ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES

K131249 · I-Flow, LLC · MEB · Feb 3, 2014 · General Hospital

Device Facts

• Record ID: K131249
• Device Name: ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES
• Applicant: I-Flow, LLC
• Product Code: MEB · General Hospital
• Decision Date: Feb 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The I-Flow Elastomeric Pump is intended for infusion of medications including antibiotic delivery, and pain management. Routes of administration include intravenous, subcutaneous, and epidural. The I-Flow Elastomeric Pump is also infusion of medication (such as local anestheirs or narcotics) for tocal or regional anesthesia and pain management. Routes of administration include: perineural (nerve block), into interoperative sites (infiltration), percutaneous and epidural. The I-Fiow Elastomeric Punp is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to or around surgical wound sites or close proximity to nerves when compared to narcolic-only pain management. The indications for use include hospital, alternate care, ambulatory and home environments.

Device Story

I-Flow Elastomeric Pump is a non-electric, pressure-driven infusion device; utilizes an elastomeric silicone bladder as both fluid reservoir and pressure source. Flow rate is controlled by a fixed restrictor orifice or tubing. Device includes an integrated administration set; may feature Y-tubing, air/particulate filters, and luer connectors. Used in hospital, ambulatory, and home settings for delivery of antibiotics, chemotherapy, or local anesthetics/narcotics for pain management. Operated by clinicians or patients. Output is continuous medication infusion; helps manage pain and reduce narcotic requirements. Design changes from predicate include transition to single-layer silicone bladder, removal of DEHP plasticizers, and reduction of filter pore size to 0.22 micron for low-flow models.

Clinical Evidence

No clinical data. Bench testing performed including flow rate accuracy, fill/crack pressure, residual volume, pump integrity, biocompatibility, and chemical characterization. Human factors simulated use study conducted to evaluate device performance, potential use errors, and user perception in intended environments. Safety case and hazard analysis demonstrated acceptable risk profile.

Technological Characteristics

Elastomeric infusion pump; single-layer silicone bladder reservoir; TOTM and DEHT plasticized PVC components (DEHP-free). Flow regulation via fixed restrictor orifice/tubing. 0.22 micron air-eliminating filter for low-flow models. Non-electric, pressure-driven. Standalone device.

Indications for Use

Indicated for patients requiring infusion of medications, including antibiotics, local anesthetics, or narcotics, for pain management or anesthesia. Routes include intravenous, subcutaneous, epidural, perineural (nerve block), and infiltration into surgical sites. Suitable for hospital, ambulatory, and home care settings.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• I-Flow Elastomeric Pump (K063530)
• I-Flow Elastomeric Pump (K052117)

Submission Summary (Full Text)

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FEB - 3 2014

# 510(k) Summary

| | 5. 510(k) Summary |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Table 5-1 510(k) Summary Table |
| Submitter: | I-Flow, LLC<br>43 Discovery, Suite 100<br>Irvine, CA 92618 |
| Contact: | Shelly Harris<br>Regulatory Affairs Manager<br>I-Flow, LLC<br><br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Trade<br>Names: | ON-Q Pain Relief System, ON-Q PainBuster, ON-Q C-bloc, Homepump C-Series and Homepump Eclipse |
| Common<br>Name: | Elastomeric Infusion Pump |
| Existing /<br>Predicate<br>Devices: | I-Flow Elastomeric Pump<br>K063530<br>K052117 |
| Device<br>Changes: | This Traditional 510(k) submission proposes the following changes to incorporate:<br>Use a single Silicone bladder for the elastomeric pump. The predicate elastomeric pump consists of a dual Kraton (inner) and Latex (outer) bladder design configuration.<br>Components will not be manufactured or formulated with DEHP as a plasticizer.<br>For the low flow (i.e., 0.5 – 10 ml/hr) elastomeric pump models, the filter pore size was reduced from 1.2 micron to 0.22 micron to further enhance the elimination of particulate matter and air bubbles from the device. |

