(56 days)
Not Found
No
The summary describes a physical medical device (guide wire) and its intended use in guiding catheters. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on substantial equivalence to predicate devices based on design and materials, not algorithmic performance.
No.
The device is a guide wire used to introduce and place diagnostic or interventional devices, rather than providing therapy itself.
No
Explanation: The device described is a guide wire used for the introduction and placement of other devices, not for diagnosing a condition itself. While it can introduce diagnostic devices, it does not perform the diagnostic function.
No
The device description clearly states it is a "guide wire," which is a physical medical device used for directing catheters. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device's function as a guide wire for percutaneous entry and placement of devices within blood vessels. This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description reinforces its use within blood vessels to direct catheters and other devices. This is also an in vivo function.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. This is the core definition of an IVD.
IVDs are used outside the body to analyze samples. This device is used inside the body to facilitate medical procedures.
N/A
Intended Use / Indications for Use
The Bard Hydrophilic Coated Angiography Guide Wires are indicated for percutaneous entry into a vessel using the Seldinger technique.
The Bard Hydrophilic Coated Angioplasty (PTCA) Guide Wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary or peripheral vasculature and may be used to reach and cross a target lesion.
Product codes
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. This testing supports the guide wires covered under this 510(k) as they are of the same design and materials of construction. No changes have been made that would warrant additional testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Bard Hydrophilic Coated Guide Wire, K974713
Reference Device(s)
Terumo Glidewire
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Bard Electrophysiology Division C.R. Bard, Inc. 55 Technology Drive Lowell, MA 01851 (800) 282-1332 (978) 441-6202 Fax: (978) 323-2222 BardEP@CRBARD.COM http://www.BardEP.com
BARD
510(k) SUMMARY FOR THE VI. BARD HYDROPHILIC COATED GUIDE WIRES
As required under Section 12, part (a)(1)(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: | 55 Technology Drive, Suite 1 |
| Lowell, MA 01851 | |
| Phone: | (978) 323-2216 (Direct Line) |
| Fax: | (978) 323-2222 |
Contact:
Deborah L. Herrington Regulatory Affairs Manager
Date of Summary:
September 3, 1999
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 Hydrophilic Coated Guide Wire
- Bard Preamendment Angiographic Guide Wires
- Bard PTCA Steerable Standard Guide Wire
- Bard Silk Guide Wire
Terumo Glidewire
Image /page/0/Picture/23 description: The image shows the logo for Bard Electrophysiology. The logo consists of a heart shape on the left, followed by the word "Bard" in a larger font and the word "electrophysiology" in a smaller font below it. The heart shape is stylized and has a small circle above it.
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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 discussed in this 510(k) is similar the Bard Hydrophilic Coated Guide Wires discussed in K974713 which were 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. This testing supports the guide wires covered under this 510(k) as they are of the same design and materials of construction. No changes have been made that would warrant additional testing.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, which is a common symbol of the United States. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nov - 2 1999
Ms. Deborah L. Herrington Regulatory Affairs Manager C.R. Bard, Inc. 55 Technology Drive, Suite 1 Lowell, MA 01851
Re: K993000 Trade Name: Bard Hydrophilic Coated Guide Wires Regulatory Class: II Product Code: DQX Dated: September 3, 1999 September 7, 1999 Received:
Dear Ms. Herrington:
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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 In addition, FDA may publish further announcements concerning action. your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation
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Page 2 - Ms. Deborah L. Herrington
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 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) Additionally, for questions on the promotion and advertising 594-4586. 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,
Lyneth Jahil for
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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D. INDICATIONS FOR USE
Bard Hydrophilic Coated Guide Wires Device Name:
Indications for Use:
The Bard Hydrophilic Coated Angiography Guide Wires are indicated for percutaneous entry into a vessel using the Seldinger technique.
The Bard Hydrophilic Coated Angioplasty (PTCA) Guide Wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary or peripheral vasculature and may be used to reach and cross a target lesion.
Contraindications: None
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use __
L. alml. de Leon 1/1/99
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K 993000 510(k) Number