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.

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.

AI/ML Overview

The provided 510(k) summary for the ACCU-CHEK® Smart Pix Device does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

This document is a 510(k) premarket notification, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through a clinical study. The focus of this type of submission is on comparing the new device's features, intended use, and technology to an existing device, and showing that any differences do not raise new questions of safety or effectiveness.

Therefore, many of the requested elements for describing an acceptance criteria study (like sample size, ground truth, expert qualifications, etc.) are not present in this type of regulatory document for this specific device.

However, based on the information provided, we can infer some "acceptance criteria" related to functional equivalence and report the described features:

Acceptance Criteria and Reported Device "Performance" (Functional Equivalence)

Since this is a 510(k) for a data transfer device, the "performance" is primarily functional equivalence to the predicate device in terms of data handling and reporting capabilities, rather than clinical efficacy or accuracy of measurements.

Acceptance Criteria Category (Inferred)	Specific "Criteria" (Inferred from Similarity Claims)	Reported Device Performance (ACCU-CHEK® Smart Pix)
Connectivity	Able to connect to and download information from ACCU-CHEK brand blood glucose monitors.	The ACCU-CHEK® Smart Pix connects to and downloads information stored on ACCU-CHEK brand blood glucose monitors. It also connects to Disetronic/ACCU-CHEK insulin infusion pumps.
Warnings & Precautions	Maintain "for in vitro diagnostic use only" warning.	Maintains "for in vitro diagnostic use only" warning.
State Messaging	Provide feedback to the consumer through a combination of LED flashes.	Provides feedback to the consumer through a combination of LED flashes.
Reports & Data Processing	Create reports and graphs using basic statistical calculations of historic data stored in connected devices.	Creates reports and graphs using basic statistical calculations of the historic data stored in the devices they can connect to. It sends data to a compatible computer as a set of reports or a data stream.
Intended Use	Enable persons with diabetes or healthcare professionals to send stored data from compatible ACCU-CHEK devices to a compatible computer, intended to help monitor and clinically manage individuals with diabetes.	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. It is intended to help monitor and clinically manage individuals with diabetes. (This is identical to the predicate's intended use in function, though the method of transfer differs).
Physical Characteristics (Differences)	While not an "acceptance criterion" in the traditional sense, the device's physical differences (power, weight, size, operating conditions) were evaluated and accepted.	Power supply: USB port (Predicate: AC adapter)Weight: 90 g (Predicate: 205 g)Size: 104 x 74 x 38 mm (Predicate: 137 x 113 x 41 mm)Ambient conditions: Service temperature: 5 - 40 C; Storage temperature: -25 - 70 C; Humidity: 9.6 - 98% Rh (Predicate: Operating temperature: 0-50 C; Storage temperature: -25 - 65 C; Humidity: 0 – 95% Rh)

Unavailable Information from the Provided Document:

Sample size used for the test set and the data provenance: Not applicable or provided. The submission focuses on functional equivalence and design differences rather than performance testing against a "test set" of clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided. Ground truth for clinical performance is not discussed for this device.
Adjudication method for the test set: Not applicable or provided.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic or interpretative device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a data transfer accessory, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable or provided.
The sample size for the training set: Not applicable or provided. This device does not involve machine learning or a "training set."
How the ground truth for the training set was established: Not applicable or provided.

Conclusion:

The provided 510(k) summary for the ACCU-CHEK® Smart Pix Device demonstrates its substantial equivalence to a predicate device by comparing their features, intended uses, and technical specifications. It highlights similarities in functions like data connectivity, reporting, and basic statistical calculations. The "study" referenced implicitly is the detailed comparison of the new device's design and functionality against the predicate, asserting that the new design (e.g., USB power, smaller size) does not alter the fundamental mechanism or intended use, thus not raising new questions of safety or effectiveness. As such, quantitative performance acceptance criteria and associated clinical studies with ground truth are not part of this specific submission type for this kind of device.

Summary

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K062395

MAY - 9 2007

510(k) Summary: ACCU-CHEK® Smart Pix Device

Introduction	According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence.
Submittername, address,contact	Roche Diagnostics9115 Hague Rd.Indianapolis, IN 46250Contact Person: Scott ThielData Prepared: March 27, 2007
Device Name	We claim substantial equivalence to the current legally marketed ACCU-CHEK® Acculink Modem.
DeviceDescription	Accessory to ACCU-CHEK® brand meters and/or Disetronic/ACCU-CHEKinsulin infusion pump that enables the persons with diabetes or healthcareprofessionals to send stored data to a compatible computer.
Indications forUse Statement	The ACCU-CHEK® Smart Pix enables persons with diabetes or healthcareprofessionals to send stored data from their compatible ACCU-CHEK bloodglucose monitor and/or Disetronic/ACCU-CHEK Insulin infusion pump to acompatible computer as a set of reports or data stream.The ACCU-CHEK Smart Pix is intended to help monitor and clinicallymanage individuals with diabetes.

Continued on next page

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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 anddownload information stored onACCU-CHEK brand blood glucosemonitors.
Warnings and precautions	For in vitro diagnostic use only.
State Messaging	Both devices provide feedback to theconsumer through a combination ofLED flashes.
Reports	Both devices create reports andgraphs using basic statisticalcalculations of the historic datastored in the devices they canconnect to.

Contimied on next page

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510(k) Summary: ACCU-CHEK® Smart Pix Device, Continued

Feature / Claim	ACCU-CHEK SmartPix	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 enablespersons with diabetesor healthcareprofessionals to sendstored data from theircompatible ACCU-CHEK blood glucosemonitor and/orDisetronic/ACCU-CHEK Insulin infusionpump to a compatiblecomputer as a set ofreports or data stream.The ACCU-CHEKSmart Pix is intended tohelp monitor andclinically manageindividuals withdiabetes.	The ACCU-CHEK®Acculink modem isdesigned to enable theself-tester to send datafrom a supported Accu-Chek brand meter toeither a facsimile (fax)machine or Rochesupported softwareutilized by a physician,pharmacist, or othermember of the self-tester's health careteam. The datatransmission takesplace over standardtelephone service(POTS) lines ortelephone lineemulator.
	Ambient conditions	Service temperature:5 - 40 CStorage temperature:-25 - 70 CHumidity:9.6 - 98% Rh	Operating temperature:0-50 CStorage temperature:-25 - 65 CHumidity:0 – 95% Rh

Differences

The following is a listing of the key differences between the ACCU-CHEK Smart Pix and the predicate device.

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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

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Indications for Use

510(k) Number (if known): ___K062395

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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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Regulation Number and Section

§ 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.