(28 days)
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 (<30 days) to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerGlide® Midline Catheter is suitable for use with power injectors.
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 (<30 days) to sample blood and administer fluids intravenously. The device consists of an introducer needle with a passive safety mechanism, guidewire, and single lumen catheter rated for power injection. The PowerGlide® Midline Catheter is available in 18 and 22 gauge sizes. The 18 gauge size is available in 8cm or 10cm lengths and the 22 gauge size is available in only an 8cm length.
The provided text does not contain information about an AI/ML device or a study proving its performance through clinical trials or a specific test set with ground truth established by experts.
The document is a 510(k) summary for the PowerGlide® Midline Catheter, a medical device that received clearance in January 2014. This is a traditional medical device, not an AI/ML product.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or types of ground truth used, as these details are specific to the evaluation of AI/ML software.
The document states that:
- "Verification and validation activities were designed and performed in accordance with Design Controls as per 21 CFR §820.30."
- Various guidance documents and standards were used to determine appropriate evaluation methods (listed in section {2}).
- "The subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device."
- Substantial equivalence was determined "Based on the indications for use, technological characteristics, and safety and performance testing".
This indicates that the device met pre-defined engineering and performance specifications based on established medical device standards and comparisons to a predicate device (K121073), which is the standard pathway for 510(k) clearance of non-AI/ML devices. There is no information about a "study that proves the device meets the acceptance criteria" in the context of an AI/ML product's performance evaluation.
{0}------------------------------------------------
. JAN 16 2014
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510(k) Summary
21 CFR 807.92
| Submitter Name: | Bard Access Systems, Inc. | |
|---|---|---|
| Submitter Address: | 605 North 5600 WestSalt Lake City, UT 84116 | |
| GeneralProvisions | Contact Person: | Casey CoombsRegulatory Affairs Specialist |
| Telephone Number: | (801) 522-5869 | |
| Fax Number: | (801) 522-5425 | |
| Date of Preparation: | December 17, 2013 | |
| SubjectDevice | Trade Name: | PowerGlide® Midline Catheter |
| Common Name: | Intravascular Catheter | |
| Classification Name: | Intravascular Catheter | |
| Product Code/Regulation: | FOZ/21 CFR §880.5200 | |
| PredicateDevice | Predicate Trade Name: | PowerGlide® Midline Catheter |
| Classification Name: | Intravascular Catheter | |
| Premarket Notification: | K121073 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| DeviceDescription | Bard Access Systems, Inc.'s PowerGlide® Midline Catheter is a sterile,single use device designed to provide access to the patient's vascularsystem. The device is intended for short term use (<30 days) to sampleblood and administer fluids intravenously. The device consists of anintroducer needle with a passive safety mechanism, guidewire, andsingle lumen catheter rated for power injection. The PowerGlide®Midline Catheter is available in 18 and 22 gauge sizes. The 18 gaugesize is available in 8cm or 10cm lengths and the 22 gauge size isavailable in only an 8cm length. |
{1}------------------------------------------------
| Intended 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. |
|---|---|
| Indications For Use | The PowerGlide® Midline Catheter is inserted into a patient's vascular system for short-term use (<30 days) to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerGlide® Midline Catheter is suitable for use with power injectors. |
| Technological Characteristics | Technological characteristics of the subject PowerGlide® Midline Catheter are substantially equivalent with respect to basic design and function to those of the cited predicate device. The differences are not critical to the intended use of the device and do not raise any new questions regarding safety or effectiveness. |
and the comments of the comments of the comments of
and the control control of the control of the control of
{2}------------------------------------------------
Verification and validation activities were designed and performed in accordance with Design Controls as per 21 CFR §820.30. The following guidance documents and standards in conjunction with inhouse protocols were used to determine appropriate methods for evaluating the performance of the device:
- · Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995
- · BS EN ISO 10555-1: 2009, Sterile, single-use intravascular catheters, Part 1: General requirements
- · ISO 10555-5: 1996, Sterile, single-use intravascular catheters, Part 5: Over-needle peripheral catheters
- · ISO 11070: 1998. Sterile, single use intravascular catheter introducer
- · Coronary and Cerebrovascular Guidewire Guidance, January 1995
- · ISO 594-1: 1986. Conical fittings with 6% luer taper for syringes, needles and certain other medical equipment - Part 1: General Requirements
- · ISO 594-2: 1998, Conical fittings with 6% luer taper for svringes, needles and certain other medical equipment - Part 2: Lock Fittings
- · ISO 9626: 2001, Stainless steel needle tubing for the manufacturer of medical devices
- · ISO 23908: 2011, Sharps injury protection
- · ISO 7864: 1993, Sterile hypodermic needles for single use
- · ISO 23907: 2012. Sharps injury protection Requirements and test methods - Sharps containers - First Edition
- FDA Guidance: Medical Devices with Sharps Injury Prevention Features, August 9, 2005
- · AAMI/ANSI/ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile
- · #G95-1: Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
- · AAMI/ANSI/ISO 10993-7:2008, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals
- · AAMI/ANSI/ISO 11135:2007, Medical Devices Validation and Routine Control of Ethylene Oxide Sterilization
- · ASTM F640 (reapproved 2000), Standard Test Methods for Radiopacity of Plastics for Medical Use
- · Design Control Guidance for Medical Device Manufacturers, March 11, 1997
The subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device.
Safety & Performance Tests
18
{3}------------------------------------------------
Summary of Substantial Equivalence
Based on the indications for use, technological characteristics, and safety and performance testing, the subject PowerGlide® Midline Catheter meets the requirements that are considered sufficient for its intended use and demonstrates that the subject device is substantially equivalent to the predicate device cited.
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo of the Department of Health & Human Services - USA. The logo features a stylized human figure with three wavy lines representing the body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
January 16, 2014
Bard Access Systems, Incorporated Ms. Casey Coombs Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, UT 84116
Re: K133856
Trade/Device Name: PowerGlide® Midline Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: December 17, 2013 Received: December 19, 2013
Dear Ms. 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.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
{5}------------------------------------------------
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 (OS) 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/Resourcesfor You/Industry/default.htm.
Sincerely vours,
Image /page/5/Picture/8 description: The image contains the text "Kwame Ulmer-S". The text is arranged in two lines, with "Kwame" on the top line and "Ulmer-S" on the bottom line. There is also a logo or symbol to the right of the text, which appears to be a combination of geometric shapes and lines.
for
Erin 1. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
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 shortterm use (<30 days) to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerGlide® Midline Catheter is suitable for use with power injectors.
Prescription 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)
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Mary S. Runner -S
Susan Runner DDS, MA 2014.01.15
15:12:52 -05'00'
§ 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).