ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B

K123033 · Rocket Medical Plc · DWM · Feb 1, 2013 · Cardiovascular

Device Facts

• Record ID: K123033
• Device Name: ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B
• Applicant: Rocket Medical Plc
• Product Code: DWM · Cardiovascular
• Decision Date: Feb 1, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Rocket IPC Insertion Kit and the Rocket IPC Dressing Pack and Bottle Set are indicated for intermittent, long-term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of underlying disease. This device should only be used by or under the supervision of trained personnel and in conjunction with current clinical practice guidelines. The devices are indicated for: 1. The palliation of dyspnea due to pleural effusion 2. Providing pleurodesis (resolution of the pleural effusion). The Rocket IPC Bottle Sets are indicated for use only with the Rocket Indwelling Pleural Catheter for intermittent drainage. The Rocket Dressing Packs are indicated for dressing of a catheter and exit site.

Device Story

Rocket IPC System consists of a fenestrated silicone drainage catheter with a polyester cuff and one-way silicone valve; used for intermittent, long-term drainage of pleural effusions. Catheter inserted into pleural space via wire-guided/tunneled technique by trained personnel. Drainage is achieved by connecting the catheter to a pre-evacuated vacuum bottle; vacuum is engaged and controlled by a button-operated valve on the system, allowing patient-titrated suction for comfort. System prevents air/fluid reflux via one-way valve. Benefits include palliation of dyspnea and potential pleurodesis. Used in clinical settings or home environments under supervision.

Clinical Evidence

No clinical data provided. Substantial equivalence established through bench testing, including resistance to deformation, connection/catheter force at break, leakage testing, impact resistance, and flow rate verification per EN 1617:1997 and EN 1618:1997 standards. Biocompatibility and sterilization validation performed per ISO 10993 and ISO 11135/11137 standards.

Technological Characteristics

Fenestrated silicone catheter (16Fg x 400mm) with radiopaque barium sulfate stripe, polyester cuff, and one-way silicone valve. Vacuum-assisted drainage via pre-evacuated bottles. Materials: biocompatible silicone, polyester. Sterilization: Ethylene Oxide (SAL 1x10^-6). Connectivity: None. Software: None.

Indications for Use

Indicated for patients with symptomatic, recurrent pleural effusion, including malignant pleural effusion and other recurrent effusions unresponsive to medical management, requiring intermittent, long-term drainage for palliation of dyspnea and pleurodesis.

Regulatory Classification

Identification

A patient care suction apparatus is a device used with an intrathoracic catheter to withdraw fluid from the chest during the recovery period following surgery.

Predicate Devices

• PleurX Pleural Catheter System (K112831)

Submission Summary (Full Text)

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# The eCopy is an exact duplicate of the paper copy;

Revised 510(k) K123033 SUMMARY 10th January, 2013

# FEB 0 1 2013

### INTRODUCTION: 1

This document contains the 510(k) summary for the Rocket IPC System. The content 1.1 of this summary is based on the requirements of 21 CFR 807.92.

#### 2 APPLICANT NAME AND ADDRESS:

Name:

# Rocket Medical Plc

Address:

2-4 Sedling Road, Wear Industrial Estate, Washington, Tyne and Wear NE38 9BZ United Kingdom Phone: [phone] Fax: [phone]

Official Contact: Tracy Charlton Regulatory Affairs Manager

Summary Preparation Date: 106 January 2013 (Revised)

#### DEVICE NAME AND CLASSIFICATION 3.

Rocket Indwelling Pleural Catheter (IPC) System Trade Name: Pleural Drainage Catheter Common Name: Classification Name: Patient Care Suction Apparatus Class II, 21 CFR 870.5050 Classification: Product Code: DWM

#### PREDICATE DEVICES: 4.

- 4.1 -The Rocket IPC System is claimed to be substantially equivalent to the following legally marketed predicate devices:
- 4.1.1 PleurX Pleural Catheter System (K112831), manufactured by CareFusion

#### PERFORMANCE STANDARDS ડ.

- There are no mandatory performance standards for this device type. 5.1
### DESCRIPTION OF THE DEVICE: 6.

- 6.1 Rocket Medical Plc. hereby submits this Traditional 510(k) notice for its Rocket Indwelling Pleural Catheter (IPC) System. The Rocket Indwelling Pleural Catheter (IPC) is a fenestrated silicone drainage catheter intended for the drainage of pleural effusions. There is a polyester cuff for attachment to the patient and a silicone one-way valve to prevent collected air and fluid from migrating back into the pleural cavity. The IPC System will consist of the IPC and components necessary for its' use such as convenience kits to aid in the implantation of the Rocket IPC.

