← Product Code [DSP](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DSP) · K960166

# PERCOR STAT-DL 9.5 FR. 34 & 40CC (K960166)

_Datascope Corp. · DSP · Apr 24, 1996 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DSP/K960166

## Device Facts

- **Applicant:** Datascope Corp.
- **Product Code:** [DSP](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DSP.md)
- **Decision Date:** Apr 24, 1996
- **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 angina, Unstable refractory angina, Impending infarction, Septic shock, Cardiac support for high risk surgical patients, Ischemic related intractable ventricular arrhythmias, Mechanical complications due to acute myocardial infarction.

## Device Story

Intra-aortic balloon (IAB) catheter; placed in descending aorta below subclavian artery; provides mechanical circulatory support. Device functions via inflation/deflation cycle to improve cardiovascular hemodynamics. Used in clinical settings (e.g., OR, ICU) by trained medical professionals. Subject device modification involves alternate inner lumen material grade/composition compared to predicate. Output is mechanical cardiac assistance; assists in stabilizing patients with acute cardiac conditions.

## Clinical Evidence

No clinical data. Bench testing only.

## Technological Characteristics

Intra-aortic balloon catheter; 9.5Fr diameter. Modification involves alternate material grade and chemical composition for the inner lumen. Mechanical device; no energy source or software.

## 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. Intra-Aortic Balloon ([K905056](/device/K905056.md), [K940178](/device/K940178.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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K960166
APR 25 1996

Datascope®
Cardiac Assist Division

K960166

# SUMMARY OF SAFETY AND EFFECTIVENESS FOR

## DATASCOPE PERCOR STAT-DL® 9.5Fr. INTRA-AORTIC BALLOON (IAB) WITH ALTERNATE INNER LUMEN MATERIAL

(Prepared in accordance with 21 CFR Part 807.92)

### A. GENERAL INFORMATION

Submitter: Datascope Corp
Address: 15 Law Drive
Fairfield, NJ 07004
Contact Person: Diane DePonte Arpino

### 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

### 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. Intra-Aortic Balloon, K905056 & K940178.

Datascope Corp., Cardiac Assist Division, 15 Law Drive, Fairfield, NJ 07004 Tel: (201) 244-6100 Fax: (201) 244-6279

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

## 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 angina | Unstable refractory angina  |
|  Impending infarction | Septic shock  |
|  Cardiac support for high risk surgical patients |   |
|  Ischemic related intractable ventricular arrhythmias |   |
|  Mechanical complications due to acute myocardial infarction |   |

## E. TECHNOLOGICAL CHARACTERISTICS

Datascope’s Percor STAT-DL® 9.5Fr. IAB is identical to the predicate device with regard to its indications for use and dimensional specifications. It differs technologically respecting material grade and chemical composition of the inner lumen. 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 has been no clinical evaluation of the new device.

## 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 IAB.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DSP/K960166](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DSP/K960166)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [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/), [get in touch](https://innolitics.com/contact).

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