(95 days)
Not Found
No
The summary describes a data transmission system and does not mention any AI or ML capabilities.
No
The device is described as a system for transmitting data from home monitoring devices to a server database and website, not for directly treating a medical condition. Its function is data management, not therapeutic intervention.
No
Explanation: The device is described as a system for transmitting data from home monitoring devices to a server database, not for diagnosing conditions or diseases. Its function is data transfer, not diagnostic interpretation.
No
The device description explicitly states that the system consists of a "transmitter, a server database and a website," indicating hardware components (transmitter) beyond just software.
Based on the provided information, Diasend is not an IVD (In Vitro Diagnostic) device.
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. This is a data management and transmission function, not a diagnostic test performed on biological samples in vitro.
- Device Description: The description confirms it's a system for transmitting data, consisting of a transmitter, server database, and website. It doesn't mention any components or processes that would involve analyzing biological samples.
- Lack of IVD Characteristics: The information provided does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, etc.)
- Providing a diagnostic result based on the analysis of biological samples
- Reagents or assays
The device's function is to facilitate the transfer of data generated by other devices (which may or may not be IVDs themselves, like a glucose meter). Diasend itself is a data handling system.
N/A
Intended Use / Indications for Use
Diasend is intended for transmitting data from home monitoring devices such as glucose meters and insulin pumps to a server data base.
Product codes (comma separated list FDA assigned to the subject device)
MRZ, NBW
Device Description
Diasend is a system for transmitting of 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.
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
Not Found
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): 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).
0
KCF3221
SUMMARY AND CERTIFICATION
510(k) SUMMARY
FEB -3 2009
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: .
CONTACT PERSON:
FAX NUMBER:
TELEPHONE NUMBER:
DATE OF SUBMISSION:
Aidera Aidera AB Sahlgrenska Science Park Medicinaregatan 8A SE 413 46 Goteborg Sweden Anders Sonesson +46 31 741 17 85 +46 31 741 17 01 October 30, 2008
1. Identification of device
Proprietary Name: Diasend Common Name: Radiofrequency physiological signal transmitter and receiver Class II according to Sec. 880.2910 and 862.1345 Classification Status: Product Codes: MRZ and NBW
2. Equivalent devices
K063484, Intermed Advicor Inc, Patient Data Handler & Devices K072698, Confidant Inc. Confidant 2.5 K042768, iMetrikus Inc. MediCompass Connect
3. Description of the Device
Diasend is a system for transmitting of 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.
4. Intended use
Diasend is intended for storage and transmitting data from home monitoring devices such as glucose meters and insulin pumps to a server database.
1
DEPARTMENT OFHEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three overlapping wings, representing health, human services, and the pursuit of well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Anders Sonesson Chief Executive Officer Aidera AB Sahlgrenska Science Park Medicinaregatan 8A SE 413 46 Goteborg SWEDEN
FFB - 3 2009
Re: K083221
Trade/Device Name: Aidera Diasend System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ, NBW Dated: December 23, 2009 Received: December 30, 2009
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.
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.
2
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); 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ginette Y. Michaud, M.D.
Ginette Y. Michaud. M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name:
Aidera Diasend System
Indications For Use:
Diasend is intended for transmitting data from home monitoring devices such as glucose meters and insulin pumps to a server data base.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Atoms.
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of
5
510(k) Number: