The 3C OrthoPatch Device is intended to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) from a small sample of a patient’s own peripheral blood. The PRP produced by the 3C OrthoPatch Device is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
Device Story
Device uses mechanical centrifugation to process patient's peripheral blood; no reagent additives. Input: patient blood sample. Process: vacuum blood draw followed by centrifugation to separate components; creates PRP gel containing fibrin, platelets, and leukocytes. Output: autologous PRP gel. Used at point-of-care by healthcare professionals. Clinician mixes PRP gel with autograft/allograft bone to improve handling/cohesion of bone graft material for application to bony defects. Benefits: provides autologous material to enhance bone graft handling.
Clinical Evidence
No clinical data. Substantial equivalence established via non-clinical bench testing, including biocompatibility, sterilization verification, shelf-life testing, and performance metrics (bone material cohesion, platelet/WBC/RBC recovery, and pH).
Technological Characteristics
Constructed of medical grade polyester (PET) and polypropylene (PP). Sterilized via gamma radiation. Operates via mechanical centrifugation. Single-use device. Includes 3C Patch Needle Holder and 3C Counterbalance accessory. No software or electronic algorithms.
Indications for Use
Indicated for patients requiring bone grafting procedures where autologous platelet-rich plasma (PRP) gel is mixed with autograft or allograft bone to improve handling characteristics of the graft material at the point-of-care.
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.”
{0}
510(k) Submission For
3C OrthoPatch Device
Reapplix A/S
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
510(k) Number: BK230968
1. Administrative Information
Submitter: Reapplix A/S
Bregneroedvej 133A, st. th.
Birkeroed 3460
Denmark
Contact person: Jinjie Hu,
Axteria BioMed Consulting Inc.
(b) (6)
Tel: (b) (6)
Email: jinjie.hu@axteriabiomed.com
2. Date prepared: March 29, 2024
3. Purpose of Submission: New Device to obtain a substantial equivalence for the 3C OrthoPatch Device
4. Type of Device: Traditional
5. Proprietary and Established Names:
3C OrthoPatch Device
6. Regulatory Information:
Regulation section: 864.9245 - Automated blood cell separator
Classification: Class II
Product Code: ORG
Panel: Hematology
CONFIDENTIAL
1
{1}
# **510(k) Submission For
3C OrthoPatch Device
Reapplix A/S**---
# **7. Indication for Use:**
The 3C OrthoPatch Device is intended to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) from a small sample of a patient’s own peripheral blood. The PRP produced by the 3C OrthoPatch Device is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
# **8. Device Description:**
The 3C OrthoPatch Device uses mechanical centrifugations process, requiring no reagent additives, to produce an autologous platelet-rich plasma (PRP) gel, which is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. The 3C OrthoPatch Device is intended to be used at point-of-care for the safe and rapid preparation of PRP gel from a small sample of a patient’s own peripheral blood under the supervision of a healthcare professional.
The 3C OrthoPatch Device is able to draw blood by vacuum and then separate the blood components by centrifugation to create a platelet-rich plasma (PRP) gel consisting of fibrin, platelets and leukocytes.
The 3C OrthoPatch Device and 3C Patch Needle Holder are constructed of medical grade polyester (PET) and polypropylene (PP) and are sterilized using gamma radiation.
# **9. Substantial Equivalence Information:**
**Predicate device name(s):** Intra-Spin System
**Predicate K number(s):** K120048
# **Comparison with predicate:**
Technology: Both the predicate device and the 3C OrthoPatch Device include centrifugation to separate red cells and plasma fractions to form a PRP gel. The 3C OrthoPatch Device use centrifugation to compact the gel into a flat gel patch whereas Intra-Spin System is manually compacted into a flat gel patch.
| | Subject Device | Predicate Device | Substantial Equivalence Comparison |
| --- | --- | --- | --- |
| **510(k) Number** | BK230968 | K120048 | |
| **Applicant** | Reapplix A/S | Intra-Lock International | |
2
CONFIDENTIAL
{2}
# **510(k) Submission For
3C OrthoPatch Device
Reapplix A/S**
| | Subject Device | Predicate Device | Substantial Equivalence Comparison |
| --- | --- | --- | --- |
| **Trade Name** | 3C OrthoPatch Device | Intra-Spin System | |
| **Classification Regulation** | 21 CFR 864.9245 | 21 CFR 864.9245 | Same |
| **Product Code** | ORG | ORG | Same |
| **Indications for Use** | The 3C OrthoPatch Device is intended to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) from a small sample of a patient's own peripheral blood. The PRP produced by the 3C OrthoPatch Device is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. | The Intra-Spin System is intended to be used for the safe and rapid preparation of autologous platelet rich fibrin (PRF) from a small sample of blood at the patient's point of care. The PRF is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. | Same |
| **Device Kit** | This kit includes the sterile 3C OrthoPatch Device and 3C Patch Needle Holder. These components are constructed of medical grade polyester (PET) and (PP). They are sterilized by Reapplix A/S using gamma radiation. Accessory components are included for draw blood. | Greiner Bio-One Tube 9ml Serum Clot activator, red cap (single use) Greiner Safety Blood Collection Set + Holder, 21G (single use) Latex Free Tourniquet Test Tube Rack | Similar The material safety of each component of the subject device has been ensured and meets the requirements in previous submission. |
3
CONFIDENTIAL
{3}
# **510(k) Submission For
3C OrthoPatch Device
Reapplix A/S**
| | Subject Device | Predicate Device | Substantial Equivalence Comparison |
| --- | --- | --- | --- |
| **Instrument needed for process** | 3C Patch centrifuge with external power supply, power cable, contra weight, hex hand wrench, tools for rotor change. | IntraSpin Centrifuge Power Cable Fuse Hex Hand Wrench | Similar |
| **Accessory** | The 3CP™ Counterbalance is a non-sterile centrifuge accessory component. It is used to counterbalance the 3C OrthoPatch Device when an odd number of devices (1 or 3) are used. | Greiner Bio-One balancing tubes White Cap 9ml | Similar |
| **Usage** | Single use only | Single use only | Same |
| **Sterile** | Yes, using gamma irradiation | Yes, using gamma irradiation | Same |
**Standard/Guidance Document referenced (if applicable):**
Not Applicable. The submission does not utilize voluntary consensus standards.
**10. Summary of Performance Data Supporting the Substantial Equivalence**
**Non-Clinical Tests:**
A series of non-clinical safety and performance studies were conducted on the subject device.
- Biocompatibility
- Sterilization verification
- Shelf life
- Performance testing included are:
- Bone Material Cohesion
- Platelet Recovery
- WBC Recovery
- RBC Recovery
- pH
CONFIDENTIAL
4
{4}
# **510(k) Submission For
3C OrthoPatch Device
Reapplix A/S**---
All test results meet the pre-defined acceptance criteria and meet intended use.
# **Clinical Tests:**
No clinical testing was performed. Clinical data and conclusions were deemed not necessary to establish substantial equivalence between the subject device and predicate device.
# **11. Propose Labeling:**
The labeling is sufficient, and it satisfies the requirements of 21 CFR Part 809.10.
# **12. Conclusion:**
The submitted information in this premarket notification supports a substantial equivalence decision.
CONFIDENTIAL
5
