(162 days)
Not Found
No
The description focuses on data transmission and storage, with no mention of AI/ML algorithms for analysis or interpretation.
No
The device is described as a system for transmitting data from home monitoring devices to a server database to support diabetes management. It does not directly treat or diagnose a disease.
No
The device transmits data from home monitoring devices to a server database to support diabetes management; it does not perform diagnosis itself.
No
The device description explicitly states the system consists of a transmitter, a server database, and a website. While the transmitter is described as a "software concept," the overall system includes hardware components (the computer device, e.g., desktop, laptop, or mobile phone) on which the software runs and interacts with the home monitoring devices. The performance studies also mention compliance with EMC and FCC requirements, which are typically associated with hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to transmit data from home monitoring devices (like glucose meters and insulin pumps) to a server database for diabetes management. It does not involve analyzing biological samples or providing diagnostic information directly from a sample.
- Device Description: The device is described as a system for transmitting data, consisting of a transmitter, server database, and website. It's a data management and communication tool, not a device that performs in vitro tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, etc.), reagents, or any process that would fall under the definition of an in vitro diagnostic device.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device facilitates the management of data obtained from other devices, but it doesn't perform the diagnostic testing itself.
N/A
Intended Use / Indications for Use
Aidera Diasend is indicated for use by individuals or healthcare professionals in the home or health care facilities for transmitting data from home monitoring devices such as glucose meters and insulin pumps to a server database to support diabetes management. The device is indicated for professional use and over-the-counter sales.
Product codes (comma separated list FDA assigned to the subject device)
MRZ, NBW
Device Description
Diasend is a system for transmitting data from patients' home monitoring devices and consists of a transmitter, a server database and a website available for the care provider and the patient.
The software transmitter is a Diasend software concept developed by Aidera that may run on a computer device, e.g. desktop computer, laptop or mobile phone, designed to transmit data to the Diasend server database. Current implementation is on Windows XP.
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
individuals or healthcare professionals in the home or health care facilities
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)
The Diasend transmitter is tested and found to comply with applicable EMC and FCC requirements and standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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SUMMARY AND CERTIFICATION
510(k) SUMMARY
DEC - 7 2010
Summary of Safety and Effectiveness
In accordance with 21 CFR 807.92, the following information constitutes the Aidera summary for the Diasend System.
| SUBMITTER'S NAME:
ADDRESS: | Aidera
Aidera AB
Sahlgrenska Science Park
Medicinaregatan 8A
SE 413 46 Goteborg
Sweden |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| CONTACT PERSON:
TELEPHONE NUMBER:
FAX NUMBER: | Anders Sonesson
+46 31 741 17 85
+46 31 741 17 01 |
| DATE OF SUBMISSION: | June 18, 2010 |
1. Identification of device
| Proprietary Name: | Diasend |
|---|---|
| Common Name: | Accessories, Pump, Infusion |
| System, Test, Blood Glucose, Over The Counter | |
| Classification Status: | Class II according to Sec. 880.2910 and 862.1345 |
| Product Codes: | MRZ, NBW |
2. Equivalent devices
K083221, Aidera AB, Aidera Diasend K072698, Confidant Inc, Confidant 2.5 K032164, Medtronic Inc, Medtronic Minimed DDMS
3. Description of the Device
Diasend is a system for transmitting data from patients' home monitoring devices and consists of a transmitter, a server database and a website available for the care provider and the patient.
The software transmitter is a Diasend software concept developed by Aidera that may run on a computer device, e.g. desktop computer, laptop or mobile phone, designed to transmit data to the Diasend server database. Current implementation is on Windows ХР.
4. Intended use
Aidera Diasend is indicated for use by individuals or healthcare professionals in the home or health care facilities for transmitting data from home monitoring devices such as glucose meters and insulin pumps to a server database to support diabetes management. The device is indicated for professional use and over-the-counter sales.
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Technological characteristics, comparison to predicate device. ട.
The Diasend system is intact except for the addition of the software transmitter compared to previously cleared device. See section 5 for a more elaborate comparison.
6. Discussion of performance testing.
The Diasend transmitter is tested and found to comply with applicable EMC and FCC requirements and standards.
7. Conclusion
.
Based on comparison with the predicate devices, the Aidera Diasend System is substantially equivalent to the previously cleared devices and presents no new concerns about safety and effectiveness.
8. Indications for Use Statement
Aidera Diasend is indicated for use by individuals or healthcare professionals in the home or health care facilities for transmitting data from home monitoring devices such as glucose meters and insulin pumps to a server database to support diabetes management. The device is indicated for professional use and over-the-counter sales.
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Image /page/2/Picture/0 description: The image contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is written in a simple, sans-serif font and is horizontally oriented. The words are evenly spaced, and the overall appearance is clean and professional.
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Anders Sonesson CEO AIDERA AB Medicinaregatan 8A SE 413 46 Goteborg Sweden
DEC - 7 2010
Re: K101806
Trade/Device Name: Aidera Diasend System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ, NBW Dated: November 17, 2010 Received: November 22, 2010
Dear Mr. Sonesson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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Page 2- Mr. Sonesson
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours
Anthony D. Watson, B.S., M.S., M.B.A. 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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DEC - 7 2010
INDICATIONS FOR USE
510(k) Number K101806
Device Name:
Aidera Diasend System
Indications for Use:
Aidera Diasend is indicated for use by individuals or healthcare professionals in the home or health care facilities for transmitting data from home monitoring devices such as glucose meters and insulin pumps to a server database to support diabetes management. The device is indicated for professional use and over-thecounter sales.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
OR
Over the Counter Use_ X
Phil C. Chapman 12/6/10
(Division Sign-Off) (Division Sign-Girl)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K101806
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