(173 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.
The provided document is a 510(k) summary for the ACCU-CHEK® Pocket Compass Diabetes Management Software. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance results, sample sizes for testing or training, ground truth establishment, or clinical studies.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- MRMC comparative effectiveness study results or effect size
- Standalone performance results
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
This document is a regulatory submission summary that focuses on demonstrating substantial equivalence to an existing device, primarily based on features and intended use, rather than presenting detailed performance study data. For such data, one would typically look for a full clinical study report, a detailed V&V (Verification and Validation) report, or perhaps a more extensive technical file that would accompany this summary.
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KoS0760 510(k) Summary
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| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
|---|---|
| 1) Submittername, address,contact | Roche Diagnostics Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 521-2000 ext. 3362Contact Person: Scott ThielDate Prepared: March 23, 2005 |
| 2) Device name | Proprietary name: ACCU-CHEK® Pocket Compass Diabetes ManagementSoftwareCommon name: diabetes management softwareClassification name: calculator/data processing module for clinical useClassification Regulations: 880.5725, 862.1345, 862.2100Product Codes: LZG, LFR, JQP |
| 3) Predicatedevice | We claim substantial equivalence to the current legally cleared AnimasezManager Plus Software. |
| 4) DeviceDescription | An accessory software that enables the person with diabetes and their health careprofessionals in review, analysis and evaluation of historical blood glucose testresults 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 singleuser system indicated for use as an accessory to compatible Disetronic insulinpumps and a number of commercially available Accu-Chek blood glucose metersto download data from these devices to a personal digital assistant (PDA) whereit may be saved, displayed, reviewed, analyzed, and evaluated to supporteffective diabetes management. The Accu-Chek Pocket Compass Software isalso indicated for the management of diabetes by calculating an insulin orcarbohydrate dose based on user entered data. The device is indicated for over-the-counter sale. |
Continued on next page
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510(k) Summary, Continued | 人んちで 76
Comparison to Predicate Device
The Roche Diagnostics ACCU-CHEK Pocket Compass Similarities Diabetes Management Software is substantially equivalent to the current legally cleared version Animas ezManager Plus 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 dataupload | Yes. |
| 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 | Similar methods of manually entering data into thesoftware. |
| Delete Data | Similar methods of deleting data. |
| Track non-blood glucosedata | Tracks similar data sets. (i.e. Carbohydrates, insulin, timeblocks, event codes). |
| Intended Use | Both products are indicated for use as an accessory toinsulin infusion pumps and blood glucose monitors.Both products provide for electronic download of datafrom these devices. Both products provide and insulin orcarbohydrate dose based upon user entered data. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 3 2005
Mr. Scott Thiel Regulatory Affairs Program Principal Roche Diagnostics 9115 Hague Road Indianapolis, Indiana 46250
Re: K050760
KU50700
Trade/Device Name: Accu-Chek Pocket Compass Diabetes Management Software Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: II Product Code: LZG Dated: August 23, 2005 Received: August 25, 2005
Dear Mr. Thiel:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becalent 510(4) per device is substantially equivalent (for the referenced above and have determined the avecally marketed predicate devices marketed in indications for use stated in the encreations of the enactment date of the Medical Device interstate collimence prior to thay 20, 1978, and cases and with the provisions of Amendments, of to devices that have book formation of require approval of a premarket the sgmarel the Federal Food, Drug, and Cosmetic Pres (Pres) - Market the device, subject to the general approval appreation (1 Mill). I our general controls provisions of the Act include controls provisions of the Fish Title Listing of devices, good manufacturing practice, requirements for and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into exactives. Existing major regulations affecting (PMA), it may be subject to such additional volulations, Title 21, Parts 800 to 898. Inte your device can be found in the Could of Preceded on games 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 Please be advised that IDA 3 issualled of a beather complies with other requirements mean that FDA has made a deceminations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other to sectimes in of the Act of ally rederal statutes and regaraments, including, but not limited to: registration You must comply with an the Act 3 requirements and 801); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gED Box 800); and i and ifsing (21 CFR Part 807), labeling (21 CFR Pat (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality by 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)
10 a This letter will anow you to begin matically your antial equivalence of your device to a premarket nothleation. THCTDA miding of baskand of the results 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), a If you desire specific advice for your de res 210) 276-0115. Also, please note the regulation please contact inc Other or Ochiphants and motification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free DIVIsion of Binan 2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sylvie Y. Michieums.
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): ├Оболь О
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 The NOOD OFFERE Foreiges of to compatible Disetronic insulin pumps and a number of multicated for use as all accused you complains meters to download data from these devices to a personal digital assistant (PDA) where it may be saved, displayed, reviewed, analyzed, and a personal digital abonument. The Accu-Chek Pocket Pocket Compass Software evaluation to support of envanagement of diabetes 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)
Tim Vme
Page 1 of
(Division Sign-Off) Division of Anesthesiology. General Hospital, Infection Control, Dental De
510(k) Number: K952761
§ 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).