Healeon Float PRP devices (HFPRP15, HFPRP30, and HFPRP45)
BK241095 · Bimini Health Tech Plano, TX · ORG · Nov 20, 2024 · Hematology
Device Facts
Record ID
BK241095
Device Name
Healeon Float PRP devices (HFPRP15, HFPRP30, and HFPRP45)
Applicant
Bimini Health Tech Plano, TX
Product Code
ORG · Hematology
Decision Date
Nov 20, 2024
Decision
SESE
Regulation
21 CFR 864.9245
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Healeon Float PRP devices (HFPRP15, HFPRP30 and HFPRP45) are intended for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of 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
Sterile, single-use, vacuum-evacuated tube; contains anticoagulant and floating separator component. Used at point-of-care; operator (clinician) collects whole blood into tube; tube placed in standard desktop centrifuge. Centrifugal force causes separator to move, isolating platelet-rich plasma (PRP) based on density; separator locks in place upon centrifuge stop, preventing remixing. Output is concentrated autologous PRP; mixed with bone graft material to improve handling during orthopedic procedures. Benefits include rapid, reliable preparation of autologous PRP for surgical use.
Clinical Evidence
Bench testing only. Comparative study evaluated platelet concentrates from subject and predicate devices. Parameters included platelet yield, concentration, CBC values, pH, activation, aggregation, hypotonic stress response, and bone graft handling characteristics. Results demonstrated substantial equivalence to the predicate. Biocompatibility, sterilization, and shelf-life/transport validation performed per ISO 10993, ISO 11607, and ASTM D4169 standards.
Technological Characteristics
Sterile, single-use evacuated tube with stopper, anticoagulant (Acid Citrate Dextrose), and polymer blend float separator. Operates via density-based centrifugal separation. Materials: medical grade polymers and elastomers. Sizes: 15mL, 30mL, 45mL. No electronic components or software.
Indications for Use
Indicated for the preparation of autologous platelet-rich-plasma (PRP) from blood samples at the point of care for mixing with autograft or 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.”
Predicate Devices
Healeon PRP Platelet Preparation System (BK170136)
Submission Summary (Full Text)
{0}
# **BK241095**
**510(k) Summary**
| **I.** | **Company** | Bimini Health Tech 420 Stevens Ave, Suite 220 Solana Beach, CA 92075 United States |
| --- | --- | --- |
| **II.** | **Contact** | Frankie Ng VP, Operations (b) (6) Phone: +1 (858) 348-8050 Fax: +1 (858) 217-5134 |
| | **Date Prepared:** | November 18, 2024 |
| **III.** | **Product Trade Name** | Healeon Float PRP devices (HFPRP15, HFPRP30, and HFPRP45) |
| **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** | BK170136, Healeon PRP Platelet Preparation System |
| **X.** | **Description** | The Healeon Float PRP devices (HFPRP15, HFPRP30, and HFPRP45) consists of an evacuated tube intended for the collection of whole blood and the separation of platelet rich plasma. The plasma separator component is comprised of a biocompatible polymer blend of precise mass and configuration that is free to float while under centrifugal force but is sealed in place under normal conditions. This configuration permits a convenient means of plasma separation and provides a reliable method for retaining platelet rich plasma without the risk of remixing the blood components. |
This device is a sterile, single use, vacuum evacuated tube that is intended for separating and concentrating blood components along with the use of a desktop centrifuge. The tube contains the separator component, an anticoagulant, and a stopper at the top.
The centrifuge is not included with the device and is not a part of the present submission.
003-01
{1}
# **XI. Indications for Use**
The Healeon Float PRP devices (HFPRP15, HFPRP30 and HFPRP45) are intended for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of 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**
The Healeon Float PRP devices (HFPRP15, HFPRP30, and HFPRP45) is a separator component and anticoagulant within a stoppered evacuated tube. It is intended for the collection of whole blood and for the safe and rapid preparation of autologous platelet rich plasma (PRP). The plasma separator is comprised of a biocompatible polymer blend of precise mass and configuration that is free to float while under centrifugal force but is locked in place when the centrifuge stops. This configuration drastically limits the potential for remixing of blood components.
