ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER

K051401 · I-Flow Corp. · BSO · Nov 30, 2005 · Anesthesiology

Device Facts

• Record ID: K051401
• Device Name: ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER
• Applicant: I-Flow Corp.
• Product Code: BSO · Anesthesiology
• Decision Date: Nov 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5120
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The ON-Q SilverSoaker Catheter is intended to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for perioperative and postoperative pain management. The ON-Q SilverSoaker Catheter is contraindicated for the epidural space and in neonatal populations. The ON-Q SilverSoaker Catheter contains an antimicrobial agent which may destroy or inhibit the growth of microorganisms on both the inner and outer surfaces of the catheter. The antimicrobial agent is intended to reduce the possibility that the catheter may become microbially compromised. The antimicrobial agent is not intended to be used as a treatment for existing infections.

Device Story

The ON-Q SilverSoaker Catheter is a modified epidural catheter designed for local anesthetic or narcotic delivery to surgical sites. It features a fenestrated distal end (up to 10 inches) for infusion; the 'Soaker' variant includes an internal hollow fiber to ensure uniform medication distribution. The device incorporates an antimicrobial agent on inner and outer surfaces to inhibit microbial growth and reduce the risk of catheter colonization. It is intended for use by clinicians in perioperative and postoperative settings. The device does not treat existing infections. It functions as a delivery conduit for pain management medication, providing a benefit by reducing the potential for catheter-related microbial compromise during the infusion period.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Modified epidural catheter; fenestrated distal infusion segment (up to 10 inches); hollow fiber internal lumen (Soaker version); antimicrobial agent coating on inner and outer surfaces. Non-electronic, mechanical delivery system.

Indications for Use

Indicated for continuous or intermittent delivery of local anesthetics or narcotics to surgical wound sites for perioperative and postoperative pain management. Contraindicated for epidural space use and neonatal populations.

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

• ON-Q Catheter (K043456)

Submission Summary (Full Text)

{0}------------------------------------------------

## NOV 3 0 2005

-

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

.

.

| Submitter: | I-Flow Corporation |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Shane Noehre<br>Director, Regulatory Affairs<br>I-Flow Corporation |
| Catheter Names:<br>Common Name: | ON-Q SilverSoaker Catheter,<br>Catheter |
| Classification Name: | Catheter, Conduction, Anesthetic |
| Existing Device: | ON-Q Catheter (K043456, previously identified as I-Flow<br>Catheter) |
| Device Description: | The ON-Q SilverSoaker Catheter consists of two design<br>options: |
| | Fenestrated Catheter: a modified epidural catheter with<br>multiple holes at the distal end up to a 10 inch infusion<br>segment |
| | Soaker Catheter: a modified epidural catheter with multiple<br>holes at the distal end up to a 10 inch infusion segment. This<br>version of the ON-Q SilverSoaker Catheter contains a hollow<br>fiber along the inner lumen of the catheter to provide even<br>distribution of medication along the infusion segment. |
| | This 510(k) adds an antimicrobial agent which may destroy or<br>inhibit the growth of microorganisms on both the inner and<br>outer surfaces of the catheter. The antimicrobial agent is<br>intended to reduce the possibility that the catheter may<br>become microbially compromised. The antimicrobial agent is<br>not intended to be used as a treatment for existing infections. |
| Technology<br>Comparison: | The ON-Q SilverSoaker Catheter utilizes an antimicrobial<br>agent which is similar to existing technology currently legally<br>marketed. |
| Conclusion: | The ON-Q SilverSoaker Catheter is substantially equivalent to<br>the existing ON-Q Catheter product line and predicate devices. |

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, featuring three parallel lines that curve and flow together.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 0 2005

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

Re: K051401

Trade/Device Name: ON-Q Catheter Regulation Number: 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: November 21, 2005 Received: November 22, 2005

Dear Mr. Noehre:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your 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 the Federal I Vou may, therefore, market the device, subject to the general approvin upprovisions of the Act. The general controls provisions of the Act include controls provisions or 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 (1 Nr.), it hay of subject to and Code of Federal Regulations, Title 21, Parts 800 to 898. In your device of the read on announcements concerning your device in the Ecderal Register.

{2}------------------------------------------------

Page 2 - Mr. Noehre

Please be advised that FDA's issuance of a substantial equivalence determination does not I least be advised that 12 a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or the For of all the Act's requirements, including, but not limited to: registration 1 od intiles compry was 807); labeling (21 CFR Part 801); good manufacturing practice and illums (1) 02 read forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as bet form 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) This reter will and The FDA finding of substantial equivalence of your device to a premaince nourseations of 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), If you desire specific at ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 may overnit 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,

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

{3}------------------------------------------------

## Indications for Use

510(k) Number (if known): K051401

Device Name:

ON-Q SilverSoaker Catheter

## Indications For Use:

- The ON-Q SilverSoaker Catheter is intended to provide continuous or intermittent delivery of 1. medication (such as local anesthetics or narcotics) to or around surgical wound sites for modion (ourion (ourioperative and postoperative pain management. The ON-Q SilverSoaker Catheter is contraindicated for the epidural space and in neonatal populations.
- The ON-Q SilverSoaker Catheter contains an antimicrobial agent which may destroy or inhibit 2. the growth of microorganisms on both the inner and outer surfaces of the catheter. The the grown. or mioroogaments on oreduce the possibility that the catheter may become aniamicrobial agent to microbial agent is not intended to be used as a treatment for existing infections.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Quy Sulcom

(Division Sign Off) (Division Sign(Off)/
Division of Anesthesiology, General Hospital, Division of Anesthoological

510(k) Number