(82 days)
Not Found
No
The summary describes a mechanical device (intra-aortic balloon pump) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for treating various cardiac conditions such as cardiogenic shock, myocardial infarction, and refractory power failure, which are conditions that require therapeutic intervention.
No
This device, an Intra-Aortic Balloon (IAB), is described as a therapeutic device used for conditions like cardiogenic shock or unstable angina, not for diagnosing them. The performance studies focus on mechanical aspects like insertion, kink resistance, and trackability rather than diagnostic accuracy.
No
The device description clearly outlines physical components like a polyurethane blend balloon, nylon shaft, and central lumen, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states the device is an Intra-Aortic Balloon (IAB) catheter, which is a physical device inserted into the aorta.
- Intended Use: The intended uses are all related to providing mechanical circulatory support within the body for various cardiac conditions. This is an in vivo (within the living body) application, not in vitro (in glass/outside the body).
The device is a therapeutic and supportive medical device, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The indications for use for the Cardiac Assist IAB's are identical to that of the currently marketed devices. The indications are as follows:
- Refractory power failure.
- Cardiogenic shock.
- Unstable refractory angina.
- Impending or extending myocardial infarction (MI).
- Hemodynamically significant mechanical complications secondary to acute MI:
- Ventricular septal defect.
- Mitral valve regurgitation.
- Papillary muscle rupture.
- Angiography/angioplasty patients.
- Septal shock.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Models 940 and 930, 30 cc and 40 cc Sensation™ and NICATH™ 40 cc and 30 cc IAB's consist of a polyurethane blend balloon at the distal end of a polyurethane-covered nylon shaft. The balloons are coated with a thin layer of Medical Grade silicone fluid. A central lumen runs throughout the length of the catheters and terminates at the distal tip. This central lumen may be used to pass the device over a guidewire. The balloon is supplied pre-wrapped for insertion.
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:
-
Insertion Test: A test was designed and manufactured with an adjustable restriction to simulate a sheathless insertion. Cardiac Assist. Datascope and Arrow IAB's were inserted through the fixture at smaller and smaller increments to ascertain the tightest restriction the device could be passed through without damaging the IAB or its guidewire. In each case the Cardiac Assist IAB's were able to be inserted through a tighter restriction without failure as compared to the Datascope and Arrow IAB's. The competitor catheters required larger openings to be able to pass through without failure.
-
Kink Resistance Test: The Cardiac Assist. Datascope and Arrow IAB's were tested for their resistance to kinking by bending the catheter samples around a radius and measuring the smallest step on the fixture that the catheter was able to be bent around without failure. The Cardiac Assist mean radius ranged from 0.124 to 0.54 inch while the Datascope mean was 0.24 inch and the Arrow mean was 0.23 inch. The Cardiac Assist IAB's have been demonstrated to be substantially equivalent in kink resistance to the Datascope and Arrow IAB's.
-
Trackability Test: The Cardiac Assist, Datascope and Arrow IAB's were inserted over their guidewire into position and removed without damaging the balloon or guidewire. All of the IAB's were able to track their quidewire into proper position in the aorta without incident. There were no catheter kinks, guidewire kinks, and no problems or difficulties encountered during insertion and removal demonstrating substantial equivalence of the Cardiac Assist IAB's to Datascope and Arrow.
-
Dimensional Comparison: A dimensional comparison was made between the Cardiac Assist and Datascope and Arrow IAB's catheter shaft diameter, folded balloon diameter, and the difference between the folded balloon diameter and catheter shaft diamter. Results indicated that the difference between the folded balloon diameter and catheter shaft diamter of the Cardiac Assist IAB's ranges from 0.009 to 0.015 inch while the Datascope is 0.009 inch and the Arrow is 0.029 inch. The difference between the folded balloon diameter and catheter shaft diameter of the Cardiac Assist IAB's is substantially equivalent to that of the Datascope and Arrow IAB's.
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
§ 870.3535 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
NOV - 4 1986
Image /page/0/Figure/2 description: The image shows a text box with the words "510(K) SUMMARY" written in bold, black letters. The text is centered within the box. The box itself is a light gray color.
Pursuant to Section 513(i)(3)(A) of the Federal Food, Drug and Cosmetic Act, Boston Scientific Corporation / Cardiac Assist (BSC/CA) is required to submit within this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." BSC/CA chooses to submit a summary of information regarding safety and effectiveness.
A. GENERAL INFORMATION
| Submitter's Name: | Boston Scientific Corporation
One Boston Scientific Place
Natick, MA 01760-1537 |
|----------------------|---------------------------------------------------------------------------------------|
| Contact Person: | Leo Basta
Director, Regulatory Affairs and Clinical Research |
| Date of Preparation: | 01 August 1996 |
B. DEVICE INFORMATION
Device Generic Name: Intra-Aortic Balloon Catheters
Device Trade Names: Model 940 Model 930 30 cc Sensation™ 40 cc Sensation™ NICATH™ 40 CC NICATH™ 30 cc
Classification Name: Percutaneous Intra-Aortic Balloon Catheter
C. PREDICATE DEVICE INFORMATION
The following devices are referenced in this premarket notification as predicate devices for the sheathless insertion of BSC/CA IAB's:
K910997: Datascope 9.5 F 40 cc PERCOR STAT-DL.
K892222: Kontron 9 F 40 cc IAB for Sheathless Insertion.
These devices are currently legally marketed for sheathless insertion.
1
PROPOSED DEVICES INFORMATION D.
