(20 days)
The MASS TRANSIT Infusion Catheters are indicated for the selective infusion of various diagnostic, therapeutic, and embolic agents into the peripheral, coronary, and neurovasculature.
Single lumen catheter designed to access small, tortuous vasculature for the delivery of diagnostic, embolic, and therapeutic agents. The shaft tapers from 3.0F proximally to 2.8F distally. The catheter has a hydrophilic coating to provide lubrication for navigation of vessels. The inner lumen is lined with PTFE to facilitate movement of guidewires and other devices.
This document, K983003, is a 510(k) premarket notification for the "MASS TRANSIT Infusion Catheter." It describes the device and its intended use but does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The 510(k) pathway, particularly for a device determined to be "substantially equivalent" to a predicate device, often relies on demonstrating that the new device has the same intended use and similar technological characteristics as a legally marketed predicate. This typically involves performance bench testing to show that the device performs as intended and is as safe and effective as the predicate, rather than establishing new clinical effectiveness.
Therefore, I cannot fulfill your request for the following sections based on the provided document:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: This information is not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not present.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs. without AI assistance: This is not an AI/software device; this type of study is not relevant here and is not mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This is not an AI/software device; this type of study is not relevant here and is not mentioned.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not present.
- The sample size for the training set: This is not an AI/software device; this information is not relevant here and is not mentioned.
- How the ground truth for the training set was established: This is not an AI/software device; this information is not relevant here and is not mentioned.
Summary based on the provided document:
The provided document, K983003, focuses on demonstrating substantial equivalence of the "MASS TRANSIT Infusion Catheter" to a previously cleared predicate device. It details the device's description, intended use, and claims of biocompatibility and substantial equivalence. It does not describe specific acceptance criteria, performance studies against those criteria, or clinical trial data often associated with proving new device effectiveness. The FDA's letter confirms the determination of substantial equivalence based on the provided information, allowing the device to be marketed.
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Attachment 4
Summary of Safety and Effectiveness
| General Provisions | Trade Name: MASS TRANSIT Infusion Catheter |
|---|---|
| Common/Classification Name: Continuous Flush Catheter | |
| Name of Predicate Devices | Cordis Endovascular Systems, Inc. MASS TRANSIT Infusion Catheter |
| Classification | Class II |
| Performance Standards | The FDA under section 514 of the Food, Drug and Cosmetic Act has not established performance standards. |
| Intended Use and Device Description | The MASS TRANSIT Infusion Catheters are indicated for the selective infusion of various diagnostic, therapeutic, and embolic agents into the peripheral, coronary, and neurovasculature. |
| The device description for the MASS TRANSIT Infusion Catheters is as follows. Single lumen catheter designed to access small, tortuous vasculature for the delivery of diagnostic, embolic, and therapeutic agents.The shaft tapers from 3.0F proximally to 2.8F distally.The catheter has a hydrophilic coating to provide lubrication for navigation of vessels.The inner lumen is lined with PTFE to facilitate movement of guidewires and other devices. | |
| Biocompatibility | All materials used in the MASS TRANSIT Infusion Catheters are biocompatible. |
| Summary of Substantial Equivalence | The MASS TRANSIT Infusion Catheters are substantially equivalent to the previously cleared MASS TRANSIT Infusion Catheters. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a symbolic representation of a human form or wave-like design above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 1998
Mr. Martine D. Schneider Sr. Regulatory Affairs Associate Cordis Endovascular System, Inc. 14000 N.W. 57th Ct. Miami Lakes, FL 33014
Re : K983003 Trade Name: Mass Transit Infusion Catheter Requlatory Class: II Product Code: KRA Dated: August 27, 1998 Received: August 28, 1998
Dear Mr. Schneider:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, --FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket
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Page 2 - Mr. Martine D. Schneider
notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Ohi+tlyllstora-for
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 2
Indications for Use Statement
| 510(k) Number(if known) | The 510(k) number has not yet been assigned. |
|---|---|
| Device Name | MASS TRANSIT Infusion Catheter Catheters |
| Indications forUse | The MASS TRANSIT Infusion Catheters are indicated for the selective infusion ofvarious diagnostic, therapeutic, and embolic agents into the peripheral, coronary,and neurovasculature. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chistopher M. Ahrenholz TTC
(Division Sign-Off) Division of Cardiovascular and Iveurological Devic 98300 3 510(k) Number
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use
§ 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).