(680 days)
Collection of patient's shed blood for Autotranstusion
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.
This 510(k) summary for the Level 1 BloodStream Recovery System (K942844) lacks the detailed study information required to complete your request. The document is a pre-amendment 510(k) and primarily focuses on demonstrating substantial equivalence to predicate devices based on the same method of operation, indicated use, and biocompatible materials. It does not contain information about specific performance studies, acceptance criteria, sample sizes, expert ground truth, or MRMC studies.
Therefore, most of the requested fields cannot be filled.
Here's an attempt to address what little information is available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness: Proven safe and effective by predicate devices. | Safety and Effectiveness: Employs the same method of operation (vacuum/air flow) for the same indicated use, demonstrating substantial equivalence to predicate devices. Construction of fluid path components is of bio-compatible plastics, and the fluid path is sterile. |
| Material Biocompatibility: Non-toxic materials meeting USP Class III or Class VI toxicity tests. | Material Biocompatibility: Materials listed (PVC, Acrylic, Polyethylene, PET, Polyester/polyurethane, Polypropylene, Co-polyester, ABS) are stated to meet USP Class III or Class VI toxicity tests. |
| Sterilization: Fluid path components sterile. | Sterilization: Fluid path stated to be sterile. |
| Manufacturing Quality: Manufactured as per GMPs. | Manufacturing Quality: All product will be manufactured as per GMPs. All fluid path components to be assembled in a Class 100,000 clean room or better. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document relies on the established safety and effectiveness of predicate devices rather than reporting specific test set data for the Level 1 BloodStream Recovery System itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. This document does not describe a test set with ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Not provided. This is a medical device (blood recovery system), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a hardware medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" here is the established safety and effectiveness of predicate blood recovery devices through historical clinical use and regulatory approval.
8. The sample size for the training set
- Not applicable/Not provided. This type of information is typically for AI/ML models, not for hardware medical devices like this in this context.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
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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.
§ 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).