MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO

K021439 · Animas Corp. · LZG · May 29, 2002 · General Hospital

Device Facts

• Record ID: K021439
• Device Name: MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO
• Applicant: Animas Corp.
• Product Code: LZG · General Hospital
• Decision Date: May 29, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Animas Model R1000 IR Insulin Infusion Pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the daily management of diabetes mellitus in insulin dependent patients. The accessories to the Model R1000 IR, the Animas RS-232 IR serial interface adator (the "dongle"), the Animas R1000 IR cradle to hold the pump and the Animas ezLink™ software are intended to transfer data stored in the pump to the personal computer of a patient or a physician, where it may be displayed, printed, and saved. This device is intended for home use and is a prescription device.

Device Story

External syringe pump for subcutaneous insulin delivery; programmable basal and bolus rates. System includes pump, infusion set, IR serial interface adapter (dongle), cradle, and ezLink PC software. Used in home setting by patients; physician oversight. Pump stores data including daily totals, alarm history, bolus history, basal rates, and settings. Data transferred via infrared (IR) link to PC for display, printing, and saving. Facilitates diabetes management by enabling patient/physician review of therapy history.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological similarity to the predicate device.

Technological Characteristics

External syringe pump; infrared (IR) communication interface; RS-232 serial interface adapter; PC-based data management software. System includes cradle and infusion set. Sterility maintained for disposable insulin syringes.

Indications for Use

Indicated for insulin-dependent patients with diabetes mellitus requiring continuous subcutaneous insulin infusion for daily management.

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

• Animas R1000 Series Insulin Infusion Pump

Submission Summary (Full Text)

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# MAY 2 9 2002

K021439

#### 510(k) Summary Section 6

- Submitter: Animas Corporation, 590 E. Lancaster Avenue, Frazer, PA 19355
- Michael J. Andrews, Ph.D., Director, Regulatory Affairs, Contact: Telephone: [phone], extension 257, Fax: [phone], Email: [e-mail]

Name of Device: Animas Model R1000 IR Insulin Infusion Pump

Predicate Device: Animas R1000 Series Insulin Infusion Pump

Description of the Modified Device: The Animas Model R1000 IR Insulin Infusion Pump is an external syringe pump and delivery system that provides subcutaneous delivery of insulin for patients with diabetes mellitus who would benefit from a continuous insulin infusion process. The Model R1000 IR is used with an infusion set, e.g., the Animas ezSet™. The pump incorporates serial communications via an infrared The Animas RS-232 IR serial interface adaptor (the (IR) interface. "dongle"), the Animas R1000 IR cradle to hold the pump, the Animas and the Animas ezLink™ software for the user's personal computer are the remaining components of the system. The ezLink™ software will allow the user to download records from the pump for Daily Totals, Alarm History, Bolus History, as well as Basal Rate programs and PUMP Settings. A leather case and a belt clip are provided as accessories. The pump is intended for multiple years of use and the insulin syringe is a sterile, single use disposable manufactured for Animas.

The system will deliver a prescribed dosage of insulin as a single programmable bolus or at multiple programmable basal rates. The system will also provide set up information, dosage history, alarms, error and warning messages, device status, and self test capabilities.

Intended Use of the Modified Device: The intended use of the Animas Model R1000 IR Insulin Infusion Pump is the same as that of the Series R1000 Insulin Infusion Pump, namely to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the management of diabetes mellitus in insulin dependent patients. The accessories to the Model R1000 IR, the Animas RS-232 IR serial interface adator (the "dongle"), the Animas R1000 IR cradle to hold the pump and the Animas ezLink™ software are intended to transfer data stored in the pump to the

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personal computer of a patient or a physician, where it may be displayed, printed, and saved.

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

Comparision of the Technological Features of the Modified Device and the Predicate Device: The modified device and the predicate (unmodified) device are nearly identical in terms of design, materials, and construction. The only difference is the addition of the short-range IR communication capability.

This difference between the modified device and the predicate device does not affect the safety or effectiveness of the device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or a cape.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 2002

Mr. Michael J. Andrews Director, Regulatory Affairs Animas Corporation 590 East Lancaster Avenue Frazer. Pennsylvania 19355

Re: K021439

Trade/Device Name: Animas Model R1000 IR Insulin Infusion Pump Regulation Number: 880.5725 Regulation Name: Insulin Pump Regulatory Class: II Product Code: LZG Dated: May 3, 2002 Received: May 6, 2002

Dear Mr. Andrews:

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 of the Act or any Federal statutes and regulations administered by other Federal agencies.

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## Page 2 - Mr. Andrews

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

[signature]

Timetly 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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### Indications for Use Statement Section 8

510(k) Number: K021439

Animas Model R1000 IR Insulin Infusion Pump Device Name:

Indications for Use: The Animas Model R1000 IR Insulin Infusion Pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the daily management of diabetes mellitus in insulin dependent patients. The accessories to the Model R1000 IR, the Animas RS-232 IR serial interface adator (the "dongle"), the Animas R1000 IR cradle to hold the pump and the Animas ezLink™ software are intended to transfer data stored in the pump to the personal computer of a patient or a physician, where it may be displayed, printed, and saved.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rilara Cincente

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Division of Dental, Infection Control, Division on Denton Benton
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