SEMPERFLO INFUSION SYSTEM

K052999 · ETHICON, Inc. · MEB · Mar 22, 2006 · General Hospital

Device Facts

• Record ID: K052999
• Device Name: SEMPERFLO INFUSION SYSTEM
• Applicant: ETHICON, Inc.
• Product Code: MEB · General Hospital
• Decision Date: Mar 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SEMPERFLO Infusion System is intended to provide continuous percutaneous infusion of prescribed solutions at a pre-set rate. The device is intended for intraoperative placement in hospital or alternate medical site environments. Once implanted, the device and pump may be used in homecare settings. The device is not intended for intravascular, intrathecal, or epidural use, nor is it indicated for use with blood, blood products, lipids or fat emulsions. When packaged in the kit configuration for pain management (to be known as the SEMPERFLO* Pain Management System), the intended use will be as follows: The SEMPERFLO Pain Management System is intended to provide continuous percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management. The SEMPERFLO Pain Management System is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or in close proximity to nerves when compared with narcotic only pain management.

Device Story

Single-use disposable elastomeric infusion pump; includes microcatheter for fluid delivery. Elastomeric reservoir maintains constant pressure; forces solution through 0.2μ filter into microcatheter. Provides continuous percutaneous infusion of prescribed solutions at pre-set rate. Used in hospital or alternate medical sites for intraoperative placement; suitable for homecare settings post-implantation. Reduces narcotic use and pain by delivering local anesthetics to surgical wound sites or near nerves. Operated by clinicians; provides passive, constant-rate medication delivery.

Clinical Evidence

Bench and animal functional performance testing conducted. Biological reactivity assessed per ISO 10993-1. No clinical trial data presented.

Technological Characteristics

Single-use disposable elastomeric infusion pump; 0.2μ filter; microcatheter. Materials assessed per ISO 10993-1. Passive mechanical energy source (elastomeric reservoir pressure). Sterile convenience kit configuration.

Indications for Use

Indicated for patients requiring continuous percutaneous infusion of prescribed solutions for post-operative pain management via local anesthetic delivery to surgical wound sites or near nerves. Contraindicated for intravascular, intrathecal, or epidural use; not for use with blood, blood products, lipids, or fat emulsions.

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

• On-Q Pain Pump (I-Flow Corp)
• VICRYL* Suture
• BAXTER Pain Management System

Submission Summary (Full Text)

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K 052999
JMP-2005-014

## MAR 2 2 2006

# Summary of Safety and Effectiveness

Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below.

#### Submitted by:

Jennifer M. Paine Manager, Regulatory Affairs Ethicon, Inc., A Johnson & Johnson Company Route 22 West, PO Box 151 Somerville, NJ 08876

#### Name/Classification of Device:

Class II in 21 CFR § 880.5725 (MEB) and 21 CFR § 868.5120 (BSO)

#### Trade Name:

SEMPERFLO Infusion System

#### Predicate Devices:

On-Q Pain Pump (I-Flow Corp) VICRYL* Suture BAXTER Pain Management System

#### Statement of Intended Use:

The SEMPERFLO Infusion System is intended to provide continuous percutaneous infusion of prescribed solutions at a pre-set rate.

The device is intended for intraoperative placement in hospital or alternate medical site environments. Once implanted, the device and pump may be used in homecare settings.

The device is not intended for intravascular, intrathecal, or epidural use, nor is it indicated for use with blood, blood products, lipids or fat emulsions.

When packaged in the kit configuration for pain management (to be known as the SEMPERFLO* Pain Management System), the intended use will be as follows:

> The SEMPERFLO Pain Management System is intended to provide continuous percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management.

The SEMPERFLO Pain Management System is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or in close proximity to nerves when compared with narcotic only pain management.

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#### Device Description:

The proposed device consists of a single-use disposable elastomeric infusion pump, designed to deliver medication/fluids at a constant flow rate, and a microcatheter for fluid delivery. The device is intended for use in tissue, and is not intended for use in intravascular, epidural or intrathecal modes of delivery. Delivery of medication is achieved via an elastomeric reservoir that maintains relatively constant pressure, forcing solution through a 0.2μ filter and into the associated microcatheter assembly. The device will be provided as a convenience kit.

### Summary of Technological Characteristics of New Device to Predicate Devices:

The modified device has similar technological characteristics as the predicate devices. Like currently marketed devices, it is a kit providing a sterile infusion system. The proposed device uses the same or similar materials as those used in other currently marketed implantable or non-implantable medical devices. The mechanism of action is the same as for predicate devices.

#### Performance Data:

Biological reactivity of the materials has been assessed using methods specified in ISO Standard 10993-1, and the material was found to be acceptable for its intended use. Results of functional performance testing (bench and animal testing) have been submitted. These results indicate that the proposed device meets or exceeds all functional requirements.

#### Conclusions:

Based on the similarities to the predicate devices identified in this submission, we conclude that the modified device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act.

*Trademark of Ethicon, Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare. The words "U.S. Department of Health and Human Services, USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 2 2006

Ms. Jennifer M. Paine Ethicon, Incorporated Route 22 West P.O. Box 151 Somerville, New Jersey 08876

Re: K052999 Trade/Device Name: SEMPERFLO Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: II Product Code: MEB Dated: February 27, 2006 Received: February 28, 2006

Dear Ms. Paine:

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 approvisions 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 Eederal Register.

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### Page 2 - Ms. Jennifer M. Paine

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 mean that i DA may Federal statutes and regulations administered by other Federal agencies. 01 the Act of ally rederal baker and segments, including, but not limited to: registration ? 1 ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and and listing (21 CFR Part 007), labeling systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quarty agon 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 letter will anow you to objak finding of substantial equivalence of your device to a premarket notification. - The PDF 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), if you desire specific ad rios for Journe 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 may overn built be generational 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,

Sujette y. Michau Oms.

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): K052999

Device Name: SEMPERFLO Infusion System

Indications for Use:

The SEMPERFLO Infusion System is intended to provide continuous percutaneous infusion of prescribed solutions at a pre-set rate.

The device is intended for intraoperative placement in hospital or alternate medical site environments. Once implanted, the device and pump may be used in homecare settings.

The device is not intended for intravascular, intrathecal, or epidural use, nor is it indicated for use with blood, blood products, lipids or fat emulsions.

When packaged in the kit configuration for pain management (to be known as the SEMPERFLO* Pain Management System), the intended use will be as follows:

The SEMPERFLO Pain Management System is intended to provide continuous percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management.

The SEMPERFLO Pain Management System is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or in close proximity to nerves when compared with narcotic only pain management.

*Trademark of Ethicon, Inc.

(21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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on Man Mogy, General Huspic II 1150 Md Dental Davices

INDICATIONS FOR USE

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