(199 days)
No
The description focuses on the physical components and function of a drainage catheter and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for the "long-term drainage of symptomatic, recurrent, effusion or ascites," which directly addresses a medical condition to alleviate symptoms and manage the disease.
No
The device is described as a "drainage catheter" for "intermittent, long-term drainage of symptomatic, recurrent, effusion or ascites." This indicates a therapeutic or palliative function rather than a diagnostic one.
No
The device description clearly states it is a "fenestrated silicone drainage catheter" and describes physical components like a polyester cuff and a silicone one-way valve. The performance studies also focus on physical properties and biocompatibility of the material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the drainage of fluid from the body (effusion or ascites). This is a therapeutic or palliative procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The description details a catheter designed to be inserted into the body to drain fluid. It mentions a one-way valve to prevent fluid from returning to the body, further supporting its function as a drainage device.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze a sample (like blood, urine, or tissue) to provide diagnostic information. The performance studies focus on the physical properties and biocompatibility of the catheter itself, not on the accuracy or reliability of a diagnostic test.
In summary, the Rocket IPC Platinum Cured Catheter is a medical device used for drainage, which is a clinical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Rocket IPC Platinum Cured Catheter is intermittent, long-term drainage of symptomatic, recurrent, effusion or ascites, including malignant effusion or ascites and other recurrent effusions or ascites 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.
Product codes (comma separated list FDA assigned to the subject device)
DWM, PNG
Device Description
The pleural space consists of two thin membranes, one lining the lung and the other lining the chest wall. Draining away the fluid can help relieve breathlessness for a short period, but the fluid often builds up again. While it is possible to have repeated drainage with a chest drain insertion, this could require repeated hospital visits. The IPC is a way of allowing fluid to be drained repeatedly without the painful drainage procedures and without having to come to hospital. The Rocket IPC Platinum Cured Catheter is a fenestrated silicone drainage catheter indicated for intermittent, long-term drainage of symptomatic, recurrent, effusion or ascites, including malignant effusion or ascites and other recurrent effusions or ascites that do not respond to medical management of underlying disease. There is a polyester cuff for attachment to the patient and a silicone one-way valve to prevent collected air and fluid from migrating back into the body. The Rocket platinum Cured Catheter is used alongside the Rocket IPC drainage line and Rocket IPC bottles (these we included in the Rocket Indwelling Pleural Catheter (IPC) System (K123033) & Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit (K152105).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pleural effusions or abdominal ascites (patients suffering from fluid build-up with within the pleural/peritoneal space).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
used by or under the supervision of trained personnel
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 Summary of Standards Based compliance testing conducted on the Rocket IPC Catheter is shown in Table 9.1 and 9.2:
TABLE 9.1
Test: Resistance to deformation, Test Method or Standard Reference: EN 1617:1997 4.2 (including Annex A), Sample Size: 3, 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, 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, Results: PASS
Test: Impact resistance - Collection device, Test Method or Standard Reference: EN 1617:1997 4.6 (including Annex B), Sample Size: 3, Results: PASS
Test: Impact resistance - Suction Source, Test Method or Standard Reference: EN1617:1997 4.6 (including Annex B), Sample Size: 3, Results: PASS
Test: Flow Rate, Test Method or Standard Reference: EN 1618:1997 Annex D, Sample Size: 3, Results: PASS
TABLE 9.2
Test Performed: MEM Elution GLP Report, Results: PASS
Test Performed: ISO Guinea Pig Maximization Sensitization Test, Results: Did not elicit a sensitization response
Test Performed: ISO Intracutaneous Reactivity Test, Results: PASS
Test Performed: ISO Acute Systemic injection Test, Results: PASS
Test Performed: Rabbit Pyrogen Test (Material Mediated) ISO, Results: Requirements Met
Test Performed: Subacute 14-day Intra Peritoneal Toxicity Study in Mice, Results: PASS
Test Performed: The Salmonella Typhimurium Reverse Mutation Assay, Results: Non-Mutagenic
Test Performed: Chromosome Aberration Assay, Results: PASS
Test Performed: In Vivo Mouse Micronucleus Assay, Results: Non-Mutagenic
Test Performed: In Vitro Mouse Lymphoma Assay, Results: Non-Mutagenic
Test Performed: Intramuscular Implant Test Thirteen Week Duration, Results: Non-Irritant
Test Performed: Intramuscular Implant Test Six Month Duration, Results: No-Irritant
Test Performed: Chemical Characterization, Results: Refer to Test
Test Performed: RA Final Evaluation of Local Tissue Effects of ZASEM222 Catheter Assembly following intramuscular Implantation in the Rabbit. (ZASEM222 is now renamed as ZASEM297)., Results: Refer to Test
Test Performed: Biological Risk Assessment, ZASEM222 Platinum Cured Silicone Catheter including ZDLTR043 Steel Dilator)., Results: Refer to Test
Test Performed: Transport Study Report J15474-TX-1, Results: Not Found
Test Performed: EtO Residual Test Reports IPC, Results: Original Catheter in substantial equivalence 510k
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 9, 2021
Rocket Medical Plc Tracy Charlton Regulatory Affairs Manager 2-4 Sedling Road Washington, Tyne and Wear NE38 9BZ UNITED KINGDOM
Re: K210509
Trade/Device Name: Rocket Platinum Cured Catheter Regulation Number: 21 CFR 870.5050 Regulation Name: Patient Care Suction Apparatus Regulatory Class: II Product Code: DWM, PNG Dated: August 6, 2021 Received: August 16, 2021
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
1
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 of medical device-related adverse events) (21 CFR 803) for devices or post marketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Glenn B Bell, Ph.D. Director THT3A1: Renal, Gastrointestinal, Obesity and Transplantation Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210509
Device Name Rocket Platinum Cured Catheter
Indications for Use (Describe)
The Rocket IPC Platinum Cured Catheter is intermittent, long-term drainage of symptomatic, recurrent, effusion or ascites, including malignant effusion or ascites and other recurrent effusions or ascites 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.
