NUVUE COLORMARK9TM) NEEDLE

• K Number: K101312
• Device Name: NUVUE COLORMARK9TM) NEEDLE
• Manufacturer: NU VUE THERAPEUTICS, INC
• Date Cleared: 2011-02-04 ( 269 days)
• Product Code: IYN
• Regulation Number: 892.1550

Intended Use

The NuVue ColorMark™ Needle is intended for use when one desires the visualization of an interventional needle (e.g. biopsy needle) on B-scan ultrasound screens which have color flow Doppler imaging capability. The NuVue ColorMark™Needle is indicated for use in clinical applications and at anatomical sites for which the biopsy needle and the ultrasound system have received marketing clearance by the FDA.

Device Description

The NuVue ColorMark™Needle combines a hand-piece and echogenic needles like its predicates. The NuVue ColorMark™Needle is intended to allow the visualization by ultrasound of a needle- such as biopsy needle- inserted into the body. The principle is that the needle is made to vibrate at low sonic frequencies (<1 kHz), which makes it visible on a Doppler Color-flow system, since the vibration of the needle appears as motion to the Doppler system. As Stipulated, NuVue's ColorMark™ Needle, a hand-held needle device, consists of the driving handpiece and integrated needle. The system is a self-contained, battery-operated, and single-use device that integrates and vibrates interventional biopsy needle(s). The hand-piece accommodates a range of NuVue Therapeutics compatible biopsy needles that fit within its integrated sleeve. The sleeve is the guide and vibration transmitter for the needle. The NuVue ColorMark™Needle is an electro-mechanical needle device. The mechanical coupling of the needle with the hand-piece exciter is mediated by two electromagnets that make the hand-piece sleeve to vibrate in an orbital-like motion, through a phasing of the coils +- 90 degrees apart. This motion is transferred to the interventional needle that is coaxially catheterizing the hand-piece sleeve. This allows for the representation of color Doppler imaging in 360 degrees of rotation of the needle while it is in NuVue's new hand held interventional driver device and in the on position. The needle motion stimulates the Doppler motion sensing function of the imager to display colors corresponding to turbulent fluid motion pattern in close vicinity with the biopsy needle. NuVue Therapeutics will purchase in bulk needles designated by application (biopsy, aspiration, other), needle type (Chiba, Franseen, spinal, other), needle gauge (19 to 27). The needle device, as stipulated, is a single use, hand-piece that integrates and guides the needle for lengths of tissue insertion from 10 to 20 cm. The needle device will be repackaged as a single use device, sterilized with Ethylene Oxide, and distributed commercially under the NuVue Therapeutics, Inc. Name, with the stipulation on the packaging, do not reuse or re-sterilize.

Predicate Devices

K031173, K926351

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the electro-mechanical vibration of the needle to enhance visualization on existing ultrasound systems. There is no mention of algorithms, learning, or data processing that would indicate AI/ML.

Therapeutic

No.
The device's intended use is for visualization of an interventional needle during ultrasound procedures, not for treating a disease or condition. It acts as an aid for imaging, not a direct therapeutic intervention.

Diagnostic

No

The device is an interventional tool, a needle, designed to be visualized during a procedure (biopsy, aspiration) using ultrasound imaging. It does not diagnose conditions itself, but rather aids in the precise placement of another tool (biopsy needle) which would then collect samples for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description clearly states it is an electro-mechanical needle device consisting of a hand-piece and integrated needles, which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the NuVue ColorMark™ Needle is not an In Vitro Diagnostic (IVD) device.

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
• NuVue ColorMark™ Needle Function: The NuVue ColorMark™ Needle is a device used during a medical procedure (biopsy, aspiration) to improve the visualization of the needle within the body using ultrasound. It does not analyze or test any biological specimens.
• Intended Use: The intended use is to aid in the visualization of an interventional needle during procedures, not to perform diagnostic tests on samples.
• Device Description: The description focuses on the mechanical and electrical aspects of the device for vibrating the needle and its interaction with the ultrasound system for visualization. It does not mention any components or processes related to analyzing biological samples.

Therefore, the NuVue ColorMark™ Needle falls under the category of a surgical or interventional device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The NuVue ColorMark™ Needle is intended for use when one desires visualization of an interventional needle (e.g. biopsy needle) on B-scan ultrasound screens which have color flow Doppler imaging capability.

The NuVue ColorMark™Needle is indicated for use in clinical applications and at anatomical sites for which the biopsy needle and the ultrasound system have received marketing clearance by the FDA.

Product codes (comma separated list FDA assigned to the subject device)

IYN

Device Description

The NuVue ColorMark™Needle combines a hand-piece and echogenic needles like its predicates. The NuVue ColorMark™Needle is intended to allow the visualization by ultrasound of a needle- such as biopsy needle- inserted into the body. The principle is that the needle is made to vibrate at low sonic frequencies (

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

510 (K) Submission Summary

FEB - 4 2011

NuVue ColorMark™ Needle (K101312)

Common/Classification Name: Ultrasonic Locator of Interventional Needles, 21CFR 892.1550

Contact: Roger S. Kolasinski, Prepared: February 3, 2011

Legally marketed Predicate Devices 1.

The NuVue ColorMark™ Needle is substantially equivalent to the EchoTip Needle Guidewire Introducer Needle (K031173) for ultrasound imaging visibility and to the ColorMark™ Visualization System (K926351) for Color flow Doppler Ultrasound imaging visibility.

II. Intended Use

Indications for Use:

The NuVue ColorMark™ Needle is intended for use when one desires visualization of an interventional needle (e.g. biopsy needle) on B-scan ultrasound screens which have color flow Doppler imaging capability.

The NuVue ColorMark™Needle is indicated for use in clinical applications and at anatomical sites for which the biopsy needle and the ultrasound system have received marketing clearance by the FDA.

III. Substantial equivalence Summary

The technology used in the NuVue ColorMark™Needle is substantially equivalent to that used in the ColorMark™ Visualization System that was previously approved under K926351. The NuVue ColorMark™Needle has improved ergonomics with similar technology and performance as its predecessor in that it presents the image of the needle as a colored line on the B-scan screen, by making the needle vibrate at low (sonic) frequencies. The Needles purchased by NuVue therapeutics have the same characteristics as similar type, gauge, and length needles for similar applications. These new characteristics do not raise new types of safety or effectiveness questions.

IV. Device description

The NuVue ColorMark™Needle combines a hand-piece and echogenic needles like its predicates. The NuVue ColorMark™Needle is intended to allow the visualization by ultrasound of a needle- such as biopsy needle- inserted into the body. The principle is that the needle is made to vibrate at low sonic frequencies (