(56 days)
The ACCU-CHEK Inform II Test strip is for use with the ACCU-CHEK Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heelstick, or fresh capillary whole blood samples drawn from the fingertip as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.
The ACCU-CHEK Inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices.
The ACCU-CHEK Inform II Controls are intended for quality control performance checks on the ACCU-CHEK Inform II system with ACCU-CHEK Inform II test strips.
The ACCU-CHEK Inform II Linearity Test Kit is intended for use for periodic verification of linearity of the ACCU-CHEK Inform II system using ACCU-CHEK Inform II test strips.
No technological, material, performance, or design changes to the ACCU-CHEK Inform II System have been implemented since its clearance on K121679.
Thus, the Device Description for the ACCU-CHEK Inform II System remains the same as that presented and cleared in K121679.
This submission deals only with the performance of Super Sani-Cloth wipes for the effective cleaning and disinfection of the ACCU-CHEK Inform II System housing and components.
Please note that we intend to modify the ACCU-CHEK Inform II System labeling by adding the Super Sani-Cloth for cleaning and disinfection of the system, in addition to the Clorox Germicidal Wipes, which were previously cleared for this purpose on K121679. The Super Sani-Cloth will not replace the current Clorox Germicidal Wipe. Both wipes will be included in the product labeling.
This 510(k) submission (K130138) is a "Special 510(k)" for a claim extension to the existing ACCU-CHEK® Inform II System. The purpose is to add another cleaning and disinfecting product, Super Sani-Cloth® wipes, for use with the device. Therefore, the acceptance criteria and study described focus on the effectiveness of the Super Sani-Cloth wipes for cleaning and disinfection, not on the glucose monitoring performance of the ACCU-CHEK Inform II System itself.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| - Cleaning and disinfection test protocol followed for evaluating Super Sani-Cloth wipes for cleaning and disinfection of the six distinct components of the ACCU-CHEK Inform II System. - Meet performance requirements for intended use. | "All components passed the cleaning and disinfection test protocol, based on the defined criteria.""The corresponding test results demonstrate that the Super Sani-Cloth wipes are effective for the cleaning and disinfection of the device..." |
| Substantial equivalence to the predicate device (ACCU-CHEK Inform II System with Clorox® Germicidal Wipes for cleaning and disinfection). | "The Super Sani-Cloth is substantially equivalent to the Clorox Germicidal Wipe when used on the ACCU-CHEK Inform II System.""Overall, the data demonstrate that the ACCU-CHEK Inform II System operates in the same manner when cleaning and disinfecting occurs with the Super Sani-Cloth wipes." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document states the test was performed on "the same six distinct components of the ACCU-CHEK Inform II System," but it does not specify the number of individual devices or components tested, nor the number of cleaning/disinfection cycles.
- Data Provenance: The document implies this was a prospective study conducted by Roche Diagnostics Corporation, as they are submitting the results. The country of origin is not explicitly stated, but the company is based in Indianapolis, IN, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The "ground truth" here would relate to the assessment of cleanliness and disinfection efficacy, which would typically be determined by laboratory methods (e.g., microbial cultures, visual inspection for cleanliness) rather than expert human interpretation in the context of device performance.
4. Adjudication method for the test set
This information is not provided in the document, as the evaluation likely involved quantitative laboratory measurements rather than human reader adjudication.
5. 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
There was no MRMC comparative effectiveness study done. This submission is about the efficacy of a cleaning/disinfecting wipe, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A "standalone" study in the typical sense of algorithm performance was not done. The study evaluated the standalone performance of the Super Sani-Cloth wipes in cleaning and disinfecting the device components, according to a defined protocol. There is no algorithm involved.
7. The type of ground truth used
The ground truth used would be based on laboratory standards and measurements for cleaning efficacy (e.g., visual cleanliness, gravimetric analysis if applicable) and disinfection efficacy (e.g., reduction in microbial load according to established disinfectant testing standards). While the specific methods aren't detailed, "All components passed the cleaning and disinfection test protocol, based on the defined criteria" indicates adherence to such objective measures.
8. The sample size for the training set
There is no training set in the context of this submission. This is a validation study for a cleaning product, not a machine learning model.
9. How the ground truth for the training set was established
As there is no training set, this question is not applicable.
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Special 510(k) Summary
MAR 1 5 2013
Introduction
In accordance with 21 CFR 807.81 (a)(3)(11) and CFR 807.92. Roche Diagnostics Corporation hereby submits official notification as required by Section 510(k) of the Federal Food, Drug and Cosmetics Act of our intention to market the device described in this Premarket Notification [510(k)].
The purpose of this Special 510(k) premarket notification is to request a claim extension for our ACCU-CHEK® Inform II System. The ACCU-CHEK Inform II System labeling will be modified to add another cleaning and disinfecting product for use with our device, Super Sani-Cloth® (EPA #9480-4).
The ACCU-CHEK Inform II system is a blood glucose monitoring system, a Class II medical device according to 21 CFR 862.1345. Super Sani-Cloth is a General Purpose Disinfectant, a Class I exempt product, according to 21 CFR 880.6890.
In building this submission, we followed FDA's Special 510(k) process and checklists. Also, we reviewed and adhered to the 2010 Letter to Manufacturers of Blood Glucose Monitoring Systems Listed with the FDA, regarding the proper validation of cleaning and disinfection methods.
The ACCU-CHEK Inform II System has not changed since its clearance on K 121679. No technological, material, performance, or design changes to the ACCU-CHEK Inform II System have been implemented since its clearance on K121679. This submission pertains only to the performance of Super . Sani-Cloth wipes for the effective cleaning and disinfecting of the ACCU-CHEK Inform II System housing and components.
