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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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 BiologicsModified Clotalyst® Clotalyst® Kit with GPS® III (Standard 60ml and Mini 30ml Platelet Separation Kits w/ACD-APredicate Clotalyst® Clotalyst® Accessory to GPS® III (Standard 60ml and Mini 30ml) Platelet Concentrate Separation Kits w/ACD-A
510(k) NumberNew 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 UsePreparation 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

YesSame
Swinging BucketYesSame
RefrigeratedNoSame

Automatic Decanting

NoSame

User Programmable

Yes, preset manufacturer program automatically displayed when switched on.Same
Speed Control0-3500 RPMSame

Centrifuge Capacity

Four disposable tubes (30ml)

Same

Imbalance Detector

YesSame

Test Results Summary Table

 Modified DevicesPredicate DevicesP-Value

Compressive Resistance (N=24)

  No significant difference
Time = 0Ave. res. 1.75 ± 1.28 lbfAve. res. 2.28  ± 2.04 lbfp=0.46
Time = 4 hrsAve. res. 2.02  ± 1.48 lbfAve. res. 1.56  ± 0.53 lbfp=0.33
Thrombin Activity (N=24)  No significant difference
Time = 0Ave. act. 46.2 ± 12.2 U/mlAve. act. 45.9 ± 14.1 U/mlp=0.93
Time = 4 hrsAve. act. 46.8 ± 10.7 U/mlAve. act. 40.6 ± 12.5 U/mlp=0.07
Clot Strength(N=24)  No significant difference
Time = 0Ave. 5,817 ± 2,380 dyne/cm²Ave. 5,333 ± 2,362 dyne/cm²p=0.48
Time = 4 hrsAve. 6,485 ± 1866 dyne/cm²Ave. 5,859 ± 2,035 dyne/cm²p=0.27

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