(53 days)
Not Found
No
The document describes a physical medical device (catheter, needle, guidewire) and its intended use for vascular access. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies focus on physical and biological properties and adherence to standards for catheters.
No
The device is a midline catheter used to sample blood or administer fluids and is not described as having a therapeutic effect on a disease or condition.
No
Explanation: The device is intended for administering fluids and sampling blood, which are therapeutic and collection functions, not diagnostic.
No
The device description explicitly states it is a physical device consisting of an introducer needle, guidewire, and catheter. The performance studies and standards referenced are related to physical device testing and biological evaluation.
Based on the provided information, the PowerGlide™ Midline Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to be inserted into the patient's vascular system to sample blood or administer fluids intravenously. This is a direct interaction with the patient's body for therapeutic or diagnostic purposes in vivo.
- 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 the device being used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnostic purposes. IVD devices typically involve reagents, test strips, analyzers, etc., which are not described here.
Therefore, the PowerGlide™ Midline Catheter is a medical device used for in vivo procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PowerGlide™ Midline Catheter is intended to be inserted in the patient's vascular system for short term use (less than 30 days) to sample blood or administer fluids intravenously.
The PowerGlide™ 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
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JUN - 1 2012 ·
ACCESS SYSTEMS
・
510(k) Summary 21 CFR 807.92(a)
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| Submitter Name: | Bard Access Systems, Inc. | |
|---|---|---|
| Address: | 605 North 5600 West | |
| Salt Lake City, UT 84116 | ||
| General | ||
| Provisions | Contact Person: | Jessica Agnello |
| Regulatory Affairs Specialist II | ||
| Telephone Number: | (801) 522-5651 | |
| Fax Number: | (801) 522-5425 | |
| Date of Preparation: | April 6, 2012 | |
| Subject | ||
| Device | Trade Name: | PowerGlide™ Midline Catheter |
| Common Name: | Intravascular Catheter | |
| Classification Name: | Intravascular Catheter | |
| Product Code/ | ||
| Regulation: | FOZ/21 CFR §880.5200 | |
| Predicate | ||
| Devices | Predicate Trade Name: | Rapid Intravascular Catheter Start System |
| Classification Name: | Intravascular Catheter | |
| Premarket Notification: | K112347 | |
| Manufacturer: | Vascular Pathways, Inc. | |
| Predicate Trade Name: | PowerWand Safety Introducer | |
| with an Extended Dwell Catheter | ||
| Classification Name: | Catheter Introducer | |
| Premarket Notification: | K101422 | |
| Manufacturer: | Access Scientific, Inc. | |
| Predicate Trade Name: | BD Nexiva Closed IV Catheter System | |
| Classification Name: | Intravascular Catheter | |
| Premarket Notification: | K102520 | |
| Manufacturer: | Becton Dickinson, Inc. |
: 上
. V ું તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્
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| | Device
Description | Bard Access Systems, Inc.'s PowerGlide™ 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 ( · '
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem is a symbol of an abstract eagle or bird-like figure, with three curved lines representing its wings or feathers.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
C.R. Bard, Incorporated Ms. Jessica Agnello Regulatory Affairs Specialist II Bard Access Systems, Incorporated 605 North 5600 West Salt Lake City, Utah 84116
JUN - 1 2012
Re: K121073
Trade/Device Name: PowerGlide Midline Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: April 6, 2012 Received: April 9, 2012
Dear Ms. Agnello:
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- Ms. Agnello
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and · Radiological Health
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Image /page/6/Picture/0 description: The image shows the logo for BARD ACCESS SYSTEMS. The word "BARD" is in large, bold, sans-serif font. Below the word "BARD" is the phrase "ACCESS SYSTEMS" in a smaller, sans-serif font. The logo is in black and white.
Indications for Use
510(k) Number (if known):
Device Name:
PowerGlide™ Midline Catheter
Indications for Use:
The PowerGlide™ Midline Catheter is inserted into a patient's vascular system for short-term use ( (Part 21 CFR §801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR §801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off) 5/30/12
Division of Anesthesiology, General Hospital Infestion Control, Dental Devices
510(k) Number: