(90 days)
No
The device description and intended use are purely mechanical/fluidic, and there is no mention of AI, ML, or any related concepts in the provided text.
No
Explanation: This device is described as conduit tubing for fluid delivery, not a device that itself provides therapy. It functions as a sterile pathway or connector for other devices.
No
The device is described as conduit tubing for fluid delivery and connector tubing for sterile fluid pathways, without any mention of diagnosing medical conditions or processing diagnostic information.
No
The device description clearly states it consists of "plastic tubing with plastic luer lock connector hubs at each end," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver fluids from an injector or provide a sterile fluid pathway between devices. This describes a device used for fluid management and delivery within the body or to connect medical devices, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details plastic tubing and connectors for fluid delivery. This aligns with a medical device for fluid handling, not an IVD which would typically involve reagents, test strips, or analytical components for sample analysis.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, based on the provided text, this device falls under the category of a general medical device for fluid delivery, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
Not Found
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 hemocompa-tibility tests. The device meets the requirements of the USP XXIII physico-chemical tests for plastics.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
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.(b)
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.
0
510 (k) SUMMARY
ADMINISTRATIVE 1.
Submitter: Maxxim Medical, Inc., Argon Division 1445 Flat Creek Road Athens, TX 75751 (903) 675-9321
Contact Person: Eddie Monroe
Image /page/0/Picture/5 description: The image shows a date stamp that reads "DEC 17 1996". The text is in a bold, sans-serif font and is slightly rotated. The date is formatted as month, day, and year.
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
!!!. 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 hemocompa-tibility 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.
1
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.