COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM
Device Facts
| Record ID | K042473 |
|---|---|
| Device Name | COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM |
| Applicant | Cobe Cardiovascular, Inc. |
| Product Code | JQC · Clinical Chemistry |
| Decision Date | Nov 19, 2004 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 862.2050 |
| Device Class | Class 1 |
Indications for Use
The COBE® Angel Whole Blood Separation System is intended to be used at the patient's point-of-care for the safe and rapid preparation of platelet poor plasma and platelet rich plasma from a sample of whole blood. The plasma and concentrated platelets can be used for diagnostic tests.
Device Story
COBE Angel Whole Blood Separation System is a point-of-care centrifuge for preparing platelet-rich and platelet-poor plasma from whole blood. System includes hardware (centrifuge, roller pump, platelet sensor, valve assembly, touch screen) and single-use sterile processing sets with variable volume separation chambers. User collects blood via access kit; system processes sample by spinning; integrated platelet sensor detects separated components exiting chamber; sensor triggers valve assembly to route components into specific collection containers (whole blood, red blood cells, platelet-poor plasma, platelet-rich plasma). Output is used by clinicians for diagnostic testing. Device requires specific labeling warning that in vivo safety/effectiveness is not established.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Centrifuge-based blood separation system. Components: centrifuge well/lid, roller pump, platelet sensor, valve assembly, touch screen interface. Sterile, single-use processing set with variable volume separation chamber and non-pyrogenic fluid pathway. Operates via automated sensing and valve switching.
Indications for Use
Indicated for the preparation of platelet poor plasma and platelet rich plasma from whole blood samples for diagnostic testing at the point-of-care.
Regulatory Classification
Identification
General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.
Predicate Devices
- Medtronic Magellan™ Autologous Platelet Separator System (K021902)
Related Devices
- K994148 — 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM · Implant Innovations, Inc. · Feb 1, 2000
- K021902 — MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300 · Medtronic Vascular · Aug 12, 2002
- K021927 — PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM · Biomet, Inc. · Jul 12, 2002
- K991430 — SMARTPREP CENTRIFUGE SYSTEM · Harvest Technologies, LLC · May 28, 1999
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE
A. 510(k) Number: K042473
B. Manufacturer and Instrument Name: COBE Diagnostics, Inc., COBE Angel Whole Blood Separation System
C. Type of Test or Tests performed: Patient point-of-care preparation of platelet poor plasma and platelet rich plasma from a sample of whole blood.
D. System Descriptions:
1. Device Description:
The Angel System consists of a blood centrifugation device and two associated disposables: the Processing Set (single use) and the Whole Blood Access Kit.
2. Principles of Operation:
Whole blood collected either from the patient or a blood bag containing ACD anticoagulant is added to the whole blood compartment of the Processing Set. Upon initiation of the processing cycle, the blood is pumped from the whole blood chamber into the variable volume separation chamber where it is separated into RBCs, platelet poor plasma, and platelet rich plasma. The process involves a two-phase spin cycle consisting of a hard spin and a soft spin. Once the two-phase separation process is complete the machine slows the centrifuge and the process pump is reversed, allowing for collection of the various blood component layers.
3. Modes of Operation: N/A
4. Specimen Identification:
Labels are used to identify collected whole blood and separated components.
5. Specimen Sampling and Handling:
The Angel Whole Blood Separation Processing Set consists of pre-connected variable volume separation chamber, a tubing set with a platelet sensor/valve assembly, and a three-compartment reservoir bag for the collection of blood products.
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6. Calibration:
The centrifuge is factory calibrated. Upon power-up, the system will perform an automatic self test. At this time, the valve assembly will also calibrate and reposition itself.
7. Quality Control:
N/A
8. Software:
FDA has reviewed the applicant’s Hazard Analysis and software
Documentation: Yes ☑ or No ☐
E. Regulatory Information:
1. Regulation Section:
21 CFR 862.2050, General purpose laboratory equipment labeled or promoted for a specific medical use and 880.5860, Syringe, piston.
2. Classification:
Class II
3. Product Code:
FMF, JQC
4. Panel:
80 General Hospital, 75 Chemistry
F. Intended Use:
1. Indication(s) for Use:
The COBE Angel Whole Blood Separation System is intended to be used at the patient’s point-of-care for the safe and rapid preparation of platelet poor plasma and platelet rich plasma from a sample of whole blood. The plasma and concentrated platelets can be used for diagnostic tests.
2. Special Condition for use Statement(s):
Components separated from whole blood cannot be used in vivo.
G. Substantial Equivalence Information:
1. Predicate device name(s) and 510(k) numbers:
Medtronic Magellan Autologous Platelet Separator System (K021902)
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2. Comparison with Predicate Device:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Principle of Operation | Separation based on density of liquids | Same |
| Blood Component separation Method | Centrifuge | Same |
| Usage | Single | Same |
| Differences | | |
| Item | Device | Predicate |
| Intended Use | To be used at the patient’s point-of-care for the safe and rapid preparation of platelet poor plasma and platelet rich plasma from a sample of whole blood. | To be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet rich plasma from a small sample of blood. The plasma and concentrated platelets can be used for diagnostic tests. |
| Processing Volume | 40 to 180 cc/cycle with one cycle/processing set (min/max processing volume/set: 40-180 cc) | 30 to 60 cc/cycle with three cycles/processing set (min/max processing volume/set: 30-180 cc) |
| PRP Collection | 20 cc syringe | 10 cc syringe |
| PPP Collection | Automatically collected into a separate compartment | Automatically collected into RBC syringe, or can be collected in a separate syringe. |
H. Standard/Guidance Document Referenced (if applicable)
1. IEC 60601-1: 1988, A1:1991, A2:1995, and Corrigendum: 1995, Medical electrical Equipment-Part 1: General Requirements for Safety
2. IEC 60601-1-2:2002, Medical electrical Equipment-Part 1-2: General Requirements for Safety-Collateral Standard, Electromagnetic Compatibility-Requirements and Tests
3. ISO 10993-1:2003, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing
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4. ANSI/AAMI/ISO 11135:1994, Medical Devices-Validation and Routine Control of Ethylene Oxide Sterilization
5. ANSI/AAMI/ISO 10993-7:1995, Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals
I. Performance Characteristics:
In Vitro testing was conducted to verify the performance of the Angel System compared to the Medtronic Magellan Autologous Platelet Separator. Platelet count and viability were measured from platelet rich plasma generated in both systems after processing fresh human blood.
The PRP platelet concentration was calculated as the number of platelets times the initial baseline count. These parameters were compared at minimum and maximum processing volumes as well as overall performance. The measurement of each parameter for each separation system was presented in tabular for in the submission.
Summary of Results:
1. There is no statistically significant difference between platelet counts and viability of the PRP produced at the minimum volume specifications of the Angel System vs. the Magellan System.
2. There is no statistically significant difference between platelet count and viability of the PRP produced at the maximum volume specifications of the Angel System and the Magellan System.
3. There is no statistically significant difference between platelet counts and viability of the PRP produced at any of the volumes tested (30ml, 40ml, and 60ml) on the Angel System and the Magellan System.
Conclusions:
No statistically significant difference was found between platelet viability and platelet yield of platelet rich plasma processed by the Angel System versus the Magellan System.
1. Analytical Performance:
a. Accuracy: N/A
b. Precision/Reproducibility: N/A
c. Linearity: N/A
d. Carryover:
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N/A
e. Interfering Substances:
N/A
2. Other Supportive Instrument Performance Data Not Covered Above:
J. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
