ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP

K063530 · I-Flow Corp. · MEB · Jan 26, 2007 · General Hospital

Device Facts

• Record ID: K063530
• Device Name: ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP
• Applicant: I-Flow Corp.
• Product Code: MEB · General Hospital
• Decision Date: Jan 26, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. The ON-Q Pump is intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural. 2. The ON-Q Pump 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 with narcotic only pain management.

Device Story

ON-Q Pump is an elastomeric infusion pump designed for continuous or intermittent delivery of local anesthetics or narcotics. Device consists of an elastomeric pressure source with an integrated administration line. Optional features include Select-A-Flow for adjustable flow rates, OnDemand bolus component, Y-adapters for multiple delivery sites, and air/particulate filters. Pump operates via elastomeric pressure; no external power source required. Used in clinical settings for regional anesthesia and pain management. Healthcare professionals manage delivery to surgical wound sites or near nerves. Device aims to reduce patient pain and narcotic consumption. Kit may include catheters, needles, and dressing accessories.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological similarities to the predicate device.

Technological Characteristics

Elastomeric infusion pump; elastomeric pressure source; flow rates 0.5-250 ml/hr; fill volumes 50-770 ml. Includes integrated administration line, optional flow control tubing/orifice, Select-A-Flow component, bolus component, Y-adapters, and air/particulate filters. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring continuous or intermittent delivery of local anesthetics or narcotics for regional anesthesia and pain management at surgical wound sites or near nerves. Applicable for preoperative, perioperative, and postoperative use via intraoperative, perineural, percutaneous, or epidural routes.

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 (K052117)

Submission Summary (Full Text)

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KDG3530 p. lotf/

JAN 26 2007

ON-Q Pump Section 5 - Summary of Safety and Effectiveness

## 510(K) -- SUMMARY OF SAFETY AND EFFECTIVENESS

| Submitter: | I-Flow Corporation<br>20202 Windrow Drive<br>Lake Forest, CA. 962630 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Shane Noehre<br>Director, Regulatory Affairs<br>I-Flow Corporation |
| Trade Names: | ON-Q Pump, ON-Q Pump with Select-A-Flow,<br>ON-Q Pump with OnDemand |
| Common Name: | Elastomeric Infusion Pump |
| Existing Device: | I-Flow Elastomeric Pump (K052117) |
| Design Change: | This Special 510(k) submission proposes an increase in the maximum fill<br>volume from 500 to 770 ml. |
| Device<br>Description: | The ON-Q Pump consists of an elastomeric pressure source with an<br>integrated administration line. Fill volumes range from 50 to 770 ml. Flow<br>rates range from 0.5 to 250 ml/hr. The administration line typically consists<br>of fixed flow rate control tubing or orifice but may contain any of the<br>following optional features: |
| | • Select-A-Flow component that provides a range of flow rates that may<br>be dialed depending on the needs of the healthcare professional. |
| | • Bolus component (e.g. OnDemand) that provides basal and/or bolus<br>delivery. |
| | • Y-adapter component that may split the administration line into two or<br>more delivery sites. The Y-adapter component may also be used to<br>provide a combination of options (such as both the Select-A-Flow and<br>OnDemand components) for one delivery site. |
| | • Air and particulate eliminating filter. |
| | The pump may be sold as a kit with additional medical devices or<br>accessories such as the following: |
| | • Catheter, introducer needle, Tunneler, syringe, dressing, filling<br>extension set, carry case, E-clip, nerve block accessories, etc. |
| Indications for Use | 1. The ON-Q Pump is intended for continuous and/or intermittent delivery of<br>medication (such as local anesthetics or narcotics) to or around surgical<br>wound sites and/or close proximity to nerves for preoperative,<br>perioperative and postoperative regional anesthesia and pain<br>management. Routes of administration may be intraoperative,<br>perineural, percutaneous and epidural. |
| | 2. The ON-Q Pump is also intended to significantly decrease narcotic use<br>and pain when used to deliver local anesthetics to or around surgical<br>wound sites or close proximity to nerves when compared with narcotic<br>only pain management. |
| Technology<br>Comparison: | There is no change in fundamental scientific technology. The design<br>remains the same as previously cleared devices. |
| Conclusion: | The ON-Q Pump with fill volumes up to 770 ml are substantially equivalent<br>to the existing I-Flow elastomeric pumps currently marketed. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 26 2007

Mr. Shane Noehre Director of Regulatory Affairs I-Flow Corporation 20202 Windrow Drive Lake Forest, California 92630

Re: K063530

Trade/Device Name: ON-Q-Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: December 28, 2006 Received: December 29, 2006

Dear Mr. Noehre:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 – Mr. Noehre

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You mav 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/cdrh/industry/support/index.html

Sincerely vours.

Chiu Lin, Ph.D.

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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| Applicant: | I-Flow Corporation |
|---------------------------|--------------------|
| 510(k) Number (if known): | K063530 |
| Device Name: | ON-Q Pump |

## Indications For Use:

- 1. The ON-Q Pump is intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural.
- 2. The ON-Q Pump 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 with narcotic only pain management.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ars

ynielogy, General Hospitzl, Control, Gental Devices