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
Impending infarction
Mechanical complications due to acute myocardial infarction
Ischemic related intractable ventricular arrhythmias
Cardiac support for high risk surgical patients and coronary angiography or angioplasty patients
Septic shock
Weaning from cardiopulmonary bypass
Interoperative pulsatile flow generation
Support for failed angioplasty and valvuloplasty

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 Impending infarction Mechanical complications due to acute myocardial infarction Ischemic related intractable ventricular arrhythmias Cardiac support for high risk surgical patients and coronary angiography or angioplasty patients Septic shock Weaning from cardiopulmonary bypass Interoperative pulsatile flow generation Support for failed angioplasty and valvuloplasty

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Datascope 8Fr. Co-Lumen (CL) Intra-Aortic Balloon (IAB) & Accessories. This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a clinical study with specific acceptance criteria and detailed performance metrics as one might find for a novel device or AI/software.

Therefore, the information typically expected for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software device is not applicable or available in this document. This submission is for a physical medical device (Intra-Aortic Balloon) seeking clearance based on its similarity to existing cleared devices, not on a performance study against predefined numerical acceptance criteria.

However, I can extract the relevant information from the document that addresses the spirit of your questions as much as possible within the context of a 510(k) for a physical medical device.

1. A table of acceptance criteria and the reported device performance

For a 510(k) submission, "acceptance criteria" are generally that the new device must be "substantially equivalent" to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness. The "reported device performance" is a demonstration that this equivalence holds.

Acceptance Criteria (Implicit for 510(k))	Reported Device Performance (Summary from Submission)
Intended Use: Device intended for same indications as predicate devices.	The device's indications for use are substantially equivalent to predicate devices (listed on page 7).
Technological Characteristics: Differences in material composition and dimensional specifications do not affect safety or efficacy.	Differences in material composition and dimensional specifications have been demonstrated not to affect safety or efficacy of the device. (Page 4)
Performance/Functionality: Functionality and performance comparable to currently marketed devices.	Results of in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed devices. (Page 4)
Safety: Device is as safe as legally marketed predicate devices.	Implicitly demonstrated through substantial equivalence claim and in-vitro testing. (Page 4)
Effectiveness: Device is as effective as legally marketed predicate devices.	Implicitly demonstrated through substantial equivalence claim and in-vitro testing. (Page 4)

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

This information is not provided in the document. The submission references "in-vitro tests" but does not detail the sample size or provenance of data for these tests. For a physical device 510(k), these tests are typically benchtop or mechanical tests, not clinical performance studies with patient data.

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)

This information is not applicable/provided. The concept of "ground truth" established by experts for a test set is typically relevant for diagnostic or AI/software devices where expert interpretation is part of the validation. For this physical IAB, the "ground truth" would be established by engineering specifications and in-vitro test results comparing against predicate device performance.

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

This information is not applicable/provided. Adjudication methods are typically used in clinical studies involving interpretation, which is not the primary mode of evaluation for this physical device in a 510(k) context.

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

This information is not applicable. An MRMC study is designed for evaluating diagnostic devices, especially those with AI components, and the impact of AI on human reader performance. This submission is for a physical Intra-Aortic Balloon and does not involve AI or human readers for diagnostic tasks.

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

This information is not applicable. This question pertains to AI/software performance. The device is a physical intra-aortic balloon.

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

The document mentions "in-vitro tests" (Page 4). The "ground truth" for demonstrating substantial equivalence for a physical device like an IAB would primarily be based on engineering specifications, material science standards, and established performance characteristics of the predicate devices as measured through these in-vitro tests. There is no mention of expert consensus, pathology, or outcomes data being used as "ground truth" for the 510(k) submission itself, though clinical outcomes from general use of IABs would underpin the predicate devices' prior clearances.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

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

This information is not applicable. As it's not an AI/ML device, there is no training set or ground truth in that context.

Summary

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1 1998 MAY

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FOR DATASCOPE 8Fr. CO-LUMEN (CL) INTRA-AORTIC BALLOON (IAB) & ACCESSORIES (Prepared in accordance with 21 CFR Part 807.92)

Pursuant to Section 513(I)(3)(A) of the Food, Drug, and Cosmetic act, Datascope Corp. is required to submit this Premarket Notification either an "…adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Datascope Corp. chooses to submit a summary of information respecting safety and effectiveness.

