(187 days)
The ATR 40 and ATR 120 Autotransfusion Reservoirs are indicated as autotransfusion reservoirs to collect, defoam, filter, and store blood prior to processing.
The Fresenius ATR 40 and ATR 120 are 3 liter blood collection reservoirs, with 40 or 120 micron filters respectively. They are used for the collection of blood lost intra- or postoperalively in surgical procedures. Collection is performed by vacuum suction via appropriate tubing systems e.g. double lumen suction lines for aspiration and simultaneous anticoagulation or drainage adapters connected to wound drains. They are connected to the respective inlet connectors on top of the reservoir: two 1/4"-connectors (one vertical, one horizontal), luer female connector. All inlet connectors drain the fluid into a filter via a filter holder. The ATR 40 contains a three-layer filter and the ATR 120 contains a two-layer filter that traps particulates greater than 40 and 120 microns, respectively. In both filters, the PUR foam is treated with a defoaming agent to dissolve bubbles generated in the blood collection process by mixing blood with air. Except for the filter ATR 40 and ATR 120 are identical. The filters are attached to the filter holder by a cable tie and hang like a pouch in the reservoir lumen. The vacuum is applied via a separate vacuum line attached to a 1/4" vacuum port. Positive and negative pressure level within the reservoir is limited by a pressure relief valve that opens in the range of approximately -300 mmHg and + 100 mmHg. Up to 3 liters of aspirated blood can pass through the filter and be stored in the reservoir lumen at one time. The volume of collected blood can be controlled by calibration marks on both sides of the reservoir; the calibration marks are in increments of 100 ml to 3000 ml. Collected blood can be transferred to an autotransfusion device via the outlet line attached to the reservoir. The flow of blood through the outlet line can be controlled with a pinch clamp. A universal adapter, compatible with 1/4" male adapters and 3/8" female connectors, it attached to the distal end of the outlet line for connection to autotransfusion tubing sets. The reservoir can be attached to an IV pole using a compatible reservoir holder or the hanger on top of the reservoir. The ATR 40 and ATR 120 Autotransfusion Devices are supplied as sterile (ETO) disposable devices with a non-pyrogenic fluid path.
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes substantial equivalence testing against predicate devices. The acceptance criteria are framed as "equal quality" or "substantially equivalent" to the predicate devices for specific performance aspects.
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| ATR 40 (compared to Medtronic EL240 Blood Collection Reservoir): | |
| Satisfies AAMI/ANSI standards for structural integrity. | Demonstrated that "The Fresenius ATR 40 satisfies requirements of the AAMI/ANSI standards for autotransfusion devices with respect to structural integrity and the materials used to manufacture the disposable set are suitable for the intended use of the device." |
| Materials suitable for intended use (biocompatibility). | Biocompatibility testing consistent with FDA's modified ISO standards. Adherence to AAMI/ANSI standards for materials. |
| Shelf-life validation (biocompatibility, structural integrity, packaging, sterility). | "Shelf-life validation studies pertinent to the Fresenius ATR 40 have determined that the biocompatibility, structural integrity, packaging integrity and sterility of the Fresenius ATR 40 will be maintained for the labeled shelf-life." |
| Equal quality in filtration efficiency. | "Testing demonstrated that the blood products prepared using the Fresenius ATR 40 device are of equal quality with respect to filtration efficiency... as the Medtronic EL240." |
| Equal quality in defoaming. | "Testing demonstrated that the blood products prepared using the Fresenius ATR 40 device are of equal quality with respect to ... defoaming... as the Medtronic EL240." |
| Equal quality in hemolysis. | "Testing demonstrated that the blood products prepared using the Fresenius ATR 40 device are of equal quality with respect to ... hemolysis... as the Medtronic EL240." |
| Equal quality in retention of cellular components. | "Testing demonstrated that the blood products prepared using the Fresenius ATR 40 device are of equal quality with respect to ... retention of cellular components as the Medtronic EL240." |
| ATR 120 (compared to Haemonetics Cell Saver® Collection Reservoir): | |
| Satisfies AAMI/ANSI standards for structural integrity. | Demonstrated that "The Fresenius ATR 120 satisfies requirements of the AAMI/ANSI standards for autotransfusion devices with respect to structural integrity and the materials used to manufacture the disposable set are suitable for the intended use of the device." |
| Materials suitable for intended use (biocompatibility). | Biocompatibility testing consistent with FDA's modified ISO standards. Adherence to AAMI/ANSI standards for materials. |
| Shelf-life validation (biocompatibility, structural integrity, packaging, sterility). | "Shelf-life validation studies pertinent to the Fresenius ATR 120 have determined that the biocompatibility, structural integrity, packaging integrity and sterility of the Fresenius ATR 120 will be maintained for the labeled shelf-life." |
| Equal quality in filtration efficiency. | "Testing demonstrated that the blood products prepared using the Fresenius ATR 120 device are of equal quality with respect to filtration efficiency... as the Haemonetics Cell Saver ®." |
| Equal quality in defoaming. | "Testing demonstrated that the blood products prepared using the Fresenius ATR 120 device are of equal quality with respect to ... defoaming... as the Haemonetics Cell Saver ®." |
| Equal quality in hemolysis. | "Testing demonstrated that the blood products prepared using the Fresenius ATR 120 device are of equal quality with respect to ... hemolysis... as the Haemonetics Cell Saver ®." |
| Equal quality in retention of cellular components. | "Testing demonstrated that the blood products prepared using the Fresenius ATR 120 device are of equal quality with respect to ... retention of cellular components as the Haemonetics Cell Saver ®." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the sample sizes used for the comparative testing (e.g., number of devices tested, number of blood samples). It refers to "comparative testing" and states that "Data is provided to the Agency."
- Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. The testing was comparative against legally marketed predicate devices (Medtronic EL240 and Haemonetics Cell Saver®).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This type of information is not applicable to this submission. The device is a physical medical device (autotransfusion reservoir) undergoing performance and safety testing, not a diagnostic or AI-driven device requiring expert interpretation for ground truth. The "ground truth" here is the measured performance of the predicate devices.
4. Adjudication Method for the Test Set:
This information is not applicable. As it's a performance and safety test for a physical device, there's no "adjudication" in the sense of reconciling multiple expert opinions on a diagnostic outcome. The assessment is based on objective measurements against established standards and predicate device performance.
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:
This information is not applicable. This is a medical device (autotransfusion reservoir), not an AI or imaging diagnostic device. Therefore, MRMC studies or AI assistance for human readers are irrelevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable. This is a physical medical device. There is no "algorithm only" performance to evaluate. The device performs its function directly.
7. The Type of Ground Truth Used:
The ground truth used for comparison was the performance parameters of legally marketed predicate devices (Medtronic EL240 and Haemonetics Cell Saver®) and compliance with relevant industry standards (AAMI/ANSI for autotransfusion devices, FDA's modified ISO standards for biocompatibility).
8. The Sample Size for the Training Set:
This information is not applicable. This device is not an AI/machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable. As there is no training set for an AI model, there is no ground truth to establish for it.
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.