(265 days)
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.
Model R51400-16-PL IPC Insertion Kit consists of the IPC, drainage line and accessories for insertion, attachment and dressing. In addition, it contains currently licensed 1% lidocaine (5 mL x 3) and DuraPrep (6 mL x 2). Model R51400-MI-PL is the Mini Kit with fewer accessories and no drugs. It is for use by surgeons where the patients are already draped and insertion components are readily available. The Rocket IPC Insertion Kits are provided sterile and are for single use only.
The Rocket Indwelling Pleural Catheter (IPC) is a fenestrated silicone catheter, with a barium sulfate stripe through its length, intended for the drainage of pleural effusion. 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 pleural space. This valve can only be operated with the specifically designed drainage line and drainage bottles supplied by Rocket Medical.
The provided text is a 510(k) Summary for a medical device (Rocket Indwelling Pleural Catheter (IPC) Insertion Kit). It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than performing a new clinical study to prove the device meets specific acceptance criteria in the manner one would for a novel AI/software medical device.
Therefore, many of the typical bullet points for AI/software device evaluation (e.g., sample sizes for training/test sets, expert adjudication methods, MRMC studies, ground truth establishment for AI models) are not applicable to this document, as it outlines a comparison to a predicate device based on existing performance data and technical specifications.
However, I can extract the closest information analogous to "acceptance criteria" and "device performance" in the context of this 510(k) submission, which revolves around demonstrating that the new device is as safe and effective as the predicate.
Here's an interpretation based on the provided text:
Acceptance Criteria and Device Performance (in the context of Substantial Equivalence):
The "acceptance criteria" here are implicitly that the subject device's performance characteristics match or are demonstrably equivalent to those of the predicate device. The "reported device performance" is not from new testing of the subject device (for most aspects), but rather a statement that its performance is identical to the predicate due to identical components and principles.
| Acceptance Criteria (Implicitly, as per Predicate) | Reported Device Performance (Subject Device) |
|---|---|
| Performance per EN 1617:1997 & EN 1618:1997: Resistance to deformation; force at break-connections; force at break-drainage catheters and all other parts; freedom from leakage. | "Since the main components of the devices are identical, the performance testing performed on the predicate is applicable to the subject device. All testing met acceptance criteria." (Implying the subject device also meets these, as it's identical). |
| Biocompatibility per ISO 10993-1: Cytotoxicity, sensitization, irritation, system toxicity, subchronic toxicity, genotoxicity, implantation, exhaustive extraction, summary report and biological risk assessment. | "Since the main components of the devices are identical, the biocompatibility testing performed on the predicate is applicable to the subject device. All testing met acceptance criteria." (Implying the subject device also meets these, as it's identical). |
| Sterility: SAL 10⁻⁶ | "Same as subject device." (Meaning the predicate achieved this). "The subject device and predicate are sterilized using the same method, the same sterility level and the same residual testing." (Implying the subject device also meets this). |
| Sterilization Method per ISO 11135-1 and ISO 10993-7: EtO and EtO residuals. | "Same as subject device." (Meaning the predicate used this). "The subject device and predicate are sterilized using the same method, the same sterility level and the same residual testing." (Implying the subject device also meets this). |
| Shelf life: (Predicate had 3 years) | "The shelf life will not exceed the shelf life of any of its kit components when packaged." "Since the subject device is identical to the predicate except for the Lidocaine HCl, USP and DuraPrep, the stability testing on the predicate is applicable to the subject device. The shelf life of the Lidocaine HCl, USP and DuraPrep are determined and monitored by the manufacturers." (Demonstrates compatibility with components' existing shelf lives). |
| Packaging components and materials: APET tray, blue field wrap, uncoated Tyvek 1073B/PET pouch, folding carton. | "Same as subject device." (Meaning the predicate used these). "The subject device and predicate use the same packaging materials and process." (Implying equivalence). |
| Indications for Use: (Slight difference in convenience kit components, but not fundamental indication) | "Same as subject device except... no impact on substantial equivalence." |
| Technological Features (Catheter and Drainage Line): Tubing, cuff, one-way valve, cap, locking section. | "Since the subject device and the predicate device catheters and drainage line are identical, they have identical technological features." |
| Principle of Operation (Catheter and Drainage Line): Attached via one-way valve to vacuum bottles/wall suction for drainage; one-way valve prevents air/fluid migration. | "Since the subject device and the predicate catheters and drainage line are identical, they have identical principles of operation." |
| Materials (Catheter and Drainage Line): Silicone tubing with barium sulfate stripe, polyester cuff, silicone adhesive, ABS one-way valve and cap; PVC tubing and ABS one-way valve and locking section. | "Since the subject device and the predicate catheters and drainage line are identical, they have identical materials." |
Regarding the study that proves the device meets acceptance criteria (interpreted as proof of substantial equivalence):
-
Sample size used for the test set and the data provenance:
- This is not a "test set" in the machine learning sense. The "study" for substantial equivalence relies on existing data and specifications of the predicate device (K123033) and a reference predicate (K162457).
