This device is intended for use as a torque device for guidewires with a diameter of 0.014 --0.038" to facilitate twisting and advancing the guidewire during a procedure.

Device Description

The JS Vascular Guide Wire Vise™ is a sterile single-use wire vise/torque device consisting of a dual pin vise clamp construction. Guidance and tracking of a guidewire through the coronary or peripheral vasculature is accomplished by manual manipulation of the vise.

AI/ML Overview

The provided document is a 510(k) summary for the JS Vascular Guide Wire Vise™. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information on acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria in the same way a PMA (Pre-Market Approval) or clinical trial might.

Therefore, I cannot extract the requested information from the provided text. The document does not describe:

A table of acceptance criteria and the reported device performance: This is not present.
Sample size used for the test set and the data provenance: No test set or study data is described.
Number of experts used to establish the ground truth for the test set and qualifications: Not applicable as no test set is detailed.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
Standalone performance study (algorithm only without human-in-the-loop performance): Not applicable as this is a physical medical device, not an AI algorithm.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The document states that "performance testing results provided in this pre-market notification" were used to demonstrate substantial equivalence, but these results are not detailed in the provided text. For 510(k) submissions of devices like this torque device, performance testing usually involves bench testing to ensure the device performs its intended mechanical function safely and effectively (e.g., proper gripping of guidewires, durability, biocompatibility if applicable). However, the specific details of such tests, their acceptance criteria, and results are not included in this summary.

Summary

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2. 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number:	TBD K032411
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Applicant Information:

Date Prepared:	August 4, 2003
Name:	JS Vascular, Inc.
Address:	3337 N. Miller Rd. Ste. 105Scottsdale, AZ 85251Office: 480-607-1927Fax: 480-948-0179
Contact Person:	Michael A. Daniel
Phone Number:	Office: 925-254-5228 / Cell 415-407-0223
Facsimile Number:	(925) 254-5187

Device Information:

Classification:	Class II
Trade Name:	JS Vascular Guide Wire Vise™
Common Name:	Torque Device, Wire Vise
Classification Name:	Catheter guidewire accessory, 74 DQX / 21 CRF 870.1330

Predicate Devices:

The JS Vascular Guide Wire Vise™ is substantially equivalent in intended use and method of operation to the following predicate devices:

Terumo Corp. Torque Device for a Guide Wire (K910969) Boston Scientific WireClip™ Torquer (K003898) Advanced Cardiovascular Services ACS Torque Device (K950752) Schneider-Shiley Wire Torquer (K861606) Advanced Cardiovascular Services Snap-on Torquer (K862409) Procedure Products Torque Device (K922356)

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Device Description:

Intended Use:

This device is intended for use as a torque device for guidewires with a diameter of 0.014 -0.038" to facilitate twisting and advancing the guidewire during a procedure.

Comparison to Predicate Device(s):

The JS Vascular Guide Wire Vise™ is substantially equivalent to the previously cleared Advanced Cardiovasuclar System's ACS Torque Device (K950752) and to Boston Scientific's WireClip™ Torquer (K003898) in terms of embodiment, pin vise shape, appearance and function. It has the same indications for use and makes use of the identical mechanism of action-a pin vise clamp.

Summary:

Based upon the intended use, product technical information, and performance testing results provided in this pre-market notification, the JS Vascular Guide Wire Vise™ has been shown to be substantially equivalent to currently marketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 7 2003

JS Vascular, Inc. c/o Mr. Michael A. Daniel Regulatory and Clinical Affairs 3337 N. Miller Rd. Ste. 105 Scottsdale, AZ 85251

Re: K032411

Trade Name: JS Vascular Guide Wire Vise™ Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: August 4, 2003 Received: August 5, 2003

Dear Mr. Daniel:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Michael A. Daniel

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

[signature]

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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4. INDICATIONS FOR USE FORM

510(k) Number (if known): __ TBD

JS Vascular Guide Wire Vise™ Device Name:

Indications For Use:

This device is intended for use as a torque device for guidewires with a diameter of 0.014 --0.038" to facilitate twisting and advancing the guidewire during a procedure.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use	X	OR	Over-The-Counter Use ______
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K032411

JS Vascular, Inc. Guide Wire Vise™ 510(k) Submission. 08/4/03

Page 10 of 25

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.