(22 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of the microcatheter, with no mention of AI or ML capabilities.
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 agents, but it does not perform the diagnostic function itself. It is an accessory to a diagnostic procedure.
No
The device description clearly details a physical microcatheter with various material components, a hub, a luer fitting, and a radiopaque tip, indicating it is a hardware device.
Based on the provided information, the Excelsior SL-10 Microcatheter is not an IVD (In Vitro Diagnostic) device.
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 the body to provide information for diagnosis.
- Device Description: The description details a catheter designed for navigation and delivery within the vasculature, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any processes typically associated with in vitro diagnostics.
This device is a medical device used for interventional procedures within the patient's body.
N/A
Intended Use / Indications for Use
The Excelsior SL-10 Microcatheter's Indications For Use are as follows:
Excelsior SL-10 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
DQY
Device Description
The Excelsior SL-10 Microcatheter is a single lumen device designed to aid the physician in accessing distal vasculature when used with a guide catheter and guidewire. The device shaft is comprised of graded materials of varying durometers, from a flexible tip to a semirigid proximal end. Stainless steel wire reinforcement provides for strength during torque transmission while the inner liner provides for lubricity. The hub / strain reliefs provide for kink resistance from the proximal end. A luer fitting on the catheter hub is used for the attachment of accessories. The radiopaque tip with one or two markers allows for visualization under fluoroscopy. The outer surface is coated with a hydrophilic coating which reduces friction during navigation in the vasculature. A steam shaping mandrel accessory is packaged with the catheter.
The Excelsior SL-10 Microcatheter will be manufactured in varying lengths. Model numbers and a device drawing are included in Section 4 of this submission.
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
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
In vitro performance testing of Excelsior SL-10 Microcatheter included dimensional inspection, tensile strength, burst pressure, flow rate and withdrawal force testing. All testing indicates that the device is safe and performs according to its intended use.
Biocompatibility testing was verified according to ISO-10993, Biological Evaluation of Medical Devices. Test results confirm biocompatibility of the Excelsior SL-10 Microcatheter.
Key Metrics
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
SECTION 2 -- 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
a. Date Prepared: November 09, 2001
DEC 0 6 2001
b. Contact Person George J. Prendergast Regulatory Affairs Specialist II Boston Scientific Target 47900 Bayside Parkway Fremont, CA 94538
c. Trade Name ExcelsiorTMSL-10 Microcatheter
- d. Common Name Microcatheter
- e. Classification Name
Percutaneous Catheter (21 CFR Section 870.1250)
f. Identification of Predicate Devices
| Number | Description | Clearance Date |
|---|---|---|
| K994155 | Excelsior 1018 Microcatheter | 03 August 2000 |
| K925813 | Tracker-10 | |
| Microcatheter | 23 March 1994 |
Special 510(k): Device Modification November 2001
1
g. Device Description
The Excelsior SL-10 Microcatheter is a single lumen device designed to aid the physician in accessing distal vasculature when used with a guide catheter and guidewire. The device shaft is comprised of graded materials of varying durometers, from a flexible tip to a semirigid proximal end. Stainless steel wire reinforcement provides for strength during torque transmission while the inner liner provides for lubricity. The hub / strain reliefs provide for kink resistance from the proximal end. A luer fitting on the catheter hub is used for the attachment of accessories. The radiopaque tip with one or two markers allows for visualization under fluoroscopy. The outer surface is coated with a hydrophilic coating which reduces friction during navigation in the vasculature. A steam shaping mandrel accessory is packaged with the catheter.
The Excelsior SL-10 Microcatheter will be manufactured in varying lengths. Model numbers and a device drawing are included in Section 4 of this submission.
h. Intended Use
The Excelsior SL-10 Microcatheter's Indications For Use are as follows:
Excelsior SL-10 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.
The intended use of the modified device, as described in its labeling, has not changed as a result of the modifications.
Special 510(k): Device Modification November 2001
2
i. Product Feature Comparison
| Feature | Tracker-10 Microcatheter
Predicate cleared under
K925813 | Excelsior SL-10
Microcatheter
Subject device | Excelsior 1018
Microcatheter
Predicate cleared under
K994155 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Tracker-10 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. | Excelsior SL-10
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. | 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. |
| Design: | | | |
| Size (French) | 2 French | 1.7 French | 2 French |
| Inside
Diameter (ID) | 0.015" minimum | 0.016" minimum | 0.0185" minimum |
| Outside
Diameter
(OD) | 0.034" | 0.031" | 0.034" |
| Materials | Predominately
polypropylene,
polyethylene and
polycarbonate | Predominately polyamide,
stainless steel and rubber | Predominately polyamide,
stainless steel and rubber |
j. Comparison of Technological Characteristics
Excelsior SL-10 Microcatheter is substantially equivalent to Boston Scientific Target 's Tracker-10 Microcatheter and Excelsior 1018 Microcatheter. Excelsior SL-10 Microcatheter is substantially equivalent to the predicate devices in terms of functionality, intended use, design, materials and method of operation.
3
k. Testing
In vitro performance testing of Excelsior SL-10 Microcatheter included dimensional inspection, tensile strength, burst pressure, flow rate and withdrawal force testing. All testing indicates that the device is safe and performs according to its intended use.
Biocompatibility testing was verified according to ISO-10993, Biological Evaluation of Medical Devices. Test results confirm biocompatibility of the Excelsior SL-10 Microcatheter.
l. Summary of Substantial Equivalence
Boston Scientific Target's determination of substantial equivalence to Tracker-10 Microcatheter and Excelsior 1018 Microcatheter predicate devices is based on the following.
The subject catheter is substantially equivalent to Tracker – 10 Microcatheter with respect to the following:
- size
- intended use .
- labeling .
- biocompatibility ●
- packaging
- sterilization methods ●
The subject catheter is substantially equivalent to Excelsior 1018 Microcatheter with respect to the following:
- materials
- intended use ●
- size
- . labeling
- biocompatibility .
- packaging ●
- sterilization methods .
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Based on the above information provided in this submission, Boston Scientific's Excelsior SL-10 Microcatheter is substantially equivalent to Boston Scientific's Excelsior 1018 Microcatheter and Tracker–10 Microcatheter.
:
:
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:
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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three tail feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 6 2001
Mr. George J. Prendergast Regulatory Affairs Specialist II Boston Scientific Target 47900 Bayside Parkway Fremont, CA 94538
Re: K013789
Excelsior™ SL-10 Microcatheter Regulation Number: 870.1250 Regulation Name: Percutaneous catheter. Regulatory Class: Class II Product Code: DQY Dated: November 9, 2001 Received: November 14, 2001
Dear Mr. Prendergast:
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 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.
6
Page 2 - Mr. George J. Prendergast
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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/dsma/dsmamain.html
Sincerely yours,
Dada Tule
Bram Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/7/Picture/0 description: The image shows the logo for Boston Scientific Target. The words "Boston Scientific" are stacked on top of each other in a serif font. There is a horizontal line underneath the words "Boston Scientific". The word "TARGET" is in a sans-serif font and is located underneath the horizontal line.
INDICATIONS FOR USE STATEMENT
KO13789 510(k) Number: __
Device Name: Excelsior SL-10 Microcatheter
Indications for Use:
The Excelsior SL-10 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 _
(Per 21 CFR 801.109)
OR
Over The Counter Use _
Division of Cardiovascular & Respiratory Devices
510(k) Number __R013787