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

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:

AI/ML Overview

This document is a 510(k) premarket notification for a medical device (Datascope Percor STAT-DL® 9.5Fr. Intra-Aortic Balloon) and does not describe a study involving algorithms, AI, or performance metrics typically associated with such systems. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on non-clinical (in-vitro) tests.

Therefore, most of the requested information regarding acceptance criteria, study design for AI/algorithm performance, ground truth, and expert evaluation is not applicable to this document.

However, I can extract the relevant information concerning the device's characteristics and the basis for its safety and effectiveness claim.

Here's a summary based on the provided text, indicating where information is not applicable (N/A) due to the nature of the submission:

Acceptance Criteria and Device Performance

The document states that the device is "substantially equivalent" to predicate devices. The "acceptance criteria" here are implicitly tied to demonstrating this substantial equivalence through non-clinical testing.

Acceptance Criteria (Implied)	Reported Device Performance
Functionality comparable to currently marketed devices (predicate).	"The results of in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed devices."
Performance characteristics comparable to currently marketed devices (predicate).	"The results of in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed devices."
Difference in inner lumen material grade and chemical composition does not affect safety or efficacy.	"The difference in material grade and chemical composition has been demonstrated not to affect safety or efficacy of the device."

Details Regarding the "Study" (Non-Clinical Tests)

Sample size used for the test set and the data provenance: Not specified. The document only mentions "in-vitro tests." No information on sample size or data provenance (country of origin, retrospective/prospective) for these tests is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was a non-clinical, in-vitro testing scenario, not one requiring expert human evaluation for ground truth in the context of diagnostic accuracy.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI/algorithm-based device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the in-vitro tests would be the established performance and safety specifications of the predicate devices. The new device's performance was measured against these predefined physical and functional parameters.
The sample size for the training set: Not applicable. This is not an AI/algorithm-based device, so there is no training set in the context of machine learning.
How the ground truth for the training set was established: Not applicable.

Key takeaway: This document describes a traditional medical device submission focused on demonstrating substantial equivalence via non-clinical (in-vitro) testing against predicate devices, rather than an AI/algorithm performance study. Therefore, many of the requested fields are not relevant.

Summary

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K960166

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 under21 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.

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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:

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.

Regulation Number and Section

§ 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.