(173 days)
Not Found
Not Found
No
The description focuses on data management, analysis, and calculation based on user-entered data, without mentioning AI/ML techniques.
No
The software is an accessory that helps manage diabetes by analyzing data and calculating insulin/carbohydrate doses, but it does not directly treat or prevent the disease.
No
The "Device Description" explicitly states, "The device is not intended to provide any diagnosis based upon patient results."
Yes
The device is described as "accessory software" and its function is to download, save, display, review, analyze, and evaluate data from other medical devices (insulin pumps and blood glucose meters). It also calculates insulin or carbohydrate doses based on user-entered data. There is no mention of any hardware component being part of the device itself.
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 used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device function: The ACCU-CHEK Pocket Compass Software primarily functions as a data management and analysis tool for information already collected by other devices (blood glucose meters and insulin pumps). It downloads, saves, displays, reviews, analyzes, and evaluates this data.
- Lack of specimen analysis: The software itself does not directly analyze any biological specimens. It processes data that has already been generated by the blood glucose meter (which performs the in vitro diagnostic test on the blood sample) and the insulin pump.
- Explicit statement: The "Device Description" explicitly states: "The device is not intended to provide any diagnosis based upon patient results." While it supports effective diabetes management, it doesn't perform the diagnostic testing itself.
Therefore, the ACCU-CHEK Pocket Compass Diabetes Management Software is considered an accessory to IVD devices (the blood glucose meters) and a medical device (the insulin pump), but it is not an IVD itself.
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 (comma separated list FDA assigned to the subject device)
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
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.
Not Found (Predicate name mentioned: Animas ezManager Plus Software)
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
KoS0760 510(k) Summary
,
| 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. 3362
Contact Person: Scott Thiel
Date Prepared: March 23, 2005 |
| 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 Animas
ezManager Plus Software. |
| 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. |
Continued on next page
1
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 data | |
| upload | Yes. |
| 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 | Similar methods of manually entering data into the |
| software. | |
| Delete Data | Similar methods of deleting data. |
| Track non- | |
| blood glucose | |
| data | Tracks similar data sets. (i.e. Carbohydrates, insulin, time |
| blocks, event codes). | |
| Intended Use | Both products are indicated for use as an accessory to |
| insulin infusion pumps and blood glucose monitors. | |
| Both products provide for electronic download of data | |
| from these devices. Both products provide and insulin or | |
| carbohydrate dose based upon user entered data. |
2
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.
3
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
4
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