BK251157 · B.T.I. Biotechnology Institute, S.L. Miñano (Álava), Spain · ORG · Oct 3, 2025 · Hematology
Device Facts
Record ID
BK251157
Device Name
ENDORET® Kit
Applicant
B.T.I. Biotechnology Institute, S.L. Miñano (Álava), Spain
Product Code
ORG · Hematology
Decision Date
Oct 3, 2025
Decision
SESE
Regulation
21 CFR 864.9245
Device Class
Class 2
Indications for Use
The ENDORET® 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.
Device Story
ENDORET® Kit facilitates point-of-care preparation of autologous platelet-rich-plasma (PRP); utilizes vacuum-based blood collection and centrifugation to separate blood components by density; includes collection tubes, needles, plasma transfer device, fractionation tubes, and activator agent. Healthcare professionals operate the system; PRP output is mixed with bone graft material to improve handling for bony defect applications. Benefits include rapid, safe autologous PRP preparation. Device components are medical-grade polymers, elastomers, rubbers, and stainless steel.
Clinical Evidence
No clinical data were included in this submission. Substantial equivalence supported by bench testing, including sterilization validation (ISO 11137-1, ISO 11137-2, ISO 17665-1), biocompatibility (ISO 10993 series), sterile barrier/shelf-life validation (ISO 11607-1, ASTM standards), and comparative performance testing of PRP parameters (platelet concentration, yield, pH, aggregation, activation, and clot integrity).
Technological Characteristics
Materials: medical grade polymers, elastomers, rubbers, stainless steel. Principle: density-based blood fractionation via centrifugation. Energy: external centrifuge (sold separately). Connectivity: none. Sterilization: irradiation, ethylene oxide, or autoclave (SAL 10⁻⁶). Shelf-life: 18 months. Standards: ISO 11137-1/2, ISO 17665-1, ISO 10993-4/5/10/11, ISO 11607-1, ASTM F88, F1886, F1929, F1140, F2096.
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.”
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# 510(k) SUMMARY – BK251157
## 1. SUBMITTER INFORMATION
| Name and address: | B.T.I. Biotechnology Institute, S.L. Parque Tecnológico de Álava C/Leonardo Da Vinci 14 01510 Miñano (Álava), Spain |
| --- | --- |
| Phone: | (+34) 945 297 030 |
| Fax: | (+34) 945 297 031 |
| Contact person: | David Fernández, Regulatory Manager |
| Date prepared: | September 18, 2025 |
## 2. DEVICE NAME AND CLASSIFICATION
| Name of device: | ENDORET® Kit |
| --- | --- |
| Regulation Number: | 21 CFR 864.9245 |
| Regulation Description: | Automated blood cell separator |
| Regulatory Class: | Class II |
| Product Code: | ORG |
| Classification Panel: | Hematology |
## 3. PREDICATE AND REFERENCE DEVICES
Primary predicate device:
- BK150294 ENDORET® Kit, B.T.I. Biotechnology Institute, S.L.
Reference device:
- BK130049 ENDORET® Kit, B.T.I. Biotechnology Institute, S.L.
## 4. INDICATIONS FOR USE
The ENDORET® 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.
## 5. DEVICE DESCRIPTION
The ENDORET® Kit includes sterile, single use components to draw blood by vacuum from at a patient’s point-of-care and separate the blood components by centrifugation to create a platelet-rich plasma (PRP) output, that is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. The ENDORET® Kit is intended to be used under the supervision of a healthcare professional.
The ENDORET® kit includes blood collection tubes with anticoagulant, blood collection needles, Plasma Transfer Device to collect the PRP fraction in sterile fractionation tubes, and an activator agent that is added to the PRP prior to its application. This ENDORET® Kit includes modified or additional components.
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The materials of the ENDORET® Kit components are medical grade polymers, elastomers, rubbers and stainless steel suitable for use in medical devices. These components are provided sterile by irradiation, ethylene oxide or autoclave.
Additional equipment used for blood centrifugation is available and sold separately to the end-user in order to operate the device as intended.
