The VTS1000 is a non-invasive electronic device to aid in the visualization of superficial vasculature. It is indicated for use during procedures requiring vascular or peripheral vessel access.

Device Description

The VueTek Scientific™ VTS1000 is a near-infrared (NIR) emitter, video acquisition, and head mounted display (HMD) device that affords viewing of superficial, and its nead invanced and, by differentiating it with higher contrast from surrounding tissue. Visualization of vascular structures is provided by a portable headset display system which supplements normal line of sight viewing during vascular access procedures. The VTS1000 device does not replace the accepted conventional vascular identification and confirmation methods used by qualified professionals.

AI/ML Overview

The provided text describes a pre-market notification (510(k) summary) for the VueTek Scientific™ VTS1000 device. While it mentions performance summary and clinical study results, it does not provide specific acceptance criteria or detailed study methodologies that would allow for a comprehensive table of acceptance criteria versus reported device performance as requested.

Here's a breakdown of what can be extracted and what is missing based on the prompt's requirements:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific quantifiable acceptance criteria (e.g., minimum sensitivity, specificity, or error rates). Instead, it provides qualitative statements about performance.

Acceptance Criteria (Not explicitly stated, inferred from general statements)	Reported Device Performance (Qualitative)
Effective visualization of superficial, subcutaneous vascular structures	- Effectively provided and enhanced visualization of superficial, subcutaneous vascular structures when compared to the naked eye.
Safety	- Found to be safe.
Meet established user and design requirements	- Demonstrated that the VTS1000 met design requirements.- Met the established user and design requirements and performs safely and effectively as designed, for its intended use.
Conformance to international standards	- Conforms to IEC60601-01, IEC60601-1-2, CIE-S009/IEC-62471, ANSI IESNA RP 27.1, 27.2 and 27.3.
Portability and flexibility	- Found to be portable, flexible.
Normal line-of-sight viewing	- Provided normal line-of-sight viewing during use.
Substantial Equivalence to predicate devices	- Determined to be substantially equivalent with similar devices currently legally commercially available.

2. Sample size used for the test set and the data provenance:

Sample Size: The document states "Clinical study results involving subjects with ages from <4 weeks to >65 years of age", but does not specify the number of subjects (sample size).
Data Provenance: The document does not explicitly state the country of origin. It mentions "Clinical, non-clinical, and independent testing performance data were submitted," but it does not specify if the study was retrospective or prospective. Given the nature of a 510(k) submission for a new device, a prospective clinical study would be more likely, but this is not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The VTS1000 is a vein locator that enhances visualization. The comparison is "compared to the naked eye," implying a direct visual assessment rather than requiring expert-established ground truth in the traditional sense of diagnostic interpretation.

4. Adjudication method for the test set:

This information is not provided in the document.

5. 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 doesn't explicitly mention an MRMC study. It states the VTS1000 "supplements normal line of sight viewing" and "does not replace the accepted conventional vascular identification and confirmation methods." The comparison is "compared to the naked eye," suggesting an evaluation of the device as an aid, but not in the format of an MRMC study comparing human performance with and without AI.
Effect size: Since an MRMC study is not described, the effect size is not provided. The device is an enhancement tool, not an AI for interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The VTS1000 is described as a "near-infrared (NIR) emitter, video acquisition, and head mounted display (HMD) device" that "affords viewing" and "supplements normal line of sight viewing." This indicates it's a visualization aid for human use, not a standalone algorithm that provides an output without human interpretation. Therefore, a standalone algorithm-only performance study would not be applicable or described.

7. The type of ground truth used:

Given the device's function (enhancing visualization of veins), the "ground truth" would likely be the actual presence and location of superficial veins, confirmed either visually by medical professionals (who would manually identify veins) or by the success of vascular access attempts. The document states it "effectively provided and enhanced visualization," implying that the enhanced view allowed for better or more accurate identification by the users. There is no mention of pathology or outcomes data being used for ground truth.

8. The sample size for the training set:

The VTS1000 is a hardware device with an optical system, not an AI or machine learning algorithm that requires a "training set" in the computational sense. Therefore, the concept of a training set sample size is not applicable.

