(20 days)
Not Found
None
No
The 510(k) summary describes a physical catheter and its material properties, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is indicated for the selective infusion of therapeutic agents, which are used for treatment purposes.
No
Explanation: The device is an infusion catheter, indicated for delivering diagnostic, therapeutic, and embolic agents. It does not perform the diagnostic imaging or analysis itself.
No
The device description clearly describes a physical catheter with a shaft, lumen, and coatings, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use of the MASS TRANSIT Infusion Catheter clearly state that it is a device used for the infusion of agents into the body (peripheral, coronary, and neurovasculature). This is an in vivo (within the living body) application, not an in vitro (in glass/outside the body) test.
The device is a tool for delivering substances into the body, not for analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The MASS TRANSIT Infusion Catheters are indicated for the selective infusion of various diagnostic, therapeutic, and embolic agents into the peripheral, coronary, and neurovasculature.
Product codes
KRA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary, and neurovasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Cordis Endovascular Systems, Inc. MASS TRANSIT Infusion Catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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. |
1
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
2
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
3
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 for | |
| Use | The MASS TRANSIT Infusion Catheters are indicated for the selective infusion of |
| various 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