(460 days)
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.
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.
The provided text is a 510(k) summary for a medical device called the "ABC In-Line Blood Sampling Kit." This document is a regulatory submission for premarket notification to the FDA, not a study report detailing performance acceptance criteria and validation studies in the way you've requested.
Therefore, I cannot extract the information you've asked for (acceptance criteria, study details, sample sizes, expert qualifications, etc.) for the following reasons:
- Clinical Performance Study Not Described: The document focuses on demonstrating substantial equivalence to a predicate device (Baxter VAMP™ blood sampling system cleared under 510(k) K/885281) for regulatory clearance. It does not describe an independent clinical performance study with acceptance criteria and results.
- Focus on Substantial Equivalence: The primary points made are about the device's function, materials, and substantial equivalence to the predicate, with a brief mention of pressure monitoring frequency response being "essentially equivalent." This is a regulatory comparison, not a detailed performance study with defined metrics.
- No Mention of AI or Algorithm Performance: The device is an "In-Line Blood Sampling Kit," a physical medical device. There is no mention of an algorithm, AI, or software component that would require the kind of performance metrics you've outlined (e.g., standalone performance, MRMC studies, ground truth establishment methods for a machine learning model).
To summarize, the document does not contain the information required to answer your prompt because it is a regulatory submission demonstrating substantial equivalence of a physical medical device, not a report on a clinical or AI performance study.
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SMDA 510(k) Summary
MAR 1 7 1997
ABC In-Line Blood Sampling Kit Trade Name: Common Name: In-Line Blood Sampling Device Classification: Continuous Flush Catheter. 21 CFR 8807.92.
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. of 150 × 485233
The device is substantially equivalent to the Baxter VAMP™ blood sampling system cleared for marketing under 510(k) K/885281. 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. Biocompatibility and sterilization information is available from Utah Medical Products, Inc. upon request.
Kid Connell
Kevin L. Cornwell President & CEO
3 d
§ 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.