8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER, by ARROW INTL., INC.

Refractory left ventricular power failure. Cardiogenic shock unstable refractory angina. Mechanical complication due to acute myocardial infraction; i.e., ventricular sepial defect mitral requrgitation or papillary muscle rupture. Impending infraction, ischemia related intractable ventricular arrhythmias. Septic shock. Support for failed angioplasty and valvuloplasty. Cardiac support for high risk general surgical patients.

Device Description

This device is identical in construction to the predicate 8 Fr-40cc NarrowFlex™ device IAB-04840 with the exception of the 30cc balloon and shorter overall length. The balloon volume and the overall length have been adapted from the 8 Fr-30cc IAB-04230 predicate.

AI/ML Overview

The provided text describes the 510(k) summary for the Arrow 8 Fr.-30cc Narrowflex™ Intra-Aortic Balloon Catheter (K963920), which was submitted for market clearance in 1997. The submission is based on substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

Acceptance Criteria and Reported Device Performance

The submission relies on a comparison to predicate devices, asserting "substantial equivalence" rather than specific numerical performance targets for this device. The acceptance criterion is that the device demonstrates comparable performance to its predicate devices in specific nonclinical tests.

Acceptance Criterion	Reported Device Performance (vs. Predicate)
Total cycle time	Comparable performance
Displaced volume	Comparable performance
First response	Comparable performance

Note: The text explicitly states "comparable performance to the predicate devices" for these tests, without providing numerical values for either the predicate or the subject device.

Study Details

Based on the provided text, the study conducted was a nonclinical performance test battery comparing the subject device to its predicate devices.

Sample size used for the test set and the data provenance:
- The sample size for the test set is not specified in the provided document.
- The data provenance is nonclinical test results, implying laboratory testing rather than human subject data. The country of origin is not specified but is presumably the USA, where Arrow International, Inc. is located. It is inherently prospective as it involves new testing for the device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a nonclinical performance test, not a study requiring expert human interpretation or establishment of ground truth against clinical endpoints.
Adjudication method for the test set:
- Not applicable. This was a nonclinical performance test.
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 MRMC study was done. This is a medical device (intra-aortic balloon catheter), not an AI-powered diagnostic or assistive technology involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the conventional sense. For these nonclinical performance tests, the "ground truth" would be the measured physical and mechanical properties of the device, compared against the measured physical and mechanical properties of the predicate devices. There is no biological "ground truth" like pathology or clinical outcomes.
The sample size for the training set:
- Not applicable. This device does not involve a "training set" as it is not an AI/machine learning product.
How the ground truth for the training set was established:
- Not applicable. This device does not involve a training set.

Summary

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K963920

JUN 17 1997

510(k) SUMMARY - K963920

The device is substantially equivalent to the following legally marketed Arrow intra-aortic balloon devices:

1. 8 Fr-40cc NarrowFlex™, with Nitinol inner lumen and kink resistant outer lumen, product no. IAB-04840, premarket notification K960713.
1. 8 Fr-30cc, with stainless steel inner lumen and plastic outer lumen, product no. IAB-04230, premarket notification K892799.

The device is indicated for the following conditions:

The device has comparable technological characteristics to the predicate devices.

The nonclinical test results in the submission showing comparable performance to the predicate devices are as follows:

Performance Test

Total cycle time .
Displaced volume ●
First response .

96123

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with two snakes entwined around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 17 1997

Mr. Thomas D. Nickel Vice President, Regulatory Affairs and Quality Assurance Arrow Intenational, Inc. ﺍ 3000 Bernville Road Reading, Pennsylvania 19605

Re: %K963920 Arrow 8 Fr. - 30cc Narrowflex™ Intra-Aortic Balloon Catheter Regulatory Class: III (Three) Product Code: 74 DSP Dated: January 14, 1997 Received: January 17, 1997

Dear Mr. Nickel:

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, qood manufacturing practice, labeling, and prohibitions aqainst 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 requlations.

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Page 2 - Mr. Thomas D. Nickel

This letter will allow you to beqin 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 labelinq 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 requlation 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"dsmo@fdadr.cdrh.fda.gov."

Sincerely yours,

Thomas J. Callahau, Ph.D.

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

Enclosure

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Page Page Page of

510(k) Number (if known): JK 963920

N 8Fr Device Name:

P.O. Box 12888 Reading, PA 19612

Image /page/3/Picture/4 description: The image shows the logo for Arrow International. The word "ARROW" is in large, bold, sans-serif font, with the letters slightly overlapping. Below "ARROW" is the word "INTERNATIONAL" in a smaller, sans-serif font. The logo is black and white.

3000 Bernville Road Reading, PA 19605

(610) 378-0131 FAX: (610) 374-5360

Section 11 - Indications

Refractory left ventricular power failure. Cardiogenic shock unstable refractory angina. Mechanical complication due to acute myocardial infraction; i.e., ventricular sepial defect mitral regurgitation or papillary muscle rupture. Impending infraction, ischemia related intractable ventricular arrhythmias. Septic shock. Support for failed angioplasty and valvuloplasty. Cardiac support for high risk general surgical patients.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bole L. Campise le

Division Sign-Off Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K963920

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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.