nSTRIDE® PRP Concentration System
Device Facts
| Record ID | BK230844 |
|---|---|
| Device Name | nSTRIDE® PRP Concentration System |
| Applicant | Biomet Biologics, Inc. Warsaw, IN |
| Product Code | ORG · Hematology |
| Decision Date | Aug 9, 2023 |
| Decision | SESE |
| Regulation | 21 CFR 864.9245 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The nSTRIDE® PRP Concentration System is intended for point of care processing of autologous blood for bone graft handling applications.
Device Story
System processes anticoagulated peripheral blood to produce Platelet-Rich Plasma (PRP) at point of care. Input: 60mL anticoagulated whole blood. Process: two-stage centrifugation using GPS III Separator to isolate cell fractions by density, followed by nSTRIDE PRP Concentrator using dehydrating beads to remove excess water. Output: 6mL concentrated PRP (≥250,000 platelets/µL, pH >6.2). Used by clinicians in orthopedic surgical settings. Output mixed with bone graft material to improve handling/cohesion. Benefits: facilitates bone graft application without hindering coagulation cascade or platelet function.
Clinical Evidence
Bench testing only. No clinical or animal testing performed. Performance validated via non-clinical testing: platelet concentration, output pH, output volume, platelet clotting ability, bone graft handling, biocompatibility (ISO 10993-1), sterilization validation, and packaging integrity.
Technological Characteristics
Materials: polymeric medical grade plastics. Principle: density-based separation via centrifugation and dehydration via beads. Energy: centrifuge-driven. Sterilization: gamma irradiation. Shelf life: 5 years (devices), 3 years (ACD-A). Connectivity: none (standalone).
Indications for Use
Indicated 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.
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
- GPS® III Platelet Concentrate Separation Kit with ACD-A (BK070026)
Reference Devices
- Plasmax® Plus Plasma Concentrator with GPS® III Platelet Concentrate Separation Kit with ACD-A (BK050016)
Submission Summary (Full Text)
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## 510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the *nSTRIDE® PRP Concentration System* 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s,' issued on September 13, 2019.
| **Sponsor** | Biomet Biologics, Inc. 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581, USA Establishment Registration Number: 1825034 |
| --- | --- |
| **Contact Person** | Eduardo Mendoza Villarroel Regulatory Affairs Project Manager Phone: (b) (6) Email: (b) (6) @zimmerbiomet.com |
| **Date Prepared** | May 11, 2023 |
| **Subject Device** | **Trade Name:***nSTRIDE® PRP Concentration System* **Common Name:** Automated blood cell separator **Product Code:** ORG **Regulatory Class:** II **Classification Name:** - 21 CFR 864.9245 – Platelet and Plasma Separator for Bone Graft Handling |
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Predicate and Reference Device(s)
| 510(k) Number | Device Name | Manufacturer |
| --- | --- | --- |
| BK070026 (Predicate) | GPS® III Platelet Concentrate Separation Kit with ACD-A | Biomet Biologics, Inc. 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581, USA |
| BK050016 (Reference) | Plasmax® Plus Plasma Concentrator with GPS® III Platelet Concentrate Separation Kit with ACD-A (Previously known as Fibrostik® Plasma Concentrator) | Biomet Biologics, Inc. 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581, USA |
Purpose and Device Description
The purpose of this submission is to obtain clearance for the subject device, *nSTRIDE® PRP Concentration System*.
The *nSTRIDE® PRP Concentration System* is intended to produce Platelet-Rich Plasma (PRP) from a small sample of peripheral blood at the patient's point of care. The PRP contains a concentration of platelets above baseline whole blood. This PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
The PRP is produced through processing anticoagulated whole blood through two sterile single-use and multi-compartmental devices:
# GPS III Separator Device with ACD-A
The GPS III Separator device with ACD-A (Anticoagulant Citrate Dextrose Solution, Solution A, USP) aids separation of the patient's own blood components by density through the use of a Zimmer Biomet centrifuge.
