(265 days)
No
The 510(k) summary describes a mechanical device for draining pleural effusion and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for the palliation of dyspnea due to pleural effusion and providing pleurodesis (resolution of the pleural effusion), which are therapeutic purposes.
No
This device is designed for drainage of symptomatic, recurrent pleural effusion for treatment/palliation, not for diagnosis.
No
The device description clearly outlines physical components like catheters, drainage lines, accessories, and even included drugs, indicating it is a hardware-based medical device kit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Rocket Indwelling Pleural Catheter (IPC) is a medical device designed for the physical drainage of fluid from the pleural space. It is an invasive device used for therapeutic purposes (palliation of dyspnea, providing pleurodesis).
- Lack of Diagnostic Testing: The description does not mention any component or function that performs a diagnostic test on a biological sample. The device facilitates drainage, not analysis of the drained fluid for diagnostic purposes.
Therefore, the Rocket Indwelling Pleural Catheter (IPC) Insertion Kit is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DWM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pleural space
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained personnel, in conjunction with current clinical practice guidelines.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No new performance, packaging, biocompatibility or shelf life testing was performed for this submission in order to establish substantial equivalence, as the subject device catheter and drainage line are identical to the predicate device, and no manufacturing or packaging materials or processes have changed, and the sterilization method has not changed.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
2
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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3
Section 5 – 510(k) Summary
| Submitter: | Rocket Medical PLC
2-4 Sedling Road, Wear Industrial Estate
Washington, Tyne and Wear
NE38 9BZ UK |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tracy Charlton, Regulatory Affairs Manager
Phone: 00 44 191 419 4488 Ext 222
Fax: 00 44 191 416 5693
tracy@rocketmedical.com |
| Date Prepared: | August 1, 2017 |
| Trade Name: | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit |
| Classification: | Class II
Patient Care Suction Apparatus
21 CFR 870.5050 |
| Product Code: | DWM |
| Predicate
Device(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)
O
Insertion Kit; (Rocket Medical PLC, K162457). This device kit
components and accessories are identical to the subject device.
Therefore, performance is identical to the subject device. |
| Device
Description: | 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. |
4
| Indications for
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. | | | |
| Substantial
Equivalence: | Parameter | Subject Device
Rocket Indwelling
Pleural Catheter
(IPC) Insertion Kit | Predicate Device
Rocket Indwelling
Pleural Catheter
(IPC) Insertion Kit | Similarities and
Differences |
| | 510(k) Number | K163321 | K123033 | n/a |
| | Classification | Class II | Same as subject
device | identical |
| | Product Code | DWM | Same as subject
device | identical |
| | Regulation | 21 CFR 870.5050 | Same as subject
device | identical |
| | Indications for
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.
This device should
only be used by or
under the
supervision of
trained personnel
and in conjunction
with current clinical
practice guidelines. | The Rocket IPC
Insertion Kit and
Rocket IPC
Dressing Pack and
Bottle Set are
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.
This device should
only be used by or
under the
supervision of
trained personnel
and in conjunction
with current clinical
practice guidelines. | Same as subject
device except:
The bottle sets and
dressing packs
accessories were
already cleared in
the predicate
(K123033);
therefore, they are
not part of the
subject device
convenience kit.
However, the bottle
sets and dressing
packs are used with
the subject device;
therefore, there is
no impact on
substantial
equivalence. |
| | The device is
indicated for:
· The palliation of
dyspnea due to
pleural effusion
· Providing
pleurodesis
(resolution of the
pleural effusion) | The devices are
indicated for:
- The palliation of
dyspnea due to
pleural effusion - Providing
pleurodesis
(resolution to the
pleural effusion).
