(269 days)
The Radial and Femoral Artery is a device that is utilized to access an artery for blood sampling and blood pressure monitoring.
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.
This is a 510(k) premarket notification for a Medical Device: Radial and Femoral Artery Catheter by B. Braun Medical, Inc. This device is a catheter. A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This document does not describe acceptance criteria for the device based on performance studies, nor does it present a study to demonstrate such performance or describe an AI/ML powered device.
However, it does describe the following:
1. Acceptance Criteria and Reported Device Performance:
The document states: "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)."
It further explains: "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."
While specific numeric acceptance criteria and reported performance values are not provided in this 510(k) summary, the general acceptance criteria are:
- Meeting required release specifications.
- Compliance with established physical testing procedures and parameters outlined in Quality Control Test Procedure documents.
- Conformity to product design specifications.
- Suitability of materials for intended use based on ISO Standard 10993 testing.
No quantified device performance metrics are reported in this summary beyond the general statement of meeting release specifications.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a "test set" in the context of an algorithmic performance study. The testing refers to manufacturing quality control and material biocompatibility. Therefore, these details are not applicable as presented in a medical device 510(k) submission for a physical device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable. The device is a physical catheter, and the "ground truth" for its safety and effectiveness is established through adherence to manufacturing specifications, material testing (ISO Standard 10993), and comparison to a predicate device. There is no mention of expert-established ground truth for a test set in the context of an algorithm.
4. Adjudication Method for the Test Set:
This information is not applicable as there is no mention of an identified "test set" that would require adjudication in the context of an algorithm-based evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This document is for a physical medical device (catheter), not an AI-powered diagnostic or assistive tool.
6. If a Standalone (Algorithm Only) Performance Study Was Done:
No, a standalone performance study was not done. This document pertains to a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for this medical device submission is established through:
- Material Biocompatibility Testing: Adherence to ISO Standard 10993 for material suitability.
- Manufacturing Quality Control: Conformance to established physical testing procedures, product design specifications, and visual examination.
- Substantial Equivalence to a Predicate Device: The Arrow Radial Artery Catheterization Kit, meaning its safety and effectiveness are deemed equivalent to a device already legally marketed.
8. Sample Size for the Training Set:
This information is not applicable as the device is a physical catheter and does not involve AI/ML requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as the device is a physical catheter and does not involve AI/ML requiring a training set.
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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
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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.
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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.
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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.
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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. 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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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)
§ 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.