BK110040 Summary

510(k) Summary

Preparation Date:
November 8, 2011 

Applicant/Sponsor:
Biomet Biologics
P.O. Box 587
Warsaw, IN 46581

Contact Person:
Lonnie Witham
Regulatory Affairs Consultant
Biomet Biologics
lonnie.witham.external@biomet.com
Tel: 574-371-3095
Fax: 574-371-1187

Proprietary Name:
Clotalyst® Kit with GPS® III Platelet Separation Kit with ACD-A
Clotalyst® Kit with GPS® III Mini Platelet Separation Kit with ACD-A

Common Name:
Clotalyst® Kit with GPS® III Separator
Clotalyst® Kit with GPS® III Mini Separator

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
BK080004:  Clotalyst® and GPS® III Platelet Separation Kit w/ACD-A
Clotalyst® and GPS® III Mini Platelet Separation Kit w/ACD-A

Device Description:

Clotalyst™ Kits with GPS™ III Separators contain a Clotalyst™ Separator and GPS™ III Separator (Standard or Mini), Clotalyst™ Reagent, ACD-A Anticoagulant (30ml), and blood draw accessories. The system produces autologous platelet-rich plasma (PRP) and autologous serum. The kit includes sterile and non-sterile, single-use, disposable accessories that aid in blood draw and preparation of the PRP/PPP. Additional equipment used in the processing includes the Biomet Biologics Centrifuge that is available and sold separately.

Indications for Use (based on product code ORG):
The GPS® III Separator is designed to be used for the safe and rapid preparation of autologous platelet-rich plasma (PRP) / platelet poor plasma (PPP) from a small sample of the patient’s blood at the point of care. The PRP / PPP can be mixed with autograft and/or allograft prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements.

The Clotalyst® Kit is designed for the preparation of autologous serum that is to be mixed with the PRP and autograft or allograft for bone graft handling prior to application to the orthopedic surgical site.

Intended Use:
This device is intended for the preparation of autologous PRP and autologous serum at the point of care. The indications are similar to BK080004 Biomet Biologics Clotalyst® Kit w/ GPS® III Platelet Separation Kit with ACD-A cleared under Product Codes JQC & FMF, and BK100014 Circle Biologics Autologous Platelet Concentrator (APC™) System cleared under Product Code ORG.

Summary of Technologies:  
The intended use, design, materials and processing methods are similar to predicate devices (BK080004) to which substantial equivalence is claimed.
 

Non-Clinical Testing:
Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicate that bone graft materials hydrated with PRP, PPP and serum produced by the modified Clotalyst® Separator remains stable for up to 4 hours when stored at 26° C and demonstrated that the use of this device was found to improve cohesive strength of bone graft material based on in vitro cohesive strength bench testing, compared to bone graft materials hydrated with PRP and PPPand serum produced by the predicate Clotalyst® Separator; thus demonstrating substantial equivalence to the predicate device. In addition, the modified Clotalyst® Separator produced substantially equivalent serum without centrifugation and without use of the Clotalyst® Heater.

Clinical Testing:   
None provided as a basis for substantial equivalence.

Biomet® and all other trademarks herein are the sole property of Biomet, Inc., or its subsidiaries.

