(129 days)
Not Found
No
The document describes a time-based control system for an X-ray therapy device and focuses on hardware, software functionality, and performance testing related to radiation delivery and safety. There is no mention of AI or ML in the description, testing, or performance summaries.
Yes
The device is intended for the "treatment of primary malignant epithelial neoplasms of the skin and keloids," which directly indicates a therapeutic purpose.
No
The device is described as an X-Ray therapy system intended for "superficial radiotherapy and surface electronic brachytherapy treatment" of various malignant conditions and keloids, indicating its role in treatment rather than diagnosis.
No
The device description clearly states that the system consists of hardware components including an X-Ray Therapy Unit, a Central Control Unit, a Control POD, and a PC. While it includes user interface software, it is an integral part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The Xstrahl Photoelectric Therapy System is an X-ray system used for superficial radiotherapy and surface electronic brachytherapy treatment. This involves delivering radiation directly to the patient's skin for therapeutic purposes. This is an in vivo (within the living body) treatment, not an in vitro diagnostic test.
- Intended Use: The intended use clearly states "treatment of primary malignant epithelial neoplasms of the skin and keloids." This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a system that delivers X-ray radiation for treatment, not a system that analyzes biological samples.
Therefore, the Xstrahl Photoelectric Therapy System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Xstrahl Photoelectric Therapy System is a low energy X-Ray system intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms of the skin and keloids.
Typical applications include treatment for Basal Cell Carcinoma, Squamous Cell Carcinoma, Metatypic Carcinoma, Cutaneous Appendage Carcinoma, Karposi's Sarcoma, Merkel Cell Carcinoma, Lentigo Maligna, Lentigo Maligna Melanoma, Cutaneous Lymphomas (B and T cell) and Keloids.
Product codes (comma separated list FDA assigned to the subject device)
JAD
Device Description
The X80 / RADiant / Photoelectric Therapy System (hereafter referred to as the RADiant System) is a compact and ergonomic superficial X-Ray therapy system operating in the 10kV to 80kV range intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms of the skin and keloids.
The RADiant System is a standalone X-Ray radiation therapy system consisting of the X-Ray Therapy Unit, a TP2 Central Control Unit (CCU), a Control POD (Control POD), and a PC on which user interface software is loaded. The system has a time-based control system used with treatment filters and applicators. A range of bespoke treatment applicators and beam filters are available for use with the RADiant System.
The system is freestanding, self-contained, unobtrusive, compact and ergonomic in design, which helps to ensure a reassuring and stress-free patient experience. The system is floor mounted in order to accommodate almost any clinical space, and features ergonomically designed controls ensuring smooth adjustment and safe, simple patient set-up. The system requires connection to the clinical facilities electrical supply and room interlocks.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The system is intended for use within a hospital or other clinical environment where the patient is treated under 'outpatient' conditions by trained medical professionals only e.g. Radiographers, Clinicians and Oncologists. It is not intended for use by a patient or general public. The clinical environment typically consists of a safety-interlocked lead lined shielded Treatment Room housing the X-Ray Therapy Unit, the TP2 Central Control Unit and an Emergency Stop Button, with a Control Room housing the Control POD and the PC. Door interlocks and warning lights are located at the access point to the treatment room. The operator is located outside the treatment room during the treatment process.
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)
Design verification and validation testing was performed to ensure that the device functionality works as per its intended use, all risks are mitigated, is substantially equivalent, and the product conforms to the required standards.
Non-clinical testing, including verification of risk control measures, was completed and detailed results of these tests are included as part of this submission. Twenty Six independent verification tests and 18 independent validation tests were executed on the RADiant Aura systems. These tests included testing the system for its retention of the applicator and filter during various ranges of motion, residual motion of the system, system's response to power loss, system stability testing, radiation leakage testing, build of the individual components and the complete system. Software run-through functionality test was also completed successfully. The versions of the software used in predicate device (K17208) worked without any changes with the RADiant Aura system. Testing was also completed to ensure that the system's ability to position the treatment head to treat different locations while the patient was laying on the bed or was in seated position was not affected by the design changes with respect to the predicate device.
Testing was also completed successfully that determined the dose reproducibility in accordance with BS EN 60601-2-8:2015+A1:2016 clause 201.10.1.2.112 'Agreement between indicated values and effective values.'
In addition, independent output measurements were completed successfully at the National Physics Laboratory UK (NPL) as per Xstrahl Customer Acceptance Test procedure and to verify compliance with the following recognized codes of practice:
- AAPM. (2001). AAPM protocol for 40-300kV x-ray beam dosimetry in radiotherapy and o radiobiology.
- IPEMB. (1996). The IPEMB code of practice for the determination of absorbed dose for x-rays O below 300kV generating potential (0.035 mm Al-4 mm Cu HVL: 10-300kV generating potential).
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.
Not Found
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
§ 892.5900 X-ray radiation therapy system.
(a)
Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II.
0
July 13, 2023
Image /page/0/Picture/1 description: The image contains 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 is 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.
Xstrahl Ltd. % Vineet Gupta Technical Director Unit 2 Maybrook Industrial Estate Maybrook Road Brownhills. West Midlands WS8 7DG UNITED KINGDOM
Re: K230611
Trade/Device Name: X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) Regulation Number: 21 CFR 892.5900 Regulation Name: X-Ray radiation therapy system Regulatory Class: Class II Product Code: JAD Dated: March 3, 2023 Received: March 6, 2023
Dear Vineet Gupta:
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. 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 located 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.
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 803) for
1
devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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.
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Lora D. Weidner. The date of the signature is 2023.07.13, and the time is 11:10:11 -04'00'.
Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices 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) K230611
Device Name
X80 / RADiant / Photoelectric Therapy System (RADiant Aura)
Indications for Use (Describe)
The Xstrahl Photoelectric Therapy System is a low energy X-Ray system intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms of the skin and keloids.
Typical applications include treatment for Basal Cell Carcinoma, Squamous Cell Carcinoma, Metatypic Carcinoma, Cutaneous Appendage Carcinoma, Karposi's Sarcoma, Merkel Cell Carcinoma, Lentigo Maligna, Lentigo Maligna Melanoma, Cutaneous Lymphomas (B and T cell) and Keloids.
| 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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Image /page/3/Picture/0 description: The image shows the logo for Xstrahl. The logo consists of a purple oval shape with a white "X" inside of it, followed by the word "strahl" in purple. The font of the word "strahl" is sans-serif.
| Xstrahl Ltd Unit 2 Maybrook Industrial Estate Maybrook Road, Brownhills, West Midlands, WS8 7DG United Kingdom T +44 (0)1543 688920 E support@xstrahl.com
Xstrahl.com
510(K) SUMMARY K230611
A. SUBMITTERS NAME
Xstrahl Ltd.
FDA Establishment Registration No. 3004561814
B. ADDRESS
Unit 2, Maybrook Industrial Estate Maybrook Road Brownhills, West Midlands WS8 7DG United Kingdom
C. CONTACT
| Name: | Vineet Gupta, Ph.D. |
|---|---|
| Designation: | Technical Director |
| Phone: | (412) 320 5048 |
| Email: | vineetgupta@xstrahl.com |
D. DATE PREPARED:
3-March-2023
E. DEVICE NAME:
| Device Trade Name: | X80 / RADiant / PhotoElectric Therapy System |
|---|---|
| Classification Name: | X-Ray Radiation Therapy System |
| Model / Market Name: | RADiant Aura |
F. DEVICE CLASS:
| Device Class: | II |
|---|---|
| Panel: | Radiology |
| Product Code: | JAD |
| Regulation Number: | 21CFR 892.5900 |
4
G. PREDICATE DEVICES:
X80 / RADiant / PhotoElectric Therapy System (K172080)
H. STATEMENT ON INDICATIONS FOR USE:
The intended use and indications for use of the system have not changed due to the modification to the product. The modification has not changed the fundamental operating principle of the product.
Intended Use
The Xstrahl Photoelectric Therapy System is a low energy X-Ray system intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms of the skin and keloids.
Indications for Use
The Xstrahl Photoelectric Therapy System is a low energy X-Ray system intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms of the skin and keloids.
Typical applications include treatment for Basal Cell Carcinoma, Squamous Cell Carcinoma, Metatypic Carcinoma, Cutaneous Appendage Carcinoma, Karposi's Sarcoma, Merkel Cell Carcinoma, Lentigo Maligna, Lentigo Maligna Melanoma, Cutaneous Lymphomas (B and T cell) and Keloids.
DEVICE DESCRIPTION: I.
The X80 / RADiant / Photoelectric Therapy System (hereafter referred to as the RADiant System) is a compact and ergonomic superficial X-Ray therapy system operating in the 10kV to 80kV range intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms of the skin and keloids.
