Rocket Indwelling Pleural Catheter (IPC) Insertion Kit

K163321 · Rocket Medical Plc · DWM · Aug 17, 2017 · Cardiovascular

Device Facts

• Record ID: K163321
• Device Name: Rocket Indwelling Pleural Catheter (IPC) Insertion Kit
• Applicant: Rocket Medical Plc
• Product Code: DWM · Cardiovascular
• Decision Date: Aug 17, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Rocket Indwelling Pleural Catheter (IPC) Insertion Kit (Model # R51400-16-PL and R51400-MI-PL) is 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. The device is indicated for: - The palliation of dyspnea due to pleural effusion - Providing pleurodesis (resolution of the pleural effusion) This device should only be used by or under the supervision of trained personnel and in conjunction with current clinical practice guidelines.

Device Story

Rocket IPC Insertion Kit provides fenestrated silicone catheter for intermittent, long-term drainage of pleural effusions; includes drainage line, accessories for insertion/dressing, and optional lidocaine/DuraPrep. Catheter features polyester cuff for tissue attachment and one-way silicone valve to prevent backflow of air/fluid into pleural space. Used in clinical settings by trained personnel (surgeons/physicians). Catheter connects to vacuum bottles or wall suction via drainage line. Output is pleural fluid drainage; clinical benefit includes symptom relief (palliation of dyspnea) and pleurodesis. Kit provided sterile, single-use.

Clinical Evidence

Bench testing only. No clinical data. Predicate performance data (resistance to deformation, force at break, leakage) and biocompatibility (ISO 10993-1) are leveraged. Lidocaine HCl tested post-EtO sterilization per USP monograph; DuraPrep validated for EtO cycles.

Technological Characteristics

Catheter: Silicone tubing with 30% barium sulfate stripe, polyester cuff, silicone adhesive, ABS one-way valve/cap. Drainage line: PVC tubing, ABS one-way valve. Sterilization: EtO (ISO 11135-1). Packaging: APET tray, Tyvek/PET pouch. Single-use, sterile.

Indications for Use

Indicated for patients with symptomatic, recurrent pleural effusion (including malignant) unresponsive to medical management. Used for palliation of dyspnea and to provide pleurodesis. For use by or under supervision of trained personnel.

Regulatory Classification

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.

Predicate Devices

• Rocket Indwelling Pleural Catheter (IPC) Insertion Kit (K123033)

Reference Devices

• Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit (K162457)

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

August 17, 2017

Rocket Medical PLC Tracy Charlton Regulatory Affairs Manager 2-4 Sedling Rd, Wear Industrial Estate Washington, NE38 9BZ, GB

Re: K163321

Trade/Device Name: Rocket Indwelling Pleural Catheter (IPC) Insertion Kit Regulation Number: 21 CFR 870.5050 Regulation Name: Patient Care Suction Apparatus Regulatory Class: Class II Product Code: DWM Dated: July 20, 2017 Received: July 21, 2017

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. 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.

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.

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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,

# Tara A. Ryan -S

for Lori Wiggins Acting 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)

#### K163321

Device Name

Rocket Indwelling Pleural Catheter (IPC) Insertion Kit

Indications for Use (Describe)

The Rocket Indwelling Pleural Catheter (IPC) Insertion Kit (Model # R51400-16-PL and R51400-MI-PL) is 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.

The device is indicated for:

- · The palliation of dyspnea due to pleural effusion
- · Providing pleurodesis (resolution of the pleural effusion)

This device should only be used by or under the supervision of trained personnel and in conjunction with current clinical practice guidelines.

