POWERGLIDE MIDLINE CATHETER

K121073 · C.R. Bard, Inc. · FOZ · Jun 1, 2012 · General Hospital

Device Facts

• Record ID: K121073
• Device Name: POWERGLIDE MIDLINE CATHETER
• Applicant: C.R. Bard, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Jun 1, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

PowerGlide™ Midline Catheter provides short-term (<30 days) vascular access for blood sampling and intravenous fluid administration. Device includes introducer needle with passive safety mechanism, guidewire, and single-lumen catheter rated for power injection. Available in 20 gauge, 8cm or 10cm lengths. Used in clinical settings by healthcare professionals. Placement technique mirrors predicate devices. Passive safety mechanism reduces needlestick risk. Power injection capability allows for contrast media delivery. Benefits include reliable vascular access and improved safety for clinicians during insertion.

Clinical Evidence

Bench testing only. Performance evaluated per ISO 10555-1, ISO 10555-5, ISO 11070, ISO 594-1/2, ISO 9626, ISO 23908, ISO 7864, and ASTM F640-79. Biological evaluation conducted per ISO 10993-1 and ISO 10993-7. Sterilization validated per ISO 11135. All predetermined acceptance criteria met.

Technological Characteristics

Sterile, single-use, 20-gauge single-lumen catheter. Includes introducer needle with passive safety mechanism and guidewire. Materials evaluated per ISO 10993. Radiopaque. Compatible with power injectors. Sterilized via ethylene oxide per ISO 11135. Conforms to ISO 594-1/2 luer standards.

Indications for Use

Indicated for patients requiring short-term (<30 days) vascular access for blood sampling or intravenous fluid administration. Suitable for any patient population based on vascular anatomy and procedure appropriateness. Compatible 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

• Rapid Intravascular Catheter Start System (K112347)
• PowerWand Safety Introducer with an Extended Dwell Catheter (K101422)
• BD Nexiva Closed IV Catheter System (K102520)

Submission Summary (Full Text)

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K121073

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JUN - 1 2012 ·

# ACCESS SYSTEMS

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## 510(k) Summary 21 CFR 807.92(a)

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| | Submitter Name: | Bard Access Systems, Inc. |
|-----------------------|------------------------------|----------------------------------------------------------------|
| | Address: | 605 North 5600 West<br>Salt Lake City, UT 84116 |
| General<br>Provisions | Contact Person: | Jessica Agnello<br>Regulatory Affairs Specialist II |
| | Telephone Number: | [phone] |
| | Fax Number: | [phone] |
| | Date of Preparation: | April 6, 2012 |
| 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>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<br>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. |

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. 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<br>Description | Bard Access Systems, Inc.'s PowerGlide™ Midline Catheter is a sterile, single<br>use device designed to provide access to the patient's vascular system. The<br>device is intended for short term use (<30 days) to sample blood and<br>administer fluids intravenously, and employs a placement technique similar to<br>the predicate devices. The device consists of an introducer needle with a<br>passive safety mechanism, guidewire, and single lumen catheter rated for<br>power injection. The PowerGlide™ Midline Catheter is 20 gauge and is<br>available in 8cm or 10cm lengths. |
|--|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Intended Use | The PowerGlide™ Midline Catheter is intended to be inserted in the patient's<br>vascular system for short term use (less than 30 days) to sample blood or<br>administer fluids intravenously. |
| | Indications For<br>Use | The PowerGlide™ Midline Catheter is inserted into a patient's vascular system<br>for short-term use (<30 days) to sample blood or administer fluids<br>intravenously. These catheters may be used for any patient population with<br>consideration given to adequacy of vascular anatomy and appropriateness of<br>the procedure. The PowerGlide™ Midline Catheter is suitable for use with<br>power injectors. |
| | Technological<br>Characteristics | Technological characteristics of the subject PowerGlide™ Midline Catheter are<br>substantially equivalent with respect to basic design and function to those of<br>the predicates, Rapid Intravascular Catheter Start System, PowerWand Safety<br>Introducer with an Extended Dwell Catheter, and BD Nexiva Closed IV<br>Catheter System. The differences are not critical to the intended use of the<br>device 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 [phone] or [phone] 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 (<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)

Page 1 of 1

(Division Sign-Off) 5/30/12

Division of Anesthesiology, General Hospital Infestion Control, Dental Devices

510(k) Number: