(238 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of the microcatheter, with no mention of AI or ML capabilities.
No
The device itself is a microcatheter intended to assist in the delivery of therapeutic agents, but it is not a therapeutic agent or device itself.
No
The device is a microcatheter intended for delivery of agents and physical access, not for diagnosing medical conditions. While it assists in the delivery of "diagnostic agents," it doesn't perform the diagnosis itself.
No
The device description clearly describes a physical microcatheter with a lumen, shaft, tip, hub, and coating, which are all hardware components.
Based on the provided information, the Excelsior 1018 Microcatheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to deliver diagnostic and therapeutic agents into the body (peripheral, coronary, and neurovasculature). IVD devices are used to examine specimens from the body (like blood, urine, tissue) outside of the body to diagnose conditions.
- Device Description: The description details a catheter designed for insertion into blood vessels, not for analyzing samples.
- Input Imaging Modality: Fluoroscopic visualization is used to guide the device within the body. IVD devices typically don't involve real-time imaging of the patient's internal anatomy during their primary function.
- Anatomical Site: The device is used within the patient's vasculature. IVD devices work with samples taken from the patient.
The Excelsior 1018 Microcatheter is a medical device used for interventional procedures within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Excelsior 1018 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 neurovasculature.
Product codes (comma separated list FDA assigned to the subject device)
KRA
Device Description
The Excelsior 1018 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 stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires without displacement of the wire. 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 with a steam shaping mandrel accessory.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary, and neurovasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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 Excelsior 1018 Microcatheter has different technological characteristics. However, the results of performance testing (tensile strength, coefficient of friction, static rupture, tip buckling, dimensional inspection, critical bend radius, particulate analysis, and coil compatibility) and biocompatibility testing support this claim of substantial equivalence. Results of the performance and biocompatibility testing, as presented in this pre-market notification, demonstrate that the Excelsior 1018 Microcatheter is substantially equivalent to the predicate TurboTracker-18 Infusion Catheter device.
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.
TurboTracker®-18 Infusion Catheter K960806
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.
Boston Scientific Target's Guglielmi Detachable Coils (K962503)
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
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
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.
Contact Person:
Linda Guthrie Senior Regulatory Affairs Specialist Boston Scientific Target 47900 Bayside Parkway Fremont, CA 94538
Device Name: Excelsior™ 1018 Microcatheter, Class II
Device Description:
The Excelsior 1018 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 stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires without displacement of the wire. 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 with a steam shaping mandrel accessory.
Indications for Use:
Like the predicate TurboTracker-18 Infusion Catheter device, the Excelsior 1018 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 neurovasculature.
Predicate Device:
TurboTracker®-18 Infusion Catheter K960806, cleared May 2, 1996
Testing in Support of Substantial Equivalence Determination
The Excelsior 1018 Microcatheter has different technological characteristics. However, the results of performance testing (tensile strength, coefficient of friction, static rupture, tip buckling, dimensional inspection, critical bend radius, particulate analysis, and coil compatibility) and biocompatibility testing support this claim of substantial equivalence. Results of the performance and biocompatibility testing, as presented in this pre-market notification, demonstrate that the Excelsior 1018 Microcatheter is substantially equivalent to the predicate TurboTracker-18 Infusion Catheter device. See Table 1 for a comparison of the technological characteristics.
Boston Scientific Target Section 2, Page 2 of 3
1
510(K) Summary of Safety and Effectiveness
| Characteristic | *Predicate Device | Excelsior 1018
Microcatheter |
|----------------------|---------------------|---------------------------------|
| Shaft Materials | Thermoplastic | Thermoplastic |
| Shaft Design | Metal reinforced | Metal reinforced |
| Distal Shaft Length | 0 - 80 cm | 6 cm |
| Proximal ID / OD | 0.020" / 0.038" | 0.0185" / 0.034" |
| Distal ID / OD | 0.020" / 0.033" | 0.0185" / 0.025" |
| Tip Markers | Platinum Iridium | Platinum Iridium |
| Coating | Hydrophilic Polymer | Hydrophilic Polymer |
| Effective Length | 15 - 200 cm | 105 cm - 150 cm |
| **GDC® Compatibility | GDC-18 | GDC-10 & GDC-18 |
| Section 2 - Table 1, Technological Characteristics Summary | |
|---|---|
| ------------------------------------------------------------ | -- |
- TurboTracker-18 Infusion Catheter (K960806, May 1996)
**Boston Scientific Target's Guglielmi Detachable Coils (K962503, September 1996)
2
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Public Health Service
3 2000 AUG
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .
Ms. Roxanne K. Baxter Manager, Regulatory Affairs Boston Scientific Target 47900 Bayside Parkway Fremont, CA 94538
K994155 Re : Excelsior 1018 Microcatheter Trade Name: Regulatory Class: II KRA Product Code: May 4, 2000 Dated: Received: May 8, 2000
Dear Ms. Baxter:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Roxanne K. Baxter
This letter will allow you to begin marketing your device as described.
The FDA to between to sectification - The FDA finding of substantial This letter will allow you to begin marketing your arrantial
in your 510(k) premarket notification. The Finding of substantial in your 510(k) premarket notification. The sted predicate device equivalence of your device to a regarly markedd provided to be
results in a classification for your device and thus, permits your
results in a classification tor your device device to proceed to the market.
If you desire specific advice for your device on our labeling
and the success of the 001 and additionally 809.10 for in vi If you desire specific advice for your actles of a for in vitro regulation (21 CFR Part 801 and additionariy oost compliance at (301)
diagnostic devices), please contact the office of Compliance and diagnostic devices), please contact the order promotion and 594–4586. Additionally, tor questions on the pffice of Compliance at
advertising of your device, please contact the office of compliance at our device, prease ocher gulation entitled, (301) 594-4639. (301) 594–4639. Also, prease note coldidation" (21CPR 807.97).
"Misbranding by reference to premarket notification" (21CPR 807.97) "Misbranding by reference to premarker nochilities under the Act may
Other general information of Small Manufacturers Assistance at i Other general information of Small Manufacturers Assistance at its internet be obtained from the Division of Smart Manufaceae on at its internet
toll-free number (800) 638-2041 or (301) 443–6597 or at its internet toll-free number (600) 056 2011 02 - 11 - 11 - 11 - 11 - 11 - 11 - 14 - 14 - 14 - 14 - 14 - 14 - 14 - 14 - 14 - 1
Sincerely yours,
James E. Dillard III
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name: Excelsior ™ 1018 Microcatheter Catheter
Indications for Use:
The Excelsior 1018 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 neurovasculature.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use | OR | Over The Counter Use |
| (Per 21 CFR 801.109) |
| Excelsior 1018 Microcatheter 510(k)
December, 1999 | (Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number Section 1. Page 8 of 8 |
| ------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------- |
|---|