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 |
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| Contact Person: | Tracy Charlton, Regulatory Affairs Manager<br>Phone: [phone] Ext 222<br>Fax: [phone]<br>[e-mail] |
| Date Prepared: | August 1, 2017 |
| Trade Name: | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit |
| Classification: | Class II<br>Patient Care Suction Apparatus<br>21 CFR 870.5050 |
| Product Code: | DWM |
| Predicate<br>Device(s): | The subject device is equivalent to the following devices:<br>Predicate: Rocket Indwelling Pleural Catheter (IPC) Insertion Kit;<br>O<br>(Rocket Medical PLC, K123033)<br>Reference Predicate: Rocket Indwelling Peritoneal Catheter (IPC)<br>O<br>Insertion Kit; (Rocket Medical PLC, K162457). This device kit<br>components and accessories are identical to the subject device.<br>Therefore, performance is identical to the subject device. |
| Device<br>Description: | Model R51400-16-PL IPC Insertion Kit consists of the IPC, drainage line<br>and accessories for insertion, attachment and dressing. In addition, it<br>contains currently licensed 1% lidocaine (5 mL x 3) and DuraPrep (6 mL<br>x 2). Model R51400-MI-PL is the Mini Kit with fewer accessories and no<br>drugs. It is for use by surgeons where the patients are already draped and<br>insertion components are readily available. The Rocket IPC Insertion Kits<br>are provided sterile and are for single use only.<br>The Rocket Indwelling Pleural Catheter (IPC) is a fenestrated silicone<br>catheter, with a barium sulfate stripe through its length, intended for the<br>drainage of pleural effusion. There is a polyester cuff for attachment to the<br>patient and a silicone one-way valve to prevent air and fluid from<br>migrating back into the pleural space. This valve can only be operated<br>with the specifically designed drainage line and drainage bottles supplied<br>by Rocket Medical. |

