BK241042 · Gale Force Aesthetics, LLC Alamo, CA · ORG · Aug 27, 2024 · Hematology
Device Facts
Record ID
BK241042
Device Name
Illuminate PRP
Applicant
Gale Force Aesthetics, LLC Alamo, CA
Product Code
ORG · Hematology
Decision Date
Aug 27, 2024
Decision
SESE
Regulation
21 CFR 864.9245
Device Class
Class 2
Indications for Use
Illuminate PRP is indicated to be used for the safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of peripheral blood at the patient point-of-care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
Device Story
Illuminate PRP is a sterile, single-use evacuated tube system for collecting whole blood and separating platelet-rich plasma (PRP). The tube contains a thixotropic separator gel with a specific gravity designed for density gradient centrifugation. When blood is added and the tube is centrifuged, the gel forms a stable barrier between plasma layers, allowing for separation and transport without removing the sample from the tube. The device is used at the point-of-care by healthcare professionals. It is intended to be used with a general-purpose desktop centrifuge (not included). The resulting PRP is mixed with bone graft material to improve handling during surgical application to bony defects. The system benefits patients by providing a rapid, safe method for autologous PRP preparation.
Clinical Evidence
Bench testing only. Comparative study between Illuminate PRP and predicate evaluated platelet yields, recoveries, average concentration, pH, p-selectin expression, ADP-stimulated response, platelet function, aggregation, hypotonic stress response, and bone graft retention. All parameters demonstrated substantial equivalence. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity). Sterilization validated to 10⁻⁶ SAL per ISO 11137. Packaging and shelf-life validated per ASTM D4169 and ISO 11607.
Technological Characteristics
Evacuated glass tube containing thixotropic separator gel and sodium citrate anticoagulant. Principle: density gradient centrifugation. Sterile (Gamma, SAL 10⁻⁶). Materials: medical grade polymers and elastomers. Dimensions: 22mL capacity. Standalone device; requires external general-purpose centrifuge. No software or electronic components.
Indications for Use
Indicated for preparation of autologous platelet-rich plasma (PRP) from peripheral blood at point-of-care for mixing with autograft/allograft bone to improve handling characteristics in 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.”
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## 510(k) Summary
| I. | **Company** | Gale Force Aesthetics, LLC 1644 Ramona Way Alamo, CA 94507 |
| --- | --- | --- |
| II. | **Contact** | Jayson Jonsson CEO Phone: (b) (6) Email: jjonsson@galeforcellc.com |
| III. | **Product Trade Name** | Illuminate PRP |
| IV. | **Common Name** | Platelet and Plasma Separator for Bone Graft Handling |
| V. | **Classification Name** | Automated blood cell separator |
| VI. | **Regulation Number** | 21 CFR 864.9245 |
| VII. | **Device Class** | Class II |
| VIII. | **Classification Product Code** | ORG |
| IX. | **Predicate Device** | BK110035 Tropocells by Estar Technologies |
| X. | **Description** | |
The Illuminate PRP Platelet Preparation System consists of an evacuated tube intended for the collection of whole blood and the separation of platelet rich plasma. The plasma separation medium is comprised of a thixotropic separator gel which has specific gravity. This configuration permits plasma separation during a single centrifugation step. The separated sample can be transported without being removed from the tube since the gel forms a stable barrier between the plasma layers. The PRP tube is a sterile, single use, media containing vacuum evacuated tube that is intended for separating and concentrating blood components along with the use of a desktop centrifuge.
The gel separation technology is based on the principle of density gradient centrifugation. The blood components differ from each other based on their respective densities. When the blood is added into the tube and centrifuged, the components separate out based on their densities.
The centrifuge and blood draw accessories are not included with the system and is not a part of the present submission.
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## **XI. Indications for Use**
Illuminate PRP is indicated to be used for the safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of peripheral blood at the patient point-of-care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
## **XII. Summary of the Technological Characteristics**
Evacuated tube containing a plasma separation medium comprised of a thixotropic separator gel which has specific gravity of (b) (4). The gel separation technology is based on the principle of density gradient centrifugation. The blood components differ from each other based on their respective densities. When the blood is added into the tube and centrifuged, the components separate out based on their densities.
