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.

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 (<30 days) to sample blood and administer fluids intravenously, and employs a placement technique similar to the predicate devices. 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 20 gauge and is available in 8cm or 10cm lengths.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the PowerGlide™ Midline Catheter, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the safety and performance testing for the PowerGlide™ Midline Catheter. It states that the device "met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate devices." However, it does not provide a specific table with numerical acceptance criteria and corresponding device performance values. Instead, it refers to compliance with various industry standards and guidance documents.

Here's a summary of the areas of performance verification mentioned:

Acceptance Criteria Area (Implied from References)	Reported Device Performance
General Catheter Requirements: (from ISO 10555-1, ISO 10555-5)	- The device met predetermined acceptance criteria for general requirements of sterile, single-use intravascular catheters.
Intravascular Catheter Introducer Requirements: (from ISO 11070)	- The device met predetermined acceptance criteria for sterile, single-use intravascular catheter introducers.
Guidewire Requirements: (from Coronary and Cerebrovascular Guidewire Guidance)	- The device met predetermined acceptance criteria for guidewire performance.
Luer Taper Fittings Requirements: (from ISO 594-1, ISO 594-2)	- The device met predetermined acceptance criteria for conical luer taper fittings.
Hypodermic Needles Requirements: (from ISO 9626, ISO 7864)	- The device met predetermined acceptance criteria for stainless steel needle tubing and sterile hypodermic needles for single use.
Sharps Injury Protection Features: (from ISO 23908, FDA Guidance: Medical Devices with Sharps Injury Prevention Features, BS 7320)	- The device met predetermined acceptance criteria for sharps injury protection features. The device description mentions a "passive safety mechanism" for the introducer needle.
Biocompatibility: (from AAMI/ANSI/ISO 10993-1, AAMI/ANSI/ISO 10993-7, #G95-1)	- The device met predetermined acceptance criteria for biological evaluation and ethylene oxide sterilization residuals.
Sterilization: (from AAMI/ANSI/ISO 11135)	- The device met predetermined acceptance criteria for ethylene oxide sterilization validation and routine control.
Radiopacity: (from ASTM F640-79)	- The device met predetermined acceptance criteria for radiopacity.
Risk Management: (from ISO 14971)	- A Failure Modes and Effects Analysis (FMEA) was conducted, and the device met predetermined acceptance criteria for risk management.
Overall Safety & Effectiveness / Substantial Equivalence:	- The device met the requirements considered sufficient for its intended use and is as safe and as effective as the cited predicate devices.

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set for performance validation studies. It only mentions that "Verification and validation tests have been performed in accordance with Design Controls as per 21 CFR §820.30."

The data provenance (country of origin, retrospective/prospective) is also not mentioned. The testing appears to be primarily bench testing and in-house validation based on compliance with international standards, rather than clinical data from human subjects.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided in the document. Given that the testing appears to be primarily bench and laboratory-based, the concept of "experts establishing ground truth for a test set" in a clinical sense (e.g., radiologist consensus) does not directly apply here. Performance was likely evaluated against engineering specifications derived from the referenced standards.

4. Adjudication Method for the Test Set

This information is not applicable and not specified. Adjudication methods are typically used in clinical studies where multiple reviewers interpret data, which is not described here.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document describes engineering and biocompatibility testing for substantial equivalence, not a clinical trial comparing human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

This question is not applicable as the device is a physical medical catheter, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the PowerGlide™ Midline Catheter was established through compliance with recognized international and national standards and guidance documents. These standards define measurable requirements (e.g., material properties, dimensional tolerances, flow rates, tensile strength, biocompatibility limits, sterilization efficacy, luer connection integrity, sharps protection effectiveness). The device's performance was measured against these predefined specifications.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical catheter, not an AI algorithm. There is no "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as the device is a physical medical catheter, not an AI algorithm. There is no "training set" or corresponding ground truth establishment for it.

Summary

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K121073

JUN - 1 2012 ·

ACCESS SYSTEMS

・

510(k) Summary 21 CFR 807.92(a)

、

	Submitter Name:	Bard Access Systems, Inc.
	Address:	605 North 5600 WestSalt Lake City, UT 84116
GeneralProvisions	Contact Person:	Jessica AgnelloRegulatory Affairs Specialist II
	Telephone Number:	(801) 522-5651
	Fax Number:	(801) 522-5425
	Date of Preparation:	April 6, 2012
SubjectDevice	Trade Name:	PowerGlide™ Midline Catheter
	Common Name:	Intravascular Catheter
	Classification Name:	Intravascular Catheter
	Product Code/Regulation:	FOZ/21 CFR §880.5200
PredicateDevices	Predicate Trade Name:	Rapid Intravascular Catheter Start System
	Classification Name:	Intravascular Catheter
	Premarket Notification:	K112347
	Manufacturer:	Vascular Pathways, Inc.
	Predicate Trade Name:	PowerWand Safety Introducerwith 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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	DeviceDescription	Bard Access Systems, Inc.'s PowerGlide™ Midline Catheter is a sterile, singleuse device designed to provide access to the patient's vascular system. Thedevice is intended for short term use (<30 days) to sample blood andadminister fluids intravenously, and employs a placement technique similar tothe predicate devices. The device consists of an introducer needle with apassive safety mechanism, guidewire, and single lumen catheter rated forpower injection. The PowerGlide™ Midline Catheter is 20 gauge and isavailable in 8cm or 10cm lengths.
	Intended Use	The PowerGlide™ Midline Catheter is intended to be inserted in the patient'svascular system for short term use (less than 30 days) to sample blood oradminister fluids intravenously.
	Indications ForUse	The PowerGlide™ Midline Catheter is inserted into a patient's vascular systemfor short-term use (<30 days) to sample blood or administer fluidsintravenously. These catheters may be used for any patient population withconsideration given to adequacy of vascular anatomy and appropriateness ofthe procedure. The PowerGlide™ Midline Catheter is suitable for use withpower injectors.
	TechnologicalCharacteristics	Technological characteristics of the subject PowerGlide™ Midline Catheter aresubstantially equivalent with respect to basic design and function to those ofthe predicates, Rapid Intravascular Catheter Start System, PowerWand SafetyIntroducer with an Extended Dwell Catheter, and BD Nexiva Closed IVCatheter System. The differences are not critical to the intended use of thedevice and do not raise any new questions regarding safety or effectiveness.

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Verification and validation tests have been performed in accordance with Design Controls as per 21 CFR §820.30. The following guidance documents and standards in conjunction with in-house 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
· 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 syringes, 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
BS 7320: 1990, Specification for sharps containers
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 F640-79 (reapproved 2000), Standard Test Methods for Radiopacity of Plastics for Medical Use
· Design Control Guidance for Medical Device Manufacturers, March 11, 1997

The subiect devices met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate devices.

Risk management, including a failure modes and effects analysis (FMEA), of the subject device was conducted in accordance with ISO 14971:2009, Medical Devices - Risk Management for Medical Devices.

Safety & Performance Tests

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Summary of Substantial Equivalence

Based on the intended use, technological characteristics, and safety and performance testing, the subject PowerGlide™ Midline Catheter met the requirements that are considered sufficient for its intended use and is as safe and as effective as predicate devices cited.

· '

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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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Indications for Use

510(k) Number (if known):

Device Name:

PowerGlide™ Midline Catheter

Indications for Use:

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)

Page 1 of 1

(Division Sign-Off) 5/30/12

Division of Anesthesiology, General Hospital Infestion Control, Dental Devices

510(k) Number:

Regulation Number and Section

§ 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).