The RADiant System is a standalone X-Ray radiation therapy system consisting of the X-Ray Therapy Unit, a TP2 Central Control Unit (CCU), a Control POD (Control POD), and a PC on which user interface software is loaded. The system has a time-based control system used with treatment filters and applicators. A range of bespoke treatment applicators and beam filters are available for use with the RADiant System.
The system is freestanding, self-contained, unobtrusive, compact and ergonomic in design, which helps to ensure a reassuring and stress-free patient experience. The system is floor mounted in order to accommodate almost any clinical space, and features ergonomically designed controls ensuring smooth adjustment and safe, simple patient set-up. The system requires connection to the clinical facilities electrical supply and room interlocks.
The system is intended for use within a hospital or other clinical environment where the patient is treated under 'outpatient' conditions by trained medical professionals only e.g. Radiographers, Clinicians and Oncologists. It is not intended for use by a patient or general public. The clinical environment typically consists of a safety-interlocked lead lined shielded Treatment Room housing the X-Ray Therapy Unit, the TP2 Central Control Unit and an Emergency Stop Button, with a Control Room housing the Control POD
5
and the PC. Door interlocks and warning lights are located at the access point to the treatment room. The operator is located outside the treatment room during the treatment process.
J. PREDICATE DEVICE INFORMATION:
The RADiant Aura system is substantially equivalent to its primary predicate device RADiant (K172080; Decision Date: 29-September-2017).
The fundamental scientific technology of the RADiant Aura System with respect to its predicate device (RADiant system) has not changed. The intended use and indications for use of the device have not changed. Based upon the performance testing results for RADiant Aura (as detailed in the submission), the system raises no new issues of safety or effectiveness.
K. COMPARISON TO THE PREDICATE DEVICE:
This section provides the summary of comparison of the RADiant Aura system to its predicate device.
| Sr. No. | Comparison
Item | Subject Device
RADiant Aura (X80 / RADiant /
Photoelectric Therapy System)
(K230611) | Predicate Device
X80 / RADiant / Photoelectric
Therapy System
(K172080) |
|--------------|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Intended Use | The Xstrahl Photoelectric Therapy
System is a low energy X-Ray system
intended for superficial radiotherapy
and surface electronic brachytherapy
treatment of primary malignant
epithelial neoplasms of the skin and
keloids. | The Xstrahl Photoelectric Therapy
System is a low energy X-Ray system
intended for superficial radiotherapy
and surface electronic brachytherapy
treatment of primary malignant
epithelial neoplasms of the skin and
keloids. |
| 2. | Indications for
Use | The Xstrahl Photoelectric Therapy
System is a low energy X-Ray system
intended for superficial radiotherapy
and surface electronic brachytherapy
treatment of primary malignant
epithelial neoplasms of the skin and
keloids. | The Xstrahl Photoelectric Therapy
System is a low energy X-Ray system
intended for superficial radiotherapy
and surface electronic brachytherapy
treatment of primary malignant
epithelial neoplasms of the skin and
keloids. |
| | | Typical applications include treatment
for Basal Cell Carcinoma, Squamous
Cell Carcinoma, Metatypic Carcinoma,
Cutaneous Appendage Carcinoma,
Karposi's Sarcoma, Merkel Cell
Carcinoma, Lentigo Maligna, Lentigo
Maligna Melanoma, Cutaneous
Lymphomas (B and T cell) and
Keloids. | Typical applications include treatment
for Basal Cell Carcinoma, Squamous
Cell Carcinoma, Metatypic Carcinoma,
Cutaneous Appendage Carcinoma,
Karposi's Sarcoma, Merkel Cell
Carcinoma, Lentigo Maligna, Lentigo
Maligna Melanoma, Cutaneous
Lymphomas (B and T cell) and
Keloids. |
| 3. | FDA Product
Code | JAD | JAD |
| Sr. No. | Comparison
Item | Subject Device
RADiant Aura (X80 / RADiant /
Photoelectric Therapy System)
(K230611) | Predicate Device
X80 / RADiant / Photoelectric
Therapy System
(K172080) |
| 4. | FDA Class | II | II |
| 5. | FDA
Classification
Name | X-Ray Radiation Therapy System | X-Ray Radiation Therapy System |
| 6. | FDA Regulation
Number | 21CFR 892.5900 | 21CFR 892.5900 |
| 7. | Physical Characteristics | | |
| 7a. | Basic Design | Base unit, with 4 lockable wheels,
contains the x-ray generator and cooler.
