(333 days)
To collect and infuse blood lost by a patient due to orthopaedic surgery
The Betatrans Orthopaedic Autotransfusion System consists of a stainless steel trocar and PVC wound drain available in 1/8", 3/16 and 1/4" ID sizes the line is connected to a PVC blood collection line with a universal Y connector and pinch clamp which connects to a 800ml PETG blood collection chamber with integral 260 micron gross clot pre-filter and either one or two female halves of a patented"Duxbury Connector" bonded to the bottom of the chamber. one or two preconnected sterile 800ml blood bag. A bag contains at it's top a male "Duxbury Connector" and a transfusion port. A safety cap covers the transfusion port and is available for use as a cover for the male connector once separated from the collection chamber. The bags male and female connector are shipped in a locked position. In this position a valve is located in each half of the connector remains closed, preventing fluid or air to pass in either direction. A vacuum tube assembly consisting of a 0.45 micron bacterial air filter, one way outflow valve, pinch clamp, and a five in one suction connector for venting of the chamber, as air is displaced by incoming blood. A vent cap assembly with a tethered screw on cap, one way inflow valve and a 0.45 micron filter to allow venting of the chamber during transfer of blood to the blood bag(s).
Here's an analysis of the provided text regarding the Betatrans™ Orthopaedic Autotransfusion System, focusing on acceptance criteria and supporting studies.
Based on the provided text, the device's acceptance criteria primarily revolve around safety, biocompatibility, and functional performance as an autotransfusion system. The study described focuses on demonstrating conformance to established standards and equivalence to predicate devices rather than a comparative clinical effectiveness study with human readers or specific numeric performance targets against a disease or condition.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from study description) | Reported Device Performance |
|---|---|
| Biocompatibility | |
| - Special Immersion Test (Duxbury Valve) | No growth of challenge organism in connector. |
| - Bacterial Endotoxin Testing | Less than 0.03 EU/ml or less than 1.2 EU/Device found. |
| - MEM Elution L929 Cytotoxicity Test | No reaction greater than grade 2. |
| - U.S.P. Intracutaneous Test | Meets the requirement of the test. No mean skin reactions greater than a difference of 1.0 from the blank. |
| - U.S.P. Systemic Injection Test | Meets the requirement of the test. No significant difference from the test group to the control group. |
| - Ames Mutagenicity Test | Not mutagenic against any of the tester strains either directly or following metabolic activation with S9(M+). |
| - Guinea Pig Maximization (Kligman) Test | Skin reactions were not observed in the guinea pigs treated with the BetaTrans™ Unit. |
| - U.S.P. Subchronic Toxicity Test | Did not show any discernible toxicity in the systemic portion of the study after 33 days. |
| - USP Class VI for various components | Negative (for Y-connector, Blood Line, Gross Blood Filter, Duxbury Connector, Blood Bags, and Vernay Duckbill). |
| Functional Performance (Physical) | |
| - Leak Test (200mmHg Pressure) | No leaks were observed. |
| - Leak Test (100mmHg Vacuum) | No leaks were observed. |
| - Particulates | Meets AAMI AT6 Standard. |
| Hemocompatibility | All blood and blood cell parameters pretest were equivalent post test and to the predicate device. |
| Sterilization | Performed using AAMI's "Guide to Industrial Sterilization", 1991: Method 3. and gamma irradiation. Performance confirmed through microbial challenge to the product and connector. (Specific microbial challenge results beyond "no growth" for special immersion test are not detailed in the summary). |
| Labeling Conformance | Conforms to 15th Edition AABB Standard. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample sizes for the biocompatibility tests (e.g., number of animals for in vivo tests, number of units for in vitro tests, number of blood samples for hemocompatibility).
- Provenance: The studies seem to be laboratory-based and conducted specifically for this device's submission.
- Hemocompatibility: Mentions "aged, pooled human blood" for comparison with predicate devices. This indicates human-derived blood samples, but the source (country, donor characteristics) is not specified. It's likely a controlled laboratory study rather than clinical data.
- Animal tests: Guinea pigs are mentioned for Kligman Test.
- In vitro tests: L929 cytotoxicity, Ames mutagenicity, bacterial endotoxin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the studies described are technical performance and safety studies (biocompatibility, physical performance, sterilization efficacy) of a medical device, not diagnostic studies where human experts establish ground truth for a test set. There were no "experts" establishing a "ground truth" in the traditional sense for these types of engineering and laboratory tests.
4. Adjudication Method for the Test Set
This is not applicable for the type of tests described. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or diagnostic performance evaluations when multiple human readers are interpreting data. The tests here involve objective measurements against predefined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
This is not applicable. The Betatrans™ Orthopaedic Autotransfusion System is a physical medical device (an autotransfusion system), not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not applicable. As mentioned above, this is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the tests performed can be characterized as:
- Reference Standards/Predefined Criteria: For biocompatibility, USP (U.S. Pharmacopeia) standards, ISO 10993-1:1992(E) (modified), and AAMI (Association for the Advancement of Medical Instrumentation) AT6 standards served as the "ground truth" to determine acceptance or rejection.
- Predicate Device Equivalence: For hemocompatibility, the "ground truth" was a comparison of blood parameters to the same parameters measured with predicate devices, demonstrating equivalence.
- Controlled Laboratory Conditions: For physical performance (leak tests, particulates), the ground truth was the absence of leaks or conformance to AAMI AT6 standard under controlled testing conditions.
- Microbial Challenge: For sterilization efficacy, the ground truth was the absence of microbial growth following challenge tests.
8. The Sample Size for the Training Set
This is not applicable. The Betatrans™ system is a physical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
§ 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).