PERSONAL INFUSOR

K971362 · Science Incorporated · MEB · Dec 4, 1997 · General Hospital

Device Facts

• Record ID: K971362
• Device Name: PERSONAL INFUSOR
• Applicant: Science Incorporated
• Product Code: MEB · General Hospital
• Decision Date: Dec 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Personal Infusor is intended for the ambulatory infusion of physician-prescribed parenteral medications. The device will be filled and prepared for administration by pharmacists, and provided to eligible patients who have been trained in the pump's operation.

Device Story

Personal Infusor is a self-contained, disposable, low-profile elastomeric infusion pump. It utilizes a substrate base with molded ullage, stored energy elastomeric film, and a preset rate control component with filter to deliver parenteral medications. Input is the medication volume; output is fluid delivery via a 36-inch tubing set to a venous access site. Device features a visual flow status indicator (Flowing, Blockage, Empty). Used in ambulatory settings; operated by trained patients after pharmacist preparation. Provides a convenient, efficient delivery method for physician-prescribed drugs, allowing for various flow rates and concentrations.

Clinical Evidence

Bench testing only. Studies demonstrated flow linearity of ±10% over a temperature range of 10-40° C using various diluents and viscosities, showing improved performance over predicate devices.

Technological Characteristics

Elastomeric infusion pump; disposable; low-profile. Components: substrate base, stored energy elastomeric film, single orifice rate control with filter. Features visual flow status indicator. Seven volume/flow rate configurations. Mechanical operation; no software or electronics.

Indications for Use

Indicated for ambulatory infusion of physician-prescribed parenteral medications in patients trained in pump operation.

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.

Predicate Devices

• Block Medical Inc., Homepump Eclipse™ (K896546)
• Baxter Healthcare Corp., Intermate® SV (K910425)

Submission Summary (Full Text)

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K971362

DEC - 4 1997

Science Incorporated Personal Infusor 510(k)

8-1

#### SUMMARY OF SAFETY AND EFFECTIVENESS 8.0

Submitters name:

Science Incorporated 7760 France Avenue South, Suite 1060 Bloomington, MN 55435 [phone] [phone] (fax) Contact person: Ralph E. Hogancamp, Director of Quality and Regulatory Affairs

| Device name: | Proprietary name: | To be determined |
|--------------------|-------------------------------------------------|------------------|
| | Common name: | Elastomeric pump |
| | Classification name: | Infusion pump |
| Predicate devices: | Block Medical Inc., Homepump Eclipse™ (K896546) | |

# Baxter Healthcare Corp., Intermate® SV (K910425)

## Device description:

The Science Incorporated Personal Infusor is a self-contained, low-profile, disposable infusion device intended for the ambulatory delivery of physician-prescribed parenteral medications to patients. Its design engages three principle elements: a substrate base with molded ullage, a stored energy elastomeric film, and a preset rate control component with filter. Fluid medicaments are delivered to a patient via an attached 36 inch tubing set that adjoins a preexisting venous access site. The unit is disposable following a single use and features a novel visual flow status indicator that facilitates patient monitoring. The pump will be available in seven volume/flow rate configurations, and prototype models have demonstrated unsurpassed accuracy and consistency of fluid flow over a broad gamut of operating temperatures and with solutions of widely varying viscosities.

# Intended use:

The Personal Infusor is intended for the ambulatory infusion of physician-prescribed parenteral medications. The device will be filled and prepared for administration by pharmacists, and provided to eligible patients who have been trained in the pump's operation.

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The flexibility offered by the device design will enable physicians to select from a variety of fluid flow rates and drug concentrations, and will provide clinicians and patients with a convenient and efficient option for the administration of beneficial drugs to patients.

## Technological characteristics:

The Personal Infusor is technologically similar to the Baxter Intermate® SV and the Block Homepump Eclipse™. However, it offers two improvements: 1) it features a single orifice rate control component that provides superior control of flow compared to the predicate devices, and 2) it has a flow indicator that displays the states of Flowing, Blockage, and Empty.

#### Performance data:

The Science Incorporated Personal Infusor exhibits improved flow performance when compared to the predicate devices. In our studies, the new devices displayed linearity of ±10% over a temperature range of 10-40° C when used with various diluents.

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The overall design is simple and professional, reflecting the organization's role in public health and welfare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 4

Mr. Ralph E. Hogancamp Director of Quality and Regulatory Affairs Science, Incorporated Minnesota Center 7760 France Avenue South, Suite 1060 Bloomington, Minnesota 55435

K971362 Re : Personal Infusor Trade Name: Requlatory Class: II Product Code: MEB September 5, 1997 Dated: Received: September 5, 1997

Dear Mr. Hogancamp:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਖ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Hogancamp

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

. Enclosure

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510(k) Number: K971362

Device Name: Science Incorporated Personal Infusor

Indications for Use:

The Science Incorporated Personal Infusor is designed for the ambulatory infusion of physician-prescribed parenteral medications. The device is intended to be filled and prepared for administration by pharmacists, and provided to patients who have been trained in the pump's operation.

The flexibility offered by the Personal Infusor will enable physicians to choose from a variety of fluid flow rates and drug concentrations, and will provide clinicians and patients with a convenient and efficient option for administration of fluid medications to patients.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Labrina Cocceratti

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

510(k) Number *K971562*

Prescription Use
(Per 21 CFR 801.109)

Over-The Counter Use__________________________________________________________________________________________________________________________________________________________ OR

(Optional Format 1-2-96)