(29 days)
Not Found
No
The summary describes a physical medical device (catheter) and its mechanical properties and performance. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a catheter used for sampling blood and administering fluids, which are supportive functions rather than direct therapeutic actions for a disease or condition.
No
Explanation: The provided text describes the PowerGlide Pro™ Midline Catheter as a device for sampling blood and administering fluids, not for diagnosing conditions. Its listed uses and performance studies focus on physical properties and biocompatibility for fluid management, not diagnostic capabilities.
No
The device description clearly outlines physical components such as an introducer needle, guidewire, and catheter, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "sample blood or administer fluids intravenously." This is a direct interaction with the patient's vascular system for therapeutic or diagnostic sampling purposes, not for testing samples in vitro (outside the body).
- Device Description: The description details a catheter, introducer needle, and guidewire, all components used for accessing the vascular system in vivo.
- Lack of IVD Characteristics: There is no mention of reagents, assays, or any process for analyzing biological samples in vitro. The performance studies focus on the physical and biological compatibility of the catheter itself, not on the accuracy or performance of a diagnostic test.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo to access the body.
N/A
Intended Use / Indications for Use
The PowerGlide Pro™ Midline Catheter 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).
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three human profiles facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 22, 2016
C. R. Bard, Inc. Mr. Jacob Lee Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116
Re: K162377
Trade/Device Name: PowerGlide Pro™ Midline Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: August 22, 2016 Received: August 24, 2016
Dear Mr. Jacob Lee:
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 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 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/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 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,
Tina
Kiang -S
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
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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)
Device Name PowerGlide Pro Midline Catheter
Indications for Use (Describe)
The PowerGlide Pro Midline Catheter is inserted into a patient's vascular system for short-term use ( Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
21 CFR 807.92(a)
| General
Provisions | Submitter Name:
Submitter Address:
Contact Person:
Telephone Number:
Fax Number:
Date of Preparation: | Bard Access Systems, Inc.
605 North 5600 West
Salt Lake City, UT 84116
Jacob Lee
Regulatory Affairs Specialist
(801) 522-5823
(801) 522-5425
September 14, 2016 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject
Device | Trade Name:
Common Name:
Regulation Name:
Product Code:
Regulation:
Regulatory Class:
Classification Panel: | PowerGlide Pro™ Midline Catheter
Intravascular Catheter
Intravascular Catheter
FOZ
21 CFR § 880.5200
II
General Hospital |
| Predicate
Device | Predicate Trade Name:
Premarket Notification:
Manufacturer:
Common Name:
Regulation Name:
Product Code:
Regulation:
Regulatory Class:
Classification Panel: | PowerGlide Pro™ Midline Catheter
K153280 (cleared June 2, 2016)
Bard Access Systems, Inc.
Intravascular Catheter
Intravascular Catheter
FOZ
21 CFR § 880.5200
II
General Hospital |
| Device
Description | The PowerGlide Pro™ Midline Catheter is a sterile, single use device
designed to provide access to the patient's vascular system. The device is
intended for short term use (