# nSTRIDE® PRP Concentrator
The nSTRIDE PRP Concentrator aids in the concentration of the patient's own plasma proteins by centrifugation utilizing a Zimmer Biomet centrifuge. Excess water is removed from the platelet-rich-plasma (PRP) with dehydrating beads to create PRP.
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The devices are not made with natural rubber latex. The materials used for the GPS III Separator and nSTRIDE Concentrator consist of polymers and elastomers suitable for use in medical devices.
## Output Characterization
The output (concentrated PRP) obtained by using the *nSTRIDE PRP Concentration System* retains the required characteristics of PRP in a reduced volume (at least 250,000 platelets per microliter and pH above 6.2).
Similarly, bone graft handling testing demonstrated the ability to clot via coagulation cascade remains unchanged when concentrating PRP with the *nSTRIDE® PRP Concentration System*.
## Intended Use and Indications for Use
| Intended Use | The *nSTRIDE® PRP Concentration System* is intended for point of care processing of autologous blood for bone graft handling applications. |
| --- | --- |
| Indications for Use | The *nSTRIDE® PRP Concentration System* with GPS® III Separator device with ACD-A is indicated 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. |
## Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following characteristics compared to the predicate and reference devices:
- Intended Use: Equivalent to predicate and reference devices.
- Indications for Use: Equivalent to predicate and reference devices.
- Materials: Identical to predicate and reference devices.
- Design Features: Equivalent to predicate and reference devices.
- Sterilization method: Identical to predicate and reference devices.
- Packaging: The subject device has equivalent packaging to predicate and reference devices.
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# Technological comparison
| Property or Characteristic | Subject Device nSTRIDE® PRP Concentration System | Predicate Device GPS® III Platelet Concentrate Separation Kit with ACD-A BK070026 | Reference Device Plasmax® Plus Plasma Concentrator with GPS®III Platelet Concentrate Separation Kit with ACD-A BK050016 | Equivalency |
| --- | --- | --- | --- | --- |
| Representative Device Image | GPS III Separator: nSTRIDE PRP Concentrator: | GPS III Separator: | GPS III Separator: Plasmax Plus Plasma Concentrator: | GPS III Separator is the same in subject, predicate and reference devices. Concentrator devices are identical except for: - Mass of the beads - Concentrated output Differences between subject and reference devices do not raise any different questions of safety and effectiveness. |
| | ORG | ORG* | ORG* | Identical to predicate and reference devices *Assigned as per FDA suggestion |
| Product Code | | | | |
| Regulation Number | 21 CFR 864.9245 | 21 CFR 864.9245* | 21 CFR 864.9245* | Identical to predicate and reference devices |
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| | | | | *Assigned as per FDA suggestion |
| --- | --- | --- | --- | --- |
| **Principle Operation** | - Isolate targeted cell fractions by density utilizing centrifugation - Concentration via dehydrating beads | - Isolate targeted cell fractions by density utilizing centrifugation | - Isolate targeted cell fractions by density utilizing centrifugation - Concentration via dehydrating beads | Identical to Primary and Reference Devices |
| **Blood Component separation method** | Centrifugation | Centrifugation | Centrifugation | Identical to predicate and reference devices |
| **Processing Fluid and Approximate Volumes** | GPS III Separator: Anticoagulated Whole Blood: 60mL | GPS III Separator: Anticoagulated Whole Blood: 60mL | GPS III Separator: Anticoagulated Whole Blood: 60mL | Identical processing fluid and approximate volume for the GSP III Separator device in subject, predicate and reference devices |
| | nSTRIDE PRP Concentrator: PRP: 6 mL | | Plasmax Plus Plasma Concentrator: Platelet Poor Plasma (PPP): 25 mL | Differences between subject and reference do not raise any different questions of safety and effectiveness |
| **Materials** | Polymeric Medical Grade Plastics | Polymeric Medical Grade Plastics | Polymeric Medical Grade Plastics | Identical to predicate and reference devices |
