(106 days)
Not Found
No
The summary describes a diabetes management system software that supports data entry and reporting, but there is no mention of AI or ML capabilities, image processing, or performance studies typically associated with AI/ML devices.
No
The device is described as a software accessory for diabetes management, allowing for data entry and reporting, but it does not directly treat or diagnose a condition. It is a tool to support effective management rather than a therapeutic intervention itself.
No
The device is described as software to support effective diabetes management, focusing on data entry, reporting, and graphical display of healthcare parameters. It does not state that it diagnoses conditions.
Yes
The device description explicitly states it is a "Software accessory" to other medical devices (meters and pumps), indicating it is a software-only component.
Based on the provided information, the ACCU-CHEK® 360° Diabetes Management System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the system as supporting effective diabetes management by allowing entry and display of healthcare parameters. It does not mention analyzing biological samples (like blood, urine, etc.) to diagnose, monitor, or screen for a disease or condition.
- Device Description: It's described as a software accessory to meters and insulin pumps. While these meters might be IVDs (as they analyze blood), the software itself is for managing the data from those devices, not performing the diagnostic test itself.
- Lack of IVD Characteristics: The description doesn't mention any analytical function performed on biological samples. It's focused on data management and reporting.
IVDs are devices specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The ACCU-CHEK® 360° Diabetes Management System's function is to organize and present data generated by other devices (like blood glucose meters), not to perform the diagnostic test itself.
N/A
Intended Use / Indications for Use
The ACCU-CHEK® 360° Diabetes Management System is indicated for use by individuals or healthcare professionals in the home or health care facilities to support effective diabetes management. The software also allows for entry of other healthcare parameters with or without diabetes related information, which can be shown in report and graphical format. This device is indicated for professional use and over-the-counter sale.
Product codes (comma separated list FDA assigned to the subject device)
LZG, LFR, JQP, MRZ
Device Description
Software accessory to ACCU-CHEK® brand meters and/or Disetronic/ACCU-CHEK insulin infusion pumps.
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)
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
MAY 1 5 2008
510(k) Summary: ACCU-CHEK® 360° Diabetes Management System
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter
name, address,
contact | Roche Diagnostics
9115 Hague Rd.
PO Box 50457
Indianapolis, IN 46250
Contact Person: Scott Thiel |
| Device
Classification | Trade Name: ACCU-CHEK® 360° Diabetes Management System
Common Name: diabetes management software
Classification Name: calculator/data processing module for clinical use
Classification Regulations: 880.5725, 862.1345, 862.2100
Product Codes: LZG, LFR, JQP |
| Predicate
Device(s) | We claim substantial equivalence of the ACCU-CHEK 360° Diabetes
Management System to the current legally marketed Camit Diabetes
Management Software (K001907) and Smart Pix Device Reader (K062395). |
| Device
Description | Software accessory to ACCU-CHEK® brand meters and/or
Disetronic/ACCU-CHEK insulin infusion pumps. |
| Indications for
Use Statement | The ACCU-CHEK® 360° Diabetes Management System is indicated for use
by individuals or healthcare professionals in the home or health care facilities
to support effective diabetes management. The software also allows for entry
of other healthcare parameters with or without diabetes related information,
which can be shown in report and graphical format. This device is indicated
for professional use and over-the-counter sale. |
:
Continued on next page
1
510(k) Summary: ACCU-CHEK® 360 Diabetes Management System, Continued
The following tables provide a listing of product similarities and differences Similarities and Differences between the ACCU-CHEK® 360° Diabetes Management System and the predicate devices: ACCU-CHEK® Camit Diabetes Management Software and ACCU-CHEK® Smart Pix.
| ACCU-CHEK® 360° | Camit | Smart Pix |
|---|---|---|
| Downloads device memory from ACCU- | ||
| CHEK blood glucose monitors. | Yes | Yes |
| Downloads device memory from ACCU- | ||
| CHEK insulin infusion pumps. | No | Yes |
| Generates reports and basic statistics to | ||
| support retrospective data analysis. | Yes | Yes |
| Generates reports using retrospective data | ||
| from both blood glucose monitors and | ||
| insulin infusion pumps. | No | Yes |
| Uses activation key to establish which | ||
| program functionality is made available to | ||
| the end user. | No | No |
| Compatible with Microsoft XP Operating | ||
| System (OS). | Yes | Yes |
| Support through ACCU-CHEK Customer | ||
| Care | Yes | Yes |
| Data storage on computer media | Yes | Yes |
| Track non-blood glucose data (e.g. | ||
| carbohydrates, insulin, time blocks, event | ||
| codes) | Yes | Yes |
| On-line help | Yes | No |
| Ability to support multiple patients in the | ||
| same database | Yes | No |
| Password protection | Yes | No |
| Allows for manual entry of data | Yes | No |
Continued on next page
2
510(k) Summary: ACCU-CHEK® 360 Diabetes Management System, Continued
Similarities and Differences (continued)
| ACCU-CHEK® 360° | Camit | Smart Pix |
|---|---|---|
| Security through secure socket layer | ||
| protocol with 128-bit encryption. Reliance | ||
| upon user to maintain security of user id | ||
| and password. | Yes | Yes |
| User has option of sending reports via | ||
| email, printing, or viewing on screen | User has option of | |
| reviewing on screen or | ||
| printing. | User has option of | |
| reviewing on screen or | ||
| printing. | ||
| On-line help, tour, getting started guide, | ||
| frequently asked questions (FAQ). | Yes | Yes |
:
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight. The symbol is composed of several curved lines that create a sense of movement and dynamism.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 15 2008
Mr. Scott Thiel Regulatory Affairs Program Manager Roche Diagnostics Corporation 9115 Hague Road Indianapolis, Indiana 46250
Re: K080227
Trade/Device Name: ACCU-CHEK® 360° Diabctes Management System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ Dated: May 1, 2008 Received: May 2, 2008
Dear Mr. Thiel:
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.
4
Page 2 - Mr. Thiel
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 Office of Compliance 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 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/industrv/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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
5
Indications for Use
510(k) Number (if known): K080227
Device Name: ACCU-CHEK® 360° Diabetes Management System
Indications for Use:
The ACCU-CHEK® 360° Diabetes Management System is indicated for use by individuals or healthcare professionals in the home or health care facilities to support effective diabetes management. The software also allows for entry of other healthcare parameters with or without nianagement. The betwere and in report and graphical format. This device is indicated for professional use and over-the-counter sale.
Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR
XX Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page _ of _
510(k) Number: K080227