K963749 · Maxxim Medical · DTL · Dec 17, 1996 · Cardiovascular
Device Facts
Record ID
K963749
Device Name
HIGH PRESSURE INJECTION LINES
Applicant
Maxxim Medical
Product Code
DTL · Cardiovascular
Decision Date
Dec 17, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 870.4290
Device Class
Class 2
Indications for Use
Conduit tubing to deliver fluids from an electronic or manual injector; connector tubing to provide a sterile fluid pathway between two devices.
Device Story
High pressure injection line; conduit tubing for fluid delivery from electronic/manual injectors; connector tubing for sterile fluid pathways between devices. Consists of plastic tubing with female/male or female/rotating male luer lock connector hubs. Lengths 10-48 inches. Supplied sterile/disposable, non-sterile bulk, or as component in catheter introducer kits/trays. Used in clinical settings; operated by healthcare professionals. Facilitates fluid transfer; ensures sterile connection between devices.
Clinical Evidence
Bench testing only. Biocompatibility established via cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, and hemocompatibility tests. Meets USP XXIII physico-chemical requirements for plastics. Performance verified via simulated use, pull tests, and static pressure tests.
Technological Characteristics
Plastic tubing with luer lock connector hubs (female/male or female/rotating male). Lengths 10-48 inches. Biocompatibility per USP XXIII. Sterilization method not specified.
Indications for Use
Indicated for use as conduit tubing for fluid delivery from electronic or manual injectors and as connector tubing to establish a sterile fluid pathway between two medical devices.
Regulatory Classification
Identification
A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.
Special Controls
*Classification.* Class II (special controls). The device 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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K963749
# 510 (k) SUMMARY
## I. ADMINISTRATIVE
Submitter: Maxxim Medical, Inc., Argon Division
1445 Flat Creek Road
Athens, TX 75751
(903) 675-9321
Contact Person: Eddie Monroe
Date of Preparation: September 9, 1996
## II. DEVICE NAME
Proprietary Name: None
Common Name: High Pressure Injection Line
Classification Name: Cardiopulmonary bypass adaptor, stopcock, manifold or fitting
## III. PREDICATE DEVICE
Advance High Pressure Lines; K911884; Advance Medical, Inc.
## IV. DEVICE DESCRIPTION
The High Pressure Line is a device used as conduit tubing to deliver fluids from an electronic or manual injector and may also be used as connector tubing to provide a sterile fluid pathway between two devices. The device consists of plastic tubing with plastic luer lock connector hubs at each end. The luer lock connector hubs are a female/male combination or a female/rotating male combination. The device is available in lengths of 10 to 48 inches and supplied as a sterile, disposable single put up in sealed pouches, in non-sterile bulk quantities, or included as a component in catheter introducer kits, trays, or packs.
Biocompatibility of the device has been established by cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity and hemocompatibility tests. The device meets the requirements of the USP XXIII physico-chemical tests for plastics.
## V. INTENDED USE
Conduit tubing to deliver fluids from an electronic or manual injector; connector tubing to provide a sterile fluid pathway between two devices.
Premarket Notification: High Pressure Inject. in tine
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# VI. COMPARISON TO PREDICATE DEVICE
The High Pressure Injection Line is similar in design and composition, and identical in function and intended use to the High Pressure Line (Advance Medical; K911884). Results of simulated use tests, pull tests and static pressure tests indicate that the High Pressure Injection Line has performance characteristics equivalent to or better than those of the predicate device.
Accordingly, Maxxim Medical, Inc., Argon Division, concluded that the High Pressure Injection Line is safe and effective for its intended use and performs at least as well as the legally marketed predicate device.
Premarket Notification: High Pressure Injection
