The AHC Platelet Concentrate Separator is designed to be used for preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
Device Story
Single-use, sterile concentrating device; processes peripheral blood samples to produce autologous platelet-rich plasma (PRP). Operates via density-based gravity separation using a centrifuge (45° fixed angle or horizontal swinging bucket). Requires external components: blood draw tools, syringes, and centrifuge. Device consists of PET tube, separator gel, and sodium citrate anticoagulant. Used in clinical settings by healthcare providers. Output is PRP, which is mixed with bone graft material to improve handling during orthopedic procedures. Benefits include enhanced bone graft application and handling. Substantial equivalence established through bench testing comparing platelet recovery, concentration, and yield against predicate devices.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing including sterilization validation, shelf-life testing (accelerated/real-time), biocompatibility (ISO 10993-1), and in vitro performance metrics (platelet recovery, concentration factor, yield, pH, P-selectin expression, aggregation, hypotonic shock response, and bone graft cohesion).
Technological Characteristics
Materials: medical-grade PET tube, separator gel, sodium citrate anticoagulant, rubber stopper. Principle: density-based gravity separation via centrifugation. Dimensions: 10, 15, 25 ml capacities. Connectivity: standalone. Sterilization: Gamma irradiation. Packaging: sterile blister with Tyvek.
Indications for Use
Indicated for patients requiring autologous platelet-rich plasma (PRP) preparation from peripheral blood for mixing with autograft or allograft bone to improve handling characteristics during application to bony defects.
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.”
RegenKit-ATS-3, RegenKit-BCT-1 Plus, RegenKit-BCT-2 Plus (BK120066)
Submission Summary (Full Text)
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# 510(k) SUMMARY
**Type of Submission:** Traditional**Date of Summary:** 01/09/2025**Submitter:** Sunphoria Co.,Ltd**Address:** 12F-1, No.51, Hengyang Rd., Zhongzheng Dist., Taipei City 10045, Taiwan (R.O.C.)**Phone:** +886-2-2313-1301**Contact:** Maggie Yen(b) (4)
## Identification of the Device:
**Proprietary/Trade name:** AHC Platelet Concentrate Separator**Model Number:** 0628-25, 0628-10-4, 0628-15-4**Classification Product Code:** ORG**Regulation Number:** 864.9245**Regulation Description:** Platelet And Plasma Separator For Bone Graft Handling**Review Panel:** Hematology**Device Class:** II
## Identification of the Predicate Device:
**Predicate Device Name:** RegenKit-BCT Family Kits**Model Number:** RegenKit-BCT-1, RegenKit-BCT-2, RegenKit-BCT-3, RegenKit-BCT-4**Manufacturer:** RegenLab SA**Classification Product Code:** ORG**Regulation number:** 864.9245
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| **Device Class:** | II |
| --- | --- |
| **510(k) Number:** | BK110061 |
#### **Identification of the Predicate Device II:**
| **Predicate Device Name:** | RegenKit-ATS-3, RegenKit-BCT-1 Plus, RegenKit-BCT-2 Plus |
| --- | --- |
| **Model Number:** | RegenKit-ATS-3, RegenKit-BCT-1 Plus, RegenKit-BCT-2 Plus |
| **Manufacturer:** | RegenLab SA |
| **Classification Product Code:** | ORG |
| **Regulation number:** | 864.9245 |
| **Device Class:** | II |
| **510(k) Number:** | BK120066 |
#### **Intended Use of the Device**
The AHC Platelet Concentrate Separator is designed to be used for preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
#### **Device Description**
The AHC Platelet Concentrate Separator is a single-use, sterile concentrating device. It concentrates blood components and aids in separation of the blood components by density through the use of additional components (not supplied), including blood draw components, syringes and centrifuge.
The system prepares platelet rich plasma (PRP) from a small volume of blood that is drawn at the time of treatment. The materials of the concentrating device consist of medical-grade PET Tube, separator gel, anticoagulant: Sodium Citrate Solution and rubber stopper.
The subject device is available in 3 models and the main differences between them are
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the quantity and capacity of AHC PRP tube.
### **Non-clinical Testing**
The following non-clinical performance testing was submitted in support of a determination of substantial equivalence between the subject and predicate device.
#### **• Sterilization Test**
The sterilization method used on AHC Platelet Concentrate Separator is Gamma Irradiation sterilization. The sterilization process was validated by sterilization test.
- Sterilization Validation of Gamma Irradiation
- Gamma Sterilization Facility Validation Report
#### **• Shelf life test**
The shelf life of AHC Platelet Concentrate Separator is claimed to be 2 years based on the 2-year accelerated study and the 2-year real time aging study is ongoing.
