(157 days)
No
The description focuses on the mechanical design and function of a catheter system, with no mention of AI or ML capabilities.
Yes
The device is used to administer fluids intravenously, sample blood, and monitor blood pressure, all of which are diagnostic or treatment functions, thus qualifying it as a therapeutic device.
No
The device is primarily used for sampling blood, monitoring blood pressure, and administering fluids. While monitoring blood pressure and sampling blood can be part of diagnostic processes, the device itself does not perform any analysis or interpretation leading to a diagnosis. It is a tool for obtaining samples or measurements, not a diagnostic instrument.
No
The device description clearly details physical components such as a catheter, guidewire, needle, and handle, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "sampling blood, monitor blood pressure, and administer fluids intravenously." These are all procedures performed on the patient's vascular system, not on samples outside the body for diagnostic purposes.
- Device Description: The description focuses on the physical characteristics of the catheter and its insertion into the patient's vascular system. There is no mention of analyzing biological samples or performing tests on them.
- Lack of IVD Characteristics: The text does not mention any components or functions typically associated with IVDs, such as reagents, assays, or analysis of biological markers.
Therefore, the AccuCath® Midline Catheter System is a medical device used for direct patient care within the vascular system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AccuCath® Midline Catheter System is a midline catheter that is inserted into a patient's vascular system for short term use (
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 8,2015
Vascular Pathways, Inc. Mr. Scott Pease Vice President Regulatory Affairs and Quality Assurance 1847 Trade Center Way Naples, Florida 34109
Re: K142136
Trade/Device Name: AccuCath® Midline Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: November 20, 2014 Received: November 24, 2014
Dear Mr. Pease:
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.
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Page 2 - Mr. Pease
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 device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Susan Runno, DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K142136
Device Name
AccuCath® Midline Catheter System
Indications for Use (Describe)
The AccuCath® Midline Catheter System is a midline catheter that is inserted into a patient's vascular system for short term use ( 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."
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510(k) SUMMARY
AccuCath® Midline Catheter System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Vascular Pathways, Inc. 1847 Trade Center Way Naples, FL 34109
Cell: 678-689-8010 Office: 239-254-0391 Fax: 239-513-1533
Contact Person: Scott Pease, VP of Regulatory Affairs and Quality Assurance (spease@vascularpathways.com)
Date Prepared: July 31, 2014
| Name of Device | AccuCath® Midline Catheter System |
|---|---|
| ---------------- | ----------------------------------- |
Classification Name Intravascular Catheter
Product Code / Regulation FOZ / 21 CFR § 880.5200
Classification Class 2
Predicate Devices
Bard Access PowerGlide™ Device (K121073) Vascular Pathways, Inc., AccuCath® BC Intravascular Catheter System (K140504)
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Indications for Use
The AccuCath® Midline Catheter System is a midline catheter that is inserted into a patient's vascular system for short term use (