(107 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 capabilities.
No
The device is a guidewire that facilitates placement and exchange of other instruments, making it an accessory device rather than a therapeutic one.
No
The device is a guidewire, used to facilitate the placement and exchange of catheters and other instruments. Its function is to provide access and guidance, not to obtain diagnostic information.
No
The device description clearly details physical components like a stainless steel core wire, coil, marker bands, and coatings, indicating it is a physical medical device, not software-only.
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 device "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 to examine specimens outside the body to provide diagnostic information.
- Device Description: The description details the physical construction of a guidewire, which is a tool used in medical procedures. It does not describe components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic results.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. This guidewire does not fit that description.
N/A
Intended Use / Indications for Use
The TechDevice Guidewire facilitates placement and exchange of catheters and other instruments in the peripheral vasculature. This device is not indicated for neuro, or cardiac use
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The Guidewire is constructed of a stainless steel core wire and a stainless steel or platinum coil welded/brazed in place over the core wire. The coil may cover the entire 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 marker bands may be placed under the coil to aid in visualization. Exit markers may be printed on the proximal section of the guidewire to aid the physician in determining the depth of insertion.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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. ്. Torqueability Tip Flexibility D. ட். Coating Integrity
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
TechDevice Corporation November 15, 2005
510(k) Premarket Notification (Traditional)
510(k) Summary
Vascular Guidewire
K053251
General Company Information
| Name | TechDevice Corporation | MAR 8 2006 |
|---|---|---|
| Address | 650 Pleasant Street | |
| Watertown, MA 02472 | ||
| Contact: | Leigh Hayward | |
| Telephone: | 617-972-5808 | |
| General Device Information | ||
| Product Name: | TechDevice Guidewire | |
| Common Name: | Guidewire | |
| Classification: | DQX, Catheter guide wire | 21 CFR 870. 1330 |
| Predicate Devices | Guidewire K943737 | |
| Boston Scientific Corporation | ||
| Natick, MA 01760 | ||
| Guidewire K935997 | ||
| Boston Scientific Corporation | ||
| Natick, MA 01760 | ||
| Guidewire K933334 | ||
| Boston Scientific Corporation | ||
| Natick MA 01760 |
Product Description:
The Guidewire is constructed of a stainless steel core wire and a stainless steel or platinum coil welded/brazed in place over the core wire. The coil may cover the entire 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 marker bands may be placed under the coil to aid in visualization. Exit markers may be printed on the proximal section of the guidewire to aid the physician in determining the depth of insertion.
Indications for Use:
The TechDevice Guidewire facilitates placement and exchange of catheters and other instruments in the peripheral vasculature. This device is not indicated for neuro, or cardiac use
1
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.
- ്. Torqueability
- Tip Flexibility D.
- ட். Coating Integrity
Conclusion:
Based on the indications for use, technological characteristics, and comparison to predicate devices, the TechDevice Guidewire has been shown to be safe and effective for its intended use.
160
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 MAR 8
TechDevice Corporation c/o Mr. Leigh Hayward Director of Technical Operations 650 Pleasant Street Watertown, MA 02472
Re: K053251
TechDevice Guidewire 1 cent20.100 Sula01722 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (Two) Product Code: DQX Dated: February 10, 2006 Received: February 14, 2006
Dear Mr. Hayward:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved 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 for abound in to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered province may 2011 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Leigh Hayward
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a determination administered by other Federal agencies. You must or any it cacal statutes und regaranents, including, but not limited to: registration and listing (21 Comply with an the Not 8 requirements)01); good manufacturing practice requirements as set CFR Part 8077, adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality bybeline (Sections 531-542 of the Act); 21 CFR 1000-1050. product lanation control pro holens (s seting your device as described in your Section 510(k) This letter will anow yours of substantial equivalence of your device of your device to a legally prematics notification. The station 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 advice 101-10-101-01-240) 276-0120. Also, please note the regulation entitled, Connact the Orition of Compullier in (set 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Donna R. Vidmer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
TechDevice Corporation
Page
510(k) Number (if known): K053251
TechDevice Guidewire Device Name:
Indications for Use:
The TechDevice 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 × (Part 21 CFR 801 Subpart D) AND/OR
Over-the -Counter Use (21 CFR 807 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. de Juney
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number Ko 5 12 5 1