(25 days)
Not Found
No
The description focuses on the hardware, X-ray source, control panel, and a standard computer system for data management and treatment planning. There is no mention of AI, ML, or any features that would typically involve these technologies for image analysis, treatment optimization, or other functions.
Yes
The device is intended to deliver X-ray radiation for superficial radiotherapy procedures and surface brachytherapy, which are medical treatments for various conditions like Basal Cell Carcinoma, Squamous Cell Carcinoma, and Keloids.
No
The Esteya is described as a device intended to deliver X-ray radiation for superficial radiotherapy and surface brachytherapy procedures, focusing on treatment of various skin cancers and conditions. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines a physical treatment unit with an X-ray source, shielded applicator, and a treatment control panel, indicating it is a hardware device with integrated software for control and data management.
Based on the provided information, the Esteya device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Esteya is for delivering X-ray radiation for superficial radiotherapy and surface brachytherapy procedures to treat various skin cancers and conditions. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical components and function of a radiation delivery system (X-ray source, applicator, control panel, computer system for treatment planning and reporting). It does not describe any components or processes for analyzing biological samples (blood, tissue, etc.) which is the hallmark of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on biological specimens.
In summary, the Esteya is a medical device used for treatment, not for diagnosis of diseases or conditions by examining samples taken from the human body.
N/A
Intended Use / Indications for Use
The Esteya is intended to deliver X-ray radiation for superficial radiotherapy procedures and surface brachytherapy. Applications include treatment for Basal Cell Carcinoma, Squamous Cell Carcinoma, Kaposi's Sarcoma, Merkel Cell Carcinoma, Lentigo Maligna Melanoma, Keloids and Cutaneous Lymphomas (B and T cell).
Product codes (comma separated list FDA assigned to the subject device)
JAD
Device Description
The Esteva is designed for high dose rate treatment of skin surface lesions. The Esteva utilizes a mobile treatment unit with an isotope free small 69.5 kV X-rav 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 dedicated computer system of Esteya 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 & superficial radiotherapy treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin surface lesions
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)
The Esteya 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, testing to recognized standards, sterility and blocompatibility testing. In addition, external testing of the applicable standards was performed by certified independent laboratories. The below table contains the performance information to meet the intended use of the device.
| Performance | Data |
|---|---|
| Fractionated treatment capabilities | ✓ |
| Source to Skin Distance (SSD) | 60 mm |
| 80% of the dose at a depth of: | 3 mm |
| Dose Rate at skin surface | 3 Gy/m |
| Maximum width of treatment surface (diameter of treatment area) | 30 mm |
| PDD curves demonstrate a sharp falloff of dose to protect underlying tissue | ✓ |
| Accelerating potential (V) | 69.5 kvp |
| Tube current (A) | 0.5,1,1.6 mA |
| Tube power (W) | 112 |
| Flattening Filter in the tube | ✓ |
| Range of applicator diameters (mm) | Standard: 0, 10, 15, 20, 25, 30 Mini set: 10, 15, 20 |
| Treatment applicator in contact with skin surface | ✓ |
| Contact material with skin surface | PPSU |
| Applicator Shielding | Densimet |
No animal or clinical tests were performed to establish substantial equivalence with the predicate devices. The performance data demonstrate that the Esteya System is as safe and effective and performs as well as the predicate devices.
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
Image /page/0/Picture/0 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Nucletron B.V. % Kiran Jose Regulatory Affairs Senior Engineer 3900 Ax Veenendaal, P.O. Box 930 Waardgelder 1 Veenendaal, Utrecht 3905 TH NETHERLANDS
Re: K213942
Trade/Device Name: Esteya Regulation Number: 21 CFR 892.5900 Regulation Name: X-ray radiation therapy system Regulatory Class: Class II Product Code: JAD Dated: December 10, 2021 Received: December 17, 2021
Dear Kiran Jose:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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,
Julie Sullivan, Ph.D. Chief Nuclear Medicine and Radiation Therapy Branch Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K213942
Device Name
Esteya
T
Indications for Use (Describe)
The Esteya is intended to deliver X-ray radiation for superficial radiotherapy procedures and surface brachytherapy. Applications include treatment for Basal Cell Carcinoma, Squamous Cell Carcinoma, Kaposi's Sarcoma, Merkel Cell Carcinoma, Lentigo Maligna Melanoma, Keloids and Cutaneous Lymphomas (B and T cell).
