INFUSION SET FOR POWERPICC SOLO 2 CATHETER

K102405 · C.R. Bard, Inc. · FPA · Jul 21, 2011 · General Hospital

Device Facts

• Record ID: K102405
• Device Name: INFUSION SET FOR POWERPICC SOLO 2 CATHETER
• Applicant: C.R. Bard, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jul 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Indications for Use

An extension set to be used as an extension to the intravascular administration set used for fluid delivery through Bard® proximally valved catheters. The extension set will connect the IV administration set to the catheter.

Device Story

Extension set designed for Bard proximally valved catheters; attaches to catheter hub to facilitate fluid delivery, central venous pressure monitoring, and blood sampling. Opens catheter valve upon connection. Single-use device; maximum 96-hour duration. Used in clinical settings by healthcare providers. Provides physical conduit between IV administration set and indwelling catheter; ensures secure connection via ISO-compatible luer fittings. Benefits patient by enabling reliable access for fluid therapy and diagnostic monitoring through existing valved catheter systems.

Clinical Evidence

Bench testing only. Verification activities included assembly leak testing (min 43.5 psi), gravity flow (min 750 ml/hr), assembly tensile strength (15 N for 15 seconds), and ISO 594-1/2 luer compatibility testing. Biocompatibility evaluated per ISO 10993-1. Sterilization validated per ISO 11135-1 to SAL 10^-6.

Technological Characteristics

Infusion tubing with ISO-compatible luer connections; distal cannula for valve actuation. Materials evaluated for biocompatibility per ISO 10993. Sterilization via Ethylene Oxide (EtO) per ISO 11135-1. Complies with ISO 8536-4 (infusion sets) and ISO 594-1/2 (luer fittings).

Indications for Use

Indicated for use as an extension to intravascular administration sets for fluid delivery through Bard proximally valved catheters. Connects IV administration set to catheter.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• IV Extension Set with Needleless Access Device (K980992)

Submission Summary (Full Text)

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K 102405

Image /page/0/Picture/1 description: The image shows the logo for BARD ACCESS SYSTEMS. The word "BARD" is in large, bold, sans-serif font, with a unique design where the letters are connected and have a slightly angled appearance. Below the word "BARD", the words "ACCESS SYSTEMS" are printed in a smaller, sans-serif font.

