(99 days)
Not Found
No
The summary describes a mechanical device (intra-aortic balloon) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The 'Intended Use' section explicitly states that the device is "intended to improve cardiovascular functioning" during various medical conditions, indicating a therapeutic purpose.
No
Explanation: The device description states its intention is to "improve cardiovascular functioning" in various critical situations, indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly describes a physical intra-aortic balloon, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Description and Intended Use: The description clearly states that the intra-aortic balloon is placed in the descending aorta and is intended to improve cardiovascular functioning. This is a device that is inserted into the body and directly interacts with the circulatory system to provide therapeutic support.
- Lack of Mention of Samples or Testing: There is no mention of the device being used to analyze samples or perform diagnostic tests on bodily fluids or tissues.
Therefore, this device is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations:
Refractory ventricular failure Cardiogenic shock Unstable refractory angina Unstable angina Septic shock Impending infarction Cardiac support for high risk surgical patients Ischemic related intractable ventricular arrhythmias Mechanical complications due to acute myocardial infarction
Product codes
Not Found
Device Description
The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations:
Refractory ventricular failure Cardiogenic shock Unstable refractory angina Unstable angina Septic shock Impending infarction Cardiac support for high risk surgical patients Ischemic related intractable ventricular arrhythmias Mechanical complications due to acute myocardial infarction
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
descending aorta just below the subclavian artery
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
The results of in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed devices. There has been no clinical evaluation of the new device.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows a large, block-letter "D" that is filled in with a grid pattern. The letter is black, and the grid lines are thin and dark. There are also some circles in the corners of the image, and diagonal lines that intersect within the letter.
APR 2 5 1996
Datascope
Cardiac Assist Division
960166
SUMMARY OF SAFETY AND EFFECTIVENESS FOR
DATASCOPE PERCOR STAT-DL® 9.5Fr. INTRA-AORTIC BALLOON (IAB) WTH ALTERNATE INNER LUMEN MATERIAL
(Prepared in accordance with 21 CFR Part 807.92)
GENERAL INFORMATION A.
Submitter:
Address:
15 Law Drive Fairfield, NJ 07004
Datascope Corp
Diane DePonte Arpino Contact Person:
DEVICE INFORMATION B.
| Generic Name: | Intra-Aortic Balloon (IAB) |
|---|---|
| Trade Name: | Datascope Percor STAT-DL® Intra-Aortic Balloon (IAB) |
| Classification Name: | Intra-Aortic Balloons (IABs) are classified under |
| 21 CFR 870.3535 |
PREDICATE DEVICE INFORMATIQN C.
Datascope's Percor STAT-DL® Intra-Aortic Balloon is substantially equivalent to the following marketed devices:
Datascope Percor STAT-DL® 9.5Fr. Intra-Aortic Balloon, K905056 & K940178.
1
Summary of Safety & Effectiveness/Datascope Percor STAT-DL® 9.5Fr. IAB Page 2
DEVICE DESCRIPTION/INTENDED USE D.
The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations:
Refractory ventricular failure Cardiogenic shock Unstable refractory angina Unstable angina Septic shock Impending infarction Cardiac support for high risk surgical patients Ischemic related intractable ventricular arrhythmias Mechanical complications due to acute myocardial infarction
TECHNOLOGICAL CHARACTERISTICS E.
Datascope's Percor STAT-DL® 9.5Fr. IAB is identical to the predicate device with regard to its indications for use and dimensional specifications. It differs technologically respecting material grade and chemical composition of the inner lumen. The difference in material grade and chemical composition has been demonstrated not to affect safety or efficacy of the device.
F. NON-CLINICAL TESTS
The results of in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed devices.
CLINICAL TESTS G.
There has been no clinical evaluation of the new device.
CONCLUSIONS H.
Based on the information presented in this 510(k) premarket notification, Datascope's Percor STAT-DL® 9.5Fr. IAB is considered substantially equivalent to Datascope's currently marketed IAB.