(50 days)
Not Found
No
The description focuses on data management, analysis, and calculation based on user-entered data, with no mention of AI or ML techniques.
No
The device is described as software that supports diabetes management by analyzing data and calculating insulin/carbohydrate doses, but it explicitly states it is "not intended to provide any diagnosis based upon patient results." While it aids in management, it does not directly treat or diagnose a condition, which is a characteristic of a therapeutic device.
No
The "Device Description" explicitly states, "The device is not intended to provide any diagnosis based upon patient results." Its purpose is to download, display, review, analyze, and evaluate historical data to support diabetes management and calculate insulin/carbohydrate doses, not to diagnose.
Yes
The device is described as "accessory software" and its function is to download, save, display, review, analyze, and evaluate data, as well as calculate doses based on user-entered data. There is no mention of any hardware component being part of the device itself, only that it interacts with external devices (insulin pumps and blood glucose meters) and runs on a PDA.
Based on the provided information, the ACCU-CHEK Pocket Compass Diabetes Management Software is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: IVDs are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves analyzing biological samples like blood, urine, or tissue.
- Device's intended use: The software's primary intended use is to download, save, display, review, analyze, and evaluate data from blood glucose meters and insulin pumps. It also calculates insulin or carbohydrate doses based on user-entered data.
- Lack of specimen analysis: The software does not directly analyze any biological specimens. It works with data that has already been generated by other devices (blood glucose meters and insulin pumps).
- Explicit statement: The device description explicitly states, "The device is not intended to provide any diagnosis based upon patient results." While it supports diabetes management, it doesn't perform the diagnostic testing itself.
Therefore, the ACCU-CHEK Pocket Compass Diabetes Management Software functions as a data management and decision support tool, not a device that performs in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ACCU-CHEK Pocket Compass Diabetes Management Software is a single user system indicated for use as an accessory to compatible Disetronic insulin pumps and a number of commercially available Accu-Chek blood glucose meters to download data from these devices to a personal digital assistant (PDA) where it may be saved, displayed, reviewed, analyzed, and evaluated to support effective diabetes management. The Accu-Chek Pocket Compass Software is also indicated for the management of diabetes by calculating an insulin or carbohydrate dose based on user entered data. The device is indicated for over-the-counter sale.
Product codes
LZG, LFR, JQP
Device Description
An accessory software that enables the person with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results and insulin infusion pump data to support effective diabetes management, including calculating an insulin or carbohydrate dose based on user entered data. The device is not intended to provide any diagnosis based upon patient results.
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
person with diabetes and their health care professionals / 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)
current legally cleared product of the same name.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
: 上
| 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. |
|---|---|
| 1) Submitter name, address, contact | Roche Diagnostics Corporation |
| 9115 Hague Rd. | |
| Indianapolis, IN 46250 | |
| (317) 521-2000 ext. 13362 | |
| Contact Person: Scott Thiel | |
| Date Prepared: September 5, 2008 | |
| 2) Device name | Proprietary name: ACCU-CHEK® Pocket Compass Diabetes Management Software |
| 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 | |
| 3) Predicate device | We claim substantial equivalence to the current legally cleared product of the same name. |
| 4) Device Description | An accessory software that enables the person with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results and insulin infusion pump data to support effective diabetes management, including calculating an insulin or carbohydrate dose based on user entered data. The device is not intended to provide any diagnosis based upon patient results. |
| 5) Intended use | The ACCU-CHEK Pocket Compass Diabetes Management Software is a single user system indicated for use as an accessory to compatible Disetronic insulin pumps and a number of commercially available Accu-Chek blood glucose meters to download data from these devices to a personal digital assistant (PDA) where it may be saved, displayed, reviewed, analyzed, and evaluated to support effective diabetes management. The Accu-Chek Pocket Compass Software is also indicated for the management of diabetes by calculating an insulin or carbohydrate dose based on user entered data. The device is indicated for over-the-counter sale. |
ﺮ ﻣﻦ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍ
:
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510(k) Summary, Continued
Comparison to Predicate Device
The Roche Diagnostics ACCU-CHEK Pocket Compass Similarities Diabetes Management Software is substantially equivalent to the current legally cleared version of ACCU-CHEK Pocket Compass Diabetes Management Software. The following is a list of some of the claims and features found to be similar to the predicate device.
| Feature/Claim | Detail |
|---|---|
| Meter / pump | |
| data download | Yes. Both products allow for the download of historical |
| data stored in the compatible devices | |
| Pump data | |
| upload | No. Neither product sends programming or parameter |
| information to the compatible pumps. | |
| Support | Yes; through call center support, labeling and health care |
| professionals. | |
| Data storage | On computer media. |
| Reports and | |
| graphs | Similar graphs and reports can be generated for viewing |
| on a display screen, and hard copy printout. | |
| Manual Data | |
| Entry | Same |
| Delete Data | Same |
| Track non- | |
| blood glucose | |
| data | Same |
| Intended use | Same |
| Fundamental | |
| scientific | |
| technology | Same |
| Security of | |
| Bolus | |
| Calculator | Same; requires user to communicate to the software with |
| a supported insulin pump before the bolus calculator is | |
| active |
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with stylized wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 8 2008
Mr. Scott Thiel Regulatory Affairs Program Manager Roche Diagnostics Diabetes Care Division 9115 Hague Road Indianapolis, Indiana 46250
Re: K082595
Trade/Device Name: ACCU-CHEK® Pocket Compass Diabetes Management Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG, LFR, JQP Dated: October 13, 2008 Received: October 15, 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.
3
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 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 Biometric's (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 vours.
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
4
Indications for Use
510(k) Number (if known):
Device Name: ACCU-CHEK® Pocket Compass Diabetes Management Software
Indications For Use:
The ACCU-CHEK Pocket Compass Diabetes Management Software is a single user system indicated for use as an accessory to compatible Disetronic insulin pumps and a number of commercially available Accu-Chek blood glucose meters to download data from these devices to a personal digital assistant (PDA) where it may be saved, displayed, reviewed, analyzed, and evaluated to support effective diabetes management. The Accu-Chek Pocket Compass Software is also indicated for the management of diabctcs by calculating an insulin or carbohydrate dose based on user entered data. The device is indicated for over-the-counter sale.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use XX (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cim
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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
1-082595 510(k) Number: _