- No new clinical data or specific sample sizes are mentioned for demonstrating the subject device's performance (outside of the pre-existing data for the predicate).
- Provenance: The predicate device (K123033) and reference predicate (K162457) are also from Rocket Medical PLC, GB. The general context of 510(k) submissions relies on historical data and verified performance of existing devices. The terms "retrospective" or "prospective" are not applicable here, as it's a comparison to established devices.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study requiring expert ground truth for a test set. The "truth" is established by the prior FDA clearances of the predicate devices.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
-
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:
- Not applicable. This is a physical medical device, not an AI/software device involving human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for proving substantial equivalence relies on pre-existing regulatory clearances, performance data, and technical specifications of the predicate device(s). For the added components (Lidocaine HCl, USP and DuraPrep), their "ground truth" for safety and efficacy comes from their individual clearances and conformance to USP monographs and manufacturer validations (e.g., for EtO sterilization).
-
The sample size for the training set:
- Not applicable. This refers to AI/ML model training, which is not relevant here.
-
How the ground truth for the training set was established:
- Not applicable. This refers to AI/ML model training, which is not relevant here.
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Image /page/0/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which consists of a stylized caduceus with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the logo in a circular fashion.
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.
{1}------------------------------------------------
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,
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 PLC2-4 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: | August 1, 2017 |
| Trade Name: | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit |
| Classification: | Class IIPatient Care Suction Apparatus21 CFR 870.5050 |
| Product Code: | DWM |
| PredicateDevice(s): | The subject device is equivalent to the following devices:Predicate: Rocket Indwelling Pleural Catheter (IPC) Insertion Kit;O(Rocket Medical PLC, K123033)Reference Predicate: Rocket Indwelling Peritoneal Catheter (IPC)OInsertion Kit; (Rocket Medical PLC, K162457). This device kitcomponents and accessories are identical to the subject device.Therefore, performance is identical to the subject device. |
| DeviceDescription: | Model R51400-16-PL IPC Insertion Kit consists of the IPC, drainage lineand accessories for insertion, attachment and dressing. In addition, itcontains currently licensed 1% lidocaine (5 mL x 3) and DuraPrep (6 mLx 2). Model R51400-MI-PL is the Mini Kit with fewer accessories and nodrugs. It is for use by surgeons where the patients are already draped andinsertion components are readily available. The Rocket IPC Insertion Kitsare provided sterile and are for single use only.The Rocket Indwelling Pleural Catheter (IPC) is a fenestrated siliconecatheter, with a barium sulfate stripe through its length, intended for thedrainage of pleural effusion. There is a polyester cuff for attachment to thepatient and a silicone one-way valve to prevent air and fluid frommigrating back into the pleural space. This valve can only be operatedwith the specifically designed drainage line and drainage bottles suppliedby Rocket Medical. |
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| Indications forUse: | 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, includingmalignant pleural effusion and other recurrent effusions that do notrespond 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 trainedpersonnel and in conjunction with current clinical practice guidelines. | ||||
