(284 days)
The Cordis STEER-IT Deflecting Tip Guidewires are intended for use in angiographic and interventional devices within the coronary and peripheral vasculature.
The Cordis STEER-IT Deflecting Tip Guidewire is similar in design and materials to the Cordis Wizdom Steerable Guidewire, Lake Region Manufacturing, Inc. Mandrel Guidewire, and the Lake Region Manufacturing, Inc. Steerable PTCA Guidewire. The difference is that the STEER-IT Deflecting Tip Guidewire employs a handle mechanism, which deflects the distal tip in two directions. The handle mechanism is butted into a stainless steel hypotube, which is soldered to a nitinol hypotube. The handle mechanism is similar to the USCI Commander™ Deflection Handle, an accessory of the USCI PilotWire™ Deflectable Guide Wire. The distal end of the STEER-IT Deflecting Tip Guidewire (3mm or 7mm) of the nitinol inner core wire is flattened, looped around and joined to the nitinol hypotube. The handle mechanism operates the movement of the distal tip by gripping the inner moveable core and allowing limited movement in two directions.
The provided text describes a 510(k) submission for the Cordis STEER-IT Deflecting Tip Guidewire. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies to prove safety and effectiveness. Therefore, the information requested in the prompt, which is typically derived from clinical trials or performance studies, is largely not present in this document.
However, based on the text, I can infer and state what is available regarding acceptance criteria and performance:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical/Physical Properties (e.g., joint strength, torqueability, coating integrity, linear stiffness, turns to failure, dimensional testing) | "The Cordis STEER-IT Deflecting Tip Guidewire passed all the established acceptance criteria." |
| Biocompatibility | "All materials were determined to be biocompatible." / "Biocompatibility... demonstrates no significant change to product characterization when compared to the predicate device." |
| Functional Equivalence | Similar in design, materials, and function to predicate steerable guidewires, specifically featuring a handle mechanism to deflect the distal tip in two directions, similar to the USCI Commander™ Deflection Handle. |
Study Information Pertaining to Acceptance Criteria:
-
Sample size used for the test set and the data provenance:
- The document does not specify a sample size for any "test set" in the context of clinical or large-scale performance studies. The testing mentioned (joint strength, torqueability, etc.) would have involved a sufficient number of samples to demonstrate compliance with internal specifications, but these numbers are not disclosed.
- Data provenance is not specified beyond "in vitro testing." No information on country of origin or whether testing was retrospective or prospective is provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The submission focuses on in vitro engineering tests and substantial equivalence claims, not clinical efficacy or diagnostic accuracy requiring expert ground truth for a test set.
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Adjudication method for the test set:
- Not applicable. There is no mention of a test set requiring adjudication in this technical review.
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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 medical guidewire, not an AI-powered diagnostic or assistive tool for human readers. Therefore, MRMC studies or AI performance metrics are irrelevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical and physical tests, the "ground truth" would be established engineering specifications and industry standards for guidewire performance. For biocompatibility, it would be established ISO standards for medical device biocompatibility. There is no biological or clinical "ground truth" in the sense of disease diagnosis or outcome for this type of device submission.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
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DEC 1 7 2004
XIV. 510(k) Summary of Substantial Equivalence:
CLASSIFICATION NAME
Common/Usual Name: Cordis Steerable Guidewire Cordis STEER-IT Deflecting Tip Guidewire Proprietary Name:
SPONSOR
Cordis Corporation 14201 NW 60th Avenue Miami Lakes, Florida 33014
CLASSIFICATION
Catheter guidewires have been placed in Class II, 21 CFR 870.1330, Cathether Guide Wire.
NAME OF PREDICATE DEVICES
- Cordis Wizdom Steerable Guidewire (K953760) .
- USCI PilotWire™ Deflectable Guide Wire with Commander™ Deflection . Handle (K934474)
- Lake Region Manufacturing, Inc. Mandrel Guidewire (K011084) .
- Lake Region Manufacturing, Inc. Steerable PTCA Guidewire (K011968) .
- ACS High Torque Standard (K881787) .
- Cordis ATW Marker Wire (K994358) .
PERFORMANCE STANDARDS
Performance standards have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.
INTENDED USE OF THE DEVICE
The intended use of the Cordis STEER-IT Deflecting Tip Guidewire is the same as the Cordis Wizdom Steerable Guidewire previously cleared by FDA.
BIOCOMPATIBILITY
All materials were determined to be biocompatible.
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SUMMARY STATEMENT OF SUBSTANTIAL EQUIVALENCE
The Cordis STEER-IT Deflecting Tip Guidewire is substantially equivalent to the following steerable guidewires:
- Cordis Wizdom Steerable Guidewire (K953760) �
- USCI PilotWire™ Deflectable Guide Wire with Commander™ Deflection . Handle (K934474)
- Lake Region Manufacturing, Inc. Mandrel Guidewire (K011084) .
- Lake Region Manufacturing, Inc. Steerable PTCA Guidewire (K011968) ●
- ACS High Torque Standard (K881787) .
- Cordis ATW Marker Wire (K994358) .
