BODYGUARD INFUSION SYSTEM

K031749 · Caesarea Medical Electronics , Ltd. · FRN · Aug 21, 2003 · General Hospital

Device Facts

• Record ID: K031749
• Device Name: BODYGUARD INFUSION SYSTEM
• Applicant: Caesarea Medical Electronics , Ltd.
• Product Code: FRN · General Hospital
• Decision Date: Aug 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

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; ambulatory infusion pump for intravenous delivery of fluids/medications. Components: pump, battery charger, infusion sets (Microset/BodySet), optional PCA cable, optional charging cable. Used in hospital and home care environments. Operates by controlling fluid transfer rates for maintenance, PCA, and parenteral nutrition. Provides clinicians/patients with controlled infusion therapy; supports patient mobility and therapy management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Infusion pump system; includes pump, battery charger, and specific infusion sets (Microset/BodySet with female luer). Supports PCA therapy via optional cable. Designed for hospital and home use. Electrical energy source.

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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Public Health Service

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AUG 2 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Caesarea Medical Electronics Limited C/O Mr. Chris Lavanchy Responsible Third Party Official Citech Medical Device Testing and Consulting 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298

Re: K031749

Trade/Device Name: BodyGuard Infusion System Regulation Number: 880.5725, 880.5440 Regulation Name: Infusion System, Intravascular Administration Set Regulatory Class: II Product Code: FRN, FPA Dated: August 14, 2003 Received: August 15, 2003

Dear Mr. Lavanchy:

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.

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

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Page 2 - Mr. Lavanchy

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/dsma/dsmamain.html

Sincerely yours,

Susan Ruane

Susan Runner, DDS, MA Interim Direction 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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## Indication for Use Statement

## 510(k) Number:

Device Name:

BodyGuard 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 (Microset/ BodySet female luer) PCA cable (optional) Charging cable (optional)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Clements

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

510(k) Number: K031749

OR

L Prescription Use

Over-The-Counter Use

7

(Per 21 CFR 801.109)

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