(133 days)
No
The description focuses on the hardware components, power, and basic control systems, with no mention of AI or ML for image processing, analysis, or other functions.
No
The device is described as a "Diagnostic X-Ray System" intended for generating X-rays of feet to produce images, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is explicitly named "PodSKAN HF Diagnostic X-Ray System" and its intended use is for "generating X-rays of feet," which are used for diagnostic purposes.
No
The device description clearly outlines multiple hardware components including a tube head assembly, base foot platform, external console, and hand switch, in addition to the software components.
Based on the provided information, the PodSKAN HF Diagnostic X-Ray System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens obtained from the human body. This includes things like blood, urine, tissue, etc., to provide information about a person's health.
- The PodSKAN system is an X-ray system. It generates X-rays to create images of the internal structures of the feet. This is an in vivo diagnostic method, meaning it is performed on a living organism.
- The intended use clearly states it is for generating X-rays of feet. This is a direct imaging technique, not a test performed on a sample outside the body.
Therefore, the PodSKAN HF Diagnostic X-Ray System falls under the category of medical imaging devices, not IVD devices.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
KPR
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
feet
Indicated Patient Age Range
adults and paediatrics
Intended User / Care Setting
qualified and trained clinicians or radiographers
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)
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
-
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.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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).
1
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
2
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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3
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 R |
| Regulatory Head | |
| Skanray Technologies Limited | |
| Plot# 15-17, Hebbal Industrial Area, Hebbal | |
| Mysore, Karnataka 570016, India | |
| P: +91 821 2415559 | |
| Email: vasundhara.r@skanray.com | |
| 510(k) Contact Person: | Vasundhara R |
| Regulatory Head | |
| Skanray Technologies Limited | |
| Plot# 15-17, Hebbal Industrial Area, Hebbal | |
| Mysore, Karnataka 570016, India | |
| P: +91 821 2415559 | |
| Email: 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 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 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 892.1680 | |
| Regulation name: Stationary X-ray system | |
| Device class: II | |
| Product code: KPR | |
| Review panel: Radiology | |
| Reference Device: | • Televere Podiatry X-Ray System HF (K180765) |
| Regulation number: 21 CFR 892.1680 | |
| Regulation name: Stationary X-ray system | |
| Device class: II | |
| Product code: KPR | |
| Review panel: Radiology |
4
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
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)
5
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.
6
Comparison to Predicate and Reference devices
| Comparable
| Properties | Subject Device | Predicate Device | Reference Device | Comparison results |
|---|---|---|---|---|
| MAKE | Skanray Technologies | |||
| Limited | X-Cel X-Ray | |||
| Corporation | Televere Systems | - | ||
| MODEL | PodSKAN HF Diagnostic | |||
| X-Ray System | HF 718BD X-Ray | |||
| System | Televere Podiatry | |||
| X-Ray System HF | - | |||
| Regulation | ||||
| number | 21 CFR 892.1680 | 21 CFR 892.1680 | 21 CFR 892.1680 | Identical |
| Regulation | ||||
| name | Stationary x-ray system | Stationary x-ray | ||
| system | Stationary x-ray | |||
| system | Identical | |||
| Product code | KPR | KPR | KPR | Identical |
| Regulatory | ||||
| Class | Class II | Class II | Class II | Identical |
| FDA 510k | ||||
| number | - | K160857 | K180765 | - |
| 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. | The HF 718BD X- | |||
| ray System is | ||||
| intended for use by | ||||
| qualified clinicians | ||||
| for the x-ray of | ||||
| hands and feet. | The Televere | |||
| Podiatry X-Ray | ||||
| System HF is | ||||
| intended for use by | ||||
| qualified clinicians | ||||
| for the x-ray of | ||||
| hands and feet. Not | ||||
| for | ||||
| mammography. | ||||
| Not fluoroscopy. | Substantially Equivalent. | |||
| PodSKAN HF covers the same indication for feet as | ||||
| compared to the predicate device but excludes the | ||||
| hand anatomy. Safety and effectiveness of the system | ||||
| remains same as compared to the predicated device | ||||
| for x-ray of feet. | ||||
| Generator | ||||
| Type | High Frequency | High Frequency | High Frequency | Identical |
| kVp Range | 40-80 kV in Steps of 2kV | 50kV to 90kV +/- | ||
| 10% adjustable in 2 | ||||
| kV steps | Adjustable kilo- | |||
| voltage from 50 to | ||||
| 90 kV | Substantially Equivalent. | |||
