(301 days)
Bard® Preamendment Angiographic Guide Wires, Bard® PTCA Steerable Standard Guide Wire, Bard® Silk™ Guide Wire, Terumo Glidewire™
Not Found
No
The document describes a physical medical device (guide wire) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a guide wire used for the introduction and placement of diagnostic or interventional devices, rather than directly treating a condition itself.
No
The device is a guide wire used for the introduction and placement of diagnostic or interventional devices, but it is not itself a diagnostic device.
No
The device description clearly indicates it is a physical guide wire, a hardware component, used for directing catheters within blood vessels.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used within the body for guiding catheters and other devices in blood vessels. This is an in vivo application.
- Device Description: The description reinforces the in vivo use by stating it fits inside a catheter to direct it through a blood vessel.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with the body internally for diagnostic or interventional purposes like a guide wire does.
N/A
Intended Use / Indications for Use
Hydrophilic Coated Angiography Guide Wires are indicated for use for percutaneous entry into a vessel using the Seldinger technique. Hydrophilic Coated Angioplasty (PTCA) Guide Wires are steerable guidewires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The Bard Hydrophilic Coated Guide Wire is a guide wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. They may be used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion.
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)
Safety and performance testing was performed to demonstrate that the Bard Hydrophilic Coated Guide Wire is substantially equivalent to the predicate devices.
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.
Bard® Preamendment Angiographic Guide Wires, Bard® PTCA Steerable Standard Guide Wire, Bard® Silk™ Guide Wire, Terumo Glidewire™
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.
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Image /page/0/Picture/0 description: The image shows a date, "OCT 1 4 1998", in a simple, sans-serif font. The letters and numbers are printed in black ink against a white background. The date is formatted with the month abbreviated as "OCT", followed by the day "14", and the year "1998".
C.R. Bard, Inc. Requlatory Affairs 129 Concord Road P.O. Box 566 Billerica, MA 01821 508-667-2511 FAX: (508) 667-8594
Image /page/0/Picture/3 description: The image shows the letters "USCI" in bold, black font. The letters are enclosed in a thin, black oval. The letters are evenly spaced within the oval.
SECTION 6.0 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
As required under Section 12, part (a)(I)(3A) of the Safe Medical Device Act of 1990, an adequate summary of any information respecting safety and effectiveness follows.
General Information
| Submitter Information: | |
|---|---|
| Name: | C.R. Bard, Inc. |
| Address: | 129 Concord Road, Billerica, MA 01821 |
| Phone: | (978) 667-2511 extension 4131 |
| Fax: | (978) 667-8594 |
| Contact: | |
| Fred Boucher | |
| Regulatory Affairs Manager | |
| Date of Summary: | |
| December 16, 1997 | |
| Name of Device: | |
| Bard® Hydrophilic Coated Guide Wire | |
| Common/Usual Name of Device: | |
| Catheter Guide Wire | |
| Device Classification: | |
| 21 CFR 870.1330 | |
| Predicate Device(s): | |
| Bard® Preamendment Angiographic Guide Wires | |
| Bard® PTCA Steerable Standard Guide Wire | |
| Bard® Silk™ Guide Wire | |
| Terumo Glidewire™ |
Image /page/0/Picture/8 description: The image shows the word "BARD" in a stylized, blocky font. The letters are thick and outlined in black, with the interior of the letters being white. The font style gives the word a bold and somewhat retro appearance.
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Description and Intended Use of Device: �
The Bard Hydrophilic Coated Guide Wire is a guide wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. They may be used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion.
Hydrophilic Coated Angiography Guide Wires are indicated for use for percutaneous entry into a vessel using the Seldinger technique. Hydrophilic Coated Angioplasty (PTCA) Guide Wires are steerable guidewires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion.
Technological Characteristics Summary: �
The Bard Hydrophilic Coated Guide Wire is similar to the Terumo Glidewire regarding materials and construction, and is similar to Bard Silk Guide Wires, Bard Angiography Guide Wires and Bard PTCA Steerable Standard Guide Wire regarding materials and construction, packaging and sterilization. The indications for use are similar to both Terumo Glidewire and the Bard Guide Wires. They are all indicated for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion.
� Performance Data:
Safety and performance testing was performed to demonstrate that the Bard Hydrophilic Coated Guide Wire is substantially equivalent to the predicate devices.
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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads. The eagle is facing to the right.
Public Health Service
OCT 1 4 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Fred L. Boucher Requlatory Affairs Manager Bard Cardiology Division C.R. Bard, Inc. 129 Concord Road P.O. Box 566 Billerica, MA 01821
Re: K974713 Bard® Hydrophilic Coated Guide Wires Trade Name: Requlatory Class: II Product Code: DQX Dated: July 16, 1998 Received: July 16, 1998
Dear Mr. Boucher:
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 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). 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this
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Paqe 2 - Mr. Fred Boucher
response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act 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 leqally 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use D.
Device Name: Hydrophilic Coated Guide Wire Indications for Use: Hydrophilic Coated Angiography Guide Wires are indicated for use for percutaneous entry into a vessel using the Seldinger technique. Hydrophilic Coated Angioplasty (PTCA) Guide Wires are steerable guidewires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. None Contraindications:
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tn A. D
(Division Sign-Off) Division of Cardiovascula and Neurological Devic 510(k) Number
Prescription Use X (Per 21 CFR 801.109)
Over-the Counter Use OR
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