BODYGUARD INFUSION PUMP SYSTEM

K042696 · Caesarea Medical Electronics , Ltd. · FRN · Mar 11, 2005 · General Hospital

Device Facts

• Record ID: K042696
• Device Name: BODYGUARD INFUSION PUMP SYSTEM
• Applicant: Caesarea Medical Electronics , Ltd.
• Product Code: FRN · General Hospital
• Decision Date: Mar 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BodyGuard infusion Pump system is designed for infusion of continuous or intermittent delivery at medically-controlled infusion rates through clinically acceptable routes of intravenous, subcutaneous, percutaneous, intraarterial, epidural, enteral, in close proximity to nerves, and into an operative/surgical wound site. The system is intended for patients who require maintenance medications, analgesics, parenteral and enteral nutrition fluids, chemotherapeutic agents or PCA therapy; parenteral fluids therapy in hospital and home care environments.

Device Story

BodyGuard Infusion Pump System delivers fluids/medications at controlled rates. Inputs: user-programmed infusion parameters via pump interface. Operation: electromechanical pump mechanism drives infusion sets (Microset/BodySet) to deliver fluids; supports optional bolus cable and drop sensor for monitoring. Output: controlled fluid delivery to patient. Used in hospital and home care environments by clinicians or patients. Healthcare providers use pump interface to set delivery parameters; output affects patient therapy by ensuring precise medication/fluid administration. Benefits: accurate, controlled delivery of maintenance meds, analgesics, nutrition, and chemotherapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electromechanical infusion pump system. Includes pump, battery charger, infusion sets (Microset/BodySet), optional bolus cable, and optional drop sensor. Supports multiple delivery routes: intravenous, subcutaneous, percutaneous, intraarterial, epidural, enteral, perineural, and surgical wound site.

Indications for Use

Indicated for patients requiring continuous or intermittent delivery of medications, analgesics, parenteral/enteral nutrition, chemotherapeutic agents, or PCA therapy via intravenous, subcutaneous, percutaneous, intraarterial, epidural, enteral, perineural, or surgical wound site routes 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)

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## MAR 1 1 2005

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gali Tzury Quality Assurance Manager Caesarea Medical Electronics Limited 16 Shacham Street Caesarca Industrial Park P.O. Box 4294 Caesarea 38900 ISRAEL

Re: K042696

Trade/Device Name: BodyGuard Infusion Pump System Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN, FPA, MEA Dated: February 15, 2005 Received: February 22, 2005

Dear Mr. Tzury:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have revious Jour becatermined 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 Intelstate comments, or to that have been reclassified in accordance with the provisions of Amendinents, on to devroes that nove of the (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls 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 IT your device is classinod (So ah additional controls. Existing major regulations affecting (1 Mrs), it may of suched in the Code of Federal Regulations. Title 21, Parts 800 to 898. In your device can be found ther announcements concerning your device in the Ecderal Register.

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Page 2 -- Mr. Tzury

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 mean that IDA has made a deceminary and regulations administered by other Federal agencies. of the Act of ally I ederal statues and regisms.
You must comply with all the Act's requirements, including, but not limited to: registration You must comply with an the Hee reg (21 CFR Part 801); good manufacturing practice. allit listing (21 CFR Part 007), lasting (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality by sections (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) I mis letter will anow you to begin mailering your
premarket notification. The FDA finding of substantial equivalence of your device to a premiarket nothreation. The PDF results in a classification for your device and thus, permits your device to proceed to the market.

ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your as at [phone]. Also, please note the regulation prease contact the Office or Somne to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general misterials and Consumer Assistance at its toll-free Dreision [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 ()ffice of Device Evaluation Center for Devices and Radiological Health

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## Indications For Use

## K042696 510(k) Number:

BodyGuard Infusion Pump System Device Name:

## Indications for Use:

The BodyGuard infusion Pump system is designed for infusion of The DodyGuara mraston rang continuous or intermittent delivery at medically-controlled infusion rates through clinically acceptable routes of precisery-controned intravenous, subcutaneous, percutaneous, intraarterial, epidural, enteral, in close proximity to nerves, and into an arterial, Chichai, Checrai, In- Chity/surgical wound site). The system is intended for patients who require maintenance medications, analgesics, Is Intended Tor patteral and enteral nutrition fluids, chemotherapeutic agents r CA therapy; pareral 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 (Part 21 CFR 801 Subpart D)

AND/ OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Chis 29

Concurrence of CDRH, Office of Device Evaluation (ODE)

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