Who is the manufacturer of ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM?

Rocket Medical Plc filed the 510(k) submission for ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM (K961287).

What is the FDA product code for ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM?

KDQ. It is classified under 21 CFR 880.6740 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM?

Atrium Chest Drainage System (not specifically named).

Who can help prepare an FDA 510(k) submission like ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM

K961287 · Rocket Medical Plc · KDQ · Jul 26, 1996 · General Hospital

Device Facts

Record ID	K961287
Device Name	ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM
Applicant	Rocket Medical Plc
Product Code	KDQ · General Hospital
Decision Date	Jul 26, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6740
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Indications for Use

Indicated for patients requiring drainage of air or fluid from the chest cavity due to anatomical disruption or intrapleural pressure disturbance.

Regulatory Classification

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)

Related Devices

K130131 — EDRAIN CHEST DRAINAGE SYSTEM · Atrium Medical Corp. · Feb 28, 2013
K984496 — ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN · Atrium Medical Corp. · May 5, 1999
K062302 — MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM · Millicore AB · Oct 6, 2006
K961147 — CLOSED FLUID COLLECTION SYSTEM · B.Braun Medical, Inc. · May 31, 1996
K081718 — EXPRESS CHEST DRAIN · Atrium Medical Corp. · Jul 25, 2008

Submission Summary (Full Text)

{0} 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