R1000 SERIES INSULIN PUMP

K993184 · Animas Corp. · LZG · Feb 10, 2000 · General Hospital

Device Facts

• Record ID: K993184
• Device Name: R1000 SERIES INSULIN PUMP
• Applicant: Animas Corp.
• Product Code: LZG · General Hospital
• Decision Date: Feb 10, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Animas Corporation R1000 Series Insulin Pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the management of diabetes mellitus in insulin dependent patients. This device is intended for home use and is a prescription device.

Device Story

The R1000 Series Insulin Pump is a portable device for subcutaneous insulin delivery; manages Type 1 and select Type 2 diabetes. Device provides programmable basal and bolus insulin rates; enables daily management of blood glucose. Intended for home use by patients; requires prescription. Device functions as an alternative to existing marketed insulin pumps; provides clinical benefit through controlled insulin administration. Healthcare providers use device output to monitor and adjust insulin therapy regimens; patient benefits from improved glycemic control through precise, programmable delivery.

Clinical Evidence

Bench testing only. No clinical trial data provided.

Technological Characteristics

Subcutaneous insulin infusion pump; programmable basal and bolus delivery rates. Device is a prescription-only, home-use system. Technical specifications and materials are not detailed in the provided documentation.

Indications for Use

Indicated for insulin-dependent diabetes mellitus patients requiring subcutaneous insulin delivery. Patients must demonstrate good personal hygiene, established blood glucose control, and lack of unpredictable or large blood glucose variations.

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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K993/84

## I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

The Animas Corporation R1000 Series Insulin Pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the daily management of Type 1 and certain instances of Type 2 diabetes mellitus. The pump is indicated for use in diabetics who have good personnal hygiene, who have established control over their blood glucose and who do not have unpredictable or large variations in blood glucose levels.

Description statements were not relied on to show substantial equivalence to legally marketed devices; instead, performance data from device validation is used. The comparison of intended use and technological features of this device to other legally marketed devices taken together with validation results indicate that this device is substantially equivalent to legally marketed predicate devices with regards to safety, effectiveness and intended use.

The intended use of this device is the same as the intended use of other insulin pumps marketed to provide the same clinical benefit. Therefore, all aspect of this device have predicates which are well accepted in the clinical community. This product simply provides an alternative to those currently marketed devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 2000

Ms. Monica Ferrante Requlatory Affairs Animas Corporation 590 Lancaster Avenue Frazer, PA 19355

Re : K993184 R1000 Series Insulin Pump Trade Name: Requlatory Class: II Product Code: LZG January 21, 2000 Dated: Received: January 21, 2000

Dear Ms. Ferrante:

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 Regulations, Title 21, Parts 800 to 895. A 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

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Page 2 - Ms. Ferrante

obligation you might have under sections 531 through 542 of obligation you might have the Electronic Product Radiation Che Act for devices andor or other Federal laws or regulations.

This letter will allow you to begin marketing your device as Info icece wire as 0 (k) premarket notification. The FDA described in your 510(i) promatice of your device to a legally Finding of Bubbeanelar ogeresults in a classification for your marketed predicate actro your device to proceed to the market.

If you desire specific advice for your device on our labeling i regulation (21 CFR Part 801 and additionally 809.10 for in regaractor (re (evices), please contact the Office of VILIO draghoseic deviced// proads of the questions on Compriance at (301) deertising of your device, please contact the Dromotion and adversible [phone]. Also, please note the orrice of Compiland, "Misbranding by reference to the regulacion entreled, "Arbranding by Other general information on your responsibilities under the Act may be Information on your responsible in the facturers Assistance obcarned from chonumber [phone] or [phone] or at at its coll-free namber (0:1/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 Radiological Health

Enclosure

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## Section A – SMDA Requirements

## INDICATIONS FOR USE

The Animas Corporation R1000 Series Insulin Pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the management of diabetes mellitus in insulin dependent patients.

This device is intended for home use and is a prescription device.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use ________

(Optional Format 1-2-96)

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Arene Hansen for fxC

Division of Dental, Infection Control, and General Hospital De 510(k) Number_________________________________________________________________________________________________________________________________________________________________