eXaSkin Plus

{0} FDA U.S. FOOD & DRUG ADMINISTRATION May 22, 2026 Anatomical Geometry S.L. % Tyler Ting Quality Director Rook Quality Systems 1155 Mount Vernon Hwy Suite 800 Dunwoody, Georgia 30338 Re: K252784 Trade/Device Name: eXaSkin Plus Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ, IXI Dated: April 23, 2026 Received: April 23, 2026 Dear Tyler Ting: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K252784 – Tyler Ting Page 2 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). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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 {2} K252784 – Tyler Ting Page 3 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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,  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 {3} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K252784 | | | Device Name eXaSkin Plus | | | Indications for Use (Describe) eXaSkin is a medical device intended to be used as a bolus for the treatment of neoplastic skin lesions through radiotherapy. The product is designed to be applied to the irradiated area by qualified healthcare professionals to address anatomical irregularities and ensure precise delivery of the prescribed dose to the skin and underlying tissues during a radiation therapy treatment. eXaSkin was evaluated using 6 MV photons but has not been assessed for use with 10 MV photons, protons, or orthovoltage X-rays. eXaSkin Plus 150 and 225 is intended for general radiotherapy use. eXaSkin Plus 650 is intended for use on breast tissue. | | | 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) | | | 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 collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {4} 510(k) Summary - K252784 Page 1 of 8 # Submitter Anatomical Geometry S.L. Parque Industrial y de Servicios Aljarafe. C/ Formación N°6, CP 41927. Mairena del Aljarafe, Sevilla Contact Person: Eduardo Suarez Phone: +34 610 075 760 Email: esuarez@anatge.com Date Prepared: 06 MAY 2025 # Device Trade Name: eXaSkin Plus Common Name: Radiotherapy Bolus Classification Name: System, Planning, Radiation Therapy Treatment Regulatory Class: II Product Code(s): MUJ, IXI Regulation Number: 892.5050, 892.5710 Classification Panel: Radiology # Predicate Device AnatGe submits the following information to demonstrate that the subject device eXaSkin Plus, is substantially equivalent to the following legally marketed predicate device: | 510(k) Number | Device Name | Product Code | | --- | --- | --- | | K211511 | .decimal Bolus | MUJ, IXI | # Reference Device AnatGe submits the following information for the reference device utilized in the submission of the subject device: | 510(k) Number | Device Name | Product Code | | --- | --- | --- | | K812893 | SUPERFLAB | IYP | # Device Description The eXaSkin Plus is a highly-adaptable bolus in a paste form that allows for a customizable bolus in 3 minutes. The eXaSkin Plus allows for precision dosage on the skin during photon beam therapy in clinical situations and is usable and specially recommended for highly-critical regions such as the scalp, hands, {5} 510(k) Summary - K252784 neck, outer ear, facial contours, and genitals. The eXaSkin Plus eliminates build-up with less bolus thickness, does not dry, shrink, or break, and does not require complex 3D systems to achieve expected results. The device enables the use of Surface Guided Radiotherapy (SGRT) technology. Unlike other SGRT-compatible boluses, eXaSkin is non-reflective and can be consistently repositioned at the same location on the patient's surface for each treatment session. As a result, it does not require an additional optical surface imaging (OSI) acquisition of the bolus itself. This allows for simultaneous patient positioning and bolus alignment in a single OSI step. # Indications for Use eXaSkin is a medical device intended to be used as a bolus for the treatment of neoplastic skin lesions through radiotherapy. The product is designed to be applied to the irradiated area by qualified healthcare professionals to address anatomical irregularities and ensure precise delivery of the prescribed dose to the skin and underlying tissues during a radiation therapy treatment. eXaSkin was evaluated using 6 MV photons but has not been assessed for use with 10 MV photons, protons, or orthovoltage X-rays. eXaSkin Plus 150 and 225 is intended for general radiotherapy use. eXaSkin Plus 650 is intended for use on breast tissue. # Comparison of Technological Characteristics with the Predicate and Reference Devices The subject device has the same or similar intended use, indications, principle of operation, technological and material characteristics as the predicate device, .decimal Bolus (K211511), and reference device, Superflab (K812983). Comparisons of the predicate, reference, and subject devices can be found in Table 1: Table 1 Comparison of the Subject, Primary Predicate, and Reference Devices | | AnatGe eXaSkin Plus (Subject) | .decimal Bolus (Predicate) K211511 | Superflab (Reference) K812893 | Discussion | | --- | --- | --- | --- | --- | | Regulation | 892.5710, 892.5050 | 892.5710, 892.5050 | 892.1370 | Same as .decimal Bolus | | Classification | Radiation therapy beam-shaping block,Medical charged-particle radiation therapy system. | Radiation therapy beam-shaping block,Medical charged-particle radiation therapy system. | Nuclear anthropomorphic phantom. | Same