Datascope's 7.5Fr. Intra-Aortic Balloon Catheters and Accessories are used for intra-aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle. This is the same intended use as previously cleared for all other Datascope Intra-Aortic Balloon Catheters.

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 .

Device Description

Datascope's 7.5Fr. Intra-aortic Balloon Catheters and Accessories are used for intra-aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle. The intra-aortic balloon is placed in the descending aorta just below the subclavian artery. The modification to the Datascope predicate 8Fr. IAB is dimensional only. The dimension of the co-extruded polyurethane blend catheter will be changed from 8Fr. to 7.5Fr. and the polyimide inner lumen dimension will be changed from .030" to .027". To accommodate the smaller 7.5Fr. IAB catheter, Datascope's predicate 8Fr. Reinforced Catheter Introducer has been modified from 8Fr. to 7.5Fr., and the Stepped Dilator from 5-8Fr. to 4-7.5Fr. Modifications to the 8Fr. Reinforced Catheter Introducer Set also include a change in the material of the sheath hub and internal tubing, color code the introducer hub and dilator to industry standard (orange for 7Fr.), change the hub cap design from round to square, change dilator/sheath interface from a snap-fit to a lock-fit design, and add an alternate source contract manufacturer.

AI/ML Overview

The provided document is a 510(k) summary for Datascope's 7.5Fr. IAB and Accessories, submitted to the FDA. It's a premarket notification for a medical device seeking substantial equivalence to already marketed devices. This type of document describes the device, its intended use, and how it is demonstrated to be substantially equivalent to predicates, often through non-clinical testing. It does not contain acceptance criteria or a study proving that a device meets acceptance criteria in the format typically used for performance studies of AI/ML or diagnostic devices.

The document claims substantial equivalence based on:

Identical intended use as previously cleared Datascope Intra-Aortic Balloon Catheters.
Dimensional modifications only (8Fr to 7.5Fr for the IAB, and related changes to introducer and dilator).
Material changes in the introducer set are to previously FDA cleared materials.
Non-clinical (in-vitro) tests demonstrating comparable functionality and performance to currently marketed devices.

Therefore, many of the requested items (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of submission, as it focuses on demonstrating substantial equivalence through non-clinical data and minor dimensional/material changes, rather than a clinical performance study with specific acceptance criteria that would typically be associated with AI/ML or diagnostic device evaluations.

Here's an attempt to answer the questions based only on the provided document:

A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in a table format. Instead, it states that "The results of in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed devices" (Page 2, Section F). This qualitative statement of comparability to predicate devices serves as the performance "acceptance" for this type of submission.

Acceptance Criteria (Implied)	Reported Device Performance
Functionality and performance comparable to currently marketed devices (predicate: K031569, K013326, K002365)	In-vitro tests demonstrated comparable functionality and performance characteristics to currently marketed devices.
Safety and efficacy unaffected by modifications	Modifications (dimensional and material) have been demonstrated not to affect safety or efficacy.

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "There has been no clinical evaluation of the new device in the U.S." (Page 2, Section G). The testing mentioned is "in-vitro tests" (Page 2, Section F). Therefore, there is no clinical test set, human data, or associated provenance. In-vitro testing typically uses bench models or simulated environments, not patient data.
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. No clinical test set or human-derived ground truth was established as per the document. The evaluation was based on in-vitro (bench/laboratory) testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set was used requiring adjudication.
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 a traditional medical device (intra-aortic balloon catheter), not an AI/ML device, and no MRMC study was conducted or mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a traditional medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For in-vitro testing of a physical device like an IAB, "ground truth" would typically refer to established engineering specifications, physical measurements, or industry standards, rather than clinical ground truth forms like pathology or expert consensus. The document implies compliance with these engineering/performance standards through its claim of "comparable functionality and performance characteristics."
The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
How the ground truth for the training set was established
Not applicable. As above, no training set was used.

Summary

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Image /page/0/Picture/0 description: The image shows the word "Datascope" in a bold, serif font. Above the word is a curved line that starts thick on the left and thins out as it curves to the right. The word is the main focus of the image and is centered.

innovation is the best medicine

JUN - 7 2004

K041281

Attachment D

Datascope Corp. Cardiac Assist Division 15 Law Drive Fairfield. NJ 07004 Tel: 973.244.6100 Fax: 973.244.6279

510(k) SUMMARY

FOR

DATASCOPE'S 7.5Fr. IAB and ACCESSORIES

(Prepared in accordance with 21 CFR Part 807.92)

GENERAL INFORMATION A.