GENERAL INFORMATION A.

Submitter:	Datascope Corp.Cardiac Assist Division
Address:	15 Law DriveFairfield, NJ 07004
Contact Person:	Whitney TorningManager, Regulatory Affairs and Product Surveillance

B. DEVICE INFORMATION

Generic Names:	Intra-Aortic Balloon (IAB), Catheter Introducer, Catheter guide wire
Trade Names:	Datascope 8Fr. Co-Lumen (CL) Intra-Aortic Balloon (IAB) and kit accessories (catheter introducer, catheter guide wire)
Classification Names:	Intra-Aortic Balloons (IABs) are classified under 21 CFR 870.3535,Catheter Introducers are classified under 21 CFR 870.1340, andCatheter Guide Wires are classified under 21 CFR 870.1330.
Product Codes:	74DSP. 74DYB. and 74DOX respectively.

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C. PREDICATE DEVICE INFORMATION

Datascope's 8Fr. Co-Lumen 34 & 40cc IABs for Optional Sheathless Insertion are substantially equivalent to the devices as described in:

K790775 -Datascope Type "S" IAB. 1)
Datascope Percor STAT-DL 9.5Fr. IAB with Optional Insertion without K905056 -2) an Introducer Sheath. . . . . . . . . . . . . .
K910997B Datascope Percor STAT Intra Aortic Balloons with Alternate Coating. 3)
Datascope Percor STAT Co-Lumen 8.5Fr. 40cc IABs. K911000 -4)
Datascope Percor STAT-DL 9.5Fr. 34cc IAB Sheathless Insertion. ર) K914802 -
Datascope Percor STAT-DL 9.5Fr. 34cc & 40cc IABs with an alternate K940178 -6) inner lumen of 80/20 hard/soft Estane
Datascope Percor STAT-DL 9.5Fr. 40cc IAB with an alternate K940231-7) membrane material; a Polyurethane/Silicone blend.
Datascope Percor STAT-DL 9.5Fr. 34 & 40cc IABs for Optional K960166 -8) Sheathless Insertion with Alternate Inner Lumen Material (Texin).
Arrow International 8Fr. 40cc NarrowFlex™ IAB (nitinol inner lumen) K960713 -9) Arrow International 8Fr. 40cc NarrowFlex™ IAB for sheathless K961358 insertion (nitinol inner lumen)
Arrow International 8Fr. 30cc NarrowFlex™ IAB (nitinol inner lumen) 11) K963865 -Arrow International 8Fr.30cc NarrowFlex™ IAB for sheathless K961358 insertion nitinol inner lumen)
Percor STAT-DL 9.5Fr. 25 & 40cc IABs for Optional Sheathless 12) K964987 -Insertion and Percor STAT-DL 10.5Fr. 40 & 50cc IABs for Sheath Insertion with Alternate Inner Lumen Material (80/20 hard/soft Estane) & Alternate Membrane Material (Polyurethane/Silicone) blend.
Boston Scientific Corp. Sub-9 Nitinol 30cc and 40cc IAB for Sheathless 13) K972113 -Insertion (nitinol inner lumen)

All of the above referenced premarket notifications were found substantially equivalent by FDA.

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An insertion kit containing a catheter introducer, composed of an 8 Fr. catheter introducer sheath with integrated hemovalve and dilator, a stepped vessel dilator, and a guide wire (.020") use the same materials as previously cleared 510(k)'s.

Datascope's 8Fr. Catheter Introducer and Stepped Vessel Dilator for use with the insertion of the 8Fr. IAB is substantially equivalent to the devices as described in:

... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Valve

- Datascope's 5 to 9 Fr. Stepped Vessel Dilator K904476 -3)
- Datascope's Stiff Guidewire for use with Datascope IABs K904477 -4)
- Arrow Fischell Corp.'s Super Arrow-Flex Percutaneous Sheath న) K924607 -Introducer
- Datascope's Staged Guide Wire for use with Datascope Percor STAT-() K943896 -DL IABs
- C.R. Bard's TS and Input Percutaneous Arterial/Venous Catheter 7) K955785 -Introducer Set

All of the above referenced premarket notifications were found substantially equivalent by FDA.