| SubstantialEquivalence: | Parameter | Subject DeviceRocket IndwellingPleural Catheter(IPC) Insertion Kit | Predicate DeviceRocket IndwellingPleural Catheter(IPC) Insertion Kit | Similarities andDifferences |
| 510(k) Number | K163321 | K123033 | n/a | |
| Classification | Class II | Same as subjectdevice | identical | |
| Product Code | DWM | Same as subjectdevice | identical | |
| Regulation | 21 CFR 870.5050 | Same as subjectdevice | identical | |
| Indications forUse | The RocketIndwelling PleuralCatheter (IPC)Insertion Kit (Model# R51400-16-PL andR51400-MI-PL) isindicated forintermittent, long-term drainage ofsymptomatic,recurrent, pleuraleffusion, includingmalignant pleuraleffusion and otherrecurrent effusionsthat do not respondto medicalmanagement ofunderlying disease.This device shouldonly be used by orunder thesupervision oftrained personneland in conjunctionwith current clinicalpractice guidelines. | The Rocket IPCInsertion Kit andRocket IPCDressing Pack andBottle Set areindicated forintermittent, long-term drainage ofsymptomatic,recurrent, pleuraleffusion, includingmalignant pleuraleffusion and otherrecurrent effusionsthat do not respondto medicalmanagement ofunderlying disease.This device shouldonly be used by orunder thesupervision oftrained personneland in conjunctionwith current clinicalpractice guidelines. | Same as subjectdevice except:The bottle sets anddressing packsaccessories werealready cleared inthe predicate(K123033);therefore, they arenot part of thesubject deviceconvenience kit.However, the bottlesets and dressingpacks are used withthe subject device;therefore, there isno impact onsubstantialequivalence. | |
| The device isindicated for:· The palliation ofdyspnea due topleural effusion· Providingpleurodesis(resolution of thepleural effusion) | The devices areindicated for:1. The palliation ofdyspnea due topleural effusion2. Providingpleurodesis(resolution to thepleural effusion).The Rocket IPCBottle Sets areindicated for useonly with theRocket IndwellingPleural Catheter forintermittentdrainage. TheRocket DressingPacks are indicatedfor dressing of acatheter and exitsite. | |||
| Kit Componentsand Accessories | IPC Catheter,drainage line andaccessories forinsertion, attachmentand dressingincluding currentlylicensed LidocaineHCl, USP (5mL x 3)and DurePrep (6 mLx 2) and four updatekit accessories | IPC Catheter,drainage line andaccessories forinsertion,attachment anddressing | The subject deviceand predicate andreference predicatedevice insertion kitshave the identicalmain components:indwelling catheter,drainage line andaccessories forinsertion,attachment anddressing. Thesubject device kitcomponentsincluding currentlylicensed LidocaineHCl, USP (5mL x3) and DuraPrep (6mL x 2) and fourupdated kitaccessories areidentical to thereference predicate(K162457). | |
| Catheter andDrainage LineTechnologicalFeatures | Catheter: Tubing,cuff, one-way valveand cap;Drainage line:tubing, one-wayvalve and lockingsection | Same as subjectdevice | Since the subjectdevice and thepredicate devicecatheters anddrainage line areidentical, they haveidenticaltechnologicalfeatures. | |
| Catheter andDrainage LinePrinciple ofOperation | Catheter is attachedvia the one-wayvalve to vacuumbottles or wallsuction withdrainage line fordrainage of thepleural space; theone-way value oncatheter or drainageline prevents air andfluid from migratingback into the pleuralspace | Same as subjectdevice | Since the subjectdevice and thepredicate cathetersand drainage lineare identical, theyhave identicalprinciples ofoperation. | |
| Catheter andDrainage LineMaterials | Catheter: Siliconetubing with 30%barium sulfate stripe,polyester cuff,silicone adhesive,ABS one-way valveand cap;Drainage line: PVCtubing and ABS one-way valve andlocking section | Same as subjectdevice | Since the subjectdevice and thepredicate cathetersand drainage lineare identical, theyhave identicalmaterials | |