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K210509 Page 1 of 7
Image /page/3/Picture/1 description: The image contains the logo for Rocketmedical. The logo consists of a blue icon on the left and the word "Rocketmedical" in blue text on the right. The icon appears to be a stylized letter "R" with medical symbols incorporated into its design.
Traditional 510(k) for
Rocket IPC Platinum Cured Catheter Section 05: 510(k) Summary
SECTION 5: 510(K) SUMMARY
1. SUBMITTER
| Name:
Address: | Rocket Medical Plc.
Sedling Road
Washington, Tyne & 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: | February 15th, 2021 |
2. DEVICE
| Trade Name: | Rocket Platinum Cured Catheter |
|---|---|
| Common Name: | Rocket Platinum Cured Catheter |
| Classification | |
| Name: | Patient Care Suction Apparatus |
| Peritoneal dialysis system and accessories | |
| Classification: | Class II, 21 CFR 870.5050 |
| Class II, 21 CFR 876.5630 | |
| Product Code: | DWM |
| PNG |
4
K210509 Page 2 of 7
Image /page/4/Picture/1 description: The image shows the logo for Rocket Medical. The logo consists of a blue circle with a white "R" inside, and the word "Rocketmedical" in blue text to the right of the circle. The font is sans-serif and the text is all lowercase.
Traditional 510(k) for
Rocket IPC Platinum Cured Catheter Section 05: 510(k) Summary
3. PREDICATE DEVICE
-
3.1 The Rocket Platinum Cured Catheter is claimed to be substantially equivalent to the following
legally marketed predicate devices: -
3.1.1 Rocket Indwelling Pleural Catheter (IPC) System (K123033) & Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit (K152105).
Verification and validation of the Rocket IPC Platinum Cured Catheter was performed through extensive bench testing, sterilization, packaging and shelf life testing. Results of the testing demonstrated that the Rocket IPC Catheter design met all specifications and is adequate for its intended use. Additionally, the test results demonstrated substantial equivalence of the Rocket IPC Catheter to its predicate device:
In conclusion, the Rocket IPC Platinum Cured Catheter is substantially equivalent intended use, technological characteristics, safety, and performance in characteristics to the following legally marketed predicate device:
K123033 - Rocket Indwelling Pleural Catheter (IPC) System,
K152105 – Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
4. DEVICE DESCRIPTION
- 4.1 The pleural space consists of two thin membranes, one lining the lung and the other lining the chest wall. Draining away the fluid can help relieve breathlessness for a short period, but the fluid often builds up again. While it is possible to have repeated drainage with a chest drain insertion, this could require repeated hospital visits. The IPC is a way of allowing fluid to be drained repeatedly without the painful drainage procedures and without having to come to hospital. The Rocket IPC Platinum Cured Catheter is a fenestrated silicone drainage catheter indicated for intermittent, long-term drainage of symptomatic, recurrent, effusion or ascites, including malignant effusion or ascites and other recurrent effusions or ascites that do not respond to medical management of underlying disease. There is a polyester cuff for attachment to the patient and a silicone one-way valve to prevent collected air and fluid from migrating back into the body. The Rocket platinum Cured Catheter is used alongside the Rocket IPC drainage line and Rocket IPC bottles (these we included in the Rocket Indwelling Pleural Catheter (IPC) System (K123033) & Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit (K152105).
