(29 days)
The CATHTONGTM II PICC Catheter is intended for short or long-term peripheral access to the central yenous system for infusion, intravenous therapy, blood sampling, power injection of contrast media, the administration of fluids, medications and nutrients, and allows for central venous pressure monitoring. The maximum recommended infusion rate is 3.0 mL/sec for 3F and 5.0 mL/sec for 4F single lumen catheters. The maximum pressure of power injection with the CATHTONG™ II PICC Catheter may not exceed 325 psi. The CATHTONG™ II PICC Catheter is indicated for adult patients.
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The provided text is an FDA 510(k) clearance letter for the CATHTONG™ II PICC Catheter. It does not contain information about acceptance criteria, device performance studies, or the methodologies for establishing ground truth, sample sizes, or expert qualifications as typically found in a clinical study report or a detailed summary of safety and effectiveness.
The document primarily focuses on the regulatory clearance process, stating that the device is substantially equivalent to legally marketed predicate devices. It lists the "Indications for Use" for the catheter and provides specific maximum flow rates and injection limits for different catheter sizes (3F and 4F single lumen) and a maximum pressure of power injection (325 psi). These specifications look like they are part of the acceptance criteria that need to be met by the device.
To answer your request, a study proving the device meets these acceptance criteria would typically involve:
- Bench testing: To verify the flow rates and pressure limits under various conditions.
- Biocompatibility testing: To ensure the materials are safe for human contact.
- Sterilization validation: To confirm the sterility assurance level.
- Performance testing: To demonstrate the catheter's ability to maintain patency and integrity under simulated use.
- Clinical data (if required for substantial equivalence): This could involve a review of existing data of the predicate devices or, in some cases, limited clinical data if the technological characteristics are significantly different.
Since the provided text is only the FDA's clearance letter, these details are not available within the given document. Therefore, I am unable to fill out the table and provide the requested information about the study design, sample sizes, ground truth establishment, expert qualifications, or MRMC data.
The document only provides the following directly relevant to acceptance criteria, which appear to be performance specifications:
| Catheter Size | Maximum Flow Rate | Injection Limit Setting | Reported Device Performance |
|---|---|---|---|
| 3F Single Lumen | 3.0 mL/sec | 325 psi | 3.0 mL/sec (specified) |
| 4F Single Lumen | 5.0 mL/sec | 325 psi | 5.0 mL/sec (specified) |
| All Catheters | - | 325 psi | 325 psi (specified) |
All other requested information is not present in the provided text.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 3, 2017
L&Z US, Inc. Jenella Coutts Director of Regulatory Affairs 6 Horizon Road Fort Lee. New Jersev 07024
Re: K172039
Trade/Device Name: CATHTONGTM II PICC Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: June 27, 2017 Received: July 5, 2017
Dear Jenella Coutts:
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
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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.
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,
James P. Bertram -S
for
Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K172039
R1/265
Device Name CATHTONG™ II PICC Catheter
Indications for Use (Describe)
The CATHTONGTM II PICC Catheter is intended for short or long-term peripheral access to the central yenous system for infusion, intravenous therapy, blood sampling, power injection of contrast media, the administration of fluids, medications and nutrients, and allows for central venous pressure monitoring. The maximum recommended infusion rate is 3.0 mL/sec for 3F and 5.0 mL/sec for 4F single lumen catheters. The maximum pressure of power injection with the CATHTONG™ II PICC Catheter may not exceed 325 psi. The CATHTONG™ II PICC Catheter is indicated for adult patients.
| Catheter Size | Maximum Flow Rate | Injection Limit Setting |
|---|---|---|
| 3F Single Lumen | 3.0 mL/sec | 325 psi |
| 4F Single Lumen | 5.0 mL/sec | 325 psi |
| 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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§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”