ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20

K082746 · Insightra Medical, Inc. · DSP · Jan 12, 2009 · Cardiovascular

Device Facts

• Record ID: K082746
• Device Name: ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20
• Applicant: Insightra Medical, Inc.
• Product Code: DSP · Cardiovascular
• Decision Date: Jan 12, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3535
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ultra IABP is placed in the descending aorta just below the subclavian artery. and is intended to improve cardiovascular function during the following situations: refractory unstable angina, impending infarction, post-infarction angina, refractory feft ventricular failure, complications of acute MI (i.e., acute MR or VSD or papillary muscle rapture), cardiogenic shock, support for diagnostic perculaneous revascularization and interventional procedures, ischemic related intractable ventricular arrhythmias, septic shock, interoperative pulsatile flow generation, weaning from cardiopulmonary bypass, cardiac support for non-cardiac surgery, prophylactic support in preparation for cardiac surgery, post-surgical myocardial dysfunction/low cardiac output syndrome, cardiac contusion, mechanical bridge to other assist devices and cardiac support following correction of anatomical defects.

Device Story

7 French intra-aortic balloon (IAB) catheter; 20-40 cc balloon volumes; dual-lumen design. Outer lumen facilitates helium-based inflation/deflation; inner lumen enables guidewire placement and arterial blood pressure monitoring. Used in clinical settings (e.g., OR, ICU) by physicians. Synchronized with external control console using ECG or arterial pressure signals to provide counterpulsation. Increases coronary perfusion; reduces left ventricular workload; promotes myocardial healing. Kit includes introducer, dilator, and adaptors.

Clinical Evidence

Bench testing only. In vitro testing confirmed device performance against clinical demand criteria. Biocompatibility testing verified compliance with device classification requirements. No clinical trial data presented.

Technological Characteristics

7 French catheter; 20-40 cc cylindrical balloon; dual-lumen (helium inflation/pressure monitoring). Materials consistent with marketed IAB catheters. Sterilization via Ethylene Oxide (EtO). Standalone device requiring external control console for synchronization.

Indications for Use

Indicated for patients requiring emergency mechanical left heart assist due to refractory unstable angina, impending/post-infarction angina, refractory left ventricular failure, acute MI complications (MR, VSD, papillary muscle rupture), cardiogenic shock, ischemic intractable ventricular arrhythmias, septic shock, or post-surgical myocardial dysfunction. Also indicated for support during percutaneous revascularization, cardiac/non-cardiac surgery, cardiopulmonary bypass weaning, cardiac contusion, and as a mechanical bridge to other assist devices.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Abiomed SupraCor Balloon Catheter (K062582)
• Datascope 7.5Fr IAB Catheter and Accessories (K041281)

Submission Summary (Full Text)

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

# JAN 1 2 2009

#### 510(k) Summary

## K082746 - Insightra Ultra IABP Catheter Kit

a. Submitter

Applicant Name:

Insightra Medical 15560-C Rockfield Boulevard Irvine, CA 92618

Contact Person: Tom Colonna Date Summary Prepare: December 22, 2008

#### b. Device Information

Ultra IABP Catheter Kit Trade Name: Common Name: Intra-aortic balloon catheter and insertion kit Classification Name: Intra-aortic balloon and control system (21 CFR 870.3535). Product Code: 74 DSP

#### c. Predicate Devices

Abiomed SupraCor Balloon Catheter (K062582) Datascope 7.5Fr IAB Catheter and Accessories (K041281)

#### d. Device Description

The Insightra Ultra IABP Catheter Kit is a 7 French catheter available with either a 40, 35, 30, 25, or 20 cc balloon. The catheter has two lumens and is designed to provide counterpulsation cardiac assist therapy. The outer lumen is a channel for helium used to inflate and deflate the balloon. The inner lumen is used for a guidewire and blood pressure measurement. It is packaged as a convenience kit with accessories (one-way valve, 50 cc syringe, guide wires, introducer needle, dilator, pressure tubing, Datascope & Arrow adaptors).

The balloon inflation and deflation cycle is synchronized (using a commercially available control console) with the ECG or arterial pressure to provide counterpulsation synchronized with the hearbeat. It is intended to increase coronary perfusion, decrease the workload of the left ventricle and allow healing of the myocardium.

#### e. Intended Use:

The Ultra IABP Catheter is used for emergency mechanical left heart assist in conjunction with an IAB catheter pumping circuit. The device is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular function during the following situations:

- . Refractory unstable angina
- Impending infarction ●
- . Post infarction angina
- Refractory left ventricular failure ●
- Complications of acute MI (i.e., acute MR or VSD or papillary muscle rapture) な
- Cardiogenic shock .

CONFIDENTIAL

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

- Support for diagnostic percutaneous revascularization and interventional . procedures
- . Ischemic related intractable ventricular arrhythmias
- Septic shock .
- Intraoperative pulsatile flow generation .
- Weaning from cardiopulmonary bypass .
- . Cardiac support for non-cardiac surgery
- Prophylactic support in preparation for cardiac surgery 0
- Post-surgical myocardial dysfunction/low cardiac output syndrome .
- Cardiac contusion .
- . Mechanical bridge to other assist devices
- . Cardiac support following correction of anatomical defects.

#### Technological Characteristics and Comparison to Predicate Devices f.

The Ultra IABP Catheter Kit is of similar design and made of materials commonly used in other marketed balloon catheters. The insertion kit contains instruments commonly provided for insertion of an IAB Catheter.

Table 1 provides a comparison of the Ultra IABP Catheter with the predicate balloon catheters. This table illustrates the equivalency of the Ultra IABP Catheter with the predicates.

| | Insightra Ultra<br>IABP | Datascope 7.5F<br>IAB | Abiomed<br>SupraCor IAB |
|---------------------------------|----------------------------|-----------------------|-------------------------|
| 510(k) Clearance | This submission | K041281 | K062582 |
| Number of Lumens | 2 | 2 | 2 |
| Catheter Outside Diameter (Fr.) | 8 | 7.5 | 7 |
| Balloon shape | Cylindrical | Cylindrical | Cylindrical |
| Balloon lengths (mm) | 170, 180, 195,<br>225, 255 | 165, 221, 258 | 260 |
| Balloon volumes (cc) | 20, 25, 30, 35, 40 | 25, 34, 40 | 40 |
| Balloon Diameters (mm) | 13.5, 14.5 | 15 | Unknown |
| Effective Catheter Length (mm) | 700 | 723 | 720 |
| Inflation Medium | Helium | Helium | Helium |
| Sterilization | EtO | EtO | EtO |

Table 1 - Comparison Table for Ultra IABP Catheter Kit

#### g. Pre-Clinical Test Results:

In vitro and biocompatibility tests were performed on the Ultra IABP Catheter Kits. The in vitro tests showed that the device meets pre-determined acceptance criteria that were based on the clinical demands the device will be subjected to. The biocompatibility testing demonstrated that the Ultra IABP Catheter Kits comply with the requirements for this device classification.

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

### h. Conclusion:

·

:

Based on the information provided in this 510(k) premarket notification, the Ultra IABP Catheter Kits are considered substantially equivalent to the currently marketed predicate devices. 11 11

:

・

.

.

:

-

.

.

# CONFIDENTIAL

.

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings and legs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JAN 1 2 2009

Mr. Tom Colonna Vice President, Regulatory Affairs & Quality Assurance Insightra Medical 15560-C Rockfield Boulevard Irvine, CA 92618

Re: K082746

> Ultra IABP Catheter Kit, Models IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20 Regulation Number: 21 CFR 870.3535 Regulation Name: Balloon, Intra-Aortic and Control System Regulatory Class: Class III Product Code: DSP Dated: September 17, 2008 Received: September 19, 2008

## Dear Mr. Colonna:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{4}------------------------------------------------

### Page 2 - Mr. Tom Colonna

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

er R. hohner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Insightra Medical 15560-C Rockfield Boulevard · Irvine, CA 92618 Phone: [phone] Fax: [phone]

র্ব

# Indications for Use Statement

510(k) Number (if known): K082746

Device Name: Ultra IABP Catheter Kit

Indications for Use:

The Ultra IABP is placed in the descending aorta just below the subclavian artery. and is intended to improve cardiovascular function during the following situations: refractory unstable angina, impending infarction, post-infarction angina, refractory feft ventricular failure, complications of acute MI (i.e., acute MR or VSD or papillary muscle rapture), cardiogenic shock, support for diagnostic perculaneous revascularization and interventional procedures, ischemic related intractable ventricular arrhythmias, septic shock, interoperative pulsatile flow generation, weaning from cardiopulmonary bypass, cardiac support for non-cardiac surgery, prophylactic support in preparation for cardiac surgery, post-surgical myocardial dysfunction/low cardiac output syndrome, cardiac contusion, mechanical bridge to other assist devices and cardiac support following correction of anatomical defects.

Prescription Use X (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)

Suva R. W. Ames
(Division Sign-Off)

CONFIDENTIAL

Division of Cardiovascular Devices

510(k) Number k082746

Page 1 of 1

Hlenn 1/8/09

September 17, 2008 510(k) Notification for Ultra IABP Catheter Kit

Page 10