(86 days)
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.
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.
The provided text describes a 510(k) submission for a modified microcatheter and does not contain information about an AI-powered device or a study involving AI. Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, or AI effectiveness studies.
The document focuses on demonstrating substantial equivalence of the modified microcatheter to a predicate device based on in-vitro testing and biological safety testing, as well as a comparison of product characteristics.
Regarding the specific questions you asked, based on the provided text, the following cannot be answered:
- A table of acceptance criteria and the reported device performance: Not available as it pertains to AI-powered devices.
- Sample sized used for the test set and the data provenance: Not relevant for this type of device modification submission. The text mentions "in-vitro testing" but doesn't detail sample sizes.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as it pertains to AI ground truth.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI device.
- If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable for an AI device. The ground truth for this device's performance would be the physical properties and biological safety as measured in the in-vitro tests.
- The sample size for the training set: Not applicable as this is not an AI device.
- How the ground truth for the training set was established: Not applicable.
Summary of the provided information:
- Device: Tracker™ Excel™-14 Pre-Shaped Microcatheter
- Modification: The predicate device (Tracker™ Excel™-14 Microcatheter) was modified to include pre-shaped tips, as opposed to a straight, steam-shapeable tip.
- Purpose of Modification: Ease of use for physicians.
- Testing Conducted: 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.
- Conclusion of Testing: The results support the claim of substantial equivalence to the predicate device.
- Substantial Equivalence Claims: Functionality, intended use, indications for use, materials, method of operation, and biological safety.
- Predicate Device: Tracker™ Excel™-14 Microcatheter (K994155).
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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.
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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 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 |
- Tracker Excel -14 Microcatheter cleared under K994155 on August 3, 2000 **Boston Scientific's Guglielmi Detachable Coils, K962503 & K001083
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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.
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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
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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 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
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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
§ 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).