SpotSkan, a multi-parameter Spot Check Device, along with the appropriate accessories mentioned / supplied with the unit, is intended to measure a single adult or pediatric (but not neonatal) patient's vital signs at the physician's clinic. SpotSkan is not a Patient Monitor.

Vital signs measured include SpO2, Non-Invasive Blood Pressure, Pulse Rate and Temperature. A thermal recorder is provided for printing measured data. The user is responsible to interpret the measured data made available, and shall be a professional health care provider. The monitor is not intended for home use.

Device Description

SpotSkan is SKANRAY's new portable Spot Check Device, which can be used to measure SpO2, Pulse rate, Blood Pressure non-invasively and Tympanic Temperature, for adult and pediatric (but not neonatal) patients. It is a compact device which has only numeric values displayed on a 6.5" LED Backlit TFT LCD display of resolution 640*480, containing SpO2, NIBP, Pulse Rate and Temperature values. It has last 12 patients' readings saved. It does not have continuous monitoring capability of the parameters or any alarms.

Interface of a thermal recorder to take print out of real time measurements and values from patient history make the data availability through a hard copy. It has got battery backup of 2 hours, which enables it to continue measurement even during mains power OFF condition. User can enter patient ID, name, age, height, weight; and select mode and sex; these details can be recorded in the thermal print out.

The scope of application is in the medical diagnostics, where a general physician will use the monitors in clinics. The user is responsible to interpret the measured data made available, and shall be a professional health care provider. The monitor is not intended for home use.

AI/ML Overview

The provided text describes the SpotSkan device, a multi-parameter spot check device, intended to measure vital signs. The documentation focuses on demonstrating substantial equivalence to predicate devices, rather than a standalone clinical study with detailed acceptance criteria and performance metrics of the SpotSkan device itself in a controlled study.

Therefore, much of the requested information regarding specific acceptance criteria, a standalone study, sample sizes, ground truth establishment, and MRMC studies is not explicitly available in the provided text. The document primarily references compliance with standards and the use of similar technologies from predicate devices.

However, based on the information provided, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria or report specific device performance metrics for the SpotSkan. Instead, it refers to compliance with various IEC and ISO standards that would implicitly define performance requirements. For example, IEC 80601-2-30 relates to the basic safety and essential performance of automatic cycling non-invasive blood pressure monitoring equipment, which would include accuracy requirements for NIBP. ANSI/SSMI SP10 also covers manual, electronic, or automated sphygmomanometers, implying performance standards for blood pressure measurement.

Implicit Acceptance Criteria (based on referenced standards):

Parameter	Referenced Standard	Implied Acceptance Criteria (General)	Reported Device Performance
Non-Invasive Blood Pressure (NIBP)	IEC 80601-2-30, ANSI/SSMI SP10	Accuracy and precision as per the standard (e.g., mean difference ≤ ±5 mmHg, standard deviation ≤ 8 mmHg for NIBP)	Not explicitly reported
SpO2 (Pulse Oximetry)	ISO 80601-2-61	Accuracy as per the standard (e.g., for SpO2 accuracy, typically within ±2-3% of reference values)	Not explicitly reported
Temperature (Tympanic)	ISO 80601-2-56	Accuracy as per the standard (e.g., within a specified range of reference temperature)	Not explicitly reported
General Safety and Performance	IEC 60601-1, IEC 60601-1-2	Basic safety and essential performance requirements for medical electrical equipment, electromagnetic compatibility	Not explicitly reported
Usability	IEC 60601-1-6	Usability requirements for medical electrical equipment	Not explicitly reported
Software Life Cycle	IEC 62304	Adherence to software life cycle processes for medical devices	Not explicitly reported
Risk Management	ISO 14971	Application of risk management to medical devices	Not explicitly reported

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "testing" in a general sense, primarily electrical and EMC testing, and "Additional Performance Testing" referencing standards. It does not describe a clinical test set with a specific sample size, country of origin, or whether the data was retrospective or prospective for the SpotSkan device's performance results. Instead, it relies on the fact that the NIBP, SpO2, and Temperature modules use "same" technologies as already cleared predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document does not describe a clinical study that required expert-established ground truth for a test set. The performance is assessed against recognized standards and the equivalence of component technologies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set with an adjudication method is described.

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

Not applicable. This device is a vital signs monitor, not an AI-powered diagnostic imaging tool that would typically involve human readers or MRMC studies.

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

While not a "standalone algorithm" in the AI sense, the device's function as a multi-parameter spot check device implies "standalone" measurement performance. The document states, "Skanray Technologies has concluded that the device does not introduce any significant questions of safety and efficacy and is substantially equivalent to the predicate devices." This substantial equivalence argument is based on the device's adherence to standards and the use of technological components identical to those cleared in predicate devices, rather than a de novo clinical trial demonstrating standalone performance against a clinical reference standard. It is likely that the individual modules (NIBP, SpO2, Temp) would have internal validation data against their respective reference methods as part of their component qualification, but this is not detailed for the SpotSkan system.

