(221 days)
Not Found
No
The summary describes a physical catheter with a heparin coating and focuses on mechanical and flow performance, with no mention of AI/ML terms or functionalities.
No
The device is a catheter used for venous access and fluid administration, and its heparin coating aims to decrease thrombosis. While it performs a medical function, it does not directly treat a disease or condition in a therapeutic sense; rather, it facilitates medical procedures.
No
The device is described as a large-bore multiple lumen catheter for venous access and rapid fluid administration, intended to provide therapeutic intervention rather than diagnose a condition.
No
The device description clearly states it is a physical catheter made of polyurethane with multiple lumens and extension lines, indicating it is a hardware device. The performance studies also focus on physical properties like flow rate, tensile strength, and pressure tests, further confirming it 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 is for "venous access to a central circulation for rapid fluid administration." This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The description details a catheter for accessing veins, which is consistent with a medical device used for treatment or procedures, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body. This device is designed to be inserted into the body for direct access and fluid administration.
N/A
Intended Use / Indications for Use
"The large-bore multiple lumen catheter permits venous access to a central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, and femoral veins. The heparin coating on the catheter intended to decrease the incidence of thrombous formation associated with catheterization."
The large bore multiple lumen catheter permits venous access to a central circulation for rapid uid administration. It may be inserted into the jugular, subclavian, or femoral veins. The heparin coating on the catheter intended to decrease the incidence of thrombus formation associated with catheterization.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
The device is a triple-lumen polyurethane catheter, 12 French in size, with three extension lines, luer hubs, and clamps. It is essentially the same in appearance and function to the Arrow multi-lumen predicate catheters except for the larger size to accommodate rapid fluid administration in emergency critical care situations in the hospital.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
jugular, subclavian, and femoral veins
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital
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)
The performance tests included in the submission include:
-
- Flow rate
-
- Tensile test
-
- Pressure leak test
-
- Positive pressure burst test
-
- Biocompatibility tests
-
- Flex (fatigue) test
No clinical testing was performed.
The results of the laboratory tests demonstrated that the device is safe, and as effective as the legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K820648, K844080, K862056, K895417
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
7-1-2004
510(k) SUMMARY - K970864
OCT 17 1997
Submitter:
Arrow International, Inc. 2400 Bernville Road Reading, PA 19605
| Contact Person: | Thomas D. Nickel
Vice President, Regulatory Affairs and Quality Assurance
610/478-3137 |
|----------------------------|----------------------------------------------------------------------------------------------|
| Date summary
prepared - | 10/16/97 |
Device:
| Trade Name - | Arrow-Howes™ Large Bore Multi-lumen central venous catheter |
|---|---|
| Common Name - | Central venous catheter |
| Classification | |
| Name - | Catheter, intravascular, 80FOZ, and 21 CFR 880.5200, |
| Intravascular catheter |
Legally marketed device to which the device is substantially equivalent:
Various Arrow central venous catheters; specifically K820648, K844080, K862056, and K895417
Description of device:
The device is a triple-lumen polyurethane catheter, 12 French in size, with three extension lines, luer hubs, and clamps. It is essentially the same in appearance and function to the Arrow multi-lumen predicate catheters except for the larger size to accommodate rapid fluid administration in emergency critical care situations in the hospital.
Intended use of the device:
The intended use and indications for use are comparable to the predicate devices, and appear below:
"Indications for use:
The large-bore multiple lumen catheter permits venous access to a central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, and femoral veins. The heparin coating on the catheter intended to decrease the incidence of thrombous formation associated with catheterization."
1
Technological characteristics:
The device has the same exact technological characteristics as the predicates, with the only difference being the larger size and accompanying greater fluid flow rates.
The performance tests included in the submission include:
-
- Flow rate
-
- Tensile test
-
- Pressure leak test
-
- Positive pressure burst test
-
- Biocompatibility tests
-
- Flex (fatigue) test
No clinical testing was performed.
The results of the laboratory tests demonstrated that the device is safe, and as effective as the legally marketed predicate devices.
97095
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle's head and three human figures.
OCT 17 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Thomas D. Nickel Vice President, Requlatory Affairs and Quality Assurance Arrow International, Incorporated 3000 Bernville Road Readinq, Pennsylvania 19605
Re : K970864 Trade Name: Arrow-Howes Large Bore Multi-Lumen Central Venous Catheters Requlatory Class: II Product Code: FOZ Dated: July 21, 1997 Received: July 22, 1997
Dear Mr. Nickel:
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 qeneral 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 Requlations, Title 21, Parts 800 to 895. ರ್ಗ 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 Druq 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
3
Page 2 - Mr. Nickel
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) 594-4618. 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,
K. Clatird.
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
P.O. Box 12888 Reading, PA 19612
Image /page/4/Picture/1 description: The image shows the logo for Arrow International. The logo consists of the word "ARROW" in large, bold, sans-serif font, with the word "INTERNATIONAL" in a smaller, thinner, sans-serif font underneath. The logo is black and white.
TM
The S 970864 : ,
Reading, PA 19605 (610) 378-0131 FAX: (610) 374-5360
3000 Bernville Road
Section 11 - Indications
K
ie large bore multiple lumen catheter permits venous access to a central circulation for rapid uid administration. It may be inserted into the jugular, subclavian, or femoral veins. The heparin coating on the catheter intended to decrease the incidence of thrombus formation associated with catheterization.
Rx Prescription Use
Viola Hilbert for Patricia Cucenti