| Kits | Model # R51400-16-PL and R51400-MI-PL | Model # R51400-16-00 and R51400-MI-PL | Unique modelnumbers for eachdevice. | |
| Performance perEN 1617:1997EN 1618:1997 | Resistance todeformation; force atbreak- connections;force at break-drainage cathetersand all other parts;freedom fromleakage | Same as subjectdevice | Since the maincomponents of thedevices areidentical, theperformance testingperformed on thepredicate isapplicable to thesubject device. | |
| Biocompatibilityper ISO 10993-1 | Cytotoxicity.sensitization,irritation, systemtoxicity, subchronictoxicity.genotoxicity,implantation,exhaustiveextraction, summaryreport and biologicalrisk assessment | Same as subjectdevice | Since the maincomponents of thedevices areidentical, thebiocompatibilitytesting performedon the predicate isapplicable to thesubject device. | |
| Packagingcomponents andmaterials | APET tray, bluefield wrap, uncoatedTyvek 1073B/PETpouch, foldingcarton | Same as subjectdevice | The subject deviceand predicate usethe same packagingmaterials andprocess. | |
| Sterility | SAL 106 | Same as subjectdevice | The subject deviceand predicate aresterilized using the | |
| SterilizationMethod per ISO11135-1 andISO 10993-7 | EtO andEtO residuals | Same as subjectdevice | sterilized using thesame method, thesame sterility leveland the sameresidual testing. | |
| Shelf life | The shelf life willnot exceed the shelflife of any of its kitcomponents whenpackaged | 3 years | Since the subjectdevice is identicalto the predicateexcept for theLidocaine HCl,USP and DuraPrep,the stability testingon the predicate isapplicable to thesubject device. Theshelf life of theLidocaine HCl,USP and DuraPrepare determined andmonitored by themanufacturers. |
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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.
{8}------------------------------------------------
| Component | Subject Device | RegulatoryStatus | PredicateDevice | ReferencePredicate |
|---|---|---|---|---|
| Tunneler | Metal | K152105 | Plastic | |
| Suture Forceps/Dressing Forceps | Blue tipped tosignify single use | 510(k)Exempt | Not bluetipped | Same assubjectdevice |
| Needle Holder | Blue tipped tosignify single use | 510(k)Exempt | Not bluetipped | |
| Suture | Dissolvable | K981935 | Silk | |
| Pinch Clamp andSlide Clamp | Removed fromkit | 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.
{9}------------------------------------------------
| Conclusion: | Rocket Medical considers the Rocket IPC Indwelling Pleural Insertion Setwith Lidocaine and DuraPrep to be substantially equivalent to the predicateand Reference predicate devices listed above. This conclusion is based uponthe fact that the subject device catheter and drainage line technologicalfeatures, principle of operation, materials, biocompatibility, performance,packaging and sterilization are identical to the predicate. Also, all kitcomponents including currently licensed Lidocaine HCl, USP and DuraPrepand four updated kit accessories (two cosmetic and two material changesidentified in the table above: Comparison of updated kit accessories topredicate and Reference predicate) are identical and have the same shelf lifeas the Reference predicate. The Lidocaine HCl, USP was tested post EtOsterilization per the Lidocaine HCl, USP monograph and met all USPrequirements as labeled. The difference in the Indication for Use statementsof the subject and predicate as described above (exclusion of Bottle Sets andDressing Packs for subject device) have not changed the intended use orsubstantial equivalence of the devices. |
|---|---|
| ------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
§ 870.5050 Patient care suction apparatus.
(a)
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.(b)
Classification. Class II (performance standards).