8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S 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 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.

Device Description

This device is identical in construction to the predicate sheathless 8 Fr-40cc NarrowFlex™ device IAB-04840S 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 Sheathless IAB-04230S predicate.

AI/ML Overview

This 510(k) summary (K963865) describes a substantial equivalence claim for an intra-aortic balloon catheter, the Arrow 8Fr - 30cc Narrowflex™ Sheathless Intra-Aortic Balloon Catheter. The document focuses on comparing its characteristics to previously marketed predicate devices rather than providing a detailed study proving performance against specific acceptance criteria.

Therefore, many of the requested details, such as specific acceptance criteria with numeric thresholds, a specific study with a sample size, expert involvement for ground truth, or MRMC studies, are not present in the provided text. The submission relies on "nonclinical test results showing comparable performance" to established predicate devices.

Here's an attempt to answer based on the provided information, noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from predicate similarity)	Reported Device Performance (from predicate similarity)
Mechanical Performance	Insertion Characteristics:	Comparable to predicate devices (IAB-04840S and IAB-04230S)
	- Distal tip flexibility	Comparable to predicate devices
	- Deflection	Comparable to predicate devices
	- Column strength	Comparable to predicate devices
Functional Performance	Performance Test:	Comparable to predicate devices
	- Total cycle time	Comparable to predicate devices
	- Displaced volume	Comparable to predicate devices (specifically the 30cc volume from IAB-04230S)
	- First response	Comparable to predicate devices
Physical Characteristics	Identical in construction to the 8 Fr-40cc NarrowFlex™ device IAB-04840S with the exception of the 30cc balloon and shorter overall length (adapted from the 8 Fr-30cc Sheathless IAB-04230S).	This device is an 8 Fr-30cc NarrowFlex™ Sheathless Intra-Aortic Balloon Catheter with a shorter overall length.

Study Proving Device Meets Acceptance Criteria:

The document explicitly states: "The nonclinical test results included in the submission showing comparable performance to the predicate devices are as follows." This indicates that the "study" was a set of nonclinical tests designed to demonstrate equivalence to the predicate devices across the listed characteristics. The submission focuses on substantial equivalence to existing legally marketed devices (K961358 for both listed predicates) rather than establishing new, independent performance thresholds.

2. Sample Size and Data Provenance:

Sample Size for Test Set: Not specified in the provided text. The document only mentions "nonclinical test results."
Data Provenance: Not specified. Given it's a nonclinical bench test, typical provenance details like country of origin or retrospective/prospective don't directly apply in the same way they would for a clinical study. It's safe to assume these were internal laboratory tests conducted by Arrow International.

3. Number of Experts and Qualifications:

Not applicable. This was a nonclinical engineering/performance test, not a study requiring expert readers for ground truth establishment.

4. Adjudication Method:

Not applicable for a nonclinical test of this nature.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not mentioned or conducted. This type of study is typically for evaluating diagnostic imaging or similar devices where human interpretation is a key component.

6. Standalone Performance Study (Algorithm Only):

Yes, in a sense, the "nonclinical test results" are a form of standalone performance evaluation for the device itself. However, it's not an "algorithm only" study as there's no algorithm involved. It's a physical device being tested without human-in-the-loop performance being a primary measure, but rather intrinsic device performance characteristics.

7. Type of Ground Truth Used:

For the nonclinical tests, the "ground truth" would likely be engineering specifications, established physical limits, or direct comparative measurements against the predicate devices using calibrated instruments and standardized test methods. It's not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI/machine learning algorithm, so there is no "training set."

9. How Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for an AI/machine learning algorithm.

Summary

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510(k) SUMMARY - K963865

SEP | 6 1997

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

1. 8 Fr-40cc Sheathless NarrowFlex™, with Nitinol inner lumen and kink resistant outer lumen, product no. IAB-04840S, premarket notification K961358.
1. 8 Fr-30cc, Sheathless, with stainless steel inner lumen and plastic outer lumen, product no. IAB-04230S, premarket notification K961358.

The device is indicated for the following conditions:

The device has comparable technological characteristics to the predicate devices.

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

Insertion characteristics

Distal tip flexibility .
Deflection .
Column strength . Performance Test
. Total cycle time
Displaced volume .
First response .

96124

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. Thomas D. Nickel Vice President, Regulatory Affairs and Quality Assurance Arrow International SEP 1 6 1997 2400 Bernville Road Reading, Pennsylvania 19605

Re: K963865 Arrow 8Fr - 30cc Narrowflex™ Sheathless Intra-Aortic Balloon Catheter Regulatory Class: III (Three) Product Code: 74 DSP Dated: July 18, 1997 Received: July 21, 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, good manufacturing practice, labelinq, 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 regulations 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.

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Page 2 - Mr. Thomas D. Nickel

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. Callshan

Thomas J. Callarian, 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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870.3535- DSP III- Intra-aortic Balloons Control
System

510(k) Number (if known): K 963865-

Arrow 8 Fr. 30cc Narrow Flex Sheathless Introl. Device Name: Balloon Casheter

Indications For Use:

Refractory left ventricular power failure. Cardiogenic shock/unstable refractory angina. Mechanical complication due to acute myocardial infraction; i.e., ventricular septal 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)

Setta L. Lemperle

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

510(k) Number K 96 3865

Prescription Use (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.