(117 days)
The HYPERTRANSIT™ Infusion Catheter is intended to be used as a mechanism for the infusion of various diagnostic and embolic agents in the coronary, neuro and peripheral vasculatures, for guidewire exchange/support and for superselective angiography of the peripheral and coronary vessels. The device is also intended to be used for infusion of therapeutic agents in the coronary and peripheral vasculature. All agents must be used in accordance with manufacturer's instructions for use.
The Cordis Neurovascular, Inc. HYPERTRANSIT Infusion Catheter is a variable stiffness, single lumen catheter designed to access small, tortuous vasculature. Each configuration has a hydrophilic coating to provide lubricity for navigation of vessels. The inner lumen is lined with PTFE to facilitate movement of guidewires and other devices. The catheter body is radiopaque to aid visualization under fluoroscopy, and the distal tip is distinguished by a radiopaque marker. Select configurations are available with pre-shaped tips.
The provided 510(k) summary describes a medical device, the HYPERTRANSIT™ Infusion Catheter, and its substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving the device meets those criteria through a standalone study with specific performance metrics.
Instead, the document details comparative and performance testing to demonstrate safety and effectiveness and substantial equivalence to existing devices already on the market. It does not present acceptance criteria with target performance metrics like sensitivity, specificity, or accuracy that would be typical for an AI/ML medical device.
Therefore, many of the requested elements for an AI/ML device study, such as sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable or available in this document.
However, I can extract information related to the types of testing conducted and the basis for substantial equivalence.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Note: This section is adapted as the document focuses on equivalence and performance testing rather than acceptance criteria for an AI/driven device's diagnostic performance. The "Acceptance Criteria" here are implicitly meeting performance benchmarks comparable to predicate devices and acceptable safety profiles. "Reported Device Performance" refers to the successful completion of these tests as implied by the FDA's clearance.
| Acceptance Criteria (Implied for Device Performance & Safety) | Reported Device Performance (Implied by FDA Clearance) |
|---|---|
| Comparative Testing: | |
| Linear Stiffness within acceptable range and comparable to predicates | Testing conducted (e.g., comparable to MASSTRANSIT®, Renegade HI-FLO, PROWLER® SELECT™) |
| Flow Rate Testing demonstrating adequate flow and comparability to predicates | Testing conducted (e.g., comparable to MASSTRANSIT®, Renegade HI-FLO, PROWLER® SELECT™) |
| Shape Retention meeting design specifications and comparable to predicates | Testing conducted |
| Acute Animal Studies demonstrate safety in-vivo and comparable to predicates | Testing conducted |
| Embolic Particle (PVA) Functional Compatibility Testing | Testing conducted |
| Pushable Coil Functional Compatibility Testing | Testing conducted |
| Performance Testing (Safety & Effectiveness): | |
| Dimensional Inspection meets specifications | Testing conducted |
| Joint Pull Test meets strength requirements | Testing conducted |
| Static Burst Test meets pressure resistance requirements | Testing conducted |
| Dynamic Burst Test meets pressure resistance requirements over time | Testing conducted |
| Particulate Testing meets cleanliness standards | Testing conducted |
| Coating Integrity maintained during use | Testing conducted |
| Flow Rate Testing demonstrates intended flow characteristics | Testing conducted |
| Acute Animal Studies demonstrate in-vivo safety | Testing conducted |
| Biocompatibility Testing meets regulatory standards for patient contact | Testing conducted |
| Overall Substantial Equivalence: | Determined to be substantially equivalent to predicate devices (MASSTRANSIT®, PROWLER® SELECT™, Renegade HI-FLO Microcatheter) for basic design, intended use, sterilization, and performance. |
Not Applicable / Not Provided Information for AI/ML Device Study:
The following information is not present in the given document because the device (HYPERTRANSIT™ Infusion Catheter) is a physical medical device, not an AI/ML software or algorithm requiring diagnostic performance metrics.
2. Sample size used for the test set and the data provenance
- Not Applicable. This document describes testing for a physical catheter, not an AI/ML algorithm that uses a test set of data. The "test set" would refer to the catheters themselves undergoing various physical and functional tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth, in the context of AI/ML, refers to a label or diagnosis established by experts for a dataset. For a physical device, testing involves measuring physical properties or observing performance in simulated/animal environments, not expert labeling of data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are used to resolve discrepancies in expert labeling for AI/ML ground truth. This is not relevant for testing a physical instrument.
5. 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. MRMC studies are specific to AI/ML devices that aim to assist human readers in tasks like image interpretation. This device is a catheter.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This refers to the performance of an AI algorithm in isolation. The HYPERTRANSIT™ Infusion Catheter is a physical device used by clinicians.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For the physical device, "ground truth" is established by engineering specifications, validated test methods (e.g., for flow rate, burst pressure), and clinical/biological observations in animal studies.
8. The sample size for the training set
- Not Applicable. Training sets are used for machine learning. This document describes the development and testing of a physical medical device.
9. How the ground truth for the training set was established
- Not Applicable. As there is no AI/ML training set, the concept of establishing ground truth for it is irrelevant in this context.