| **Clotting Ability / Platelet Function** | Processing autologous whole blood through the nSTRIDE PRP Concentration System does not hinder the blood clotting mechanism via the coagulation cascade. | Processing autologous whole blood through the GPS III Platelet Concentrate Separation Kit with ACD-A does not hinder the blood clotting mechanism via the coagulation cascade. | Plasmax Plus Plasma: Final Output: Platelet Poor Plasma Concentrate (PPPc) Clotting Ability / Platelet Function: Non-Applicable | Identical to predicate |
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| **Bone Graft Handling** | Processing autologous whole blood through the *nSTRIDE PRP Concentration System* does not hinder the formation of cohesive logs when mixed with bone graft material | Processing autologous whole blood through the *GPS III Platelet Concentrate Separation Kit with ACD-A* does not hinder the formation of cohesive logs when mixed with bone graft material | Plasmax Plus Plasma: Final Output: PPPc Bone Graft Handling: Non-Applicable | Identical to predicate |
| --- | --- | --- | --- | --- |
| **Biocompatibility** | Meets ISO 10993-1 requirements for | Meets ISO 10993-1 requirements for | Meets ISO 10993-1 requirements for | Identical to predicate and reference devices |
| **Packaging** | Packaged in industry – standard gamma compatible sterile barrier materials using industry-standard package sealing processes, and then into a retail paperboard carton. | Packaged in industry – standard gamma compatible sterile barrier materials using industry-standard package sealing processes, and then into a retail paperboard carton. | Packaged in industry – standard gamma compatible sterile barrier materials using industry-standard package sealing processes, and then into a retail paperboard carton. | Identical to predicate and reference devices |
| **Anatomy** | Orthopedic surgical site as deemed necessary by the clinical use requirements | Orthopedic surgical site as deemed necessary by the clinical use requirements | Orthopedic surgical site as deemed necessary by the clinical use requirements | Identical to predicate and reference devices |
| **Sterilization** | Devices: Sterile, Gamma irradiation | Devices: Sterile, Gamma irradiation | Devices: Sterile, Gamma irradiation | Identical to predicate and reference devices |
| **Shelf Life** | 5 years – Devices 3 years – ACD-A Labeled shelf life does not exceed expiration date of earliest expiring component | 5 years – Devices 3 years – ACD-A Labeled shelf life does not exceed expiration date of earliest expiring component | 5 years – Devices 3 years – ACD-A Labeled shelf life does not exceed expiration date of earliest expiring component | Identical to predicate and reference devices |
| **Anti-Coagulant** | ACD-A | ACD-A | ACD-A | Identical to predicate and reference devices |
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**Summary of Performance Data to Support Substantial Equivalence (Nonclinical and/or Clinical)**
**Non-Clinical Tests:**
All necessary non-Clinical testing was conducted to support and establish substantial equivalence, in terms of safety and performance, between subject and identified predicate and reference devices:
- Platelet Clotting
- Bone Graft Handling
- Platelet Concentration
- Output pH
- Output Volume
- Biocompatibility Evaluation
- Sterilization Validation
- Packaging Testing
**Clinical Tests:**
- No clinical testing was performed. Clinical data and conclusions were deemed not necessary to establish substantial equivalence between the subject device, *nSTRIDE® PRP Concentration System*, and the identified predicate.
**Animal Testing**
- No animal testing was performed. Animal data and conclusions were deemed not necessary to establish substantial equivalence between the subject device, *nSTRIDE® PRP Concentration System*, and the identified predicate.
**Substantial Equivalence Conclusion**
The proposed *nSTRIDE® PRP Concentration System* has equivalent intended use and indications for use to the predicate device. The proposed device has equivalent technological characteristics to the predicate and reference devices, and the information provided herein demonstrates that:
- any differences do not raise new questions of safety and effectiveness; and
- the proposed device is at least as safe and effective as the legally marketed predicate and reference devices.
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