SOAKER CATHETER

K022869 · I-Flow Corp. · FRN · Sep 20, 2002 · General Hospital

Device Facts

• Record ID: K022869
• Device Name: SOAKER CATHETER
• Applicant: I-Flow Corp.
• Product Code: FRN · General Hospital
• Decision Date: Sep 20, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

With I-Flow Corporation's PainBuster, ON-Q and Nerve Block pain management kits; and 1. As a stand alone device to provide continuous or intermittent delivery of local anesthetics 2. or narcotics to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative, percutaneous or perineural.

Device Story

Soaker Catheter is an anesthetic conduction catheter designed for continuous or intermittent delivery of local anesthetics or narcotics to surgical wound sites or near nerves. Device features a closed-end tip with multiple holes arranged radially along the distal infusion segment. A membrane located on the outside diameter of the catheter promotes even fluid distribution along the infusion segment. Device is used in clinical settings for pain management; operated by healthcare professionals. Output is the controlled delivery of medication to the target site, facilitating localized pain relief.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Anesthetic conduction catheter with closed-end tip and radial holes. Features a membrane on the outside diameter to facilitate even fluid distribution. Designed for continuous or intermittent infusion of anesthetics/narcotics. Non-electronic, mechanical device.

Indications for Use

Indicated for patients requiring continuous or intermittent delivery of local anesthetics or narcotics to surgical wound sites or near nerves outside the epidural space. Used with I-Flow pain management kits or as a standalone device via intraoperative, percutaneous, or perineural 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

• Soaker Catheter (K991543)
• Soaker Catheter (K994374)

Submission Summary (Full Text)

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Special 510(k)
Soaker Catheter
K022869

## SEP 2 0 2002

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

August 23, 2002

| Submitter: | I-Flow Corporation<br>20202 Windrow Drive<br>Lake Forest, CA 92630 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Shane Noehre<br>Director, Regulatory Affairs<br>I-Flow Corporation |
| Trade Name: | Soaker Catheter |
| Common Name: | Anesthetic Catheter |
| Classification Name: | Anesthesia Conduction Catheter |
| Existing Device: | Soaker Catheter (K991543 and K994374) |
| Device Description: | The Soaker Catheter has a closed end tip with multiple holes arranged<br>radially along the lateral surface along the infusion segment at the<br>distal end of the device. A membrane in the inner diameter of the<br>catheter promotes even distribution along the infusion segment. This<br>special 510(k) proposes a slight design change that has the membrane<br>along the outside diameter of the catheter instead of the inside<br>diameter. |
| Technology<br>Comparison: | The new Soaker Catheter utilizes the exact same technology for<br>promoting even distribution along the infusion segment. |
| Conclusion: | The Soaker Catheter is substantially equivalent to the existing Soaker<br>Catheter. |

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. The central image is a stylized depiction of an eagle with three heads, suggesting a focus on people and services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 2 0 2002

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

Re: K022869 Trade/Device Name: Soaker Catheter Regulation Number: 880.5725 Regulation Name: Accessories, Infusion Pump Regulatory Class: II Product Code: MRZ and FRN Dated: August 23, 2002 Received: August 29, 2002

Dear Ms. 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.

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.

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Page 2 - Ms. Noehre

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

Timothy A. Ulatowski

Timothy A. Ulatowski 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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I-Flow Corporation Applicant:

510(k) Number (if known): _ KO22869

Device Name: Soaker Catheter

Indications For Use:

- With I-Flow Corporation's PainBuster, ON-Q and Nerve Block pain management kits; and 1.
- As a stand alone device to provide continuous or intermittent delivery of local anesthetics 2. or narcotics to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative, percutaneous or perineural.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Patticia Cucurullo

510(k) Number: K022867