PodSKAN HF Diagnostic X-Ray System is intended for use by the qualified and trained clinicians or radiographers for generating X-rays of feet. It can be used for adults and paediatrics.

PodSKAN is not intended for Mammography and Fluoroscopy Applications.

Device Description

PodSKAN is an advanced high frequency type X-Ray system designed for superior image quality with powerful 2.8KW generator and very low leakage radiation. The system houses two microprocessors, one for control/supervisory functions and another one man-machine/User interface. It can be easily plugged into 16A wall socket with 120 VAC or 240 VAC, 50/60 Hz. The technology incorporates feedback circuits to ensure highest accuracy & reproduceability of X-Ray output. It consists of

. Tube head assembly (including collimator and goniometer)
Base foot platform and side handle for patient support .
External console and Hand switch .

PodSKAN HF diagnostic X-ray system can be used with Film, Computed Radiography (CR) and Digital Radiography system image receptors along with associated image capture software. Skanray recommends using 510(k) cleared flat panel detectors with AED functionality wired or wireless of size 10"x12" or 14"x17"and image acquisition systems to maintain compliance and quality

AI/ML Overview

The provided document is a 510(k) summary for the PodSKAN HF Diagnostic X-ray System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study.

Therefore, the acceptance criteria and study details as requested (sample size, data provenance, ground truth establishment, MRMC study, standalone performance) are not explicitly present in the provided text. The document refers to compliance with various IEC standards and FDA performance standards (21 CFR 1020.30-1020.31) but does not present a specific study with defined acceptance criteria and reported device performance in a tabular format as requested for a diagnostic AI/medical device.

However, I can extract the relevant information regarding performance and compliance from the document and highlight what is missing based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with "acceptance criteria" and "reported device performance" in the context of a diagnostic accuracy study. Instead, it discusses compliance with regulatory standards and compares technical specifications to predicate devices.

Acceptance Criteria (Implied by Compliance)	Reported Device Performance (from "Comparison to Predicate and Reference devices" and "Performance data")
IEC 60601-1: General requirements for basic safety and essential performance	The subject device has been evaluated and found to be compliant to safety and essential performance as per IEC 60601-1.
IEC 60601-2-28: Basic safety and essential performance of X-ray tube assemblies	Not explicitly stated as "met" but implied by overall compliance.
IEC 60601-2-54: Basic safety and essential performance of X-ray equipment for radiography and radioscopy	The subject device has been evaluated and found to be compliant as per IEC 60601-2-54 regarding accuracy of loading factors, reproducibility of radiation output.
IEC 60601-1-3: Radiation protection in diagnostic X-ray equipment	The subject device has been evaluated and found to be compliant as per IEC 60601-1-3 regarding half value layer, leakage radiation in loading and normal state, and stray radiation.
IEC 60601-1-6 & IEC 62366-1: Usability Engineering	The device complies with these standards (listed).
IEC 62304: Medical device software – Software life-cycle processes	The device complies with this standard (listed).
ISO 10993-1: Biological evaluation of medical devices	The device complies with this standard (listed).
IEC 60601-1-2: Electromagnetic disturbances	The subject device has been evaluated and found to be compliant as per IEC 60601-1-2 regarding conducted emission, radiated emission, harmonics, voltage fluctuations, electrostatic discharge (ESD), electrical fast transients (EFT), radiated RF electromagnetic field, continuous conducted RF, surges, power frequency magnetic field, voltage dips and short interruption.
FDA Performance standards 21 CFR 1020.30-1020.31: Diagnostic X-Ray system and Radiographic equipment	The device also complies with FDA performance standards 21CFR 1020.30-1020.31.
kV Accuracy: (Self-imposed for better performance)	+/- 5% (Predicate devices: +/- 8%) - Better performance than predicate.
Collimator lamp timer: (Functionality)	30 seconds (Predicate devices: 13 seconds) - Substantially Equivalent. Function is available; timing does not impact indicated application.
Image Quality: (Implied for diagnostic systems)	"The validation testing, which includes sample clinical images, demonstrates compliance to the diagnostic quality imaging performance when used with 510k cleared detector and imaging software for the intended application."

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

The document states: "The validation testing, which includes sample clinical images, demonstrates compliance to the diagnostic quality imaging performance when used with 510k cleared detector and imaging software for the intended application."
No specific sample size for a test set (e.g., number of images/patients) is provided.
No data provenance (country of origin, retrospective/prospective) is mentioned.
This device is an X-ray system (hardware), not an AI diagnostic algorithm. The "validation testing" with "sample clinical images" appears to be for general image quality assessment of the hardware, not for diagnostic accuracy of an AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not mentioned. Since this is a submission for an X-ray hardware system, not an AI diagnostic algorithm, the concept of "ground truth" for diagnostic labels established by experts is not discussed in the provided text. The performance data focuses on compliance with physical and electrical standards for X-ray generation and image quality.

