(24 days)
No
The description focuses on the physical characteristics and function of a microcatheter for delivering agents, with no mention of AI or ML capabilities.
No
The device is described as assisting in the delivery of therapeutic agents, but it is not itself a therapeutic device; it is a microcatheter designed for delivery and access.
No
The device is intended to assist in the delivery of diagnostic and therapeutic agents, not to directly diagnose conditions. While it assists with the delivery of "diagnostic agents," it doesn't perform the diagnostic imaging or analysis itself.
No
The device description clearly describes a physical microcatheter with a shaft, tip, luer fitting, and coating, 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 within 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, not for analyzing biological samples.
- Input Imaging Modality: Fluoroscopic visualization is an imaging technique used to view structures inside the body, not a method for analyzing biological specimens.
- Anatomical Site: The specified anatomical sites are within the body's circulatory system, not locations where biological samples are typically collected for IVD testing.
The device is a medical device used for interventional procedures within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Boston Scienfitic's Excelsior™ SL-10 Pre-Shaped Microcatheter and Excelsion™ 1018" Pre-Shaped Microcatifeler are intended to assist in the domery of charger, coronary, and neuro vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Excelsior " 1018" Pre-Shaped Microcatheter and the Excelsior" SL-10 Pre-Shaped Microcatheter are a I he zateenton - 1010 - 170 bd 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 semirigid proximal section aids the physician in tracking over selectively placed guidewires without displacement of the wire. A luer fitting located on the cather hub is used for the attachment of accessories. A radiopague tip facilitates fluoroscopic visualization. The outer diameter is coated with a hydrophilic surface that reduces tip tachitatis nuoroscopic 75the catheters are 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
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 results of in-vitro testing (tip shape retention, appearance of the tip, tip dimensions, static rupture, tensile I ho reading of the worling test, and coil, 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.
Excelsior " 1018" Microcatheter (510(k) # K994155, Excelsior "" SL-10 Microcatheter (510 (k) # K013789
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's Guglielmi Detachable Coils, K962503 & K001083
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
OCT 1 5 2004
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: September 20, 2004 Contact Person: Victor Ham Regulatory Affairs Project Manager Boston Scientific 47900 Bayside Parkway Fremont, CA 94538 Tel: (510) 440-7604
Device Name: Excelsior™ 1018™ Pre-Shaped Microcatheter, Class II
Excelsior™ SL-10 Pre-Shaped Microcatheter, Class II
Common name: Microcatheters Classification name: Percutaneous Catheters
Product Code: DQY
Device Description:
The Excelsior " 1018" Pre-Shaped Microcatheter and the Excelsior" SL-10 Pre-Shaped Microcatheter are a I he zateenton - 1010 - 170 bd 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 semirigid proximal section aids the physician in tracking over selectively placed guidewires without displacement of the wire. A luer fitting located on the cather hub is used for the attachment of accessories. A radiopague tip facilitates fluoroscopic visualization. The outer diameter is coated with a hydrophilic surface that reduces tip tachitatis nuoroscopic 75the catheters are packaged individually with a variety of Pre-Shaped tips.
Indications for Use:
Like the predicate devices, Boston Scienfitic's Excelsior™ SL-10 Pre-Shaped Microcatheter and Excelsion™ 1018™ Pre-Shaped Microcatheter are intended to assist in the delivery of diagnostic agents, Excelsion - 1010 - 176 bhappeatic agents, such as occlusion coils to the peripheral, coronary, and neuro vasculature.
Predicate Device(s):
Excelsior " 1018" Microcatheter (510(k) # K994155 cleared August 3, 2000) Excelsior "" SL-10 Microcatheter (510 (k) # K013789 cleared December 6, 2001)
Testing in Support of Substantial Equivalence Determination
The predicate devices which were originally cleared for straight steam-shapeable tips were 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 I ho reading of the worling test, and coil, guide catheter compatibility) and biological safety testing support the claim of substantial equivalence.
1
Technological Characteristics and Product Feature Comparison
Excelsior ™ SL-10 Microcatheter and the Excelsior ™ 1018 ™ Microcatheter are substantially equivalent to the predicate devices in terms of functionality, materials, method of operation, intended use, indications for use, and biological safety.
| 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 physicia | |
| prior to use |
Product Feature Comparison for the
** Boston Scientific's Guglielmi Detachable Coils, K962503 & K001083
2
| Product Feature Comparison for the | ||
|---|---|---|
Excelsior ™ SL-10 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 |
*Excelsior SL-10 Microcatheter cleared under K 013789 on December 6, 2001
**Boston Scientific's Guglielmi Detachable Coils, K962503 & K001083
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
3
- method of operation .
- biological safety .
Based on the above information provided in this submission, Boston Scientific's Excelsior " 1018" Pre-Shaped Microcatheter is substantially equivalent to Boston Scientific's Excelsior "" 1018"" Microcatheter; and Boston Scientific's Excelsior "" SL-10 Pre-Shaped Microcatheter is substantially equivalent to Boston Scientific's Excelsior™ SL-10 Microcatheter.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a bird or a stylized human figure with outstretched arms, composed of three curved lines.
Public Health Service
OCT 1 5 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific c/o Mr. Victor Ham Regulatory Affairs Project Manager 47900 Bayside Parkway Fremont, CA 94538
K042568 Re:
K042506
Trade/Device Name: Excelsior™ 1018™ and SL-10 Pre Shaped Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: September 20, 2004 Received: September 21, 2004
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
5
Page 2 – Mr. Victor Ham
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systellis (QS) regulation (21-542 of the Act); 21 CFF 100-1050.
product radiation control provisions (Sections 531-542 of the Action Section S product radiation control provisions (overloris (overlor states in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a legal This letter will anow you to begin makemily of substantial equivalence of your device to a legally premarket notification. The FDA Intellig of substantial equice 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
s and the may be and cases and as a the color set the reculption continen a If you desire specific advice for your de not and one on one note the regulation entitled, they may obtain contact the Office of Compliation at (217) 276-6801' (21CFR Part 807.97). You may obtain "Misbranding by reference to premance routlited. Set from the Division of Small other general information on your responsion.com its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-bir consin html Manufacturers, International and Ochosa.http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
ua R. Lochner
GA Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ K042568
Device Name:
Excelsior™ 1018" Pre-Shaped Microcatheter
Excelsior™ SL-10 Pre-Shaped Microcatheter
Indications For Use:
Boston Scienfitic's Excelsior™ SL-10 Pre-Shaped Microcatheter and Excelsion™ 1018" Pre-Shaped Boston Scientitle S L.celsion - SE-76 Tre Online Microcanns, such as contrast media, and Microcatifeler are intended to assist in the domery of charger, coronary, and neuro vasculature.
Prescription Use_ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Lochner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number Ko42568
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