(53 days)
Not Found
No
The description focuses on programmable basal and bolus rates, data transfer, and software for managing settings and food information. There is no mention of AI or ML capabilities for decision-making, pattern recognition, or adaptive control of insulin delivery.
Yes
The device is intended to provide subcutaneous delivery of insulin for the daily management of diabetes mellitus, which is a therapeutic intervention.
No
The device description indicates that the Animas Model IR1250 Insulin Infusion Pump is an external syringe pump and delivery system for the subcutaneous delivery of insulin. It manages existing conditions (diabetes mellitus) by providing insulin, not by diagnosing conditions. While it can store and display historical data, this is for monitoring and managing the insulin delivery, not for diagnostic purposes.
No
The device description clearly states it is an "external syringe pump and delivery system" and mentions hardware components like the pump itself, insulin cartridges, and an IR interface. While it includes software (ezManager Plus), it is not solely software.
Based on the provided information, the Animas Model IR1250 Insulin Infusion Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "provide subcutaneous delivery of insulin... for the daily management of diabetes mellitus in insulin dependent patients." This describes a therapeutic device that delivers medication, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a pump and delivery system for insulin. It mentions data transfer and software for managing pump settings and information, but it does not describe any components or processes for analyzing biological samples.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, or other bodily fluids.
- Providing diagnostic information.
- Using reagents or assays.
Therefore, the Animas Model IR1250 Insulin Infusion Pump is a therapeutic device for insulin delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Animas Model IR1250 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.
Product codes
LZG
Device Description
The Animas Model IR1250 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 IR1250 is used with any insulin infusion set which incorporates a luer style connection.
The pump incorporates serial communications via an infrared (IR) interface with accessories which include the Animas IR to RS-232 serial interface adaptor (the "dongle"), the Animas IR1200 cradle to hold the pump and the Animas ezManager Plus software for the user's personal computer. As with the IR1200, this connection allows the user and/or the physician to transfer (download) data stored in the pump to the personal computer where it may be displayed, printed and saved. With the IR1250 this same connection will allow the user to program the pump, via the PC with ezManager Plus software, with selected user pump settings (basal program, bolus limits, etc.) and non-operational, personalized information including user selection of names for basal settings and musical tunes for initial alert/reminder warnings prior to the present pump alert/warning sounds. Also available to the user is the option to use a PC with ezManager Plus software, to upload and/or modify selected food items and related carbohydrate information, for storage in, and reference/use directly from, pump memory.
The pump is intended for multiple years of use. To hold the insulin for subcutaneous delivery, Animas provides sterile, single use, disposable insulin cartridges for use specifically with the IR1200 series pumps.
As with the IR1200, the IR1250 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home Use; Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Animas Model IR1200 Insulin Infusion Pump
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
DEC 1 0 2004
Section 6 510(k) Summary
- Submitter: Animas Corporation, 200 Lawrence Drive, West Chester, PA 19380
- Contact: Thomas L. Parker, Manager, Requlatory Affairs, Telephone: (484)-568-1257, Fax: (484)-568-1329, Email: thomasp@animascorp.com
- Name of Device: Animas Model IR1250 Insulin Infusion Pump
Predicate Device: Animas Model IR1200 Insulin Infusion Pump
Description of the Modified Device: The Animas Model IR1250 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 IR1250 is used with any insulin infusion set which incorporates a luer style connection.
The pump incorporates serial communications via an infrared (IR) interface with accessories which include the Animas IR to RS-232 serial interface adaptor (the "dongle"), the Animas IR1200 cradle to hold the pump and the Animas ezManager Plus software for the user's personal computer. As with the IR1200, this connection allows the user and/or the physician to transfer (download) data stored in the pump to the personal computer where it may be displayed, printed and saved. With the IR1250 this same connection will allow the user to program the pump, via the PC with ezManager Plus software, with selected user pump settings (basal program, bolus limits, etc.) and non-operational, personalized information including user selection of names for basal settings and musical tunes for initial alert/reminder warnings prior to the present pump alert/warning sounds. Also available to the user is the option to use a PC with ezManager Plus software, to upload and/or modify selected food items and related carbohydrate information, for storage in, and reference/use directly from, pump memory.
The pump is intended for multiple years of use. To hold the insulin for subcutaneous delivery, Animas provides sterile, single use, disposable insulin cartridges for use specifically with the IR1200 series pumps.
As with the IR1200, the IR1250 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.
1
Intended Use of the Modified Device: The intended use of the Animas Model IR1250 Insulin Infusion Pump is the same as that of the Series IR1200 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.
Accessories to the Model IR1250 are the same as the IR1200 and include the Animas IR serial interface adaptor (the "dongle") and the Animas IR1200 Cradle to hold and align the pump while using with Animas ezManager Plus software on a personal computer. As with the IR1200, this connection allows the user and/or the physician to transfer (download) data stored in the pump to the personal computer where it may be displayed, printed, and saved. With the IR1250, this same connection will allow the user the option to program the pump, via a PC using the ezManager Plus software, with selected user pump settings (basal program, bolus limits, etc.) and non-operational, personalized information. Also available to the user, using the IR connection to the PC with ezManager Plus software, will be the ability to upload and/or modify selected food items and related carbohydrate information, for storage in, and reference/use directly from pump memory.
This device is intended for home use and is a prescription device.
Comparison of the Technological Features of the Modified Device The modified device and the predicate and the Predicate Device: device are identical in terms of design, materials, and construction. The only change made to the IR1200 is increased storage capability, in pump memory, and the minor software modifications which allow the IR1250 pump to receive program instructions from a PC, with ezManager Plus software, and accept into pump storage approximately 500 food items with associated carbohydrate information. This information can be referenced, at any time, on the pump screen, for evaluating insulin needs.
These minor differences between the modified device and the predicate device do not affect the safety or effectiveness of the device's performance.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines, representing the department's mission of protecting the health of all Americans and providing essential human services. The bird is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 2004
Mr. Thomas L. Parker Manager, Regulatory Affairs Animas Corporation 200 Lawrence Drive West Chester, Pennsylvania 19380
Re: K042873
Ro42073
Trade/Device Name: Animas Model IR1250 Insulin Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: October 15, 2004 Received: October 18, 2004
Dear Mr. Parker:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have roviewed your ever hetermined the device is substantially equivalent (for the releicheco above and have attermilosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to arrived Cosmetic Act (Act) that do not require approval of a premarket the rederal 1 600; Drug, and Comment , therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the stration, 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 If your device is classified (boo as a 10) .
(PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Writ), it may of such of Federal Regulations, Title 21, Parts 800 to 898. In your device can or roundsh further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Parker
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease oc advisod that 1 DTF is lesaultes on that your device complies with other requirements Incall that I DX mas mace a actess and regulations administered by other Federal agencies. or the Act of ally I outers. Including, but not limited to: registration r ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF RT rat 807), adoling systems (QS) regulation (21 CFR Part 820); and if requirenches as sol form in are quadiation 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 premainer netirement on 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), rr you desire specific at 100 for your ce at (240) 276-0115. 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 maj occare 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 Runner
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
4
Indications for Use
| 510(k) Number (if known): | K042873 |
|---|---|
| Device Name: | Animas Model IR1250 Insulin Infusion Pump |
| Indications For Use: | The Animas Model IR1250 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. |
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cintia Vrance
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control. Dental Devices
Page 1 of 1_
48/2873 510(k) Number:________________________________________________________________________________________________________________________________________________________________