(60 days)
Not Found
No
The summary describes a physical diagnostic catheter and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The "Intended Use / Indications for Use" section states that the device is "designed to deliver contrast medium during angiography as well as to provide a conduit for various diagnostic and therapeutic procedures."
Yes
The device is explicitly named a "diagnostic catheter" in its intended use, indications for use, and device description sections. It is designed to deliver contrast medium for angiography, which is a diagnostic procedure.
No
The device description clearly indicates it is a physical catheter, 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 designed to "deliver contrast medium during angiography as well as to provide a conduit for various diagnostic and therapeutic procedures." This describes a device used in vivo (within the body) for imaging and interventions, not for testing samples in vitro (outside the body).
- Device Description: The description of a catheter with different lengths and distal stem configurations is consistent with a device used for accessing and navigating within the body's vascular system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This catheter's function is to facilitate procedures performed directly on the patient.
N/A
Intended Use / Indications for Use
The 4 French SELECTOR™ diagnostic catheter is designed to deliver contrast medium during angiography as well as to provide a conduit for various diagnostic and therapeutic procedures.
Product codes (comma separated list FDA assigned to the subject device)
74 DQO
Device Description
The 4 French SELECTOR™ diagnostic catheter is manufactured in multiple lengths and with multiple distal stem configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The following tests were performed on the 4 French SELECTOR™ diagnostic catheter and on the predicate device to show equivalence: bond strength tests, flexural rigidity, bodystock force decay, shape recovery, flow rate, dynamic pressure, and output/input torque to failure testing. The results of these tests indicate that the 4 French SELECTOR™ diagnostic catheter is equivalent to the previously approved predicate device and is therefore safe for its intended use.
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.
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
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
K98207
AUG | | 1998
Schneider (USA) Inc Pfizer Medical Technology Group 5905 Nathan Lane Minneapolis, MN 55442 Tel 612 550 5500 Fax 612 550 5771
Image /page/0/Picture/3 description: The image shows the logo for Pfizer, a pharmaceutical company. The logo consists of the word "Pfizer" in a stylized, bold, sans-serif font. The word is white and is set against a black oval background. The logo is simple and recognizable.
510(K) SUMMAR
Image /page/0/Picture/5 description: The image contains the word "SUMMARY" in large, bold font on the left side. To the right of the word "SUMMARY" is a logo with the word "SCHNEIDER" stacked on top of the word "WORLDWIDE". The letters in "WORLDWIDE" are spaced out.
5 French and 6 French SELECTOR™ diagnostic catheters
4 French SUPER TORQUE and SUPERTORQUEPLUS™
(March 3, 1993: K925522/March 29, 1996: K960801)
diagnostic catheter (April 2, 1996: K960975).
Date Prepared:
Sponsor:
June 12, 1998
Schneider (USA) Inc 5905 Nathan Lane Plymouth, MN 55442 Phone: (612)550-5500
Contact:
Janell A. Colley Regulatory Affairs Specialist
Trade/Proprietary Name: 4 French SELECTOR™ diagnostic catheter
Class II
Classification:
Equivalent Devices
Device Description
The 4 French SELECTOR™ diagnostic catheter is manufactured in multiple lengths and with multiple distal stem configurations.
The 4 French SELECTOR" is designed to deliver contrast Intended Use medium during angiography as well as to provide a conduit for various diagnostic and therapeutic procedures.
Technological Characteristics
The following tests were performed on the 4 French SELECTOR™ diagnostic catheter and on the predicate device to show equivalence: bond strength tests, flexural rigidity, bodystock force decay, shape recovery, flow rate, dynamic pressure, and output/input torque to failure testing.
The results of these tests indicate that the 4 French SELECTOR" diagnostic catheter is equivalent to the previously approved predicate device and is therefore safe for its intended use.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG / 1 1998
Ms. Janell A. Colley Schneider (USA) Inc. Pfizer Medical Technology Group 5905 Nathan Lane Minneapolis, MN 55442
Re: K982077 4 French SELECTOR™ Diagnostic Catheter Regulatory Class: II (two) Product Code: 74 DQO Dated: June 12, 1998 Received: June 12, 1998
Dear Ms. Colley:
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 legally marketed predicate 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with 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 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.
2
Page 2 - Ms. Janell A. Colley
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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J V Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
emarket Notification 510(k) for the French SELECTORTM Diagnostic Cathete
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
4 French SELECTOR™ diagnostic catheter
Indications for Use:
The 4 French SELECTOR™ diagnostic catheter is designed to deliver contrast medium during angiography as well as to provide a conduit for various diagnostic and therapeutic procedures.
PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tara A. Ry
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
Prescription Use (Per 21 CRF 801.109)
or
Over-The-Counter Use
(Optional Format 1-2-96)