(108 days)
The TORAYGuide guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the heart and peripheral vasculature. The device is not intended for use in the coronary arteries.
The TORAYGUIDE™ Guidewire is manufactured of 304 stainless steel, which is consistent with guidewires presently in commercial distribution and with the same intended use. The device diameter is 0.65 mm, and is supplied in lengths ranging from 175 to 230 cm. The guidewire has a spring core at the distal end, also of stainless steel. The device is ethylene oxide sterilized and intended for single use only.
The provided text describes the 510(k) summary for the TORAYGUIDE™ Guidewire and its substantial equivalence to a predicate device. However, it does not contain specific details about acceptance criteria, detailed performance results, sample sizes for test or training sets, ground truth establishment, expert qualifications, or comparative effectiveness studies.
The document makes a general statement: "Applicable testing was conducted on the TORAYGUIDE guidewire in accordance with the FDA guidance. All samples met the acceptance criteria. The test results establish that the TORAYGUIDE Guidewire possesses performance characteristics that make it acceptable for its intended use." This indicates that some testing was done and passed, but the specifics are not provided in the summary.
Therefore, most of the information requested cannot be extracted directly from the given text.
Here is a summary of what can be inferred or directly stated from the provided text, along with what cannot be found:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the provided text. The document generically states "All samples met the acceptance criteria."
- Reported Device Performance: No specific performance metrics or results are reported in this summary. It only states that the guidewire "possesses performance characteristics that make it acceptable for its intended use."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document only mentions "All samples met the acceptance criteria."
- Data Provenance (country of origin, retrospective/prospective): Not specified.
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 as this is a medical device (guidewire) and not an AI/diagnostic software. Ground truth in this context would likely refer to engineering specifications and physical performance tests, not expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of medical device's performance testing.
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 is a physical medical device (guidewire), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" would likely be engineering specifications and physical testing standards for guidewires (e.g., tensile strength, torqueability, flexibility, kink resistance). These specific standards or methods are not detailed in the summary.
8. The sample size for the training set
- Not applicable. This is a medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a medical device, not an AI model.
In summary, the provided 510(k) summary is for a guidewire and primarily focuses on demonstrating substantial equivalence to a predicate device through physical and performance testing that met general FDA guidance. The detailed information typically requested for AI/diagnostic software performance studies (like sample sizes, expert qualifications, ground truth methodology) is not relevant or available in this type of device submission summary.
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510(k) SUMMARY DEC 17 2004
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
Submitter's Name: Toray Industries (America), Inc. 461 Fifth Avenue, 9th Floor New York, NY 10017 Telephone: (212) 697-8150 Contact person: Mr. Koji Hagimoto, Director, Medical and Pharmaceutical
Date of Summary: November 12, 2004
Device Name: TORAYGUIDE™ Guidewire
Device Classification Name: Catheter Guide Wire (74 DQX); 21 CFR, Part 870.1330
Legally Marketed Device to which Equivalence is Claimed: The legally marketed predicate device is the Guidewire (K982559) manufactured by Galt Medical Corporation, determined to be substantially equivalent to a legally marketed (preAmendment) device on February 1, 1999.
Device Description: The TORAYGUIDE™ Guidewire is manufactured of 304 stainless steel, which is consistent with guidewires presently in commercial distribution and with the same intended use. The device diameter is 0.65 mm, and is supplied in lengths ranging from 175 to 230 cm. The guidewire has a spring core at the distal end, also of stainless steel. The device is ethylene oxide sterilized and intended for single use only.
Intended Use: The TORAYGUIDE guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the heart and peripheral vasculature. The device is not intended for use in the coronary arteries.
Descriptive Summary of Technological Characteristics and Those of Predicate Device: The TORAYGUIDE Guidewire has the same indications for use and is otherwise technically identical to the legally marketed predicate device.
Performance Data: Applicable testing was conducted on the TORAYGUIDE guidewire in accordance with the FDA guidance. All samples met the acceptance criteria. The test results establish that the TORAYGUIDE Guidewire possesses performance characteristics that make it acceptable for its intended use.
Conclusion: The information and data provided in this 510(k) Notification establish that the TORAYGUIDE Guidewire is substantially equivalent to the legally marketed predicate device.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and 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 human profiles facing to the right, stacked on top of each other. The profiles are abstract and created with thick, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 2004
Toray Industries (America), Inc c/o Ms. Lisa S. Jones Regulatory Affairs Consultant 461 Fifth Avenue, 9th Floor New York, NY 10017
K042370 Re: Torayguide™ Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: November 12, 2004 Received: November 16, 2004
Dear Ms. Jones:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use statu in the encrosule) to regars and the Medical Device Amendments, or to commence prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have occh recuire in assee approval of a premarket approval application (PMA). and Costine Act (1107 that to hovice, subject to the general controls provisions of the Act. The r ou may, therefore, market the act include requirements for annual registration, listing of gencral controls provisions of the tice, labeling, and prohibitions against 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 classince (600 a00 rols. Existing major regulations affecting your device can may be subject to sublications, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Lisa S. Jones
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
Durna R. Lockines
( 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): K042370
Device Name: TORAYGUIDE Guidewire
Indications For Use: The TORAYGuide guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the heart and peripheral The device is not intended for use in the vasculature. coronary arteries.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Richard
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_K042370
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§ 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.