(167 days)
Not Found
No
The description focuses on the mechanical design and function of a catheter for infusion, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an infusion catheter for delivering pharmacological agents and contrast media, which are not therapeutic devices themselves. The device facilitates a medical procedure but does not directly provide therapy.
No
The device is intended for the infusion of pharmacological agents and contrast media, which is a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly details a physical catheter with various components (lumen, luer adapter, infusion holes, valve, radiopaque markers) and mentions physical testing, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the controlled selective infusion of pharmacological agents and contrast media into the general vasculature. This is a therapeutic and diagnostic imaging procedure performed in vivo (within the body).
- Device Description: The device is a catheter designed for delivering substances directly into blood vessels. This is a medical device used for intervention and delivery, not for analyzing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. The device's function is purely mechanical and delivery-based.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This catheter does not fit that description.
N/A
Intended Use / Indications for Use
The 2.9F Cragg-McNamara™ Valved Infusion Catheter is intended to be used for the controlled selective infusion of physician specified pharmacological agents and radiopaque contrast media into the general vasculature. It is not intended for coronary, neurological, pediatric or neonatal use.
Product codes
KRA
Device Description
The 2.9F Cragg-McNamara™ Valved Infusion Catheter is a single lumen plastic catheter suitable for infusion of physician-specified pharmacological agents or contrast media through its proximal luer adapter to infusion holes circumferentially placed in the distal portion of the catheter. The device is designed to be placed over a guide wire into the general vasculature. The device will be available in various catheter and infusion lengths.
The 2.9F Cragg-McNamara™ Valved Infusion Catheter utilizes a plastic valve at the tip which will allow effective transmission of infusate through the side holes by effectively occluding infusion out the catheter. As a guide wire is introduced, the valve opens to permit smooth passage of the guide wire and closes again as the guide wire is removed. The recommended maximum guide wire OD is 0.018 inch.
The 2.9F Cragg-McNamara™ Valved Infusion Catheter has two radiopaque markers that define fluoroscopically the location of the exit holes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general vasculature
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
Biocompatibility testing was performed on the 2.9F Cragg-McNamara™ Valved Infusion Catheter in Tests in accordance with the International Standard for the Biological Evaluation of Medical Devices, Part 1: Guidance on Selection of Tests (ISO 10993-1:1992(E)) to establish that the materials and processes used in the manufacture of the device met the qualifications for short term use in the vascular system. Results of the tests showed that the device passed biocompatibility testing and is suitable for its application.
Physical testing of the product included: dimensional inspection, catheter tensile strength tests, static and dynamic burst pressure tests, flow rate test, and performance under simulated conditions. All testing of the product yielded acceptable results.
Key Metrics
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).
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o Therapeutics Inc.
2964868
MAY 2 0 1997
Image /page/0/Picture/3 description: The image shows a logo with the letters 'MTI' in a stylized, bold font. The left side of the 'M' has a series of dots that appear to be dispersing or fading away. The letters are connected and have a geometric design, with sharp angles and straight lines.
510(k) Summary of Safety and Effectiveness
2.9F Cragg-McNamara™ Valved Infusion Catheter
General Information
| Classification | Class II |
|---|---|
| Trade Name | 2.9F Cragg-McNamara™ Valved Infusion Catheter |
| Generic Name | Infusion Catheter |
| Submitter | Micro Therapeutics, Inc. |
| 1062-F Calle Negocio | |
| San Clemente, CA 92673 | |
| Contact | Linda D'Abate |
| Clinical and Regulatory Affairs |
Predicate Devices
Micro Therapeutics Infusion Catheters (K940634, October 14, 1994)
Device Description
The 2.9F Cragg-McNamara™ Valved Infusion Catheter is a single lumen plastic catheter suitable for infusion of physician-specified pharmacological agents or contrast media through its proximal luer adapter to infusion holes circumferentially placed in the distal portion of the catheter. The device is designed to be placed over a guide wire into the general vasculature. The device will be available in various catheter and infusion lengths.
The 2.9F Cragg-McNamara™ Valved Infusion Catheter utilizes a plastic valve at the tip which will allow effective transmission of infusate through the side holes by effectively occluding infusion out the catheter. As a guide wire is introduced, the valve opens to permit smooth passage of the guide wire and closes again as the guide wire is removed. The recommended maximum guide wire OD is 0.018 inch.
The 2.9F Cragg-McNamara™ Valved Infusion Catheter has two radiopaque markers that define fluoroscopically the location of the exit holes.
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The method of construction and materials used for these infusion catheters are substantially equivalent to previous infusion catheter products.
Intended Use
The 2.9F Cragg-McNamara™ Infusion Catheter is intended to be used for the controlled selective infusion of physician-specified pharmacological agents or contrast media into the general vasculature.
Testing
Biocompatibility testing was performed on the 2.9F Cragg-McNamara™ Valved Infusion Catheter in Tests in accordance with the International Standard for the Biological Evaluation of Medical Devices, Part 1: Guidance on Selection of Tests (ISO 10993-1:1992(E)) to establish that the materials and processes used in the manufacture of the device met the qualifications for short term use in the vascular system. Results of the tests showed that the device passed biocompatibility testing and is suitable for its application.
Physical testing of the product included: dimensional inspection, catheter tensile strength tests, static and dynamic burst pressure tests, flow rate test, and performance under simulated conditions. All testing of the product yielded acceptable results.
Summary of Substantial Equivalence
The 2.9F Cragg-McNamara™ Valved Infusion Catheter is constructed of the same or substantially equivalent materials as the Micro Therapeutics Infusion Catheters and other legally marketed infusion catheters. The sizes and configurations available along with the packaging and sterilization methods are also equivalent.
The clinical indications for use are identical to the predicate devices.
Therefore, due to the similarity of materials to other infusion catheters, the test results and the identical indications for use to other infusion catheters, Micro Therapeutics believes these products do not raise any new safety or effectiveness issues.
, 1 मीना
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Image /page/2/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. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 1997
Ms. Joy Tan Regulatory Affairs Micro Therapeutics, Inc. 1062-F Calle Negocio San Clemente, California 92673
K964868 Re: 2.9F Cragg-McNamara™ Valved Infusion Catheter Regulatory Class: II (two) Product Code: KRA Dated: February 19, 1997 Received: February 20, 1997
Dear Ms. Tan:
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 Requiations, Title 21, Parts 800 " A substantially equivalent determination assumes compliance to 895. with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in
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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 requlations.
This letter will allow you to begin marketing your device as described in you 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 at (301) 443-6597.
Sincerely yours,
Thomas J. Callahan
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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: 上
510(k) Number (if known): K964868
Device Name:
2.9F Cragg-McNamara™ Valved Infusion Catheter
Indications for Use:
The 2.9F Cragg-McNamara™ Valved Infusion Catheter is intended to be used for the controlled selective infusion of physician specified pharmacological agents and radiopaque contrast media into the general vasculature. It is not intended for coronary, neurological, pediatric or neonatal use.
Ta A R
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 16964868 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Pcr 21 CFR 801.109)
OR
Over the Counter Use