(73 days)
Not Found
No
The document describes a physical medical device (catheter and accessories) and its intended use for drainage. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is used for "intermittent drainage of symptomatic, recurrent malignant ascites" and "palliation of symptoms related to recurrent malignant ascites," which are therapeutic actions to manage a medical condition.
No
The device is described as an "Indwelling Peritoneal Catheter (IPC) Insertion Kit" used for "intermittent drainage of symptomatic, recurrent malignant ascites" and "palliation of symptoms." Its function is drainage, not diagnosis.
No
The device description clearly lists physical components such as a catheter, drainage line, and accessories for insertion, attachment, and dressing, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the "intermittent drainage of symptomatic, recurrent malignant ascites" and "palliation of symptoms related to recurrent malignant ascites." This describes a therapeutic or palliative intervention performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a "fenestrated silicone drainage catheter" designed for "drainage of peritoneal ascites." This is a physical device used to remove fluid from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is a medical device used for drainage, not an IVD.
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
The Rocket Indwelling Peritoneal Catheter (IPC) is a fenestrated silicone drainage catheter intended for the drainage of peritoneal ascites. The catheter has 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 consists of the IPC, drainage line and accessories for insertion, attachment and dressing. In addition, the Rocket IPC Insertion Kit contains currently licensed 1% lidocaine (5 mL x 3) and DuraPrep (6 mL x 2).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal
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)
Resistance to deformation; force at break- connections; force at break- drainage catheters and all other parts; freedom from leakage
Biocompatibility: Cytotoxicity, sensitization, irritation, system toxicity, subchronic toxicity, genotoxicity, implantation, exhaustive extraction, summary report and biological risk assessment
Sterility: SAL 106
Sterilization Method: EtO
Shelf life: 3 years
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.
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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 stylized caduceus symbol, which features three abstract human figures in profile, arranged in a row. The figures are connected by flowing lines, creating a sense of unity and continuity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 14, 2016
Rocket Medical PLC % Tracy Charlton Regulatory Affairs Manager Rocket Medical PLC 2-4 Sedling Rd. Washington, Tyne and Wear NE38 9BZ UK
Re: K162457
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: September 1, 2016 Received: September 2, 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. 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Tracy Charlton
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
In addition, we have determined that your device kit contains Lidocaine and DuraPrep™ which are subject to regulation as drugs.
Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:
Director, Division of Drug Labeling Compliance Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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.
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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, Joyce M. Whang -S
for 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
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Indications for Use
510(k) Number (if known)
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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5 – 510(k) Summary
| Submitter: | Rocket Medical Plc.
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: | September 1, 2016 | | |
| Trade Name: | Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit | | |
| Classification: | Class II
Peritoneal dialysis system and accessories
21 CFR 876.5630 | | |
| Product Code: | PNG | | |
| Predicate
Device(s): | The subject device is equivalent to the following device:
◦ Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit; (Rocket
Medical Plc, K152105) | | |
| Device
Description: | The Rocket Indwelling Peritoneal Catheter (IPC) is a fenestrated silicone
drainage catheter intended for the drainage of peritoneal ascites. The
catheter has 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 consists of the IPC, drainage line and accessories for
insertion, attachment and dressing. In addition, the Rocket IPC Insertion Kit
contains currently licensed 1% lidocaine (5 mL x 3) and DuraPrep (6 mL x
2). | | |
| 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. | | |
| Substantial
Equivalence: | Parameter | Subject Device
Rocket Indwelling Peritoneal
Catheter (IPC) Insertion Kit | Predicate Device
Rocket Indwelling
Peritoneal Catheter (IPC)
Insertion Kit |
| | 510(k) Number | TBD | K152105 |
| | Classification | Class II | Same |
| | Product Code | PNG | Same |
| | Regulation | 21 CFR 876.5630 | Same |
| | 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. | Same |
| | Kit Components
and Accessories | Identical to predicate except also
contains currently licensed
Lidocaine (5mL x 3) and DurePrep
(6 mL x 2) | IPC Catheter, drainage line
and accessories for insertion,
attachment and dressing |
| | Kits | Model # R51401-16-PT and
R51401-MI-PT | Same |
| | Performance | Resistance to deformation; force at
break- connections; force at break-
drainage catheters and all other
parts; freedom from leakage | Same |
| | Biocompatibility | Cytotoxicity, sensitization,
irritation, system toxicity,
subchronic toxicity, genotoxicity,
implantation, exhaustive
extraction, summary report and
biological risk assessment | Same |
| | Packaging
components and
materials | APET tray, blue field wrap,
uncoated Tyvek 1073B/PET
pouch, folding carton | Same |
| | Sterility | SAL 106 | Same |
| | Sterilization
Method | EtO | Same |
| | Shelf life | 3 years | Same |
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