The Rocket IPC
Bottle Sets are
indicated for use
only with the
Rocket Indwelling
Pleural Catheter for
intermittent
drainage. The
Rocket Dressing
Packs are indicated
for dressing of a
catheter and exit
site. | | |
| Kit Components
and Accessories | IPC Catheter,
drainage line and
accessories for
insertion, attachment
and dressing
including currently
licensed Lidocaine
HCl, USP (5mL x 3)
and DurePrep (6 mL
x 2) and four update
kit accessories | IPC Catheter,
drainage line and
accessories for
insertion,
attachment and
dressing | The subject device
and predicate and
reference predicate
device insertion kits
have the identical
main components:
indwelling catheter,
drainage line and
accessories for
insertion,
attachment and
dressing. The
subject device kit
components
including currently
licensed Lidocaine
HCl, USP (5mL x
- and DuraPrep (6
mL x 2) and four
updated kit
accessories are
identical to the
reference predicate
(K162457). | |
| Catheter and
Drainage Line
Technological
Features | Catheter: Tubing,
cuff, one-way valve
and cap;
Drainage line:
tubing, one-way
valve and locking
section | Same as subject
device | Since the subject
device and the
predicate device
catheters and
drainage line are
identical, they have
identical
technological
features. | |
| | | | | |
| Catheter and
Drainage Line
Principle of
Operation | Catheter is attached
via the one-way
valve to vacuum
bottles or wall
suction with
drainage line for
drainage of the
pleural space; the
one-way value on
catheter or drainage
line prevents air and
fluid from migrating
back into the pleural
space | Same as subject
device | Since the subject
device and the
predicate catheters
and drainage line
are identical, they
have identical
principles of
operation. | |
| Catheter and
Drainage Line
Materials | Catheter: Silicone
tubing with 30%
barium sulfate stripe,
polyester cuff,
silicone adhesive,
ABS one-way valve
and cap;
Drainage line: PVC
tubing and ABS one-
way valve and
locking section | Same as subject
device | Since the subject
device and the
predicate catheters
and drainage line
are identical, they
have identical
materials | |
| Kits | Model # R51400-16-
PL and R51400-MI-
PL | Model # R51400-
16-00 and R51400-
MI-PL | Unique model
numbers for each
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 | Same as subject
device | Since the main
components of the
devices are
identical, the
performance testing
performed on the
predicate is
applicable to the
subject device. | |
| Biocompatibility
per ISO 10993-1 | Cytotoxicity.
sensitization,
irritation, system
toxicity, subchronic
toxicity.
genotoxicity,
implantation,
exhaustive
extraction, summary
report and biological
risk assessment | Same as subject
device | Since the main
components of the
devices are
identical, the
biocompatibility
testing performed
on the predicate is
applicable to the
subject device. | |
| | | | | |
| | Packaging
components and
materials | APET tray, blue
field wrap, uncoated
Tyvek 1073B/PET
pouch, folding
carton | Same as subject
device | The subject device
and predicate use
the same packaging
materials and
process. |
| | Sterility | SAL 106 | Same as subject
device | The subject device
and predicate are
sterilized using the |
| | Sterilization
Method per ISO
11135-1 and
ISO 10993-7 | EtO and
EtO residuals | Same as subject
device | sterilized using the
same method, the
same sterility level
and the same
residual testing. |
| | Shelf life | The shelf life will
not exceed the shelf
life of any of its kit
components when
packaged | 3 years | 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. |
5
6
7
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 | Regulatory
Status | Predicate
Device | Reference
Predicate |
|-------------------------------------|--------------------------------------|----------------------|---------------------|------------------------------|
| Tunneler | Metal | K152105 | Plastic | |
| Suture Forceps/
Dressing Forceps | Blue tipped to
signify single use | 510(k)
Exempt | Not blue
tipped | Same as
subject
device |
| Needle Holder | Blue tipped to
signify single use | 510(k)
Exempt | Not blue
tipped | |
| Suture | Dissolvable | K981935 | Silk | |
| Pinch Clamp and
Slide Clamp | Removed from
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.
9
| Conclusion: | Rocket Medical considers the Rocket IPC Indwelling Pleural Insertion Set
with Lidocaine and DuraPrep to be substantially equivalent to the predicate
and Reference predicate devices listed above. This conclusion is based upon
the fact that the subject device catheter and drainage line technological
features, principle of operation, materials, biocompatibility, performance,
packaging and sterilization are identical to the predicate. Also, all kit
components including currently licensed Lidocaine HCl, USP and DuraPrep
and four updated kit accessories (two cosmetic and two material changes
identified in the table above: Comparison of updated kit accessories to
predicate and Reference predicate) are identical and have the same shelf life
as the Reference predicate. The Lidocaine HCl, USP was tested post EtO
sterilization per the Lidocaine HCl, USP monograph and met all USP
requirements as labeled. The difference in the Indication for Use statements
of the subject and predicate as described above (exclusion of Bottle Sets and
Dressing Packs for subject device) have not changed the intended use or
substantial equivalence of the devices. |
| ------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|