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

The Rocket Indwelling Peritoneal Catheter (IPC) is a fenestrated silicone drainage catheter intended for the drainage of peritoneal ascites. The catheter has 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 consists of the IPC, drainage line and accessories for insertion, attachment and dressing. In addition, the Rocket IPC Insertion Kit contains currently licensed 1% lidocaine (5 mL x 3) and DuraPrep (6 mL x 2).

AI/ML Overview

This document is a 510(k) premarket notification for the Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit. It is a Class II medical device used for intermittent drainage and palliation of symptoms related to recurrent malignant ascites. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit; K152105).

The table provided details the "Substantial Equivalence" comparison between the subject device and its predicate. This section outlines various parameters where the subject device is deemed equivalent to the predicate, with a specific focus on performance, biocompatibility, packaging, sterility, sterilization method, and shelf life.

Here's the breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of strict numerical thresholds or target metrics for the device's clinical performance (e.g., success rates in draining ascites, complication rates). Instead, the "Performance" section within the "Substantial Equivalence" table describes the types of tests conducted to demonstrate equivalence to the predicate. Therefore, the "acceptance criteria" are implied to be meeting the established safety and performance characteristics of the predicate device as evaluated through the specified tests. The "reported device performance" is that the subject device performs similarly to the predicate under these tests.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance:
Resistance to deformation	Meets criteria (implied as "Same" as predicate)
Force at break - connections	Meets criteria (implied as "Same" as predicate)
Force at break - drainage catheters and all other parts	Meets criteria (implied as "Same" as predicate)
Freedom from leakage	Meets criteria (implied as "Same" as predicate)
Biocompatibility: (evaluated against ISO 10993 standards)
Cytotoxicity	Meets criteria (implied as "Same" as predicate)
Sensitization	Meets criteria (implied as "Same" as predicate)
Irritation	Meets criteria (implied as "Same" as predicate)
System toxicity	Meets criteria (implied as "Same" as predicate)
Subchronic toxicity	Meets criteria (implied as "Same" as predicate)
Genotoxicity	Meets criteria (implied as "Same" as predicate)
Implantation	Meets criteria (implied as "Same" as predicate)
Exhaustive extraction	Meets criteria (implied as "Same" as predicate)
Summary report and biological risk assessment	Meets criteria (implied as "Same" as predicate)
Packaging Components and Materials Performance:
APET tray, blue field wrap, uncoated Tyvek 1073B/PET pouch, folding carton	Meets predicate's performance (implied as "Same")
Sterility:
Achieves Sterility Assurance Level (SAL) 10⁻⁶	Achieves SAL 10⁻⁶ (implied as "Same" as predicate)
Sterilization Method:
Ethylene Oxide (EtO)	Effective (implied as "Same" as predicate)
Shelf Life:
3 years	Demonstrates 3 years (implied as "Same" as predicate)

2. Sample Size Used for the Test Set and Data Provenance

The document describes performance testing (resistance to deformation, force at break, freedom from leakage) and biocompatibility testing. However, it does not specify the sample sizes used for these tests. The data provenance is implied to be from Rocket Medical Plc. (UK manufacturer). Given the context of a 510(k) submission primarily comparing the subject device to a predicate, these tests would typically be prospective experimental studies performed on samples of the subject device. The document does not mention any clinical studies using human patients for the direct evaluation of this specific device's general performance.

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

This document describes a 510(k) substantial equivalence submission, which relies heavily on laboratory-based performance testing and adherence to recognized standards (e.g., for biocompatibility). It does not mention the use of experts to establish "ground truth" in the context of clinical interpretation or diagnostic accuracy, as might be seen for an AI or imaging device. The "ground truth" for the performance tests would be defined by the measurement instruments and protocols used in the laboratory settings.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "test set" here refers to physical performance and biocompatibility tests, not clinical data requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for devices that involve human interpretation of diagnostic data (e.g., imaging devices with AI assistance) to assess the impact of the device on reader performance. The Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is a medical device for draining fluids, not a diagnostic tool requiring human interpretation for its primary function.

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

No, a standalone performance evaluation (in the context of an algorithm or AI) was not done. This device is a physical medical device, not an algorithm or AI software.

