(89 days)
The Cordis Hydronol Steerable Guidewires are designed for use in angiographic procedures to introduce and position catheters and interventional devices within the peripheral vasculature.
The Cordis Hydronol Steerable Guidewire is constructed from a superelastic nitinol core wire. A hydrophilic coating is applied over the guidewire. Cordis Hydronol Steerable Guidewires have a flexible, shapeable, and highly radiopaque platinum alloy coil on the distal tip.
This report describes the acceptance criteria and the study conducted to demonstrate that the Cordis Hydronol Steerable Guidewire meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) premarket notification for a medical device (guidewire) and does not contain explicit, quantitative acceptance criteria or detailed performance study results in the format typically used for AI/ML device evaluations. Instead, it focuses on demonstrating substantial equivalence to predicate devices through design, construction, indication for use, and performance characteristics.
The "performance" referred to in this document primarily relates to the device's functional integrity and safety as compared to existing, legally marketed guidewires. The key performance-related statement is:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993-1 standards for materials used. | "All appropriate Biocompatibility tests were successfully performed on the materials used for the Cordis Hydronol Steerable Guidewires per ISO 10993-1." (Page 1, under "Biocompatibility") |
| Functional Equivalence: Be similar in performance characteristics to other commercially available hydrophilic steerable guidewires. | "The Cordis Hydronol Steerable Guidewire is similar in design, construction, indication for use and performance characteristics to other commercially available hydrophilic steerable guidewires." (Page 1, under "Summary of Substantial Equivalence") This is a qualitative claim of similarity rather than a quantitative performance metric. |
| Safety: Device materials and construction should not pose undue risk in clinical use. | Implied by successful biocompatibility testing and substantial equivalence claim. No specific quantitative safety metrics are reported. |
| Intended Use: Function effectively for its stated Indications for Use (introduce and position catheters/interventional devices within peripheral vasculature). | Implied by the design and comparison to predicate devices used for the same purpose. No specific quantitative performance metrics (e.g., steerability force, pushability, torque transmission, tip flexibility, coating durability) are provided in this summary. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical "test set" in the context of evaluating a medical device's performance through a study with specific data points or patient cases. The evaluation is based on pre-clinical testing (biocompatibility) and a declaration of substantial equivalence to existing predicate devices.
- Sample Size for Testing: Not specified for functional performance. Biocompatibility tests would involve specific samples of device materials, but the number is not detailed.
- Data Provenance: Not applicable in the context of clinical data. Biocompatibility testing is typically conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This type of submission relies on:
- Regulatory Experts: FDA reviewers (like Thomas J. Callahan, Ph.D., Director, Division of Cardiovascular, Respiratory, and Neurological Devices) make the determination of substantial equivalence based on the submitted documentation and their knowledge of medical device regulations and relevant science.
- Company Experts: The manufacturer (Cordis Corporation) employs engineers, scientists, and regulatory affairs personnel (e.g., Ms. Jacqueline Zimovan) who design the device, conduct tests, and compile the submission based on their expertise.
There's no mention of external clinical experts establishing "ground truth" for a test set in this 510(k) summary.
4. Adjudication Method for the Test Set
Not applicable, as there is no described clinical test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is common for diagnostic imaging devices, especially those incorporating AI, and involves multiple readers evaluating cases with and without AI assistance to measure human performance improvement. This document is for a mechanical guidewire and does not involve such an evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a physical, mechanical guidewire, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by existing regulatory standards and successful predicate devices.
- Biocompatibility: ISO 10993-1 provides the "ground truth" standard for safety of materials in contact with the body.
- Functional Performance: The performance of the predicate devices (Terumo Radifocus Glidewire, LRM Steerable Hydrophilic Guidewire) serves as the "ground truth" for acceptable performance characteristics, asserting that the new device is "similar."
8. The Sample Size for the Training Set
Not applicable. This submission does not involve an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI/ML model, there is no training set or associated ground truth establishment process for a training set.
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00-000008
K973845
JAN - 5 1998
Summary Of Safety And Effectiveness
| GeneralProvisions | The name of the device is: |
|---|---|
| ----------------------- | ---------------------------- |
| Proprietary Name | Common or Usual Name |
|---|---|
| Cordis Hydronol Steerable Guidewire | Catheter Guide Wire |
| PredicateDevice | The name of the predicate devices are: |
|---|---|
| • Terumo Radifocus Glidewire | |
| • LRM Steerable Hydrophilic Guidewire |
| Classification | The FDA has classified catheter guide wires as: |
|---|---|
| • Class II, 21CFR 870.1330, 74 DQX |
| PerformanceStandards | Performance standards have not been established by the FDA under Section 514 of the Food, Drug, and Cosmetic Act. |
|---|---|
| -------------------------- | ------------------------------------------------------------------------------------------------------------------- |
| Indications forUse | The Cordis Hydronol Steerable Guidewires are designed for use in angiographic procedures to introduce and position catheters and interventional devices within the peripheral vasculature. |
|---|---|
| ------------------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| DeviceDescription | The Cordis Hydronol Steerable Guidewire is constructed from a superelastic nitinol core wire. A hydrophilic coating is applied over the guidewire. Cordis Hydronol Steerable Guidewires have a flexible, shapeable, and highly radiopaque platinum alloy coil on the distal tip. |
|---|---|
| ----------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Continued on next page PREMARKET NOTIFICATION Cordis Corporation
Hydronol Steerable Guidewire
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Summary Of Safety And Effectiveness, Continued
| Biocompatibility | All appropriate Biocompatibility tests were successfully performed on the materials used for the Cordis Hydronol Steerable Guidewires per ISO 10993-1. |
|---|---|
| Summary ofSubstantialEquivalence | The Cordis Hydronol Steerable Guidewire is similar in design, construction, indication for use and performance characteristics to other commercially available hydrophilic 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).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its head and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jacqueline Zimovan Regulatory Affairs Associate Cordis Corporation P.O. Box 025700 Miami, Florida 33102-5700
JAN - 5 1998
Re : K973845 Cordis Hydronol Steerable Guidewire Regulatory Class: II (two) Product Code: DQX Dated: October 7, 1997 Received: October 8, 1997
Dear Ms. Zimovan:
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 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 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 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.
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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) 594-4648. 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" (21 CFR 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/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
| 510(K) Number (if known): | [To be assigned by the FDA] |
|---|---|
| Device Name: | Hydronol Steerable Guidewire |
| Indications for Use: | The Cordis Hydronol Steerable Guidewires are designed for use inangiographic procedures to introduce and position catheters andinterventional 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)
Tina A Ry
(Division Sign-Off) Division of Cardinvoscular Respiratory, - ad New .
510(k) Number K973843
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use _
PREMARKET NOTIFICATION Cordis Corporation Hydronol Steerable Guidewire
§ 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.