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

K040337 · I-Flow Corp. · MEB · May 24, 2004 · General Hospital

Device Facts

• Record ID: K040337
• Device Name: I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)
• Applicant: I-Flow Corp.
• Product Code: MEB · General Hospital
• Decision Date: May 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K040337 · May 24, 2004	I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)	I-Flow Corp.	Published clinical literature	The sponsor utilized published clinical studies to support a labeling change that references specific types of surgeries and potential benefits (e.g., decreased narcotic use and pain) associated with the use of the elastomeric pump in routine clinical practice.	Labeling change; Clinical literature; Pain management; Surgical wound sites

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Published clinical studies; Published clinical literature (retrospective/routine clinical use)	Patients undergoing surgery requiring pain management	Narcotic only pain management	Decrease in narcotic use and pain

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 I-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to 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 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 is a non-electronic, elastomeric infusion device; delivers medications (local anesthetics, narcotics, antibiotics, chemotherapy) via continuous or intermittent infusion. Used in clinical settings (surgical, perioperative) for pain management; operated by healthcare professionals. Device utilizes elastomeric tension to drive fluid flow; no external power source required. This submission updates labeling to reference specific surgical types and clinical benefits supported by published literature; specifically, the reduction of narcotic use and pain levels when delivering local anesthetics to surgical sites or near nerves. Output is the controlled delivery of medication to the patient; assists clinicians in managing postoperative pain; potential patient benefit includes reduced narcotic dependency and improved pain control.

Clinical Evidence

No new clinical trials were conducted for this submission. The manufacturer relies on published clinical studies in esteemed journals to support the updated labeling regarding the efficacy of the device in reducing narcotic use and pain when delivering local anesthetics to surgical sites.

Technological Characteristics

Elastomeric infusion pump; non-electronic; passive delivery mechanism using elastomeric tension. No external energy source. Materials and design are identical to the previously cleared I-Flow Elastomeric Pump. Standalone device; no software or connectivity.

Indications for Use

Indicated for patients requiring continuous or intermittent infusion of medications including antibiotics, chemotherapy, or pain management agents. Routes include IV, intra-arterial, subcutaneous, intramuscular, epidural, intraoperative, perineural, or percutaneous. Used for preoperative, perioperative, and postoperative regional anesthesia and pain management.

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.

Submission Summary (Full Text)

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K640337

## MAY 2 4 2004

Appendix E

Summary of Safety and Effectiveness

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

February 9, 2004

- Submitter: I-Flow Corporation 20202 Windrow Drive Lake Forest, CA 92630
- Shane Noehre Contact: Director, Regulatory Affairs I-Flow Corporation

ON-Q, PainBuster, C-bloc, Eclipse, C-Series, Easypump, Homepump Trade Names:

- Pump, Infusion, Elastomeric Classification Name:
- Existing Device: I-Flow Elastomeric Pump
- The current package labeling of the I-Flow Elastomeric Pump does not Device Description: reference specific types of surgeries or potential benefits. This 510(k) proposes a labeling change that would reference the specific type(s) of surgery and potential benefits that are supported by published clinical studies.
- The I-Flow Elastomeric Pump was used in the published clinical Conclusion: studies. The device was used according to FDA cleared indications for use (i.e. intraoperative or perineural local anesthetic delivery to relieve pain at the surgical site). I-Flow believes this change would not impact safety or efficacy and is supported by published clinical studies in widely known and esteemed journals.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized lines representing its wings or feathers.

Public Health Service

MAY 2 4 2004

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: K040337

Trade/Device Name: I-Flow Elastomeric Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: May 18, 2004 Received: May 19, 2004

Dear Mr. Nochre:

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 cevices 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 (Spccial 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 Eederal Register.

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Page 2 - Mr. Noehre

Please be advised that FDA's issuance of a substantial equivalence determination does not r lease to acressed that 12 a determination that your device complies with other requirements mount that I Dr. may Federal statutes and regulations administered by other Federal agencies. or the riot of any a outh all the Act's requirements, including, but not limited to: registration 1 od listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fishlig (21 CF revis in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bettronic 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) I mis letter mification. The FDA finding of substantial equivalence of your device to a premained formaticate 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 maj Sound Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Junre
C. Shih-Lin, Ph.D.

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

K040337 510(k) Number (if known):

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 I-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to 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 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 X (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)

Irene Navesee for AW 3/21/04

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

510(k) Number: K040337