They are all .014" diameter guidewires used to support the advancement of I hey a the coronary and peripheral vasculature. Both the indications and contraindications are the same as previous steerable guidewires cleared by FDA.
DESIGN/MATERIALS
The Cordis STEER-IT Deflecting Tip Guidewire is similar in design and materials to the Cordis Wizdom Steerable Guidewire, Lake Region Manufacturing, Inc. Mandrel Guidewire, and the Lake Region Manufacturing, Inc. Steerable PTCA Guidewire. The difference is that the STEER-IT Deflecting Tip Guidewire employs a handle mechanism, which deflects the distal tip in two directions. The handle mechanism is butted into a stainless steel hypotube, which is soldered to a nitinol hypotube. The handle mechanism is similar to the USCI Commander™ Deflection Handle, an accessory of the USCI PilotWire™ Deflectable Guide Wire. The distal end of the STEER-IT Deflecting Tip Guidewire (3mm or 7mm) of the nitinol inner core wire is flattened, looped around and joined to the nitinol hypotube. The handle mechanism operates the movement of the distal tip by gripping the inner moveable core and allowing limited movement in two directions. (See Table 1 and Figures 1 and 2, Pages 5-7 for detailed comparison of design/material differences).
MANUFACTURING
The manufacturing processes are similar to Cordis steerable guidewires and to Lake Region guidewires cleared by FDA. Component joining methods, core grinding, coil winding, etc are the same or similar processes to predicate devices. The differences in the processes are primarily related to the handle mechanism and attachment.
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SPECIFICATIONS AND TESTING
Specifications to ensure the safety and effectiveness of the device are similar to the specifications for the Cordis Wizdom Steerable Guidewire. Joint strength, torqueability, coating integrity, linear stiffness, turns to failure and dimensional testing have all been completed on the Cordis STEER-IT Deflecting Tip Guidewire. Additional testing, specific to the handle mechanism has been completed. The Cordis STEER-IT Deflecting Tip Guidewire passed all the established acceptance criteria.
CONCLUSION
This 510(k) submission represents an addition to the current Cordis steerable guidewire line. Both the Cordis STEER-IT Deflecting Tip Guidewire and the Cordis Wizdom Steerable Guidewire are .014" diameter guidewires used to support the advancement of devices in the coronary and peripheral vasculature. The Cordis STEER-IT Deflecting Tip Guidewire incorporates a handle mechanism, which deflects the distal tip in two directions to aid the clinician in positioning the guidewire. This aspect of the device is similar in function to the USCI Commander™ Deflection Handle, an accessory of the USCI PilotWire™ Deflectable Guide Wire. Biocompatibility and in vitro testing demonstrates no significant change to product characterization when compared to the predicate device. Product design and indications for use for the Cordis STEER-IT Deflecting Tip Guidewire are substantially equivalent' to the predicate device as cleared by FDA.
A statement regarding 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 premarket approval. The present submission is therefore not related tot he 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 premarket approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suits." 42 Fed. Reg. 45.520, et seg. (1977).
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Image /page/3/Picture/2 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines, which are meant to represent the flow of people.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 2004
Cordis Corporation c/o Stephen M. Enos, RN P.O. Box 025700 Miami, FL 33102
K040592 Re:
Cordis STEER-IT Deflecting Tip Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: November 1, 2004 Received: November 2, 2004
Dear Mr. Enos:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Sectori JTQ(x) premained is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and nave delemined the devices marketed in interstate
for use stated in the enclosure) to legally marketed presidents Device Amendments for use stated in the enclosure) to legally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chaculted with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval assessions of the Act The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the generation, listing of You may, therefore, market the device, subject to the gents for annual registration, listing of
general controls provisions of the Act include requires ageinst misbranding an general controls provisions of the Act merate requirement in the management misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mio crimi on the properal tions affecting your device can
may be subject to such additional controls. Tim may be subject to such additional controlis. Existing major regalato 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 500 to 898. I be found in the Code of Federal Regalations, Frid 21, 2017, 1977, 1997, 1991, 1991, 1991, 1991, 1991, 199
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Page 2 -- Mr. Stephen M. Enos
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that 1271 3185aanse or our device complies with other requirements of the Act that I DA has made a aver regulations administered by other Federal agencies. You must or any I cacal stututes and regainments, including, but not limited to: registration and listing (21 Comply with an the rice of requirements, in the manufacturing practice requirements as set CFN in the quality systems (DS) regulation (21 CFR Part 820); and if applicable, the electronic forul in the quant) 5) Systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro tegin marketing your device as described in your Section 510(k) I mis letter wif anow you to ought tinding of substantial equivalence of your device to a legally prematics notification. The stassification 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), please If you desire specific acrioliance at (240) 276-0120. Also, please note the regulation entitled, Connact the Office of been arket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
During R. Victories
A / Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K040592
Device Name: Cordis STEER-IT Deflecting Tip Guidewire
r
Indications For Use:
The Cordis STEER-IT Deflecting Tip Guidewires are intended for use in angiographic I he Cordis STEER-11 Deliecting Tip Guidentres and interventional devices within the coronary and peripheral vasculature.
Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duane R. Richter
i-om
Cardiovascular Devices
ber K040593
Page 1 of 1
2
§ 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.