(29 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a guidewire, with no mention of AI or ML.
No
The device is a guidewire used for placement and exchange of catheters and other instruments, which is an accessory to a procedure, not a therapeutic intervention itself.
No
The device is a guidewire used to facilitate the placement and exchange of catheters and other instruments. Its function is mechanical (guidance), not to diagnose a condition. The performance studies listed are also mechanical and material tests, not diagnostic accuracy studies.
No
The device description clearly outlines physical components like a stainless steel core wire, platinum coil, and marker bands, indicating it is a hardware device. The performance studies also focus on physical characteristics and bench testing of these components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the guidewire "facilitates placement and exchange of catheters and other instruments in the peripheral vasculature." This describes a device used within the body for a procedural purpose, not a device used outside the body to examine specimens (like blood, urine, or tissue) for diagnostic information.
- Device Description: The description details the physical construction of a guidewire used for navigation within blood vessels. This aligns with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information based on in vitro testing.
IVDs are devices used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This guidewire does not fit that description.
N/A
Intended Use / 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.
Product codes
DQX
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Comparative performance testing included:
- Tensile Strength A.
- Torque Strength B.
- C. Torqueability
- . Tip Flexibility D.
- ய் Coating Integrity
- Corrosion Testing F.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Street | |
| Watertown, 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 K053251 | ||
| TechDevice Corporation | ||
| Watertown, MA 02472 | ||
| Guidewire K053028 | ||
| TechDevice Corporation | ||
| Watertown, 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.
1
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.
2
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
3
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
4
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