as .decimal Bolus | {6} 510(k) Summary - K252784 Page 3 of 8 | Product Code | IXI, MUJ | MUJ, IXI | IYP | Same as .decimal Bolus | | --- | --- | --- | --- | --- | | Class | II | II | I | Same as .decimal Bolus | | OTC or Rx | Rx | Rx | Rx | Same | | Indications for Use | eXaSkin is a medical device intended to be used as a bolus for the treatment of neoplastic skin lesions through radiotherapy. The product is designed to be applied to the irradiated area by qualified healthcare professionals to address anatomical irregularities and ensure precise delivery of the prescribed dose to the skin and underlying tissues during a radiation therapy treatment. eXaSkin was evaluated using 6 MV photons but has not been assessed for use with 10 MV photons, protons, or orthovoltage X-rays. eXaSkin Plus 150 and 225 is intended for general radiotherapy use. eXaSkin Plus 650 is intended for use on breast tissue. | The decimal Bolus product is a solid piece of material (rigid or rubber-like) that will be placed on the skin of a patient with the intended use and primary purpose of helping control the dose received by that patient when undergoing radiation therapy treatment. decimal Bolus devices are designed by radiation therapy professionals to a unique shape that is specific to each patient being treated. The device is intended to modify the dose delivered during a radiation therapy treatment. As this product is a simple general purpose bolus device, the intended patient population and indications for use are quite broad. The most common indications for use are for the treatment of patients receiving radiation therapy, which encompasses a wide range of potential disease types and locations. As such, these devices will be required to have a wide range of potential shapes, sizes, and material properties and each device must be | This product is single-use only, and single patient use only. Do not Reprocess and dispose of this product after use. This product is to be used to increase the targeted radiation dose during photon and electron treatment by providing scattering of the beam and build-up of the radiation dose at the skin surface. | Different The .decimal Bolus is made of a solid material that is custom designed to be a unique shape specific to the patient being treated, while the eXaSkin is a putty designed to harden in a unique shape specific to the patient that it is applied to. This difference in material does not constitute a new intended use because the different materials used in each device serve the same intended purpose. Both the eXaSkin and .decimal Bolus are intended to control the radiation dose delivered to patients during radiation therapy treatments via a material that will be fit to the patient's skin. The difference does not raise different questions of substantial equivalence. Biocompatibility testing was performed, supporting substantial equivalence of skin-safe material. Data from bench testing for the eXaSkin supports substantial equivalence. Similar to the eXaSkin moldable putty, the Superflab is made of a moldable, elastic material that can conform to the contours of the patient. Testing was performed comparing the performance of the | {7} 510(k) Summary - K252784 Page 4 of 8 | | | tested and approved by the radiation therapy professional prior to use on a patient. | | eXaSkin and Superflab (see Performance Testing section for more details), and performance was found to be substantially equivalent. | | --- | --- | --- | --- | --- | | Materials | Putty and Catalyzer | 100% Silicone | Synthetic oil gel including PVC Resin 01 and Plasticizer 34 | Different The eXaSkin, predicate, and reference device are all constructed from skin-safe materials and are used to control the dose delivered to patients undergoing radiation therapy treatments via fitting to the contours of a patient's skin. Unlike the predicate, the eXaSkin is not custom-made solid material, but a moldable putty. The difference in material does not raise concerns regarding substantial equivalence and the eXaSkin has been proven biocompatible via biocompatibility testing. | | Material Characteristics | Skin-safe, moldable material | Skin-safe, solid piece of rubber-like, flexible material | Skin-safe, moldable material | Different The eXaSkin, predicate, | {8} 510(k) Summary - K252784 | | | | | and reference device are all constructed from skinsafe materials and are used to control the dose delivered to patients undergoing radiation therapy treatments via fitting to the contours of a patient's skin. Unlike the predicate, the eXaSkin is not custom-made solid material, but a moldable putty. This difference in material characteristics does not raise different questions of substantial equivalence of the eXaSkin has been proven through literature and testing. | | --- | --- | --- | --- | --- | | Patient Contact | Direct skin | Direct skin | Direct skin | The eXaSkin, predicate, and reference device are all placed directly on patient skin, but the eXaSkin has a contraindication for being used on open wounds. This difference does not raise different question related to the substantial equivalence of the device. | | Use Environment | Radiotherapy clinic | Radiotherapy clinic | Radiotherapy clinic | Same | | Patient Population | Patients undergoing radiation therapy treatment | Patients undergoing radiation therapy treatment | Patients undergoing radiation therapy treatment | Same | # Biocompatibility