(56 days)
Not Found
No
The device description and intended use focus on the physical characteristics and function of a microcatheter for delivering agents. There is no mention of AI, ML, image processing, or any computational analysis of data.
No
The device is intended to assist in the delivery of diagnostic and therapeutic agents, but it is not a therapeutic agent itself.
No
The device is intended to assist in the delivery of diagnostic and therapeutic agents, not to perform diagnosis itself.
No
The device description clearly describes a physical microcatheter with a lumen, shaft, hub, luer fitting, and radiopaque tip, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist in the delivery of diagnostic and therapeutic agents into the body (peripheral, coronary, and neuro vasculature). IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description details a catheter designed for insertion into blood vessels. This is consistent with an interventional device, not a diagnostic test performed on a sample outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
This device is clearly an interventional medical device used for delivering substances within the patient's body.
N/A
Intended Use / Indications for Use
Stryker Neurovascular's Tracker-17 Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary and neuro vasculature.
Product codes
DQY
Device Description
Stryker Neurovascular's Tracker-17 Microcatheter is a single lumen device designed to aid the physician in accessing distal vasculature when used with a guiding catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires. A luer fitting located on the microcatheter hub is used for the attachment of accessories. A radiopaque tip facilitates fluoroscopic visualization. Hydrophilically coated Reinforced Microcatheters are coated on the outer surface with Hydrolene™ Coating that reduces friction during manipulation in the vessel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary and neuro 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)
Results of verification testing have demonstrated the Tracker-17 Microcatheters are substantially equivalent to the predicate Tracker Excel-14 Microcatheters.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
:
.
Image /page/0/Picture/1 description: The image shows the logo for Stryker Neurovascular. The word "Stryker" is in a bold, sans-serif font on the top line. Below that, the word "Neurovascular" is in a smaller, bold, sans-serif font. The logo is black and white.
JAN 0 3 2013
、
| 510(k) Summary | |
|---|---|
| Summary Date | December 03, 2012 |
| Submitter Name and | |
| Address | Stryker Neurovascular |
| 47900 Bayside Parkway | |
| Fremont, CA. 94538 | |
| Contact Person: | Jean Chen |
| Regulatory Affairs Specialist I | |
| Phone: 510 413 2591 | |
| Fax: 510 413 2244 | |
| Email: jean.chen @stryker.com | |
| Trade Name: | Tracker®-17 Microcatheter |
| Common Name: | Percutaneous Catheter; Microcatheter |
| Classification Name: | Percutaneous catheters are currently classified as Class II devices |
| per 21 CFR 870.1250. No performance standards have been | |
| established under Section 514 of the Food, Drug and Cosmetic Act | |
| for these devices. |
Legally Marketed Predicate Device:
| Reference (Clearance Date) | Device |
|---|---|
| K994155 (3 Aug 2010) | Tracker Excel-14 Microcatheters |
:
·
1
510(k) Summary (cont.)
| Device Description: | Stryker Neurovascular's Tracker-17 Microcatheter is a single lumen device designed to aid the physician in accessing distal vasculature when used with a guiding catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires. A luer fitting located on the microcatheter hub is used for the attachment of accessories. A radiopaque tip facilitates fluoroscopic visualization. Hydrophilically coated Reinforced Microcatheters are coated on the outer surface with Hydrolene™ Coating that reduces friction during manipulation in the vessel. |
|---|---|
| Accessories: | Tracker-17 Microcatheters are packaged with a steam shaping mandrel as an accessory. |
Indications for Use / Intended Use:
Stryker Neurovascular's Tracker-17 Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary and neuro vasculature.3
Technological Characteristics and Product Feature Comparison:
Stryker Neurovascular's Tracker-17 Microcatheter is substantially equivalent to the predicate device in terms of
- . functionality
- method of operation .
- . intended use
- . indication for use
- . biological safety
A tabular comparison of the specific technological characteristics between the predicate device and the proposed device is provided below.
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3 Please note, the peripheral and coronary indications are currently not included on the labeling materials because of a contractual agreement Stryker Neurovascular has with Boston Scientific.
2
510(k) Summary (cont.)
Product feature comparison for the Tracker-17 Microcatheter Characteristics Results Offered with Pebax as compared to the predicate device, which was Shaft Material Proximal cleared with Carbothane proximal shaft material. Shaft Material Mid Same as predicate. Shaft Material Distal Same as predicate. Shaft Design Same as predicate. Distal Shaft Length Same as predicate. Mid shaft length Same as predicate. Mid transition length Same as predicate. Proximal shaft length Same as predicate. Proximal ID/OD Same as predicate. Same as predicate. Distal ID/OD Tip Marker Same as predicate. Coating Same as predicate. Effective Length Same as predicate. Hydrolene Uncoated length Uncoated length of proximal shaft has increased from 35 cm to 50 cm. Same as predicate. Indication Sterilization Method Same as predicate. Packaging Material Same as predicate. Offered as Stryker branded products. Packaging Artwork Offered with perforated opening, as compared to the flap-insert Packaging Carton opening. Closure Strip Offered with smaller packaging closure strip without slits compared to
the predicate device.
Risk assessment of the modifications in the form of Design and Use FMEAs has been conducted in accordance with EN ISO 14971:2012. Stryker Neurovascular has determined the modifications to the predicate device raise no new questions of safety or effectiveness.
Results of verification testing have demonstrated the Tracker-17 Microcatheters are substantially equivalent to the predicate Tracker Excel-14 Microcatheters.
Conclusion:
Because the subject modifications do not alter the intended use or indications for use of the predicate device, or the fundamental scientific technology of the predicate device; and because risk assessment of the modifications and successful verification testing raise no new questions of safety and effectiveness, Stryker Neurovascular has determined the Tracker-17 Microcatheters to be substantially equivalent to the predicate device.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
January 3, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Stryker Neurovascular Ms. Jean Chen Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, CA 94538
Re: K123452
Trade/Device Name: Tracker-17 Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 3, 2012 Received: December 5, 2012
Dear Ms. Chen:
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.
4
Page 2 - Ms. Jean Chen
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 that I Dri has Intacted and regulations administered by other Federal agencies. You must or any I 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 Gortoo related autvers (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality of bloms (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 17 you aso!//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 note to 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/ReportaProblem/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 I ou may overnment. generers, 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang
for
Victor Krauthamer, Ph.D. Acting Division Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K123452
Device Name: Tracker-17 Microcatheter
Indications For Use:
Stryker Neurovascular's Tracker-17 Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary and neuro vasculature.
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)
Joyce M. Whang
(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number K123452
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