(244 days)
Not Found
No
The 510(k) summary describes a physical medical device (catheter and insertion kit) for draining ascites. There is no mention of software, algorithms, or any computational components that would suggest the use of AI or ML. The performance studies described are bench testing of the physical device's properties.
Yes
The device is intended for "intermittent drainage of symptomatic, recurrent malignant ascites" and "palliation of symptoms" related to it, indicating a therapeutic purpose.
No
The device is described as an "Indwelling Peritoneal Catheter (IPC) Insertion Kit" intended for the "intermittent drainage of symptomatic, recurrent malignant ascites" and "palliation of symptoms related to recurrent malignant ascites." It is a drainage catheter, not a device used to diagnose a condition.
No
The device description clearly states it is an "Indwelling Peritoneal Catheter (IPC) Insertion Kit" which includes physical components like a catheter, drainage line, and accessories for insertion. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the drainage of symptomatic, recurrent malignant ascites and the palliation of symptoms related to it. This is a therapeutic and palliative intervention, not a diagnostic one.
- Device Description: The device is a catheter designed to drain fluid from the body. It is a physical device used for a medical procedure.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to diagnose a condition or provide information about a patient's health status.
- Performance Studies: The performance studies focus on the physical characteristics and safety of the catheter (sterilization, biocompatibility, packaging, catheter-specific testing), not on the accuracy or reliability of a diagnostic test.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for drainage.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
PNG
Device Description
Rocket Medical Plc. hereby submits this Traditional 510(k) notice for its Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit. The Rocket Indwelling Peritoneal Catheter is a fenestrated silicone drainage catheter intended for the drainage of peritoneal ascites. 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 peritoneum. The IPC Insertion Kit will consist of the IPC and components necessary for its use such as a drainage line. In addition, the Rocket IPC is packaged into convenience kits to aid in the implantation of the Rocket IPC.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneum, subcutaneous tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance bench testing of the Rocket IPC was conducted in accordance with all applicable FDA Guidance documents and ISO standards. A list of Performance Testing conducted on the Rocket IPC includes;
- Sterilization Validation
- Biocompatibility Validation
- Packaging Validation
All bench testing, unless otherwise specified, was conducted on the finished devices, which were sterilized by the final validated sterilization process.
Summary of Catheter Specification Performance Testing:
Test: Resistance to deformation
Test Method or Standard Reference: EN 1617:1997 4.2 (including Annex A)
Sample Size: 3
Accept/Reject Criteria: The drainage system or any component intended to operate under negative pressure shall not show deformation sufficient to impair the function of the device at the maximum negative pressure stated by the manufacturer
Results: PASS
Test: Force at break – Connections
Test Method or Standard Reference: EN 1617:1997 4.3.1; EN 1618:1997 Annex F
Sample Size: 3
Accept/Reject Criteria: The minimum force at break for connections shall be 15 N. (Nominal outside diameter >4mm).
Results: PASS
Test: Force at break – Drainage catheters and all other parts of the system
Test Method or Standard Reference: EN 1617:1997 4.3.2; EN 1618:1997 Annex B
Sample Size: 3
Accept/Reject Criteria: The minimum force at break for catheter and all other parts of system shall be 20 N. (Nominal outside diameter >4mm).
Results: PASS
Test: Freedom from leakage – During aspiration or vacuum
Test Method or Standard Reference: EN 1617:1997 4,5; EN 1618:1997 Annex D
Sample Size: 3
Accept/Reject Criteria: Neither the drainage system nor any components shall leak at the maximum negative pressure stated by the manufacturer.
Results: PASS
Test: Impact resistance – Collection device
Test Method or Standard Reference: EN 1617:1997 4.6 (including Annex B)
Sample Size: 3
Accept/Reject Criteria: The collection device shall not leak
Results: PASS
Test: Impact – resistance – Suction Source
Test Method or Standard Reference: EN 1617:1997 4.6 (including Annex B)
Sample Size: 3
Accept/Reject Criteria: The suction source shall not show any loss of vacuum greater than 2%
Results: PASS
Test: Flow Rate
Test Method or Standard Reference: EN 1618:1997 Annex D
Sample Size: 3
Accept/Reject Criteria: Calculate the arithmetic average of three determinations and express it as water flow rate through the catheter in millilitres per minute.
