DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329

K994157 · Datascope Corp. · DSP · Mar 13, 2000 · Cardiovascular

Device Facts

• Record ID: K994157
• Device Name: DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329
• Applicant: Datascope Corp.
• Product Code: DSP · Cardiovascular
• Decision Date: Mar 13, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3535
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations: · Refractory ventricular failure · Cardiogenic shock · Unstable refractory angina · Impending infarction Mechanical complications due to acute myocardial infarction . · Ischemic related intractable ventricular arrhythmias · Cardiac support for high risk surgical patients 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 (IAB) catheter; 8Fr polyimide construction; 25cc, 34cc, 40cc volumes. Placed in descending aorta; provides mechanical circulatory support. Used in clinical settings (OR/ICU) by physicians to improve cardiovascular function via counterpulsation. Device assists heart by reducing afterload and increasing coronary perfusion. Benefits include hemodynamic stabilization in shock or high-risk surgical/interventional contexts.

Clinical Evidence

No clinical evaluations performed. Substantial equivalence supported by in-vitro bench testing comparing functionality and performance characteristics to predicate devices.

Technological Characteristics

8Fr polyimide IAB catheter; 25cc, 34cc, 40cc volumes. Mechanical circulatory support device. Differs from predicates in material grade and chemical composition. No software or electronic components.

Indications for Use

Indicated for patients requiring cardiovascular support due to refractory ventricular failure, cardiogenic shock, unstable refractory angina, impending infarction, mechanical complications of acute myocardial infarction (e.g., ventricular septal defect, mitral regurgitation, papillary muscle rupture), ischemia-related intractable ventricular arrhythmias, high-risk surgical/angiography/angioplasty procedures, septic shock, weaning from cardiopulmonary bypass, intraoperative pulsatile flow generation, or 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

• 8Fr. Co-Lumen (CL) Intra-Aortic Balloon 34cc and 40cc (IAB) & Accessories (K980385)
• Percor-STAT-DL 9.5 Fr. 25cc, 34cc and 40cc Intra-Aortic Balloon (IAB) Catheter with Alternate "B" Membrane for Optional Sheathless Insertion (K980780)

Submission Summary (Full Text)

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K994157

## MAR 1 3 2000 10(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## FOR

# DATASCOPE 8Fr. Polyimide

# 25, 34 & 40cc Intra-Aortic Balloon Catheters

(Prepared in accordance with 21 CFR Part 807.92)

Pursuant to Section 513(I)(3)(A) of the Food, Drug, and Cosmetic act, Datascope Corp. is required to submit this Premarket Notification either an "…adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Datascope Corp. chooses to submit a summary of information respecting safety and effectiveness.

#### GENERAL INFORMATION A.

| Submitter: | Datascope Corp.<br>Cardiac Assist Division |
|-----------------|---------------------------------------------------------------------------|
| Address: | 15 Law Drive<br>Fairfield, NJ 07004 |
| Contact Person: | Whitney G. Törning<br>Director, Regulatory Affairs & Product Surveillance |

#### DEVICE INFORMATION B.

| Generic Name: | Intra-Aortic Balloon (IAB) |
|----------------------|----------------------------------------------------------------------|
| Trade Name: | Datascope 8Fr. Intra-Aortic Balloon (IAB) |
| Classification Name: | Intra-Aortic Balloons (IABs) are classified under<br>21 CFR 870.3535 |

Product Code: 74DSP

#### C. PREDICATE DEVICE INFORMATION

Datascope's Percor STAT-DL® Intra-Aortic Balloon is substantially equivalent to the following marketed devices:

- K980385 8Fr. Co-Lumen (CL) Intra-Aortic Balloon 34cc and 40cc (IAB) & Accessories
- K980780- Percor-STAT-DL 9.5 Fr. 25cc, 34cc and 40cc Intra-Aortic Balloon (IAB) Catheter with Alternate "B" Membrane for Optional Sheathless Insertion.

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#### DEVICE DESCRIPTION/INTENDED USE D.

The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations:

- · Refractory ventricular failure
- · Cardiogenic shock
- · Unstable refractory angina
- · Impending infarction
- Mechanical complications due to acute myocardial infarction .
- · Ischemic related intractable ventricular arrhythmias
- · Cardiac support for high risk surgical patients 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 25, 34 & 40cc IAB is substantially equivalent to the predicate devices with regard to its indications for use. They differ technologically respecting material grade and chemical composition of the components. The difference in material grade and chemical composition has been demonstrated not to affect safety or efficacy of the device.

#### F. NON-CLINICAL TESTS

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

#### G. CLINICAL TESTS

There have been no clinical evaluations of the new device.

#### H. CONCLUSIONS

Based on the information presented in this 510(k) premarket notification, Datascope's 8Fr. Polyimide IAB is considered substantially equivalent to Datascope's currently marketed IABs.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing left and appears to be in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2000

Ms. Whitney Törning Datascope Corporation Cardiac Assist Division 15 Law Drive, CN 40011 Fairfield, NJ 07004

Re: K994157 Datascope's 8FR. Polymide 25 cc, 34 cc and 40 cc Intra-Aortic Balloon Catheters Requlatory Class: III (three) Product Code: 74DSP November 29, 1999 Dated: December 9, 1999 Received:

Dear Ms. Törning:

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 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). 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 Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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

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### Page 2 - Ms. Whitney Törning

for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, [phone]. "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Sot. Bute R. Campirelle

Celia M. Witten, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) Number (if known):_K994/57

Device Name: Datascope's 8Fr. Polyimide 25, 34 & 40cc Intra-Aortic Balloon Catheters

Indications for Use:

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

This information can be found in Volume 1 (Section 3 - Attachment II) of our Premarket Notification under the section titled "II. Indications".

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K 994157