Biocompatibility testing was conducted on representative final manufactured samples in accordance with ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Test results are summarized in Table 2: Table 2 Summary of Biocompatibility Testing Conducted on the eXaSkin Plus {9} 510(k) Summary - K252784 Page 6 of 8 | Biocompatibility Testing Requirements | Test Method | Material | Acceptance Criteria | Test Result | | --- | --- | --- | --- | --- | | ISO 10993-5 – Tests for in vitro cytotoxicity | Direct Contact | eXaSkin Plus | Not cytotoxic | Not cytotoxic | | ISO 10993-10 – Tests for skin sensitization | Assessment of sensitizing properties on albino guinea pigs, Maximisation test according to Magnusson and Kligman | eXaSkin Plus | Non-skin sensitizer | Non-skin sensitizer | | ISO 10993-23 - Tests for irritation | Assessment of acute local tolerance and general tolerance on white rabbits | eXaSkin Plus | Not an irritant | Not an irritant | ## Performance Data ### Bench Non-clinical validation testing was performed to demonstrate substantial equivalence of the device. The following tests were performed: | Test | Objective | Reference | Pass/Fail Criteria | Results | | --- | --- | --- | --- | --- | | Mixing Time | Evaluate the time required for two or more components to mix homogeneously in a mixture, process, or product. | ISO 4823: 2021 | 30 s | Pass | | Setting time at 35°C | Evaluate the time it takes for a material, typically in paste or liquid form, to transition from a fluid or plastic state to a solid or rigid state. | 2100-AM QC-023 | Catalyzer: 190 - 320 s Putty: 210 - 75s | Pass | | Hardness after 8 minutes | Evaluate the hardness of a material after 8 minutes (early curing stage). | 2100-AM QC-013 | Catalyzer: 20 - 34 Shore A Putty: 60 - 75 Shore A | Pass | | Hardness after 1 hour | Evaluate the hardness of a material after 1 hour. | 2100-AM QC-013 | Catalyzer: 24 - 35 Shore A Putty: 65 - 77 Shore A | Pass | {10} 510(k) Summary - K252784 Page 7 of 8 | Consistency | Evaluate the material’s ability to maintain a specific viscosity or fluidity under certain conditions. | 2100-AM QC-011 | Catalyzer: 33-44 mm Putty: ≤ 35 mm | Pass | | --- | --- | --- | --- | --- | | Mixed Material | Ensure that the mixture of materials has reached the expected homogeneity and to assess how the characteristics of the combined material behave under specific conditions. | 2100-AM QC-004 | Homogeneous and free of extraneous matter | Pass | | Visual aspect | Evaluates the external appearance of the material to ensure it meets the quality standards in terms of aspect. | 2100-AM QC-004 | Homogeneous and free of extraneous matter | Pass | | Color | evaluates the external appearance of the material to ensure it meets the quality standards in terms of color. | 2100-AM QC-004 | Purple | Pass | | Odor | evaluates the external appearance of the material to ensure it meets the quality standards in terms of odor. | 2100-AM QC-005 | Catalyzer: Mint Putty: Vanilla | Pass | | Working Time | Evaluates the time during which the material maintains its workability properties before it begins to change or harden significantly. | ISO 4823: 2021 | 75 s | Pass | | Elastic recovery | Evaluates the material’s ability to recover its original shape after being deformed under load and then released. | ISO 4823: 2021 | ≥ 96.5% | Pass | | Strain-in-compression | Evaluates deformation (or change in dimensions of the material) when a compressive force is applied until a specific point. | ISO 4823: 2021 | 0.8 - 20% | Pass | | Detail reproduction | Assess the material’s ability to accurately reproduce fine details or characteristics of a mold or reference surface. | ISO 4823: 2021 | 75 μm | Pass | | Compatibility with gypsum | Evaluates the interaction between the material and the gypsum used in impression or manufacturing processes. | ISO 4823: 2021 | 75 μm | Pass | | Linear | Evaluate the material’s dimensional | ISO 4823: 2021 | ≤ 1.5% | Pass | {11} 510(k) Summary - K252784 Page 8 of 8 | dimensional change 24h | stability after a 24-hour period. It measures whether the material undergoes expansion or contraction in its linear dimensions (length, width, or height) during the first 24 hours after its curing or formation process. | | | | | --- | --- | --- | --- | --- | | Material Properties | Evaluate eXaSkin, a novel high-density bolus alternative to commercial tissue-equivalent Superflab, for 6MV photon-beam radiotherapy. | N/A | Improved adaptation to phantom's surface over Superflab Full dosage achieved (agreement within 1% of calculations) | Pass | | Dose Distribution and Radiation Attenuation | Determine dosimetric accuracy for calculating photon dose distribution in the presence of eXaSkin bolus. | N/A | Agreement in dose calculation - 3mm/3% Improved surface dose | Pass | | Usability | Evaluate eXaSkin to commercial tissue-equivalent Superflab, for 6MV photon-beam radiotherapy. | N/A | N/A | Pass | ## Animal No animal or clinical testing was performed in support of this submission. ## Clinical No animal or clinical testing was performed in support of this submission. ## Substantial Equivalence Conclusion Based on the comparison of indication of use, material characteristics, technological features, and principle of operation, and conclusions drawn from performance testing to demonstrate substantial equivalence (SE), the AnatGe eXaSkin Plus is substantially equivalent to the predicate device.