Datascope's .020" guidewire for use with the insertion of the 8Fr. IAB is substantially equivalent to the devices as described in:

Datascope's Stiff Guidewire for use with Datascope IABs 1) K904477 -Datascope's Staged Guide Wire for use with Datascope Percor STAT-2) K943896 -DL IABs Flexmedic's Finesse guide wire for coronary use 3) K952430 -Scimed Sceptor TM PTCA guide wire (platinum spring coil) 4) K960563 -Terumo's Radiofocus® Glidewire® for coronary use (nickel titanium 5) K961445 coil with platinum spring coil)

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Lake Region's Nitinol core and platinum coil .014" . 045"guide wire for K970994 -6) extravascular use.
Lake Region's Nitinol core and platinum coil .014" and .018" guide wire K971322 -7) for intravascular use.

All of the above referenced premarket notifications were found substantially equivalent by FDA with the exception of K971322 which is currently pending FDA's SE decision.

Datascope's Devices described above are referenced in this Premarket Notification as predicate devices for the 8 Fr. IAB insertion kit, and catheter introducer set, and guidewire pack. All other device components that make up the insertion kit are the same as previously cleared by the FDA.

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 Impending infarction Mechanical complications due to acute myocardial infarction Ischemic related intractable ventricular arrhythmias Cardiac support for high risk surgical patients and coronary angiography or angioplasty patients Septic shock Weaning from cardiopulmonary bypass Interoperative pulsatile flow generation Support for failed angioplasty and valvuloplasty

E. TECHNOLOGICAL CHARACTERISTICS

Datascope's 8Fr. Co-Lumen IABs with accessories are substantially equivalent to the predicate devices with regard to its indications for use. They differ technologically respecting material composition and dimensional specifications of the components. The difference in material composition and dimensional specifications have been demonstrated not to affect safety or efficacy of the device.

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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.

The 8Fr. Co-Lumen 34cc and 40cc Intra-Aortic Balloon Catheter with accessories are CE Marked and commercially available in Europe.

CONCLUSIONS H.

Based on the information presented in this 510(k) premarket notification, Datascope's 8Fr. Co-Lumen IABs with accessories are considered substantially equivalent to the currently marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right.

10000 MAY

Ms. Whitney G. Törning Manager, Regulatory Affairs & Product Surveillance Datascope Corporation Cardiac Assist Division 15 Law Drive, CN 40011 Fairfield, NJ 07004

Re : K980385 Datascope 8Fr. CO-LUMEN (CL) Intra-Aortic Balloon 34cc and 40cc (IAB) & Accessories Requlatory Class: III (Three) Product Code: DSP Dated: January 28, 1998 Received: February 2, 1998

Dear Ms. Törning:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS). for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Page 2 - Ms. Whitney G. Törning

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahon

Thomas J. CallaWan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K9803 85

Device Name: Datascope's 8Fr. Co-Lumen 34 & 40cc Intra-Aortic Balloon Catheters for Optional Sheathless Insertion with Accessories.

Indications for Use:

Refractory ventricular failure. 1 .
Cardiogenic shock. 2.
Unstable refractory angina. 3.
1. Impending infarction.
Mechanical complications due to acute myocardial infarction, i.e., ventricular septal 5. defect, mitral regurgitation or papillary muscle rupture.
Ischemia related intractable ventricular arrhythmias. 6.
Cardiac support for high risk general surgical patients and coronary 7. angiography/angioplasty patients.
1. Septic shock.
1. Weaning from cardiopulmonary bypass.
Intraoperative pulsatile flow generation. 10.
1. Support for failed angioplasty and valvuloplasty.

This information can be found in Volume 1 (Section 3 - Attachment II) of our Premarket Notification under the section titled "II. Indications".

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
✓

Over-the-Counter Use

Bota R. Quiperle

(Optional Format 1-2-96)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K 980385 510(k) Number .

Page 2

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.