(680 days)
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None
No
The summary describes a blood recovery system using vacuum/air flow and standard components, with no mention of AI, ML, image processing, or data analysis that would suggest AI/ML technology.
No
The device is described as a system for collecting shed blood for autotransfusion, which is a collection and processing function, not a direct therapeutic intervention.
No
Explanation: The device is described as a "BloodStream Recovery System" for the "Collection of patient's shed blood for Autotransfusion." This indicates a therapeutic or collection purpose, not a diagnostic one. No diagnostic terms like 'detect,' 'diagnose,' 'measure,' or 'analyze' are used in relation to patient health.
No
The device description explicitly mentions "fluid path components," "bio-compatible plastics," and "sterile fluid path," indicating physical hardware components are part of the system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Collection of patient's shed blood for Autotranstusion." This describes a process of collecting blood from a patient for reinfusion back into the same patient. This is a therapeutic procedure, not a diagnostic test performed in vitro (outside the body) on a sample to diagnose a condition.
- Device Description: The description focuses on the mechanical operation (vacuum/air flow) and the materials used for the fluid path. It describes a system for handling blood within the patient's treatment process, not for analyzing a sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (proteins, genes, metabolites, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is clearly designed for a blood collection and processing procedure for autotransfusion, which is a medical treatment, not a diagnostic test.
N/A
Intended Use / Indications for Use
Collection of patient's shed blood for Autotranstusion
Product codes
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Device Description
The Level 1 BloodStream Recovery System 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 Aspiration tubing Collection Chamber Chamber Cap Filter Filter Frame Pump Tubing Male Luer Female Luer Filter Bag Filter Mesh Bag Tubing Spike Port Anti-Cogulant Tubing Bag Spike
PVC, Acrylic, or Polyethylene PVC or Polyethylene/PVC PET. Polyethylene or Acrylic PET or Polyethylene Polyester/polyurethane Polypropylene PVC Acrylic Co-polvester PVC Polyester PVC PVC PVC 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY 2
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 Autotranstusion 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 Aspiration tubing Collection Chamber Chamber Cap Filter Filter Frame Pump Tubing Male Luer Female Luer Filter Bag Filter Mesh Bag Tubing Spike Port Anti-Cogulant Tubing Bag Spike
PVC, Acrylic, or Polyethylene PVC or Polyethylene/PVC PET. Polyethylene or Acrylic PET or Polyethylene Polyester/polyurethane Polypropylene PVC Acrylic Co-polvester PVC Polyester PVC PVC PVC 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.