## 6. PERFORMANCE DATA
Non-clinical testing information submitted in order to demonstrate substantial equivalence of the proposed device include:
- Sterilization validation for subject device components, provided sterile, to a sterility assurance level (SAL) of 10⁻⁶, according to ISO 11137-1, ISO 11137-2 and ISO 17665-1.
- Biocompatibility testing for new or modified device components, according to ISO 10993-4, ISO 10993-5, ISO 10993-10, and ISO10993-11.
- Sterile Barrier/Shelf-Life validation according to ISO 11607-1, ASTM F88, ASTM F1886/F1886M, ASTM 1929, ASTM F1140/F1140M and ASTM F2096.
- Comparative performance bench testing, including measurements of the following parameters:
- Platelet concentration factor
- Platelet yield
- pH
- platelet aggregation
- platelet activation
- clot integrity of the composite clot formed with bone graft material and PRP.
The results obtained in the study demonstrate substantial equivalence performance between the PRP obtained with subject and predicate ENDORET® kit.
No clinical data were included in this submission.
## 7. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE DISCUSSION
The proposed device is substantially equivalent in Indications for Use, operating principle and design to the primary predicate and reference devices identified above. Table 1 below compares the subject device to the predicate and reference devices indications for use and technological characteristics.
The subject ENDORET® Kit is substantially equivalent to the ENDORET® kit currently cleared in BK150294 in design, materials, manufacturing processes, sterilization and shelf-life. Reference device ENDORET® kit, cleared in BK130294 is in support of fractionation tube included in selected subject device models.
## 8. CONCLUSION
The subject device components have identical Indications for use and equivalent technological characteristics of primary predicate and reference device identified above. The subject device has identical intended use and shares basic design features with the already cleared ENDORET® Kits. The subject device, predicate device and reference device include components to obtain a Platelet-rich Plasma output by centrifugation. The subject device includes modified or additional components that do not raise new concerns of safety and effectiveness.
The information included in this submission demonstrates that the subject ENDORET® Kit is substantially equivalent to the identified predicate and reference devices.
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**Table 1.** Substantial Equivalence – Indications for use and technological characteristics comparison
| FEATURE | SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICE | ASSESSMENT |
| --- | --- | --- | --- | --- |
| **Name** | **ENDORET® Kit** | **ENDORET® Kit (BK150294)** | **ENDORET® Kit (BK130049)** | (not applicable) |
| **Product Classification** | Product Code: ORG Regulation No.: 21 CFR 864.9245 Device Class II | Product Code: ORG Regulation No.: 21 CFR 864.9245 Device Class II | Product Code: ORG Regulation No.: 21 CFR 864.9245 Device Class II | Identical. |
| **Indications for Use (STATEMENT)** | The ENDORET® 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 ENDORET® 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 system 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. | Identical to BK150294. Very similar wording is included in BK130049, for same intended use. |
| **Principle of operation** | Separation of blood fractions by density. | Separation of blood fractions by density. | Separation of blood fractions by density. | Identical. |
| **Blood Component separation method** | Centrifugation | Centrifugation | Centrifugation | Identical. |
| **Device components** | Blood collection tubes, anticoagulated. | Blood collection tubes, anticoagulated. | Blood collection tubes, anticoagulated. | Equivalent. Very similar or identical components included in predicate and reference device are included in subject device. Identical anticoagulant and activator agents are used in subject, predicate and reference devices. The additional components inclusion does not modify the intended use of the device. |
| | Blood collection set. | Blood collection set. | Blood collection set. | |
| | Plasma Transfer Device. | Plasma Transfer Device. | Plasma Transfer Device. | |
| | Fractionation tubes (evacuated and non-evacuated). | Fractionation tubes (non-evacuated). | Fractionation tubes (evacuated). | |
| | ENDORET Activator. | ENDORET Activator. | ENDORET Activator. | |
| | Syringe for Activator. | Syringe for Activator. | Syringe for Activator. | |
| **Sterilization** | Additional caps, connectors and needles. | - | - | Identical |
| | Device components provided sterile. | Device components provided sterile. | Device components provided sterile. | |
| **Shelf-life** | 18 months | 12 months | 12 months | Equivalent. Shelf-life analyses performed and provided in this submission support this extended shelf life for subject device. |
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