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 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 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 .
Modifications to Datascope's predicate 8 Fr. IAB catheters include a material modification of Datascope's currently marketed balloon membrane to enable the balloon to be manufactured using different molding process. The catheter tip material is that of a previously FDA cleared IAB tip material and the catheter's tip dimension has been tapered.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for Datascope's CA 40 8Fr. Intra-Aortic Balloon Catheters:

Acceptance Criteria and Reported Device Performance

The provided document describes a 510(k) premarket notification for a Class III medical device. In the context of 510(k) submissions, the primary "acceptance criterion" is Substantial Equivalence to a predicate device. This means demonstrating that the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness.

The document does not explicitly list quantitative acceptance criteria for specific performance metrics in the way one might see for a diagnostic AI algorithm (e.g., sensitivity, specificity thresholds). Instead, the acceptance is based on demonstrating that modifications do not negatively impact safety or efficacy, and the device performs comparably to its predicates.

Acceptance Criterion (Implicit)	Reported Device Performance
Substantial Equivalence to Predicate Devices	The device is considered substantially equivalent to Datascope's currently marketed IABs (K013326 and K003598).
Functionality and Performance Comparable to Marketed 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."
No adverse effect on Safety or Efficacy due to modifications	"These modifications to the 8Fr. IAB catheters have been demonstrated not to affect safety or efficacy of the device." Modifications include a material change to the balloon membrane for a different molding process, a previously cleared catheter tip material, and a tapered tip dimension.
Intended Use Matches Predicate Devices	Datascope's CA 40 8Fr. IAB Catheters are substantially equivalent to the predicate devices with regard to intended use, covering a range of cardiovascular conditions and support scenarios.

Study Details

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

No clinical test set was used. The document explicitly states: "There have been no clinical evaluations of the new device."
The evaluation was based on in-vitro tests to demonstrate comparable functionality and performance. The sample size for these in-vitro tests is not specified.
The data provenance is not applicable as it was an in-vitro study, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Since no clinical test set was used and the evaluation was based on in-vitro performance, there was no ground truth requiring expert establishment in the clinical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical test set requiring adjudication.

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

No. This is a medical device (Intra-Aortic Balloon Catheter), not an AI diagnostic or assistance system that involves human readers interpreting data. Therefore, an MRMC study is not applicable.

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

Not applicable. This device is an invasive medical catheter, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the in-vitro tests: The "ground truth" would be established by engineering specifications, established physical and mechanical properties, and functional benchmarks derived from the performance of the predicate devices. The document implies performance was compared against these established standards of the predicate devices.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model, so there is no "training set."

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

Not applicable. No training set was used.

Summary

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K031569

Attachment D

SUMMARY OF SAFETY AND EFFECTIVENESS FOR

DATASCOPE'S CA 40 8Fr. Intra-Aortic Balloon Catheters Prepared in accordance with 21 CFR Part 807.92)

GENERAL INFORMATION A.

Submitter:	Datascope Corp.Cardiac Assist Division
Address	15 Law DriveFairfield, NJ 07004
Contact Person:	JoAnn TaylorGlobal Regulatory Affairs Specialist

B. DEVICE INFORMATION

Generic Name:	Intra-Aortic Balloon Catheter (IAB)
Trade Name:	Datascope's 8 Fr. Intra-Aortic Balloon Catheter (IAB)
Classification Name:	Intra-Aortic Balloon Catheters (IAB) are classified under 21 CFR870.3535

C. PREDICATE DEVICE INFORMATION

Datascope's CA 40 Intra-Aortic Balloon Catheters (IAB) are substantially equivalent to the following marketed devices:

K013326, Datascope Fidelity 8Fr. Alt B Intra-Aortic Balloon Catheters (S/E . 11/02/01).
K003598, Datascope Profile 8Fr. Intra-Aortic Balloon Catheters w/Alt B and Gas . Lumen Insert (S/E 12/21/00)

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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 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 .

TECHNOLOGICAL CHARACTERISTICS E.

Datascope's CA 40 8Fr. IAB Catheters are substantially equivalent to the predicate devices with regard to intended use.

Modifications to Datascope's predicate 8 Fr. IAB catheters include a material modification of Datascope's currently marketed balloon membrane to enable the balloon to be manufactured using different molding process. The catheter tip material is that of a previously FDA cleared IAB tip material and the catheter's tip dimension has been tapered.

These modifications to the 8Fr. IAB catheters have 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.

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G. CLINICAL TESTS

There have been no clinical evaluations of the new device.

H. CONCLUSIONS

Based on the information presented in this 510(k) premarket notification, Datascope's CA 40 8 Fr. IAB Catheters are considered substantially equivalent to Datascope's currently marketed IABs.

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Public Health Service

JUN 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Datascope Corporation Cardiac Assist Division c/o Ms. JoAnn Taylor Global Regulatory Affairs Specialist 15 Law Drive Fairfield. NJ 07004

Re: K031569

8Fr. Intra-Aortic Balloon Catheter Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-Aortic Balloon Catheter Regulatory Class: Class III (three) Product Code: DSP Dated: May 19, 2003 Received: May 20, 2003

Dear Ms. Taylor:

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. Iisting 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. JoAnn Taylor

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 (301) 594-4646. 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/dsmaldsmamain.html

Sincerely yours,

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 Statement

510(k) Number	K031569
Device Name	Datascope's CA 40 8Fr. Intra-Aortic Balloon Catheters
Indicationsfor Use	Datascope's CA 40 8Fr. Intra-Aortic Balloon Catheters have the followingindications for use:Refractory unstable anginaImpending infarctionAcute MIRefractory ventricular failureComplications of acute MI (i.e. Acute MR or VSD, or papillary muscle rupture)Cardiogenic shockSupport for diagnostic, percutaneous revascularization, and interventional procedures.Ischemia related intractable ventricular arrhythmiasSeptic shockIntraoperative pulsatile flow generationWeaning from bypassCardiac support for non-cardiac surgeryProphylactic support in preparation for cardiac surgeryPost surgical myocardial dysfunction/low cardiac output syndromeMyocardial contusionMechanical bridge to other assist devicesCardiac support following correction of anatomical defects

510(k) Number

K031569

Device Name

Datascope's CA 40 8Fr. Intra-Aortic Balloon Catheters

Indicationsfor Use

Datascope's CA 40 8Fr. Intra-Aortic Balloon Catheters have the followingindications for use:Refractory unstable anginaImpending infarctionAcute MIRefractory ventricular failureComplications of acute MI (i.e. Acute MR or VSD, or papillary muscle rupture)Cardiogenic shockSupport for diagnostic, percutaneous revascularization, and interventional procedures.Ischemia related intractable ventricular arrhythmiasSeptic shockIntraoperative pulsatile flow generationWeaning from bypassCardiac support for non-cardiac surgeryProphylactic support in preparation for cardiac surgeryPost surgical myocardial dysfunction/low cardiac output syndromeMyocardial contusionMechanical bridge to other assist devicesCardiac support following correction of anatomical defects

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CCRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Cardiovascular Devices

Prescription Use(Per 21 CFR 801.109)	X
Over-The-Counter Use	_________________
510(k) Number	K031569

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.