9. How the ground truth for the training set was established:

As the concept of a training set is not applicable (see point 8), this information is not provided.

Summary

{0}------------------------------------------------

FEB 1 8 2011

Pre-Market Notification 510(k) Summary

K101838

1. Sponsor Information:

Company Name & Address:	VueTek™ Scientific
	PO Box 665
	25 Northbrook Drive
	Gray, Maine 04039 USA
Contact Person:	Douglas A. Moran
Contact Title:	Executive Vice President
Contact Phone Number:	(207) 657-6525
Contact Fax Number:	(207) 657-6582
Date of Summary:	June 11, 2010
Device Name and Classification:
Common and Usual Name:	Vein Locator
Proprietary Name:	VTS1000
Classification Name:	Device, Vein Location, Liquid Crystal
Classification Regulation:	21 CFR 880.6970
Regulatory Class:	Class 1
Product Code:	KZA
Performance Standards:	No applicable performance standards have beenissued under section 514 or under section 513(b) ofthe Food, Drug and Cosmetic Act.
Predicate Device(s):	Vustik® (Vustik, Inc.)Head Mounted Display (Vista Medical)

4. Description of Device:

{1}------------------------------------------------

ડ. Indications for Use:

The VTS1000 is a non-invasive electronic device to aid in the visualization of superficial vasculature. It is indicated for use during procedures requiring vascular or peripheral vessel access.

Comparison with Predicate Device(s): 6.

The VTS1000 is substantially equivalent when compared to the identified predicate devices.

7. Performance Summary:

Clinical, non-clinical, and independent testing performance data were submitted that demonstrated that the VTS1000 met design requirements and is safe and effective for its intended use. The VTS1000 conforms to IEC60601-01, IEC60601-1-2, CIE-S009/IEC-62471, ANSI IESNA RP 27.1, 27.2 and 27.3.

Clinical study results involving subjects with ages from <4 weeks to >65 years of age of varving genders, ethnicity, weight, and skin tone, demonstrated that the VTS1000 effectively provided and enhanced visualization of superficial, subcutaneous vascular structures when compared to the naked eye. The device was additionally found to be safe, portable, flexible, and provided normal line-of-sight viewing during use.

The performance data demonstrated that the VTS1000 met the established user and design requirements and performs safely and effectively as designed, for its intended use.

8. Conclusions:

The VTS1000 was determined to be substantially equivalent with similar devices currently legally commercially available.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) in the United States. The seal features the department's name encircling a symbol. The symbol consists of three stylized lines that form a human figure, representing the department's focus on health and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

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

Vuetek Scientific LLC C/O Mr. Paul Sumner Arkin Consulting Group 1733 Canton Lane, Suite B Marietta, Georgia 30062-2679

Re: K101838

Trade/Device Name: VTS1000 Regulation Number: 21 CFR 880.6970 Regulation Name: Liquid Crystal Vein Locator Regulatory Class: I Product Code: KZA Dated: February 4, 2011 Received: February 7, 2011

FEB 1 8 20 !

Dear Mr. Sumner:

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 indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and 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 misleading.

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.

{3}------------------------------------------------

Page 2- Mr. Sumner

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 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/CDRHOffices/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.htmlfor 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Jamal Assad
for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, Genera Hospital, Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

4	Indications for Use Statement
---	-------------------------------

Indications for Use Statement

510(k) Number (if known):

Device Name: VTS1000

Indications For Use:

The VTS1000 is a non-invasive electronic device to aid in the visualization of superficial vasculature. It is indicated for use in procedures requiring vascular or peripheral vessel access.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

× Over-The-Counter Use (21 CFR 801 Subpart C)

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

VueTek Scientific VTS1000 510(k)

(Division Sign-Off)
Concurrence of CDRH, Office of DevEvaluation (ODE)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K101838

Regulation Number and Section

§ 880.6970 Liquid crystal vein locator.

(a)
Identification. A liquid crystal vein locator is a device used to indicate the location of a vein by revealing variations in the surface temperature of the skin by displaying the color changes of heat sensitive liquid crystals (cholesteric esters).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.