(86 days)
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.
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.
The provided text is a 510(k) summary for the Animas Model IR 1200 Insulin Infusion Pump. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific information about:
- Acceptance criteria for device performance.
- A study proving the device meets acceptance criteria.
- Sample sizes for test sets or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for training sets.
- How ground truth for training set was established.
The document primarily focuses on establishing substantial equivalence based on design, materials, and construction, rather than detailed performance study results against specific criteria. The statement in Section 1 "The differences between the new device and the predicate device do not affect the safety or effectiveness of the device" is a high-level assertion but not supported by detailed study data in this document.
Therefore, I cannot fulfill your request for this specific information based on the provided input. The document does not contain the necessary details to construct the requested table and answer the study-related questions.
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OCT 1 6 2003
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: (610)-644 8990, extension 1257, Fax: (610)-644-8717, Email: michaeland@animascorp.com
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
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 features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird. The text is in all capital letters and is evenly spaced around the circle.
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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 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)
§ 880.5725 Infusion pump.
(a)
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.(b)
Classification. Class II (performance standards).