This premarket notification proposes to allow the labeling of the BSC/CA Models 940 and 930, 30 cc and 40 cc Sensation™ and NICATH™ 40 cc and 30 cc IAB's for an optional sheathless method of insertion. The sheathless insertion technique is proposed to be offerred in the Directions for Use along with the current instructions for a sheathed insertion.
E. DEVICE DESCRIPTIONS
The Models 940 and 930, 30 cc and 40 cc Sensation™ and NICATH™ 40 cc and 30 cc IAB's consist of a polyurethane blend balloon at the distal end of a polyurethane-covered nylon shaft. The balloons are coated with a thin layer of Medical Grade silicone fluid. A central lumen runs throughout the length of the catheters and terminates at the distal tip. This central lumen may be used to pass the device over a guidewire. The balloon is supplied pre-wrapped for insertion.
F. INDICATIONS FOR USE
The indications for use for the Cardiac Assist IAB's are identical to that of the currently marketed devices. The indications are as follows:
-
- Refractory power failure.
-
- Cardiogenic shock.
-
- Unstable refractory angina.
-
- Impending or extending myocardial infarction (MI).
-
- Hemodynamically significant mechanical complications secondary to acute MI:
-
- Ventricular septal defect.
-
- Mitral valve regurgitation.
-
- Papillary muscle rupture.
-
- Hemodynamically significant mechanical complications secondary to acute MI:
-
- Angiography/angioplasty patients.
-
- Septal shock.
G. TECHNOLOGICAL CHARACTERISTICS
The Cardiac Assist IAB's proposed to be labeled for optional sheathless insertion are Identical to the current legally marketed IAB's. Test data and information demonstrates that the use of the Cardiac Assist IAB's is substantially equivalent to the performance of the predicate devices (Datascope 9.5 F 40 cc PERCOR STAT-DL and Arrow 9 F 40 cc) when tested for sheathless insertion.
H. NONCLINICAL TESTS
The following tests were performed:
-
- Insertion Test:
A test was designed and manufactured with an adjustable restriction to simulate a sheathless insertion. Cardiac Assist. Datascope and Arrow IAB's were inserted through the fixture at smaller and smaller increments to ascertain the tightest restriction the device could be passed through without damaging the IAB or its guidewire.
- Insertion Test:
2
In each case the Cardiac Assist IAB's were able to be inserted through a tighter restriction without failure as compared to the Datascope and Arrow IAB's. The competitor catheters required larger openings to be able to pass through without failure.
- Kink Resistance Test:
The Cardiac Assist. Datascope and Arrow IAB's were tested for their resistance to kinking by bending the catheter samples around a radius and measuring the smallest step on the fixture that the catheter was able to be bent around without failure. The Cardiac Assist mean radius ranged from 0.124 to 0.54 inch while the Datascope mean was 0.24 inch and the Arrow mean was 0.23 inch.
The Cardiac Assist IAB's have been demonstrated to be substantially equivalent in kink resistance to the Datascope and Arrow IAB's.
- Trackability Test:
The Cardiac Assist, Datascope and Arrow IAB's were inserted over their guidewire into position and removed without damaging the balloon or guidewire. All of the IAB's were able to track their quidewire into proper position in the aorta without incident. There were no catheter kinks, guidewire kinks, and no problems or difficulties encountered during insertion and removal demonstrating substantial equivalence of the Cardiac Assist IAB's to Datascope and Arrow.
-
- Dimensional Comparison:
A dimensional comparison was made between the Cardiac Assist and Datascope and Arrow IAB's catheter shaft diameter, folded balloon diameter, and the difference between the folded balloon diameter and catheter shaft diamter. Results indicated that the difference between the folded balloon diameter and catheter shaft diamter of the Cardiac Assist IAB's ranges from 0.009 to 0.015 inch while the Datascope is 0.009 inch and the Arrow is 0.029 inch.
- Dimensional Comparison:
The difference between the folded balloon diameter and catheter shaft diameter of the Cardiac Assist IAB's is substantially equivalent to that of the Datascope and Arrow IAB's.
CLINICAL TESTS 1.
Based on conversations with FDA in April 1996, it was agreed that no formal clinical data was required to support this premarket notification.
J. STERILIZATION AND PACKAGING
There are no changes to the packaging and sterilization of the Cardiac Assist IAB's. The catheters are placed in plastic trays and sealed into Tyvek/Mylar pouches and are sterilized using ethylene oxide gas. Ethylene oxide gas residuals and bacterial endotoxin levels are monitored for compliance with maximum release limits.
3
POTENTIAL COMPLICATIONS K.
Potential complications associated with the use of intra-aortic balloon catheters in general appear in the devices' Directions for Use and are reproduced below:
-
- Leg ischemia.
-
- Femoral, aortic or illiac dissection.
-
- Arterial injury.
-
- Renal artery occlusion.
-
- Arterial rupture.
-
- Hypotension.
-
- Distal embolization.
-
- Death.
-
- Vascular thrombosis.
-
- Short-term hemodynamic deterioration.
-
- Hemorrhage.
-
- Arteriovenous fistula formation.
لــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ CONCLUSIONS
Based on the performance data and information submitted in this premarket notification, Boston Scientific Corporation / Cardiac Assist believes that the Cardiac Assist Models 940 and 930, 30 cc and 40 cc Sensation™ and NICATH™ 40 cc and 30 cc IAB's are substantially equivalent to the predicate devices, Datascope 9.5 F 40 cc PERCOR STAT-DL and Arrow 9 F 40 cc IAB's, with regard to sheathless insertion of the devices.