← Product Code [KDQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KDQ) · K961287

# ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM (K961287)

_Rocket Medical Plc · KDQ · Jul 26, 1996 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KDQ/K961287

## Device Facts

- **Applicant:** Rocket Medical Plc
- **Product Code:** [KDQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KDQ.md)
- **Decision Date:** Jul 26, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6740
- **Device Class:** Class 2
- **Review Panel:** General Hospital
- **Attributes:** Therapeutic

## Indications for Use

This device has been designed to allow the safe and effective drainage of fluid from a patient following disruption in the normal anatomical arrangement of the chest or a disturbance of the intrapleural pressure mechanism causing the entry and accumulation of air and or fluid.

## Device Story

Chest drainage system; maintains constant suction pressure; prevents backflow of air/fluid into chest cavity; ensures unobstructed drainage. Used in clinical settings for patients with pleural space issues. Operated by healthcare professionals. Benefits include safe, effective removal of air/fluid to restore normal intrapleural pressure.

## Clinical Evidence

No clinical data provided; safety and effectiveness supported by over 1 year of incident-free use in the UK.

## Technological Characteristics

Chest drainage system; mechanical design for suction regulation and backflow prevention. No software or electronic components.

## Regulatory Identification

A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

## Predicate Devices

- Atrium Chest Drainage System (not specifically named)

## Submission Summary (Full Text)

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Rocket Medical - 510(k) Notification
Pleuraseal III - Chest Drainage System
K961287

# Rocketmedical

JUL 26 1996

## Summary of Safety and Effectiveness

### Pleuraseal III Chest Drainage System

This device has been designed to allow the safe and effective drainage of fluid from a patient following disruption in the normal anatomical arrangement of the chest or a disturbance of the intrapleural pressure mechanism causing the entry and accumulation of air and or fluid.

This is achieved by a design incorporating safety features to maintain a constant suction pressure, prevent the ingress of air and fluid back into the chest cavity, whilst maintaining an unobstructed drain from the patient.

This is a class II device, registered by Rocket Medical (Establishment number: 8010022/9610632). This device is substantially equivalent to a medical device which is currently in commerce and has been submitted to the FDA, marketed by Atrium.

The device is safe and effective for the application for which it is intended and has been tested to confirm its safety and effectiveness for over 1 year, without incident in the UK.

Rocket Medical continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.

## CERTIFICATION

I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated device.

Date: 27th March 1996

Signed by Leslie Todd
Quality Assurance Manager
Rocket Medical
Wear Industrial Estate, Washington
Tyne & Wear, England. NE37 1NE

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KDQ/K961287](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KDQ/K961287)

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