The fundamental scientific technology, materials of construction, processing methods and mechanism of operation of the subject device are substantially equivalent to the predicate device. All devices are provided as sterile concentrating systems, designed to concentrate and aid in separation of a starting source material (blood) by density using a centrifuge. All devices include a single-use, disposable receptacle (e.g. concentrating device, separator, centrifuge tube assembly, etc.) that is designed to accept a volume of blood, and then undergo centrifugal processing in order to obtain platelet rich plasma (PRP). The table below summarizes the comparison of characteristics between the subject and predicate devices.
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| Description | Illuminate™ PRP (Subject Device) | TropoCells (Predicate Device) |
| --- | --- | --- |
| **510(K)** | **BK241042** | **BK110035** |
| **Product code** | ORG | ORG |
| **Manufacturer** | DiponEd BioIntelligence LLP | Estar Technologies Ltd |
| **Indications for Use statement** | The Illuminate PRP Kit is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient's point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling Characteristics. | The TropoCells PRP Kit is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient's point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling Characteristics. |
| **Prescription/Healthcare professional/OTC** | Prescription | Prescription |
| **System components** | The Illuminate PRP kit contains an evacuated glass tube, thixotropic separator gel, sodium citrate as anticoagulant | Blood collection system, Vacuum tube for PRP separation with GEL & MNC7 anticoagulant |
| **Materials** | Medical grade polymers and elastomers, separator gel (thixotropic) and sodium citrate as anticoagulant | Medical grade polymers, elastomers and anticoagulant |
| **Principle of Operation** | Separation of blood based on density | Separation of blood based on density |
| **Method of processing** | Centrifugation | Centrifugation |
| **Centrifuge device** | General purpose centrifuge | General purpose centrifuge |
| **Sterile** | Sterile, Gamma | Sterile, Gamma |
| **Sizes** | 22mL | 11mL and 22mL |
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# XIII. Discussion of the Non-Clinical Testing
## Biocompatibility Testing
Biocompatibility testing on the patient contacting materials of the device was conducted in accordance with ISO 10993-1 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process. Per ISO 10993-1, Illuminate PRP is categorized as an externally communicating device, with limited exposure (contact < 24 hours) with indirect blood contact. Testing included cytotoxicity (per ISO 10993-5), sensitization & intracutaneous reactivity (per ISO 10993-10), acute systemic toxicity (per ISO 10993-11), pyrogenicity per USP: 151 and USP 41-NF 36.
## Sterilization Validation
A sterilization qualification using the (b) (4) method in compliance with ISO 11137 was performed to validate a gamma sterilization process for the Illuminate PRP Tubes. Results demonstrated that the product is reliably sterilized to a 10⁻⁶ sterility assurance level (SAL) using predetermined parameters. Gale Force intends to use this same procedure to increase sterilization efficiency, such as load capacity, configuration, or location post clearance.
## Transport and Shelf-life
A transportation validation per ASTM D4169 and a packaging shelf life validation per ISO 11607 was conducted using accelerated aging to demonstrate that the package is designed, manufactured, and packed in such a way that the characteristics and performances of the packaging during the intended use will not adversely be affected during the full life cycle of the device; that there is assurance that the device is sterile when placed in the market and will remain sterile, under the storage and transport conditions laid down, until the protective packaging is opened; and that the product will be kept without deterioration at the high level of cleanliness so as to minimize the risk of microbial contamination.
## Predicate Equivalency Evaluation
A study was conducted to compare platelet concentrates produced by the Illuminate PRP and those produced by the predicate. Parameters included platelet yields, platelet recoveries, average PRP platelet concentration, pH, p-selectin expression on resting platelets, platelet response to ADP-stimulation, platelet function, platelet aggregation, hypotonic stress response, and Bone graft material retention. This evaluation demonstrated that the platelet concentrates obtained by Illuminate PRP is substantially equivalent to those of the predicate.
Additionally, Illuminate PRP and the predicate possess the same indications, device class, device code, principles of operation, methods of processing, sterility assurance level, and biocompatibility. The subject device uses components readily available to the user, and the size, where the larger size of the subject device provides increased usability. None of the differences negatively impact the device’s substantial equivalence when compared to the predicate. All validations, verifications, and qualifications passed the predetermined acceptance criteria. The Illuminate PRP therefore has been shown to be substantially equivalent to the predicate.