X-Ray tube head is mounted on a
support arm that is mounted on the base
unit. | Base unit, with 4 lockable wheels,
contains the x-ray generator and
cooler. X-Ray tube head is mounted
on a support arm that is mounted on
the base unit. |
| 7b. | Base Unit
Dimension | 52 cm (D) x 57 cm (W) x 55 cm (H) | 52 cm (D) x 57 cm (W) x 55 cm (H) |
| 7c. | CCU Dimension | 28 cm (W) x 140 cm (H) x 170 cm (D) | 28 cm (W) x 140 cm (H) x 170 cm (D) |
| 7d. | POD Dimension | 20 cm (W) x 7.5 cm (H) x 150 cm (D) | 20 cm (W) x 7.5 cm (H) x 150 cm (D) |
| 8. | ARM Specifications | | |
| 8a. | Maximum Weight
Supported | 8 kg | 4.5 kg |
| 8b. | Rotation about the
base unit | $\pm 95°$
(Total rotation is the same with
reference to 0 degrees) | $\pm 180°$
(Total rotation is the same with
reference to 0 degrees) |
| 8c. | Vertical Range | 125.7 cm to -23 cm | 59.5 cm to -23 cm |
| 8d. | Horizontal Range | 8.5 cm to 118 cm | 43 cm to 105 cm |
| 8e. | Number of
electromagnetic
brakes | 2 (1 between vertical arm and base unit
and 1 between vertical and horizontal
arm) | 2 (1 between vertical arm and base unit
and 1 between vertical and horizontal
arm) |
| 8f. | Number of gas
struts | 4 (all 4 of them in the vertical arm: two
of them to control the vertical arm
motion and two of them to control the
horizontal arm motion) | 2 (one in vertical arm and 1 in
horizontal arm) |
| 9. | X-Ray Tube Head Specifications | | |
| 9a. | X-Ray Tube
Manufacturer | Varex Imaging | Varex Imaging |
| 9b. | Source Voltage | 10 kV to 80 kV | 10 kV to 80 kV |
| 9c. | Model Number | VF-80 | VF-80 |
| 9d. | Continuous Max
Tube Power | 100 W | 100 W |
| 9d. | Rotation of the
Tube Head | $\pm 110°$ | $\pm 90°$ |
| 9e. | Tilt of the Tube
Head | $\pm 45°$ | + 90° to - 15° |
| 9f. | Vertical Motion | 0-1 cm | None |
| 9e. | Number of
Electromechanical
Brakes | 2 (one to control the head rotation and
the other to control the head tilt) | None. This is based on a single
mechanical locking mechanism |
| Sr. No. | Comparison Item | Subject Device
RADiant Aura (X80 / RADiant /
Photoelectric Therapy System)
(K230611) | Predicate Device
X80 / RADiant / Photoelectric
Therapy System
(K172080) |
| 9f. | Image of Tube Head and controls | Image: Tube head and controls of RADiant Aura (X80 / RADiant / Photoelectric Therapy System) (K230611)
- Tube head movement handle
- Tube head vertical movement handle
- Movement enable button for arm and head joints movement. Either button can be used.
- LED light ring switch | Image: Tube head and controls of X80 / RADiant / Photoelectric Therapy System (K172080)
• Brake Button is the movement enable button for the arm joints movement
• Thumb screw is the mechanical locking mechanism for head movement |
| 10. | Image showing arm and head movement labels | Image: Arm and head movement labels of RADiant Aura (X80 / RADiant / Photoelectric Therapy System) (K230611) | Image: Arm and head movement labels of X80 / RADiant / Photoelectric Therapy System (K172080) |
| 11. | Base Unit Components | | |
| 11a. | X-Ray Generator | Spellman
Power: 100 W
KV Range: 0 to 80 kV
mA Range: 0 to 2 mA | Spellman
Power: 100W
KV Range: 0 to 80 kV
mA Range: 0 to 2 mA |
| 11b. | Cooling System | Type: Air-cooled water-cooling system
Pump: Laing D5-Pump 12V D5-Vario
Fan: 2 off 120 mm Noctua | Type: Air-cooled water-cooling system
Pump: Laing D5-Pump 12V D5-Vario
Fan: 180mm Silverstone |
| 11c. | Number of PCBs in the Base Unit | 2 | 5 |
| 12. | Applicators | | |
| 12a. | Max Focal Spot Distance (FSD) supported | 10 cm | 10 cm |
| 12b. | Standard Applicator kit | Electronic Brachytherapy: 5 cm FSD (1 cm, 1.5 cm, 2 cm, 3 cm, 4 cm)
Superficial Radiation Therapy: 6 cm FSD (1 cm, 1.5 cm, 2 cm, 3 cm, 4 cm) | Electronic Brachytherapy: 5 cm FSD (1 cm, 1.5 cm, 2 cm, 3 cm, 4 cm)
Superficial Radiation Therapy: 6 cm FSD (1 cm, 1.5 cm, 2 cm, 3 cm, 4 cm) |
| Sr. No. | Comparison
Item | Subject Device
RADiant Aura (X80 / RADiant /
Photoelectric Therapy System)
(K230611) | Predicate Device
X80 / RADiant / Photoelectric
Therapy System
(K172080) |
| 12c. | Applicator
Material | Clear Cast Acrylic (PMMA) | Clear Cast Acrylic (PMMA) |
| 13. | | Filters | |
| 13a. | Filter Material | Aluminum | Aluminum |
| 13b. | Standard Filter
thickness | 2.5 mm Al and 1.5 mm Al | 2.5 mm Al and 1.5 mm Al |
| 14. Software | | | |
| 14a. | Concerto | Version: 2.3 | Version: 2.3 |
| 14b. | Fisica | Version: 1.06 | Version: 1.06 |