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Image /page/1/Picture/0 description: The image shows the logo for Rocketmedical. The logo consists of a stylized "R" inside a circle on the left, followed by the word "Rocketmedical" in a bold, sans-serif font. The "R" in the circle has a unique design, and the word "Rocketmedical" is written in black.

Traditional 510(k) for Rocket IPC System K123033/S001 510(k) Summary

### INDICATIONS FOR USE 7.

- The Rocket IPC Insertion Kit and the Rocket IPC Dressing Pack and Bottle Set are 7.1 indicated for intermittent, long-term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of underlying disease. This device should only be used by or under the supervision of trained personnel and in conjunction with current clinical practice quidelines.
The devices are indicated for:

- 1. The Palliation of dyspnea due to pleural effusion
- Providing pleurodesis (resolution of the pleural effusion). 2.

The Rocket IPC Bottle Sets are indicated for use only with the Rocket Indwelling Pleural Catheter for intermittent drainage. The Rocket Dressing Packs are indicated for dressing of a catheter and exit site.

### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 8.

- The Rocket IPC has the same intended use and the same technological characteristics 8.1 as the identified predicate device.
- 8.1.1 The system employs the same technologies as the identified predicate including:
- 8.1.1.1 Fenestrated silicone catheter with a one-way silicone valve mechanism to prevent the reflux of fluid or air, a polyester cuff, and a radiopaque barium sulfate stripe.
- 8.1.1.2 Convenience kits are provided to aid in the insertion of the catheter, to aid in the removal of excessive pleural fluid, and to dress the wound site.
- 8.1.1.3 The catheter system uses the vacuum from a drainage bottle as a negative pressure to remove fluid from the pleural space quickly and efficiently
- The system has the same technical characteristics including; 8.1.2
- 8.1.2.1 Materials: Biocompatible Silicone tubing, polyester cuff, and silicone adhesive are implanted in the pleural space ﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

8.1.2.2 Sterility Assurance Level: 1x10-6

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Image /page/2/Picture/0 description: The image shows the logo for Rocketmedical. The logo consists of a stylized symbol to the left of the word "Rocketmedical". The symbol appears to be a stylized medical cross inside of a circle.

### 9 SUMMARY OF PERFORMANCE TESTING

- Performance bench testing of the Rocket IPC was conducted in accordance with all 9.1 applicable FDA Guidance documents and ISO standards, including:
- ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation 9.1.1 and Testing
- ISO 10993-3: 2009 Biological evaluation of medical devices Part3: Tests for 9.1.2 genotoxicity, carcinogenicity and reproductive toxicity
- 9.1.3 ISO 10993-6: 2009 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
- ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene 9.1.4 oxide Sterilization Residuals
- 8.1.5 ISO 10993-10: 2009 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
- 9.1.6 ISO 10993-11: 2009 Biological evaluation of medical devices. Tests for systemic toxicity
- 9.1.7 ISO 10993-12: 2009 Biological Evaluation Of Medical Devices - Part 12: Sample Preparation And Reference Materials
- 9.1.8 ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide -Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- 9.1.9 ISO11137-2:2007 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
- 9.1.10 ASTM F1980- 07(2007) Standard Guide for Accelerated Aging of Sterlie Barrier Systems for Medical Devices batch testing
- 9.1.11 USP <85> Bacterial Endotoxins Test
- 9.1.12 EN 1617:1997 Sterile Drainage Catheters and Accessory Devices for Single Use
- 9.1.13 EN 1618:1997 Catheters Other than Intravascular Catheters Test Methods for Common Properties
- 9.1.14 EN 868-5:1999 Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous and plastic film construction. Requirements and test methods
- 9.1.15 ISO15223-1 Medical Devices Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
- 9.1.16 ISO 13485:2003 Medical devices Quality management systems -Requirements for regulatory purposes
- 9.1.17 ISO 9001:2008 Quality management systems Requirements

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Image /page/3/Picture/0 description: The image shows the logo for Rocket Medical. The logo consists of a stylized "R" with a plus sign inside of it, followed by the word "Rocket" in bold, and then the word "medical" in a smaller, non-bold font. The logo is simple and professional, and it is likely used to represent a medical company or organization.