- 4.2 The intended patient population is patients requiring external drainage of pleural effusions or abdominal ascites (patients suffering from fluid build-up with within the pleural/peritoneal space).
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 "R" inside, with a medical cross incorporated into the "R". To the right of the logo is the text "Rocketmedical" in blue sans-serif font.
Rocket IPC Platinum Cured Catheter Section 05: 510(k) Summary
INDICATIONS FOR USE 5.
- 5.1 The Rocket IPC Platinum Cured Catheter is indicated for intermittent, long-term drainage of symptomatic, recurrent, effusion or ascites, including malignant effusion or ascites and other recurrent effusions or ascites 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.
6. COMPARISON TECHNOLOGICAL CHARACTERISTICS WITH OF THE PREDICATE DEVICE
- 6.1 The Rocket Platinum Cured Catheter has the same intended use and the same technological characteristics as the identified predicate device.
- 6.1.1 The system employs the same technologies as the identified predicate including:
- 6.1.1.1 Fenestrated silicone catheter with a one-way silicone valve mechanism to prevent the reflux of fluid or air, a polyester cuff, and a radiopaque barium sulfate stripe.
- 6.1.1.2 The catheter system uses the vacuum from a drainage bottle as a neqative pressure to remove fluid from the pleural / peritoneal space quickly and efficiently.
- 6.1.2 The system has the same technical characteristics including:
- Materials: Biocompatible Silicone tubing, polyester cuff, and 6.1.2.1 silicone adhesive is implanted in the pleural / peritoneal space.
- 6.1.2.2 Sterility Assurance Level: 1x10-6.
- 6.1.1 The system employs the same technologies as the identified predicate including:
7. PERFORMANCE DATA
- 7.1 Performance bench testing of the Rocket IPC was conducted in accordance with all applicable FDA Guidance documents and ISO standards, including:
- 7.1.1 ISO 10993-1:2009 - Biological evaluation of medical devices Part 1: Evaluation and Testing.
- ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene 7.1.2 oxide Sterilization Residuals.
- 7.1.3 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.
- 7.1.4 ASTM F1980- 07(2011): Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices batch testing.
- 7.1.5 EN 1617:1997 Sterile Drainage Catheters and Accessory Devices for Single Use.
- 7.1.6 EN 1618:1997 Catheters Other than Intravascular Catheters - Test Methods for Common Properties.
- 7.1.7 ISO 15223:2000 Medical Devices - Symbols to be used with medical device labels, labeling, and information to be supplied.
- 7.1.8 EU MDD Applicable sections of the European Medical Device Directive
6
Traditional 510(k) for
Image /page/6/Picture/1 description: The image shows the logo for Rocket Medical. The logo consists of a blue circle with a white "R" inside, with a plus sign in the upper left quadrant of the "R". To the right of the logo is the word "Rocketmedical" in blue, with the "Rocket" portion in a bolder font than the "medical" portion.
(MDD) 93/42/EEC as amended by 2007/47/EC.
- 7.1.9 EU MDR Applicable Sections of the European Medical Device Requlation (MDR) 2017/745/EU amended 2020/561.
- 7.1.10 2016 FDA Biocompatibility Guidance Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process", Guidance for Industry and Food and Drug Administration Staff, June 16, 2016.
- 7.1.11 ISO 10993-1 (2018) *Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process.
- 7.1.12 ISO 10993-2 (2006) Biological Evaluation of Medical Devices Part 2: Animal welfare requirements.
- 7.1.13 ISO 10993-3 (2014) Biological Evaluation of Medical Devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
- 7.1.14 ISO 10993-5 (2009) Biological Evaluation of Medical Devices Part 5: Tests for in vitrocytotoxicity.
- 7.1.15 ISO 10993-6 (2016) Biological Evaluation of Medical Devices Part 6: Tests for local effects after implantation.
- 7.1.16 ISO 10993-10 (2010) Biological Evaluation of Medical Devices - Part10: Tests for irritation and skin sensitization.
- 7.1.17 ISO 10993-11 (2017) Biological Evaluation of Medical Devices- Part 11: Tests for systemic toxicity.
- 7.1.18 ISO 10993-12 (2012) Biological Evaluation of Medical Devices - Part 12: Sample preparation and reference materials.
- 7.1.19 ISO 10993-17 (2002) Biological Evaluation of Medical Devices - Part 17: Establishment of allowable limits for leachable substances.
- 7.1.20 ISO 10993-18 (2020) Biological Evaluation of Medical Devices Part 18: Chemical characterization of materials.