In alignment with the approach utilized in our K121679 submission, the same cleaning and disinfecting test protocol was followed to evaluate the Super Sani-Cloth wipes for cleaning and disinfection of the same six distinct components of the ACCU-CHEK Inform II System. The corresponding test results demonstrate that the Super Sani-Cloth wipes are effective for the cleaning and disinfection of the device, in addition to the Clorox® Germicidal Wipes (EPA #67619-12).
| 1) Submitter | Roche Diagnostics Corporation |
|---|---|
| name, | 9115 Hague Rd. |
| address, | Indianapolis, IN 46250 |
| contact | Contact Person: Justin DavisDate Prepared: March 14, 2013 |
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Special 510(k) Summary, continued ·
・
| 2) Devicename | Proprietary name: ACCU-CHEK Inform II System, consisting of• Meter: ACCU-CHEK Inform II Meter• Test Strip: ACCU-CHEK Inform II Test Strip• Controls: ACCU-CHEK Inform II Control Solutions• Linearity Kit: ACCU-CHEK Inform II Linearity Test Kit |
|---|---|
| Common name: whole blood glucose test system | |
| Classification name: Glucose Dehydrogenase, Glucose (21 C.F.R.§862.1345) | |
| Subsequent Product Code:- LFR, Glucose Dehydrogenase- NBW, System, Test, Blood Glucose, Over The Counter | |
| 510(k) History: K121679 | |
| 3) Predicatedevice | The 510(k) history for the ACCU-CHEK Inform II System with CloroxGermicidal Wipes for cleaning and disinfection is K121679. |
| Please note that in this submission we did not make any changes orenhancements to the ACCU-CHEK Inform II System. | |
| 4) DeviceDescription | No technological, material, performance, or design changes to the ACCU-CHEK Inform II System have been implemented since its clearance onK121679. |
| Thus, the Device Description for the ACCU-CHEK Inform II System remainsthe same as that presented and cleared in K121679. | |
| This submission deals only with the performance of Super Sani-Cloth wipesfor the effective cleaning and disinfection of the ACCU-CHEK Inform IISystem housing and components. | |
| Please note that we intend to modify the ACCU-CHEK Inform II Systemlabeling by adding the Super Sani-Cloth for cleaning and disinfection of thesystem, in addition to the Clorox Germicidal Wipes, which were previouslycleared for this purpose on K121679. The Super Sani-Cloth will not replacethe current Clorox Germicidal Wipe. Both wipes will be included in theproduct labeling. |
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Special 510(k) Summary, continued
use
The ACCU-CHEK Inform II Test strip is for use with the ACCU-CHEK 5) Intended Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heelstick, or fresh capillary whole blood samples drawn from the fingertip as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.
The ACCU-CHEK Inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices.
The ACCU-CHEK Inform II Controls are intended for quality control performance checks on the ACCU-CHEK Inform II system with ACCU-CHEK Inform II test strips.
The ACCU-CHEK Inform II Linearity Test Kit is intended for use for periodic verification of linearity of the ACCU-CHEK Inform II system using ACCU-CHEK Inform II test strips.
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Special 510(k) Summary, continued
.
| 6) Substantialequivalence | No technological, material, performance, or design changes to the ACCU-CHEK Inform II System have been implemented since its clearance onK121679.In alignment with the approach utilized in our K121679 submission, the samecleaning and disinfecting test protocol was followed to evaluate the SuperSani-Cloth wipes for cleaning and disinfection of the same six distinctcomponents of the ACCU-CHEK Inform II System.The corresponding test results demonstrate that the Super Sani-Cloth wipesare effective for the cleaning and disinfection of the device, in addition toClorox Germicidal Wipes (previously cleared for use with the system onK121679).Robustness and effectiveness clearing and disinfecting testing on the ACCU-CHEK Inform II System for Super Sani-Cloths demonstrated that the devicemeets the performance requirements for its intended use. This also covers thecomponents listed above, and is included within K121679.Overall, the data demonstrate that the ACCU-CHEK Inform II Systemoperates in the same manner when cleaning and disinfecting occurs with theSuper Sani-Cloth wipes. |
|---|---|
| 7) Datademonstratingsubstantialequivalence | All components passed the cleaning and disinfection test protocol, based onthe defined criteria.The data demonstrates that the Super Sani-Cloth is substantially equivalent tothe Clorox Germicidal Wipe when used on the ACCU-CHEK Inform IISystem. |
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 15, 2013
Roche Diagnostics Corporation c/o Justin Davis 9115 Hague Rd. Indianapolis, IN 46250
Re: K130138
Trade/Device Name: ACCU-CHEK Inform II Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR Dated: February 12, 2013 Received: February 13, 2013
Dear Mr. Davis:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for
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Page 2-Mr. Davis
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
CarolG.Benson-S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K130138
Device Name: ACCU-CHEK Inform II Blood Glucose Monitoring System
Indications for Use:
The ACCU-CHEK Inform II Test strip is for use with the ACCU-CHEK Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neveratal heelstick, or fresh capillary whole blood samples drawn from the fingertip as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.
The ACCU-CHEK Inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in rofessional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices.
The ACCU-CHEK Inform II Controls are intended for quality control performance checks on the ACCU-CHEK Inform II system with ACCU-CHEK Inform II test strips.
The ACCU-CHEK Inform II Linearity Test Kit is intended for use for periodic verification of linearity of the ACCU-CHEK Inform II system using ACCU-CHEK Inform II test ntouss
Prescription Use XX (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use XX (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Katherine & Serrano
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K130138
§ 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.