(24 days)
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, therapeutic agents, such as occlusion coils to the peripheral, coronary, and neuro vasculature.
The Excelsior " 1018" Pre-Shaped Microcatheter and the Excelsior" SL-10 Pre-Shaped Microcatheter are intended to assist 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.
This document describes the 510(k) summary for the Excelsior™ 1018™ and SL-10 Pre-Shaped Microcatheters. The core of the submission is to demonstrate substantial equivalence to predicate devices, where the primary modification is the pre-shaped tips for ease of use.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the typical quantitative sense (e.g., a specific percentage accuracy or precision). Instead, the acceptance criteria are implicitly that the modified devices (with pre-shaped tips) retain the same performance characteristics and safety profile as the predicate devices. The study performed is a "testing in support of substantial equivalence determination."
| Characteristic/Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Functionality | Equivalent to predicate devices | "Same as predicate device" for all listed characteristics (materials, design, dimensions, markers, coating, effective length, GDC compatibility) |
| Materials | Equivalent to predicate devices | "Same as predicate device" |
| Method of Operation | Equivalent to predicate devices | Stated as "substantially equivalent" |
| Intended Use | Equivalent to predicate devices | Stated as "substantially equivalent" |
| Indications for Use | Equivalent to predicate devices | Stated as "substantially equivalent" |
| Biological Safety | Equivalent to predicate devices | "Biological safety testing support the claim of substantial equivalence," stated as "substantially equivalent." |
| Tip configuration | Ability to offer pre-shaped tips with secondary shaping option | "Offered with Pre-Shaped Tips with the option of secondary shaping... As compared to the predicate which was cleared with straight tip, steam shapeable by physician prior to use." |
| In-vitro testing results (various) | Performance equivalent to predicate devices / safety thresholds | "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) ... support the claim of substantial equivalence." |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not specified. The document refers to "in-vitro testing" but does not detail the number of units tested for each characteristic.
- Data Provenance: The data appears to be prospective as it involves "in-vitro testing" conducted specifically for this 510(k) submission. No information is given about the country of origin of the data beyond "Boston Scientific" which is a US-based company, suggesting the testing was likely conducted in the US or by a US-affiliated entity.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This submission is for a medical device (microcatheter) and relies on engineering and biocompatibility testing, not on expert interpretations of medical images or clinical data to establish a "ground truth" in the diagnostic sense.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this isn't a study involving human interpretation of data where adjudication would be necessary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is typically performed for diagnostic devices where the performance of human readers, with and without AI assistance, is evaluated. This submission is for a microcatheter, which is an interventional device, not a diagnostic one.
6. Standalone (Algorithm Only) Performance
Not applicable. The device is a physical microcatheter, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation is based on engineering specifications, material science, and established safety standards for medical devices (e.g., biocompatibility standards, mechanical testing standards for catheters). The predicate devices serve as the reference point for equivalence.
8. Sample Size for the Training Set
Not applicable. This device does not involve a "training set" as it is not an AI/ML-driven device.
9. How Ground Truth for the Training Set was Established
Not applicable, for the same reason as point 8.
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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.
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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 Tipswith the option of secondaryshaping for proper adjustment tothe anatomy prior to use.As compared to the predicatewhich was cleared with straighttip, steam shapeable by physiciaprior to use |
Product Feature Comparison for the
** Boston Scientific's Guglielmi Detachable Coils, K962503 & K001083
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| 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 Tipswith the option of secondaryshaping for proper adjustment tothe anatomy prior to use. |
| As compared to the predicatewhich was cleared with straighttip, steam shapeable by physicianprior 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
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- 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.
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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
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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
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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
Page 1 of __ 1 ___
§ 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).