← Product Code [DSP](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DSP) · K964987

# DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0 (K964987)

_Datascope Corp. · DSP · Mar 17, 1997 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DSP/K964987

## Device Facts

- **Applicant:** Datascope Corp.
- **Product Code:** [DSP](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DSP.md)
- **Decision Date:** Mar 17, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.3535
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **Attributes:** Therapeutic

## Indications for 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 below subclavian artery; provides mechanical circulatory support. Device functions by inflating/deflating balloon to improve cardiovascular hemodynamics. Used in clinical settings (OR, cath lab) by physicians. Output is hemodynamic support; assists cardiac output; reduces myocardial oxygen demand. Benefits include stabilization of patients in shock or during high-risk cardiac procedures.

## Clinical Evidence

No clinical evaluation performed in the U.S. Substantial equivalence supported by in-vitro bench testing comparing functionality and performance to predicate devices.

## Technological Characteristics

Intra-aortic balloon catheter. Dimensions and form factor identical to predicate devices. Materials modified in grade and chemical composition compared to predicates; verified via in-vitro testing. No software or electronic components described.

## Regulatory 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. & 10.5Fr. Intra-Aortic Balloons ([K940231](/device/K940231.md) & [K940178](/device/K940178.md))
- Pediatric IAB ([K905663](/device/K905663.md))
- Datascope Type “S” IAB ([K790775](/device/K790775.md))
- 30cc/40cc Sensation™ IAB; Model 930/940 IAB’s (Boston Scientific Corp.) ([K952221](/device/K952221.md))
- 9.5 Fr. Sensation™ IAB (Boston Scientific Corp.) ([K943919](/device/K943919.md))
- 8.0 Fr. 30/40cc, 10.0 Fr. 50cc Sheathless IAB (Arrow International) ([K961358](/device/K961358.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

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K964987

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FOR

## DATASCOPE PERCOR STAT-DL® 9.5Fr. & 10.5 Fr. 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 corporation 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 Corporation chooses to submit a summary of information respecting safety and effectiveness.

## A. GENERAL INFORMATION

Submitter: Datascope Corp.
Cardiac Assist Division

Address: 15 Law Drive
Fairfield, NJ 07004

Contact Person: Kevin Crossen
Director, Regulatory Affairs and Quality Assurance

## B. DEVICE INFORMATION

Generic Name: Intra-Aortic Balloon (IAB)

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

- Datascope Percor STAT-DL® 9.5Fr. & 10.5Fr. Intra-Aortic Balloons, K940231 & K940178.
- K905663 - Pediatric IAB
- K790775 - Datascope Type “S” IAB
- K952221 - 30cc/40cc Sensation™ IAB; Model 930/940 IAB’s (Boston Scientific Corp.)

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Summary of Safety & Effectiveness/Datascope Percor STAT-DL® 9.5 & 10.5Fr. IAB
Page 2

- K943919 - 9.5 Fr. Sensation™ IAB (Boston Scientific Corp.)
- K961358 - 8.0 Fr. 30/40cc, 10.0 Fr. 50cc Sheathless IAB (Arrow International)

## D. DEVICE DESCRIPTION/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

## E. TECHNOLOGICAL CHARACTERISTICS

Datascope’s Percor STAT-DL® 9.5Fr. & 10.5Fr. IAB are identical to the predicate devices with regard to its indications for use and dimensional specifications. 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.

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Summary of Safety & Effectiveness/Datascope Percor STAT-DL® 9.5 & 10.5Fr. IAB

## G. CLINICAL TESTS

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. & 10.5Fr. IABs are considered substantially equivalent to Datascope’s currently marketed IABs.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DSP/K964987](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DSP/K964987)

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