(56 days)
Stryker Neurovascular's Tracker-17 Microcatheters are 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.
Stryker Neurovascular's Tracker-17 Microcatheter is a single lumen device designed to aid the physician in accessing 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. A luer fitting located on the microcatheter hub is used for the attachment of accessories. A radiopaque tip facilitates fluoroscopic visualization. Hydrophilically coated Reinforced Microcatheters are coated on the outer surface with Hydrolene™ Coating that reduces friction during manipulation in the vessel.
The provided FDA 510(k) summary for the Tracker-17 Microcatheter describes a device that is substantially equivalent to a predicate device, the Tracker Excel-14 Microcatheter. This document focuses on the mechanical and material characteristics of the microcatheter, rather than its performance in diagnostic or therapeutic tasks, which would typically involve AI/ML components and human reader studies.
Therefore, the requested information on acceptance criteria, reader studies, ground truth, and training sets as they relate to AI/ML device performance is not applicable to this submission. This document describes a traditional medical device's substantial equivalence based on engineering and material comparisons, not a software-driven diagnostic or prognostic tool.
However, I can extract information related to the device's functional equivalence and the testing performed to demonstrate that.
Acceptance Criteria and Device Performance (for a non-AI/ML device):
The acceptance criteria for this type of device are primarily based on demonstrating substantial equivalence to a predicate device in terms of functionality, method of operation, intended use, indication for use, and biological safety, as well as meeting predefined engineering specifications.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functionality (design, operation, intended use, indications for use) | Substantially equivalent to predicate (Tracker Excel-14 Microcatheter) |
| Material Composition (Shaft Material Proximal) | Offered with Pebax (predicate used Carbothane) |
| Other Material Compositions (Mid, Distal Shaft) | Same as predicate |
| Shaft Design | Same as predicate |
| Distal Shaft Length | Same as predicate |
| Mid Shaft Length | Same as predicate |
| Mid Transition Length | Same as predicate |
| Proximal Shaft Length | Same as predicate |
| Proximal ID/OD | Same as predicate |
| Distal ID/OD | Same as predicate |
| Tip Marker | Same as predicate |
| Coating | Same as predicate |
| Effective Length | Same as predicate |
| Hydrolene Uncoated Length | Increased from 35 cm to 50 cm (compared to predicate) |
| Indication (for labeling) | Same as predicate (with contractual note on peripheral/coronary) |
| Sterilization Method | Same as predicate |
| Packaging Material | Same as predicate |
| Packaging Artwork | Offered as Stryker branded products |
| Packaging Carton/Closure Strip | Offered with perforated opening (vs flap-insert) and smaller closure strip (vs predicate) |
| Risk Assessment (modifications to predicate) | No new questions of safety or effectiveness raised per EN ISO 14971:2012 |
| Verification Testing | Demonstrated substantial equivalence to predicate |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a "test set" in the context of AI/ML. The "test set" here refers to the actual physical devices (Tracker-17 Microcatheters) that underwent verification testing. The number of devices tested for each characteristic (e.g., burst pressure, tensile strength, kink resistance, etc., though not detailed in this summary) is not specified.
- Data Provenance: The data comes from internal verification testing conducted by Stryker Neurovascular. The geographic origin of this testing is not specified but would typically be at their manufacturing or R&D facilities. This is a prospective evaluation of the newly designed device against engineering specifications and comparison to the predicate.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. This is a hardware device. "Ground truth" would refer to established engineering standards, material properties, and performance benchmarks, not expert consensus on medical images or patient outcomes. The "experts" would be engineers, material scientists, and regulatory specialists.
4. Adjudication Method for the Test Set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in a diagnostic or clinical assessment context. For a physical device, performance is measured objectively against specifications. Decisions on whether a test passes or fails are typically based on predefined acceptance limits.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and Effect Size:
- No, Not Applicable. MRMC studies are designed to compare the performance of human readers, often with and without AI assistance, especially in image interpretation. This device is a microcatheter, a physical tool for delivery of agents, not an AI diagnostic software.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- No, Not Applicable. This question relates to AI algorithm performance.
7. The type of ground truth used:
- The "ground truth" for this device's evaluation is primarily engineering specifications, material science standards, and performance characteristics of the predicate device. For instance, burst pressure, tensile strength, flexibility, trackability, radiopacity, and biocompatibility would be measured and compared against established limits and the predicate's performance. The "clinical ground truth" for its intended use is derived from its design to assist in the delivery of diagnostic and therapeutic agents.
8. The sample size for the training set:
- Not Applicable. This question relates to AI algorithm training.
9. How the ground truth for the training set was established:
- Not Applicable. This question relates to AI algorithm training.
In summary, the provided document describes a 510(k) submission for a non-AI/ML medical device. The "acceptance criteria" revolve around demonstrating substantial equivalence to a legally marketed predicate device through engineering analysis, material characterization, and verification testing against predefined specifications. The concepts of "AI models," "human readers," "ground truth determination" in a clinical context, and "training sets" are not relevant to this submission.
