(97 days)
Not Found
No
The summary describes a physical medical device (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" states that the device is intended for the "selective infusion of various diagnostic, embolic and therapeutic agents". The presence of "therapeutic agents" indicates that the device facilitates therapy.
No
The device is described as a "mechanism for the selective infusion of various diagnostic, embolic and therapeutic agents." Its purpose is to deliver agents, not to diagnose. The agents themselves might be diagnostic, but the catheter is the delivery mechanism.
No
The device description explicitly states it is an "Infusion Catheter," which is a physical medical device used for delivering substances into the body. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "selective infusion of various diagnostic, embolic and therapeutic agents into the peripheral, coronary and neurovasculatures." This describes a device used within the body for delivering substances, not a device used to test samples outside the body to diagnose conditions.
- Device Description: The description reiterates the same function of infusing agents into the vasculature.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This infusion catheter does not fit that description.
N/A
Intended Use / Indications for Use
The CES FG Infusion Catheter is intended to be used as a mechanism for the selective infusion of various diagnostic, embolic and therapeutic agents into the peripheral, coronary and neurovasculatures.
Product codes
74DQO, 74KRA
Device Description
The CES FG Infusion Catheter is substantially equivalent in its basic design, construction, indications for use, performance characteristics, packaging and sterilization to other commercially available infusion catheters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary and neurovasculatures
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Entire FG Infusion Catheters were subjected to biocompatibility testing based on 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
1971306
0-000036
SUMMARY OF SAFETY AND EFFECTIVENESS
I. General Provisions
JUL 1 4 1997
Common or Usual Name: Diagnostic, Intravascular Catheter FG Infusion Catheter Proprietary Name:
II. Name of Predicate Devices
MAGIC Infusion Catheter - K923368 Balt, distributed by Target Therapeutics Product Code: 74DQO Predicate for design, intended use and packaging
CES Infusion Catheters - K965181 Cordis Endovascular Systems, Inc. Product Code: 74KRA Predicate for design, intended use, sterilization and packaging
EDDY Infusion Catheter Medi-tech - Boston Scientific Corporation Product Code: 74KRA Predicate for design and intended use and packaging
III. Classification
Class II
IV. Performance Standards
Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.
V. Intended Use and Device Description
CES Infusion Catheters are intended to be used as a mechanism for the selective infusion of various diagnostic, embolic and therapeutic agents into the peripheral, coronary and neurovasculatures.
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VI. Biocompatibility
Entire FG Infusion Catheters were subjected to biocompatibility testing based on 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.
VII. Summary of Substantial Equivalence
The CES FG Infusion Catheter is substantially equivalent in its basic design, construction, indications for use, performance characteristics, packaging and sterilization to other commercially available infusion catheters.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & H." is arranged vertically on the left side of the logo, and the text "AN SERVICES - USA" is arranged horizontally along the top of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa Wells Manager, Requlatory Affairs and Clinical Research and Clinical Research
Cordis Endovascular Systems, Inc. JUL | 4 |997
P Systems, 205700 P.O. Box 025700 . Miami, Florida 33102-5700 ־¨¨ ¯¯
K971306 Re: FG Infusion Catheter Regulatory Class: II (two) Product Code: KRA Dated: June 26, 1997 Received: June 30, 1997
Dear Ms. Wells:
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, Druq, 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 requlations 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 requirement, 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.
3
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. Callahan
Thomas J. Callahan, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number:
Indications For Use
The CES FG Infusion Catheter is intended to be used as a mechanism for the selective infusion of various diagnostic, embolic and therapeutic 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 Usc_
Tn A. h
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K471306