The fundamental scientific technology, materials of construction, processing methods and mechanism of operation are similar between the subject and predicate devices. All devices are provided sterile and are designed to concentrate and aid in separation of a starting source material (blood) by density through the use of a centrifuge. All devices are made of medical grade polymers and elastomers suitable for use in medical devices, the predicate also includes (b) (4) gel. All devices include a single-use, disposable receptacle (i.e. concentrating device with separator) that is designed to accept a volume of blood, and then undergo centrifugal processing to obtain platelet concentrate (PRP). The table below summarizes the comparison of technological characteristics between the subject and predicate devices.
| | Predicate Device (BK170136, Healeon HD PRP) | Subject Device (Healeon Float PRP devices (HFPRP15, HFPRP30, and HFPRP45)) |
| --- | --- | --- |
| **Indications for Use** | The Healeon HD PRP 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 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 Healeon Float PRP devices (HFPRP15, HFPRP30 and HFPRP45) are intended for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of 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. |
| **Components** | - PRP Tube - Stopper - Separator component, gel - ACD-A Anticoagulant | - PRP Tube - Stopper - Separator component, float - ACD-A Anticoagulant |
| **Materials** | - Tube and Stopper: medical grade polymers and elastomers | - Tube and Stopper: medical grade polymers and elastomers - Separator Component: Polymer blend. |
003-02
{2}
| | - Separator Component: (b) (4) Gel - Anticoagulant: Acid Citrate Dextrose | - Anticoagulant: Acid Citrate Dextrose |
| --- | --- | --- |
| **Principle of Operation** | Separation of blood based on density | Same as predicate |
| **Method of Processing** | Centrifugation | Same as predicate |
| **Centrifuge Device** | General purpose centrifuge | Same as predicate |
| **Sterile** | Yes | Same as predicate |
| **Sizes** | 15mL and 30mL | 15mL, 30mL, 45mL |
### 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, the device is categorized as an externally communicating device, with limited exposure (contact < 24 hours) with blood path, indirect contact. Testing included cytotoxicity (per ISO 10993-5), skin sensitization (per ISO 10993-10), irritation (per ISO 10993-23), acute systemic toxicity, pyrogenicity (per ISO 10993-11), and hemocompatibility (per ISO 10993-4).
#### Sterilization Validation
A sterilization qualification using the (b) (4) method in compliance with (b) (4) was performed to validate a (b) (4) sterilization process for the Healeon Float PRP devices (HFPRP15, HFPRP30, and HFPRP45). Results demonstrated that the product is reliably sterilized to a (b) (4) sterility assurance level (SAL) using predetermined parameters. Bimini Health Tech intends to use this same procedure to increase sterilization efficiency, such as load capacity, configuration, or location post clearance.
#### Shelf-life and Transport
A transportation validation per ASTM D4169 and a packaging shelf-life validation per ISO 11607 was conducted using 2 year 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. To this end, this testing provided assurance that the device is sterile when placed in the market and will remain sterile, under the established storage and transport conditions, until the protective packaging is opened. This testing further demonstrates that the product will be kept without deterioration at the high level of cleanliness to minimize the risk of microbial contamination. Bimini Health Tech intends to use this same procedure to increase the product shelf life. The shelf-life claimed for the devices is one year.
#### Predicate Equivalency Evaluation
A study was conducted to compare platelet concentrates produced by the Healeon Float PRP devices (HFPRP15, HFPRP30, and HFPRP45) and those produced by the predicate. Parameters included acceptable platelet yield, platelet concentration, CBC values, pH, platelet activation, platelet aggregation, hypotonic stress response, and bone graft handling
003-03
{3}
characteristics. This evaluation demonstrated that the platelet concentrates obtained by the Healeon Float PRP devices (HFPRP15, HFPRP30, and HFPRP45) is substantially equivalent to those of the predicate.
Additionally, the Healeon Float PRP devices (HFPRP15, HFPRP30, and HFPRP45) and the predicate possess the same indications, device class, device code, principles of operation, methods of processing, sterility assurance level, and equally biocompatibility for its purpose. The subject device offers a larger size to provide 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 Healeon Float PRP devices (HFPRP15, HFPRP30, and HFPRP45) therefore has been shown to be substantially equivalent to the predicate.
003-04
Predicate graph will load when search results are available.
Embedding visualization will load when search results are available.
PDF viewer will load when search results are available.
Loading panels...
Select an item from Submissions
Click any panel, subpart, regulation, product code, or device to see details here.
Section Matches
Results will appear here.
Product Code Matches
Results will appear here.
Special Control Matches
Results will appear here.
Loading collections...
Loading
My Alerts
You will receive email notifications based on the filters and frequency you set for each alert.
Sort by:
Create Alert
Search Filters
Agent Token
Create a read-only bearer token for Claude, ChatGPT, or other agents that can call HTTP APIs.
Copy this now. It will not be shown again.
Connected apps
Apps you authorized through browser sign-in. Disconnecting revokes their access immediately.
Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
