Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set

K152105 · Rocket Medical Plc · PNG · Mar 29, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K152105
• Device Name: Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set
• Applicant: Rocket Medical Plc
• Product Code: PNG · Gastroenterology, Urology
• Decision Date: Mar 29, 2016
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is intermittent drainage of symptomatic, recurrent malignant ascites. Also the palliation of symptoms related to recurrent malignant ascites.

Device Story

The Rocket IPC Insertion Kit is a sterile, single-use system for managing recurrent malignant ascites. The device consists of a fenestrated silicone drainage catheter with a polyester cuff for subcutaneous attachment and a one-way valve to prevent backflow. The kit includes components for insertion and a drainage line. The system operates by connecting the catheter to a pre-evacuated drainage bottle, creating negative pressure to draw fluid from the peritoneal space. A suction control valve allows the patient to titrate the vacuum level for comfort, replacing the traditional pinch clamp method. The device is intended for use in clinical settings or home environments where patients or caregivers manage drainage. By facilitating the removal of accumulated fluid, the device provides symptomatic relief for patients suffering from malignant ascites.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included sterilization validation, biocompatibility (ISO 10993 series), packaging validation, and mechanical testing (EN 1617/1618) covering resistance to deformation, force at break, leakage, impact resistance, and flow rate. All tests passed.

Technological Characteristics

Materials: Biocompatible silicone tubing, polyester cuff, silicone adhesive. Sensing/Actuation: Passive drainage via pre-evacuated vacuum bottle; manual suction control valve. Dimensions: 16Fg x 400mm catheter. Sterilization: Ethylene Oxide (EtO). Connectivity: None. Software: None.

Indications for Use

Indicated for intermittent drainage of symptomatic, recurrent malignant ascites and palliation of symptoms related to recurrent malignant ascites in patients.

Regulatory Classification

Identification

(1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments. (3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles. (4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.

Special Controls

*Classification.* Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.

Predicate Devices

• Pleurx Peritoneal Catheter Kit and Pleurx Drainage Kits (K051711)

Submission Summary (Full Text)

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

March 29, 2016

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

Re: K152105

> Trade/Device Name: Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit Regulation Number: 21 CFR 876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: Class II Product Code: PNG Dated: February 26, 2016 Received: February 29, 2016

Dear Tracy 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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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

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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.

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K152105

Device Name

Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit

### Indications for Use (Describe)

The Rocket Indwelling Perioneal Catheter (IPC) Insertion Kit (Model # R51401-16-PT and R51401-MI-PT) contains the following MAJOR components:

- Indwelling Peritoneal Catheter (Model # ZASEM192)
- Drainage Line (Model #R54410-00-DL) ●
- Accessories for insertion, attachment and dressing

The Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is intermittent drainage of symptomatic, recurrent malignant ascites. Also the palliation of symptoms related to recurrent malignant ascites.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

# FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/4/Picture/0 description: The image shows the logo for Rocket Medical. The logo consists of a blue icon on the left and the text "Rocketmedical" on the right. The icon is a stylized "R" with a cross in the upper left quadrant. The text "Rocketmedical" is in a blue sans-serif font.

# SECTION 05: 510(K) Summary

# 1. INTRODUCTION

- 1.1 This document contains the 510(k) summary for the Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit. The content 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,<br>Washington, Tyne and Wear<br>NE38 9BZ<br>United Kingdom |
| Phone: | 00 44 191 419 4488 |
| Fax: | 00 44 191 416 5693 |

- Official Contact: Tracy Charlton Regulatory Affairs Manager
Summary Preparation Date: 24th February 2016

# 3. DEVICE NAME AND CLASSIFICATION

| Trade Name: | Rocket Indwelling Peritoneal Catheter (IPC) Insertion K |
|-------------------------|---------------------------------------------------------|
| Common Name: | Peritoneal Drainage Catheter |
| Classification<br>Name: | Peritoneal dialysis system and accessories |
| Classification: | Class II, 21 CFR 876.5630 |
| Product Code: | PNG |

#### PREDICATE DEVICES: 4.

- 4.1 The Rocket IPC Insertion Kit is claimed to be substantially equivalent to the following legally marketed predicate devices:
- Pleurx Peritoneal Catheter Kit and Pleurx Drainage Kits (K051711) 4.1.1

# 5. PERFORMANCE STANDARDS:

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

- 6.1 Rocket Medical Plc. hereby submits this Traditional 510(k) notice for its Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit. The Rocket Indwelling Peritoneal Catheter is a fenestrated silicone drainage catheter intended for the drainage of peritoneal ascites. There is a polyester cuff for attachment to the patient and a silicone one-way valve to prevent air and fluid from migrating back into the peritoneum. The IPC Insertion Kit will consist of the

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Image /page/5/Picture/0 description: The image shows the logo for Rocket Medical. The logo consists of a blue circle with a white plus sign inside, followed by the text "Rocketmedical" in blue. The "medical" part of the text is slightly smaller and in a lighter shade of blue.

