Platelet And Plasma Separator For Bone Graft Handling
Applicant
OrthoAscent Ashland, MA
Product Code
ORG · Hematology
Decision Date
Sep 26, 2024
Decision
SESE
Regulation
21 CFR 864.9245
Device Class
Class 2
Indications for Use
The FG-001 Platelet Rich Plasma (PRP) Device is designed to be used for the safe and rapid preparation of platelet rich plasma (PRP) from a small sample of blood at the patient’s point of care. The PRP is mixed with autograft or allograft bone prior to application to an orthopedic surgical site to improve bone graft handling characteristics.
Device Story
Single-use, sterile concentrating device; utilizes centrifuge to separate blood components by density. Operates at point of care; processes 60 mL blood sample to produce 7 mL PRP. Clinician mixes output with bone graft material to improve handling characteristics during orthopedic surgery. Device does not deliver PRP to circulatory system. Bench testing confirms performance equivalence to predicate.
Clinical Evidence
Bench testing only. Evaluated bone graft retention, pH, blood cell counts, platelet recovery/concentration, P-selectin expression, hypotonic stress response, and platelet aggregation. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, systemic toxicity, pyrogenicity, irritation, blood interaction). Sterility achieved per ISO 11137-2 (SAL 10⁻⁶). Shelf-life validated via ASTM F1980-21 and ASTM D4169-23.
Technological Characteristics
Centrifugally driven, density-based separation device. 60 mL input volume, 7 mL output volume. Sterile, single-use. Biocompatibility per ISO 10993. Sterilization per ISO 11137-2. Shelf-life testing per ASTM F1980-21 and ASTM D4169-23.
Indications for Use
Indicated for the preparation of autologous platelet rich plasma (PRP) from a small blood sample at the point of care, to be mixed with autograft or allograft bone for orthopedic surgical site application to improve bone graft handling.
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
PurePRP SupraPhysiologic Concentrating System (BK190317)
Submission Summary (Full Text)
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# 510(k) SUMMARY
# I. SUBMITTER
510(k) Holder: OrthoAscent
6151 Thornton Ave Suite 400
Des Moines IA 50321
Contact Person: Jean-Marie Toher
Regulatory Consultant
MEDIcept, Inc.
jtoher@medicept.com
Date Prepared: September 5, 2024
# II. DEVICES
Names of Device: FG-001 Platelet Rich Plasma (PRP) Device
Classification Name: Platelet And Plasma Separator For Bone Graft Handling
Regulatory Class: Class II
Product Codes: ORG
# III. PREDICATE DEVICES
510(k) Number: BK190317
Applicant: EmCyte Corporation
Device Name: PurePRP SupraPhysiologic Concentrating System
Decision Date: 2/12/2020
# IV. DEVICE DESCRIPTION
The FG-001 Platelet Rich Plasma (PRP) Device is a single-use, sterile concentrating device. It concentrates blood components and aids in the separation of the blood components by density using a centrifuge.
The PRP prepared by this device has not been evaluated for any clinical indications. The PRP prepared by this device is NOT indicated for delivery to the patient's circulatory system.
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## **V. INTENDED USE**
The FG-001 Platelet Rich Plasma (PRP) Device is designed to be used for the safe and rapid preparation of platelet rich plasma (PRP) from a small sample of blood at the patient’s point of care.
## **VI. INDICATIONS FOR USE**
The FG-001 Platelet Rich Plasma (PRP) Device is designed to be used for the safe and rapid preparation of platelet rich plasma (PRP) from a small sample of blood at the patient’s point of care. The PRP is mixed with autograft or allograft bone prior to application to an orthopedic surgical site to improve bone graft handling characteristics.
## **VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE**
In accordance with the *510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]* issued July 28, 2014, the comparison between the predicate and the subject device is shown to be substantially equivalent by comparing the indications for use, principles of operation, technological characteristics, and performance testing similarities and differences (Table 1).
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*Table 1. Substantial Equivalence Subject Device PRP Device Compared to the Predicate Device: EmCyte - PurePRP SupraPhysiologic Concentrating System.*
| Characteristic | Subject Device FG-001 Platelet Rich Plasma (PRP) Device | PurePRP SupraPhysiologic Concentrating System BK190317 | Equivalence Comparison |
| --- | --- | --- | --- |
| Volume Capacity | 60 mL | 60 mL | Same |
| Final Output Volume | 7 mL | 7 mL | Same |
| Two Spin Processing | Yes | Yes | Same |
| Intended Use Statement | The OrthoAscent FG-001 Platelet Rich Plasma (PRP) Device 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 care. The PRP is mixed with autograft or allograft bone prior to application to an orthopedic surgical site to improve bone graft handling characteristics. | The PurePRP SupraPhysiologic Concentrating System 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 care. The PRP is mixed with autograft and allograft bone prior to application to an orthopedic surgical site to improve bone graft handling characteristics. | Same |
| Technology | Centrifugally driven, concentrating device | Centrifugally driven, concentrating device | Same |
| Sterility Claim | Sterile | Sterile | Same |
| Shelf Life | 1 year | 3 years | Different |
| Principle of Operation | Separation based on density of liquids | Separation based on density of liquids | Same |
## VIII. PERFORMANCE DATA
Non-clinical performance testing was conducted to verify the subject device performance. The following performance data was provided in support of the substantial equivalence determination.
### *Performance Testing:*
The following testing was conducted based on feedback received in pre-submission BQ220742:
The final finished sterilized device was used for all performance testing.
- Bone graft retention
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- pH
- Blood cell count (RBC, WBC);
- Platelet count;
- Platelet recovery;
- Platelet concentration factor;
- P-selectin expression on platelets (on resting and ADP activated platelets); T= 0 & T>4hr
- Hypotonic stress response; T= 0 & T>4hr
- Platelet aggregation (collagen). Extended centrifugation cycle; T= 0 & T>4hr
Statistical equivalency was confirmed for all critical parameters of benchtop testing.
Testing was performed to confirm statistically equivalent extraction/input and injection/output volumes between the subject and predicate device .
Evaluated biocompatibility endpoints per ISO 10993-1 include:
- Interactions with Blood (ISO 10993-4)
- Cytotoxicity (ISO 10993-5)
- Sensitization (ISO 10993-10)
- Systemic Toxicity (ISO 10993-11)
- Pyrogenicity (ISO 10993-12)
- Irritation (ISO 10993-23)
Shelf-life was tested in accordance with ASTM F1980-21, Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices and ASTM D4169-23 Standard Practice for Performance Testing of Shipping Containers and Systems.
Sterility was tested per ISO 13004, ISO 10993-7 and ANSI/AAMI/ISO 11137-2 to achieve a Sterility Assurance Level of 10⁻⁶.
### IX. CONCLUSIONS
The substantial equivalence tables and performance testing results demonstrate that the Platelet Rich Plasma (PRP) Device and EmCyte PurePRP SupraPhysiologic Concentrating System are substantially equivalent.
