(83 days)
No
The summary describes a traditional electronic brachytherapy system with a computer for treatment planning and data management, but there is no mention of AI or ML capabilities.
Yes
The device is described as an electronic brachytherapy system intended to deliver x-ray radiation for skin surface brachytherapy procedures to treat various conditions like Basal Cell Carcinoma and Kaposi's Sarcoma, indicating its use in treating diseases or injuries.
No
The device is described as a system for delivering X-ray radiation for brachytherapy treatment of skin lesions, not for diagnosis. Its purpose is to treat, not to identify or characterize a disease.
No
The device description clearly outlines a physical treatment unit with an X-ray source, shielded applicator, treatment control panel, and a quality assurance device, indicating it is a hardware-based system with integrated software.
Based on the provided information, the Esteya electronic brachytherapy system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "deliver x-ray radiation for surface brachytherapy procedures" to treat various skin conditions. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a system that generates and delivers radiation for treatment. It does not describe any components or processes for analyzing biological samples (like blood, tissue, or urine) to diagnose a condition.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing information for diagnosis, monitoring, or prognosis.
- Using reagents or assays.
The Esteya system is clearly described as a therapeutic device used to treat existing conditions with radiation.
N/A
Intended Use / Indications for Use
The Esteya electronic brachytherapy system is intended to deliver x-ray radiation for surface brachytherapy procedures. Typical applications Include treatment for Basal Cell Carcinoma, Squamous Cell Carcinoma, Kaposi 's sarcoma, Merkel Cell Cardnoma, Lentigo Maligna, Lentigo Maligna Melanoma, Keloids and Cutaneous Lymphomas (8 and T cell).
Product codes
JAD
Device Description
The Esteya Electronic Brachytherapy System is designed for High Dose Rate (HDR) brachytherapy treatment of skin surface lesions. The Esteya Electronic Brachytherapy System utilizes a mobile treatment unit with an isotope free small 69.5 kV X-ray source that focuses the treatment dose directly to the skin lesion with the aid of a shielded surface applicator. This technique provides a uniform dose to the underlying tissue within minutes. The small X-ray source is activated by the treatment control panel that is located adjacent to the treatment area where the operator is protected from radiation exposure during the patient treatment. The Esteya Electronic Brachytherapy dedicated computer system provides fractionated treatment times, plan approval, patient information and treatment reports in a protected database which is administrator controlled. The quality of the X-ray source output is measured on a daily basis with a dedicated quality assurance device that is connected directly to the treatment unit. This quality assurance check ensures consistent and accurate electronic brachytherapy treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin surface lesions / skin surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Esteya Electronic Brachytherapy System has been tested to meet the product requirements, electrical and mechanical safety standards, and clinical expectations. Testing was performed In accordance with defined test cases with clearly defined acceptance criteria and included bench testing, functional testing to recognized standards, sterility and biocompatibility testing, In addition, external testing of the applicable standards was performed by certified independent laboratories.
Clinical testing was performed to compare the treatment output, dose distribution and clinical acceptance of the Esteya Electronic Brachytherapy System as compared to the Nudetron Valencia Skin Applicator Set (K073107). The results of the clinical testing clearly demonstrated substantial equivalence of the Esteya Electronic Brachytherapy System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Traditional 510(k) Esteya
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K132092
Page 19 Page 1 of 2
July 2013
Image /page/0/Picture/2 description: The image shows the logo for Nucletron, an Elekta company. The logo consists of a stylized graphic to the left of the company name. The graphic appears to be an abstract representation of an atom or molecule. The text "AN ELEKTA COMPANY" is printed in smaller font beneath the company name.
Nucletron B.V. Waardgelder 1 3905 TH Veenendaal The Netnerlands
Phone:{+31} 318-557-133 Fax: {+31) 318 557 118
Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section
SEP 2 6 2013
510[K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 21 CFR 807.92
| Submitter of 510(k): | |
|---|---|
| Company name: | Nucletron B.V. |
| Establishment Registration number: | 9611894 |
| Address: | Nucletron B.V. |
| Waardgelder 1 | |
| 3905 TH Veenendaal | |
| The Netherlands | |
| Phone: | (+31) 318-557-133 |
| Fax: | (+31) 318 557 118 |
| Correspondent: | Jeroen Schuurman |
| Project Manager | |
| jeroen.schuurman@elekta.com | |
| Trade/Proprietary Name: | Esteya |
| Common/Usual Name: | Electronic Brachytherapy System |
| Classification | Class II |
| Classification Name: | X-Ray radiation therapy system |
Legally Marketed Device(s)
Our device is based on the legally marketed devices cited in the table below:
| Manufacturer | Device | 510(k) # |
|---|---|---|
| iCAD Inc | Axxent Electronic Brachytherapy System | K122951 |
| Nucletron B.V. | Valencia Skin Applicator Set | K073107 |
| Topex Inc. | Topex SRT 100 Superficial Radiation Therapy System | K063456 |
21 CFR 892.5900 Product Code: JAD
Device description:
The Esteya Electronic Brachytherapy System is designed for High Dose Rate (HDR) brachytherapy treatment of skin surface lesions. The Esteya Electronic Brachytherapy System utilizes a mobile treatment unit with an isotope free small 69.5 kV X-ray source that focuses the treatment dose directly to the skin lesion with the aid of a shielded surface applicator. This technique provides a uniform dose to the underlying tissue within minutes. The small X-ray source is activated by the
.
