(101 days)
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No
The provided 510(k) summary describes a PICC catheter and its intended use, without any mention of AI, ML, image processing, or performance studies typically associated with AI/ML-powered devices.
Yes
The device is described as a PICC (Peripherally Inserted Central Catheter) Catheter intended for various medical therapies and procedures such as infusion, intravenous therapy, administration of medications and nutrients, and central venous pressure monitoring, all of which fall under therapeutic interventions.
No
The CATHTONG™ II PICC Catheter is intended for infusion, intravenous therapy, blood sampling, power injection of contrast media, and administration of substances, not for diagnosing medical conditions. While it allows for central venous pressure monitoring, that is an input to diagnosis rather than a diagnostic output of the device itself.
No
The device description explicitly states "CATHTONG™ II PICC Catheter," indicating a physical catheter, which is a hardware component. The intended use also describes a physical device for accessing the central venous system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for accessing the central venous system for various therapeutic and monitoring purposes (infusion, blood sampling, power injection, etc.). This is a direct interaction with the patient's circulatory system.
- IVD Definition: In vitro diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
The CATHTONG™ II PICC Catheter is a medical device used in vivo (within the living body) for direct patient care, not for analyzing samples in vitro.
N/A
Intended Use / Indications for Use
The CATHTONG™ II PICC Catheter is intended for short or long-term peripheral access to the central venous 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 2.5 mL/sec for 4F and 5.0 mL/sec for 5F dual 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.
The CATHTONG™ II PICC Catheter is indicated for adult patients.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
central venous system
peripheral access
Indicated Patient Age Range
adult patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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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.”
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 25, 2017
L&Z US, Inc. Jenella Coutts, MPH Director of Regulatory Affairs 6 Horizon Road Fort Lee, New Jersey 07024
Re: K170486
Trade/Device Name: Cathtong™ 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: April 21, 2017 Received: April 26, 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.
1
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,
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Tina Kiang, Ph.D. 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) K170486
Device Name CATHTONG™ II PICC Catheter
Indications for Use (Describe)
The CATHTONG™ II PICC Catheter is intended for short or long-term peripheral access to the central venous 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 2.5 mL/sec for 4F and 5.0 mL/sec for 5F dual 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 |
|---|---|---|
| 4 F Dual Lumen | 2.5 mL/sec | 325 psi |
| 5 F Dual Lumen | 5.0 mL/sec | 325 psi |
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 201 Subpart D) | ☐ Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------- | ----------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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