(269 days)
Not Found
Not Found
No
The summary describes a physical catheter for accessing arteries and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is used for diagnostic purposes (blood sampling and blood pressure monitoring) rather than treating a disease or condition.
No
The device is described as being used to access an artery for blood sampling and blood pressure monitoring, which are primarily collection and monitoring functions, not diagnostic interpretation.
No
The device description explicitly states it is a "Radial and Femoral Artery Catheter," which is a physical, invasive medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "access an artery for blood sampling and blood pressure monitoring." This describes a device used in vivo (within the body) to collect a sample and monitor a physiological parameter.
- Device Description: The description reinforces the intended use of accessing an artery.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is used to obtain the specimen and monitor a parameter directly from the body, not to analyze the specimen itself.
Therefore, the Radial and Femoral Artery Catheter described is a medical device used for accessing the arterial system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Radial and Femoral Artery is a device that is utilized to access an artery for blood sampling and blood pressure monitoring.
Product codes
DQX
Device Description
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce a Radial and Femoral Artery Catheter. The Radial and Femoral Artery is a device that is utilized to access an artery for blood sampling and blood pressure monitoring. The Radial and Femoral Artery Catheter composed of materials that have been tested in accordance with the ISO Standard 10993 and have been determined to be suitable for the intended use of this product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Artery (Radial and Femoral)
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
All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product). The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications. The testing instruction records for each of the individually required procedures are approved. released, distributed and revised in accordance with document control GMP"s.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90
B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem, PA 18018 (610)691-5400
ﻣﺴﻴﺴﻴﺴﻬﺎ
ﻟﻨﺘﻬﺎ ﺑﻬﺎ ﻓ
March 12, 1997
DEC 19 1997
Mark S. Alsberge, Regulatory Affairs Manager Contact:
Product Name: Radial and Femoral Artery Catheter
Wire, Guide, Catheter Trade Name:
Classification name:
Cardiovascular Class II, 80DQX 21 CFR 870.1330
SUBSTANTIAL EQUIVALENCE1 TO:
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Device Description:
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce a Radial and Femoral Artery Catheter. The Radial and Femoral Artery is a device that is utilized to access an artery for blood sampling and blood pressure monitoring.
1 The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.
1
Material;
The Radial and Femoral Artery Catheter composed of materials that have been tested in accordance with the ISO Standard 10993 and have been determined to be suitable for the intended use of this product.
Substantial equivalence:
The Radial and Femoral Artery Catheter is similar in materials, form, and intended use to the Arrow Radial Artery Catheterization Kit cleared by Arrow International Inc. There are no new issues of safety or effectiveness raised by The Radial and Femoral Artery Catheter.
Safety And Effectiveness:
All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product).
The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.
The testing instruction records for each of the individually required procedures are approved. released, distributed and revised in accordance with document control GMP"s.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes extending from its wing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kerry S. Hanright Regulatory Affairs Assistant B. Braun Medical Inc. 824 12th Avenue Bethlehem, Pennsylvania 18018-0027
DEC 1 9 1997
K971086 Re : Radial and Femoral Artery Catheter Regulatory Class: II (two) Product Code: DQX September 20, 1997 Dated: Received: September 24, 1997
Dear Ms. Hanright:
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 www 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 to A substantially equivalent determination assumes compliance with 895. 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 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 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.
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, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
adjal and Fimoral a Device Name: Indications For Use:
The Radial and Femoral
Artery is a device that is
utilized to access an artery
for blood sampling and blood
pressure monitoring.
Pert-R
(Division Sir Division of and Neurolog 1971086 510(k) Number .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDEL
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Ootional Format 1-2-96)