← Product Code [CAC](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC) · K942844 # LEVEL 1 BLOOD STREAM RECOVERY SYSTEM (K942844) _Level 1 Technologies, Inc. · CAC · Apr 26, 1996 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K942844 ## Device Facts - **Applicant:** Level 1 Technologies, Inc. - **Product Code:** [CAC](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC.md) - **Decision Date:** Apr 26, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5830 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic ## Indications for 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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. - 2 - --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K942844](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K942844) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com