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| Indications for<br>Use: | The Rocket Indwelling Pleural Catheter (IPC) Insertion Kit (Model #<br>R51400-16-PL and R51400-MI-PL) is indicated for intermittent, long-<br>term drainage of symptomatic, recurrent, pleural effusion, including<br>malignant pleural effusion and other recurrent effusions that do not<br>respond to medical management of underlying disease.<br><br>The device is indicated for:<br>• The palliation of dyspnea due to pleural effusion<br>• Providing pleurodesis (resolution of the pleural effusion)<br> | | | |
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| | This device should only be used by or under the supervision of trained<br>personnel and in conjunction with current clinical practice guidelines. | | | |
| Substantial<br>Equivalence: | Parameter | Subject Device<br>Rocket Indwelling<br>Pleural Catheter<br>(IPC) Insertion Kit | Predicate Device<br>Rocket Indwelling<br>Pleural Catheter<br>(IPC) Insertion Kit | Similarities and<br>Differences |
| | 510(k) Number | K163321 | K123033 | n/a |
| | Classification | Class II | Same as subject<br>device | identical |
| | Product Code | DWM | Same as subject<br>device | identical |
| | Regulation | 21 CFR 870.5050 | Same as subject<br>device | identical |
| | Indications for<br>Use | The Rocket<br>Indwelling Pleural<br>Catheter (IPC)<br>Insertion Kit (Model<br># R51400-16-PL and<br>R51400-MI-PL) is<br>indicated for<br>intermittent, long-<br>term drainage of<br>symptomatic,<br>recurrent, pleural<br>effusion, including<br>malignant pleural<br>effusion and other<br>recurrent effusions<br>that do not respond<br>to medical<br>management of<br>underlying disease.<br>This device should<br>only be used by or<br>under the<br>supervision of<br>trained personnel<br>and in conjunction<br>with current clinical<br>practice guidelines. | The Rocket IPC<br>Insertion Kit and<br>Rocket IPC<br>Dressing Pack and<br>Bottle Set are<br>indicated for<br>intermittent, long-<br>term drainage of<br>symptomatic,<br>recurrent, pleural<br>effusion, including<br>malignant pleural<br>effusion and other<br>recurrent effusions<br>that do not respond<br>to medical<br>management of<br>underlying disease.<br>This device should<br>only be used by or<br>under the<br>supervision of<br>trained personnel<br>and in conjunction<br>with current clinical<br>practice guidelines. | Same as subject<br>device except:<br><br>The bottle sets and<br>dressing packs<br>accessories were<br>already cleared in<br>the predicate<br>(K123033);<br>therefore, they are<br>not part of the<br>subject device<br>convenience kit.<br>However, the bottle<br>sets and dressing<br>packs are used with<br>the subject device;<br>therefore, there is<br>no impact on<br>substantial<br>equivalence. |
| | The device is<br>indicated for:<br>· The palliation of<br>dyspnea due to<br>pleural effusion<br>· Providing<br>pleurodesis<br>(resolution of the<br>pleural effusion) | The devices are<br>indicated for:<br>1. The palliation of<br>dyspnea due to<br>pleural effusion<br>2. Providing<br>pleurodesis<br>(resolution to the<br>pleural effusion).<br>The Rocket IPC<br>Bottle Sets are<br>indicated for use<br>only with the<br>Rocket Indwelling<br>Pleural Catheter for<br>intermittent<br>drainage. The<br>Rocket Dressing<br>Packs are indicated<br>for dressing of a<br>catheter and exit<br>site. | | |
| Kit Components<br>and Accessories | IPC Catheter,<br>drainage line and<br>accessories for<br>insertion, attachment<br>and dressing<br>including currently<br>licensed Lidocaine<br>HCl, USP (5mL x 3)<br>and DurePrep (6 mL<br>x 2) and four update<br>kit accessories | IPC Catheter,<br>drainage line and<br>accessories for<br>insertion,<br>attachment and<br>dressing | The subject device<br>and predicate and<br>reference predicate<br>device insertion kits<br>have the identical<br>main components:<br>indwelling catheter,<br>drainage line and<br>accessories for<br>insertion,<br>attachment and<br>dressing. The<br>subject device kit<br>components<br>including currently<br>licensed Lidocaine<br>HCl, USP (5mL x<br>3) and DuraPrep (6<br>mL x 2) and four<br>updated kit<br>accessories are<br>identical to the<br>reference predicate<br>(K162457). | |
| Catheter and<br>Drainage Line<br>Technological<br>Features | Catheter: Tubing,<br>cuff, one-way valve<br>and cap;<br>Drainage line:<br>tubing, one-way<br>valve and locking<br>section | Same as subject<br>device | Since the subject<br>device and the<br>predicate device<br>catheters and<br>drainage line are<br>identical, they have<br>identical<br>technological<br>features. | |
| | | | | |
| Catheter and<br>Drainage Line<br>Principle of<br>Operation | Catheter is attached<br>via the one-way<br>valve to vacuum<br>bottles or wall<br>suction with<br>drainage line for<br>drainage of the<br>pleural space; the<br>one-way value on<br>catheter or drainage<br>line prevents air and<br>fluid from migrating<br>back into the pleural<br>space | Same as subject<br>device | Since the subject<br>device and the<br>predicate catheters<br>and drainage line<br>are identical, they<br>have identical<br>principles of<br>operation. | |
| Catheter and<br>Drainage Line<br>Materials | Catheter: Silicone<br>tubing with 30%<br>barium sulfate stripe,<br>polyester cuff,<br>silicone adhesive,<br>ABS one-way valve<br>and cap;<br>Drainage line: PVC<br>tubing and ABS one-<br>way valve and<br>locking section | Same as subject<br>device | Since the subject<br>device and the<br>predicate catheters<br>and drainage line<br>are identical, they<br>have identical<br>materials | |
| Kits | Model # R51400-16-<br>PL and R51400-MI-<br>PL | Model # R51400-<br>16-00 and R51400-<br>MI-PL | Unique model<br>numbers for each<br>device. | |
| Performance per<br>EN 1617:1997<br>EN 1618:1997 | Resistance to<br>deformation; force at<br>break- connections;<br>force at break-<br>drainage catheters<br>and all other parts;<br>freedom from<br>leakage | Same as subject<br>device | Since the main<br>components of the<br>devices are<br>identical, the<br>performance testing<br>performed on the<br>predicate is<br>applicable to the<br>subject device. | |
| Biocompatibility<br>per ISO 10993-1 | Cytotoxicity.<br>sensitization,<br>irritation, system<br>toxicity, subchronic<br>toxicity.<br>genotoxicity,<br>implantation,<br>exhaustive<br>extraction, summary<br>report and biological<br>risk assessment | Same as subject<br>device | Since the main<br>components of the<br>devices are<br>identical, the<br>biocompatibility<br>testing performed<br>on the predicate is<br>applicable to the<br>subject device. | |
| | | | | |
| | Packaging<br>components and<br>materials | APET tray, blue<br>field wrap, uncoated<br>Tyvek 1073B/PET<br>pouch, folding<br>carton | Same as subject<br>device | The subject device<br>and predicate use<br>the same packaging<br>materials and<br>process. |
| | Sterility | SAL 106 | Same as subject<br>device | The subject device<br>and predicate are<br>sterilized using the |
| | Sterilization<br>Method per ISO<br>11135-1 and<br>ISO 10993-7 | EtO and<br>EtO residuals | Same as subject<br>device | sterilized using the<br>same method, the<br>same sterility level<br>and the same<br>residual testing. |
| | Shelf life | The shelf life will<br>not exceed the shelf<br>life of any of its kit<br>components when<br>packaged | 3 years | Since the subject<br>device is identical<br>to the predicate<br>except for the<br>Lidocaine HCl,<br>USP and DuraPrep,<br>the stability testing<br>on the predicate is<br>applicable to the<br>subject device. The<br>shelf life of the<br>Lidocaine HCl,<br>USP and DuraPrep<br>are determined and<br>monitored by the<br>manufacturers. |

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There have been no technological modifications made to the subject device Technological catheter or drainage line as it relates to the predicate device (they are and identical), therefore the performance of the subject device catheter and Performance drainage line is identical to the performance of the predicate device. Comparison: Currently licensed Lidocaine HCl, USP and DuraPrep have been added as accessories to the Pleural IPC convenience kit, but they do not affect the technology, performance or principle of operation of the catheter and drainage line. The Lidocaine HCl, USP and DuraPrep were cleared as kit components in the Reference predicate (K162457). The Lidocaine HCL, USP was tested post EtO sterilization per the Lidocaine HCl, USP monograph and confirmed it met all Lidocaine HCl, USP monograph requirements as labeled. The DuraPrep is validated for 2 cycles of EtO sterilization by the manufacturer.

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| Component | Subject Device | Regulatory<br>Status | Predicate<br>Device | Reference<br>Predicate |
|-------------------------------------|--------------------------------------|----------------------|---------------------|------------------------------|
| Tunneler | Metal | K152105 | Plastic | |
| Suture Forceps/<br>Dressing Forceps | Blue tipped to<br>signify single use | 510(k)<br>Exempt | Not blue<br>tipped | Same as<br>subject<br>device |
| Needle Holder | Blue tipped to<br>signify single use | 510(k)<br>Exempt | Not blue<br>tipped | |
| Suture | Dissolvable | K981935 | Silk | |
| Pinch Clamp and<br>Slide Clamp | Removed from<br>kit | N/A | Present in kit | |

Comparison of subject device updated kit accessories to predicate and Reference predicate:

Summary of Because the subject device catheter and drainage line are identical to the Performance predicate device, and no manufacturing or packaging materials or processes Testing: have changed and the sterilization method has not changed, no new performance, packaging, biocompatibility or shelf life testing was performed for this submission in order to establish substantial equivalence. Performance testing on the predicate included resistance to deformation, force at break-connections, force at break- drainage catheters and all other parts, and freedom from leakage. All testing met acceptance criteria. Biocompatibility testing on the predicate included cytotoxicity, sensitization, irritation, system toxicity, subchronic toxicity, genotoxicity, implantation, exhaustive extraction, and biological risk assessment. All testing met acceptance criteria. The shelf life will not exceed the shelf life of any of its kit components. The Lidocaine HCl, USP and DuraPrep were cleared as kit components in the Reference predicate (K162457). Lidocaine HCl, USP was tested post sterilization per the Lidocaine HCl, USP monograph and confirmed it met all Lidocaine HCl, USP requirements as labeled. DuraPrep is validated by the manufacturer for two EtO sterilization cycles and therefore required no additional testing.

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| Conclusion: | Rocket Medical considers the Rocket IPC Indwelling Pleural Insertion Set<br>with Lidocaine and DuraPrep to be substantially equivalent to the predicate<br>and Reference predicate devices listed above. This conclusion is based upon<br>the fact that the subject device catheter and drainage line technological<br>features, principle of operation, materials, biocompatibility, performance,<br>packaging and sterilization are identical to the predicate. Also, all kit<br>components including currently licensed Lidocaine HCl, USP and DuraPrep<br>and four updated kit accessories (two cosmetic and two material changes<br>identified in the table above: Comparison of updated kit accessories to<br>predicate and Reference predicate) are identical and have the same shelf life<br>as the Reference predicate. The Lidocaine HCl, USP was tested post EtO<br>sterilization per the Lidocaine HCl, USP monograph and met all USP<br>requirements as labeled. The difference in the Indication for Use statements<br>of the subject and predicate as described above (exclusion of Bottle Sets and<br>Dressing Packs for subject device) have not changed the intended use or<br>substantial equivalence of the devices. |
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