(63 days)
Not Found
No
The device description and intended use clearly describe a manual mechanical tool for manipulating guidewires. There is no mention of AI, ML, image processing, or any other computational or data-driven features.
No
The device is a tool to facilitate the manipulation of guidewires during a procedure, not a device that directly treats a condition or disease. It is a mechanical aid for a medical procedure rather than a therapeutic instrument itself.
No.
The device is described as a torque device for guidewires, intended to facilitate twisting and advancing the guidewire, which is a therapeutic or interventional function, not diagnostic.
No
The device description clearly states it is a "sterile single-use wire vise/torque device consisting of a dual pin vise clamp construction," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "use as a torque device for guidewires... to facilitate twisting and advancing the guidewire during a procedure." This describes a tool used during a medical procedure to manipulate a guidewire within the body.
- Device Description: The description confirms it's a "wire vise/torque device" for "Guidance and tracking of a guidewire through the coronary or peripheral vasculature." This is a mechanical tool for manipulating a medical device in vivo.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. This device does not interact with patient specimens or perform any diagnostic testing.
Therefore, the JS Vascular Guide Wire Vise™ is a medical device used in vivo during a procedure, not an in vitro diagnostic device.
N/A
Intended Use / 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.”
Product codes (comma separated list FDA assigned to the subject device)
DQX
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.”
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
“coronary or 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K950752, K003898, K910969, K861606, K862409, K922356
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 |
|---|---|
| ---------------- | ------------- |
Applicant Information:
| Date Prepared: | August 4, 2003 |
|---|---|
| Name: | JS Vascular, Inc. |
| Address: | 3337 N. Miller Rd. Ste. 105 |
| Scottsdale, AZ 85251 | |
| Office: 480-607-1927 | |
| Fax: 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)
1
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.
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.
2
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.
3
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) | |
|---|---|
| -------------------------------------------------------- | -- |
| 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
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