(106 days)
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.
Software accessory to ACCU-CHEK® brand meters and/or Disetronic/ACCU-CHEK insulin infusion pumps.
This K080227 submission for the ACCU-CHEK® 360° Diabetes Management System is a 510(k) summary and not a detailed study report. Therefore, it does not contain the specific information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, or comparative effectiveness studies.
The document primarily focuses on demonstrating substantial equivalence to predicate devices (Camit Diabetes Management Software and Smart Pix Device Reader) rather than presenting a performance study against predefined acceptance criteria. This type of submission relies on showing that the new device has the same intended use and technological characteristics as a legally marketed device, or that any differences do not raise new questions of safety and effectiveness.
Here's a breakdown of why the requested information is absent:
- Acceptance Criteria and Reported Device Performance (Table): Not provided. The submission’s core is a comparison of features and functionalities with predicate devices, not performance metrics against criteria.
- Sample Size and Data Provenance (Test Set): Not applicable as a formal performance test set with a specific sample size for evaluating accuracy or specific performance metrics is not detailed. The "study" here is a comparison of features.
- Number of Experts and Qualifications (Ground Truth): Not applicable for this type of submission. There's no clinical "ground truth" establishment described in the context of device performance evaluation.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not mentioned or applicable. This is not a study assessing human reader improvement with AI assistance.
- Standalone Performance Study: Not explicitly described with performance metrics. The submission focuses on functional equivalence.
- Type of Ground Truth Used: Not applicable in the context of device performance. The "truth" in this submission relates to the functional attributes and capabilities of the software.
- Sample Size for Training Set: Not applicable. This software is a diabetes management system, not an AI/ML model that would typically have a "training set" in the conventional sense of machine learning.
- How Ground Truth for Training Set was Established: Not applicable.
Summary of what the document does provide:
- Device Name: ACCU-CHEK® 360° Diabetes Management System
- Indications for Use: For individuals or healthcare professionals to support effective diabetes management, allowing entry of healthcare parameters and report/graphical output. Indicated for professional use and over-the-counter sale.
- Predicate Devices: Camit Diabetes Management Software (K001907) and Smart Pix Device Reader (K062395).
- Similarities and Differences Table: This table compares features of the ACCU-CHEK® 360° with the predicate devices, covering aspects like device memory downloading, report generation, compatibility, data storage, and security. This is the primary "evidence" for substantial equivalence.
Without a detailed performance study, which is often not required for this type of software a 510(k) submission, the specific information requested cannot be extracted from the provided text.
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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 informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
|---|---|
| Submittername, address,contact | Roche Diagnostics9115 Hague Rd.PO Box 50457Indianapolis, IN 46250Contact Person: Scott Thiel |
| DeviceClassification | Trade Name: ACCU-CHEK® 360° Diabetes Management SystemCommon Name: diabetes management softwareClassification Name: calculator/data processing module for clinical useClassification Regulations: 880.5725, 862.1345, 862.2100Product Codes: LZG, LFR, JQP |
| PredicateDevice(s) | We claim substantial equivalence of the ACCU-CHEK 360° DiabetesManagement System to the current legally marketed Camit DiabetesManagement Software (K001907) and Smart Pix Device Reader (K062395). |
| DeviceDescription | Software accessory to ACCU-CHEK® brand meters and/orDisetronic/ACCU-CHEK insulin infusion pumps. |
| Indications forUse Statement | The ACCU-CHEK® 360° Diabetes Management System is indicated for useby individuals or healthcare professionals in the home or health care facilitiesto support effective diabetes management. The software also allows for entryof other healthcare parameters with or without diabetes related information,which can be shown in report and graphical format. This device is indicatedfor professional use and over-the-counter sale. |
:
Continued on next page
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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 tosupport retrospective data analysis. | Yes | Yes |
| Generates reports using retrospective datafrom both blood glucose monitors andinsulin infusion pumps. | No | Yes |
| Uses activation key to establish whichprogram functionality is made available tothe end user. | No | No |
| Compatible with Microsoft XP OperatingSystem (OS). | Yes | Yes |
| Support through ACCU-CHEK CustomerCare | Yes | Yes |
| Data storage on computer media | Yes | Yes |
| Track non-blood glucose data (e.g.carbohydrates, insulin, time blocks, eventcodes) | Yes | Yes |
| On-line help | Yes | No |
| Ability to support multiple patients in thesame database | Yes | No |
| Password protection | Yes | No |
| Allows for manual entry of data | Yes | No |
Continued on next page
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510(k) Summary: ACCU-CHEK® 360 Diabetes Management System, Continued
Similarities and Differences (continued)
| ACCU-CHEK® 360° | Camit | Smart Pix |
|---|---|---|
| Security through secure socket layerprotocol with 128-bit encryption. Relianceupon user to maintain security of user idand password. | Yes | Yes |
| User has option of sending reports viaemail, printing, or viewing on screen | User has option ofreviewing on screen orprinting. | User has option ofreviewing on screen orprinting. |
| On-line help, tour, getting started guide,frequently asked questions (FAQ). | Yes | Yes |
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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.
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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
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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
§ 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).