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

Not explicitly stated for the SpotSkan system as a whole. For the individual measurement parameters (NIBP, SpO2, Temperature), the "ground truth" would implicitly be established by the reference measurement methods defined in the relevant consensus standards (e.g., invasive arterial pressure for NIBP, co-oximetry for SpO2, calibrated thermometer for temperature). The document focuses on compliance with these standards, not the primary establishment of such ground truth for a new clinical study.

8. The sample size for the training set

Not applicable. This device is not described as involving machine learning or AI models that require a training set.

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

Not applicable. This device is not described as involving machine learning or AI models that require a training set.

Summary

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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

February 23, 2016

Skanray Technologies Private Limited % Yolanda Smith, Consultant Smith Associates 1468 Harwell Ave Crofton, Maryland 21114

Re: K152831

Trade/Device Name: SpotSkan Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, MWI Dated: January 19, 2016 Received: January 21, 2016

Dear Yolanda Smith:

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

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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 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/ResourcesforYou/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 vours

Mitchell Zeller

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K152831

Device Name

SpotSkan,

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 Use (21 CFR 801 Subpart C)

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K152831

510(k) Summary (As Per 21 CFR 807.92)

SPONSOR
Company Name:	Skanray Technologies PVt LtdHealthcare Division
Company Address:	#360, KIADB Industrial Area,Hebbal, Mysore - 570018, Karnataka, India.
Telephone:	91-821-2407202
Fax:	92-821-2407001
Contact Person:	J. Mahadevan
Summary Prepared	May 08, 2015
Trade Name:	SPOTSKAN
Common/Usual Name:	Spot Vital Signs Measurement Device
Classification Name:	Noninvasive Blood Pressure System
Product Code:	DXN
Device Class:	Class II
Regulation Number:	870.1130

Traditional 510k – 510k Summary

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K152831

Predicate Device

Company	Product	510(k) #
Welch Allyn	Spot Vital Signs LXi	K101680
Philips Medical Systems	SureSigns VS4	K120132
Suntech Medicals	Cycle BP Monitor & PulseOximeter, Model 1060	K060820
L&T Medical & Systems	Stellar 300	K103763

Device Description

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Indications for Use

Summary of Technological Characteristics

SpotSkan is designed and developed with reference to previous 510K cleared products as a Substantial Equivalent product.

The Technologies used and the processes followed are the same as described below and is comparable and in compliance to all the required Safety and performance standards.

Similarities:

Spotskan is compared with Suntech Medical's Cycle BP Monitor Model 1060 for ● the Pulse Oximeter. SpO2 technology and module used in these two products are same.
Spotskan is compared with L&T Medical & Systems Stellar 300 for the NIBP technology and module used in these two products are same.
Spotskan and Philips Medical Systems, SureSigns VS4 monitors are compared . for the Tympanic Temperature thermometer technology and module used in these two products are same.
Spotskan and Welch Allyn, Spot Vital Signs LXi monitor is compared to show equivalence for Spot Check device.

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Differences:

Spotskan uses a different Power supply and Battery in comparison with predicate devices. These changes are verified and validated to confirm the performance, safety and efficacy of the device in meeting the standard requirements. Also the Power supply and Battery has got the CE and UL marking adding to the safety and performance compliance.

Non Clinical Testing

Electrical and EMC Testing for the Star 90 included the following

IEC 60601-1	Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance
IEC 60601-1-2	Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility -Requirements and tests.
IEC 60601-1-6	Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essential performance -Collateral standard: Usability
ISO 80601-2-61	Medical electrical equipment - Part 2-61: Particularrequirements for basic safety and essential performance ofpulse Oximeter equipment
ISO 80601-2-56	Medical electrical equipment - Part 2-56: Particularrequirements for basic safety and essential performance ofclinical thermometers for body temperature measurement.
IEC 80601-2-30	Medical electrical equipment - Part 2-30: Particularrequirements for the basic safety and essentialperformance of automatic cycling non-invasive bloodpressure monitoring equipment.

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Additional Performance Testing:

ANSI/SSMI SP10	Manual, Electronic or Automated Sphygmomanometers
IEC 62304	Medical device software – software life cycle processes(Software/Informatics)
ISO 14971	Application of risk management to medical devices

Substantial Equivalence

The SpotSkan is substantially equivalent to the predicate device in Indications for Use, Materials and Design. Safety and performance testing was performed and Skanray Technologies has concluded that the device does not introduce any significant questions of safety and efficacy and is substantially equivalent to the predicate devices.

Prakash U. P.

Head - Design & Development

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).