SMARTINFUSER PAINPUMP

K042122 · Precise Medical Products · MEB · Sep 22, 2004 · General Hospital

Device Facts

• Record ID: K042122
• Device Name: SMARTINFUSER PAINPUMP
• Applicant: Precise Medical Products
• Product Code: MEB · General Hospital
• Decision Date: Sep 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SmartInfuser PainPump is intended to provide continuous delivery of a local anesthetic through a catheter inserted directly into the surgical site for postoperative pain management.

Device Story

SmartInfuser PainPump is a disposable pain management system for postoperative care. It consists of a compression unit (pump), a SmartCatheter, a SmartInfuser set with a SmartReg flow regulator, an empty infusion bag (100ml or 250ml), a peel-off introducer, and a carrying pouch. The system is designed to deliver local anesthetic continuously to a surgical site. The device is filled with medication by a pharmacist according to a physician's prescription. It functions as a mechanical infusion system to manage pain post-surgery, allowing for patient mobility via the carrying pouch. The device is intended for use in a clinical or home setting under the direction of a healthcare provider.

Clinical Evidence

No clinical data provided; substantial equivalence is based on device description and performance characteristics compared to the predicate.

Technological Characteristics

Disposable infusion system comprising a compression pump, flow regulator (SmartReg), catheter, and infusion bag. Materials include synthetic cloth for the carrying pouch. Operates as a mechanical infusion pump. No electronic components, software, or external energy sources described.

Indications for Use

Indicated for postoperative pain management in patients requiring continuous delivery of local anesthetic via a catheter inserted directly into the surgical site.

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

• Painbuster Infusion Kit (K982946)

Submission Summary (Full Text)

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K042122

Image /page/0/Picture/1 description: The image shows a logo for Precise Medical Products LTD. The logo is in black and white and features the letters PMP in a stylized font. The letters are stacked on top of each other and are slightly angled. The words "PRECISE MEDICAL PRODUCTS LTD." are written below the letters in a smaller font.

SEP 2 2 2004

# 510(k) Summary: SmartInfuser PainPump™

Company Name: Precise Medical Products Ltd.

## Contact Person:

Ofer Shai Managing Director

[phone] Phone: [phone] Fax: E-mail: [e-mail]

## Authorized US Agent:

Mark Dollinger - President Trendlines America 2940 West, 123rd Terrace Leawood, Kansas 66200

Phone: [phone] [phone] Fax: E-mail: [e-mail]

Date prepared: July 30, 2004

Trade Name: SmartInfuser PainPump™

Classification name: Pump, infusion

Common/usual name: Disposable Pain Management System

Product Code: MEB

Regulation No.: 880.5725

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2042122 0.2

Image /page/1/Picture/1 description: The image shows the logo for Precise Medical Products LTD. The logo is in black and white and features the letters PMP in a stylized, three-dimensional font. The words "PRECISE MEDICAL PRODUCTS LTD." are written in a smaller font below the letters PMP.

Class: II Panel identification: General Hospital Panel

#### Predicate Device:

Painbuster Infusion Kit, I-Flow Corp. 20202 Widrow Dr., Lake Forest, CA 92630, cleared under 510(k) no. K982946.

### Description of the device:

The device comprises of the following parts:

- SmartCatheter -
- SmartInfuser set with SmartReg flow regulator (regulating set) -
- Compression unit (pump) -
- 100 ml or 250 ml infusion bag (empty) -
- Peel-off introducer -
- -Medication label
- Pump label -
- Carrying pouch made of synthetic cloth -

The empty infusion bag is included as a back-up container. Under normal circumstances, a standard solution bag filled by a pharmacist according to the physician's prescription will be used.

#### Indications for Use:

The SmartInfuser PainPump is intended to provide continuous delivery of a local anesthetic through a catheter inserted directly into the surgical site for postoperative pain management.

#### Substantial Equivalence:

The SmartInfuser PainPump™ has the same intended use as the Painbuster Infusion Kit, cleared under 510(k) no. K9982946 and has equivalent performance characteristics. It is therefore substantially equivalent to that device.

#### Conclusion -

The evaluation of the SmartInfuser PainPump™ does not raise any additional concerns regarding safety and effectivity and may therefore be considered substantially equivalent to the predicate devices.

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Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three parallel lines that curve and flow together, resembling a human figure or a wave-like design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 2004

Mr. Ofer Shay Managing Director Precise Medical Products Limited P.O. Box 88 Shlomi 22832 ISRAEL

Re: K042122

Trade/Device Name: Smartinfuser PainPump™, Disposable Pain Management System Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: July 30, 2004 Received: August 6, 2004

Dear Mr. Shay:

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 Eederal Register.

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#### Page 2 - Mr. Shay

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 vour 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 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,

Susan Runno
fo 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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K042122

# Indications for Use

510(k) Number (if known):

Device Name: SmartInfuser PainPump™, Disposable Pain Management System

Indications For Use:

The SmartInfuser PainPump™ is intended to provide continuous delivery of a local anesthetic through a catheter inserted directly into the surgical site for postoperative pain management.

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

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)

Susan Runne

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

510(k) Number:_

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