Results: PASS
Verification and validation of the Rocket IPC was performed through extensive bench testing, sterilization, packaging and shelf life testing. Results of the testing demonstrated that the Rocket IPC design met all specifications and is adequate for its intended use.
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.
Not Found
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
§ 876.5630 Peritoneal dialysis system and accessories.
(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 29, 2016
Rocket Medical Plc Tracy Charlton Regulatory Affairs Manager 2-4 Sedling Rd, Wear Industrial Estate Washington, Tyne and Wear NE38 9BZ United Kingdom
Re: K152105
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: February 26, 2016 Received: February 29, 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. 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
1
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.
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 yours,
Benjamin R. Fisher -S
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
2
Indications for Use
510(k) Number (if known) K152105
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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the logo for Rocket Medical. The logo consists of a blue icon on the left and the text "Rocketmedical" on the right. The icon is a stylized "R" with a cross in the upper left quadrant. The text "Rocketmedical" is in a blue sans-serif font.
SECTION 05: 510(K) Summary
1. INTRODUCTION
- 1.1 This document contains the 510(k) summary for the Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit. The content of this summary is based on the requirements of 21 CFR 807.92.
2. APPLICANT NAME AND ADDRESS:
| Name: | Rocket Medical Plc. |
|---|---|
| Address: | 2-4 Sedling Road, Wear Industrial Estate, |
| Washington, Tyne and Wear | |
| NE38 9BZ | |
| United Kingdom | |
| Phone: | 00 44 191 419 4488 |
| Fax: | 00 44 191 416 5693 |
- Official Contact: Tracy Charlton Regulatory Affairs Manager
Summary Preparation Date: 24th February 2016
3. DEVICE NAME AND CLASSIFICATION
| Trade Name: | Rocket Indwelling Peritoneal Catheter (IPC) Insertion K |
|---|---|
| Common Name: | Peritoneal Drainage Catheter |
| Classification | |
| Name: | Peritoneal dialysis system and accessories |
| Classification: | Class II, 21 CFR 876.5630 |
| Product Code: | PNG |
PREDICATE DEVICES: 4.
- 4.1 The Rocket IPC Insertion Kit is claimed to be substantially equivalent to the following legally marketed predicate devices:
- Pleurx Peritoneal Catheter Kit and Pleurx Drainage Kits (K051711) 4.1.1
5. PERFORMANCE STANDARDS:
- 5.1 There are no mandatory performance standards for this device type.
6. DESCRIPTION OF THE DEVICE:
- 6.1 Rocket Medical Plc. hereby submits this Traditional 510(k) notice for its Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit. The Rocket Indwelling Peritoneal Catheter is a fenestrated silicone drainage catheter intended for the drainage of peritoneal ascites. 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 peritoneum. The IPC Insertion Kit will consist of the
5
Image /page/5/Picture/0 description: The image shows the logo for Rocket Medical. The logo consists of a blue circle with a white plus sign inside, followed by the text "Rocketmedical" in blue. The "medical" part of the text is slightly smaller and in a lighter shade of blue.
IPC and components necessary for its use such as a drainage line. In addition, the Rocket IPC is packaged into convenience kits to aid in the implantation of the Rocket IPC.
7. INDICATIONS FOR 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 indicated for intermittent drainage of symptomatic, recurrent malignant ascites. Also the palliation of symptoms related to recurrent malignant ascites.
8. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
- 8.1.The Rocket IPC insertion kit has the same intended use and the same technological characteristics as the identified predicate device. Minor difference in technological characteristics do not raise new or different questions of safety and effectiveness and validation data supports that the system performs in accordance with its intended use and is substantially equivalent to the predicate device.
- 8.2 The Rocket Indwelling Peritoneal Catheter (IPC) is a fenestrated silicone drainage catheter intended for the drainage of peritoneal ascites. 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 peritoneum.
- 8.3 The catheter insertion kit uses the option of the vacuum from a drainage bottle as a negative pressure to remove fluid from the peritoneum.
- 8.4 Materials: Biocompatible Silicone tubing, polyester cuff and silicone adhesive are implanted in the peritoneal space.
- 8.5 Sterility Assurance Level; 1x10 6
9. SUMMARY OF PERFORMANCE TESTING
-
9.1 Performance bench testing of the Rocket IPC was conducted in accordance with all applicable
FDA Guidance documents and ISO standards, including: -
9.1.1 ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and Testing within a risk management process.
