(50 days)
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.
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.
This medical device submission for the ACCU-CHEK® Pocket Compass Diabetes Management Software (K082595) primarily establishes substantial equivalence to a previously cleared device of the same name. As such, the submission does not contain detailed information on acceptance criteria for novel performance claims or a dedicated study proving device performance against such criteria. Instead, it relies on the similarity of features and functionality to the predicate.
Given the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
No specific numerical acceptance criteria or quantifiable performance metrics are directly stated for this 510(k) submission. The submission focuses on demonstrating that the new version of the software is substantially equivalent to the predicate by having the "Same" or "Similar" features and intended use.
| Feature/Claim | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Meter / pump data download | Must allow download of historical data from compatible devices | Yes. Both products allow for the download of historical data stored in the compatible devices. |
| Pump data upload | Must not send programming or parameter information to pumps | No. Neither product sends programming or parameter information to the compatible pumps. |
| Support | Must provide support | Yes; through call center support, labeling and health care professionals. |
| Data storage | Must store data | On computer media. |
| Reports and graphs | Must generate reports and graphs | Similar graphs and reports can be generated for viewing on a display screen, and hard copy printout. |
| Manual Data Entry | Must allow manual data entry | Same. |
| Delete Data | Must allow data deletion | Same. |
| Track non-blood glucose data | Must track non-blood glucose data | Same. |
| Intended use | Must have the same intended use without new risks | Same. |
| Fundamental scientific technology | Must use the same fundamental scientific technology | Same. |
| Security of Bolus Calculator | Must require communication with a supported insulin pump before activation | Same; requires user to communicate to the software with a supported insulin pump before the bolus calculator is active. |
2. Sample Size Used for the Test Set and Data Provenance
The submission does not detail a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for a primary performance study. The assessment is primarily against the predicate device's existing clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. Since the submission focuses on substantial equivalence to an existing cleared device of the same name, a de novo ground truth establishment study for performance is not explicitly described.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No mention of an MRMC comparative effectiveness study, or effect size improvements with AI assistance, is found in the provided text. This is a software accessory without "AI" in the modern sense of interpreting complex clinical data.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone performance study is described. The device is a "single user system" and the purpose of the software is to facilitate review, analysis, and evaluation by the user and healthcare professionals, and to calculate an insulin or carbohydrate dose based on user-entered data. It is inherently "human-in-the-loop."
7. Type of Ground Truth Used
The ground truth, in this context, is implicitly defined by the performance and safety characteristics of the legally cleared predicate device. The submission aims to demonstrate that the new version maintains these characteristics.
8. Sample Size for the Training Set
No training set or its sample size is mentioned. This type of software, designed to manage and display user-entered and device-downloaded data, and perform calculations based on established formulas (e.g., insulin/carbohydrate dose), generally does not involve machine learning algorithms that require a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is described. The calculations performed by the bolus calculator would be based on established medical formulas and parameters configured by the user/healthcare professional, rather than learned patterns from a training set.
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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 Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 521-2000 ext. 13362Contact Person: Scott ThielDate Prepared: September 5, 2008 |
| 2) Device name | Proprietary name: ACCU-CHEK® Pocket Compass Diabetes Management SoftwareCommon name: diabetes management softwareClassification name: calculator/data processing module for clinical useClassification Regulations: 880.5725, 862.1345, 862.2100Product 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. |
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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 / pumpdata download | Yes. Both products allow for the download of historicaldata stored in the compatible devices |
| Pump dataupload | No. Neither product sends programming or parameterinformation to the compatible pumps. |
| Support | Yes; through call center support, labeling and health careprofessionals. |
| Data storage | On computer media. |
| Reports andgraphs | Similar graphs and reports can be generated for viewingon a display screen, and hard copy printout. |
| Manual DataEntry | Same |
| Delete Data | Same |
| Track non-blood glucosedata | Same |
| Intended use | Same |
| Fundamentalscientifictechnology | Same |
| Security ofBolusCalculator | Same; requires user to communicate to the software witha supported insulin pump before the bolus calculator isactive |
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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.
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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 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
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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: _
§ 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).