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

Not applicable/Not mentioned. This information is typically relevant for studies evaluating the diagnostic accuracy of a software algorithm, particularly when establishing a consensus ground truth. It is not discussed for this X-ray hardware system.

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

No MRMC comparative effectiveness study was performed or mentioned. The device is an X-ray system, not an AI software intended to assist human readers.

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

Not applicable. This refers to the standalone performance of an AI algorithm. The PodSKAN HF Diagnostic X-ray System is hardware.

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

Not explicitly defined/Not applicable in the typical sense for a diagnostic algorithm. For an X-ray hardware system, "ground truth" would relate to the physical and radiation output accuracy relative to established standards (e.g., kV accuracy, mAs reproducibility, HVL), as well as the ability to produce images of "diagnostic quality," which is assessed qualitatively or against established phantom images/standards rather than disease-specific pathology or outcomes data in this context.

8. The sample size for the training set

Not applicable. The device is hardware, not a machine learning model that undergoes a training phase.

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

Not applicable. As above, this is hardware, not an AI/ML system requiring a training set with established ground truth.

Summary

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October 27, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Skanray Technologies Limited Vasundhara R Regulatory Head Plot#15-17, Hebbal Industrial Area Mysore, Karnataka 570016 INDIA

Re: K231761

Trade/Device Name: PodSKAN HF Diagnostic X-ray System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR Dated: June 16, 2023 Received: June 16, 2023

Dear Vasundhara R:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Gabriela M. Rodal -S

for

Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231761

Device Name

PodSKAN HF Diagnostic X-ray System

Indications for Use (Describe)

PodSKAN HF Diagnostic X-Ray System is intended for use by the qualified and trained clinicians or radiographers for generating X-rays of feet. It can be used for adults and paediatrics.

PodSKAN is not intended for Mammography and Fluoroscopy Applications.

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

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510(k) Summary

510(k) summary of safety and effectiveness for PodSKAN HF Diagnostic X-ray system is provided in accordance with 21 CFR 807.92

Date:	10th June 2023
Submitter (Owner):	Vasundhara RRegulatory HeadSkanray Technologies LimitedPlot# 15-17, Hebbal Industrial Area, HebbalMysore, Karnataka 570016, IndiaP: +91 821 2415559Email: vasundhara.r@skanray.com
510(k) Contact Person:	Vasundhara RRegulatory HeadSkanray Technologies LimitedPlot# 15-17, Hebbal Industrial Area, HebbalMysore, Karnataka 570016, IndiaP: +91 821 2415559Email: vasundhara.r@skanray.com
Device Trade Name:	PodSKAN HF Diagnostic X-ray system
Regulation Number:	892.1680
Regulation Name:	Stationary X-ray system
Regulation Description:	A stationary x-ray system is a permanently installeddiagnostic system intended to generate and control X-raysfor examination of various anatomical regions.This generic type of device may include signal analysisand display equipment, patient and equipment support,component parts, and accessories
Review Panel:	Radiology
Device Class:	Class II
Product Code:	KPR
Predicate Device:	• HF 718BD X-Ray System (K160857)Regulation number: 21 CFR 892.1680Regulation name: Stationary X-ray systemDevice class: IIProduct code: KPRReview panel: Radiology
Reference Device:	• Televere Podiatry X-Ray System HF (K180765)Regulation number: 21 CFR 892.1680Regulation name: Stationary X-ray systemDevice class: IIProduct code: KPRReview panel: Radiology

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Device Description

. Tube head assembly (including collimator and goniometer)
Base foot platform and side handle for patient support .
External console and Hand switch .

Intended Use / Indications for Use

PodSKAN HF Diagnostic X-Ray System is intended for use by the qualified and trained clinicians or radiographers for generating X-rays of feet. It can be used for adults and paediatrics.

PodSKAN is not intended for Mammography and Fluoroscopy Applications.

Comparison to predicate and reference devices

One predicate device and one reference device is selected in this submission for the PodSKAN HF Diagnostic X-ray system. Predicate device : HF 718BD X-ray Ray System (K160857)

Reference device: Televere Podiatry X-Ray System HF (K180765)

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The image quality of X-ray system depends on two main factors - the X-Ray generation and the image acquisition system. The X-Ray voltage generator, the technology, design of the subject device is substantially equivalent to the predicate device, with changes in the ranges of kV, mA, and exposure time which does not affect the safety and effectiveness of the device. Image receptors that can be used with PodSKAN HF Diagnostic X-ray System include film, computed radiography and digital radiography.

The details of the substantial equivalence between the subject device, predicate device and reference device are explained in the table below.