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Image /page/0/Picture/1 description: The image shows the logo for Stryker Neurovascular. The word "Stryker" is in a bold, sans-serif font on the top line. Below that, the word "Neurovascular" is in a smaller, bold, sans-serif font. The logo is black and white.
JAN 0 3 2013
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| 510(k) Summary | |
|---|---|
| Summary Date | December 03, 2012 |
| Submitter Name andAddress | Stryker Neurovascular47900 Bayside ParkwayFremont, CA. 94538 |
| Contact Person: | Jean ChenRegulatory Affairs Specialist IPhone: 510 413 2591Fax: 510 413 2244Email: jean.chen @stryker.com |
| Trade Name: | Tracker®-17 Microcatheter |
| Common Name: | Percutaneous Catheter; Microcatheter |
| Classification Name: | Percutaneous catheters are currently classified as Class II devicesper 21 CFR 870.1250. No performance standards have beenestablished under Section 514 of the Food, Drug and Cosmetic Actfor these devices. |
Legally Marketed Predicate Device:
| Reference (Clearance Date) | Device |
|---|---|
| K994155 (3 Aug 2010) | Tracker Excel-14 Microcatheters |
:
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510(k) Summary (cont.)
| Device Description: | Stryker Neurovascular's Tracker-17 Microcatheter is a single lumen device designed to aid the physician in accessing 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. A luer fitting located on the microcatheter hub is used for the attachment of accessories. A radiopaque tip facilitates fluoroscopic visualization. Hydrophilically coated Reinforced Microcatheters are coated on the outer surface with Hydrolene™ Coating that reduces friction during manipulation in the vessel. |
|---|---|
| Accessories: | Tracker-17 Microcatheters are packaged with a steam shaping mandrel as an accessory. |
Indications for Use / Intended Use:
Stryker Neurovascular's Tracker-17 Microcatheters are 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.3
Technological Characteristics and Product Feature Comparison:
Stryker Neurovascular's Tracker-17 Microcatheter is substantially equivalent to the predicate device in terms of
- . functionality
- method of operation .
- . intended use
- . indication for use
- . biological safety
A tabular comparison of the specific technological characteristics between the predicate device and the proposed device is provided below.
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3 Please note, the peripheral and coronary indications are currently not included on the labeling materials because of a contractual agreement Stryker Neurovascular has with Boston Scientific.
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510(k) Summary (cont.)
Product feature comparison for the Tracker-17 Microcatheter Characteristics Results Offered with Pebax as compared to the predicate device, which was Shaft Material Proximal cleared with Carbothane proximal shaft material. Shaft Material Mid Same as predicate. Shaft Material Distal Same as predicate. Shaft Design Same as predicate. Distal Shaft Length Same as predicate. Mid shaft length Same as predicate. Mid transition length Same as predicate. Proximal shaft length Same as predicate. Proximal ID/OD Same as predicate. Same as predicate. Distal ID/OD Tip Marker Same as predicate. Coating Same as predicate. Effective Length Same as predicate. Hydrolene Uncoated length Uncoated length of proximal shaft has increased from 35 cm to 50 cm. Same as predicate. Indication Sterilization Method Same as predicate. Packaging Material Same as predicate. Offered as Stryker branded products. Packaging Artwork Offered with perforated opening, as compared to the flap-insert Packaging Carton opening. Closure Strip Offered with smaller packaging closure strip without slits compared to
the predicate device.
Risk assessment of the modifications in the form of Design and Use FMEAs has been conducted in accordance with EN ISO 14971:2012. Stryker Neurovascular has determined the modifications to the predicate device raise no new questions of safety or effectiveness.
Results of verification testing have demonstrated the Tracker-17 Microcatheters are substantially equivalent to the predicate Tracker Excel-14 Microcatheters.
Conclusion:
Because the subject modifications do not alter the intended use or indications for use of the predicate device, or the fundamental scientific technology of the predicate device; and because risk assessment of the modifications and successful verification testing raise no new questions of safety and effectiveness, Stryker Neurovascular has determined the Tracker-17 Microcatheters to be substantially equivalent to the predicate device.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
January 3, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Stryker Neurovascular Ms. Jean Chen Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, CA 94538
Re: K123452
Trade/Device Name: Tracker-17 Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 3, 2012 Received: December 5, 2012
Dear Ms. Chen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2 - Ms. Jean Chen
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 that I Dri has Intacted and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set Gortoo related autvers (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality of bloms (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 17 you aso!//www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note to for questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the I ou may overnment. generers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang
for
Victor Krauthamer, Ph.D. Acting Division Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K123452
Device Name: Tracker-17 Microcatheter
Indications For Use:
Stryker Neurovascular's Tracker-17 Microcatheters are 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 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joyce M. Whang
(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number K123452
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§ 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).