to allow healthcare professionals to safely prepare a whole blood clot from a small sample of the patient's own blood.
The subject and predicate devices are substantially equivalent based on the following similar elements:
All kit components are single-use
All are based on phlebotomy with the provided blood collection set
Automatic blood collection in sterile vacuum tubes containing ACD-A anticoagulant
- Mixing with calcium gluconate and kaolin to coagulate
There is no processing or manipulation of the blood
- Similar blood volumes are used and similar whole blood clot volumes are produced
Whole blood clot formed is used for topical management of wounds
Same indications for use statement
The table below compares the key features of the two systems:
| Device | Subject Device | Predicate Device |
| --- | --- | --- |
| Trade Name | FastSkin® Patch | ActiGraft® RD2 Ver.02 System |
| Applicant | MimiX Biotherapeutics Ltd | RedDress Ltd |
| 510(k) Number | BK251174 (New) | BK210570 |
| Classification Product Code | PMQ | PMQ |
| Device Class | Class II | Class II |
| Regulation Number | 21 CFR 864.9245 | 21 CFR 864.9245 |
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| Intended Use Indications for Use | The FastSkin® Patch is intended to be used at the point of care for the safe and rapid preparation of Whole Blood Clot (WBC) from a small sample of a patient's own peripheral blood. Under the supervision of a healthcare professional, the WBC produced by the FastSkin® Patch is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, diabetic ulcers, and mechanically or surgically debrided wounds. | The RD2 Ver.02 System is intended to be used at point-of-care for the safe and rapid preparation of Whole Blood Clot (WBC) from a small sample of a patient's own peripheral blood. Under the supervision of a healthcare professional, the WBC produced by the RD2 Ver.02 System is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, diabetic ulcers, and mechanically or surgically-debrided wounds. |
| --- | --- | --- |
| Coagulation Cartridge / Mold | Single size sterile PETG sealed with Tyvek cover inside Polyamide- Polyethylene (OPA-PE) pouch | Single size sterile PETG sealed with Tyvek cover |
| Anticoagulant Reagent | ACDA (manufactured by Beijing Hanbaihan Medical Devices Co., Ltd) | ACDA (manufactured by Beijing Hanbaihan Medical Devices Co., Ltd) |
| Coagulation Reagents | Kaolin supplied sterile in 4ml vial Calcium Gluconate solution (*not supplied in kit*) | Kaolin supplied sterile in coagulation mold Calcium Gluconate powder supplied in coagulation mold |
| Blood management kit | Tourniquet, 18' length Sterile blood collection set, 21G winged with 7' Tube with holder 2 sterile ACD-A vacuum tubes, each containing up to 10 mL for blood collection 30 mL sterile syringe 5 mL sterile syringe for coagulation initiator mixing. 18 G safety needle - for coagulation initiators transfer 18 G safety needle - for blood injection | Tourniquet, 18' length Sterile blood draw/infusion set, 21G winged with 7' Tube with holder Sterile alcohol pad 2' x 2' Gauze pad Bandage Sterile gloves, Nitrile Powder-Free Sterile alcohol pad Sterile Non-adherent dressing / Gauze pad |
| Blood Draw | 20mL | 15mL |
| Reagent Titration | Blood: 20ml ACD-A: 1.0ml within vacuum tube CG: 360mg in 3.6ml solution (10%) Kaolin: 28mg | Blood: 15ml ACD-A: 1.5ml within vacuum tube CG: 85mg powder Kaolin: 28mg |
| Operation | 20 mL of blood from the patient is drawn into two sterile vacuum tubes containing ACD-A anticoagulant. Calcium gluconate solution is injected into the kaolin powder vial and mixed. This suspension and the citrated blood are then gently mixed and added to the sterile coagulation cartridge to coagulate for 8 minutes. The whole blood clot that is formed is then transferred to a non-adherent dressing and applied to the patient's wound. All FastSkin Patch kit elements and reagents are disposed of after a single use of the kit. The procedure may be repeated with a new FastSkin Patch kit after a few days. | 15ml of blood from the patient is drawn into a sterile vacuum tube containing ACD-A anticoagulant. Subsequently, the citrated blood is injected into a sterile coagulation mold (clotting tray) which contains cotton gauze, calcium gluconate powder and kaolin powder, to coagulate for 8 minutes. The whole blood clot that is formed is then extracted using the supplied clot extraction ring, placed on the patient's wound, and dressed with a secondary sterile non-adherent dressing. All RD2 Ver.02 System kit elements and reagents are disposed of after a single use of the kit. The procedure may be repeated with a new RD2 Ver.02 System kit after a few days. |
