MODIFICATION TO SOAKER CATHETER

K043456 · I-Flow Corp. · BSO · Jan 11, 2005 · Anesthesiology

Device Facts

• Record ID: K043456
• Device Name: MODIFICATION TO SOAKER CATHETER
• Applicant: I-Flow Corp.
• Product Code: BSO · Anesthesiology
• Decision Date: Jan 11, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

With I-Flow Corporation's ON-Q, PainBuster and C-bloc pain management kits; and 1. As a stand alone device to provide continuous or intermittent delivery of medication 2. (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves. Routes of administration may be intraoperative, percutaneous, perineural. The Soaker version of the I-Flow Catheter is contraindicated for the epidural space.

Device Story

I-Flow Catheter system comprises standard epidural, fenestrated, and soaker catheter designs; infusion segments up to 10 inches. Soaker version utilizes hollow fiber along inner lumen or outer diameter for even medication distribution. Device delivers local anesthetics or narcotics to surgical sites or near nerves; used intraoperatively, percutaneously, or perineurally. Operated by clinicians for pain management. System integrates with ON-Q, PainBuster, and C-bloc pain management kits. Provides continuous or intermittent medication delivery to facilitate patient pain relief.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological comparison to predicate devices.

Technological Characteristics

Catheter-based delivery system; includes standard, fenestrated, and soaker configurations. Soaker model features hollow fiber for medication distribution. Infusion segments up to 10 inches. Non-electronic, mechanical device.

Indications for Use

Indicated for patients requiring continuous or intermittent delivery of medication (local anesthetics or narcotics) to surgical wound sites or near nerves via intraoperative, percutaneous, or perineural routes. Soaker catheter version contraindicated for epidural space.

Regulatory Classification

Identification

An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.

Predicate Devices

• I-Flow Catheter (K991543)
• I-Flow Catheter (K994374)
• I-Flow Catheter (K022869)

Submission Summary (Full Text)

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K043456

JAN 1 1 2014

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

| Submitter: | I-Flow Corporation |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Shane Noehre<br>Director, Regulatory Affairs<br>I-Flow Corporation |
| Catheter Names: | I-Flow Catheter, Soaker Catheter, Fenestrated Catheter,<br>Epidural Catheter |
| Common Name: | Catheter |
| Classification Name: | Catheter, Conduction, Anesthetic |
| Existing Device: | I-Flow Catheter (K991543, K994374 and K022869) |
| Device Description: | The I-Flow Catheter consists of three design options which can utilize infusion segments ranging from epidural to 10 inches (same as the predicate devices with the exception of the 10 inch infusion segment): Standard epidural catheter: 3 radial holes at the distal end with an approximate 0.5 inch infusion segment. Fenestrated Catheter: a modified epidural catheter with multiple holes at the distal end up to a 10 inch infusion segment Soaker Catheter: a modified epidural catheter with multiple holes at the distal end up to a 10 inch infusion segment. This version of the I-Flow Catheter contains a hollow fiber along the inner lumen or along the outside diameter of the distal end of the catheter to provide even distribution of medication along the infusion segment. |
| Technology<br>Comparison: | The new 10 inch I-Flow Catheter model utilizes the exact same technology as the existing I-Flow Catheter product line. |
| Conclusion: | The new 10 inch I-Flow Catheter model is substantially equivalent to the existing I-Flow Catheter product line. |

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 1 1 2005

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

Re: K043456

Trade/Device Name: I-Flow Catheter Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: December 10, 2004 Received: December 15, 2004

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), r Joe acontact 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/dsma/dsmamain.html

Sincerely yours.

Chiu, 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

510(k) Number (if Known): K043456

I-Flow Catheter / Soaker Catheter Device Name:

Indications For Use:

- With I-Flow Corporation's ON-Q, PainBuster and C-bloc pain management kits; and 1.
- As a stand alone device to provide continuous or intermittent delivery of medication 2. (such as local anesthetics or narcotics) to surgical wound sites and/or close (vaximity to nerves. Routes of administration may be intraoperative, percutaneous, proximity to neineural. The Soaker version of the I-Flow Catheter is contraindicated for the epidural space.

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)

Anton 23 me

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Division of Antrol, Dental Devices

510(k) Number - Kory Jazz

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