(157 days)
TAD II Guide Wire System 510K Number Unknown, Wholey Hi-Torque Guide Wire System K861765
Not Found
No
The description focuses on the mechanical and material properties of a guidewire and does not mention any computational or algorithmic features indicative of AI/ML.
No
The device is a guidewire used to introduce and position other devices; it does not directly treat a medical condition.
No
The device is a guidewire used to introduce and position other devices, not to diagnose a condition.
No
The device description clearly describes a physical guidewire made of stainless steel and platinum alloy, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "angiographic procedures to introduce and position catheters and interventional devices within the peripheral vasculature." This describes a device used within the body for a medical procedure, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description details a physical guidewire with a corewire, coil, and potential steering device. This aligns with a medical device used in a procedure, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Cordis Vanguard Steerable Guidewires are a medical device used in interventional procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cordis Vanguard Guidewire is intended for use in angiographic procedures to introduce Indications for and position catheters and interventional devices within the peripheral vasculature. Use
The Cordis Vanguard Steerable Guidewires are designed for use in angiographic procedures to introduce and position catheters and interventional devices within the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
74DQX, DQX
Device Description
The Cordis Vanguard Steerable Guidewires have a multi-tapered stainless steel corewire with a soft, flexible, highly radiopaque platinum alloy coil over the tip. A steering / torquing device may be attached to aid in steering/torquing the guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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.
TAD II Guide Wire System 510K Number Unknown, Wholey Hi-Torque Guide Wire System K861765
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
00-00008
K974560
MAY | | 1998
Image /page/0/Picture/2 description: The image shows the logo for Cordis, a Johnson & Johnson company. The word "Cordis" is written in a bold, sans-serif font, with a thick line underneath. Below the line, the words "a Johnson & Johnson company" are written in a smaller, serif font. The logo is simple and professional, and it clearly identifies the company.
510(k) Summary of Safety and Effectiveness
Date: December 4, 1997
General Information
| Manufacturers Address | Contact |
|---|---|
| Cordis Corporation | |
| 14201 NW 60th Avenue | |
| Miami Lakes, Florida 33014 | Dennis Griffin |
| Proprietary Name | Common/Usual Name |
|---|---|
| Cordis Vanguard Steerable | |
| Guidewire | Catheter Guide Wire |
| Classification | Catheter Guide Wire |
|---|---|
| Class II, 21 CFR 870.1330, 74DQX |
| Predicate | TAD II Guide Wire System 510K Number Unknown |
|---|---|
| Devices | Wholey Hi-Torque Guide Wire System K861765 |
| management of the program of the promote of Propertial of Propertial Andrews of Children and Children and Children and | |
| ად იდლისიის მაკულტული სამხრეთვე დღება 1930 წლების მონაწილეოდა სოციალი სამარტი დღელები მამ P-ზილეთი სათარი მარტი სამხრეთით სამარტი მო |
Performance standards have not been established by the FDA under section 514 of the Food Performance and Drug Cosmetic Act. Standards
The Cordis Vanguard Guidewire is intended for use in angiographic procedures to introduce Indications for and position catheters and interventional devices within the peripheral vasculature. Use
ので、その他の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の
The Cordis Vanguard Steerable Guidewires have a multi-tapered stainless steel corewire Device with a soft, flexible, highly radiopaque platinum alloy coil over the tip. A steering / Description torquing device may be attached to aid in steering/torquing the guidewire.
Continued on next page
PREMARKET NOTIFICATION Cordis Corporation Vanguard Steerable Guidewire
1
Image /page/1/Picture/1 description: The image shows the word "Cordis" in a bold, sans-serif font. There is a horizontal line underneath the word. Below the line, the text "a Johnson & Johnson company" is written in a smaller, cursive font. The text is black and the background is white.
510(k) Summary of Safety and Effectiveness, Continued
Biocompatibility
All appropriate Biocompatibility tests were successfully performed on the materials used for the Cordis Vanguard Steerable Guidewires per ISO 10993-1.
Summary of Substantial Equivalence
I
The Cordis Vanguard Steerable Guidewire is similar in design, construction, indication for use and performance characteristics to other commercially available steerable guidewires.
Any statement of substantial equivalence to another product is required by 21 CFR 807.87, and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent, and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, "... a determination of substantial equivalence under the federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520, et seg. (1977).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY | | 1998
Mr. Dennis S. Griffin Manager, Regualtory and Clinical Affairs Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014
Re : K974560 Cordis Vanguard Steerable Guidewires Trade Name: Requlatory Class: II Product Code: DQX Dated: March 30, 1998 Received: March 31, 1998
Dear Mr. Griffin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act
3
Page 2 - Mr. Dennis S. Griffin
for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
INDICATIONS FOR USE
| 510(K) Number (if known): [To be assigned by the FDA] | |
|---|---|
| Device Name: | Vanguard Steerable Guidewire |
| Indications for Use: | The Cordis Vanguard Steerable Guidewires are designed for use in |
| angiographic procedures to introduce and position catheters and | |
| interventional devices within the peripheral vasculature. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Th. A. R.
(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular, Res Division of ourological Devices 510(k) Number
ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ Prescription Use (Per 21 CFR 801.109)
OR
ﺔ ﺍﻟﻤﺘﺤﺪﺓ
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
PREMARKET NOTIFICATION Cordis Corporation Vanguard Steerable Guidewire