ABC IN-LINE BLOOD SAMPLING KIT

K955663 · Utah Medical Products, Inc. · CBT · Mar 17, 1997 · Anesthesiology

Device Facts

• Record ID: K955663
• Device Name: ABC IN-LINE BLOOD SAMPLING KIT
• Applicant: Utah Medical Products, Inc.
• Product Code: CBT · Anesthesiology
• Decision Date: Mar 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1100
• Device Class: Class 1

Intended 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.

Device Story

Closed blood sampling system; integrates with continuous blood pressure monitoring lines; utilizes reservoir to draw/retain heparinized blood from catheter; allows undiluted sample collection via in-line port; enables reinfusion of heparin/blood mixture post-sampling to minimize fluid loss; used in critical care settings; operated by clinicians; facilitates blood sampling without disconnecting monitoring lines.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material comparison to predicate.

Technological Characteristics

Closed-system blood sampling kit; compatible with disposable/reusable pressure transducers; connects to central/arterial catheters; materials equivalent to predicate VAMP system; biocompatible; sterilized.

Indications for Use

Indicated for patients in critical care settings requiring continuous blood pressure monitoring and frequent blood sampling via central line or arterial catheters.

Regulatory Classification

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.

Predicate Devices

• Baxter VAMP™ blood sampling system (K885281)

Submission Summary (Full Text)

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UTAH MEDICAL PRODUCTS INC.

K 955663

SMDA 510(k) Summary

MAR 17 1997

Trade Name: ABC In-Line Blood Sampling Kit

Common Name: In-Line Blood Sampling Device

Classification: Continuous Flush Catheter. 21 CFR §807.92.

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.

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.

Kevin L. Cornwell
President & CEO

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