(90 days)
Not Found
Not Found
No
The document does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies.
Yes
The "Intended Use / Indications for Use" section lists various medical conditions (e.g., refractory left ventricular failure, cardiogenic or septic shock, unstable refractory angina) that the device is intended to treat or support during medical procedures, indicating a therapeutic purpose.
No
The device is an intra-aortic balloon catheter, used for circulatory support in patients with heart conditions, not for diagnosing diseases.
No
The device description clearly details physical components like catheters, tubing, syringes, and insertion kits, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to providing mechanical support and stabilization within the circulatory system for patients with various cardiac conditions. These are therapeutic interventions, not diagnostic tests performed on samples taken from the body.
- Device Description: The device is an intra-aortic balloon catheter and associated insertion tools. This is a medical device used for direct intervention within the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for diagnosis based on such analysis. The device's function is mechanical support.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
-Refractory left ventricular failure,
-Cardiogenic or septic shock.
-Unstable refractory angina.
-Impending infarction,
-Ischemia related ventricular arrhythmias,
-Weaning from cardiopulmonary bypass,
-Support and stabilization during coronary angioplasty,
-Intraoperative pulsatile flow generation,
-Associated mechanical complications of acute myocardial infarction,
-Support and stabilization of high-risk patients undergoing general surgical procedures.
Product codes
Not Found
Device Description
Each double lumen percutaneous TaperSeal" IAB catheter is pre-furled and has a hemostasis device attached to the catheter which may be slid down the catheter and into the insertion site as necessary in the event of excessive bleeding from the puncture site. Each TaperSeal" IAB catheter is packaged into a balloon kit that contains airway tubing, a syringe, syringe adaptor. Kontron and/or Datascope adaptor, and pressure tubing with a stopcock. The TaperSeal" IAB catheters also come packaged with an insertion kit which contains a percutaneous tear away introducer, two guidewire, an angiography needle, and a vessel dilator.
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
Bench testing was performed to verify that the TaperSeal Catheter can withstand insertion forces associated with sheathless insertion. All testing was completed successfully.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.3535 Intra-aortic balloon and control system.
(a)
Identification. An intra-aortic balloon and control system is a prescription device that consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle.(b)
Classification. (1) Class II (special controls) when the device is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure. The special controls for this device are:(i) Appropriate analysis and non-clinical testing must be conducted to validate electromagnetic compatibility and electrical safety of the device;
(ii) Software verification, validation, and hazard analysis must be performed;
(iii) The device must be demonstrated to be biocompatible;
(iv) Sterility and shelf-life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components;
(v) Non-clinical performance evaluation of the device must demonstrate mechanical integrity, durability, and reliability to support its intended purpose; and
(vi) Labeling must include a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(2) Class III (premarket approval) when the device is indicated for septic shock and pulsatile flow generation.
(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 31, 2014, for any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976, or that has, on or before March 31, 2014, been found to be substantially equivalent to any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976. Any other intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
Bard Vascular Systems Division C.R. Bard, Inc. 25 Computer Drive Haverhill, MA 01832 508-373-1000
SEP - 4 1996
VI. 510(k) SUMMARY FOR THE BARD TAPERSEAL IAB CATHETERS
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
A. Submitter Information
Submitter's Name: Bard Vascular Systems. C.R. Bard Inc. Address: 25 Computer Drive, Haverhill, MA 01832 Phone #: (508) 373-1000 Fax #: (508) 374-6200 Contact Person: Sandra L. Perreand Date of Preparation: May 29, 1996
B. Device Name
| Trade Name: | Bard TaperSeal IAB Catheters |
|---|---|
| Common/Usual Name: | Intra-Aortic Balloon Catheter |
| Classification Name: | Intra-Aortic System, Balloon, Intra-Aortic and Control |
C. Predicate Device
Trade Name: Sheathless 40cc Pre-Wrapped Double-Lumen 9.0 F. Intra-Aortic Balloon Catheter. (Model IAB-04240S)
D. Device Description
Each double lumen percutaneous TaperSeal" IAB catheter is pre-furled and has a hemostasis device attached to the catheter which may be slid down the catheter and into the insertion site as necessary in the event of excessive bleeding from the puncture site. Each TaperSeal" IAB catheter is packaged into a balloon kit that contains airway tubing, a syringe, syringe adaptor. Kontron and/or Datascope adaptor, and pressure tubing with a stopcock. The TaperSeal" IAB catheters also come packaged with an insertion kit which contains a percutaneous tear away introducer, two guidewire, an angiography needle, and a vessel dilator.
E. Intended Use
-Refractory left ventricular failure,
-Cardiogenic or septic shock.
-Unstable refractory angina.
-Impending infarction,
1
-Ischemia related ventricular arrhythmias,
-Weaning from cardiopulmonary bypass,
-Support and stabilization during coronary angioplasty,
-Intraoperative pulsatile flow generation,
-Associated mechanical complications of acute myocardial infarction,
-Support and stabilization of high-risk patients undergoing general surgical procedures.
F. Technological Characteristics Summary
Both the TaperSeal and Arrow IAB catheters are very similar, with only a few minor differences with respect to design and materials.
| Table VI-1 Comparison of General Characteristics | ||
|---|---|---|
| Characteristic | Bard TaperSeal" 30cc & 40cc | |
| IAB Catheters | Arrow Sheathless 40cc Pre-Wrapped | |
| Double-Lumen 9.0 F. IAB Catheter | ||
| Balloon Membrane | Polyurethane/Silicone | Polyurethane/Silicone (Cardiothane™) |
| Outer Lumen | Polyurethane | Polyurethane |
| Inner Lumen | Stainless Steel coiled around a | |
| Polyurethane tube | Stainless Steel Tube | |
| Catheter Tip | Polyurethane | Stainless Steel |
| Bifurcation | Polycarbonate | Polyolefin |
| Tracer Ring | Stainless Steel | None |
| Tie down | Thermo Plastic Elastomer | Thermo Plastic Elastomer |
| Hemostasis Device | Polyolefin | Polyolefin |
| Hemostasis seal | Silicone | None |
| Hemostasis Cap | Nylon | None |
G. Performance Data
Bench testing was performed to verify that the TaperSeal Catheter can withstand insertion forces associated with sheathless insertion. All testing was completed successfully.
Sandra L. Penano
Sandra L. Perreand Regulatory Affairs Program Manager
9/3/96
Date