(87 days)
An intravascular diagnostic catheter is a device used to record intracardiac pressure, to sample blood, and to introduce substances into the circulatory system.
The 4F SiteSeer catheter is an intravascular diagnostic catheter for use in the cardiovascular svstem.
This document is a 510(k) summary for the Bard® 4F SiteSeer™ Angiographic Cardiovascular Catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new, innovative device feature. Therefore, much of the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of typical AI/medical imaging device submissions is not present.
However, I can extract information related to the device's equivalence to existing technology based on the provided text.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in the way a modern AI or imaging device submission would (e.g., target sensitivity, specificity, or AUC). Instead, the "acceptance criteria" here is implicitly defined as substantial equivalence to predicate devices in terms of materials, construction, packaging, sterilization, and intended use.
Acceptance Criteria (Implicit: Substantial Equivalence to Predicate Devices)
| Characteristic | Acceptance Criteria (Predicate Equivalent) | Reported Device Performance (SiteSeer) |
|---|---|---|
| Material & Construction | Similar to Bard Envision Angiographic catheters. | The Bard Cardiology 4F SiteSeer Angiographic Catheter is similar to the Envision Angiographic catheters regarding materials and construction. |
| Packaging | Similar to Bard Envision Angiographic catheters. | The Bard Cardiology 4F SiteSeer Angiographic Catheter is similar to the Envision Angiographic catheters regarding packaging. |
| Sterilization | Similar to Bard Envision Angiographic catheters. | The Bard Cardiology 4F SiteSeer Angiographic Catheter is similar to the Envision Angiographic catheters regarding sterilization. |
| Indications for Use | Similar to Cordis Infiniti, Cordis Super Torque, Bard Envision, Bard Pro-Flo, Namic Selector catheters (all indicated to deliver media/substances into the vascular system; specifically, to record intracardiac pressures, sample blood, and introduce substances into the heart and vessels.) | The indications for use are similar to both the Cordis catheters and the Bard Cardiology Angiographic catheters. The Bard 4F SiteSeer is indicated for use in the cardiovascular system. Its 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." The Bard SiteSeer will be available in 4 French size and various curve styles, similar to Cordis catheters. |
| Safety and Performance | Demonstrated to be substantially equivalent to predicate devices. | "Safety and performance testing was performed to demonstrate that the Bard SiteSeer Angiographic Catheter is substantially equivalent to the predicate devices." (No specific data or metrics reported in this summary document.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states "Safety and performance testing was performed." However, it does not provide details about:
- The sample size of any test set.
- The data provenance (e.g., country of origin, retrospective or prospective nature).
- The specific tests performed, other than stating they were to demonstrate substantial equivalence. This would typically involve bench testing for material properties, mechanical integrity, biocompatibility, etc., but no specifics are given in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable or not provided in this type of 510(k) submission. This is a medical device (catheter) and not an AI or diagnostic imaging device that typically requires expert-established ground truth for performance evaluation against a diagnostic standard. The performance testing would be against engineering specifications and biocompatibility standards, not clinical diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or not provided. Adjudication methods are typically used in clinical studies involving interpretation (e.g., by radiologists), not for the engineering and safety testing of a physical medical device like a catheter for which this 510(k) was submitted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. An MRMC study is relevant for AI-assisted diagnostic devices. This submission concerns a physical intravascular diagnostic catheter and does not involve human readers interpreting images, nor does it involve AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As this is a physical medical device (catheter), the "ground truth" for its performance would typically be established by validated engineering standards, biocompatibility testing results, and other relevant regulatory tests. The document does not specify the exact "type of ground truth" used beyond stating that "safety and performance testing was performed."
8. The sample size for the training set
This information is not applicable. This is a physical medical device and does not involve AI or machine learning models that require training sets.
9. How the ground truth for the training set was established
This information is not applicable. This is a physical medical device and does not involve AI or machine learning models that require training sets.
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C.R. Bard. Inc. Requiatory Affairs 129 Concord Road P.O. Box 566 Billerica, MA 01821 978-667-2511 FAX: (978) 667-8594
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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. BrunelleRegulatory 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
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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
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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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
§ 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).