| Size of Final Blood Clot | Square: 5cmx5cm Area: 25cm^{2} | Diameter: 6cm diameter Area: 28.3 cm^{2} |
| Kit sterilization | Non sterile kit assembly with sterile components | Non sterile kit assembly with sterile components |
| Shelf Life | 24 Months | 24 Months |
MimiX Biotherapeutics has demonstrated that the difference in technological characteristics of the subject device and the predicate device do not raise questions of safety or effectiveness.
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# Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
Non Clinical:
The FastSkin Patch components were subjected to in vitro testing, with results demonstrating the device is safe for its intended use.
The FastSkin Patch coagulation cartridge was subjected to the following tests in its final sterile, packaged configuration:
- Performance validation
- Physico-chemical validation
- Sterility validation
- Bioburden validation
- Chemical cleanliness testing
- Shelf life validation
- Transit testing simulation validation
- Biocompatibility testing per ISO 10993-1
The FastSkin Patch coagulation initiator (kaolin) was subjected to the following tests in its final sterile, packaged configuration:
- Performance validation
- Physico-chemical validation
- Sterility validation
- Bioburden validation
- Shelf life validation
- Transit testing simulation validation
- Biocompatibility testing per ISO 10993-1
In accordance with the FDA guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing included:
- Chemical characterization
- Cytotoxicity Study
- Guinea Pig Maximization Sensitization Test
- Acute systemic toxicity
- Intracutaneous Study
- Acute Systemic Toxicity Study
- Pyrogen study
- Endotoxin study
The FastSkin Patch was also subjected to physico-chemical testing, identical to the physico-chemical testing performed on the predicate device to compare the outputs of the two devices. The results demonstrated that the whole blood clot output of FastSkin Patch is substantially equivalent to that of the predicate.
- Cell recovery
- Rheology
- Moisture content
In addition, bench testing was performed on the final FastSkin Patch to confirm that it functioned per its specifications throughout its shelf life. The device functioned as intended and all results passed, and considered equivalent to the performance of the predicate device.
Clinical:
The FastSkin Patch has been assessed in patients with diabetic foot ulcers. A summary from a multi-center, open label controlled clinical study comparing safety and efficacy of the FastSkin Patch to standard of care (SOC) in patients with chronic diabetic foot ulcers (DFUs) was provided as part of the submission. The study enrolled patients with DFU's between 1cm² and 25cm² in size, a history of at least 4 weeks chronicity and documented failure of prior treatments. Twenty patients completed treatment to 12 weeks or wound closure per the protocol (10 in treatment group and 10 in the control group with SOC alone). The Per Protocol analysis of the study showed that at Week 12 the incidence of complete wound closure was 60% (6 wound closures out of 10 patients) in the FastSkin Patch treatment group compared to 10% (1 wound closure out of 10 patients) in the control group. The FastSkin Patch was well tolerated with no treatment related adverse events.
Conclusions:
The FastSkin Patch has the same intended use, incorporates the same fundamental technology and has the same indications for use as the predicate. Based on the comparison of intended use and technological characteristics, MimiX Biotherapeutics has demonstrated that the FastSkin Patch is substantially equivalent to the predicate device and is safe and effective for its intended use.
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