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 Description

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 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.

AI/ML Overview

The provided text describes the Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit. It is a 510(k) premarket notification for a Class II medical device used for intermittent drainage of symptomatic, recurrent malignant ascites and palliation of related symptoms.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Test Method or Standard Reference	Sample Size	Final Report	Acceptance Criteria	Results
Resistance to deformation	EN 1617:1997 4.2 (including Annex A)	3	NPD QA 1050	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	EN 1617:1997 4.3.1; EN 1618: 1997 Annex F	3	NPD QA 1054 and 1055	The minimum force at break for connections shall be 15 N. (Nominal outside diameter >4mm).	PASS
Force at break – Drainage catheters and all other parts of the system	EN 1617:1997 4.3.2; EN 1618: 1997 Annex B	3	NPD QA 1054	The minimum force at break for catheter and all other parts of system shall be 20 N. (Nominal outside diameter >4mm).	PASS
Freedom from leakage – During aspiration or vacuum	EN 1617:1997 4,5; EN 1618:1997 Annex D	3	NPD QA 1051	Neither the drainage system nor any components shall leak at the maximum negative pressure stated by the manufacturer.	PASS
Impact resistance – Collection device	EN 1617:1997 4.6 (including Annex B)	3	NPD QA 1052	The collection device shall not leak.	PASS
Impact – resistance – Suction Source	EN 1617:1997 4.6 (including Annex B)	3	NPD QA 1053	The suction source shall not show any loss of vacuum greater than 2%.	PASS
Flow Rate	EN 1618:1997 Annex D	3	NPD QA 1053	Calculate the arithmetic average of three determinations and express it as water flow rate through the catheter in millilitres per minute. (No specific numerical acceptance criterion is provided in the table, but it passed the test).	PASS

Beyond these specific tests, the document also mentions compliance with numerous ISO and EN standards related to biocompatibility, sterilization, packaging, and quality management systems (Sections 9.1 and 9.2). The overall conclusion is that "the Rocket IPC design met all specifications and is adequate for its intended use" (Section 10.1).

2. Sample Size used for the test set and the data provenance:

Sample Size: For the specific performance tests listed in the table, the sample size used was 3 for each test.
Data Provenance: The document does not explicitly state the country of origin for the test data, but the applicant's address is United Kingdom (Washington, Tyne and Wear, NE38 9BZ, United Kingdom). It does not specify if the testing was retrospective or prospective, but bench testing on new devices is typically considered prospective for that specific testing, even if the overall design builds on existing knowledge.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The tests performed are engineering/performance bench tests against established standards, not clinical studies requiring expert ground truth for interpretation of patient data.

4. Adjudication method for the test set:

This information is not applicable as the tests are objective material/performance characteristic evaluations, not assessments requiring human adjudication of subjective data.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This document describes the regulatory submission for a physical medical device (catheter kit) and its performance characteristics, not an AI-powered diagnostic or assistive technology.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical catheter kit for drainage, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance tests was defined by the acceptance criteria of the referenced ISO and EN standards. These standards stipulate objective physical and functional requirements (e.g., minimum force at break, no leakage, no significant deformation). In essence, the standard is the ground truth for these engineering tests.

8. The sample size for the training set:

This information is not applicable as this is a physical medical device, not a machine learning model that requires a "training set."

9. How the ground truth for the training set was established:

This information is not applicable as this is a physical medical device.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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,Washington, Tyne and WearNE38 9BZUnited 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
ClassificationName:	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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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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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	TestMethod 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 shallnot show deformation sufficientto impair the function of thedevice at the maximum negativepressure stated by themanufacturer	PASS
Force atbreak –Connections	EN1617:19974.3.1;EN 1618:1997Annex F	3	NPDQA1054and1055	The minimum force at break forconnections shall be 15 N.(Nominal outside diameter>4mm).	PASS
Force atbreak –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 >4mm).	PASS
Freedomfrom leakage– Duringaspiration orvacuum	EN1617:19974,5;EN1618:1997Annex D	3	NPDQA1051	Neither the drainage system norany components shall leak at themaximum negative pressurestated by the manufacturer.	PASS
Impactresistance –Collectiondevice	EN1617:19974.6(includingAnnex B)	3	NPDQA1052	The collection device shall notleak	PASS
Impact –resistance –SuctionSource	EN1617:19974.6(includingAnnex B)	3	NPDQA1053	The suction source shall notshow any loss of vacuum greaterthan 2%	PASS
Flow Rate	EN1618:1997Annex D	3	NPDQA1053	Calculate the arithmetic averageof three determinations andexpress it as water flow rate	PASS
				through the catheter in millilitresper minute.

Summary of Catheter Specification Performance Testing

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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) incurrent use	Devices forevaluation	Gap Analysis
Description/code/reference	Pleurx PeritonealCatheter Kit	Rocket Medical IPCInsertion Kit	Identify reasons for ansignificance of differences
Essentialdimensions	15.5Fg x 400mmCatheter,500ml/1000ml DrainageBottle	16Fg x 400mmCatheter,600ml/1000mlDrainage Bottle	None
Materialspecifications	Silicone, valve material,bottle material	Silicone, valvematerial, bottlematerial	None
Operatingenvironment	Body temperature,peritoneum,subcutaneous tissue	Body temperature,peritoneum,subcutaneoustissue	None
Design concept	15.5Fg x 400mmCatheter with one wayvalve	16Fg x 400mmCatheter with oneway valve	Despite stated differencesbetween the catheters, thecatheters measureidentically and are both5mm OD catheter with a3mm ID. As shown in thetesting documented.

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Parameter	Predicate device(s) incurrent use	Devices forevaluation	Gap Analysis
Principles ofoperation	Catheter is inserted usinga mixture of wire guidedand tunnelled techniqueWhen insitu one wayvalve is opened using aspecifically designeddrainage bottle. Thedrainage bottle is pre-evacuated and thecontrol of the level ofsuction is provided via apinch clamp. This allowsfluid to be drawn from theperitoneum via thecatheter into the drainagebottle. When the drainagebottle is filled with fluid,the drainage is completeand the bottle isdisconnected from thedrainage line anddiscarded.	Catheter is insertedusing a mixture ofwire guided andtunnelled techniqueWhen insitu oneway valve is openedusing a specificallydesigned drainagebottle. The drainagebottle is pre-evacuated and thecontrol of the levelof suction isprovided via asuction controlvalve. This allowsfluid to be drawnfrom the peritoneumvia the catheter intothe drainage bottle.When the drainagebottle is filled withfluid, the drainage iscomplete and thebottle isdisconnected fromthe drainage lineand discarded.	The control valve wasintroduced over the pinchclamp to offer the end usermore control over theapplication of vacuum andthe flow of fluid. When thevacuum is applied this cancause discomfort to thepatient. The vacuum controlunit works by the patientpressing down a button toinitiate the applicationvacuum. The patient canthen titrate this level ofvacuum to a personal levelof comfort.
Method ofsterilisation	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

Regulation Number and Section

§ 876.5630 Peritoneal dialysis system and accessories.

(a)
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.
(b)
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.