| 14c. | TP2 | Version: 1.24 | Version: 1.24 |
| 15. | System Image | Image: System Image | |
| 16. | Overall System
Architecture | Image: Overall System Architecture | |
Table 1: Comparison of the Subject Device with Predicate Device
6
7
8
RADiant Aura contains all the features and components for the system as present in the predicate device. RADiant Aura enhances the design of the arm and the head joint of the system. The similarities and differences are described in detail as part of this submission.
RADiant Aura's (subject device (K230611) fundamental technological characteristics are the same as those of the predicate device (K172080). The x-ray tube (VF-80) and the generator (Spellman) used on both the systems are the same. The control system on the subject device (K230611) and the predicate device (K172080) is also the same. The firmware and the software used on both the devices (predicate (K172080) and subject (K230611)) are also the same. The overall system architecture of both the systems is also the same.
In addition, the target population and the indications for use are similar to that of the predicate device. Any minor differences in the features do not raise any concerns for safety, performance, or effectiveness of the
9
device. The characteristics / features of RADiant Aura with respect to the predicate device is described in the comparison chart in the submission.
L. SUMMARY OF TESTING:
Design verification and validation testing was performed to ensure that the device functionality works as per its intended use, all risks are mitigated, is substantially equivalent, and the product conforms to the required standards.
Non-clinical testing, including verification of risk control measures, was completed and detailed results of these tests are included as part of this submission. Twenty Six independent verification tests and 18 independent validation tests were executed on the RADiant Aura systems. These tests included testing the system for its retention of the applicator and filter during various ranges of motion, residual motion of the system, system's response to power loss, system stability testing, radiation leakage testing, build of the individual components and the complete system. Software run-through functionality test was also completed successfully. The versions of the software used in predicate device (K17208) worked without any changes with the RADiant Aura system. Testing was also completed to ensure that the system's ability to position the treatment head to treat different locations while the patient was laying on the bed or was in seated position was not affected by the design changes with respect to the predicate device.
Testing was also completed successfully that determined the dose reproducibility in accordance with BS EN 60601-2-8:2015+A1:2016 clause 201.10.1.2.112 'Agreement between indicated values and effective values.'
In addition, independent output measurements were completed successfully at the National Physics Laboratory UK (NPL) as per Xstrahl Customer Acceptance Test procedure and to verify compliance with the following recognized codes of practice:
- AAPM. (2001). AAPM protocol for 40-300kV x-ray beam dosimetry in radiotherapy and o radiobiology.
- IPEMB. (1996). The IPEMB code of practice for the determination of absorbed dose for x-rays O below 300kV generating potential (0.035 mm Al-4 mm Cu HVL: 10-300kV generating potential).
Conclusion:
The verification and validation results demonstrate that the RADiant Aura system met its design requirements and specifications, is substantially equivalent to its predicate device, and conforms to the applicable sections of standards that includes:
- . IEC 60601-1: Medical Electrical Equipment – General Requirements for basic safety and essential performance
- IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for basic safety and . essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- . IEC 60601-2-8: Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
- IEC 60601-1-6: Medical electrical equipment Part 1-6: General requirements for basic safety and ● essential performance - Collateral standard: Usability
- IEC 62366: Medical devices Part 1: Application of usability engineering to medical devices ●
- IEC 62304: Medical device software Software life cycle processes ●
- ISO 14971: Medical devices Application of risk management to medical devices ●