MODIFICATION TO: BODYGUARD INFUSION SYSTEM

K070718 · Caesarea Medical Electronics , Ltd. · FRN · Apr 13, 2007 · General Hospital

Device Facts

• Record ID: K070718
• Device Name: MODIFICATION TO: BODYGUARD INFUSION SYSTEM
• Applicant: Caesarea Medical Electronics , Ltd.
• Product Code: FRN · General Hospital
• Decision Date: Apr 13, 2007
• Decision: SESE
• Submission Type: Special
• 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, PCA therapy, Parenteral nutritional fluids and general I.V. fluids therapy in hospital and home care environments.

Device Story

BodyGuard Infusion System is an infusion pump for intravenous delivery of medications and fluids. System components include infusion pump, battery charger, infusion sets, and optional PCA/charging cables. Used in hospital and home care environments to administer maintenance medications, PCA therapy, parenteral nutrition, and general IV fluids. Operates by controlling fluid transfer to patient; healthcare providers or patients use device to manage therapy delivery. Output consists of controlled fluid infusion; assists in clinical decision-making by automating medication administration and ensuring accurate dosing. Benefits patient through reliable, consistent fluid and medication delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Infusion pump system; includes pump, battery charger, infusion sets, and cables. Intended for intravenous fluid/medication delivery. Class II device (21 CFR 880.5725).

Indications for Use

Indicated for patients requiring intravenous delivery of maintenance medications, PCA therapy, parenteral nutrition, and general IV fluids in hospital and 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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 3 2007

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

Re: K070718

Trade/Device Name: Body Guard Infusion System Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: March 7, 2007 Received: March 14, 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 (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.

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): K070718

Device Name: Body Guard Infusion System

Indications For Use:

The BodyGuard Infusion system is designed to transfer medication and fluids intravenously. The system is intended for patients who require maintenance medications, PCA therapy, Parenteral nutritional fluids and general I.V. fluids therapy in hospital and home care environments.

The BodyGuard Infusion system includes: Infusion Pump Battery Charger Infusion Sets PCA cable (optional) Charging cable (optional)

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


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| | <p>Division of Anesthesiology, General Hospital,</p> <p>Infection Control, Qatar, Devices</p> |
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| 510(k) Number: | K070718 |
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Page 1 of ______· Caesarea Medical Electronics Ltd. · Abbreviated 510(k) Premarket Submission · BodyGuard Infusion System · Confidential