(74 days)
No
The description focuses on electrochemical measurement and signal processing, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is an in vitro diagnostic device used to measure blood glucose levels, aiding in monitoring the effectiveness of diabetes control. It does not directly treat or cure a disease or condition.
Yes
Explanation: The device is intended for "in vitro diagnostic use" and provides quantitative measurement of glucose in blood samples, which is a diagnostic function. However, it explicitly states it "should not be used for the diagnosis of or screening of diabetes," indicating it aids in monitoring a pre-existing condition, which is still a diagnostic application in the broader sense of providing information about a patient's health status.
No
The device description explicitly details hardware components like the meter, test strips, and control solutions, and describes the physical and electrical processes involved in measuring glucose. It is a system that includes both hardware and software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The ACCU-CHEK Nano SmartView Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control."
This statement clearly identifies the device as being used for testing biological samples (blood) outside of the body to provide information about a person's health status (glucose levels for diabetes management), which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ACCU-CHEK Nano SmartView Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm. The ACCU-CHEK Nano SmartView Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The ACCU-CHEK Nano SmartView Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The ACCU-CHEK Nano SmartView Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The ACCU-CHEK* SmartView Test Strips are for use with the ACCU-CHEK Nano Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.
Product codes
NBW, LFR
Device Description
The ACCU-CHEK® Nano meter was developed to utilize the ACCU-CHEK® Aviva Plus test system's technology and performance characteristics. The ACCU-CHEK® Nano meter designers took the measurement components of the ACCU-CHEK® Aviva Plus system, slightly changed the firmware and hardware supporting the new user interface and housing and embedded/programmed the strip lot code information within the meter so a physical code key or code key port are no longer used.
The ACCU-CHEK ® SmartView test strip is a No Code Freedom 2 Chemistry test strip which shares the same scientific technology as the predicate device, the ACCU-CHEK® Aviva Plus test strips. The instrument's measurement method is not modified as a part of this test strip modification project.
When an ACCU-CHEK® SmartView test strip is inserted into the ACCU-CHEK® Nano meter, a small alternating current (AC) is applied until the application of blood causes a spike in the conductivity to be observed at the measurement and sample-sufficiency electrodes – both are used to assure an adequate sample has been applied.
The instrument then applies a series of AC voltages at four frequencies and reads the AC responses. These carry information about the sample type and environmental temperature; they also allow the system to perform various internal quality checks.
After the AC measures are completed, a small (DC) voltage is applied and current is observed which is proportionate to the glucose. The AC and DC information are then combined to provide a hematocrit and temperature compensated glucose result.
The single-patient use ACCU-CHEK® Nano SmartView Blood Glucose Monitoring System will consist of:
Meter: ACCU-CHEK® Nano Meter Test Strip: ACCU-CHEK® SmartView Test Strip Controls: ACCU-CHEK® SmartView Control Solutions
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertips or palm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
People with diabetes at home (for self testing)
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)
Performance testing on the ACCU-CHEK® Nano SmartView Blood Glucose Monitoring System demonstrated that the device meets the performance requirements for its intended use. The data demonstrates that the test strip is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ACCU-CHEK® Aviva Plus System (K101299)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K 113/37
JAN - 6 2012
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) 521-7593 | |
| Contact Person: Khone Saysana | |
| Date Prepared: October 18, 2011 | |
| 2) Device name | Proprietary name: |
| ACCU-CHEK® Nano SmartView Blood Glucose Monitoring System | |
| Meter: ACCU-CHEK® Nano Meter | |
| Test Strip: ACCU-CHEK® SmartView Test Strip | |
| Controls: ACCU-CHEK® SmartView Control Solutions |
Classification name: Glucose dehydrogenase, glucose test system (21 C.F.R. § 862.1345)
NBW, Blood Glucose Test System, Over-the-Counter
LFR, Glucose Dehydrogenase |
| 3) Predicate device | ACCU-CHEK® Aviva Plus System (K101299) |
Continued on next page
1
510(k) Summary, Continued
4) Device Description
・・・・
The ACCU-CHEK® Nano meter was developed to utilize the ACCU-CHEK® Aviva Plus test system's technology and performance characteristics. The ACCU-CHEK® Nano meter designers took the measurement components of the ACCU-CHEK® Aviva Plus system, slightly changed the firmware and hardware supporting the new user interface and housing and embedded/programmed the strip lot code information within the meter so a physical code key or code key port are no longer used.
The ACCU-CHEK ® SmartView test strip is a No Code Freedom 2 Chemistry test strip which shares the same scientific technology as the predicate device, the ACCU-CHEK® Aviva Plus test strips. The instrument's measurement method is not modified as a part of this test strip modification project.
When an ACCU-CHEK® SmartView test strip is inserted into the ACCU-CHEK® Nano meter, a small alternating current (AC) is applied until the application of blood causes a spike in the conductivity to be observed at the measurement and sample-sufficiency electrodes – both are used to assure an adequate sample has been applied.
The instrument then applies a series of AC voltages at four frequencies and reads the AC responses. These carry information about the sample type and environmental temperature; they also allow the system to perform various internal quality checks.
After the AC measures are completed, a small (DC) voltage is applied and current is observed which is proportionate to the glucose. The AC and DC information are then combined to provide a hematocrit and temperature compensated glucose result.
Continued on next page
2
510(k) Summary, Continued
The ACCU-CHEK® Nano SmartView Blood Glucose Monitoring System is 5) Intended use intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm. The ACCU-CHEK® Nano SmartView Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The ACCU-CHEK® Nano SmartView Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The ACCU-CHEK® Nano SmartView Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The ACCU-CHEK® SmartView Test Strips are for use with the ACCU-CHEK® Nano Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.
The single-patient use ACCU-CHEK® Nano SmartView Blood Glucose Monitoring System will consist of:
Meter: ACCU-CHEK® Nano Meter Test Strip: ACCU-CHEK® SmartView Test Strip Controls: ACCU-CHEK® SmartView Control Solutions
| 6) Substantial
equivalence | The modified ACCU-CHEK® Nano SmartView Blood Glucose Monitoring
System is substantially equivalent to the ACCU-CHEK® Aviva Plus System
(K101299). |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7) Data
demonstrating
substantial
equivalence | Performance testing on the ACCU-CHEK® Nano SmartView Blood Glucose
Monitoring System demonstrated that the device meets the performance
requirements for its intended use. The data demonstrates that the test strip is
substantially equivalent to the predicate device. |
0012
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized design of a human figure, with three overlapping profiles facing to the right. The design is simple and modern, with bold lines and a sense of movement.
10903 New Hampshire Avenue Silver Spring, MD 20993
Roche Diagnostics c/o Khonesavanh Saysana 9115 Hague Road Indianapolis, Indiana 46250-0416
JAN - 6 2012
Re: K113137 Trade Name: Roche ACCU-CHEK Nano SmartView Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW. LFR Dated: December 7, 2011 Received: December 8, 2011
Dear Mr. Saysana:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
4
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and
Biometrics/Division of Postmarket Surveillance...
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 (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
从113137 Device Name: ACCU-CHEK Nano SmartView Blood Glucose Monitoring System
Indications for Use:
The ACCU-CHEK Nano SmartView Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm. The ACCU-CHEK Nano SmartView Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The ACCU-CHEK Nano SmartView Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The ACCU-CHEK Nano Smartview Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The ACCU-CHEK* SmartView Test Strips are for use with the ACCU-CHEK Nano Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.
Prescription Use _ (Part 21 CFR 801 Subpart D) AND
Over-The-Counter Use __ XX (Part 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)
Division Sign Off
ision Sian-
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k"313
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