(107 days)
The VSI Torque Device is intended for use in manipulating a guidewire that is in the vasculature.
The VSI Torque Device is a two-part oblong-shaped, medical grade plastic device designed to be used with guidewires ranging in size from 0.014" - 0.038". The two halves of the torque device snap together and the device is then placed onto a guidewire. One half of the device is rotated to lock it onto the guidewire. The VSI Torque Device provides additional control of the movement of the guidewire.
The provided text describes the VSI Torque Device and states that its design has been qualified through "tensile and torque testing, dimensional verification, and visual inspection to verify the performance of the device." However, the text does not include specific acceptance criteria or detailed results of these tests such as numerical targets or reported performance values. It only states that "The results of the verification testing and biomaterial assessment did not raise new safety or performance questions."
Therefore, I cannot populate a table with acceptance criteria and reported device performance.
Here's what can be extracted from the provided text:
- Study Title: Not explicitly named, but the studies relate to "tensile and torque testing, dimensional verification, and visual inspection" of the VSI Torque Device.
- Purpose of Study: To verify the performance of the device and ensure substantial equivalence to predicate devices.
Here's a breakdown of the other requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text | Not specified in the provided text (The text only states that results "did not raise new safety or performance questions.") |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. The studies described are engineering verification tests, not clinical studies requiring expert ground truth establishment in the traditional sense for medical imaging or diagnostic devices.
4. Adjudication method for the test set:
- Not applicable/Not mentioned. This is typically relevant for studies involving human interpretation or subjective assessments.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The studies mentioned are engineering verification tests.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the described "tensile and torque testing, dimensional verification, and visual inspection" are standalone engineering tests of the device itself. There is no algorithm involved here; it's a physical device.
7. The type of ground truth used:
- For "tensile and torque testing, dimensional verification, and visual inspection," the ground truth would typically be established specifications, engineering drawings, and material properties. For example, a specified tensile strength, a precise dimension from a blueprint, or a visual standard for acceptable finish. The document does not detail these specific ground truths.
8. The sample size for the training set:
- Not applicable. This is an engineering device, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable. (See #8)
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K100093 p1 of 2
Vascular Solutions, Inc.
Traditional 510(k) Premarket Notification VSI Torque Device
2 510(k) Summary
APR 3 0 2010
Date Prepared: March 31, 2010
Submitter's Name / Contact Person
Manufactured for
Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 USA Establishment Registration # 2134812
Contact Person
Jennifer Ruether Sr. Regulatory Affairs Associate Tel: 763-656-4370 (direct); Fax: 763-656-4253 Email: jruether@vascularsolutions.com
General Information
| Trade Name | VSI Torque Device |
|---|---|
| Common / Usual Name | Torque Device |
| Classification Name | 870.1330 Wire, Guide, Catheter; Class II |
| Predicate Devices | K032411 Wire Vise (JS Vascular, Inc.) |
| K021243 ILT Torquer (IntraLuminal Therapeutics, Inc.) | |
| K092711 Guidewire Torquer (Zerusa Limited) |
Device Description
The VSI Torque Device is a two-part oblong-shaped, medical grade plastic device designed to be used with guidewires ranging in size from 0.014" - 0.038". The two halves of the torque device snap together and the device is then placed onto a guidewire. One half of the device is rotated to lock it onto the guidewire. The VSI Torque Device provides additional control of the movement of the guidewire.
Intended Use / Indications
The VSI Torque Device is intended for use in manipulating a guidewire that is in the vasculature.
Technological Characteristics
The VSI Torque Device, the Zerusa Guidwire Torquer, and the Wire Vise use a pin vise clamp as the mechanism to lock the torque device onto a guidewire. The VSI Torque Device and the predicate devices have similar guidewire compatibility, and the Wire Vise has the same range of guidewire compatibility as the VSI Torque Device. The VSI Torque Device and the Zerusa Guidewire Torquer consist of the same design and material of construction (medical grade plastic material, Celanex 2401 MT). The VSI Torque Device and the ILT Torquer are sterilized in an ethylene oxide process, and have similar sterile barrier packaging materials.
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Vascular Solutions, Inc.
Traditional 510(k) Premarket Notification VSI Torque Device
Substantial Equivalence and Summary of Studies
The VSI Torque Device is substantially equivalent in intended use and indications to the predicate devices. The device design has been qualified through tensile and torque testing, dimensional verification, and visual inspection to verify the performance of the device. A biomaterial assessment was conducted in accordance with ISO 10993; because the torque device does not come into direct or indirect contact with the patient, no biocompatibility testing was required. The results of the verification testing and biomaterial assessment did not raise new safety or performance questions.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
APR 3 0 2010
Vascular Solutions, Inc. C/O Ms. Jennifer Ruether Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, MN 55369
Re: K100093
Trade/Device Name: VSI Torque Device Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: April 13, 2010 Received: April 14, 2010
Dear Ms. Ruether:
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.
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
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Page 2 - Ms. Jennifer Ruether
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.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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Dura R. Varner
A Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Ki00093 510(k) Number (if known):
Device Name: VSI Torque Device
Indications for Use:
The VSI Torque Device is intended for use in manipulating a guidewire that is in the vasculature.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Posted November 13, 2003)
Dina R. Achner
(Division Sign-Off) ്. Nision of Cardiovascular Devices
10/k) Number_K100093_
§ 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.