- Accelerated aging test
- Real time aging test plan
- Burst test
- Creep test
- Dye penetration test
- Seal peel test
#### **• Biocompatibility test**
A series of biocompatibility tests were conducted to assess the biocompatibility of AHC Platelet Concentrate Separator, in accordance with the FDA Guidance document, “Use of International Standard ISO 10993-1, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process,’” September 4, 2020.
- In Vitro Cytotoxicity Test
- Guinea Pig Skin Sensitization Study (Maximization Test)
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- Rabbit Intracutaneous Irritation Study
- Acute Systemic Toxicity Study
- Pyrogen Study in Rabbits
- In vitro haemolysis study of AHC Platelet Concentrate Separator using rabbit blood (direct contact method)
# • Performance Test
A series of in vitro performance tests were conducted to verify the performance and equivalency of AHC Platelet Concentrate Separator and the predicate device.
- Separation gel tests
- Blood cell counts
- Platelet recovery percentage
- Platelet concentration factor
- Platelet yield
- pH measurement
- P-selectin expression of platelet
- Platelet aggregation
- Hypotonic shock response (HSR)
- Sterility test
- Bone Graft cohesion
All the test results demonstrate AHC Platelet Concentrate Separator meets the requirements of its pre-defined acceptance criteria and intended use and is substantially equivalent to the predicate device.
# Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
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### Substantial Equivalence Determination
The subject device has similar intended use, same technology/principle of operation, and similar claim of safety and performance as the predicate device.
Please refer to the following comparison table:
| Comparison of Technological Characteristics | | | |
| --- | --- | --- | --- |
| Item | Subject device | Predicate device | Substantial equivalence determination |
| Manufacturer | Sunphoria Co.,Ltd | RegenLab SA | N/A |
| Trade Name | AHC Platelet Concentrate Separator | RegenKit-BCT Family Kits | N/A |
| Model | 0628-25 0628-10-4 0628-15-4 | RegenKit-BCT-1 RegenKit-BCT-2 RegenKit-BCT-3 RegenKit-BCT-4 | N/A |
| 510(k) No. | (to be assigned) | BK110061 | N/A |
| Product Code | ORG | ORG | *Same* |
| Classification | Class II (21 CFR 864.9245) | Class II (21 CFR 864.9245) | *Same* |
| Intended Use | The AHC Platelet Concentrate Separator is designed to be used for preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with | The RegenKit-BCT Family Kit is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient's point of | *Similar* |
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| | autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. | care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. The RegenKit-BCT Family Kits are for single use only. | |
| --- | --- | --- | --- |
| Separation principle | Gravity separation based on blood density | Gravity separation based on blood density | *Same* |
| Capacity | 10, 15, 25 ml | 15 ml | *Equivalent* The subject device has models designed for various capacity, and this difference does not raise any new issue of substantial equivalence. |
| Required blood amount | 7, 10, 20 ml | 10 ml | |
| Extracted amount of PRP | 3.5, 5, 6 ml | 5-6 ml | |
| Used anticoagulant | USP 4% Sodium Citrate Solution | USP 4% Sodium citrate solution | *Same* |
| Method of processing | Centrifugation | Centrifugation | *Same* |
| Type of Centrifuge Used | Use a 45° fixed angle rotor centrifuge or a horizontal head swinging bucket centrifuge | Use a 45° fixed angle rotor centrifuge or a horizontal head swinging bucket centrifuge | *Same* |
| Centrifuge Condition | Centrifugal force: 740-820G Time: 10 mins | Centrifugal force: 1500G Time: 5 mins | *Equivalent* The subject device has |
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| | | | different centrifuge condition, and this difference does not raise any new issue of substantial equivalence. |
| --- | --- | --- | --- |
| Chambers | Single tube with plasma separated from red blood cells by cell selector gel | Single tube with plasma separated from red blood cells by cell selector gel | *Same* |
| Prescription Use | Yes | Yes | *Same* |
| Sterilization | Gamma Irradiation sterilization | Gamma Irradiation sterilization | *Same* |
| Sterile barrier | Packaged in sterile blister sealed with Tyvek | Packaged in sterile blister sealed with Tyvek | *Same* |
| Packaging | Blister | Blister | *Same* |
| Usage | For single use only | For single use only | *Same* |
| Self life | 2 years | 2 years | *Same* |
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## Similarity and Difference
AHC Platelet Concentrate Separator is compared with “RegenKit-BCT Family Kits”. The subject device has similar intended use, same technology/mechanism of action, and similar safety and performance characteristics as the predicate device. Although there are some different specifications between these devices, the performance test was completed and demonstrated these differences don’t affect the safety and performance of the subject device. (referring to **Section 18**). Therefore, the differences between the subject device and the predicate device do not raise any new issue of substantial equivalence.
## Conclusion
In conclusion, Sunphoria Co.,Ltd. believes that AHC Platelet Concentrate Separator maintains the same safety and effectiveness, and thus, is substantially equivalent to the predicate device.