-
9.1.2 ISO 10993-3: 2009 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
-
9.1.3 ISO 10993-5: 2009 Biological evaluation of medical devices Part 5: Tests for in vitro Cytotoxicity
6
Image /page/6/Picture/0 description: The image contains the logo for Rocketmedical. The logo consists of a stylized letter "R" with a plus sign incorporated into its design, followed by the text "Rocketmedical" in a sans-serif font. The color of the logo and text is a dark blue.
- 9.1.4 ISO 10993-6: 2009 Biological evaluation of medical devices Part 6: Tests for local effects after implantation.
- 9.1.5 ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide Sterilization Residuals.
- 9.1.6 ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Tests for irritation
and delayed-type hypersensitivity.
9.1.7 ISO 10993-11: 2009 Biological evaluation of medical devices. Tests for systemic toxicity
- 9.1.8 ISO 10993-12: 2009 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials.
- 9.1.9 ISO 10993-17: 2002 Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances
- 9.1.10 ISO 10993-18: 2005 Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
- 9.1.11 ISO 11135-1:2007 Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for
medical devices.
9.1.12 ASTM F1980- 07(2007) Standard Guide for Accelerated Aging of Sterile Barrier Systems
for Medical Devices batch testing.
- 9.1.13 USP Bacterial Endotoxins Test
- 9.1.14 EN 1617:1997 Sterile Drainage Catheters and Accessory Devices for Single Use.
- 9.1.15 EN 1618:1997 Catheters Other than Intravascular Catheters Test Methods for Common Properties.
- 9.1.16 EN 868-5:2009 Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous and plastic film construction. Requirements and test methods.
- 9.1.17 ISO 15223-1:2012- Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirement.
- 9.1.18 ISO 13485:2012 Medical devices Quality management systems Requirements for regulatory purposes
- 9.1.19 ISO 9001:2008 Quality management systems Requirements
- 9.2 A list of Performance Testing conducted on the Rocket IPC includes;
- 9.2.1 Sterilization Validation
- 9.2.2 Biocompatibility Validation
- 9.2.3 Packaging Validation
7
Image /page/7/Picture/0 description: The image shows the logo for Rocketmedical. The logo consists of a blue circle with a white cross and the letter "R" inside. To the right of the circle is the word "Rocketmedical" in blue font. The font is sans-serif and the word is written in lowercase.
- 9.2.4 All bench testing, unless otherwise specified, was conducted on the finished devices, which were sterilized by the final validated sterilization process.
- 9.3 A Summary of Standards Based compliance testing specific for catheter devices conducted on the Rocket IPC is show in the below:
| Test | Test
Method or
Standard
Reference | Sample
Size | Final
Report | Accept/Reject Criteria | Results |
|--------------------------------------------------------------------------------------|----------------------------------------------------------|----------------|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Resistance to
deformation | EN
1617:1997
4.2
(including
Annex A) | 3 | NPD
QA
1050 | The drainage system or any
component intended to operate
under negative pressure shall
not show deformation sufficient
to impair the function of the
device at the maximum negative
pressure stated by the
manufacturer | PASS |
| Force at
break –
Connections | EN
1617:1997
4.3.1;
EN 1618:
1997
Annex F | 3 | NPD
QA
1054
and
1055 | The minimum force at break for
connections shall be 15 N.
(Nominal outside diameter
4mm). | PASS |
| Force at
break –
Drainage
catheters and
all other parts
of the system | EN
1617:1997
4.3.2;
EN 1618:
1997
Annex B | 3 | NPD
QA
1054 | The minimum force at break for
catheter and all other parts of
system shall be 20 N. (Nominal
outside diameter >4mm). | PASS |
| Freedom
from leakage
– During
aspiration or
vacuum | EN
1617:1997
4,5;
EN
1618:1997
Annex D | 3 | NPD
QA
1051 | Neither the drainage system nor
any components shall leak at the
maximum negative pressure
stated by the manufacturer. | PASS |
| Impact
resistance –
Collection
device | EN
1617:1997
4.6
(including
Annex B) | 3 | NPD
QA
1052 | The collection device shall not
leak | PASS |
| Impact –
resistance –
Suction
Source | EN
1617:1997
4.6
(including
Annex B) | 3 | NPD
QA
1053 | The suction source shall not
show any loss of vacuum greater
than 2% | PASS |
| Flow Rate | EN
1618:1997
Annex D | 3 | NPD
QA
1053 | Calculate the arithmetic average
of three determinations and
express it as water flow rate | PASS |
| | | | | through the catheter in millilitres
per minute. | |
Summary of Catheter Specification Performance Testing
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Image /page/8/Picture/0 description: The image shows the logo for Rocket Medical. The logo consists of a blue icon that looks like a stylized letter "R" with a cross in the upper left corner. To the right of the icon is the text "Rocketmedical" in blue sans-serif font.