| kV is termed as quality of X-ray which determines | ||||
| the penetrating power with optimum contrast. Minor | ||||
| range difference shall not impact the clinical image | ||||
| quality because user need to select appropriate | ||||
| technique parameter (kV & mAs) for the subjective | ||||
| anatomy. Settings are however, allowed to the user | ||||
| to set as needed clinically. | ||||
| mA Range | 10mA-60mA | Fixed at 10mA +/- | ||
| 1% | X-ray tube current | |||
| 10 mA fixed | Substantially Equivalent. | |||
| As compared to the predicate device. Skanray | ||||
| podiatry includes 10mA in its user controlled | ||||
| parameter with extended mA range for any clinical | ||||
| need by the user | ||||
| mAs Range | 0.32 mAs-16mAs in 23 | |||
| Steps | Exposure times | |||
| from 50 to 500 mS | ||||
| Adjustable kilo- | ||||
| voltage from 50 to | ||||
| 90 kV | ||||
| No automatic | ||||
| exposure control or | ||||
| mAs | ||||
| settings | Exposure times | |||
| from 50 to 500 mS | ||||
| Adjustable kilo- | ||||
| voltage from 50 to | ||||
| 90 kV | ||||
| No automatic | ||||
| exposure control or | ||||
| mAs | ||||
| settings | Substantially Equivalent. | |||
| Device support preset mAs range for the needed | ||||
| clinical purpose. With extended mA range and time | ||||
| creating similar combination as predicate device. | ||||
| Configuration | X-ray generator | X-ray generator | ||
| and Software only. | ||||
| No digital flat panel | X-ray generator | |||
| and Software only. | ||||
| No digital flat panel | Substantially Equivalent. | |||
| X-Ray Generator and it can be used with any | ||||
| approved software and digital flat panel having AED | ||||
| functionality | ||||
| Focal Spot | Stationary anode :1.2mm | |||
| as per IEC 60366 | Stationary anode | |||
| Focal spot 1.0 mm | ||||
| NEMA | Stationary anode | |||
| Focal spot 1.0 mm | ||||
| NEMA | Substantially Equivalent. | |||
| 1.0 to 1.2mm focal spots are usually used for | ||||
| stationary x ray tubes other than mammography. | ||||
| Clinically not much difference in quality and | ||||
| sharpness. | ||||
| Half Value | ||||
| Layer | 3.619mm Al @80kV | 3.31mm Al @90kV | 3.31mm Al @90kV | Substantially Equivalent. |
| Meet the 21CFR1020.30(m) Half value layer | ||||
| requirements | ||||
| Mains Voltage | ||||
| Range and | ||||
| Frequency | 100-240V AC RMS @50- | |||
| 60Hz | 105-130 volt AC @ | |||
| 58-62Hz. Single | ||||
| phase. | ||||
| Less than 20 | ||||
| Amperes. | 105-130 volt AC @ | |||
| 58-62Hz. Single | ||||
| phase. | ||||
| Less than 20 | ||||
| Amperes. | Substantially Equivalent. | |||
| meets predicate device input voltage range. | ||||
| Exposure | ||||
| switch | Deadman switch | Deadman switch | Deadman switch | Identical |
| Exposure | ||||
| Control | Manual Touchscreen | Manual | ||
| Touchscreen | Tigerview Software | Identical | ||
| Goniometer | Yes | Yes | Yes | Identical |
| Performance | ||||
| Accuracy | 21 CFR 1020.31 | |||
| compliant | 21 CFR 1020.31 | |||
| compliant | 21 CFR 1020.31 | |||
| compliant | Identical | |||
| kV accuracy | +/- 5% | +/- 8% | +/- 8% | Better. Substantially Equivalent |
| Electrical | ||||
| Safety & | ||||
| EMC | Electrical Safety per IEC | |||
| 60601-1 | ||||
| and EMC per IEC 60601- | ||||
| 1-2. | Electrical Safety | |||
| per IEC 60601-1 | ||||
| and EMC per IEC | ||||
| 60601-1-2. | Electrical Safety | |||
| per IEC 60601-1 | ||||
| and EMC per IEC | ||||
| 60601-1-2. | Identical | |||
| Product Type | Fixed X-Ray Machine | Fixed X-Ray | ||
| Machine | Fixed X-Ray | |||
| Machine | Identical | |||
| Collimator | ||||
| Type | Fixed | Fixed | Fixed | Identical |
| Collimator | ||||
| lamp timer | 30 seconds | 13 seconds | 13 seconds | Substantially Equivalent. |
| Function is available. Timing does not impact | ||||
| indicated application, as this is used to visually | ||||
| ensure the x-ray'ed region | ||||
| Exposure | ||||
| Presets | 11 positions in APR chart | 14 - For repeatedly | ||
| used techniques | 37 total (Ankle 10, | |||
| Foot 9, Calcaneus | ||||
| 9, Other 9) | Substantially Equivalent. | |||
| APR chart available for various anatomical positions, | ||||
| similar to the predicate. | ||||
| Source to | ||||
| Image | ||||
| Receptor | ||||
| Distance | 32.7" inch | 29" inches | 29" inches | Substantially Equivalent. |
| Source to image receptor is a distance selected from | ||||
| engineering perspective for the X-Ray area to be | ||||
| covered, depends on the Anode angle of the tube. | ||||
| This does not impact the performance and intended | ||||
| application of the device |
7
8
9
10
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
11
-
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
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Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff , November 28, 2017
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Postmarket Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff
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Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
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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.