PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORT

K990208 · Science Incorporated · MEG · Mar 25, 1999 · General Hospital

Device Facts

• Record ID: K990208
• Device Name: PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORT
• Applicant: Science Incorporated
• Product Code: MEG · General Hospital
• Decision Date: Mar 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PDS Personal Infusor with Drug Disposal Septal Port is intended for the ambulatory infusion of physician-prescribed parenteral medications. The device will be filled and prepared for administration by pharmacists, and administered by eligible patients and providers who have been trained in the pump's operation. 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.

Device Story

Self-contained, low-profile, disposable elastomeric infusion pump; delivers parenteral medications to patients via 36-inch tubing connected to venous access site. Operates via stored energy elastomeric film, substrate base with molded ullage, and preset rate control component with filter. Features visual flow status indicator for patient monitoring and septal port for removal/disposal of unused medication. Used in ambulatory settings; filled by pharmacists; operated by trained patients or providers. Enables physician selection of flow rates and drug concentrations; facilitates convenient drug administration and safe disposal of device and unused medication.

Clinical Evidence

Bench testing only. Flow performance and linearity (±10%) were evaluated across a temperature range of 10-40° C using various diluents to demonstrate equivalence to the predicate device.

Technological Characteristics

Disposable elastomeric infusion pump. Components: substrate base with molded ullage, stored energy elastomeric film, preset rate control component with filter, 36-inch tubing set, and drug disposal septal port. Mechanical flow control. No software or electronic components.

Indications for Use

Indicated for ambulatory infusion of physician-prescribed parenteral medications in patients requiring fluid therapy. Intended for use by trained patients and healthcare providers.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• Science Incorporated Personal Infusor (K971362)

Submission Summary (Full Text)

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3/25/99

K990208

Science Incorporated Personal Infusor with Drug Disposal Septal Port 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: | Science Incorporated Personal Infusor<br>(510 number K971362) |

#### Device description:

The Science Incorporated PDS Personal Infusor with Drug Disposal Septal Port 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 has a septal port which allows easy removal of unused medications to allow for proper disposal of both device and medication. 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 multiple 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. It has a drug disposal septal port for proper disposal of the unused drug per normal hospital practice.

Intended use:

The PDS Personal Infusor with Drug Disposal Septal Port is intended for the ambulatory infusion of physician-prescribed parenteral medications. The device will

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Science Incorporated Personal Infusor with Drug Disposal Septal Port 510(k) 8-2

be filled and prepared for administration by pharmacists, and administered by eligible patients and providers who have been trained in the pump's operation.

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 PDS Personal Infusor with Drug Disposal Septal Port is technologically identical to the Science Incorporated Personal Infusor except for the addition of the drug disposal septal port.

## Performance data:

The Science Incorporated PDS Personal Infusor with Drug Disposal Septal Port exhibits equivalent flow performance when compared to the predicate device. 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/1 description: The image is a black and white logo for the U.S. Department of Health and 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 caduceus symbol. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health and Human Services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 2 5 1999

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

Re : K990208 Personal Infusor with Drug Disposal Septal Trade Name: Port II Requlatory Class: Product Code: MEG January 20, 1999 Dated: January 21, 1999 Received:

Dear Mr. Hoqancamp

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 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਚੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of

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Page 2 - Mr. Hoqancamp

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to beqin 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,

Susan Runper

ta Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number:

Indications for Use:

The Science Incorporated PDS Personal Infusor with Drug Disposal Septal Port 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 device is, also, designed to allow for the removal of parenteral medication to allow for the proper disposal of both the device and the medication where disposal of both together would be contrary to normal professional health care practice.

The flexibility offered by the PDS Personal Infusor with Drug Disposal Septal Port will enable physicians to choose from a variety of fluid flow rates and drug concentrations. It will provide clinicians and patients with a convenient and efficient option for administration of fluid medications to patients, as well as allow for proper disposal of device and unused fluid medications.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricio Cucente

vision of Dental, Infection Control. and General Hospital Devic 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The Counter Use_ OR

(Optional Format 1-2-96)