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Comparison to Predicate and Reference devices

ComparableProperties	Subject Device	Predicate Device	Reference Device	Comparison results
MAKE	Skanray TechnologiesLimited	X-Cel X-RayCorporation	Televere Systems	-
MODEL	PodSKAN HF DiagnosticX-Ray System	HF 718BD X-RaySystem	Televere PodiatryX-Ray System HF	-
Regulationnumber	21 CFR 892.1680	21 CFR 892.1680	21 CFR 892.1680	Identical
Regulationname	Stationary x-ray system	Stationary x-raysystem	Stationary x-raysystem	Identical
Product code	KPR	KPR	KPR	Identical
RegulatoryClass	Class II	Class II	Class II	Identical
FDA 510knumber	-	K160857	K180765	-
Indications foruse	PodSKAN HF DiagnosticX-Ray System is intendedfor use by the qualifiedand trained clinicians orradiographers forgenerating X-rays of feet.It can be used for adultsand paediatrics.PodSKAN is not intendedfor Mammography andFluoroscopy Applications.	The HF 718BD X-ray System isintended for use byqualified cliniciansfor the x-ray ofhands and feet.	The TeleverePodiatry X-RaySystem HF isintended for use byqualified cliniciansfor the x-ray ofhands and feet. Notformammography.Not fluoroscopy.	Substantially Equivalent.PodSKAN HF covers the same indication for feet ascompared to the predicate device but excludes thehand anatomy. Safety and effectiveness of the systemremains same as compared to the predicated devicefor x-ray of feet.
GeneratorType	High Frequency	High Frequency	High Frequency	Identical
kVp Range	40-80 kV in Steps of 2kV	50kV to 90kV +/-10% adjustable in 2kV steps	Adjustable kilo-voltage from 50 to90 kV	Substantially Equivalent.kV is termed as quality of X-ray which determinesthe penetrating power with optimum contrast. Minorrange difference shall not impact the clinical imagequality because user need to select appropriatetechnique parameter (kV & mAs) for the subjectiveanatomy. Settings are however, allowed to the userto set as needed clinically.
mA Range	10mA-60mA	Fixed at 10mA +/-1%	X-ray tube current10 mA fixed	Substantially Equivalent.As compared to the predicate device. Skanraypodiatry includes 10mA in its user controlledparameter with extended mA range for any clinicalneed by the user
mAs Range	0.32 mAs-16mAs in 23Steps	Exposure timesfrom 50 to 500 mSAdjustable kilo-voltage from 50 to90 kVNo automaticexposure control ormAssettings	Exposure timesfrom 50 to 500 mSAdjustable kilo-voltage from 50 to90 kVNo automaticexposure control ormAssettings	Substantially Equivalent.Device support preset mAs range for the neededclinical purpose. With extended mA range and timecreating similar combination as predicate device.
Configuration	X-ray generator	X-ray generatorand Software only.No digital flat panel	X-ray generatorand Software only.No digital flat panel	Substantially Equivalent.X-Ray Generator and it can be used with anyapproved software and digital flat panel having AEDfunctionality
Focal Spot	Stationary anode :1.2mmas per IEC 60366	Stationary anodeFocal spot 1.0 mmNEMA	Stationary anodeFocal spot 1.0 mmNEMA	Substantially Equivalent.1.0 to 1.2mm focal spots are usually used forstationary x ray tubes other than mammography.Clinically not much difference in quality andsharpness.
Half ValueLayer	3.619mm Al @80kV	3.31mm Al @90kV	3.31mm Al @90kV	Substantially Equivalent.Meet the 21CFR1020.30(m) Half value layerrequirements
Mains VoltageRange andFrequency	100-240V AC RMS @50-60Hz	105-130 volt AC @58-62Hz. Singlephase.Less than 20Amperes.	105-130 volt AC @58-62Hz. Singlephase.Less than 20Amperes.	Substantially Equivalent.meets predicate device input voltage range.
Exposureswitch	Deadman switch	Deadman switch	Deadman switch	Identical
ExposureControl	Manual Touchscreen	ManualTouchscreen	Tigerview Software	Identical
Goniometer	Yes	Yes	Yes	Identical
PerformanceAccuracy	21 CFR 1020.31compliant	21 CFR 1020.31compliant	21 CFR 1020.31compliant	Identical
kV accuracy	+/- 5%	+/- 8%	+/- 8%	Better. Substantially Equivalent
ElectricalSafety &EMC	Electrical Safety per IEC60601-1and EMC per IEC 60601-1-2.	Electrical Safetyper IEC 60601-1and EMC per IEC60601-1-2.	Electrical Safetyper IEC 60601-1and EMC per IEC60601-1-2.	Identical
Product Type	Fixed X-Ray Machine	Fixed X-RayMachine	Fixed X-RayMachine	Identical
CollimatorType	Fixed	Fixed	Fixed	Identical
Collimatorlamp timer	30 seconds	13 seconds	13 seconds	Substantially Equivalent.Function is available. Timing does not impactindicated application, as this is used to visuallyensure the x-ray'ed region
ExposurePresets	11 positions in APR chart	14 - For repeatedlyused techniques	37 total (Ankle 10,Foot 9, Calcaneus9, Other 9)	Substantially Equivalent.APR chart available for various anatomical positions,similar to the predicate.
Source toImageReceptorDistance	32.7" inch	29" inches	29" inches	Substantially Equivalent.Source to image receptor is a distance selected fromengineering perspective for the X-Ray area to becovered, depends on the Anode angle of the tube.This does not impact the performance and intendedapplication of the device

