Who is the manufacturer of HIGH PRESSURE INJECTION LINES?

Maxxim Medical filed the 510(k) submission for HIGH PRESSURE INJECTION LINES (K963749).

What is the FDA product code for HIGH PRESSURE INJECTION LINES?

DTL. It is classified under 21 CFR 870.4290 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for HIGH PRESSURE INJECTION LINES?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like HIGH PRESSURE INJECTION LINES?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HIGH PRESSURE INJECTION LINES

Q: What are the predicate devices for HIGH PRESSURE INJECTION LINES?

Advance High Pressure Lines (K911884).

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

Intended 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.

Predicate Devices

Advance High Pressure Lines (K911884)

Related Devices

K131517 — MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING · Medrad, Inc. / Bayer Medical Care, Inc. · Aug 2, 2013
K071196 — DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS · Coeur, Inc. · Sep 6, 2007
K023591 — ULTRA HIGH PRESSURE INJECTOR LINES · Deroyal Industries, Inc. · Jun 18, 2003
K020926 — EXTENSION SET, MODELS 1911-512 · Epimed International, Inc. · Jul 12, 2002
K090809 — MPS ACACIA POWER INJECTABLE INFUSION SET · Mps Acacia · Apr 28, 2009

Submission Summary (Full Text)

{0} 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 ![img-0.jpeg](img-0.jpeg) ## 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 {1} 11 # 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