- 7.1.21 ASTM Standard D4169 Standard Practice for Performance Testing of Shipping Containers and Systems
- 7.2 A list of Performance Testing conducted on the Rocket IPC Catheter includes:
- 7.2.1 Sterilization Validation
- 7.2.2 Biocompatibility Validation
- 7.2.3 Packaging Validation
- 7.2.4 All bench testing, unless otherwise specified, was conducted on the finished devices, which were sterilized by the final validated sterilization process.
7
Traditional 510(k) for
Image /page/7/Picture/1 description: The image shows the logo for Rocketmedical. The logo consists of a blue circle with a white cross inside, followed by the word "Rocketmedical" in blue. The font is sans-serif and the text is all lowercase except for the "R" in Rocket.
Rocket IPC Platinum Cured Catheter Section 05: 510(k) Summary
- 7.3 A Summary of Standards Based compliance testing conducted on the Rocket IPC Catheter is shown in Table 9.1 and 9.2 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 - 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 >4 mm) | 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 (73.2-73.6 cmHg) | 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 | EN1617:1997 4.6 (including Annex B) | 3 | NPD QA 1052 | 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 through the catheter in millilitres per minute | PASS |
Table 9.1: Summary of Verification Testing
8
Image /page/8/Picture/0 description: The image shows the logo for Rocket Medical. The logo consists of a blue circle with a white "R" inside, and the word "Rocketmedical" in blue text to the right of the circle. The "R" in the circle has a cross-like shape in the middle.
Rocket IPC Platinum Cured Catheter Section 05: 510(k) Summary
| Ref No. | Test Performed | Results |
|---|---|---|
| A1 584464 | MEM Elution GLP Report | PASS |
| A2 584476 | ISO Guinea Pig Maximization Sensitization Test | Did not elicit a |
| sensitization | ||
| response | ||
| A3 584477 | ISO Intracutaneous Reactivity Test | PASS |
| A4 584454 | ISO Acute Systemic injection Test | PASS |
| A5 584455 | Rabbit Pyrogen Test (Material Mediated) ISO | Requirements Met |
| A6 584456 | Subacute 14-day Intra Peritoneal Toxicity Study in | |
| Mice | PASS | |
| A7 584465 | The Salmonella Typhimurium Reverse Mutation | |
| Assay | Non-Mutagenic | |
| A8 584466 | Chromosome Aberration Assay | PASS |
| A9 584462 | In Vivo Mouse Micronucleus Assay | Non-Mutagenic |
| A10 584463 | In Vitro Mouse Lymphoma Assay | Non-Mutagenic |
| A11 584453 | Intramuscular Implant Test Thirteen Week Duration | Non-Irritant |
| A12 584452 | Intramuscular Implant Test Six Month Duration | No-Irritant |
| 19T 35058-11, | ||
| 12, 13 | Chemical Characterization | Refer to Test |
| 267037 | RA Final Evaluation of Local Tissue Effects of | |
| ZASEM222 Catheter Assembly following | ||
| intramuscular Implantation in the Rabbit. | ||
| (ZASEM222 is now renamed as ZASEM297). | Refer to Test | |
| UK000326 - | ||
| Rev 1 | Biological Risk Assessment, ZASEM222 Platinum | |
| Cured Silicone Catheter including ZDLTR043 Steel | ||
| Dilator). | Refer to Test | |
| 54400-16-MT Transport Study Report J15474-TX-1 | ||
| EtO Residual Test Reports IPC | Original Catheter in | |
| substantial | ||
| equivalence 510k |
Table 9.2: Summary of Further Testing Performed
9
Image /page/9/Picture/0 description: The image shows the logo for Rocket Medical. The logo consists of a blue circle with a white stylized "R" inside, followed by the text "Rocketmedical" in blue. The font is sans-serif and the text is all lowercase.
K210509 Page 7 of 7 Traditional 510(k) for
Rocket IPC Platinum Cured Catheter Section 05: 510(k) Summary
CONCLUSIONS 8
K152033 - The technology characteristics of the Rocket Medical IPC system are slightly different in the following ways. Although the premise of inserting a silicone catheter to drain pleural fluid and the technique of insertion are identical to the Pleurx version, the one-way valve design itself is slightly different, however the performance and its intended use are identical. The way the catheters are connected differs in that the Pleurx catheter has a push fit system, whereas the Rocket Medical system has a push fit and bayonet cap to ensure that dislocation does not occur. Verification and validation of the Rocket IPC System 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. Additionally, the test results demonstrated substantial equivalence of the Rocket IPC to its predicate device: In conclusion, the Rocket IPC is substantially equivalent in intended use, technological characteristics, safety, and performance characteristics to the following legally marketed predicate device: PleurX Pleural Catheter System (K112831), manufactured by CareFusion
K152105 - 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.