The LiteSaber WTAD is used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. The LiteSaber WTAD is not intended for use in the neurovasculature.

Device Description

The LiteSaber Wire Torque Assist Device (WTAD) is an electrically driven device that delivers a controlled, predictable number of rotations to guidewires.

The device consists of an ergonomically designed white case, onto which is attached a guidewire holder with a pin vise clamp. Once the pin vise is screwed open, the lumen is opened to permit the insertion of guidewires ranging in size from 0.009" – 0.018" in diameter into the holder. Screwing the pin vise clamp closed causes the inserted device to be firmly clamped into place.

The inside of the case contains a pack of three AAA batteries, a miniature brushed DC motor and a software driven electronic control unit (ECU). The outside of the case has a red button to turn the power on, a green light that illuminates when the unit is turned on, and a black adjustment knob at the bottom of the case to control the number of rotations. The number of rotations can be adjusted from 0 - 8 by rotating the knob in the direction shown by the indicator (increase or decrease rotations). If the user requires that the rotations be halted mid-procedure, then either the power may be turned off using the red button, or the white clamp can be held. Both actions will stop the rotations from occurring.

The device is provided sterile and is intended for single use.

AI/ML Overview

The provided text is a 510(k) Summary for the LiteSaber Wire Torque Assist Device. This document focuses on demonstrating substantial equivalence to a predicate device through bench testing, rather than presenting a study where a device's performance is compared against acceptance criteria in the way typically seen for diagnostic AI/ML devices or clinical effectiveness studies.

Therefore, much of the requested information regarding acceptance criteria for device performance, study details (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance), ground truth details (type, training set size, and how established) is not applicable or not present in this type of FDA submission.

However, I can extract information related to the device's technical specifications and the non-clinical performance data that was collected to support substantial equivalence.

Here's the breakdown of the information that can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific numerical acceptance criteria and reported device performance for these tests in a table format. It only lists the types of tests performed and states that "All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements."

Acceptance Criteria Category	Reported Device Performance
Power Activation	Met acceptance criteria and pre-determined product specifications.
Control Knob Functionality	Met acceptance criteria and pre-determined product specifications.
Guidewire Rotation	Met acceptance criteria and pre-determined product specifications.
Manual Torque Override	Met acceptance criteria and pre-determined product specifications.
Peak Rotational Speed	Met acceptance criteria and pre-determined product specifications.
Rotations in CW and CCW Directions	Met acceptance criteria and pre-determined product specifications.
Torque Output	Met acceptance criteria and pre-determined product specifications.
Minimum Battery Life	Met acceptance criteria and pre-determined product specifications.
Software Validation	Met acceptance criteria and pre-determined product specifications.
EMC and Product Safety	Met acceptance criteria and pre-determined product specifications.
Sterilization (ISO 11135, AAMI TIR 28)	Demonstrated continued compliance with sterilization requirements, maintaining SAL of 10-6.
Transportation and Shelf Life (ISTA 2A)	Performed and data supports substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document states "bench testing" was performed, which typically involves a defined number of units or test configurations, but specific sample sizes are not provided.
Data Provenance: Not specified. The tests were performed pursuant to Vesatek's risk analysis, implying internal testing, likely in the US (where Vesatek is located). The data is from "bench testing," which is a form of prospective simulation/testing rather than data collected from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a mechanical torque assist device. "Ground truth" in the clinical or imaging sense (e.g., expert consensus on medical images) is not relevant to its performance evaluation for substantial equivalence in this context. The performance was evaluated against engineering specifications and standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept applies to human interpretation of data, typically in diagnostic studies. Bench testing of a mechanical device does not involve adjudication.

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

Not applicable. This device is not an AI/ML diagnostic tool, and no MRMC study was conducted or mentioned. The submission explicitly states: "No pre-clinical or clinical data were generated to establish substantial equivalence. Bench data are considered adequate to support a determination of substantial equivalence."

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

Not applicable. This device is a manual assist device for guidewires, not an algorithm, and does not have a "standalone" algorithmic performance in the context of AI/ML or diagnostic imaging. The bench tests evaluate the device's mechanical and electrical functions.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this type of device's performance evaluation would be its adherence to engineering specifications, design requirements, and relevant industry standards, as measured by various bench tests. It's an objective measurement against defined parameters, not a subjective clinical "ground truth."

