The Nova StatSensor Creatinine Hospital Meter System consists of the StatSensor Creatinine Hospital Meter and the Stat-Sensor Creatinine Test Strips. The Nova StatSensor Creatinine Hospital Meter System is intended for in vitro diagnostic use by healthcare professionals and for Point-Of-Care usage for the quantitative measurement of creatinine in capillary. venous, and arterial whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis. Not for use in neonates.

Device Description

The Nova StatSensor Creatinine Hospital Meter System consists of a hand held meter, test strips, control solutions, and linearity solutions. The Nova StatSensor Creatinine Hospital Meter System is a hand-held, battery-powered, in vitro diagnostic laboratory instrument that works in conjunction with Nova Biomedical creatinine electrochemical test strips to measure creatinine in a whole blood sample, a Quality Control (QC) solution, linearity, or proficiency solutions. In addition to measuring creatinine, the meter stores patient test data, QC test data, and other information relating to patient sample, operator, reagents, and the meter. A user interface provides a self-prompting environment via a color LCD. The Charging Station recharges the batteries of the meter.

AI/ML Overview

The document describes the Nova StatSensor Creatinine Hospital Meter System, which is intended for quantitative measurement of creatinine in whole blood.

Here's an analysis of the provided information against your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a specific table of acceptance criteria with corresponding performance data from a study. Instead, it describes the device and states that its performance characteristics (measuring range, sample type, measuring technology, operating principle, analysis time, sample volume, sample application, meter calibration, controls, linearity solutions, and test strip reagents) are the "Same as Predicate" device (K070068).

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed new clinical study results for acceptance criteria. The claim of "Same as Predicate" for performance implies that the predicate device's acceptance criteria and performance data are being relied upon, but these are not explicitly listed or provided for the proposed device in this document.

2. Sample size used for the test set and the data provenance

This information is not provided in the document. The document states that "No changes have been made to Nova StatSensor Creatinine Test Strips and they are not a subject of this submission," and similar for control and linearity solutions. It also states the proposed device uses "the exact same technology, functionality, analytical and operational performance characteristics, as the predicate." This suggests that new analytical or clinical studies for the performance of the device were not conducted as part of this submission for the proposed device, as it is claiming equivalence based on unchanged performance characteristics.

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. As explained above, no new performance study data (and thus no ground truth establishment process for such a study) is detailed in this 510(k) summary.

4. Adjudication method for the test set

This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC study or AI components in this device description. The device is a "Creatinine Hospital Meter System" which measures creatinine directly from a blood sample using electrochemical biosensor test strips. It is not an AI-assisted diagnostic imaging or interpretation device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a point-of-care meter system, not an algorithm. Its performance is inherent in the meter and test strip system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided for the proposed device. For a creatinine test system, the "ground truth" for analytical performance studies would typically be established by validated reference methods (e.g., laboratory-based creatinine assays with established accuracy and precision). However, as noted, new performance study data is not detailed here.

8. The sample size for the training set

This information is not provided. The document is not about a machine learning or AI algorithm that would typically involve a "training set."

9. How the ground truth for the training set was established

This information is not provided and is not applicable to this type of device.

Summary of what is provided and what is missing:

Acceptance Criteria/Performance: The document states the proposed device has the "Same as Predicate" performance characteristics, including measuring range, acceptable samples, measuring technology, operating principle, analysis time, sample volume, and meter calibration. However, the specific quantitative acceptance criteria and detailed performance data (e.g., accuracy, precision) are not explicitly listed for either the predicate or the proposed device in this summary.
Studies: The document acts as a 510(k) summary to establish substantial equivalence for a modified device (ergonomic design changes) to an existing predicate. It asserts that the modified device uses the "exact same technology, functionality, analytical and operational performance characteristics" as the predicate. Therefore, it does not detail new analytical or clinical studies to demonstrate performance because it relies on the predicate's established performance.
Specifics (Sample Size, Experts, Adjudication, Ground Truth, AI, MRMC): None of these details are available in the provided text, as the submission focuses on claiming equivalence rather than detailing new performance studies.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 26, 2017

NOVA BIOMEDICAL CORPORATION PAUL MACDONALD SENIOR DIRECTOR OF REGULATORY AFFAIRS 200 PROSPECT STREET WALTHAM MA 02454

Re: K171059

Trade/Device Name: Nova StatSensor Creatinine Hospital Meter System Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: II Product Code: CGL Dated: April 26, 2017 Received: April 27, 2017

Dear Paul MacDonald:

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 Parts 801 and 809); 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.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kellie B. Kelm -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K171059

Device Name

Nova StatSensor Creatinine Hospital Meter System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter

er Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Summary

510(K) Owner:	Nova Biomedical Corporation
Registration Number:	1219029
Address:	200 Prospect St.Waltham, MA 02454
Phone:	781-894-0800
Fax Number:	784-891-4806
Contact Person:	Adam Heroux
Date Prepared:	May 26, 2017

Proprietary Name: Nova StatSensor Creatinine Hospital Meter System

Common or Usual Name: Electrode, Ion Based, Enzymatic, Creatinine

Device Classification:

Classification Names:	Class No.	Reg. No.	Class	Review Panel
Creatinine test system	CGL(75)	862.1225	II	Clinical Chemistry

Product Codes: CGL, Electrode, Ion Based, Enzymatic, Creatinine

Predicate Device: K070068 Nova StatSensor Creatinine Hospital Meter

Device Description:

Mechanism of Action:

A test strip is inserted into the meter, and the sample is applied to the sample entry end of the strip. The test strip contains a reaction layer that contains creatinine amidohydrolase, creatinine amidinohydrolase and sarcosine oxidase that reacts with the test sample. When enough sample has been added to the test strip (sample is drawn into strip though capillary action) the meter begins its analysis. A digital readout is displayed on the meter in 30 seconds.

Test Strips:

The test strips contain a reaction layer that contains creatinine amidohydrolase, creatinine amidinohydrolase and sarcosine oxidase. The test strip is touched to a drop of blood to initiate the test process. The test strip is designed such that when a drop of blood is touched to the end of the test strip, the blood is drawn into the reaction space via capillary action. A simple one-step process provides a blood creatinine result. Test strips are sold in vials of 25 strips.

The Nova StatSensor Creatinine Test Strips that are intended for use with the StatSensor Creatinine Hospital Meter are identical in form, fit, function and packaging, to the Nova StatSensor Creatinine Test Strips previously cleared for use with the Nova StatSensor Creatinine Hospital Meter System (K070088).

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No changes have been made to Nova StatSensor Creatinine Test Strips and they are not a subject of this submission.

Control and Linearity Solutions:

The control solutions contain aqueous assayed solutions, creatining creatinine, preservative, viscosityadjusting agent, and other non-reactive ingredients (dye). They contain no products of human origin. There are three levels of controls, (Level 1, Level 2 and Level 3). These solutions are offered for sale separately from the meter.

The linearity solutions contain creatinine, viscosity agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. These solutions are offered to users to verify the performance of the system. There are five levels of linearity solutions (Level 1, Level 3, Level 3, Level 3, Level 3, Level 4. Level 5). These solutions are offered for sale separately from the meter.

The Nova StatSensor Creatinine Control and Linearity Solutions that are intended for use with the StatSensor Creatinine Hospital Meter are identical in formulation and packaging, to the Control and Linearity Solutions originally cleared for use with the Nova StatSensor Creatinine Hospital Meter System (K070068). No changes have been made to Nova StatSensor Creatinine Control and Linearity Solutions and they are not a subject of this submission.

Docking/Charging Station:

The meter charging station is a stationary accessory used to recharge the meter. The charging station has one slot for the meter to be placed for charging and a slot for an extra battery to be charged. The charging station should be located central to the patient care area being served by the meter (e.g. a nursing station). The data charging station must remain plugged in to a wall outlet for power. Replacement batteries are offered separately.

Intended Use:

The Nova StatSensor Creatinine Hospital Meter System consists of the StatSensor Creatinine Hospital Meter and the StatSensor Creatinine Test Strips. The Nova StatSensor Creatinine Hospital Meter System is intended for in vitro diagnostic use by healthcare professionals and for Point-Of-Care usage for the quantitative measurement of capillary, venous, and arterial whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis. Not for use in neonates.

Summary of the Technological Characteristics:

The Nova StatSensor Creatinine Hospital Meter System that is the subject of this submission uses the exact same technology, functionality, analytical and operational performance characteristics, as the predicate. The Main CPU and the Primary Strip Board Electronics are identical in both the meters. The only difference is the change in ergonomic design.

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Characteristic	Predicate: Nova StatSensor Creatinine HospitalMeter (K070068)	Proposed: NovaStatSensorCreatinine HospitalMeter
Intended Use	Is intended for in vitro diagnostic use by healthcareprofessionals and for Point- Of-Care usage for thequantitative measurement of creatinine in capillary,venous, and arterial whole blood. Creatininemeasurements are used in the diagnosis and treatmentof renal diseases and in monitoring renal dialysis. Not foruse in neonates.	Same as Predicate
Measuring Range	0.30 - 12.0 mg/dL or 27-1056 µmol/L	Same as Predicate
Acceptable Samples	Whole blood: Capillary, Arterial, Venous	Same as Predicate
MeasuringTechnology	Enzyme, Amperometric	Same as Predicate
Operating Principle	Electrochemical biosensor test strip	Same as Predicate
Analysis Time	30 seconds	Same as Predicate
Sample Volume	1.2 µL	Same as Predicate
Sample application	Test strip capillary draw	Same as Predicate
Handheld meter	YES	Same as Predicate
Meter Calibration	Automatic, no Calibration Code	Same as Predicate
Docking/ChargingStation	Desk mount	Same as Predicate
Meter Memory	1000 patient tests, 200 QC tests, 4000 Operators	Same as Predicate
Power source	3.7V Li Polymer battery (Rechargeable/Replaceable)	Same as Predicate
Controls:	Liquid, 3 levels	Same as Predicate
Linearity Solutions	Liquid, 5 levels	Same as Predicate
Test Strips -Active reagent:	creatinine amidohydrolase, creatine amidinohydrolaseand sarcosine oxidase	Same as Predicate
Screen Display	Small Font Size	Large Font Size
Keypad	Hard buttons	Soft Buttons
Dimensions	Height:153 mm (6.0 in)Width: 82.5 mm (3.25 in)Depth 46 mm (1.8 in)	Height: 146 mm (5.8in)Width:79 mm (3.1in)Depth:30 mm (1.18in)
Weight	360 grams (0.8 lb)	220 g (0.49 lb)
Bar code scanner	Bottom of the Meter (1D: Symbol 965, 2D: SymbolSE4400, 2D: Symbol SE4500)	Top of the Meter(2D: OpticonMDI3100)
Housing Material	Aluminum	Lighter Plastic
Location of Strip Port	Top of Meter	Bottom of the Meter

Table 1: Comparison of Predicate and Proposed Devices

Regulation Number and Section

§ 862.1225 Creatinine test system.

(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.