BODYGAURD PAIN MANAGER INFUSION SYSTEM

K061325 · Caesarea Medical Electronics , Ltd. · FRN · Aug 24, 2006 · General Hospital

Device Facts

• Record ID: K061325
• Device Name: BODYGAURD PAIN MANAGER INFUSION SYSTEM
• Applicant: Caesarea Medical Electronics , Ltd.
• Product Code: FRN · General Hospital
• Decision Date: Aug 24, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BodyGuard Infusion system is designed to transfer medication and fluids intravenously. The system is intended for patients who require maintenance medications in hospital and home care environments. The system is intended for delivery of patient controlled analgesia (PCA) The system is intended for delivery of pain therapy (EPIDURAL)

Device Story

BodyGuard Pain Management Infusion System; ambulatory infusion pump for intravenous, PCA, and epidural medication delivery. Used in hospital and home care environments by clinicians or patients. Device transfers fluids/medications via programmed infusion parameters. Provides controlled delivery of analgesics to manage pain. Benefits include precise medication administration and support for patient-controlled therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ambulatory infusion pump; intended for IV, PCA, and epidural delivery. Class II device (Product Code FRN).

Indications for Use

Indicated for patients requiring intravenous maintenance medications, patient-controlled analgesia (PCA), or epidural pain therapy in hospital or home care settings.

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.

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 2 4 2006

Mr. Shlomi Dines Quality Assurance Manager Caesarea Medical Electronics Limited 16 Shacham Street Cacsarea Industrial Park Caesarea, Israel 38900

Re: K061325

Trade/Device Name: BodyGuard Pain Management Infusion System Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: July 21, 2006 Received: July 21, 2006

Dear Mr. Dines:

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.

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

Page 2 - Mr. Dines

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), 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/industry/support/index.html.

Sincerely yours.

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

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

## Indication for Use Statement

510(k) Number: K061325

Device Name: BodyGuard Pain Management Infusion System

## Indications for Use:

ﻟﻬﻢ ﺍﻟﺮ

The BodyGuard Infusion system is designed to transfer medication and fluids intravenously. The system is intended for patients who require maintenance medications in hospital and home care environments. The system is intended for delivery of patient controlled analgesia (PCA) The system is intended for delivery of pain therapy (EPIDURAL)

Prescription Use

AND / OR

Over-The-Counter Use ________

(Part 21 CFR 801 subpart D)

(Part 21 CFR 801 subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anten ont

1 Jugn-Off) on of Anesthesiology, General Hospital, .on Control, Dental Devices

: Number ._ K961325

· Caesarca Medical Electronics Ltd. · Abbreviated 510(k) Premarket Submission · BodyGuard Pain Management Infusion System · Confidential

7