8. The sample size for the training set

Not applicable. This device is not an AI/ML product that undergoes machine learning training.

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

Not applicable. As above, this device does not involve a training set for machine learning.

Summary

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

May 7, 2020

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Vesatek, LLC Paul Gasser Medical Device RA/QA Consultant 17171 Daimler Street Irvine, California 92614

Re: K200120

Trade/Device Name: LiteSaber Wire Torque Assist Device Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: April 6, 2020 Received: April 6, 2020

Dear Paul Gasser:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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 of medical device-related adverse events) (21 CFR 803) for

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

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/ training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance/contact-usdivision-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K200120

Device Name LiteSaber Wire Torque Assist Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

Traditional 510(k) Summary

Submitter:	Vesatek, LLC17171 Daimler StreetIrvine, CA 92614USA
Contact:	Brad CulbertVP, EngineeringVesatek, LLCTelephone: 949-752-9642Fax: 949-752-9658Email: bsculbert@yahoo.com
Date Summary Prepared:	May 6, 2020
Device Trade Name:	LiteSaber Wire Torque Assist Device
Common Name:	Torque Device
Classification Name:	Catheter guide wire (21 CFR 870.1330)
Product Code:	DQX
Predicate Device:	Firebow Wire Torque Assist Device(510(k) K170684)

Device Description:

The LiteSaber Wire Torque Assist Device (WTAD) is an electrically driven device that delivers a controlled, predictable number of rotations to guidewires.

The device is provided sterile and is intended for single use.

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

Indications for Use:

Statement of Equivalence:

The subject device and the predicate share the same intended use and have the same fundamental technological characteristics.

Key technological differences between the subject and predicate devices are reflected in the following table.

Design Features	Predicate	Subject
	Firebow Wire Torque Assist Device	LiteSaber Wire Torque Assist Device
Overall design	Spring tension, push button clamp to grasp the guidewire, attached to a case containing two AAA batteries, a stepper motor and an electronic control unit (ECU)	Pin vise clamp to grasp the guidewire, attached to a case containing three AAA batteries, a brushed DC motor and an electronic control unit (ECU)
Torque assist provided by	Motor	Same
Power provided by	2 AAA batteries	3 AAA batteries
Activation strip	Present	None
Rotations	0 – 8	Same
Markings for number of rotations selected	None	Indicator showing which direction to turn to either increase or decrease the number of rotations
Guidewire compatibility (inches)	0.014 - 0.038	0.009 - 0.018
Materials	Plastic and stainless steel	Same

The LiteSaber Wire Torque Assist Device is substantially equivalent to the predicate device.

Summary of Non-Clinical Performance Data:

Device evaluation consisted of bench testing performed pursuant to Vesatek's risk analysis. All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements. The following design verification testing was performed to support the determination of substantial equivalence:

Power activation Control knob functionality Guidewire rotation Manual torque override Peak rotational speed Rotations in CW and CCW directions Torque output Minimum battery life Software validation EMC and product safety

{5}------------------------------------------------

Biocompatibility Testing:

Biocompatibility testing was not conducted, as the subject device has no patient contact.

Sterilization Testing:

ISO 11135 is used to ensure continued compliance with sterilization requirements and to maintain a sterility assurance level (SAL) of 10-6.

A sterilization adoption assessment was conducted in accordance with AAMI TIR 28 in order to support the ability of the current sterilization cycle to adequately sterilize the subject device.

Transportation and Shelf Life Testing:

Shipping and distribution testing was conducted in accordance with ISTA 2A.

Shelf life testing was performed.

The data from the bench testing supports the substantial equivalence of the subject device to the predicate device.

Summary of Pre-Clinical and Clinical Data:

No pre-clinical or clinical data were generated to establish substantial equivalence. Bench data are considered adequate to support a determination of substantial equivalence.

Summary:

Based on the intended use and bench testing information provided in this premarket notification, the LiteSaber Wire Torque Assist Device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.