These are located in Appendix C Pages 336-406
10 SUBSTANTIAL EQUIVALENCE
-
10.1 Verification and validation of the Rocket IPC was performed through extensive bench testing, sterilization, packaging and shelf life testing. Results of the testing demonstrated that the Rocket IPC design met all specifications and is adequate for its intended use.
In conclusion, the Rocket IPC is substantially equivalent in intended use, technological characteristics, safety, and performance characteristics to the following legally marketed predicate device: -
10.1.1 Pleurx Peritoneal Catheter Kit and Pleurx Drainage Kits (K051711), manufactured by CareFusion.
-
10.1.2 Clinical Equivalence Justification
Refer to the table below.
Clinical Equivalence Justification
| Parameter | Predicate device(s) in
current use | Devices for
evaluation | Gap Analysis |
|--------------------------------|----------------------------------------------------------------|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description/code/
reference | Pleurx Peritoneal
Catheter Kit | Rocket Medical IPC
Insertion Kit | Identify reasons for an
significance of differences |
| Essential
dimensions | 15.5Fg x 400mm
Catheter,
500ml/1000ml Drainage
Bottle | 16Fg x 400mm
Catheter,
600ml/1000ml
Drainage Bottle | None |
| Material
specifications | Silicone, valve material,
bottle material | Silicone, valve
material, bottle
material | None |
| Operating
environment | Body temperature,
peritoneum,
subcutaneous tissue | Body temperature,
peritoneum,
subcutaneous
tissue | None |
| Design concept | 15.5Fg x 400mm
Catheter with one way
valve | 16Fg x 400mm
Catheter with one
way valve | Despite stated differences
between the catheters, the
catheters measure
identically and are both
5mm OD catheter with a
3mm ID. As shown in the
testing documented. |
9
Image /page/9/Picture/1 description: The image contains the logo for Rocket Medical. The logo consists of a blue icon that looks like a stylized letter R with a cross in the upper left quadrant. To the right of the icon is the text "Rocketmedical" in blue, with the first letter capitalized and the rest in lowercase.
| Parameter | Predicate device(s) in
current use | Devices for
evaluation | Gap Analysis |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principles of
operation | Catheter is inserted using
a mixture of wire guided
and tunnelled technique
When insitu one way
valve is opened using a
specifically designed
drainage bottle. The
drainage bottle is pre-
evacuated and the
control of the level of
suction is provided via a
pinch clamp. This allows
fluid to be drawn from the
peritoneum via the
catheter into the drainage
bottle. When the drainage
bottle is filled with fluid,
the drainage is complete
and the bottle is
disconnected from the
drainage line and
discarded. | Catheter is inserted
using a mixture of
wire guided and
tunnelled technique
When insitu one
way valve is opened
using a specifically
designed drainage
bottle. The drainage
bottle is pre-
evacuated and the
control of the level
of suction is
provided via a
suction control
valve. This allows
fluid to be drawn
from the peritoneum
via the catheter into
the drainage bottle.
When the drainage
bottle is filled with
fluid, the drainage is
complete and the
bottle is
disconnected from
the drainage line
and discarded. | The control valve was
introduced over the pinch
clamp to offer the end user
more control over the
application of vacuum and
the flow of fluid. When the
vacuum is applied this can
cause discomfort to the
patient. The vacuum control
unit works by the patient
pressing down a button to
initiate the application
vacuum. The patient can
then titrate this level of
vacuum to a personal level
of comfort. |
| Method of
sterilisation | EtO | EtO | None |
11 RISK MANAGEMENT
Refer to Appendix D (Pages 407-416) 11.1
T. Chautz
Tracy Charlton Regulatory Affairs Manager
24th February, 2015