A list of Performance Testing conducted on the Pocket IPC includes: 9.2

- Sterilization Validation 9.2.1
- Biocompatibility Validation 9.2.2
- 9.2.3 Packaging Validation
- All bench testing, unless otherwise specified, was conducted on the finished 9.2.4 devices, which were sterilized by the final validated sterilization process
- A Summary of Standards Based compliance testing specific for catheter devices 9.3 conducted on the Rocket IPC is shown in Table 7.1 below:

| Test | Test Method or<br>Standard<br>Reference | Sample<br>Size | Final<br>Report | Accept/Reject Criteria | Results |
|-----------------------------------------------------------------------------------|----------------------------------------------------------|----------------|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Resistance to<br>deformation | EN<br>1617:1997<br>4.2<br>(Including<br>Annex A) | 3 | NPD<br>QA<br>1050 | The drainage system or any<br>component intended to operate<br>under negative pressure shall not<br>show deformation sufficient to<br>impair the function of the device at<br>the maximum negative pressure<br>stated by the manufacturer. | PASS |
| Force at break<br>- connections | EN<br>1617:1997<br>4.3.1:<br>EN 1618:<br>1997<br>Annex F | 3 | NPD<br>QA<br>1054<br>and<br>1055 | The minimum force at break for<br>connections shall be 15 N. (Nominal<br>outside diameter >4 mm) | PASS |
| Force at break<br>- Drainage<br>catheters and<br>all other parts<br>of the system | EN<br>1617:1997<br>4.3.2:<br>EN 1618:<br>1997<br>Annex B | 3 | NPD<br>QA<br>1054 | The minimum force at break for<br>catheter and all other parts of<br>system shall be 20 N. (Nominal<br>outside diameter >4 mm) | PASS |
| Freedom from<br>leakage -<br>During<br>aspiration or<br>vacuum | EN<br>1617:1997<br>4.5:<br>EN<br>1618:1997<br>Annex D | 3 | NPD<br>QA<br>1051 | Neither the drainage system nor any<br>components shall leak at the<br>maximum negative pressure stated<br>by the manufacturer | PASS |
| Impact<br>resistance -<br>Collection<br>device | EN<br>1617:1997<br>4.6<br>(including<br>Annex B) | 3 | NPD<br>QA<br>1052 | The collection device<br>shall not leak | PASS |
| Impact<br>resistance -<br>Suction<br>Source | EN1617:1<br>997 4.6<br>(including<br>Annex B) | 3 | NPD<br>QA<br>1052 | The suction source shall<br>not show any loss of<br>vacuum greater than 2 % | PASS |
| Flow Rate | EN<br>1618:1997<br>Annex D | 3 | NPD<br>QA<br>1053 | Calculate the arithmetic<br>average of three determinations and<br>express it as water flow rate through<br>the catheter in millilitres per minute | PASS |

, J

### Table 7.1: Summary of Catheter Specification Performance Testing

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Image /page/4/Picture/0 description: The image shows the logo for Rocketmedical. The logo consists of a stylized "R" inside a circle, followed by the text "Rocketmedical". The text is in a bold, sans-serif font and is black in color.

### 10 SUBSTANTIAL EQUIVALENCE

- The technology characteristics of the Rocket Medical IPC system are slightly different in 10.1 the following ways.
Although the premise of inserting a silicone catheter to drain pleural fluid and the technique of insertion are identical to the Pleurx version, the one way valve design itself is slightly different. However the performance and its intended use are identical.

The way the catheters are connected differs in that the Pleurx catheter has a push fit system, whereas the Rocket Medical system has a push fit and bayonet cap to ensure that dislocation does not occur.

With regards to the drainage bottles, only a 500ml version will be supplied as compared to the Pleurx 500ml and 1000ml bottles.

Also the ways that the vacuum is engaged and controlled are different.

Pleurx require you to pierce a foil lid to engage the vacuum whereas the Rocket system requests that a clip is removed. These differences do not change the function of the product; they are simply differing ways of engaging the vacuum.

To apply vacuum to the patient the Pleurx drainage bottles ask you to open a pinch clamp. If the patient wishes to stop draining at any time or for any reason the patient must close the pinch clamp to stop the application of vacuum.

The Rocket Medical version has an enclosed valve control with which the patient or clinician presses down on the button, this will apply the vacuum. If the patient wishes to stop draining at any time or for any reason the patient simply stops pressing the button and the system will stop the application of vacuum.

Verification and validation of the Rocket IPC System was performed through extensive bench testing, sterilization, packaging and shelf life testing. Results of the testing demonstrated that the Rocket IPC design met all specifications and is adequate for its intended use. Additionally, the test results demonstrated substantial equivalence of the Rocket IPC to its predicate device:

In conclusion, the Rocket IPC is substantially equivalent in intended use, technological characteristics, safety, and performance characteristics to the following legally marketed predicate device:

10.1.1 Pleural Catheter System (K112831), manufactured by CareFusion

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.

