(90 days)
No
The device description and performance studies focus on the physical characteristics, filtration capabilities, and biocompatibility of a blood collection and filtration reservoir. There is no mention of any computational or algorithmic components that would suggest the use of AI or ML.
No
The device is described as an "accessory to an autotransfusion device" and is intended for "sterile collection and filtration of recovered blood for subsequent processing for autotransfusion," not for directly treating a medical condition.
No
The device is described as an "accessory to an autotransfusion device" and its purpose is the "sterile collection and filtration of recovered blood for subsequent processing for autotransfusion." It does not perform any diagnostic function.
No
The device description clearly outlines a physical reservoir with an internal filter system, ports, and an overflow valve, indicating it is a hardware device. The performance studies also focus on physical properties like integrity, filtration efficiency, and connector strength.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "sterile collection and filtration of recovered blood for subsequent processing for autotransfusion." This describes a process involving blood outside the body for reinfusion, not for diagnostic testing in vitro (in a test tube or lab setting).
- Device Description: The description details a reservoir with filters and ports for collecting and draining blood. This aligns with a device used in a medical procedure (autotransfusion) rather than a diagnostic test.
- Performance Studies: The performance studies focus on aspects like biocompatibility, integrity, filtration efficiency, and residual volume. These are relevant to a device handling blood for reinfusion, not to the accuracy or performance of a diagnostic test.
- Lack of IVD Indicators: There is no mention of analyzing blood components for diagnostic purposes, using reagents, or providing information about a patient's health status based on the blood analysis.
Therefore, the Dideco ATS Autotransfusion Cardiotomy Reservoir is a medical device used in the process of autotransfusion, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Dideco ATS Autotransfusion Cardiotomy Reservoir is an accessory to an autotransfusion device and is intended for the sterile collection and filtration of recovered blood for subsequent processing for autotransfusion.
Product codes
74 DTN
Device Description
The Dideco ATS Autotransfusion Cardiotomy Reservoir (Dideco ATS) is a modification of the Dideco-Shiley ACR-40 Autotransfusion Reservoir (ACR-40) The Dideco ATS is identical in intended use and fundamental (K884872). technology to the previously cleared autotransfusion reservoir. Both the proposed and predicate devices consist of a reservoir with an internal filter system.
The proposed device is available with two different means of removing fluids from the reservoir. The "draw tube configuration" has a draw tube attached to a fluid outlet port in the reservoir cover. Fluids may also be drained from this version of the reservoir via a piercable connector at the bottom of the reservoir housing. In the second form of the device, the "bottom outlet" version, the fluid outlet port is located on the bottom of the housing.
In both configurations of the device, fluids enter the reservoir through an inlet port in the reservoir cover which is connected to the internal filter system. There is also a Luer lock connector on the reservoir cover which bypasses the filter system. Both versions of the reservoir also contain an overflow valve to prevent the volume of fluid in the reservoir from exceeding the maximum holding capacity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Biocompatibility testing was performed to meet the requirements of ISO 10993-1, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" for an external communicating device in limited (
§ 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.
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ABBREVIATED 510(k) SUMMARY FOR DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR
1. SPONSOR
Dideco S.P.A Via Statale 12 Nord 86 P.O. Box 87 41037 Mirandola (MO), Italy
Contact Person: Luigi Vecchi 01139 0535 29811 Telephone:
August 2, 1999 Date Prepared:
2. DEVICE NAME
| Proprietary Name: | Dideco ATS Autotransfusion Cardiotomy Reservoir |
|---|---|
| Common/Usual Name: | Autotransfusion reservoir |
| Classification Name: | Accessory to an autotransfusion apparatus |
3. PREDICATE DEVICE
Dideco-Shiley ACR-40 Autotransfusion Cardiotomy Reservoir (K884872)
4. DEVICE DESCRIPTION
The Dideco ATS Autotransfusion Cardiotomy Reservoir (Dideco ATS) is a modification of the Dideco-Shiley ACR-40 Autotransfusion Reservoir (ACR-40) The Dideco ATS is identical in intended use and fundamental (K884872). technology to the previously cleared autotransfusion reservoir. Both the proposed and predicate devices consist of a reservoir with an internal filter system.
The proposed device is available with two different means of removing fluids from the reservoir. The "draw tube configuration" has a draw tube attached to a fluid outlet port in the reservoir cover. Fluids may also be drained from this version of
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the reservoir via a piercable connector at the bottom of the reservoir housing. In the second form of the device, the "bottom outlet" version, the fluid outlet port is located on the bottom of the housing.
In both configurations of the device, fluids enter the reservoir through an inlet port in the reservoir cover which is connected to the internal filter system. There is also a Luer lock connector on the reservoir cover which bypasses the filter system. Both versions of the reservoir also contain an overflow valve to prevent the volume of fluid in the reservoir from exceeding the maximum holding capacity.
- ട. INTENDED USE
The Dideco ATS is an accessory to an autotransfusion device and is intended for the sterile collection and filtration of recovered blood for subsequent processing for autotransfusion.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The proposed Dideco ATS is modified from the Dideco-Shiley ACR-40 as follows:
- . increased holding capacity of the reservoir
- addition of a second configuration with the outlet port on the bottom of the . reservoir housing
- . elimination of the need for a reusable outer shell
- modification of the support system for the filter assembly .
7. PERFORMANCE TESTING
Biocompatibility testing was performed to meet the requirements of ISO 10993-1, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" for an external communicating device in limited (