IPC and components necessary for its use such as a drainage line. In addition, the Rocket IPC is packaged into convenience kits to aid in the implantation of the Rocket IPC.

# 7. INDICATIONS FOR USE

The Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit (Model # R51401-16-PT and R51401-MI-PT) contains the following MAJOR components:

- Indwelling Peritoneal Catheter (Model # ZASEM192) .
- Drainage Line (Model #R54410-00-DL)
- . Accessories for insertion, attachment and dressing

The Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is indicated for intermittent drainage of symptomatic, recurrent malignant ascites. Also the palliation of symptoms related to recurrent malignant ascites.

# 8. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

- 8.1.The Rocket IPC insertion kit has the same intended use and the same technological characteristics as the identified predicate device. Minor difference in technological characteristics do not raise new or different questions of safety and effectiveness and validation data supports that the system performs in accordance with its intended use and is substantially equivalent to the predicate device.
- 8.2 The Rocket Indwelling Peritoneal Catheter (IPC) is a fenestrated silicone drainage catheter intended for the drainage of peritoneal ascites. There is a polyester cuff for attachment to the patient and a silicone one-way valve to prevent air and fluid from migrating back into the peritoneum.
- 8.3 The catheter insertion kit uses the option of the vacuum from a drainage bottle as a negative pressure to remove fluid from the peritoneum.
- 8.4 Materials: Biocompatible Silicone tubing, polyester cuff and silicone adhesive are implanted in the peritoneal space.
- 8.5 Sterility Assurance Level; 1x10 6

# 9. SUMMARY OF PERFORMANCE TESTING

- 9.1 Performance bench testing of the Rocket IPC was conducted in accordance with all applicable
FDA Guidance documents and ISO standards, including:

- 9.1.1 ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and Testing within a risk management process.
- 9.1.2 ISO 10993-3: 2009 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
- 9.1.3 ISO 10993-5: 2009 Biological evaluation of medical devices Part 5: Tests for in vitro Cytotoxicity

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Image /page/6/Picture/0 description: The image contains the logo for Rocketmedical. The logo consists of a stylized letter "R" with a plus sign incorporated into its design, followed by the text "Rocketmedical" in a sans-serif font. The color of the logo and text is a dark blue.

- 9.1.4 ISO 10993-6: 2009 Biological evaluation of medical devices Part 6: Tests for local effects after implantation.
- 9.1.5 ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide Sterilization Residuals.
- 9.1.6 ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Tests for irritation

and delayed-type hypersensitivity.

9.1.7 ISO 10993-11: 2009 Biological evaluation of medical devices. Tests for systemic toxicity

- 9.1.8 ISO 10993-12: 2009 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials.
- 9.1.9 ISO 10993-17: 2002 Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances
- 9.1.10 ISO 10993-18: 2005 Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
- 9.1.11 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.

9.1.12 ASTM F1980- 07(2007) Standard Guide for Accelerated Aging of Sterile Barrier Systems

for Medical Devices batch testing.

- 9.1.13 USP <85> Bacterial Endotoxins Test
- 9.1.14 EN 1617:1997 Sterile Drainage Catheters and Accessory Devices for Single Use.
- 9.1.15 EN 1618:1997 Catheters Other than Intravascular Catheters Test Methods for Common Properties.
- 9.1.16 EN 868-5:2009 Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous and plastic film construction. Requirements and test methods.
- 9.1.17 ISO 15223-1:2012- Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirement.
- 9.1.18 ISO 13485:2012 Medical devices Quality management systems Requirements for regulatory purposes
- 9.1.19 ISO 9001:2008 Quality management systems Requirements
- 9.2 A list of Performance Testing conducted on the Rocket IPC includes;
- 9.2.1 Sterilization Validation
- 9.2.2 Biocompatibility Validation
- 9.2.3 Packaging Validation

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Image /page/7/Picture/0 description: The image shows the logo for Rocketmedical. The logo consists of a blue circle with a white cross and the letter "R" inside. To the right of the circle is the word "Rocketmedical" in blue font. The font is sans-serif and the word is written in lowercase.

