(193 days)
These guidewires are intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.
The material of construction is stainless steel which is consistent with guidewires presently in commercial distribution. The wires are also manufactured using a PTFE coating. The wires are available straight, with "J" end, or moveable core. The wires range from .014" diameter through .065' diameter and lengths from 15cm. to 400cm.
The provided text describes a 510(k) premarket notification for Galt Medical's Guidewires, focusing on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, many of the requested categories for a study that proves a device meets acceptance criteria cannot be extracted because such a study was not performed or detailed in the provided documents. The submission relies on non-clinical testing and comparison to predicate devices, not human or animal clinical trials with specific performance metrics for acceptance.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-Clinical Functional and Performance Characteristics: | Functionality and performance characteristics are comparable to currently marketed guidewires (predicate devices). |
| - Tensile Strength | Comparable to predicate devices. |
| - Torque Strength | Comparable to predicate devices. |
| - Torqueability | Comparable to predicate devices. |
| - Flexibility | Comparable to predicate devices. |
| - Coating Adherence | Comparable to predicate devices. |
| Substantial Equivalence: | The guidewires are considered substantially equivalent to legally marketed predicate devices (Argon Medical, Cordis, Cook Acme - K920884). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. Non-clinical tests were performed, but the number of guidewires tested for each characteristic is not detailed.
- Data Provenance: Not specified. This would be non-clinical lab data, likely from in-house testing by Galt Medical Corp. in Garland, TX, USA. It is prospective testing, as it was conducted for the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This was a non-clinical device performance claim, not a diagnostic or clinical efficacy study requiring expert-established ground truth. The "ground truth" for non-clinical tests would be established by industry standards, design specifications, and comparison to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was a non-clinical device performance claim, not a clinical study involving human judgment or adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a guidewire, a physical medical device for interventional procedures, not an AI or imaging diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a guidewire, not an algorithm. The "standalone" performance refers to the device's functional integrity as evidenced by the non-clinical tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable directly. For the non-clinical tests, the "ground truth" is implied by accepted engineering standards for tensile strength, torque, flexibility, and coating adherence for guidewires, as well as the performance characteristics of the legally marketed predicate devices. The focus is on demonstrating comparable physical and mechanical properties.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this type of device submission.
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510(k) Summary of Safety and Effectiveness for Galt Medical's Guidewires (Prepared in accordance with 21 CFRPart 807.92) Date 1/28/99
510(k) Number: K982559
(1) Submitter: Galt Medical Corp. 2475 Merritt Drive Garland, TX 75041 (972) 271-5177 Contact Person: David Catlin
- (2) Device Name: Guidewire Trade Name: No proprietary name has been established. Classification Name: Wire, Guide, Catheter Classification Code: 74DQX
- (3) Substantial Equivalency: Galt Medical Corp.'s guidewires are substantially equivalent to guidewires from: Argon Medical
Cordis Cook Acme 510(k) K920884
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(4) Device Description and Intended Use: The material of construction is stainless steel which is consistent with guidewires presently in commercial distribution. The wires are also manufactured using a PTFE coating. The wires are available straight, with "J" end, or moveable core. The wires range from .014" diameter through .065' diameter and lengths from 15cm. to 400cm.
These guidewires are intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature. -
(5) Technological Characteristics: Galt Medical's guidewires have the same indications for use and are otherwise technically the same as the predicate devices
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(6) Non-Clinical Tests: The results of these tests demonstrated that the functionality and performance characteristics of the guidewires are comparable to the currently marketed guidewires. Tests performed include: tensile strength, torque strength, torqueablility, flexibility, and coating adherence.
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(7) Conclusions: Based on the information presented in this 510(k) premarket notification, Galt Medical's guidewires are considered substantially equivalent to the currently marketed predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which is the department's symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1999
Mr. David G. Catlin Executive Vice President Galt Medical Corporation 2475 Merritt Drive Garland, TX 75041
K982559 Re : Guidewire Trade Name: Regulatory Class: II Product Code: DQX Dated: January 19, 1999 Received: January 20, 1999 :
Dear Mr. Catlin:
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 Register. Please note: this response to
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Page 2 - Mr. David G. Catlin
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 requlations.
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) 594-4586. 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 requlation 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. Callahon
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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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:____ GILDELIRE
Indications For Use:
These guidewires are intended for use in percutaneous procedure to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER. PAGE IN NEEDED)
Conourrence of CDRH, Office of Device Evaluation (ODE)
Ohitorn Attr
(Division Sign-Off) · Division of Cardiovascular, Respiratory, and Neurological Devices 982559 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formst 1-2-96)
§ 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.