LEVEL 1 BLOOD STREAM RECOVERY SYSTEM

K942844 · Level 1 Technologies, Inc. · CAC · Apr 26, 1996 · Anesthesiology

Device Facts

• Record ID: K942844
• Device Name: LEVEL 1 BLOOD STREAM RECOVERY SYSTEM
• Applicant: Level 1 Technologies, Inc.
• Product Code: CAC · Anesthesiology
• Decision Date: Apr 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5830
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Collection of patient's shed blood for Autotransfusion.

Device Story

System collects shed blood for autotransfusion; utilizes vacuum/air flow principle of operation; components include aspiration handtool, tubing, collection chamber, and filter; used in clinical settings; operated by healthcare professionals; output is collected, filtered blood for reinfusion; benefits patient by facilitating autologous blood transfusion; fluid path components are sterile and biocompatible.

Clinical Evidence

No clinical data; safety and effectiveness established via predicate device comparison and bench testing of biocompatibility (USP Class III/VI).

Technological Characteristics

Materials: PVC, Acrylic, Polyethylene, PET, Polypropylene, Polyester, Polyurethane, ABS. Fluid path components meet USP Class VI/III toxicity standards. Operation: Vacuum/air flow. Sterilization: Sterile fluid path. Manufacturing: GMP compliant, Class 100,000 clean room assembly.

Indications for Use

Indicated for patients requiring autotransfusion via collection of shed blood.

Regulatory Classification

Identification

An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.

Submission Summary (Full Text)

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2 510(k) SUMMARY K942844

510(k) Submission, continued: Level 1 BloodStream Recovery System APR 30 1996

## g. Summary of Safety and Effectiveness

Collection of patient's shed blood for Autotransfusion has been proven safe and effective by the predicate devices cited. The Level 1 BloodStream Recovery System is safe and effective as it employs the same method of operation (vacuum/air flow) for the same indicated use. Construction of fluid path components is of bio-compatible plastics as in the predicate devices, and as in those devices, the fluid path is sterile. The Level 1 BloodStream Recovery System may be used with the same anti-coagulant and standard blood administration sets currently used with those devices.

Patient safety is assured through the use of non-toxic materials which meet USP Class III or Class VI toxicity tests.

| Aspiration handtool | PVC, Acrylic, or Polyethylene |
| --- | --- |
| Aspiration tubing | PVC or Polyethylene/PVC |
| Collection Chamber | PET, Polyethylene or Acrylic |
| Chamber Cap | PET or Polyethylene |
| Filter | Polyester/polyurethane |
| Filter Frame | Polypropylene |
| Pump Tubing | PVC |
| Male Luer | Acrylic |
| Female Luer | Co-polyester |
| Filter Bag | PVC |
| Filter Mesh | Polyester |
| Bag Tubing | PVC |
| Spike Port | PVC |
| Anti-Cogulant Tubing | PVC |
| Bag Spike | ABS |

All product will be manufactured as per GMP.s.
All fluid path components are to be assembled in a Class 100,000 clean room or better.

CONFIDENTIAL
LEVEL 1 TECHNOLOGIES INC.

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