K131 249

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| Table 5-1 510(k) Summary Table | | | | | | |
|--------------------------------|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-------------|------------------|----------------------|
| Device<br>Description: | Trade Name | Target Market<br>Primary Application | ON-Q Pain Relief<br>System/ON-Q PainBuster | ON-Q C bloc | Homepump Eclipse | Homepump<br>C-Series |
| | | Regional analgesia and anesthesia | Surgical Site<br>or Nerve Block | | Home infusion | |
| | | | | | Antibiotics | Chemotherapy |
| | Device<br>Description | The I-Flow Silicone/Non-DEHP Elastomeric Pumps consist of an elastomeric pressure source with an<br>integrated administration set. The elastomeric membrane functions as the fluid reservoir and the pressure<br>source. The desired flow rate is regulated by a restrictor orifice or fixed flow tubing that controls flow<br>generated by the pressurized bladder. The pre-attached administration set may incorporate any of the<br>following components: | | | | |
| | | • Y-tubing for multi-site delivery (single or dual)<br>• Air and particulate eliminating filter<br>• Flow Restrictor<br>• Luer Connector | | | | |
| | | The pump may be sold as a kit with additional devices or accessories such as the following: catheter,<br>introducer needle, syringe, and E-clip. | | | | |
| | Approx. Deliver<br>Times | | 1 - 5 days | | 15 min - 5 hrs | 8 days |
| Indication<br>for Use: | | The I-Flow Elastomeric Pump is intended for infusion of medications including antibiotic delivery, chemotherapy and pain<br>management. Routes of administration include intravenous, subcutaneous and epidural. | | | | |
| | | The I-Flow Elastomeric Pump is also intended for infusion of medication (such as local anesthetics or narcotics) for local or<br>regional anesthesia and pain management. Routes of administration include: perineural (nerve block), into intraoperative sites<br>(infiltration), percutaneous and epidural. | | | | |
| | | The I-Flow Elastomeric Pump is also intended to significantly decrease narcotic use and pain when used to deliver local<br>anesthetics to or around surgical wound sites or close proximity to nerves when compared with narcotic-only pain management. | | | | |
| | | The indications for use include hospital, alternate care, ambulatory and home environments. | | | | |

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| Table 5-1 | 510(k) Summary Table | | |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology Comparison: | There is no change in fundamental scientific technology or principles of operation. The design remains the same as the predicate devices.<br>All the non-clinical data and tests (i.e., flow rate accuracy, fill/crack pressure, residual volume, pump integrity, biocompatibility, chemical characterization, drug compatibility) performed, met the design requirements and acceptance criteria, thereby demonstrating substantial equivalence to the predicate devices. | | |
| Technology Characteristics | Drug reservoir material | Predicate Devices | New Pump |
| | Administration set | Dual bladder:<br>Latex Outer bladder<br>Kraton Inner bladder (fluid contact)<br>Di(2-ethylhexhyl) phthalate (DEHP)<br>Plasticized Polyvinyl Chloride (PVC)<br>DEHP plasticized PVC | Single bladder:<br>Single layer silicone<br>Trioctyl Trimellitate<br>(TOTM) plasticized PVC<br>Di(2-ethylhexyl) terephthalate<br>(DEHT) plasticizer PVC |
| | Bag, 100ml ON-Q, Radio Frequency (RF)<br>Seal w/Vent (non-fluid path) | | |
| | Inline Filter | 1.2 micron size filter, air eliminating | 0.22 micron,<br>air-eliminating filter |
| Performance Data | Testing of the I-Flow Silicone/Non-DEHP Elastomeric Pump was conducted, including performance, biocompatibility, and chemical characterization testing. A Clinical Evaluation was determined not to be required; however, a simulated use study of human factors was conducted with intended users in the intended use environment that evaluated device performance, possible use error and user perception of difficulties with pump use. The study assessed the critical tasks or use scenarios where use related errors are most likely to occur.<br><br>A Safety Case and Hazard Analysis demonstrated an acceptable risk profile based on design-based risk mitigation and satisfactory performance testing.<br><br>Results of design verification and validation testing demonstrated that the 1-Flow Silicon/Non-DEHP Elastomeric Pump functions as designed and can be operated by the user as intended through the user interface and instuctions provided. | | |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Public Health Service

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

February 3, 2014

Shelly Harris Regulatory Affairs Manager I-Flow, LLC 20202 Windrow Drive Lake Forest, California 92630

Re: K131249

Trade/Device Name: I-Flow Elastomeric Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MEB Dated: December 31, 2013 Received: January 2, 2014

## Dear Ms. Harris:

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.

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

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Page 2 - Ms. Harris

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 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/ResourcesforYou/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer
-s FDA

for

Erin I. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

510(k) Number (if known) K131249

Device Name I-Flow Elastomeric Pump

Indications for Use (Describe)

The I-Flow Elastomeric Pump is intended for infusion of medications including antibiotic delivery, and pain management. Routes of administration include intravenous, subcutaneous, and epidural.

The I-Flow Elastomeric Pump is also infusion of medication (such as local anestheirs or narcotics) for tocal or regional anesthesia and pain management. Routes of administration include: perineural (nerve block), into interoperative sites (infiltration), percutaneous and epidural.

The I-Fiow Elastomeric Punp is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to or around surgical wound sites or close proximity to nerves when compared to narcolic-only pain management.

The indications for use include hospital, alternate care, ambulatory and home environments.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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