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

JUL 2 1 2011

## Extension Set for Bard® Proximally Valved Catheters

| General<br>Provisions | Submitter Name:<br>Address: | Bard Access Systems, Inc.<br>605 North 5600 West<br>Salt Lake City, UT 84116 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person:<br>Telephone Number:<br>Fax Number:<br>Date of Preparation: | Lynn Kirchoff<br>Regulatory Affairs Manager<br>[phone]<br>[phone]<br>March 9, 2011 |
| Subject<br>Device | Trade Name:<br>Classification Name: | Extension Set for Bard Proximally Valved Catheters<br>Set, Administration, Intravascular<br>FPA, 21 CFR § 880.5440 Class II |
| Predicate<br>Device | Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer: | IV Extension Set with Needleless Access Device<br>Set, Administration, Intravascular<br>FPA, 21 CFR § 880.5440 Class II<br>K980992<br>Venetec Intl., Inc. now owned by Bard Medical<br>Division |
| Device<br>Description | The Extension Set is designed for Bard proximally valved catheters and<br>attaches to the end of the catheter hub for use in the administration of fluids.<br>The Extension Set opens the valve to facilitate central venous pressure<br>monitoring and/or blood sampling. Extension Sets are packaged individually<br>for single use for a period no longer than 96 hours. | |
| Intended Use | An extension set to be used as an extension to the intravascular<br>administration set used for fluid delivery through Bard proximally valved<br>catheters. The extension set will connect the IV administration set to the<br>catheter. | |
| Indications For<br>Use | An extension set to be used as an extension to the intravascular<br>administration set used for fluid delivery through Bard proximally valved<br>catheters. The extension set will connect the IV administration set to the<br>catheter. | |
| Technological<br>Characteristics | Technological characteristics of the subject Bard Extension Set are equivalent<br>with respect to the basic design and function to those of the predicate IV<br>Extension Set with Needleless Access Device. Both the subject and predicate<br>device have infusion tubing with ISO compatible luers connections with the<br>exception that the subject device has a cannula on the distal end of the<br>device. Differences do not raise any new questions regarding safety and<br>effectiveness. Accepted scientific methods such as, performance (bench)<br>testing do exist for assessing the effect of the differences in characteristics. | |
| | The Bard Extension Set met the bench performance testing requirements of<br>the following standards where applicable in conjunction with in-house<br>protocols which were used to determine appropriate methods for evaluating<br>the performance of the device:<br>ISO 8536-4:2007 :- Infusion equipment for medical use - Part 4:<br>Infusion sets for single use, gravity feed ISO 594-1:1986 :- Conical Fittings with a 6 % (Luer) Taper for<br>Syringes, Needles and Certain Other Medical Equipment - Part 1:<br>General Requirements ISO 594-2:1998 :- Conical Fittings with a 6 % (Luer) Taper for<br>Syringes, Needles and Certain Other Medical Equipment - Part 2:<br>Lock Fittings Guidance for Industry and FDA Review Staff - Intravascular<br>Administration Sets Premarket Notification Submissions [510(k)],<br>dated April 15, 2005 | |
| Summary of<br>Nonclincal<br>Testing | Risk management, including a failure modes and effects analysis (FMEA), of<br>the subject device was conducted in accordance with ISO 14971:2009,<br>Medical Devices - Risk Management for Medical Devices. No new types of<br>safety or efficacy questions were identified for the subject Bard Extension Set.<br><br>Biocompatibility assessment was conducted on the Bard Extension Set based<br>on the guidelines presented in blue book memorandum #G95-1 entitled "Use<br>of International Standard ISO-10993, "Biological Evaluation of Medical<br>Devices Part-1: Evaluation and Testing and ISO 10993-1:2009 - Biological<br>Evaluation of Medical Devices Part-1: Evaluation and Testing.<br><br>The sterility of the Bard Extension Set is assured by using a validated<br>sterilization method qualified in accordance with ISO 11135-1:2007 :-<br>Sterilization of Healthcare products - Ethylene Oxide- Part 1: Requirements<br>for Development, Validation and Routine Control of a Sterilization Process for<br>Medical Devices to a sterility assurance level (SAL) of 10-6. Ethylene Oxide<br>residual levels resulting from EtO Sterilization are in compliance with ISO<br>10993-7:2008 - Biological Evaluation of Medical Devices- Part 7: Ethylene<br>Oxide Sterilization Residuals. The Bard Extension is also tested for<br>pyrogenicity. | |

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## Summary of Verification Activities

| Summary Results of Verification Testing | |
|-----------------------------------------|------------------------------------------------------------------------------------|
| Evaluation | Predetermined Acceptance Criteria |
| Assembly Leak | No leaks at 43.5 psi minimum (air method<br>used) |
| Gravity Flow | 750 ml/hr minimum |
| Priming Volume | NA, test and report results |
| Assembly Tensile | Must withstand an axial, static tensile force<br>of 15 N (3.37 lbs) for 15 seconds |
| ISO 594 - 1 & 2 Luer<br>Testing | Must pass acceptance criteria outlined in<br>ISO 594-1 and -2. |
| Aspiration Flow | NA, test and report results |

Summary of Substantial Equivalence

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Based on the indications for use, technological characteristics, and safety and performance testing, the subject Bard Extension Set met the requirements for its intended use/indications for use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available predicate infusion set.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Lynn M. Kirchoff Regulatory Affairs Manager C.R. Bard, Incorporated 605 North 5600 West Salt Lake City, Utah 84116

JUL 21 2011

Re: K102405

Trade/Device Name: Extension Set for Bard Proximally Valved Catheters Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: June 27, 2011 Received: June 29, 2011

Dear Ms. Kirchoff:

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. Kirchoff

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/CDR H/CDRHOffices/ucm1 1.5809.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 yours.

Antmony D. Orona

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

Enclosure

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Indications for Use

510(k) Number (if known):

K102405

Device Name:

Extension Set for Bard® Proximally Valved Catheters

Indications for Use:

An extension set to be used as an extension to the intravascular administration set used for fluid delivery through Bard® proximally valved catheters. The extension set will connect the IV administration set to the catheter.

> 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)

Richard C. Chayen 7/21/11

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K102405

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