MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B

K013326 · Datascope Corp. · DSP · Nov 2, 2001 · Cardiovascular

Device Facts

• Record ID: K013326
• Device Name: MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B
• Applicant: Datascope Corp.
• Product Code: DSP · Cardiovascular
• Decision Date: Nov 2, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3535
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The intra-aortic balloon is placed in the descending aorta just below the subclavian The intra-aortic banoon is placed in the costoming during the following the following situations: Refractory ventricular failure Cardiogenic shock Unstable refractory angina . Impending infarction . Impending infarctions due to acute myocardial infarction . Ischemic related intractable ventricular arrhythmias . Ischemic related intractable voluncial and coronary angiography or . angioplasty patients . Septic shock Weaning from cardiopulmonary bypass Interoperative pulsatile flow generation . Support for failed angioplasty and valvuloplasty .

Device Story

Intra-aortic balloon catheter (IAB) inserted into descending aorta; provides circulatory support. Device consists of balloon membrane, polyimide co-lumen, and catheter tip. Used in clinical settings (OR/ICU) by physicians. Functions as mechanical circulatory support; inflates/deflates to augment cardiac output. Modifications include alternate membrane material (Alt B), polyimide co-lumen with blue colorant, composite catheter tip, and .025 stainless steel guide wire. Output is hemodynamic support; assists clinicians in managing patients with acute cardiac failure or during high-risk procedures.

Clinical Evidence

No clinical evaluations were performed. Substantial equivalence is supported by in-vitro bench testing demonstrating performance comparable to predicate devices.

Technological Characteristics

8Fr. catheter; polyimide co-lumen with blue colorant; Alt B membrane material; composite catheter tip; .025 stainless steel guide wire. Dimensions: lumen diameter changed from .023" to .030".

Indications for Use

Indicated for patients with refractory ventricular failure, cardiogenic shock, unstable refractory angina, impending infarction, mechanical complications of acute MI (VSD, mitral regurgitation, papillary muscle rupture), ischemia-related intractable ventricular arrhythmias, high-risk surgical/angiography/angioplasty patients, septic shock, weaning from cardiopulmonary bypass, intraoperative pulsatile flow generation, and support for failed angioplasty/valvuloplasty.

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

• Datascope Profile 8 Fr. Alt B Intra-Aortic Balloon Catheters w/Gas Lumen Insert (K003598)
• Datascope 8Fr. Polyimide Intra-Aortic Balloon Catheters (K994157)
• Datascope Staged Guide Wire (K943896)

Submission Summary (Full Text)

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**NOV 02 2001**

KD13326

## Attachment D

### SUMMARY OF SAFETY AND EFFECTIVENESS FOR

DATASCOPE'S 8Fr. Polyimide Alt B 25, 34 & 40cc Intr-Aortic Balloon Catheters Prepared in accordance with 21 CFR Part 807.92)

#### GENERAL INFORMATION A.

| Submitter: | Datascope Corp. |
|-----------------|------------------------------|
| | Cardiac Assist Division |
| Address: | 15 Law Drive |
| | Fairfield, NJ 07004 |
| Contact Person: | JoAnn Wolf |
| | Regulatory Affairs Associate |

#### DEVICE INFORMATION B.

| Generic Name: | Intra-Aortic Balloon Catheter (IAB) |
|----------------------|------------------------------------------------------------------------------|
| Trade Name: | Datascope's Intra-Aortic Balloon Catheter (IAB) |
| Classification Name: | Intra-Aortic Balloon Catheters (IAB) are classified under 21 CFR<br>870.3535 |

#### PREDICATE DEVICE INFORMATION C.

Datascope's 8Fr. Polyimide Alt B 25, 34 & 40cc Intra-Aortic Balloon Catheters (IAB) are substantially equivalent to the following marketed devices:

- · K003598, Datascope Profile 8 Fr. Alt B Intra-Aortic Balloon Catheters w/Gas Lumen Insert (S/E 12/21/00).
- · K994157, Datascope 8Fr. Polyimide Intra-Aortic Balloon Catheters (S/E 3/13/00)
- · K943896, Datascope Staged Guide Wire (S/E 12/22/95)

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#### DEVICE DESCRIPTION/INTENDED USE D.