Type of Use (Select one of both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.## This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collections for reducing this burden, to:
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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-67
3
510(K) SUMMARY (21 CFR § 807.92)
| I. SUBMITTER | Nucletron B.V.
3900 Ax Veenendaal, P.O. Box 930
Waardgelder 1
Veenendaal, Utrecht NL, 3905 TH |
|-------------------------------|--------------------------------------------------------------------------------------------------------|
| Contact: | Kiran Jose
Regulatory Affairs Senior Engineer |
| Establishment Registration #: | 9611894 |
| 510(k) Number: | K213942 |
| Date Prepared: | 10 December 2021 |
| II. DEVICE | |
| Trade Name: | Esteya |
| Product Classification: | Class II |
| Common Name: | Superficial Radiation Therapy System and Electric
Brachytherapy System |
|-------------------------|---------------------------------------------------------------------------|
| Regulation Number: | 21 CFR § 892.5900 |
| Regulation Description: | X-ray radiation therapy system |
| Product Code: | JAD |
lll. PREDICATE DEVICES
Primary Predicate: K132092 – Esteya Electronic Brachytherapy System
Secondary Predicate: K150037 - Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities (SRT-100 Vision)
IV. INTENDED USE / INDICATIONS FOR USE
The Esteya is intended to deliver X-ray radiation for superficial radiotherapy procedures and surface brachytherapy. Applications include treatment for Basal Cell Carcinoma, Squamous Cell Carcinoma, Kaposi's Sarcoma, Merkel Cell Carcinoma, Lentigo Maligna, Lentigo Maligna Melanoma, Keloids and Cutaneous Lymphomas (B and T cell).
V. DEVICE DESCRIPTION
The Esteva is designed for high dose rate treatment of skin surface lesions. The Esteva utilizes a mobile treatment unit with an isotope free small 69.5 kV X-rav 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 dedicated computer system of Esteya 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 & superficial radiotherapy treatment.
4
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE
The Esteya System is substantially equivalent to the predicate devices, Esteya Electronic Brachytherapy System (K132092) and SRT-100 Vision (K150037). Other than the addition of superficial radiotherapy capability as an additional indication for use, there is no functional difference between the Esteya System versus the previously cleared Esteya Electronic Brachytherapy System.
The technological characteristics are substantially equivalent to the predicate device: the clarification of the intended use statement does not affect the fundamental scientific technology or raise different questions of safety or effectiveness of the device. The device safety and performance have been addressed by non-clinical testing in conformance with predetermined performance criteria. FDA quidance, clinical use and recognized consensus standards. The results of verification and validation as well as conformance to relevant safety standards demonstrate that the Esteva System meets the established safety and performance criteria and is substantially equivalent to the predicate devices.
VII. SUMMARY OF PERFORMACE TESTING (NON-CLINICAL)
The Esteya 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, testing to recognized standards, sterility and blocompatibility testing. In addition, external testing of the applicable standards was performed by certified independent laboratories. The below table contains the performance information to meet the intended use of the device.
| Performance | Data |
|---|---|
| Fractionated treatment capabilities | ✓ |
| Source to Skin Distance (SSD) | 60 mm |
| 80% of the dose at a depth of: | 3 mm |
| Dose Rate at skin surface | 3 Gy/m |
| Maximum width of treatment surface | |
| (diameter of treatment area) | 30 mm |
| PDD curves demonstrate a sharp falloff of dose | |
| to protect underlying tissue | ✓ |
| Accelerating potential (V) | 69.5 kvp |
| Tube current (A) | 0.5,1,1.6 mA |
| Tube power (W) | 112 |
| Flattening Filter in the tube | ✓ |
| Range of applicator diameters (mm) | Standard: 0, 10, 15, 20, 25, 30 |
| Mini set: 10, 15, 20 | |
| Treatment applicator in contact with skin surface | ✓ |
| Contact material with skin surface | PPSU |
| Applicator Shielding | Densimet |
5
VIII. SUMMARY OF PERFORMACE TESTING (CLINICAL)
No animal or clinical tests were performed to establish substantial equivalence with the predicate devices. The performance data demonstrate that the Esteya System is as safe and effective and performs as well as the predicate devices.
IX. SUBSTANTIAL EQUIVALENCE CONCLUSION
The Esteya System has the same intended use as the predicate devices. Any technological differences do not raise new questions of safety or effectiveness. Performance testing, along with verification and validation activities demonstrate that the Esteya System is as safe and effective and performs as well as the predicate devices. Therefore, the Esteya System is substantially equivalent to the predicate devices.