MODEL IR 1200 INSULIN PUMP

K032257 · Animas Corp. · LZG · Oct 16, 2003 · General Hospital

Device Facts

• Record ID: K032257
• Device Name: MODEL IR 1200 INSULIN PUMP
• Applicant: Animas Corp.
• Product Code: LZG · General Hospital
• Decision Date: Oct 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Animas Model IR 1200 Insulin Infusion Pump is the same as that of the Series IR 1000 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. This device is intended for home use and is a prescription device.

Device Story

External syringe pump for subcutaneous insulin delivery; manages diabetes mellitus. Inputs: user-programmed basal rates and bolus dosages. Operation: delivers insulin via infusion set (e.g., Animas ezSet); incorporates infrared (IR) interface for data communication. Output: insulin delivery; device status; dosage history; alarm/error messages. Used in home setting by patients. Healthcare providers use downloaded records (Daily Totals, Alarm History, Bolus History, Basal Rate programs) to monitor therapy and adjust insulin regimens. Benefits: continuous insulin infusion for improved glycemic management.

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 for data download; sterile, single-use disposable insulin syringe. System provides programmable basal/bolus delivery, self-test capabilities, and alarm/error monitoring.

Indications for Use

Indicated for insulin-dependent patients with diabetes mellitus requiring subcutaneous insulin delivery via programmable basal and bolus rates. Intended for home use by prescription.

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 IR 1000 Series Insulin Infusion Pump

Submission Summary (Full Text)

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## OCT 1 6 2003

K032257

## Section 7 510(k) Summary

- Submitter: Animas Corporation, 590 E. Lancaster Avenue, Frazer, PA 19355
- Michael J. Andrews, Ph.D., Director, Regulatory Affairs, Contact: Telephone: [phone], extension 1257, Fax: [phone], Email: [e-mail]

Name of Device: Animas Model IR 1200 Insulin Infusion Pump

Predicate Device: Animas IR 1000 Series Insulin Infusion Pump

Description of the New Device: The Animas Model IR 1200 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 IR 1200 is used with an infusion set, e.g., the Animas ezSet™ The pump incorporates serial communications via an infrared (IR) interface. The user may download records from the pump for Daily Totals, Alarm History, Bolus History, as well as Basal Rate programs and Pump Settings. 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 New Device: The intended use of the Animas Model IR 1200 Insulin Infusion Pump is the same as that of the Series IR 1000 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.

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

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Comparision of the Technological Features of the New Device and the Predicate Device: The new device and the predicate device are nearly identical in terms of design, materials, and construction. The only differences are certain additional features found on the IR 1200 that make the IR 1200 more convenient for the user.

The differences between the new device and the predicate device do not affect the safety or effectiveness of the device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 6 2003

Mr. Richard R. Michelin Vice President Quality Assurance Animas Corporation 590 E. Lancaster Avenue Frazer, Pennsylvania 19355

Re: K032257

Trade/Device Name: Animas Model IR 1200 Insulin Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: July 21, 2003 Received: July 22, 2003

Dear Ms. 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.

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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. 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 (OS) 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Susan Runne

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement Section 9

KOS2257 -510(k) Number:

Device Name: Animas Model IR 1200 Insulin Infusion Pump

Indications for Use: The Animas Model IR 1200 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.

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

Patroux Lucente

Division of Anesthesiology, General Hospital Infection Control, Dental D

510(k) Number: K032257

Concurrence of CDRH, Office of Device Evaluation (ODE)