(81 days)
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.
The Photoelectric Therapy 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 Photoelectric Therapy 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 Photoelectric Therapy 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.
This document describes a 510(k) premarket notification for the Xstrahl Photoelectric Therapy System, an X-ray radiation therapy system. The notification primarily focuses on demonstrating substantial equivalence to a predicate device (Sensus Healthcare SRT-100 Superficial Radiation Therapy System) through non-clinical testing.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly provide a table of acceptance criteria with corresponding device performance for a clinical evaluation. Instead, it details adherence to various international and national standards for electrical safety, electromagnetic compatibility, usability, and dosimetry for an X-ray therapy system. The "reported device performance" in this context refers to compliance with these standards, not necessarily clinical efficacy.
| Acceptance Criteria Category | Specific Standard/Protocol | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1: General requirements for basic safety and essential performance | Verified compliance through non-clinical tests |
| Usability | IEC 60601-1-6: Collateral standard. Usability | Verified compliance through non-clinical tests |
| IEC 62366: Application of usability engineering to medical devices | Verified compliance through non-clinical tests | |
| X-ray Therapy Specific Safety & Performance | EN 60601-2-8 (IEC-60601-2-8): Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV | Verified compliance through non-clinical tests |
| Electromagnetic Compatibility (EMC) | EN 60601-1-2 (IEC 60601-1-2): General requirements for safety - Collateral standard: Electromagnetic compatibility requirements and tests | Verified compliance through non-clinical tests |
| Dosimetry Verification | IPEMB Code of Practice Phys. Med. Biol. 41 (1996) 2605–2625 | Verified compliance through independent measurements at NPL UK |
| AAPM Task Group 61 (TG-61) Protocol | Verified compliance through independent measurements at NPL UK | |
| Manufacturing/Quality Control | Xstrahl Customer Acceptance Test (CAT) procedure | Verified compliance through independent measurements at NPL UK |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical testing for safety, EMC, usability, and dosimetry. Therefore, there is no "test set" of patient data in the context of a clinical study. The "test set" would refer to the physical device prototypes and components subjected to these engineering and physics tests. The data provenance is from non-clinical laboratory settings in the UK (Xstrahl Ltd. and National Physics Laboratory UK). The data is prospective in the sense that the device was specifically manufactured and tested against these standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Since this document focuses on non-clinical engineering and physics tests, the concept of "ground truth for a test set" established by medical experts (like radiologists) does not apply in the typical sense of a clinical trial.
However, the National Physics Laboratory UK (NPL) is a recognized authority in measurement science, and their involvement in dosimetry verification suggests that their experts (likely medical physicists or similar specialists) were used. The IPEMB Code of Practice and AAPM Task Group 61 Protocol are established by expert bodies in medical physics, and adherence to these protocols reflects an expert consensus on accurate dosimetry.
The "experts" involved in establishing the "ground truth" for these technical tests would be:
- Engineers and physicists at Xstrahl Ltd. involved in the design, development, and internal testing of the device.
- Independent medical physicists/scientists at the National Physics Laboratory UK (NPL) who performed the verification measurements according to recognized professional codes of practice. Their qualifications would typically include advanced degrees in physics, medical physics, or related fields, with expertise in radiation dosimetry and medical device testing.
4. Adjudication Method for the Test Set:
Not applicable in the context of non-clinical engineering and physics testing. Adjudication methods like "2+1" are typically used in clinical studies involving multiple human readers to resolve discrepancies in diagnoses or interpretations. The non-clinical tests described involve objective measurements and compliance verification against predefined technical standards.
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. The document does not describe any MRMC comparative effectiveness study, nor does it mention AI or human-in-the-loop performance. This device is an X-ray radiation therapy system, not an imaging or diagnostic AI-powered device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No. This question is also not applicable. The device is a physical X-ray therapy system. There is no "algorithm only" performance reported in the context of AI or diagnostic interpretation. The "system" operates as a standalone piece of equipment for delivering radiation therapy as intended.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is defined by:
- Established international and national standards: IEC 60601 series, EN 60601 series, IEC 62366. Compliance with these standards is the "truth" being verified for safety, EMC, and usability.
- Recognized codes of practice for dosimetry: IPEMB Code of Practice and AAPM Task Group 61 Protocol. The physical measurements conducted by NPL are compared against the expected values as defined by these protocols to establish the "ground truth" for radiation output accuracy.