The intra-aortic balloon is placed in the descending aorta just below the subclavian The intra-aortic banoon is placed in the costoming during the following the following situations:

- Refractory ventricular failure ●
- Cardiogenic shock ●
- Unstable refractory angina .
- Impending infarction .
- Impending infarctions due to acute myocardial infarction .
- Ischemic related intractable ventricular arrhythmias .
- Ischemic related intractable voluncial and coronary angiography or . angioplasty patients
- . Septic shock
- Weaning from cardiopulmonary bypass ●
- Interoperative pulsatile flow generation ●
- Support for failed angioplasty and valvuloplasty .

#### TECHNOLOGICAL CHARACTERISTICS E.

Datascope's 8Fr. Polyimide Alt B 25, 34 & 40cc Catheters are substantially qquivalent to the predicate devices with regard to intended use. Material modifications to Datascope's 8Fr. catheters include adding a previously cleared alternate membrane material (Alt B), adding a full length polyimide co-lumen with blue colorant to the material (All B), adding a full lenging the catheter tip to a composite of previously cleared catheter tip materials. A dimensional change to the cather's imem previously cleared caneter thange from .023" to .030". In addition, a modified .025 stainless steel guide wire has replaced the nitinol guide wire the insertion kit. These .025 stamiess stech guide who has replaced and B IAB have been demonstrated not to affect safety or efficacy of the device.

#### NON-CLINICAL TESTS F.

The results of in-vitro tests conducted demonstrate that the functionality and The results of in-viro tests conceeted are comparable to the currently marketed devices.

#### CLINICAL TESTS G.

There have been no clinical evaluations of the new device.

#### CONCLUSIONS H.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with a bird-like shape above them. The text reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES - USA'.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 02 2001

Ms. JoAnn Wolf Regulatory Affairs Associate Datascope Corporation Cardiac Assist Division 15 Law Drive Fairfield, NJ 07004

K013326 Re:

Datascope 8 Fr. Polyimide Alt B Intra-Aortic Balloon Catheter Regulation Number: 870.3535 Regulation Name: Intra-Aortic balloon and control system Regulatory Class: Class III Product Code: 74 DSP Dated: October 4, 2001 Received: October 5, 2001

Dear Ms. Wolf:

We have reviewed your Section 510(k) promarket notification of intent to market the device w & no reviews 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 ass butted in the enactment date of the Medical Device Amendments, or to devices that provision in the provisions 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 therefore, mainer the act include requirements for annual registration, listing of devices, good econufacturing 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 n your de rio is orasthild 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.

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

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Page 2 - Ms. JoAnn Wolf

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.

control provisions (because begin marketing your device as described in your Section 510(k) This icter will anow you to oegin mains of substantial equivalence of your device to a legally premitset notification: "The I DA miding of babbanian or 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 If you desire specific acrison. 10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF Far 80%. Additionally, for questions on the promotion and advertising of Compliance at [phone]. First of Compliance at [phone]. Also, please note the your device, prease comable by reference to premarket notification" (21CFR Part 807.97). Ice users information on your responsibilities under the Act may be obtained from the Division Offici general information on Jour 1957 100 Proper Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrlv/dsma/dsmamain.html

Sincerely yours,

James E. Dillard III
Director

Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KD13326

# Attachment B

# Indications for Use Statement

| 510(k) Number | K013326 |
|---------------------|---------------------------------------------------------------------------------------------------------|
| Device Name | Datascope 8Fr. Polyimide Alt B 25, 34 & 40cc Intra-Aortic Balloon Catheter |
| Indications for Use | The Datascope 8Fr. Polyimide Alt B Intra-Aortic Balloon Catheter has the following indications for use: |

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

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

Concurrence of CCRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number R013326

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use