7. The Type of Ground Truth Used

For mechanical performance and material properties, the "ground truth" is established by objective measurements against defined engineering specifications and international standards (e.g., ISO standards for breaking force, leakage).
For biocompatibility, the "ground truth" is established by validated laboratory assays (e.g., cytotoxicity tests, sensitization tests) according to recognized standards like ISO 10993.
For sterility, the "ground truth" is established by specific sterility testing methods to confirm a Sterility Assurance Level (SAL) of 10⁻⁶.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device and does not involve AI or machine learning algorithms that require a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

Summary

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

November 14, 2016

Rocket Medical PLC % Tracy Charlton Regulatory Affairs Manager Rocket Medical PLC 2-4 Sedling Rd. Washington, Tyne and Wear NE38 9BZ UK

Re: K162457

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: September 1, 2016 Received: September 2, 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. Please note: 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 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 - Tracy 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

In addition, we have determined that your device kit contains Lidocaine and DuraPrep™ which are subject to regulation as drugs.

Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:

Director, Division of Drug Labeling Compliance Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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.

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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, Joyce M. Whang -S

for 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)

K162457

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)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 5 – 510(k) Summary

Submitter:	Rocket Medical Plc.2-4 Sedling Road, Wear Industrial EstateWashington, Tyne and WearNE38 9BZ UK
Contact Person:	Tracy Charlton, Regulatory Affairs ManagerPhone: 00 44 191 419 4488 Ext 222Fax: 00 44 191 416 5693tracy@rocketmedical.com
Date Prepared:	September 1, 2016
Trade Name:	Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
Classification:	Class IIPeritoneal dialysis system and accessories21 CFR 876.5630
Product Code:	PNG
PredicateDevice(s):	The subject device is equivalent to the following device:◦ Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit; (RocketMedical Plc, K152105)
DeviceDescription:	The Rocket Indwelling Peritoneal Catheter (IPC) is a fenestrated siliconedrainage catheter intended for the drainage of peritoneal ascites. Thecatheter has 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 consists of the IPC, drainage line and accessories forinsertion, attachment and dressing. In addition, the Rocket IPC Insertion Kitcontains currently licensed 1% lidocaine (5 mL x 3) and DuraPrep (6 mL x2).
Indications forUse:	The Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit (Model #R51401-16-PT and R51401-MI-PT) contains the following MAJORcomponents:● Indwelling Peritoneal Catheter (Model # ZASEM192)● Drainage Line (Model #R54410-00-DL)● Accessories for insertion, attachment and dressingThe Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is indicatedfor intermittent drainage of symptomatic, recurrent malignant ascites. Alsothe palliation of symptoms related to recurrent malignant ascites.
SubstantialEquivalence:	Parameter	Subject DeviceRocket Indwelling PeritonealCatheter (IPC) Insertion Kit	Predicate DeviceRocket IndwellingPeritoneal Catheter (IPC)Insertion Kit
	510(k) Number	TBD	K152105
	Classification	Class II	Same
	Product Code	PNG	Same
	Regulation	21 CFR 876.5630	Same
	Indications forUse	The Rocket Indwelling PeritonealCatheter (IPC) Insertion Kit(Model # R51401-16-PT andR51401-MI-PT) contains thefollowing MAJOR components:• Indwelling Peritoneal Catheter(Model # ZASEM192)• Drainage Line (Model #R54410-00-DL)• Accessories for insertion,attachment and dressingThe Rocket Indwelling PeritonealCatheter (IPC) Insertion Kit isindicated for intermittent drainageof symptomatic, recurrentmalignant ascites. Also thepalliation of symptoms related torecurrent malignant ascites.	Same
	Kit Componentsand Accessories	Identical to predicate except alsocontains currently licensedLidocaine (5mL x 3) and DurePrep(6 mL x 2)	IPC Catheter, drainage lineand accessories for insertion,attachment and dressing
	Kits	Model # R51401-16-PT andR51401-MI-PT	Same
	Performance	Resistance to deformation; force atbreak- connections; force at break-drainage catheters and all otherparts; freedom from leakage	Same
	Biocompatibility	Cytotoxicity, sensitization,irritation, system toxicity,subchronic toxicity, genotoxicity,implantation, exhaustiveextraction, summary report andbiological risk assessment	Same
	Packagingcomponents andmaterials	APET tray, blue field wrap,uncoated Tyvek 1073B/PETpouch, folding carton	Same
	Sterility	SAL 106	Same
	SterilizationMethod	EtO	Same
	Shelf life	3 years	Same

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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.