- 9.2.4 All bench testing, unless otherwise specified, was conducted on the finished devices, which were sterilized by the final validated sterilization process.
- 9.3 A Summary of Standards Based compliance testing specific for catheter devices conducted on the Rocket IPC is show in the below:

| Test | Test<br>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<br>not show deformation sufficient<br>to impair the function of the<br>device at the maximum negative<br>pressure stated by the<br>manufacturer | PASS |
| Force at<br>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.<br>(Nominal outside diameter<br>>4mm). | PASS |
| Force at<br>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 >4mm). | PASS |
| Freedom<br>from 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<br>any components shall leak at the<br>maximum negative pressure<br>stated 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 shall not<br>leak | PASS |
| Impact –<br>resistance –<br>Suction<br>Source | EN<br>1617:1997<br>4.6<br>(including<br>Annex B) | 3 | NPD<br>QA<br>1053 | The suction source shall not<br>show any loss of vacuum greater<br>than 2% | PASS |
| Flow Rate | EN<br>1618:1997<br>Annex D | 3 | NPD<br>QA<br>1053 | Calculate the arithmetic average<br>of three determinations and<br>express it as water flow rate | PASS |
| | | | | through the catheter in millilitres<br>per minute. | |

# Summary of Catheter Specification Performance Testing

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Image /page/8/Picture/0 description: The image shows the logo for Rocket Medical. The logo consists of a blue icon that looks like a stylized letter "R" with a cross in the upper left corner. To the right of the icon is the text "Rocketmedical" in blue sans-serif font.

These are located in Appendix C Pages 336-406

#### 10 SUBSTANTIAL EQUIVALENCE

- 10.1 Verification and validation of the Rocket IPC 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.
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 Pleurx Peritoneal Catheter Kit and Pleurx Drainage Kits (K051711), manufactured by CareFusion.
- 10.1.2 Clinical Equivalence Justification

Refer to the table below.

# Clinical Equivalence Justification

| Parameter | Predicate device(s) in<br>current use | Devices for<br>evaluation | Gap Analysis |
|--------------------------------|----------------------------------------------------------------|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description/code/<br>reference | Pleurx Peritoneal<br>Catheter Kit | Rocket Medical IPC<br>Insertion Kit | Identify reasons for an<br>significance of differences |
| Essential<br>dimensions | 15.5Fg x 400mm<br>Catheter,<br>500ml/1000ml Drainage<br>Bottle | 16Fg x 400mm<br>Catheter,<br>600ml/1000ml<br>Drainage Bottle | None |
| Material<br>specifications | Silicone, valve material,<br>bottle material | Silicone, valve<br>material, bottle<br>material | None |
| Operating<br>environment | Body temperature,<br>peritoneum,<br>subcutaneous tissue | Body temperature,<br>peritoneum,<br>subcutaneous<br>tissue | None |
| Design concept | 15.5Fg x 400mm<br>Catheter with one way<br>valve | 16Fg x 400mm<br>Catheter with one<br>way valve | Despite stated differences<br>between the catheters, the<br>catheters measure<br>identically and are both<br>5mm OD catheter with a<br>3mm ID. As shown in the<br>testing documented. |

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Image /page/9/Picture/1 description: The image contains the logo for Rocket Medical. The logo consists of a blue icon that looks like a stylized letter R with a cross in the upper left quadrant. To the right of the icon is the text "Rocketmedical" in blue, with the first letter capitalized and the rest in lowercase.

| Parameter | Predicate device(s) in<br>current use | Devices for<br>evaluation | Gap Analysis |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principles of<br>operation | Catheter is inserted using<br>a mixture of wire guided<br>and tunnelled technique<br>When insitu one way<br>valve is opened using a<br>specifically designed<br>drainage bottle. The<br>drainage bottle is pre-<br>evacuated and the<br>control of the level of<br>suction is provided via a<br>pinch clamp. This allows<br>fluid to be drawn from the<br>peritoneum via the<br>catheter into the drainage<br>bottle. When the drainage<br>bottle is filled with fluid,<br>the drainage is complete<br>and the bottle is<br>disconnected from the<br>drainage line and<br>discarded. | Catheter is inserted<br>using a mixture of<br>wire guided and<br>tunnelled technique<br>When insitu one<br>way valve is opened<br>using a specifically<br>designed drainage<br>bottle. The drainage<br>bottle is pre-<br>evacuated and the<br>control of the level<br>of suction is<br>provided via a<br>suction control<br>valve. This allows<br>fluid to be drawn<br>from the peritoneum<br>via the catheter into<br>the drainage bottle.<br>When the drainage<br>bottle is filled with<br>fluid, the drainage is<br>complete and the<br>bottle is<br>disconnected from<br>the drainage line<br>and 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. 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<br>vacuum. The patient can<br>then titrate this level of<br>vacuum to a personal level<br>of comfort. |
| Method of<br>sterilisation | EtO | EtO | None |

#### 11 RISK MANAGEMENT

Refer to Appendix D (Pages 407-416) 11.1

T. Chautz

Tracy Charlton Regulatory Affairs Manager

24th February, 2015