(82 days)
No
The device description and intended use are purely mechanical and do not mention any computational or analytical functions that would typically involve AI/ML. The comparison to a predicate device also focuses on physical design equivalence.
No
The device serves as a conduit for fluid delivery and an injection site, not directly treating a medical condition or restoring a bodily function.
No
The device is described as a conduit for delivering I.V. fluids and an injection site, which are functions related to fluid administration, not diagnosis. The text does not mention any analytical, interpretive, or measurement capabilities for diagnostic purposes.
No
The device description clearly describes a physical medical device (I.V. Manifold) with hardware components like ports, valves, and adapters, intended for the delivery of I.V. fluids. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for delivering I.V. fluids to a patient's vascular system and serving as an injection site. This is a direct interaction with the patient's body for therapeutic purposes (fluid delivery and medication administration).
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis of patient specimens.
- Device Description: The description focuses on the physical components and their function in connecting to I.V. lines and providing injection ports. It doesn't mention any components or processes related to analyzing biological samples.
Therefore, the KippMed I.V. Manifold is a medical device used for fluid administration and injection, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended to be used as a conduit for the delivery of I.V. fluids from a container to a patient's vascular system through a needle or cather inserted into a vein. Additionally, this device is intended to serve as an injection site for other influsion fluids.
Product codes
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Device Description
The KippMed I.V. Manifold is substantially equivalent to the Braun Safesite Manifold, Minor differences in design specifications have been listed in Table One. Both devices are intended to provide connections to an I.V. Administration Set. Both devices provide a multi-port connector with a female leur-lock adapter, three normally closed backcheck valves and a connection adapter. The inlet connection adapter for both devices includes a free-spinsing hub/leur lock to connect to I.V. lines. Both devices are sterile and nonpyrogenic.
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
This device is intended to be used only by trained professionals in a clinical or hospital environment.
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
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Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
PREMARKET NOTIFICATION SUMMARY
APR 1 4 1997
Classification Name:
Set. Administration, Intravascular
Common Name;
I.V. Manifold
Trade Name:
KippMed I.V. Manifold
Predicate Device:
The predicate device is marketed B. Braun Medical Inc. and is named the Safesite -Anesthesia Tripple Valve Manifold; #AET-3000; 510(k) K942391.
Device Description:
The KippMed I.V. Manifold is substantially equivalent to the Braun Safesite Manifold, Minor differences in design specifications have been listed in Table One. Both devices are intended to provide connections to an I.V. Administration Set. Both devices provide a multi-port connector with a female leur-lock adapter, three normally closed backcheck valves and a connection adapter. The inlet connection adapter for both devices includes a free-spinsing hub/leur lock to connect to I.V. lines. Both devices are sterile and nonpyrogenic.
Intended Use:
This device is intended to be used as a conduit for the delivery of I.V. fluids from a container to a patient's vascular system through a needle or cather inserted into a vein. Additionally, this device is intended to serve as an injection site for other influsion fluids. This device is intended to be used only by trained professionals in a clinical or hospital environment.
Comparison of Technical Characteristics to Predicate Device(s):
Table 1, included on the last page of this summary, provides a comparison of the technological characteristics of the KippMed device to the Braun Safesite.
1
Sterilization:
TheKippMed manifold is sterilized by Gamma radiation. The sterilization process has been validated to provide a SAL of 104.
Biocompatibility:
Biocompatibility for the components used in the KippMed device have been tested in accordance with ISO 10993 and FDA General Program Memorandum G95-1. Tested components were subjected to the maximum number of sterilization cycles specified in the Device Master Record. All tested components were biocompatible.
Reviewed and Approved By (Contact Person):
Luin K. Linson
Tim Truitt R&D Manager The KippGroup 909 Wanamaker Ontario, CA 91761 (909) 390-9080 FAX: (909) 390-9081