(29 days)
The Guidewire facilitates placement and exchange of catheters and other instruments in the peripheral vasculature. This guidewire is not intended for use in the coronary arteries or neurovasculature.
The Guidewire is constructed of a stainless steel core wire and a platinum coil welded/brazed in place over the core wire. The coil may cover the entire core wire or just the floppy distal portion. The exposed core wire and or the coil may be uncoated stainless steel or coated with a PTFE spray or a PTFE jacket. Platinum Tungsten marker bands may be placed under the coil to aid in visualization.
The provided text describes a 510(k) Premarket Notification for a vascular guidewire and does not contain information about a study involving an AI-powered device or software. The document pertains to a physical medical device (guidewire) and its substantial equivalence to predicate devices based on physical and performance characteristics.
Therefore, many of the requested categories for AI/software-related studies cannot be filled as they are not applicable to the provided document.
Here's an attempt to answer the questions based only on the provided text, noting where information is absent or irrelevant:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists "Safety and Performance" as a section and describes how substantial equivalence was based on a comparison to predicate devices and "comparative bench testing." The specific tests performed are listed, but no explicit numerical acceptance criteria or performance metrics are provided for these tests within the given text.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Tensile Strength A | (Not explicitly stated, but deemed substantially equivalent to predicate) |
| Torque Strength B | (Not explicitly stated, but deemed substantially equivalent to predicate) |
| Torqueability C | (Not explicitly stated, but deemed substantially equivalent to predicate) |
| Tip Flexibility D | (Not explicitly stated, but deemed substantially equivalent to predicate) |
| Coating Integrity E | (Not explicitly stated, but deemed substantially equivalent to predicate) |
| Corrosion Testing F | (Not explicitly stated, but deemed substantially equivalent to predicate) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "comparative bench testing" and "Physical testing has been conducted to confirm the proposed products performance characteristics." However, it does not specify the sample size, data provenance, or whether the tests were retrospective or prospective.
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 document describes the testing of a physical medical device (guidewire) against predicate devices, not an AI or software algorithm requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As above, this is not a study involving expert adjudication for a test set in the context of AI/software performance. The evaluation is based on bench testing of physical properties.
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 document describes the premarket notification for a physical guidewire, not an AI-assisted device or software that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm described in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical bench testing, the "ground truth" would be the direct measurements obtained from the various tests (Tensile Strength, Torque Strength, etc.) which are then compared to established specifications for such devices or to the predicate device's performance. It is not expert consensus, pathology, or outcomes data in the context of diagnostic interpretation.
8. The sample size for the training set
Not applicable. This document does not describe the development or testing of an AI or software device that would require a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set for an AI/software device is described.
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KIIO241 P. 1 of 2
TechDevice Corporation January 19, 2011
510(k) Premarket Notification (Special) Vascular Guidewire
510(k) Summary
| General Company Information | ||
|---|---|---|
| Name | TechDevice Corporation | |
| Address | 650 Pleasant StreetWatertown, MA 02472 | FEB 25 2011 |
| Contact: | Gary Bunnewith | |
| Telephone: | 617-972-5810 | |
| General Device Information | ||
| Product Name: | Endologix Guidewire | |
| Common Name: | Guidewire | |
| Classification: | DQX, Catheter guide wire | 21 CFR 870. 1330 |
| Predicate Devices | ||
| Guidewire K053251TechDevice CorporationWatertown, MA 02472 | ||
| Guidewire K053028TechDevice CorporationWatertown, MA 02472 |
Product Description:
The Guidewire is constructed of a stainless steel core wire and a platinum coil welded/brazed in place over the core wire. The coil may cover the entire core wire or just the floppy distal portion. The exposed core wire and or the coil may be uncoated stainless steel or coated with a PTFE spray or a PTFE jacket. Platinum Tungsten marker bands may be placed under the coil to aid in visualization.
Indications for Use:
The Guidewire facilitates placement and exchange of catheters and other instruments in the peripheral vasculature. This guidewire is not intended for use in the coronary arteries or neurovasculature.
Safety and Performance:
Substantial equivalence for this device was based on a comparison of labeling, physical and performance design characteristics as compared to the predicate device, as well as on the results of comparative bench testing. Comparative performance testing included:
- Tensile Strength A.
- Torque Strength B.
- C. Torqueability
- . Tip Flexibility D.
- ய் Coating Integrity
- Corrosion Testing F.
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510(k) Premarket Notification (Special) Vascular Guidewire
TechDevice Corporation January 19, 2011
Substantial Equivalence
The proposed guidewires are substantially equivalent to the currently marketed guidewires which were cleared for marketing by FDA under K053251 and K053258. Substantial equivalence for the proposed devices is based on a companson of materials, dimensional specifications, design characteristics, labeling and indications for use. The two guidewires are of the exact same design and the only changes are the heat annealing process going from ambient air to vacuum and alternative labeling (i.e. naming) requested for the two wires. Physical testing has been conducted to confirm the proposed products performance characteristics.
Conclusion:
. .
Based on the indications for use, technological characteristics, and comparison to predicate devices, the Guidewires have been shown to be safe and effective for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is positioned to the right of the department's name, which is written in a circular fashion around the logo.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
TechDevice Corporation C/O Gary Bunnewith Director of Quality 650 Pleasant Street Watertown, MA 02472
FEB 2 5 2011
Re: K110241
Trade/Device Name: Endologix Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DOX Dated: January 19, 2011 Received: January 27, 2011
Dear Mr. Garv Bunnewith:
We have reviewed your Section 510/k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
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Page 2 - Mr. Gary Bunnewith
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
[signature]
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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TechDevice Corporation January 19, 2011
510(k) Premarket Notification (Special) Vascular Guidewire
Page
510(k) Number (if known): Kl | 024 |
Device Name: Endologix Guidewire
Indications for Use:
The Guidewire facilitates placement and exchange of catheters and other instruments in the peripheral vasculature. This guidewire is not intended for use in the coronary arteries or neurovasculature.
Prescription Use ਮ (Part 21 CFR 801 Subpart D) Over-the -Counter Use (21 CFR 807 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CORH, Office of Device Evaluation (ODE)
(Division Sign-Oth
Division of Cardiovascular Devices
510(k) Number/K110241
009
§ 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.