(240 days)
- Evacuation and collection of blood and/or air from the mediastinal and pleural cavity in post-operative and trauma situations.
- Collection and reinfusion of autologous blood from the mediastinal and pleural cavity in post-operative and trauma situations.
- Prevention of fluid and/or air re-accumulation in the mediastinal and pleural cavity.
- Facilitation of complete lung re-expansion and restoration of normal breathing dynamics.
The Argyle® Aqua-Seal® All Purpose Autotransfusion Chest Drainage Unit (CDU) and Argyle Aqua-Seal" Evacuating Autotransfusion Accessory (Evacuating Accessory) is classified as an "Auto-transfusion Device", Class II (performance standards) under section 868.5830 of the Code of Federal Regulations (CFR).
The Argyle Aqua-Seal® Evacuating Autotransfusion Accessory is a sterile , single-use accessory to the Argyle Aqua-Seal® All Purpose Autotransfusion CDU and is intended to be used for the purpose of transferring the lost blood recovered by the CDU into a conventional blood bag. The blood can subsequently be re-infused back into the patient using a conventional pressure cuff or by gravity means.
The Argyle Aqua-Seal® Evacuating Autotransfusion Accessory consists of a conventional blood bag contained in an air-tight vessel. The input line from the bag passes through a sealed opening located at the top of the vessel. This line attaches to the spike port "Y" connector of the infusion tube assembly of the CDU. Transfer of blood from the CDU to the bag commences when a vacuum line is removed from the CDU and attached to the suction port of the Argyle® Aqua-Seal® Evacuating Autotransfusion Accessory. The pressure differential across the surface of the bag compels the bag to expand and thereby drawing blood from the CDU into the bag.
The Argyle Aqua-Seal® All Purpose Autotransfusion CDU incorporates the automatic negative pressure relief valve with a manual override feature whereas the Argyle Aqua-Seal® Continuous Autotransfusion CDU and the Atrium Multipurpose CDU utilize a strictly manual negative pressure relief valve.
While all three CDU's incorporate shut-off valves to prevent the loss of the water seal, the shut-off valves on the Argyle® Aqua-Seal® All Purpose Autotransfusion CDU and the Atrium Multipurpose CDU are flow sensing. Therefore, at low flow rates associated with the autotransfusion process, the valve "shuttles" and remains open to allow for improved blood collection times.
The provided text describes two devices, the Argyle® Aqua-Seal® Evacuating Autotransfusion Accessory and the Argyle® Aqua-Seal® All Purpose Autotransfusion Chest Drainage Unit (CDU), highlighting their substantial equivalence to existing predicate devices and stating that testing was performed to demonstrate their safety and effectiveness. However, it does not contain specific acceptance criteria, detailed performance results, or a study that rigorously proves the device meets those criteria in the way typically expected for an AI/ML device (e.g., performance metrics like sensitivity, specificity, AUC).
The document is a 510(k) summary for a medical device that is a physical product (an autotransfusion accessory). Therefore, many of the questions related to AI/ML device testing methodologies (like "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "training set size," etc.) are not applicable in this context.
Based on the available information, here's an attempt to answer the relevant questions as best as possible within the scope of the provided text:
Acceptance Criteria and Study for the Argyle® Aqua-Seal® Evacuating Autotransfusion Accessory and All Purpose Autotransfusion Chest Drainage Unit
This submission is for a medical device (autotransfusion system), not an AI/ML device. Therefore, the acceptance criteria and study detailed differ significantly from those typically used for software-based diagnostic tools. The document indicates that testing was performed to ensure compliance with relevant standards and demonstrate safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific quantitative acceptance criteria or detailed performance metrics in a tabular format. Instead, it broadly states that testing was conducted to ensure compliance with established standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Argyle® Aqua-Seal® Evacuating Autotransfusion Accessory: | |
| Compliance with Applicable Blood Handling Requirements | Undergone testing to ensure that the device meets the applicable blood handling requirements outlined in the American National Standards Institute (ANSI) / Association for the Advancement of Medical Instrumentation (AAMI) Standard for Autologous devices. |
| Biocompatibility | Biocompatibility testing in accordance with ISO 10993 requirements has been done. |
| Performance under Simulated Conditions of Use | Performance testing under simulated conditions of use has been done. |
| Overall Conclusion (for Accessory): | Results of all testing demonstrate the safety and effectiveness of the Argyle Aqua-Seal® Evacuating Autotransfusion Accessory for its intended use. |
| Argyle® Aqua-Seal® All Purpose Autotransfusion Chest Drainage Unit: | |
| Compliance with Applicable Blood Handling Requirements (with new features) | Undergone testing to ensure that the device meets the applicable blood handling requirements outlined in the American National Standards Institute (ANSI) / Association for the Advancement of Medical Instrumentation (AAMI) Standard for Autologous devices. |
| Biocompatibility (with new features) | Biocompatibility testing in accordance with ISO 10993 requirements has been done. |
| Performance under Simulated Conditions of Use (with new features) | Performance testing under simulated conditions of use has been done. |
| Overall Conclusion (for CDU): | Results of all testing demonstrate the safety and effectiveness of the Argyle Aqua-Seal® All Purpose Autotransfusion CDU for its intended use. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The testing appears to be primarily laboratory-based performance testing, biocompatibility testing, and compliance verification against standards, rather than a clinical study with a "test set" of patient data.
- Data Provenance: Not applicable in the context of device performance testing against engineering standards. The testing would have been conducted internally by Sherwood - Davis & Geck or a qualified third-party lab under simulated conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the context of this device involves physical performance metrics (e.g., blood handling, vacuum generation, flow rates, sterility, biocompatibility) measured against engineering and medical device standards, rather than expert interpretation of medical data.
4. Adjudication method for the test set:
- Not applicable. No adjudication method is described as this is not a study involving human interpretation of data where consensus or tie-breaking would be needed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data, which is not the primary function of this physical autotransfusion device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm. Its "standalone performance" refers to its mechanical and functional operation as per its design specifications and relevant standards.
7. The type of ground truth used:
- The "ground truth" for this device would be objective measurements and verified compliance with:
- American National Standards Institute (ANSI) / Association for the Advancement of Medical Instrumentation (AAMI) Standard for Autologous devices
- ISO 10993 requirements for biocompatibility
- Pre-defined performance specifications under simulated conditions of use.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is a physical medical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established:
- Not applicable (as above).
§ 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).