(203 days)
No
The description focuses on the physical components and intended use of a catheter, with no mention of AI or ML capabilities.
No.
The device is used to sample blood or administer fluids intravenously, which are diagnostic and supportive functions, not directly therapeutic.
No
This device is a midline catheter used for sampling blood and administering fluids, not for diagnosing conditions. While it can collect blood samples, the device itself doesn't perform diagnosis.
No
The device description clearly outlines physical components such as a catheter, introducer needle, and guidewire, 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 "inserting into a patient's vascular system for short-term use (
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).
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus-like symbol with three intertwined figures representing human profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 2, 2016
C. R. Bard, Inc. Mr. Casey Coombs Regulatory Affairs Specialist II Bard Access Systems, Inc. 605 North 5600 West Salt Lake City, Utah 84116
Re: K153280
Trade/Device Name: PowerGlide Pro™ Midline Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: April 29, 2016 Received: May 2, 2016
Dear Mr. Coombs:
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 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,
Tina Kiang -
for 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
Enclosure
2
Indications for Use
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 ( 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."
3
Image /page/3/Picture/0 description: The image contains the logo for BARD ACCESS SYSTEMS. The word "BARD" is in large, bold, sans-serif font, with a stylized "A" that resembles an upside-down "V". Below "BARD" is the text "ACCESS SYSTEMS" in a smaller, sans-serif font. The logo is black and white.
510(k) Summary
21 CFR 807.92(a)
| | Submitter Name:
Address: | Bard Access Systems, Inc.
605 North 5600 West
Salt Lake City, UT 84116 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| General
Provisions | Contact Person:
Telephone Number:
Fax Number:
Date of Preparation: | Mr. Casey Coombs
(801) 522-5869
(801) 522-5425
1 June 2016 |
| Subject
Device | Trade Name:
Common Name:
Classification Name:
Product Code:
Regulation: | PowerGlide Pro™ Midline Catheter
Intravascular Catheter
Intravascular Catheter
FOZ
21 CFR § 880.5200 |
| Predicate
Device | Predicate Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | PowerGlide™ Midline Catheter
Intravascular Catheter
K133856
Bard Access Systems, Inc. |
| Reference
Device | Reference Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | PowerGlide™ Midline Catheter
Intravascular Catheter
K121073
Bard Access Systems, Inc. |
| Device
Description | Bard Access Systems, Inc.'s 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 (