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Discussion of similarities and differences

PodSKAN HF Diagnostic X-Ray System is intended for use by the qualified and trained clinicians or radiographers for generating X-rays of feet. It can be used for adults and paediatrics.

PodSKAN is not intended for Mammography and Fluoroscopy Applications.

Predicate, Reference and subject device are stationary x-ray system covering the similar anatomy as indicated in the comparison table above. KV & mAs minor range difference shall not impact the clinical image quality because user need to select appropriate technique parameter for the subjective anatomy. Settings are however, allowed to the user to set as needed clinically. The controls of the subject device is either identical or similar to predicate devices. The other components like the Basefoot platform and handles provided for patient support have no impact on the safety and effectiveness of the system.

Performance data:

The risks identified during risk analysis were reduced by applying suitable risk control measures and it was noted that there were no unacceptable risks after risk control measures.

Design verification and validation activities have been carried both in-house and by outsourcing to appropriate third-party vendors. The design verification, design validation and performance testing activities have been documented and indicate that the subject device is as safe and effective as the predicate device.

PodSKAN HF Diagnostic X-ray system complies with the following standards.

1.IEC 60601-1:2005. IEC 60601-1:2005/AMD1:2012. IEC 60601-1:2005/AMD2:2020 -General requirements for basic safety and essential performance

IEC 60601-2-28:2010 Ed 2.0 Medical electrical equipment- Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
IEC 60601-2-54:2009+Amd1-2015+Amd 2-2018 Ed 1.2 Medical electrical equipment-Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
IEC 60601-1-3 :2008 +Amd 1-2013 Ed 2.1Medical electrical equipment -Part 1: General requirements for safety - Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 Ed 3.2 Medical electrical equipment -Part 1-6: General requirements for basic safety and essential performance - Collateral 8standard: Usability.
IEC 62366-1:2015+AMD1:2020 Ed 1.1 Medical devices- Application of usability engineering to medical devices

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IEC 62304:2006+AMD1:2015 Ed 1.1 Medical device software – Software life-cycle processes
ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.
60601-1-2 Edition 4.1 2020-09 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
FDA Performance standards 21 CFR 1020.30-Diagnostics X-Ray system and their major components and 21 CFR 1020.31-Radiographic equipment.
BS EN ISO 15223-1:2021: Symbols for use in the labeling of medical devices- for Manufacturer, Date of Manufacture, Serial Number, and Part/Model Number.
EN ISO 14971:2019 Medical devices – Application of Risk Management to medical devices.

FDA guidance documents used in the development of PodSKAN HF Diagnostic X-ray System

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff, October 2014
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff, April 2022
Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff , November 28, 2017
Postmarket Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and Food and Drug Administration Staff

Summary of Non-Clinical Testing.

The subject device has been evaluated and found to be compliant to safety and essential performance as per IEC 60601-1, accuracy of loading factors, reproducibility of radiation output as per IEC 60601-2-54. half value layer, leakage radiation in loading and normal state and stray radiation as per IEC 60601-1-3, conducted emission, radiated emission, harmonics, voltage fluctuations, electrostatic discharge (ESD), electrical fast transients (EFT), radiated RF electromagnetic field, continuous conducted RF, surges, power frequency magnetic field, voltage dips and short interruption as per IEC 60601-1-2. The device also complies with FDA

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performance standards 21CFR 1020.30-1020.31. The validation testing, which includes sample clinical images, demonstrates compliance to the diagnostic quality imaging performance when used with 510k cleared detector and imaging software for the intended application.

Summary of Clinical Testing:

Subject device has substantial similarities when compared to the predicate devices.

Since the clinical application remain same as of predicate device/s, Non-clinical data is considered sufficient to demonstrate safety and performance of PodSKAN HF Diagnostic Xray System, Clinical studies are not deemed necessary.

Conclusion:

Above details collectively demonstrate that PodSKAN HF Diagnostic X-ray System is safe and effective when the device is used as labelled and is found substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.