CS300 Intra-Aortic Balloon Pump has the following indications for use: The balloon pump is an electromechanical system used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation. The intraaortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle. The target populations are adult and pediatric. The balloon pump is intended for use in the health care facility setting. Datascope's Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Catheter has the following indications for use: - Refractory unstable angina - Impending infarction - Acute MI - Refractory ventricular failure - Complications of acute MI (i.e. Acute MR or VSD, or papillary muscle rupture) - Cardiogenic shock - Support for diagnostic, percutaneous revascularization, and interventional procedures - Ischemia related intractable ventricular arrhythmias - Septic shock - Intraoperative pulsatile flow generation - Weaning from bypass - Cardiac support for non-cardiac surgery - Prophylactic support in preparation for cardiac surgery - Post surgical myocardial dysfunction/low cardiac output syndrome - Myocardial contusion - Mechanical bridge to other assist devices - Cardiac support following correction of anatomical defects

Device Description

The Datascope IABP System [Fiber Optic Pressure Sensor IAB Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System] is used for intra-aortic balloon counterpulsation therapy in the aorta. The Datascope IABP System [Fiber Optic Pressure Sensor IAB Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System] includes the following: - CS300 Intra-Aortic Balloon Pump - Fiber optic pressure Sensor IAB assembly - Revised packaging tray with cable retention feature

AI/ML Overview

The provided text is a 510(k) summary for Datascope's IABP System, specifically the Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria, a dedicated clinical study proving device performance against those criteria, or the methodology typically associated with AI/ML device evaluations.

Therefore, I cannot fully complete the requested table and descriptions based only on the provided text for the following reasons:

No explicit acceptance criteria: The document does not list quantitative performance metrics (e.g., sensitivity, specificity, accuracy, precision) as "acceptance criteria" for the device's function or a study comparing them. The evaluation is based on "substantial equivalence" to existing devices through non-clinical (in-vitro) testing.
No "study" in the requested sense: There is no mention of a clinical trial designed to assess the new device against specific performance endpoints, particularly not one involving AI, human readers, or ground truth establishment.
Absence of AI/ML specific information: The device is an Intra-Aortic Balloon Pump system, not a software-as-a-medical-device (SaMD) or an AI/ML diagnostic tool. Therefore, concepts like "test set," "training set," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone performance," and "type of ground truth" are not applicable in their typical sense to this submission.

However, I can extract the available information regarding how the device's performance was evaluated and the conclusions drawn:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Functionality and performance comparable to currently marketed devices (Predicate Devices)	"The results of in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed devices."

2. Sample size used for the test set and the data provenance

Sample Size (Test Set): Not applicable in the context of this 510(k) submission, which relies on in-vitro testing for substantial equivalence, not a clinical "test set" and ground truth as would be used for an AI/ML device. The document explicitly states: "There has been no clinical evaluation of the new device in the U.S."
Data Provenance: Not applicable. The evaluation was in-vitro testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. This device is not an AI/ML diagnostic tool requiring expert review to establish ground truth for a test set.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. No test set requiring expert adjudication was described.

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

MRMC Study: No. This device is an IABP system, not an AI/ML image analysis or diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This device is a mechanical/electronic medical system, not an algorithm. Its performance is inherent to its design and function, demonstrated through in-vitro tests and comparison to predicate devices, not through "standalone algorithm performance."

7. The type of ground truth used

Type of Ground Truth: Not applicable in the sense of expert consensus, pathology, or outcomes data for diagnostic accuracy. The "ground truth" here is effectively the established performance characteristics of the predicate devices to which the new device was compared using in-vitro tests.

8. The sample size for the training set

Sample Size (Training Set): Not applicable. This device does not involve a training set as it is not an AI/ML device.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable.

Summary of the Study:

The study described is a non-clinical in-vitro testing program. The objective was to demonstrate substantial equivalence to predicate devices. The study concluded that "the functionality and performance characteristics of the device are comparable to the currently marketed devices" based on these in-vitro tests. No clinical trials or human subject studies were conducted for this 510(k) submission for the new device in the U.S.

Summary

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063525

Attachment D

JAN -5 2007

510(k) SUMMARY FOR DATASCOPE'S IABP SYSTEM FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON (IAB) CATHETER and CS300 INTRA-AORTIC BALLOON PUMP (IABP) CONTROL SYSTEM

(Prepared in accordance with 21 CFR Part 807.92)

A. GENERAL INFORMATION

Submitter:	Datascope Corp.Cardiac Assist Division
Address:	15 Law DriveFairfield, NJ 07004
Contact Person:	Nancy CohenManager Regulatory Affairs and ProductSurveillance
Phone:	973/244-6104
Fax:	973/244-6243
Email:	Nancy_Cohen@datascope.com
Date:	November 21, 2006

B. DEVICE INFORMATION

Generic Name:	Intra-Aortic Balloon (IAB) Catheter andControl System
Trade Name:	Datascope's IABP System [Fiber OpticPressure Sensor Intra-Aortic Balloon (IAB)Catheter and CS300 Intra-Aortic BalloonPump (IABP) Control System]
Classification Name:	Intra-Aortic Balloon (IAB) Catheter andControl System is classified under 21CFR870.3535