1
K132092
Page 2 of 2
Page 20
July 2013
treatment control panel that is located adjacent to the treatment area where the operator is protected from radiation exposure during the patient treatment. The Esteya Electronic Brachytherapy dedicated computer system provides fractionated treatment times, plan approval, patient information and treatment reports in a protected database which is administrator controlled. The quality of the X-ray source output is measured on a daily basis with a dedicated quality assurance device that is connected directly to the treatment unit. This quality assurance check ensures consistent and accurate electronic brachytherapy treatment.
Intended Use:
The Esteya electronic brachytherapy system is intended to deliver x-ray radiation for surface brachytherapy procedures. Typical applications Include treatment for Basal Cell Carcinoma, Squamous Cell Carcinoma, Kaposi 's sarcoma, Merkel Cell Cardnoma, Lentigo Maligna, Lentigo Maligna Melanoma, Keloids and Cutaneous Lymphomas (8 and T cell).
Summary of the Technical Characteristics
Esteva Electronic Brachytherapy System and the predicate devices are designed to provide radiation therapy treatment of skin surface lesions. This treatment is performed with a radiation source and skin surface applicator which provides a uniform dose distribution to underlying tissue.
The Esteya Electronic Brachytherapy System and the predicate devices are nearly Identical in design, technology and functionality. The differences between the devices are minimal and indude additional features integrated into the Esteva Electronic Brachytherapy System to improve safety and effectiveness. The similarities in design and technology are the basis and reason for substantial equivalence of the Esteya Electronic Brachytherapy System to the legally marketed predicate devices.
Summary of Non- dinical testing
Esteya Electronic Brachytherapy System has been tested to meet the product requirements, electrical and mechanical safety standards, and clinical expectations. Testing was performed In accordance with defined test cases with clearly defined acceptance criteria and included bench testing, functional testing to recognized standards, sterility and biocompatibility testing, In addition, external testing of the applicable standards was performed by certified independent laboratories.
Summary of Clinical testing
Clinical testing was performed to compare the treatment output, dose distribution and clinical acceptance of the Esteya Electronic Brachytherapy System as compared to the Nudetron Valencia Skin Applicator Set (K073107). The results of the clinical testing dearly demonstrated substantial equivalence of the Esteya Electronic Brachytherapy System.
Conclusion
The Esteya Electronic Braghytherapy System is substantially equivalent to the deared predicate
| Labels | Values |
|---|---|
| Name | John Lapre' |
| Title | President\Nudetron B.V. |
July 1ˢᵗ 2013
Date
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines representing its wings, symbolizing health, services, and humanity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 26, 2013
Nucletron B.V. % Ms. Lu Anne Johnson President Capamed, Inc. 1917 29 3/4 Avenue RICE LAKE WI 54868
Re: K132092
Trade/Device Name: Esteya Regulation Number: 21 CFR 892.5900 Regulation Name: X-ray radiation therapy system Regulatory Class: II Product Code: JAD Dated: July 2, 2013 Received: July 12, 2013
Dear Ms. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28. 1976, the enactment date of the Medical Device Amendments. or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2-Ms. Johnson
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers. International and Consumer Assistance 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 yours.
Richard D. O'Hara
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
for
Enclosure
4
Indications for Use
K132092 510(k) Number (if known):
Device Name: Esteya
Indications for Use:
The Esteya electronic brachytherapy system is intended to deliver x-ray radiation for suface brachytherapy procedures. Typical applications include treatment for Basal Cell Carcinoma, Squamous Cell Carcinoma, Kaposi's Sarcoma, Merkel Cell Carcinoma, Lentigo Maligna, Lentigo Malingna Melanoma, Keloids and Cutaneous Lymphoma (B and T cell).
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Michael D. O'Hara
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K132092 510(k)
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