# 10.1.2 Clinical Equivalence Justification

| | Predicate device(s) in current use | Devices for evaluation | Gap Analysis |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description/code/<br>reference | Pleurx Pleural Cathoter Kit,<br>500ml/1000ml Drainage bottle | Rocket Medical IPC Insertion<br>pack<br>500ml Drainage bottle | Identify, reasons for and<br>significance of differences) |
| Essential dimensions | 15.5Fg x 400mm Catheter,<br>500ml/1000ml | 16Fg x 400mm Catheter,<br>500ml Drainage bottle. | |
| Material specifications | Silicone, valve material, bottle<br>material | Silicone, valve material, bottle<br>material | none |
| Operating environment | Body temperature, pleural space,<br>subcutaneous tissue | Body temperature, pleural<br>space, subcutaneous tissue | none |
| Design concept | 15.5Fg x 400mm Catheter with one<br>way valve | 16Fg x 400mm Catheter with<br>one way valve | Despite stated differences<br>between the catheters, the<br>catheters measure<br>identically and are both<br>5mm OD catheters with a<br>3mm ID. As shown in the<br>the testing documented. |
| Principles of operation | Catheter is inserted using a mixture<br>of wire guided and<br>tunnelled technique<br>When Insitu one way<br>valve is opened using a specifically<br>designed drainage bottle. The<br>drainage bottle is pre-evacuated<br>and the control of the level of<br>suction is provided via a pinch<br>clamp. This allows fluid to be drawn<br>from the pleural space via the<br>catheter into the drainage bottle.<br>When the drainage bottle is filled<br>with fluid, the drainage is complete<br>and the bottle is disconnected from<br>the drainage fine and discarded. | Catheter is inserted using a<br>mixture of wire guided and<br>tunnelled technique When<br>insitu one way valve is opened<br>using a specifically designed<br>drainage bottle. The drainage<br>bottle is pre-evacuated and the<br>control of the level of suction is<br>provided via a suction control<br>valve. This allows fluid to be<br>drawn from the pleural space<br>via the catheter into the<br>drainage bottle. When the<br>drainage bottle is filled with<br>fluid, the drainage is complete<br>and the bottle is disconnected<br>from the drainage line and<br>discarded. | The control valve was<br>introduced over the pinch<br>clamp to offer the end user<br>more control over the<br>application of vacuum and<br>the flow of fluid. As many in<br>this patient group have<br>thickend pleura when the<br>vacuum is applied this can<br>cause discomfort to the<br>patient. The vacuum control<br>unit works by the patient<br>pressing down a button to<br>initiate the application of<br>vacuum. The patient can<br>then titrate this level of<br>vacuum to a personal level<br>of comfort. |
| Method of sterilisation | ETO | ETO | none |

T. Choults

Tracy Charlton Regulatory Affairs Manager

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

# February 1, 2013

Ms. Tracy Charlton Regulatory Affairs Manager Rocket Medical Plc 2-4 Sedling Road, Wear Industrial Estate, Washington, Tyne and Wear United Kingdom NE38 9BZ

Re: K123033

Trade/Device Name: Rocket Indwelling Pleural Catheter (IPC) System Regulation Number: 21 CFR 870.5050 Regulation Name: Patient Care Suction Apparatus Regulatory Class: II Product Code: DWM Dated: January 2, 2013 Received: January 15, 2013

## Dear Ms. Charlton:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Ms. Charlton

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

hor

Reti

Harshfield.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

### Enclosure

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# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Rocket Indwelling Pleural Catheter (IPC) System Device Name:

Indications for Use:

The Rocket IPC Insertion Kit and the Rocket IPC Dressing Pack and Bottle Set are indicated for intermittent, long-term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of underlying disease. This device should only be used by or under the supervision of trained personnel and in conjunction with current clinical practice guidelines.

The devices are indicated for:

- 1. The pailiation of dyspnea due to pleural effusion
- 2. Providing pleurodesis (resolution of the pleural effusion).

The Rocket IPC Bottle Sets are indicated for use only with the Rocket Indwelling Pleural Catheter for intermittent drainage. The Rocket Dressing Packs are indicated for dressing of a catheter and exit site.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Albert E. Moyal AlbertE.Moyal
2013.01.29 13:46:28 -05:00 for LS

(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices

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11/23033 510{k} Number:_

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