C. PREDICATE DEVICE INFORMATION

Datascope's IABP System [Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System] is substantially equivalent to the following marketed devices:

K041281 Datascope's Linear 7.5Fr. IAB, Substantially . Equivalent 6/07/04
Datascope's CS100 IAB Pump, Substantially K031636 -. Equivalent 8/11/03
K031569 Datascope's 8Fr. IAB. Substantially Equivalent . 6/10/03

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K013326 Datascope's Fidelity 8Fr. IAB, Substantially . Equivalent 11/02/01
Arrow AutoCAT Intra-Aortic Balloon Pump . K060309 -(IABP) Series, Substantially Equivalent 4/06/06
K040801 Arrow International's Intra-Aortic Balloon . Catheter, Substantially Equivalent 5/06/04
. K021462 - Arrow International's IAB Fiber Optic Sensor (FOS)/FOS Measurement System, Substantially Equivalent 6/06/02
Arrow International (C.R. Bard, Inc.) 8Fr 40 cc . K981660 and 7Fr. 30 cc Sheathless Intra-Aortic Balloon (IAB)

D. DEVICE DESCRIPTION/INTENDED USE DEVICE DESCRIPTION

The Datascope IABP System [Fiber Optic Pressure Sensor IAB Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System] is used for intra-aortic balloon counterpulsation therapy in the aorta.

INTENDED USE

CS300 Intra-Aortic Balloon Pump has the following indications for use:

The balloon pump is an electromechanical system used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation. The intraaortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle.

The target populations are adult and pediatric. The balloon pump is intended for use in the health care facility setting.

Datascope's Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Catheter has the following indications for use:

Refractory unstable angina .
. Impending infarction
. Acute MI
Refractory ventricular failure .
. Complications of acute MI (i.e. Acute MR or VSD, or papillary muscle rupture)
. Cardiogenic shock

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Support for diagnostic, percutaneous revascularization, and . interventional procedures
Ischemia related intractable ventricular arrhythmias .
Septic shock .
Intraoperative pulsatile flow generation .
. Weaning from bypass
Cardiac support for non-cardiac surgery .
Prophylactic support in preparation for cardiac surgery .
. Post surgical myocardial dysfunction/low cardiac output syndrome
. Myocardial contusion
Mechanical bridge to other assist devices .
Cardiac support following correction of anatomical defects .

E. TECHNOLOGICAL CHARACTERISTICS

The Datascope IABP System [Fiber Optic Pressure Sensor IAB Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System] includes the following:

. CS300 Intra-Aortic Balloon Pump
Fiber optic pressure Sensor IAB assembly .
. Revised packaging tray with cable retention feature

These modifications to the Datascope IAB System [Fiber Optic Pressure Sensor IAB Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System] have been demonstrated not to affect safety or effectiveness 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.

G. CLINICAL TESTS

There has been no clinical evaluation of the new device in the U.S.

H. CONCLUSIONS

Based on the information presented in this 510(k) premarket notification, Datascope's IABP System [Fiber Optic Pressure Sensor IAB Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System] is considered substantially equivalent to Datascope's currently marketed IAB Catheters and Control Systems.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's commitment to health, well-being, and human services. The eagle is positioned in the center of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN -5 2007

Datascope Corp. c/o Ms. Nancy Cohen Manager Regulatory Affairs and Product Surveillance 15 Law Drive Fairfield, NJ 07004

K063525 Re:

Datascope's IABP System [Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System] Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-aortic Balloon and Control System Regulatory Class: III Product Code: DSP Dated: December 15, 2006 Received: December 18, 2006

Dear Ms. Cohen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Nancy Cohen

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Blymmuta for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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· Attachment B

Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Datascope's IABP System Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Device Name: Catheter & CS300 Intra-Aortic Balloon Pump (IABP) Control System)

Indications For Use:

CS300 Intra-Aortic Balloon Pump has the following indications for use:

The balloon pump is an electromechanical system used to inflate and deflate intra-aortic It provides temporary support to the left ventricle via the principle of balloons. counterpulsation. The intra-aortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle.

The target populations are adult and pediatric. The balloon pump is intended for use in the health care facility setting.

B. Asmmento

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K063525

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Attachment B

Indications for Use

Koc 35 25 510(k) Number (if known):

Datascope's IABP System Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Device Name: Catheter & CS300 Intra-Aortic Balloon Pump (IABP) Control System

Indications For Use:

Datascope's Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Catheter has the following indications for use:

Refractory unstable angina .
. Impending infarction
. Acute Mi
Refractory ventricular failure .
Complications of acute MI (i.e. Acute MR or VSD, or papillary muscle rupture) .
. Cardiogenic shock
Support for diagnostic, percutaneous revascularization, and interventional procedures .
Ischemia related intractable ventricular arrhythmias .
. Septic shock
Intraoperative pulsatile flow generation .
. Weaning from bypass
. Cardiac support for non-cardiac surgery
. Prophylactic support in preparation for cardiac surgery
Post surgical myocardial dysfunction/low cardiac output syndrome .
Myocardial contusion .
Mechanical bridge to other assist devices .
Cardiac support following correction of anatomical defects .

Blummo

on Sign-Off lon of Cardiovascular Devices

Prescription Use x

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.