(90 days)
No
The document describes a physical catheter for infusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is indicated for the "selective infusion of various diagnostic, therapeutic and embolic agents". This indicates its use in therapy.
No
The device, a catheter, is used for the delivery of diagnostic agents, not for the diagnosis itself. Its function is to facilitate the infusion, not to perform a diagnostic assessment.
No
The device description clearly describes a physical catheter with a shaft, lumen, coating, and lining, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The CES MassTRANSIT Infusion Catheter is a device used to deliver substances directly into the body's vasculature (peripheral, coronary, and neurovasculature). It's an invasive device used for therapeutic, diagnostic (in the sense of delivering contrast agents for imaging), and embolic purposes within the body.
The description clearly indicates its use for infusion into the body, not for testing samples taken from the body.
N/A
Intended Use / Indications for Use
The MassTRANSIT is indicated for the infusion of various diagnostic, therapeutic and embolic agents in the peripheral, coronary, and neurovasculature.
Product codes
KRA
Device Description
The MassTRANSIT is a single lumen catheter designed to access small, tortuous vasculature for the delivery of diagnostic, embolic and therapeutic agents. The shaft tapers from 3.0F proximal 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)
K952874, K936260, K936282, K965181, K972518, K960806, K953900, K953892
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
Appendix A - Summary of Safety and Effectiveness
Appendix A - Summary of Safety and Effectiveness and K974222
FEB 1 0 1998
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Image /page/1/Picture/0 description: The image shows two lines of handwritten text. The first line contains the string "K974222", while the second line contains the string "0-000030". The text appears to be written in black ink on a white background. The handwriting is somewhat stylized, with some of the characters having unique shapes.
510(k) Summary of Safety and Effectiveness
The predicate devices are listed in the table below. Predicate Devices
Device | Company | 510 (k) Number, Concurrence Date | Product Code |
---|---|---|---|
CES TRANSIT | Cordis Endovascular Systems, Inc. | K952874, K936260 | |
K936282, K965181, | |||
K972518 | DQO | ||
KRA | |||
FasTRACKER ® 325 | Target Therapeutics | K960806* | DQO* |
JETSTREAM® 327 | Medtronic | K953900, K953892* | DQO |
KRA |
- This information is assumed based on our best current knowledge.
Classification | Class II |
---|---|
Performance | |
Standard | Performance standards have not been established by the FDA under Section 514 of |
the Food, Drug and Cosmetic Act. | |
Intended use | The MassTRANSIT is indicated for the infusion of various diagnostic, therapeutic and |
embolic agents in the peripheral, coronary, and neurovasculature. | |
Device | |
Description | The MassTRANSIT is a single lumen catheter designed to access small, tortuous |
vasculature for the delivery of diagnostic, embolic and therapeutic agents. The shaft | |
tapers from 3.0F proximal 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. |
·
2
510(k) Summary of Safety and Effectiveness (col
| Biocompatibility | All appropriate biocompatibility tests have been performed according to the FDA
modified matrix of ISO-10993 (Blue Book Memorandum G95-1). The catheters
demonstrated compatibility with biological tissue by meeting the acceptance
criteria stipulated in the test protocols. |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
Substantial
Equivalence | The CES MassTRANSIT Infusion Catheter is similar in its basic design, construction,
indication for use and performance characteristics to the predicate devices.2 |
2 A statement of substantial equivalence to another product is required by 21CFR 807.87, and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent, and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, " ... a determination of substantial equivalence under the federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suits" 42 Fed. Reg. 42,520, et seq. (1977).
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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 1998
Ms. Ariel MacTavish Sr. · Requlatory Affairs Associate Cordis Corporation P.O. Box 025700 Miami, FL 33102-5700
Re : K974222 CES Mass Transit™ Infusion Catheter Regulatory Class: II (two) Product Code: 74 KRA Dated: November 7, 1997 November 12, 1997 Received:
Dear Ms. MacTavish:
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 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, 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. 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 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 regulations.
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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) 594-4648. 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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K974222 510 (k) Number:_______________________________________________________________________________________________________________________________________________________________
Indications for Use Statement
CES MassTRANSIT Infusion Catheters are indicated for the selective infusion of various diagnostic, therapeutic and embolic agents into the peripheral, coronary and neurovasculatures.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Tan A Ra
(Division Sign-O)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K974222