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.

AI/ML Overview

Because the provided text is a 510(k) summary for the NuVue ColorMark™ Needle, it focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study report with acceptance criteria and specific performance metrics. Therefore, many of the requested elements are not explicitly stated or quantifiable in the provided document.

However, I can extract the information that is present and indicate where specific details are missing based on the nature of a 510(k) submission.

Acceptance Criteria and Device Performance

The 510(k) submission does not provide explicit numerical acceptance criteria (e.g., minimum sensitivity, specificity, accuracy, or a specific level of improved visibility) or a quantitative report of the NuVue ColorMark™ Needle's performance against such criteria. Instead, it relies on demonstrating that the device is "effective in the visualization of image of the biopsy needle, and can be easily used by the operator" and that its "imaging performance" is not lessened compared to predicate devices.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Not explicitly stated with quantifiable thresholds in the document)	Reported Device Performance (as implied or stated in the document)
Visibility/Imaging Performance	No explicit, quantifiable criterion provided (e.g., specific percentage increase in visualization, or a score on a scale).	"Our imaging studies show that NuVue's ColorMark™ Needle is effective in the visualization of image of the biopsy needle, and can be easily used by the operator." "The changes implemented into the NuVue ColorMark™ Needle... do not lessen any imaging performance compared to the predicate devices." "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..." "The NuVue ColorMark™ Needle is effective in the visualization of image of the biopsy needle."
Safety	No explicit, quantifiable criterion provided (e.g., specific rate of adverse events, or a threshold for tissue damage).	"A detailed analysis of the safety of NuVue's device shows no addition risk issues." "In case of failure of the device, Color Doppler visualization may be lost, but the needle is still visible and can be followed by conventional techniques."
Ergonomics/Usability	No explicit, quantifiable criterion provided.	"The NuVue ColorMark™Needle has improved ergonomics..." "...can be easily used by the operator."
Functionality (360° Visualization)	No explicit, quantifiable criterion provided for the degree of visualization.	"NuVue has the ability of Quadriture, which allows visualization of any of its needles in a 360 degree visualized capability, compared to the cleared ColorMark™ Visualization System, who's vibratory signal was designed in a linear responsibility..."

Study Information

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided text. The document states "Our imaging studies show..." but does not provide details on the number of cases, patients, or images included in these studies.
- Data Provenance: Not specified. It is not mentioned whether the data was retrospective or prospective, nor the country of origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: The document does not describe a multi-reader multi-case comparative effectiveness study involving human readers with and without AI assistance. This device is not an AI-powered system; it's an interventional needle enhanced for ultrasound visualization. While it compares its performance to predicate devices (K031173 and K926351), this is not an MRMC study in the context of AI.
- Effect Size: Not applicable as no such study is described, and the device is not an AI system.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. The device is a physical needle designed for human-in-the-loop interventional procedures, not a standalone algorithm. Its "effectiveness" is linked to its ability to be visualized by an operator using an ultrasound machine.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not explicitly stated. Given the nature of the device (improving visualization of a needle), the "ground truth" for imaging performance would likely be subjective expert assessment of visibility or objective measures of signal strength/contrast in an imaging study, rather than pathology or outcomes data related to the biopsy itself. However, the document only broadly refers to "imaging studies."
The sample size for the training set:
- Sample Size for Training Set: Not applicable. This device is an electro-mechanical medical device, not an AI/machine learning model that requires a "training set" in the conventional sense. The "training" in its development would refer to engineering design, prototyping, and iterative testing.
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable for the reasons mentioned above. Development and testing would involve engineering specifications, materials science, and physical performance validations.

Summary

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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

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V. Testing

NuVue Therapeutics has carried out energy and imaging performance testing on the NuVue ColorMark™ Needles.

The changes implemented into the NuVue ColorMark™ Needle do not introduce any added safety risk nor do they lessen any imaging performance compared to the predicate devices. NuVue has the ability of Quadriture, which allows visualization of any of its needles in a 360 degree visualized capability, compared to the cleared ColorMark™ Visualization System, who's vibratory signal was designed in a linear responsibility, demanding the operator of the device to always be assured of the orientation of the needle to the head of the Doppler Transducer, per the manufactures mandates.

A detailed analysis of the safety of NuVue's device shows no addition risk issues. In case of failure of the device, Color Doppler visualization may be lost, but the needle is still visible and can be followed by conventional techniques.

Our imaging studies show that NuVue's ColorMark™ Needle is effective in the visualization of image of the biopsy needle, and can be easily used by the operator.

VI. Conclusion

This premarket submission has demonstrated Substantial equivalence as defined by the Federal Food and Drug and Cosmetic Act.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines forming its body and wing. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NuVue Therapeutics, Inc. % Mr. Roger S. Kolasinski, CEO 11135 Sedgefield Road Fairfax, Virginia 22030

FEB - 4 201

Re: K101312

Trade/Device Name: NuVue Colormark™ Needle Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN Dated: December 15, 2010 Received: December 17, 2010

Dear Mr. Kolasinski:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indice) ons for use stated in the enclosure) to legally marketed predicate devices marketed in internate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act The general controls provisions of the Act include requirements for annual registration, insting of devices, good manufacturing practice, labeling, and prohibitions against misbaratif insand adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not migleding.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Mr. Roger S. Kolasinski, CEO

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.

Sincerely yours.

Ais B. R. for

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K101312

Device Name: NUVUE COLORMARK™ NEEDLE

Indications for Use:

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.

Prescription Use X X Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF

NEEDED)

Concurrence of CDRH Evaluation (ODE) (Division Sign-Off) Division of Surgical, Orthopedic,

and Restorative Devices

510(k) Number K101312

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.