(460 days)
K/885281
K/885281
No
The description focuses on a mechanical blood sampling system and does not mention any computational or analytical capabilities that would suggest AI/ML.
No.
The device is used for blood sampling and reinfusion to reduce fluid loss, not for treating a disease or condition.
No
The device is a blood sampling system used for drawing and retaining blood samples, not for analyzing or diagnosing conditions.
No
The device description clearly outlines a physical kit with components for blood sampling, reinfusion, and connection to catheters and transducers, indicating it is a hardware device, not software-only.
Based on the provided information, the ABC In-Line Blood Sampling Kit is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens outside the body. The primary function of this device is to facilitate the drawing of blood samples from a patient's catheter and then reinfuse a portion of that blood back into the patient. While it allows for blood samples to be drawn, the device itself is not performing any diagnostic testing or analysis on the blood in vitro (in glass or outside the living organism).
- The intended use is for blood sampling and pressure monitoring. The description focuses on the mechanics of blood collection and its use in conjunction with continuous blood pressure monitoring. It does not mention any diagnostic purpose or analysis of the blood sample by the device itself.
- The predicate device is also a blood sampling system. The predicate device (Baxter VAMP™ blood sampling system) is also a system for collecting blood samples, not an IVD.
Therefore, the ABC In-Line Blood Sampling Kit is a medical device used for blood collection and management within a patient's circulatory system, not a device used for diagnostic testing of specimens outside the body.
N/A
Intended Use / Indications for Use
The ABC ("Arterial Blood Collection") In-Line Blood Sampling Kit is a closed blood sampling system used in conjunction with continuous blood pressure monitoring in a critical care setting. The ABC Kit is designed for use with all disposable and reusable pressure transducers and for connection to central line catheters and arterial catheters. The ABC Kit is used for the drawing and retention within the line of heparinized blood from the catheter/cannula, allowing undiluted blood samples to be drawn from an in-line sampling site. At the completion of sample drawing, the mixed heparin/blood solution is reinfused into the patient to reduce fluid loss.
Product codes
21 CFR 8807.92
Device Description
The ABC ("Arterial Blood Collection") In-Line Blood Sampling Kit is a closed blood sampling system used in conjunction with continuous blood pressure monitoring in a critical care setting. The ABC Kit is designed for use with all disposable and reusable pressure transducers and for connection to central line catheters and arterial catheters. The ABC Kit is used for the drawing and retention within the line of heparinized blood from the catheter/cannula, allowing undiluted blood samples to be drawn from an in-line sampling site. At the completion of sample drawing, the mixed heparin/blood solution is reinfused into the patient to reduce fluid loss. Although the ABC blood collection reservoir is of a different shape and larger capacity compared to the VAMP reservoir, the frequency response of the system in pressure monitoring is essentially equivalent. Materials used that contact IV fluids and blood are equivalent to materials of the VAMP system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
critical care setting.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K/885281
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1100 Arterial blood sampling kit.
(a)
Identification. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
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