Who is the manufacturer of ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE?

Roche Diagnostics Corp. filed the 510(k) submission for ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE (K050760).

What is the FDA product code for ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE?

LZG. It is classified under 21 CFR 880.5725 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE

K050760 · Roche Diagnostics Corp. · LZG · Sep 13, 2005 · General Hospital

Device Facts

Record ID	K050760
Device Name	ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
Applicant	Roche Diagnostics Corp.
Product Code	LZG · General Hospital
Decision Date	Sep 13, 2005
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5725
Device Class	Class 2
Attributes	Software as a Medical Device, Therapeutic

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.

Device Story

Software accessory for PDAs; interfaces with Disetronic insulin pumps and Accu-Chek blood glucose meters. Downloads, stores, displays, and analyzes historical glucose and insulin data. Calculates insulin or carbohydrate doses based on user-entered parameters. Used by patients for diabetes management; supports healthcare professional review. Provides data visualization via graphs and reports. Intended for over-the-counter use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based diabetes management system; operates on personal digital assistants (PDAs). Features include data download from insulin pumps and glucose meters, data storage on computer media, and calculation algorithms for insulin/carbohydrate dosing. Connectivity via device-specific interfaces.

Indications for Use

Indicated for single-user diabetes management as an accessory to compatible Disetronic insulin pumps and Accu-Chek blood glucose meters. Enables data download, storage, review, and analysis on a PDA. Supports insulin or carbohydrate dose calculation based on user-entered data. Indicated for over-the-counter sale.

Regulatory Classification

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.

Predicate Devices

Animas ezManager Plus Software

Related Devices

K082595 — MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE · Roche Diagnostics · Oct 28, 2008
K063674 — EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE · Animas Corp. · Mar 30, 2007
K080227 — ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM · Roche Diagnostics Corp. · May 15, 2008
K080587 — EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE · Animas Corp. · May 15, 2008
K014139 — DIABETES ASSISTANT SOFTWARE · Roche Diagnostics Corp. · Mar 21, 2002

Submission Summary (Full Text)

{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