- Manufacturer's own Customer Acceptance Test (CAT) procedure: This internal standard serves as a ground truth for the device's specific manufactured performance characteristics.
8. The Sample Size for the Training Set:
Not applicable. The document describes a medical device, not an AI or machine learning model. Therefore, there is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for an AI model, the question of establishing its ground truth is irrelevant to this submission.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 29, 2017
Xstrahl Ltd. % Mr. Andrew Mullen Operations Director Unit 2 Maybrook Industrial Estate, Maybrook Road, Walsall Wood Brownhills.West Midlands WS8 7DG UNITED KINGDOM
Re: K172080
Trade/Device Name: Photoelectric Therapy System Regulation Number: 21 CFR 892.5900 Regulation Name: X-ray radiation therapy system Regulatory Class: II Product Code: JAD Dated: June 30, 2017 Received: July 13, 2017
Dear Mr. Mullen:
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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 (DICE) 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 (DICE) 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.
Michael D. O'Hara For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172080
Device Name Photoelectric Therapy System
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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510(k) Summary (in accordance with 21 CFR 807.87(h) and 21 CFR 807.92)
1. Submitter's name and address:
Xstrahl Limited Unit 2 Maybrook Industrial Estate Maybrook Road Walsall Wood Brownhills West Midlands WS8 7DG U.K.
FDA Establishment Registration No. 3004561814
2. Submitter's telephone number and fax number:
Tel: 011 44 1543 688920 Fax: 011 44 1543 688928
3. Contact person:
Mr. Andrew Mullen, Operations Director
4. Date this 510(k) summary prepared:
June 30th 2017
5. Trade/proprietary name of the device:
Photoelectric Therapy System
6. Classification name and number of the device:
FDA Class - II FDA Product Code: JAD FDA Classification Name: X-Ray Radiation Therapy System FDA Regulation Number: 21CFR 892.5900
7. Legally marketed predicate device to which substantial equivalence is claimed:
| Device Manufacturer | Sensus Healthcare |
|---|---|
| Device Name | SRT-100 Superficial RadiationTherapy System |
| FDA 510(k) No. | K123985 |
| Clearance given by FDAto market this device on | May 14th 2013 |
| FDA Class | II |
| FDA Product Code | JAD |
Section 5 Page 1 of 6
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| FDA Classification Name | X-Ray Radiation Therapy System |
|---|---|
| FDA Regulation Number: | 21CFR 892.5900 |
8. Description of the device that is the subject of this premarket notification:
The Photoelectric Therapy 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 Photoelectric Therapy 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 Photoelectric Therapy 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 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.
9. Intended use and indication 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.
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The system, which is intended to be used by trained medical professionals, is compact and ergonomic and with its ease of use and installation can be utilised in hospital oncology centres, in addition to smaller dermatology and oncology practices.
10. Technological characteristics:
The primary application for the Photoelectric Therapy System is non-surgical non-melanoma skin cancer treatment. With the system being sufficiently small, ergonomic, with ease of use and installation such that it could be utilised in hospital oncology centres, in addition to smaller dermatology and oncology practices.
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 feature ergonomically designed controls ensuring smooth adjustment and patient set-up with a flexibility that allows patients to be treated in any position. The system requires connection to the clinical facilities electrical supply and safety circuits.
The system comprises a small freestanding base unit, with a footprint measuring 550mm x 550mm, incorporating 4 total-locking wheel castors, permitting movement of the base unit and X-Ray treatment head within the treatment room. with the system fixed in place prior to treatment with operation of a single foot lever.
The Control POD and PC are located in the control room, with the PC connecting to the Control POD by a USB cable. A single cable connects the POD and the TP2 Central Control Unit between the control room and the controller.
The TP2 Central Control Unit is wall mounted in the treatment room, with two small cables connecting to the X-Ray Therapy Unit.
An Emergency Stop button is incorporated on the controller, and provision for a second Emergency Stop to be fitted within the treatment room.
