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:

The palliation of dyspnea due to pleural effusion
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 Description

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.

AI/ML Overview

The Rocket IPC System, a fenestrated silicone drainage catheter for pleural effusions, underwent performance testing in accordance with applicable FDA Guidance documents and ISO standards. The device demonstrated satisfactory performance against predefined acceptance criteria for various physical and functional characteristics.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Resistance to deformation	The drainage system or any component intended to operate under negative pressure shall not show deformation sufficient to impair the function of the device at the maximum negative pressure stated by the manufacturer.	PASS
Force at break - connections	The minimum force at break for connections shall be 15 N. (Nominal outside diameter >4 mm)	PASS
Force at break - Drainage catheters and all other parts of the system	The minimum force at break for catheter and all other parts of system shall be 20 N. (Nominal outside diameter >4 mm)	PASS
Freedom from leakage - During aspiration or vacuum	Neither the drainage system nor any components shall leak at the maximum negative pressure stated by the manufacturer.	PASS
Impact resistance - Collection device	The collection device shall not leak.	PASS
Impact resistance - Suction Source	The suction source shall not show any loss of vacuum greater than 2%.	PASS
Flow Rate	Calculate the arithmetic average of three determinations and express it as water flow rate through the catheter in millilitres per minute.	PASS

2. Sample Sizes Used for the Test Set and Data Provenance:

For the performance tests listed in the table, a sample size of 3 devices was used for each test. The document does not specify the country of origin of the data or whether the study was retrospective or prospective, as these were bench tests performed on the device itself.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not applicable as the evaluation involved objective bench testing against measurable physical and functional criteria, not interpretation by human experts to establish ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable as the evaluation involved objective bench testing against measurable physical and functional criteria, not an adjudication process by human experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study was not conducted. The document describes bench testing for device performance and a comparison of technological characteristics to a predicate device, but not a study involving human readers with and without AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

This information is not applicable as the device is a physical medical device (catheter system), not an algorithm or AI system. The performance tests focused on the device's physical and functional properties.

7. Type of Ground Truth Used:

The "ground truth" for the performance tests was established by objective, measurable criteria defined in referenced international and national standards (e.g., EN 1617:1997, EN 1618:1997, ASTM F1980). These standards define the acceptable performance limits for the device's physical and functional characteristics.

8. Sample Size for the Training Set:

This information is not applicable as the submission describes a physical medical device and its bench testing, not an AI or algorithm-based device that would require a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the reasons stated above.

Summary

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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: 00 44 191 419 4488 Fax: 00 44 191 416 5693

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.

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 orStandardReference	SampleSize	FinalReport	Accept/Reject Criteria	Results
Resistance todeformation	EN1617:19974.2(IncludingAnnex A)	3	NPDQA1050	The drainage system or anycomponent intended to operateunder negative pressure shall notshow deformation sufficient toimpair the function of the device atthe maximum negative pressurestated by the manufacturer.	PASS
Force at break- connections	EN1617:19974.3.1:EN 1618:1997Annex F	3	NPDQA1054and1055	The minimum force at break forconnections shall be 15 N. (Nominaloutside diameter >4 mm)	PASS
Force at break- Drainagecatheters andall other partsof the system	EN1617:19974.3.2:EN 1618:1997Annex B	3	NPDQA1054	The minimum force at break forcatheter and all other parts ofsystem shall be 20 N. (Nominaloutside diameter >4 mm)	PASS
Freedom fromleakage -Duringaspiration orvacuum	EN1617:19974.5:EN1618:1997Annex D	3	NPDQA1051	Neither the drainage system nor anycomponents shall leak at themaximum negative pressure statedby the manufacturer	PASS
Impactresistance -Collectiondevice	EN1617:19974.6(includingAnnex B)	3	NPDQA1052	The collection deviceshall not leak	PASS
Impactresistance -SuctionSource	EN1617:1997 4.6(includingAnnex B)	3	NPDQA1052	The suction source shallnot show any loss ofvacuum greater than 2 %	PASS
Flow Rate	EN1618:1997Annex D	3	NPDQA1053	Calculate the arithmeticaverage of three determinations andexpress it as water flow rate throughthe 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/reference	Pleurx Pleural Cathoter Kit,500ml/1000ml Drainage bottle	Rocket Medical IPC Insertionpack500ml Drainage bottle	Identify, reasons for andsignificance of differences)
Essential dimensions	15.5Fg x 400mm Catheter,500ml/1000ml	16Fg x 400mm Catheter,500ml Drainage bottle.
Material specifications	Silicone, valve material, bottlematerial	Silicone, valve material, bottlematerial	none
Operating environment	Body temperature, pleural space,subcutaneous tissue	Body temperature, pleuralspace, subcutaneous tissue	none
Design concept	15.5Fg x 400mm Catheter with oneway valve	16Fg x 400mm Catheter withone way valve	Despite stated differencesbetween the catheters, thecatheters measureidentically and are both5mm OD catheters with a3mm ID. As shown in thethe testing documented.
Principles of operation	Catheter is inserted using a mixtureof wire guided andtunnelled techniqueWhen Insitu one wayvalve is opened using a specificallydesigned drainage bottle. Thedrainage bottle is pre-evacuatedand the control of the level ofsuction is provided via a pinchclamp. This allows fluid to be drawnfrom the pleural space via thecatheter into the drainage bottle.When the drainage bottle is filledwith fluid, the drainage is completeand the bottle is disconnected fromthe drainage fine and discarded.	Catheter is inserted using amixture of wire guided andtunnelled technique Wheninsitu one way valve is openedusing a specifically designeddrainage bottle. The drainagebottle is pre-evacuated and thecontrol of the level of suction isprovided via a suction controlvalve. This allows fluid to bedrawn from the pleural spacevia the catheter into thedrainage bottle. When thedrainage bottle is filled withfluid, the drainage is completeand the bottle is disconnectedfrom the drainage line anddiscarded.	The control valve wasintroduced over the pinchclamp to offer the end usermore control over theapplication of vacuum andthe flow of fluid. As many inthis patient group havethickend pleura when thevacuum is applied this cancause discomfort to thepatient. The vacuum controlunit works by the patientpressing down a button toinitiate the application ofvacuum. The patient canthen titrate this level ofvacuum to a personal levelof 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 (800) 638-2041 or (301) 796-7100 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 devices are indicated for:

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

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

Page 1 of 1

11/23033 510{k} Number:_

Page 25 of 529

Regulation Number and Section

§ 870.5050 Patient care suction apparatus.

(a)
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.(b)
Classification. Class II (performance standards).