(86 days)
No
The device description and performance studies focus on the physical properties and compatibility of a microcatheter, with no mention of AI or ML capabilities.
No.
The device itself is not a therapeutic device, but rather a delivery device intended to assist in the delivery of diagnostic and therapeutic agents.
No
This device is intended to assist in the delivery of diagnostic agents, but it does not perform the diagnosis itself. It is a tool for drug and device delivery, not a diagnostic device.
No
The device description clearly outlines a physical catheter with a lumen, luer fitting, radiopaque tip, and hydrophilic coating, indicating it is a hardware device.
Based on the provided information, the Boston Scientific Tracker™ Excel™-14 Pre-Shaped Microcatheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to assist in the delivery of diagnostic and therapeutic agents into the vasculature (peripheral, coronary, and neuro). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details a physical device designed for insertion into blood vessels, with features like a lumen for delivery, a radiopaque tip for visualization, and a hydrophilic coating for manipulation within the vessel. These are characteristics of a device used directly on a patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are specifically designed for testing samples taken from the body in a laboratory or other setting outside of the body. This microcatheter is designed for direct intervention within the body.
N/A
Intended Use / Indications for Use
Boston Scientific's Tracker™ Excel™-14 Pre-Shaped Microcatheter is 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 (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Tracker™ Excel™-14 Pre-Shaped Microcatheter is a single lumen device designed to aid the physician in accessing the distal vasculature when used with a guiding catheter and steerable guidewire. Graded shaft astifiess 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 catheter hub is used for the attachment of accessories. A radiopaque tip facilitates fluoroscopic visualization. The outer diameter is coated with a hydrophilic surface that reduces friction during manipulation in the vessel. The catheter is packaged individually with a variety of pre-shaped tips.
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)
The results of in-vitro testing (tip shape retention, appearance of the tip, tip dimensions, static rupture, tensile strength of tip, buckling test, and coil, guidewire and guide catheter compatibility) and biological safety testing support the claim of substantial equivalence.
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.
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
§ 870.1250 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
Special 510(k): Modification -Boston Scientific's Tracker™ -14 Pre-Shaped Microcatheter
510(K) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Date prepared: March 7, 2005 Contact Person: Victor Ham Regulatory Affairs Project Manager Boston Scientific 47900 Bayside Parkway Fremont, CA 94538 Tel: (510) 440-7604
Device Name: Tracker™ ExcelTM_J4 Pre-Shaped Microcatheter, Class II
Common name: Microcatheters Classification name: Percutaneous Catheters
Product Code: DQY
Device Description:
Doney Dosenbarm.
The Tracker™ Excel™-14 Pre-Shaped Microcatheter is a single lumen device designed to aid the physician in accessing the distal vasculature when used with a guiding catheter and steerable guidewire. Graded shaft astifiess 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 catheter hub is used for the attachment of accessories. A radiopaque tip facilitates fluoroscopic visualization. The outer diameter is coated with a hydrophilic surface that reduces friction during manipulation in the vessel. The catheter is packaged individually with a variety of pre-shaped tips.
Indications for Use:
Like the predicate devices, Boston Scientific's Tracker™ Excel™-14 Pre-Shaped Microcatheter is 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.
Predicate Device(s): Tracker™ Excel™-14 Microcatheter (510(k) # K994155 cleared August 3, 2000)
Testing in Support of Substantial Equivalence Determination
The predicate device which was originally cleared for straight steam-shapeable tip was modified to include pre-shaped tips. The modification is made for ease of use to the physicians. The modification involves a new tip shaping process and the necessary packaging modifications to protect the new tip shapes.
The results of in-vitro testing (tip shape retention, appearance of the tip, tip dimensions, static rupture, tensile strength of tip, buckling test, and coil, guidewire and guide catheter compatibility) and biological safety testing support the claim of substantial equivalence.
1
Technological Characteristics and Product Feature Comparison
Tracker™ Excel™-14 Pre-Shaped Microcatheter is substantially equivalent to the predicate device in terms of functionality, materials, method of operation, intended use, indications for use, and biological safety.
Product Feature Comparison for the
Tracker™ Excel™-14 Pre-Shaped Microcatheter
| Characteristic | Results |
|---|---|
| Shaft Materials | Same as predicate* device |
| Shaft Design | Same as predicate* device |
| Distal Shaft Length | Same as predicate* device |
| Proximal ID / OD | Same as predicate* device |
| Distal ID / OD | Same as predicate* device |
| Tip Markers | Same as predicate* device |
| Coating | Same as predicate* device |
| Effective Length | Same as predicate* device |
| **GDC™ Compatibility | Same as predicate* device |
| Tip Configuration | Offered with Pre-Shaped Tips |
| with the option of secondary | |
| shaping for proper adjustment to | |
| the anatomy prior to use. | |
| As compared to the predicate | |
| which was cleared with straight | |
| tip, steam shapeable by physician | |
| prior to use |
- Tracker Excel -14 Microcatheter cleared under K994155 on August 3, 2000 **Boston Scientific's Guglielmi Detachable Coils, K962503 & K001083
2
510(K) Summary of Safety and Effectiveness
Results of the performance and biocompatibility testing, as presented in this Special 510(K), demonstrate that the Pre-Shaped devices are substantially equivalent to the respective predicate unmodified devices.
The subject catheters with Pre-Shaped tips are substantially equivalent to their respective predicate devices with respect to the following:
- . functionality
- intended use ◆
- indications for use .
- materials ●
- method of operation .
- biological safety .
Based on the above information provided in this submission, Boston Scientific's Tracker™ Excel™ 14 Pre-Shaped Microcatheter is substantially equivalent to Boston Scientific's Tracker™ Excel™ 14 Microcatheter.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle head in profile, facing right, with three parallel lines extending from the back of its head, resembling feathers or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 - 2005
Boston Scientific c/o Mr. Victor Ham Regulatory Affairs Project Manager 47900 Bayside Parkway Fremont, CA 94538
Re: K050599
Trade/Device Name: Tracker™ Excel™-14 Pre-Shaped Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DQY Dated: May 3, 2005 Received: May 4, 2005
Dear Mr. Ham:
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.
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.
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
4
Page 2 - Mr. Victor Ham
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic for the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product launtion control provisions (seting your device as described in your Section 510(k) This letter will anow you to begin maing of substantial equivalence of your device to a legally premarket notification. The PDA maining of basification 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 dealer specific da reliance 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 other general informational 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,
Duna P. Lachner
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
K650599 510(k) Number:
Device Name:
Tracker™ Excel™-14 Pre-Shaped Microcatheter
Indications for Use:
Boston Scientific's Tracker™ Excel™-14 Pre-Shaped Microcatheter is 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 X (Per 21 CFR 801.109)
OR
Over The Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Deanna P. Vachner
(Division of Cardiovascular Devices
510(k) number K050594
Boston Scientific March, 2005