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510(k) Summary of Safety and Effectiveness
| Applicant'sName | Cordis Neurovascular, Inc.14000 NW 57th CourtMiami, Florida 33014 |
|---|---|
| Contact Person | Maritza CelayaRegulatory Affairs Manager(786) 313-6546(786) 313-6480 (Fax) |
| Trade Name /Common Name | The trade name of the device is: HYPERTRANSIT™ Infusion Catheter.The common name of the device is: Catheter, Continuous Flush. |
| Classification | These devices have been classified as Class II, per 21 CFR 870.1210 (KRA)which have been classified within the Division of Cardiology and RespiratoryDevices. |
| PerformanceStandard | There are no performance standards applicable under Section 514 of theFood, Drug and Cosmetic Act for Continuous Flush Catheters. |
| Intended Use | The HYPERTRANSIT™ Infusion Catheter is intended to be used as amechanism for the infusion of various diagnostic and embolic agents in thecoronary, neuro and peripheral vasculatures, for guidewire exchange/supportand for superselective angiography of the peripheral and coronary vessels. The device is also intended to be used for infusion of therapeutic agents in thecoronary and peripheral vasculature. |
| All agents must be used in accordance with manufacturer's instructions foruse | |
| DeviceDescription | The Cordis Neurovascular, Inc. HYPERTRANSIT Infusion Catheter is avariable stiffness, single lumen catheter designed to access small, tortuousvasculature. Each configuration has a hydrophilic coating to provide lubricityfor navigation of vessels. The inner lumen is lined with PTFE to facilitatemovement of guidewires and other devices. The catheter body is radiopaqueto aid visualization under fluoroscopy, and the distal tip is distinguished by aradiopaque marker. Select configurations are available with pre-shaped tips. |
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510(k) Summary of Safety and Effectiveness, continued
The predicate devices are listed in the table below: Predicate Devices
| Device | Company | 510(k)Number | Product Code | Predicate for: |
|---|---|---|---|---|
| MASSTRANSIT®Infusion Catheter | CordisNeurovascular, Inc. | K983003 | KRA | Intended UseSterilization |
| Renegade HI-FLOMicrocatheter | Boston ScientificCorporation | K000177 | KRA | Intended UseDimensionsPerformance |
| PROWLER®SELECT™ InfusionCatheters | CordisNeurovascular, Inc. | K021591 | KRA | Intended UseSterilizationPackaging |
The following in-vitro and in-vivo testing was conducted to support Summary of substantial equivalence to the predicate devices. Studies
| Comparative Testing |
|---|
| Linear Stiffness |
| Flow Rate Testing |
| Shape Retention |
| Acute Animal Studies |
| Embolic Particle (PVA) Functional CompatibilityTesting |
| Pushable Coil Functional Compatibility Testing |
The following in-vitro and in-vivo testing was conducted to demonstrate the safety and effectiveness of the device, and to demonstrate that the device performs as it is intended.
| Performance Testing |
|---|
| Dimensional Inspection |
| Joint Pull Test |
| Static Burst Test |
| Dynamic Burst Test |
| Particulate Testing |
| Coating Integrity |
| Flow Rate Testing |
| Acute Animal Studies |
| Biocompatibility Testing |
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| Summary of | The HYPERTRANSIT™ Infusion Catheter is similar in its basic design |
|---|---|
| Substantial | indication for use, sterilization, and performance characteristics to the |
| Equivalence | predicate devices, the MASSTRANSIT® Infusion Catheter, the PROWLER® SELECT™ Infusion Catheter and the Renegade HI FLO Microcatheter. |
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 8 2005
Ms. Maritza Celaya Regulatory Affairs Manager Cordis Neurovascular, Inc. P.O. Box 025700 Miami, FL 33102-5700
Re: K043538
Trade/Device Name: HYPERTRANSIT™ Infusion Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: II Product Code: KRA Dated: March 18, 2005 Received: March 21, 2005
Dear Ms. Celaya:
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 - Ms. Maritza Celaya
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
t (2005) (2000) (2006) (2006) (20053) (20053) 542 of the Act): 21 CFR 1000-1 forth in the quality systems (QS) regulation (21 -51 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action S product radiation control provisions (Sections 31 cevice as described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a leg This letter will allow you to begin marketing your active of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of yo premarket notification. The FDA imding of substantial equive 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
r the register and and any and 18 10 - Alge, also, alless note the regulati If you desire specific advice for your uc vice on on A. Also, please note the regulation entitled,
contact the Office of Compliance at (240) 276-0120. Also, please note the r contact the Office of Compilalice at (24) 270 - 1207 Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21 CFR from the Division of Small "Misbranding by reference to prematicilities under the Act from the Division of Small
other general information on your responsibilities under the Act from the 1800) 638-200 other general internation on your responsionines and its toll-free number (800) 638-2041 or 1980)
Manufacturers, International and Consumer Assistance at its toll-arcery/supp Manufacturers, International and Consumer Assistance at les confire and consistements of the
Sincerely yours,
R. Wichner
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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Page 1 of 1 Effective Date: 11/15/00
Image /page/5/Picture/2 description: The image shows the word "Cordis" in a bold, sans-serif font. A horizontal line is drawn underneath the word. Below the line, the text "a Johnson & Johnson company" is written in a cursive font. The logo is simple and corporate, likely representing the brand identity of Cordis, a company owned by Johnson & Johnson.
Page 1 of 1
510(k) Number (if known):
Device Name: HYPERTRANSIT™ Infusion Catheter
Indications for Use Statement
The HYPERTRANSIT™ Infusion Catheter is intended to be used as a mechanism for the infusion of various diagnostic and embolic agents in the coronary, neuro and perioheral vasculatures, for guidewire exchange/support, and for superselective angiography of the peripheral and coronary vessels. The device is also intended to be used for infusion of theraseutic agents in the coronary and peripheral vasculature.
All agents must be used in accordance with manufacturer's instructions for use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Mana K. Jochner
Prescription Use ✓
Division Slan-Off) ardiovascular De goer-The-Counter Use____
510(k) Number K04
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).