Section 5 Page 3 of 6
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Summary of the Technological Characteristics of the Device compared with the Predicate Device
| Feature | Candidate Device:Xstrahl Ltd.Photoelectric TherapySystem | Predicate Device:Sensus HealthcareSRT-100 SuperficialRadiation Therapy System |
|---|---|---|
| Basic design | Mobile base unit, with 4lockable wheels, contains theX-Ray generator, the X-Raytube head mounted on asupport arm and the X-Raytube cooling | Mobile base unit, with 4lockable wheels, contains theX-Ray generator, power supplycomponents, the X-Ray tubehead mounted on a supportarm, the X-Ray tube coolingsystem, and controls andindicators |
| Dimensions andWeight | Base Unit:The height of the base unit is31" (80cm) and with the armfitted the height is 54" (138cm).Weight 140lb (64kg).Footprint 22" (550mm) x 22"(500mm). | Base Unit:67" H x 30 " W x 30" DWeight 350lb (160kg)Footprint 30" (762mm) x 30"(762mm). |
| TP2 Central Control Unit:11" (275mm) W x 5.5"(140mm) H x 6.5" (165mm) DWeight 11lb (5kg) | Control Console:9.5" H x 13.125" W x 7.25" DWeight 25lb (12kg) | |
| Voltage | 100 - 240 VAC | 100-120V220-240V |
| Mains Frequency | 50-60Hz | 50-60Hz |
| X-Ray SourceVoltage | 10 kV to 80 kV | 50kV at 10mA 1.0mm Al HVL70kV at 10mA 1.0mm Al HVL100 kV at 8mA 2.0mm Al HVL |
| OperatingTemperatureRange | 15°C to 30°C (59°F to 86°F) | 10°C to 30°C (50°F to 86°F) |
| Operating RelativeHumidity Range | 10 to 80% (non-condensing) | 30% to 70% (non-condensing) |
| OperatingTemperatureRange | 15°C to 30°C (59°F to 86°F) | 10°C to 30°C (50°F to 86°F) |
| Feature | Candidate Device:Xstrahl Ltd.Photoelectric TherapySystem | Predicate Device:Sensus HealthcareSRT-100 SuperficialRadiation Therapy System |
| TreatmentApplicators | Standard Circular Applicatorsare available in the followingdiameters:1.5cm, 2.0cm, 3.0cm, 4.0cmand 5.0cm, all 5 cm FSD.Optional Oval Lip Applicatorsare available in the followingdiameters:1.0cm x 1.5cm, 1.0cm x2.0cm, 1.0cm x 3.0cm,1.5cm x3.0cm and 1.5 cm x 4.0cmdiameter, all at 5 cm FSD. | Standard Circular Applicatorsare available in the followingdiameters:1.5cm,1.5cm, 2.0cm, 2.5cm,3.0cm, 4.0cm and 5.0cm, all at15 cm SSD10.0cm and 12.7cm, both at 25cm SSDOptional Circular Applicator;1.0cm at 15cm SSD isavailable. |
| Filters | Standard Filters are availablewith the following values;1.85mm Al HVL and2.5mm Al HVL. | Standard Filters are availablewith the following values;1.3mm Al HVL and2.1mm Al HVL |
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11.Summary of Non-clinical Tests Undertaken
IEC 60601-1 Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-6 Medical Electrical Equipment Part 1-6: General requirements for basic safety and essential performance. Collateral standard. Usability
EN 60601-2-8 (IEC-60601-2-8) Medical Electrical Equipment Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
EN 60601-1-2 (IEC 60601-1-2) Medical Electrical Equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility requirements and tests
IEC 62366 Medical Devices - Application of usability engineering to medical devices
Section 5 Page 5 of 6
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Additionally independent measurements were completed at the National Physics Laboratory UK (NPL) to verify compliance with the following recognized codes of practice and Xstrahl Customer Acceptance Test (CAT) procedure
IPEMB Code of Practice Phys. Med. Biol. 41 (1996) 2605–2625. Institute of Physics and Engineering in Medicine and Biology (IPEMB), Code of Practice for the determination of absorbed dose for x-rays below 300 kV generating potential (0.035 mm Al-4 mm Cu HVL; 10-300 kV generating potential)
American Association of Physicists in Medicine (AAPM) Task Group 61 (TG-61), Protocol for 40-300 kV x-ray beam dosimetry in radiotherapy and radiobiology
This concludes the 510(k) Summary.
Section 5 Page 6 of 6
§ 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.