(107 days)
No
The description details a simple electromechanical device with a software-driven electronic control unit (ECU) that controls a DC motor based on a user-adjustable knob. There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML. The software validation mentioned is likely for basic control logic and safety features, not AI/ML algorithms.
No
The device is described as a "Wire Torque Assist Device (WTAD)" used to maneuver guidewires. It does not directly treat, diagnose, or cure a disease, but rather assists in a medical procedure.
No
The device is used to maneuver guidewires during interventional or diagnostic procedures, but the device itself is a Wire Torque Assist Device that "delivers a controlled, predictable number of rotations to guidewires," which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly details hardware components such as a case, guidewire holder, batteries, motor, electronic control unit (ECU), buttons, light, and adjustment knob. While it mentions a "software driven electronic control unit," the device is clearly a physical, electrically driven device with mechanical components, not solely software.
Based on the provided information, the LiteSaber WTAD is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures." This describes a device used within the body during a medical procedure, not a device used to examine specimens outside the body.
- Device Description: The description details a mechanical device that interacts directly with a guidewire for manipulation within the body. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information based on the analysis of specimens
- Reagents or assays
The LiteSaber WTAD is a medical device used for manipulating instruments within the body during procedures. It falls under the category of interventional or surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
DQX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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
No pre-clinical or clinical data were generated to establish substantial equivalence. Bench data are considered adequate to support a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Firebow Wire Torque Assist Device (510(k) K170684)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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
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Indications for Use
510(k) Number (if known) K200120
Device Name LiteSaber Wire Torque Assist Device
Indications for Use (Describe)
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.
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) |
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Traditional 510(k) Summary
| Submitter: | Vesatek, LLC
17171 Daimler Street
Irvine, CA 92614
USA |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Brad Culbert
VP, Engineering
Vesatek, LLC
Telephone: 949-752-9642
Fax: 949-752-9658
Email: 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 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.
4
Indications for Use:
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.
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.