(266 days)
Not Found
Not Found
No
The summary describes a data transfer device and software for generating reports, with no mention of AI or ML capabilities.
No
The device is an accessory that enables data transfer from blood glucose monitors and insulin pumps to a computer for monitoring and management, but it does not directly treat or prevent the disease itself.
No
Explanation: The device is described as an accessory that enables data transfer from blood glucose monitors and insulin pumps to a computer for monitoring and clinical management. It does not perform a diagnostic function itself, but rather facilitates the use of data for management.
No
The description refers to the device as an "Accessory" to hardware devices (blood glucose monitor and insulin pump) and enables sending data to a "compatible computer." While it facilitates data transfer and reporting, the summary does not explicitly state that the device itself is solely software. It could be a hardware accessory with embedded software.
Based on the provided information, the ACCU-CHEK® Smart Pix is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for various health issues.
- ACCU-CHEK Smart Pix Function: The ACCU-CHEK Smart Pix is described as an accessory that facilitates the transfer of data from blood glucose monitors and insulin pumps to a computer. It does not perform any tests on biological samples itself. Its purpose is to help monitor and manage diabetes by providing access to stored data.
Therefore, while it is used in the context of managing a condition diagnosed through in vitro methods (blood glucose testing), the Smart Pix device itself is a data transfer and management tool, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The ACCU-CHEK® Smart Pix enables persons with diabetes or healthcare professionals to send stored data from their compatible ACCU-CHEK blood glucose monitor and/or Disetronic/ACCU-CHEK Insulin infusion pump to a compatible computer as a set of reports or data stream.
The ACCU-CHEK Smart Pix is intended to help monitor and clinically manage individuals with diabetes.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LZG, JQP
Device Description
Accessory to ACCU-CHEK® brand meters and/or Disetronic/ACCU-CHEK insulin infusion pump that enables the persons with diabetes or healthcare professionals to send stored data to a compatible computer.
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
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Intended User / Care Setting
persons with diabetes or healthcare 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
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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.
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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.
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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
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
MAY - 9 2007
510(k) Summary: ACCU-CHEK® Smart Pix Device
| 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. |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter
name, address,
contact | Roche Diagnostics
9115 Hague Rd.
Indianapolis, IN 46250
Contact Person: Scott Thiel
Data Prepared: March 27, 2007 |
| Device Name | We claim substantial equivalence to the current legally marketed ACCU-
CHEK® Acculink Modem. |
| Device
Description | Accessory to ACCU-CHEK® brand meters and/or Disetronic/ACCU-CHEK
insulin infusion pump that enables the persons with diabetes or healthcare
professionals to send stored data to a compatible computer. |
| Indications for
Use Statement | The ACCU-CHEK® Smart Pix enables persons with diabetes or healthcare
professionals to send stored data from their compatible ACCU-CHEK blood
glucose monitor and/or Disetronic/ACCU-CHEK Insulin infusion pump to a
compatible computer as a set of reports or data stream.
The ACCU-CHEK Smart Pix is intended to help monitor and clinically
manage individuals with diabetes. |
Continued on next page
..............................................................................................................................................................................
:
1
510(k) Summary: ACCU-CHEK® Smart Pix Device, Continued
Similarities
The proposed modification is relatively modest in scope. The following is a list of some of the claims and features unaffected by the proposed modifications.
| Feature / Claim | Detail |
|---|---|
| Connect to blood glucose monitors | Both devices connect to and |
| download information stored on | |
| ACCU-CHEK brand blood glucose | |
| monitors. | |
| Warnings and precautions | For in vitro diagnostic use only. |
| State Messaging | Both devices provide feedback to the |
| consumer through a combination of | |
| LED flashes. | |
| Reports | Both devices create reports and |
| graphs using basic statistical | |
| calculations of the historic data | |
| stored in the devices they can | |
| connect to. |
Contimied on next page
... ... .. ..
2
510(k) Summary: ACCU-CHEK® Smart Pix Device, Continued
| Feature / Claim | ACCU-CHEK Smart
Pix | Predicate | |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Power supply | USB port | AC adapter | |
| Weight | 90 g | 205 g | |
| Size | 104 x 74 x 38 mm | 137 x 113 x 41 mm | |
| Intended use | The ACCU-CHEK®
Smart Pix enables
persons with diabetes
or healthcare
professionals to send
stored data from their
compatible ACCU-
CHEK blood glucose
monitor and/or
Disetronic/ACCU-
CHEK Insulin infusion
pump to a compatible
computer as a set of
reports or data stream.
The ACCU-CHEK
Smart Pix is intended to
help monitor and
clinically manage
individuals with
diabetes. | The ACCU-CHEK®
Acculink modem is
designed to enable the
self-tester to send data
from a supported Accu-
Chek brand meter to
either a facsimile (fax)
machine or Roche
supported software
utilized by a physician,
pharmacist, or other
member of the self-
tester's health care
team. The data
transmission takes
place over standard
telephone service
(POTS) lines or
telephone line
emulator. | |
| | Ambient conditions | Service temperature:
5 - 40 C
Storage temperature:
-25 - 70 C
Humidity:
9.6 - 98% Rh | Operating temperature:
0-50 C
Storage temperature:
-25 - 65 C
Humidity:
0 – 95% Rh |
Differences
The following is a listing of the key differences between the ACCU-CHEK Smart Pix and the predicate device.
:
. . . . . .
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three diagonal lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY - 9 2007
Roche Diagnostics Corp. c/o Mr. Scott Thiel Global Regulatory Affairs Diabetes Care 9115 Hague Road Indianapolis, IN 46256
Re: K062395 Trade/Device Name: ACCU-CHEK® Smart Pix Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, LZG, JQP Dated: March 28, 2007 Received: March 29, 2007
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): ___K062395
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The ACCU-CHEK® Smart Pix enables persons with diabetes or healthcare professionals to send stored data from their compatible ACCU-CHEK blood glucose monitor and/or Disetronic/ACCU-CHEK Insulin infusion pump to a compatible computer as a set of reports or data stream.
The ACCU-CHEK Smart Pix is intended to help monitor and clinically manage individuals with diabetes.
Prescription Use XX (Part 21 CFR 801 Subpart D)
ANDJOR
Over-The-Counter Use XX (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Arin M. Cooper, M.S., D.V.M
Division Sign-Off
ce of In Vitro Di
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