DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES

K980780 · Datascope Corp. · DSP · May 29, 1998 · Cardiovascular

Device Facts

• Record ID: K980780
• Device Name: DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES
• Applicant: Datascope Corp.
• Product Code: DSP · Cardiovascular
• Decision Date: May 29, 1998
• 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 placed in descending aorta; provides mechanical circulatory support. Device inflates/deflates to improve cardiovascular function; assists hemodynamics during cardiac crises or procedures. Used in clinical settings (OR, cath lab) by physicians. Output is mechanical pulsatile flow; assists patient by reducing cardiac workload and increasing coronary perfusion. Device features alternate 'B' membrane material.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

9.5 Fr. IAB catheter with alternate 'B' membrane material. Designed for optional sheathless insertion. Mechanical circulatory support device. No software or electronic components described.

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 (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

• Datascope Percor STAT-DL 9.5Fr. with Optional Insertion without an Introducer Sheath (K905056)
• Datascope Percor STAT IABs with Alternate Coating (K910997)
• Datascope Percor STAT-DL®9.5Fr. 34 & 40cc IABs (K940178)
• Datascope Percor STAT-DL 9.5Fr. 40cc IAB (K940231)
• Datascope's Staged Guidewire (K943846)
• Datascope Percor STAT-DL 9.5Fr. 34 & 40cc IABs for Optional Sheathless Insertion (K960166)
• Datascope Percor STAT DL 9.5Fr. 25 & 40cc IABs for Optional Sheathless Insertion (K964987)
• Arrow International 8 Fr. 40 NarrowFlexTM IAB (K960713)
• Arrow International 8 Fr. 30cc IAB (K892799)
• Arrow International Kink Resistant 9.5 Fr. Flexi-Cath IAB (K945230)
• Arrow International 9.5 Fr. Flexi-Cath IAB (K963104)

Submission Summary (Full Text)

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A.

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FOR

DATASCOPE PERCOR STAT-DL® 9.5Fr. INTRA-AORTIC BALLOON (IAB) (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.

| <b>GENERAL INFORMATION</b> | |
|----------------------------|-------------------------------------------------|
| Submitter: | Datascope Corp. |
| | Cardiac Assist Division |
| Address: | 15 Law Drive |
| | Fairfield, NJ 07004 |
| Contact Person: | Whitney Torning |
| | Mgr., Regulatory Affairs & Product Surveillance |

#### B. DEVICE INFORMATION

Generic Name: Intra-Aortic Balloon (IAB)

Datascope Percor STAT-DL® Intra-Aortic Balloon Trade Name: (IAB)

Classification Name: Intra-Aortic Balloons (IABs) are classified under 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:

- K905056- Datascope Percor STAT-DL 9.5Fr. with Optional -Insertion without an Introducer Sheath
- ﺖ K910997- Datascope Percor STAT IABs with Alternate Coating
- K940178- Datascope Percor STAT-DL®9.5Fr. 34 & 40cc IABs -
- K940231- Datascope Percor STAT-DL 9.5Fr. 40cc IAB

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## Summary of Safety & Effectiveness/Datascope Percor STAT-DL® 9.5 Fr. IAB Page 2

- K943846 Datascope's Staged Guidewire -
- K960166- Datascope Percor STAT-DL 9.5Fr. 34 & 40cc IABs for -Optional Sheathless Insertion
- K964987- Datascope Percor STAT DL 9.5Fr. 25 & 40cc IABs for -Optional Sheathless Insertion
- K960713 Arrow International 8 Fr. 40 NarrowFlexTM IAB -
- K892799 Arrow International 8 Fr. 30cc IAB -
- K945230 Arrow International Kink Resistant 9.5 Fr. Flexi-Cath IAB ﺖ
- K963104 Arrow International 9.5 Fr. Flexi-Cath IAB -

#### 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

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## Summary of Safety & Effectiveness/Datascope Percor STAT-DL®9.5 Fr. IAB Page 3

#### TECHNOLOGICAL CHARACTERISTICS E.

Datascope's Percor STAT-DL® 9.5Fr. 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 membrane aterial. 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.

#### CLINICAL TESTS G.

There has been no clinical evaluation of the new device in the U.S.

#### H. CONCLUSIONS

Based on the information presented in this 510(k) premarket notification, Datascope's Percor STAT-DL® 9.5Fr. IAB is considered substantially equivalent to Datascope's currently marketed IABs.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

## MAY 2 9 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Whitney Törning Manager, Requlatory Affairs and Product Surveillance Datascope Corporation Cardiac Assist Division 15 Law Division CN 40011 Fairfield, NJ 07004

Re : K980780 Datascope's Percor STAT-DL® 9.5 Fr. 25cc, 34cc and 40cc Intra-Aortic Balloon (IAB) Catheter with Alternate "B" Membrane for Optional Sheathless Insertion Requlatory Class: III (Three) Product Code: 74 DSP Dated: February 27, 1998 Received: March 2, 1998

Dear Ms. Törning:

We have reviewed your Section 510(k) notification of intent to market the device referenced aboye 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 Requlations, 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 Regulation (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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this

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### Page 2 - Ms. Whitney Törning

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.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html."

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

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# =10(k) Number (if known):___ k 980780

Device Name: Datascope's Percor STAT-DL® 9.5 Fr. 25cc, 34cc & 40cc Intra-Aortic Balloons (IAB) for Optional Sheathless Insertion with Alternate "B" Membrane Material

## Indications for Use:

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

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 | K980780 |
|---------------|---------|
|---------------|---------|

| Prescription Use | X |
|----------------------|---|
| (Per 21 CFR 801.109) | |

OR

| Over-the-Counter Use | _________________ |
|----------------------|-------------------|
|----------------------|-------------------|

(Optional Format 1-2-96)