POWERGLIDE MIDLINE CATHETER

K133856 · C.R. Bard, Inc. · FOZ · Jan 16, 2014 · General Hospital

Device Facts

• Record ID: K133856
• Device Name: POWERGLIDE MIDLINE CATHETER
• Applicant: C.R. Bard, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Jan 16, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

PowerGlide® Midline Catheter is a sterile, single-use intravascular catheter for short-term (<30 days) vascular access. Device components include an introducer needle with a passive safety mechanism, a guidewire, and a single-lumen catheter rated for power injection. Available in 18G (8cm or 10cm) and 22G (8cm) sizes. Used by clinicians in clinical settings to sample blood or administer intravenous fluids. The device provides a pathway for fluid delivery or blood withdrawal; the safety mechanism on the introducer needle is designed to reduce sharps injury risk. Benefits include reliable vascular access for patients requiring short-term therapy.

Clinical Evidence

Bench testing only. Performance evaluated per 21 CFR §820.30 using established standards including ISO 10555-1/5 (catheter requirements), ISO 11070 (introducer), ISO 23908/23907 (sharps protection), and ISO 10993 (biocompatibility). Testing confirmed device met all predetermined acceptance criteria for mechanical integrity, radiopacity (ASTM F640), and sterilization (ISO 11135).

Technological Characteristics

Single-lumen intravascular catheter; 18G and 22G sizes. Materials include stainless steel needle tubing (ISO 9626). Features passive safety mechanism for sharps injury protection (ISO 23908). Includes luer taper fittings (ISO 594-1/2). Radiopaque. Sterilized via ethylene oxide (ISO 11135). Rated for power injection.

Indications for Use

Indicated for any patient population requiring short-term (<30 days) vascular access for blood sampling or intravenous fluid administration, contingent upon adequate vascular anatomy and procedural appropriateness. Suitable for use with power injectors.

Regulatory Classification

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.

Predicate Devices

• PowerGlide® Midline Catheter (K121073)

Submission Summary (Full Text)

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K183856

. JAN 16 2014

Image /page/0/Picture/2 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 text "ACCESS SYSTEMS" in a smaller, sans-serif font. The logo is black and white.

## 510(k) Summary
21 CFR 807.92

| | Submitter Name: | Bard Access Systems, Inc. |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| | Submitter Address: | 605 North 5600 West<br>Salt Lake City, UT 84116 |
| General<br>Provisions | Contact Person: | Casey Coombs<br>Regulatory Affairs Specialist |
| | Telephone Number: | [phone] |
| | Fax Number: | [phone] |
| | Date of Preparation: | December 17, 2013 |
| Subject<br>Device | Trade Name: | PowerGlide® Midline Catheter |
| | Common Name: | Intravascular Catheter |
| | Classification Name: | Intravascular Catheter |
| | Product Code/<br>Regulation: | FOZ/21 CFR §880.5200 |
| Predicate<br>Device | Predicate Trade Name: | PowerGlide® Midline Catheter |
| | Classification Name: | Intravascular Catheter |
| | Premarket Notification: | K121073 |
| | Manufacturer: | Bard Access Systems, Inc. |
| Device<br>Description | Bard Access Systems, Inc.'s PowerGlide® Midline Catheter is a sterile,<br>single use device designed to provide access to the patient's vascular<br>system. The device is intended for short term use (<30 days) to sample<br>blood and administer fluids intravenously. The device consists of an<br>introducer needle with a passive safety mechanism, guidewire, and<br>single lumen catheter rated for power injection. The PowerGlide®<br>Midline Catheter is available in 18 and 22 gauge sizes. The 18 gauge<br>size is available in 8cm or 10cm lengths and the 22 gauge size is<br>available in only an 8cm length. | |

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| 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

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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

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## 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.

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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Indications for Use

510(k) Number (if known):

K133856

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'