I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)

K052117 · I-Flow Corp. · MEB · Sep 9, 2005 · General Hospital

Device Facts

• Record ID: K052117
• Device Name: I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)
• Applicant: I-Flow Corp.
• Product Code: MEB · General Hospital
• Decision Date: Sep 9, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. The I-Flow Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural. 2. The I-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of local anesthetics (or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia. Routes of administration may be intraoperative, perineural or percutaneous. 3. The I-Flow Elastomeric Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

Device Story

I-Flow Elastomeric Pump utilizes elastomeric pressure source to deliver medications; integrated administration line provides fluid path. Device modification introduces multi-Y adapter allowing 3+ administration lines for multi-site delivery. Operates via passive elastomeric pressure; no external power source. Used in clinical settings for infusion of antibiotics, chemotherapy, and local anesthetics for pain management. Healthcare providers manage infusion setup; device provides continuous or intermittent delivery to surgical sites or systemic routes. Benefits include reduced narcotic requirements for pain management.

Clinical Evidence

No clinical data provided; substantial equivalence based on design similarity and technological extension of the predicate device.

Technological Characteristics

Elastomeric pressure-driven infusion pump. Consists of elastomeric reservoir and administration tubing with multi-Y adapter. Passive delivery mechanism. No electronic components or software.

Indications for Use

Indicated for patients requiring continuous or intermittent infusion of medications (antibiotics, chemotherapy, pain management, local anesthetics) via intravenous, intra-arterial, subcutaneous, intramuscular, epidural, intraoperative, perineural, or percutaneous routes for regional anesthesia or general infusion.

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 (K040337)

Submission Summary (Full Text)

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## SPECIAL 510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS

K052117

August 3, 2005

Submitter:

I-Flow Corporation 20202 Windrow Drive Lake Forest, CA 92630

Contact:

Shane Noehre Director, Regulatory Affairs I-Flow Corporation

Trade Name: I-Flow Elastomeric Pump

Infusion Pump and Administration Set Common Name:

Classification Name: Pump, Infusion

Existing Device: I-Flow Elastomeric Pump (K040337)

Device Description: The I-Flow Elastomeric Pump consists of an elastomeric pressure source with an integrated administration line. The current device has an optional Y-adapter that splits the administration line into two delivery sites. This special 510(k) proposes a multi-Y adapter that can provide 3 or more integrated administration lines for multi-site delivery.

| Technology<br>Comparison: | The multi-Y adapter utilizes the same technology for<br>splitting the administration line as the existing<br>unmodified design. |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------|
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------|

Conclusion: The new I-Flow Elastomeric Pump with a multi-Y adaptor model is simply an extension of the existing I-Flow Elastomeric Pump product line.

I-Flow Corporation believes that the new I-Flow Elastomeric Pump with a mulit-Y adaptor model is substantially equivalent to the existing (unmodified) I-Flow Elastomeric Pump and no new issues of safety or effectiveness arise from this design change.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three wings and two legs, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circle around the eagle.

SEP - 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K052117

Trade/Device Name: I-Flow Elastomeric Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: August 3, 2005 Received: August 11, 2005

Dear Mr. Noehre:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave roviewed your become mined 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to devroos that have o Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvin uppheansed (the Act. The general controls provisions of the Act include controls providents of the ristration, 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 (1 Mr), it may of subject to Bach adam Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements 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 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/cdrh/industry/support/index.html.

Sincerely yours.

Clus

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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## Indications for Use

510(k) Number (if known): K(152117

Device Name:

I-Flow Elastomeric Pump

Indications For Use:

- 1. The I-Flow Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural.
- 2. The 1-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of r no i row Esucturesthetics or narcotics) to surgical wound sites and/or close modiation (so nerves for preoperative, perioperative and postoperative regional anesthesia proxinity to norvos for processf administration may be intraoperative, perineural or percutaneous.
- 3. The I-Flow Elastomeric Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to 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)

Shula M. Minsky, MD for A. Wilson, GA DB 9/8/05

Division of Anesthesiology, General Hospit Infection Control, Dental Device

510(k) Number: Ka52117