Predicate Device Comparison Table

Manufacturer Biomet Biologics	Modified Clotalyst® Clotalyst® Kit with GPS® III (Standard 60ml and Mini 30ml Platelet Separation Kits w/ACD-A	Predicate Clotalyst® Clotalyst® Accessory to GPS® III (Standard 60ml and Mini 30ml) Platelet Concentrate Separation Kits w/ACD-A
510(k) Number	New 510(k)	BK080004
Indications for Use	The GPS® III Separator is designed to be used for the safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of the patient’s blood at the point of care. The PRP can be mixed with autograft and allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements. The Clotalyst® Kit is designed for the preparation of autologous serum that is to be mixed with the PRP and autograft or allograft for bone graft handling prior to application to the orthopedic surgical site.	Same
Intended Use	Preparation of autologous PRP and autologous serum at point of care	Same
Classification Regulation	21 CFR 862.2050 (JQC) 21 CFR 862.5860 (FMF)	Same
Device Class	JQC (Class 1) FMF (Class 2)	Same
Technological Characteristics
Principle of Operation	Separation of autologous blood based on density, processing speed, and centrifuge equipment	Same
GPS® III Separator input/output	Input Volume 60 ML Total             30 ml Total 55 ml Whole Blood              27 ml Whole Blood 5 ml ACD-A              3 ml ACD-A Output Volume 6 ml PRP              3 ml PRP	Same
Clotalyst® Separator input/output	Input Volume 12 ml Total 11ml Whole Blood 1 ml ACD-A Output Volume 6 ml Autologous Serum	Same
	Modified Clotalyst®	Predicate Clotalyst®
Tube Dimensions     Port Locations & Cap Color	Clotalyst® Separator Tube Length: 3.5 inches Tube Diameter: 1.161 inches Port #1 Blue: Top end of tube    Port #2 Red: Top side of tube Port #3 Yellow: Bottom end of tube	Clotalyst® Separator Tube Length: 4 inches Tube Diameter: 1 inch Port #1 Blue: Top side of tube Port #2 Red: Top side of tube Port #3 Yellow: Top end of tube
Materials	GPS® III Separators medical grade polymers Clotalyst® Separator polymeric medical grade plastics borosilicate micro-spheres (glass) Beads acrylic and polyester Silicone (latex free)   Clotalyst® Reagent 66% v/v ethyl alcohol, U.S.P and 25mM Calcium Chloride, U.S.P. ACD-A Anticoagulant 30ml Citric acid (Anhydrous) U.S.P. Sodium Citrate (dihydrate) U.S.P. Dextrose (monohydrate) U.S.P. Water for injection (U.S.P.)	Same
Biocompatibility	Clotalyst® and GPS® III Separators Biocompatible materials per ISO 10993 Clotalyst® Reagent Non-cytotoxic Negligible irritant Non-toxic Hemocompatible	Same
Centrifuge Specifications
Centrifuge	Biomet Biologics Centrifuge Drucker Co. Model 755VES	Same
Micro-Processor Controlled	Yes	Same
Swinging Bucket	Yes	Same
Refrigerated	No	Same
Automatic Decanting	No	Same
User Programmable	Yes, preset manufacturer program automatically displayed when switched on.	Same
Speed Control	0-3500 RPM	Same
Centrifuge Capacity	Four disposable tubes (30ml)	Same
Imbalance Detector	Yes	Same

Test Results Summary Table

	Modified Devices	Predicate Devices	P-Value
Compressive Resistance (N=24)			No significant difference
Time = 0	Ave. res. 1.75 ± 1.28 lbf	Ave. res. 2.28  ± 2.04 lbf	p=0.46
Time = 4 hrs	Ave. res. 2.02  ± 1.48 lbf	Ave. res. 1.56  ± 0.53 lbf	p=0.33
Thrombin Activity (N=24)			No significant difference
Time = 0	Ave. act. 46.2 ± 12.2 U/ml	Ave. act. 45.9 ± 14.1 U/ml	p=0.93
Time = 4 hrs	Ave. act. 46.8 ± 10.7 U/ml	Ave. act. 40.6 ± 12.5 U/ml	p=0.07
Clot Strength(N=24)			No significant difference
Time = 0	Ave. 5,817 ± 2,380 dyne/cm²	Ave. 5,333 ± 2,362 dyne/cm²	p=0.48
Time = 4 hrs	Ave. 6,485 ± 1866 dyne/cm²	Ave. 5,859 ± 2,035 dyne/cm²	p=0.27

See the complete test report in the Performance Testing section of this submission.