Submitter:	Datascope Corp.
	Cardiac Assist Division
Address:	15 Law Drive
	Fairfield, NJ 07004
Contact Person:	JoAnn Taylor
	Global Regulatory Affairs Specialist
Phone:	973/244-6123
Fax:	973/244-6243
Date:	May 12, 2004

DEVICE INFORMATION B.

Generic Name:	Intra-Aortic Balloon Catheter (IAB)
Trade Name:	Datascope's 7.5Fr. IAB and Accessories
Classification Name:	Intra-Aortic Balloon Catheters (IABs) are classifiedunder 21CFR 870.3535

PREDICATE DEVICE INFORMATION C.

Datascope's 7.5Fr. IAB and Accessories are substantially equivalent to the following marketed devices:

K031569 - Datascope's Blow-Molded 8Fr. IAB, S/E 6/10/03
K013326 - Datascope's Fidelity 8Fr. IAB, S/E 11/02/01
K002365 - Datascope's Reinforced Catheter Introducer Set, S/E 8/25/00

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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 7.5Fr. IABs and Accessories are substantially equivalent to the predicate devices with regard to intended use.

The modification to the Datascope predicate 8Fr. IAB is dimensional only. The dimension of the co-extruded polyurethane blend catheter will be changed from 8Fr. to 7.5Fr. and the polyimide inner lumen dimension will be changed from .030" to .027".

To accommodate the smaller 7.5Fr. IAB catheter, Datascope's predicate 8Fr. Reinforced Catheter Introducer has been modified from 8Fr. to 7.5Fr., and the Stepped Dilator from 5-8Fr. to 4-7.5Fr.

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Modifications to the 8Fr. Reinforced Catheter Introducer Set also include a change in the material of the sheath hub and internal tubing, color code the introducer hub and dilator to industry standard (orange for 7Fr.), change the hub cap design from round to square, change dilator/sheath interface from a snap-fit to a lock-fit design, and add an alternate source contract manufacturer. The material changes are all previously FDA cleared materials.

These modifications to the 8Fr. IABs and Accessories have been demonstrated not to affect safety or efficacy of the device.

NON-CLINICAL TESTS F.

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 in the U.S.

H. CONCLUSIONS

Based on the information presented in this 510(k) premarket notification, Datascope's 7.5Fr. IAB and Accessories are considered substantially equivalent to Datascope's currently marketed IABs and accessories.

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Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol of medicine and health. The caduceus is composed of three wavy lines that represent the staff of Asclepius, the Greek god of healing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 7 2004

Datascope Corp. c/o Ms. JoAnn Taylor Global Regulatory Affairs Specialist 15 Law Drive Fairfield, NJ 07004

Re: K041281

Datascope's 7.5Fr. IAB and Accessories Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-Aortic Balloon and Control System Regulatory Class: Class III (three) Product Code: DSP Dated: May 12, 2004 Received: May 13, 2004

Dear Ms. Taylor:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becement of the device is substantially equivalent (for the indications forched a o re and in sure) to legally marketed predicate devices marketed in interstate for ass stated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1978, in excordance with the provisions of the Federal Food, Drug, de nees that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, morelore, manner in to 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 may 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 I that FDA has made a determination that your device complies with other requirements of the Act that I DT has intates and regulations administered by other Federal agencies. You must or any I cactar stutures and regulaments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); adomig (21 CFR Part 820); and if applicable, the electronic forth in the quart) Bybellio (Sections 531-542 of the Act); 21 CFR 1000-1050. product raction control provisions (seting your device as described in your Section 510(k) This letter will anow you to begin maing of substantial equivalence of your device to a legally prematice notification. The President 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 If you desire of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to (2017) 594-1057. Thiss, production as about 97) you may obtain. Other general information on your presponsibilities under the Act may be obtained from the Division of Small Manufacturers, Itsponsional 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,

Dina R. Vachner

GA 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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Indications for Use

510(k) Number (if known):

Device Name:Datascope's 7.5Fr. Intra-Aortic Balloon Catheters and Accessories

Indications For Use:

Datascope's 7.5Fr. Intra-Aortic Balloon Catheters and Accessories have 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 .

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (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)

Duna R. Lochner
(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number_k04128

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.