BODYGUARD PAIN MANAGER INFUSION SYSTEM

K070235 · Caesarea Medical Electronics , Ltd. · FRN · May 18, 2007 · General Hospital

Device Facts

• Record ID: K070235
• Device Name: BODYGUARD PAIN MANAGER INFUSION SYSTEM
• Applicant: Caesarea Medical Electronics , Ltd.
• Product Code: FRN · General Hospital
• Decision Date: May 18, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BodyGuard infusion Pump system is designed for infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes, of administration, including intravenous, subcutaneous, percutaneous, intraarterial, epidural, enteral, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents and general fluids therapy in hospital and home care environments.

Device Story

BodyGuard Infusion Pump System delivers medications/fluids at controlled rates; supports continuous or intermittent delivery. Routes include IV, subcutaneous, percutaneous, intraarterial, epidural, enteral, perineural, and intraoperative sites. Used in hospital and home care environments. System components include infusion pump, battery charger, infusion sets (Microset/BodySet), optional bolus cable, and optional drop sensor. Operated by healthcare professionals or patients (for home care). Provides precise fluid administration for maintenance, analgesia, PCA, nutrition, and chemotherapy. Benefits include accurate dosing and flexible delivery options for various clinical needs.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Infusion pump system; includes pump, battery charger, and specific infusion sets (Microset/BodySet). Supports optional drop sensor and bolus cable. Designed for precise flow control across multiple administration routes. Electrical power source.

Indications for Use

Indicated for patients requiring continuous or intermittent delivery of maintenance medications, analgesics, PCA therapy, parenteral/enteral nutrition, chemotherapeutic agents, and general fluids via IV, subcutaneous, percutaneous, intraarterial, epidural, enteral, perineural, or intraoperative routes in hospital or home 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)

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Public Health Service

Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and formal nature.

Mr. Shlomi Dines Quality Manager Caesarea Medical Electronics, Limited 16 Shacham Street Caesarea ISRAEL 38900

MAY 1 8 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K070235

Trade/Device Name: BodyGuard Infusion Pump System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: March 29, 2007 Received: April 18, 2007

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.

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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 (OS) 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,

Chris Lins, 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: 070235

Device Name: BodyGuard Infusion Pump System

## Indications for Use:

The BodyGuard infusion Pump system is designed for infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes, of administration, including intravenous, subcutaneous, percutaneous, intraarterial, epidural, enteral, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents and general fluids therapy in hospital and home care environments.

The BodyGuard Infusion system includes: Infusion Pump Battery Charger Infusion Sets (Microset/ BodySet) Bolus cable (optional) Drop sensor (optional)

Prescription Use x AND/OR (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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sion of Anesthesiology, General Hospital,
ion Control, Dental Devices

(k) Number: K07022

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