Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit

K162457 · Rocket Medical Plc · PNG · Nov 14, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K162457
• Device Name: Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
• Applicant: Rocket Medical Plc
• Product Code: PNG · Gastroenterology, Urology
• Decision Date: Nov 14, 2016
• Decision: SEKD
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 intermittent drainage of symptomatic. recurrent malignant ascites. Also the palliation of symptoms related to recurrent malignant ascites.

Device Story

Fenestrated silicone drainage catheter for peritoneal ascites; features polyester cuff for patient attachment and silicone one-way valve to prevent air/fluid backflow. Kit includes catheter, drainage line, insertion/dressing accessories, and drug components (Lidocaine, DuraPrep). Used for intermittent drainage of malignant ascites; provides symptom palliation. Operated by clinicians in clinical settings. Output is fluid drainage; enables management of recurrent ascites symptoms.

Clinical Evidence

Bench testing only. Performance data includes resistance to deformation, force at break for connections and catheters, and leakage testing. Biocompatibility testing includes cytotoxicity, sensitization, irritation, systemic toxicity, subchronic toxicity, genotoxicity, implantation, and exhaustive extraction.

Technological Characteristics

Fenestrated silicone catheter; polyester cuff; silicone one-way valve. Kit includes drainage line and accessories. Sterilization via EtO (SAL 10^-6). Packaging includes APET tray, blue field wrap, and Tyvek/PET pouch. Shelf life: 3 years.

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

• Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit (K152105)

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

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 [phone]

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 [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.

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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 [phone] or [phone] 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

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)

> 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.<br>2-4 Sedling Road, Wear Industrial Estate<br>Washington, Tyne and Wear<br>NE38 9BZ UK | | |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Contact Person: | Tracy Charlton, Regulatory Affairs Manager<br>Phone: [phone] Ext 222<br>Fax: [phone]<br>[e-mail] | | |
| Date Prepared: | September 1, 2016 | | |
| Trade Name: | Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit | | |
| Classification: | Class II<br>Peritoneal dialysis system and accessories<br>21 CFR 876.5630 | | |
| Product Code: | PNG | | |
| Predicate<br>Device(s): | The subject device is equivalent to the following device:<br>◦ Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit; (Rocket<br>Medical Plc, K152105) | | |
| Device<br>Description: | The Rocket Indwelling Peritoneal Catheter (IPC) is a fenestrated silicone<br>drainage catheter intended for the drainage of peritoneal ascites. The<br>catheter has a polyester cuff for attachment to the patient and a silicone one-<br>way valve to prevent air and fluid from migrating back into the peritoneum.<br>The IPC Insertion Kit consists of the IPC, drainage line and accessories for<br>insertion, attachment and dressing. In addition, the Rocket IPC Insertion Kit<br>contains currently licensed 1% lidocaine (5 mL x 3) and DuraPrep (6 mL x<br>2). | | |
| Indications for<br>Use: | The Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit (Model #<br>R51401-16-PT and R51401-MI-PT) contains the following MAJOR<br>components:<br>● Indwelling Peritoneal Catheter (Model # ZASEM192)<br>● Drainage Line (Model #R54410-00-DL)<br>● Accessories for insertion, attachment and dressing<br><br>The Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is indicated<br>for intermittent drainage of symptomatic, recurrent malignant ascites. Also<br>the palliation of symptoms related to recurrent malignant ascites. | | |
| Substantial<br>Equivalence: | Parameter | Subject Device<br>Rocket Indwelling Peritoneal<br>Catheter (IPC) Insertion Kit | Predicate Device<br>Rocket Indwelling<br>Peritoneal Catheter (IPC)<br>Insertion Kit |
| | 510(k) Number | TBD | K152105 |
| | Classification | Class II | Same |
| | Product Code | PNG | Same |
| | Regulation | 21 CFR 876.5630 | Same |
| | Indications for<br>Use | The Rocket Indwelling Peritoneal<br>Catheter (IPC) Insertion Kit<br>(Model # R51401-16-PT and<br>R51401-MI-PT) contains the<br>following MAJOR components:<br>• Indwelling Peritoneal Catheter<br>(Model # ZASEM192)<br>• Drainage Line (Model #R54410-<br>00-DL)<br>• Accessories for insertion,<br>attachment and dressing<br>The Rocket Indwelling Peritoneal<br>Catheter (IPC) Insertion Kit is<br>indicated for intermittent drainage<br>of symptomatic, recurrent<br>malignant ascites. Also the<br>palliation of symptoms related to<br>recurrent malignant ascites. | Same |
| | Kit Components<br>and Accessories | Identical to predicate except also<br>contains currently licensed<br>Lidocaine (5mL x 3) and DurePrep<br>(6 mL x 2) | IPC Catheter, drainage line<br>and accessories for insertion,<br>attachment and dressing |
| | Kits | Model # R51401-16-PT and<br>R51401-MI-PT | Same |
| | Performance | Resistance to deformation; force at<br>break- connections; force at break-<br>drainage catheters and all other<br>parts; freedom from leakage | Same |
| | Biocompatibility | Cytotoxicity, sensitization,<br>irritation, system toxicity,<br>subchronic toxicity, genotoxicity,<br>implantation, exhaustive<br>extraction, summary report and<br>biological risk assessment | Same |
| | Packaging<br>components and<br>materials | APET tray, blue field wrap,<br>uncoated Tyvek 1073B/PET<br>pouch, folding carton | Same |
| | Sterility | SAL 106 | Same |
| | Sterilization<br>Method | EtO | Same |
| | Shelf life | 3 years | Same |

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