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 infrfaction, ischemia related intractable ventricular arrhythmias. Septic shock. Support for failed angioplasty and valvuloplasty. Cardiac support for high risk general surgical patients.

Device Description

The addition of a new peel-away hemostasis device to four existing Arrow IABs makes them now "universal" IABs, in that they can be used as is for sheathless insertion techniques, or can be used with current standard sheaths if the sheathless feature is not desired, by peeling it away and discarding it.

AI/ML Overview

This appears to be a 510(k) summary for a medical device submitted to the FDA, specifically concerning an "Arrow Intra-Aortic Balloon Catheter with Peel-Away Hemostasis Device." The document states that the new "Universal" IABs are substantially equivalent to existing Arrow IAB products.

However, the provided text does not contain any specific acceptance criteria or details of a study with numerical performance data that would typically be presented in a table. It states that "The nonclinical performance test results included in the submission show comparable performance to the predicate sheathless devices," but it does not elaborate on what those tests were, what the criteria were, or what the specific results were.

Therefore, I cannot directly extract the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader studies from the provided text.

Here is a breakdown of what can be inferred from the provided text, and where the requested information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing. The document only states "comparable performance to the predicate sheathless devices." It does not provide specific performance metrics or acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

Missing. There is no mention of a "test set" in the context of performance evaluation, nor any sample size for such a test. Data provenance (country of origin, retrospective/prospective) is also not available.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Missing. This document does not describe a study involving human readers or expert consensus for establishing ground truth on a test set. This type of information is typically found in studies involving software or imaging devices.

4. Adjudication Method for the Test Set

Missing. As no test set or human review is described, there is no adjudication method mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Missing. The document describes a medical device (catheter) and its substantial equivalence, not an AI or imaging diagnostic tool that would typically undergo an MRMC study. Therefore, no information on AI assistance effect size is available.

6. If a Standalone (Algorithm Only) Performance Was Done

Missing. This device is a physical medical instrument, not an algorithm. Standalone performance typically refers to the performance of an AI algorithm without human intervention, which is not applicable here.

7. The Type of Ground Truth Used

Missing. The nature of the device (catheter) suggests that "ground truth" might refer to physical/mechanical properties conforming to design specifications or clinical outcomes in animal or human trials. However, the document only broadly refers to "nonclinical performance test results" without specifying how performance was measured or validated against a "ground truth."

8. The Sample Size for the Training Set

Missing. This concept is primarily relevant for machine learning algorithms. For a physical device, "training set" is not a standard term, though design iterations and validation testing might involve prototypes and materials. The document provides no such numerical detail.

9. How the Ground Truth for the Training Set Was Established

Missing. (See point 8).

Summary of what the document does provide:

Device: Arrow Intra-Aortic Balloon Catheter with Peel-Away Hemostasis Device.
Purpose: The addition of a new peel-away hemostasis device to existing Arrow IABs to make them "universal," usable with or without sheaths.
Claimed Equivalence: Substantially equivalent to eight current Arrow IAB products.
Indications for Use: Refractory left ventricular power failure, cardiogenic shock, unstable refractory angina, mechanical complications of acute myocardial infarction, impending infarction, ischemia-related intractable ventricular arrhythmias, septic shock, support for failed angioplasty and valvuloplasty, cardiac support for high-risk general surgical patients.
Performance Statement: "The nonclinical performance test results included in the submission show comparable performance to the predicate sheathless devices." This is a qualitative statement, not a quantitative one.
Regulatory Class: Class III.
510(k) Number: K970689.

To obtain the detailed information requested, one would need to review the full 510(k) submission to the FDA, which would contain the actual test reports, methodologies, and specific data for the "nonclinical performance tests." The provided snippets are a high-level summary and the FDA's clearance letter.

Summary

{0}------------------------------------------------

K970689

. Il IN 1 1998

SECTION 2 - 510(k) SUMMARY and CERTIFICATION

510(k) SUMMARY

The four new "Universal" products are therefore substantially equivalent to eight current Arrow IAB products.

The device new "Universal" are indicated for the following conditions:

Refractory left ventricular power failure. Cardiogenic shock unstable refractory angina. mechanical complication due to acute myocardial infraction; i.e., ventricular sepial defect mitral requraitation 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.

The devices have comparable technological characteristics to the predicate devices.

The nonclinical performance test results included in the submission show comparable performance to the predicate sheathless devices.

CERTIFICATION

Since this is a class III device, the required class III Special Certification is appended as Attachment 1.

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JUN 4 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. Robert A. Szurgot Project Engineer Arrow International Research/Enqineerinq 3000 Bernville Road Readinq, Pennsylvania 19605

Re: K970689 Arrow Intra-Aortic Balloon Catheter with Peel-Away Hemostasis Device (IAB-04840-U; IAB-04250-U; IAB-04240-U; IAB-04230-U) Regulatory Class: III (Three) Product Code: 74 DSP Dated: June 6, 1997 Received: June 11, 1997

Dear Mr. Szurgot:

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 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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.

{2}------------------------------------------------

Page 2 - Mr. Robert A. Szurgot

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,

sincerely yours,
Thomas J. Callahan

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

Enclosure

{3}------------------------------------------------

510(k) Number (if known):	K970689
Device Name:	Arrow Intra-Aortic Balloon Catheter wutnPeel-Away Hemostasis Device
Indications For Use:	IAB-04840-UIAB-04240-UIAB-64230-U

DSP TI

970,3535

Antia-Aartic Balloon and Cantrol

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bose L. Lemuele

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K970689 510(k) Number_

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.