AIDERA DIASEND

K083221 · Aidera AB · MRZ · Feb 3, 2009 · General Hospital

Device Facts

• Record ID: K083221
• Device Name: AIDERA DIASEND
• Applicant: Aidera AB
• Product Code: MRZ · General Hospital
• Decision Date: Feb 3, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2

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.

Device Story

Diasend system facilitates remote data management for patients using home monitoring devices; specifically glucose meters and insulin pumps. System comprises a transmitter, server database, and web-based interface. Patients or caregivers use the transmitter to upload physiological data from monitoring devices to the central server. Data is then accessible via a website for review by healthcare providers and patients. System enables remote monitoring and data storage, allowing providers to view patient data to assist in clinical decision-making and management of conditions requiring glucose or insulin monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System consists of a hardware transmitter, server database, and web-based software interface. Operates as a data transmission and storage platform for physiological signals from glucose meters and insulin pumps. Connectivity is facilitated via radiofrequency transmission to a server. No specific materials or software architecture details provided.

Indications for Use

Indicated for the transmission and storage of data from home monitoring devices, specifically glucose meters and insulin pumps, to a server database for use by patients and care providers.

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

• Patient Data Handler & Devices (K063484)
• Confidant 2.5 (K072698)
• MediCompass Connect (K042768)

Submission Summary (Full Text)

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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 [phone] [phone] 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.

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## 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.

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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); 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 [phone]. 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 [phone] or [phone] 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

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## Indications for Use

510(k) Number (if known):

K083221

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

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