(87 days)
Not Found
Not Found
No
The summary describes a standard intravascular diagnostic catheter and does not mention any AI or ML capabilities.
No.
The intended use explicitly states its function as a "diagnostic catheter" to record pressure, sample blood, and introduce substances, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an intravascular diagnostic catheter."
No
The device description explicitly states it is an "intravascular diagnostic catheter," which is a physical hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is an "intravascular diagnostic catheter" used to "record intracardiac pressure, to sample blood, and to introduce substances into the circulatory system." These are procedures performed within the body (in vivo) and involve direct interaction with the circulatory system.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro) to detect diseases, conditions, or infections.
The function of this catheter is to interact with the cardiovascular system directly, not to analyze samples taken from the body in a laboratory setting.
N/A
Intended Use / Indications for Use
The Bard® 4F SiteSeer™ is indicated for use in the cardiovascular system. Their primary function is to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels.
Product codes (comma separated list FDA assigned to the subject device)
74 DOO
Device Description
The 4F SiteSeer catheter is an intravascular diagnostic catheter for use in the cardiovascular svstem.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiovascular system
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)
Safety and performance testing was performed to demonstrate that the Bard SiteSeer Angiographic Catheter is substantially equivalent to the 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.
Cordis Infiniti™ Angiographic Catheter, Cordis Super Torque™ Catheter, Bard Envision™ Catheter, Bard Pro-Flo™ Catheter, Namic Selector™ Catheter
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
C.R. Bard. Inc. Requiatory Affairs 129 Concord Road P.O. Box 566 Billerica, MA 01821 978-667-2511 FAX: (978) 667-8594
Image /page/0/Picture/3 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and prominent appearance. The overall design is simple and clean, with a focus on readability.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS ... .. VI. INFORMATION
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
A. Submitter Information:
| Name: | Bard Cardiology Div. of C.R. Bard, Inc. |
|---|---|
| Address: | 129 Concord Road, Billerica, MA 01821 |
| Phone: | (978) 667-2511 extension 4490 |
| Fax: | (978) 667-8594 |
| Contact Person: | Victoria A. Brunelle |
| Regulatory Affairs Coordinator | |
| Date of Preparation: | February 13, 1998 |
B. Device Name
Trade Name:
Common Name: Classification Name:
C. Predicate Device Name(s):
D. Device Description
E. Intended Use
Bard® 4F SiteSeer™ Angiographic Cardiovascular Catheter Cardiovascular Angiographic Catheter Diagnostic Intravascular Catheter/Percutaneous Catheter
-
- Cordis Infiniti™ Angiographic Catheter
-
- Cordis Super Torque™ Catheter
-
- Bard Envision™ Catheter
-
- Bard Pro-Flo™ Catheter
-
- Namic Selector™ Catheter
The 4F SiteSeer catheter is an intravascular diagnostic catheter for use in the cardiovascular svstem.
Intravascular diagnostic catheters are used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels.
Premarket Notification for Bard Cardiology 4F SiteSeer Catheter
1
VI. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION (CONT.)
F. Technological Characteristics The Bard Cardiology 4F SiteSeer Angiographic Catheter is similar to the Envision Angiographic catheters regarding materials and construction. packaging, and sterilization. The indications for use are similar to both the Cordis catheters and the Bard Cardiology Angiographic catheters. They are all indicated to deliver media or substances into the vascular system. The actual indications are listed below: The Bard 4F SiteSeer is indicated for use in the cardiovascular system. Their primary function is to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. The Cordis Infiniti indications are designed to deliver radiopaque contrast media to selected sites in the vascular system. Similar to the Cordis catheters, the Bard SiteSeer catheter will be available in 4 French size, and will
G. Performance Date
Safety and performance testing was performed to demonstrate that the Bard SiteSeer Angiographic Catheter is substantially equivalent to the predicate devices.
be offered in various curve styles.
Premarket Notification for Bard Cardiology 4F SiteSeer Catheter
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows a partial view of a logo or emblem, featuring a stylized depiction of an eagle or similar bird-like figure. The eagle is rendered in black and appears to be in flight or poised for action. To the left of the eagle, there is text that reads "DEPARTMENT OF HEALTH & H", arranged vertically along the edge of the image. The text is also in black and is oriented to be read from bottom to top.
MAY 1 5 1908
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Victoria Brunelle Regulatory Affairs Coordinator C.R. Bard, Inc. Regulatory Affairs 129 Concord Road P.O. Box 566 Billerica, MA 01821
Re: K980575 BARD® 4F SiteSeer™ Angiographic Catheter Regulatory Class: II (Two) Product Code: 74 DOO Dated: February 13, 1998 Received: February 17, 1998
Dear Ms. Brunelle:
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 regulations 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.
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Paqe 2 - Ms. Victoria Brunelle
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.qov/cdrh/dsma/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
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D. INDICATIONS FOR USE
BARD® 4F SiteSeer™ Angiographic Catheter Device Name:
Indications for Use: An intravascular diagnostic catheter is a device used to record intracardiac pressure, to sample blood, and to introduce substances into the circulatory system.
Contraindications: None
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tu A. R
(Division Sign-Off) Division of Cardiovasc and Neurological Dev 1980575 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use ...................................................................................................................
Premarket Notification for Bard Cardiology 4F SiteSeer Catheter