LymphaTech Mobile 3D Measuring Tool

{0} FDA U.S. FOOD & DRUG ADMINISTRATION July 22, 2025 Lymphatech, Inc. % Grace Powers Founder/ Principal Consultant Powers Regulatory Consulting 2451 Cumberland Parkway SE Suite 3740 Atlanta, Georgia 30339 Re: K251255 Trade/Device Name: LymphaTech Mobile 3D Measuring Tool Regulation Number: 21 CFR 878.4160 Regulation Name: Surgical Camera And Accessories Regulatory Class: Class I Product Code: SFG Dated: April 21, 2025 Received: April 23, 2025 Dear Grace Powers: 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} K251255 - Grace Powers 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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 systems (QS) regulation (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 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K251255 - Grace Powers Page 3 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, YAN FU-S Digitally signed by YAN FU-S Date: 2025.07.22 12:31:24 -04'00' for Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K251255 Device Name LymphaTech Mobile 3D Measuring Tool Indications for Use (Describe) The LymphaTech Mobile 3D Measuring Tool is a software application that uses input from the Structure Sensor, an off-the-shelf long-wave infrared camera, to measure the diameter, surface area, volume, and perimeter/circumference of a part of the body. The 3D Measuring Tool is non-contact with respect to the patient and provides an adjunctive tool to help a qualified health care professional measure and record body part data. The device uses input from the Structure Sensor camera to accurately capture and construct a 3D model of a patient's anatomy. It is intended for trained and qualified healthcare professionals, who are trained in its use. The 3D Measuring Tool is to be used on a patient population that includes non-pregnant female or male adults. The 3D Measuring Tool is intended to be used in any environment where health care is provided by a qualified health care professional. The 3D Measuring Tool does not provide a diagnosis or therapy. 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. 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FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 {4} K251255 510(k) Summary Traditional 510(k) - LymphaTech LymphaTech Mobile 3D Measuring Tool # 510(k) Summary: K251255 In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the LymphaTech Traditional 510(k) premarket notification. Sponsor: LymphaTech Submission Contact: Grace Powers, FRAPS, MS, MBA, RAC Founder/Principal Consultant Powers Regulatory Consulting grace@powersregulatory.com Submission Date: April 21, 2025 Subject Device: Trade Name: LymphaTech Mobile 3D Measuring Tool Common Name: Camera, surgical, measurement Classification Name: Surgical camera and accessories Regulation: 21 CFR §878.4160 Regulatory Classification: Class 1 Product Code: SFG Predicate Device: Scout (K131596) Reference Device: decimal3D (K192554) # Device Description The LymphaTech Mobile 3D Measuring Tool is a standalone software mobile application that uses a high-accuracy off-the-shelf long-wave infrared camera for measuring the diameter, surface area, volume, and circumference of a part of the body. The software allows clinicians to measure body region volume, circumference, surface area, and length with high precision. Specifically, this device uses an off-the-shelf depth sensing scanner, which is a type of long-wave infrared camera, together with an off-the-shelf iPad to acquire complete 3D renderings of the body regions. # Intended Use/Indications for Use The LymphaTech Mobile 3D Measuring Tool is a software application that uses input from the Structure Sensor, an off-the-shelf long-wave infrared camera, to measure the diameter, surface area, volume, and perimeter/circumference of a part of the body. The 3D Measuring Tool is non-contact with respect to the patient and provides an adjunctive tool to help a qualified health care professional measure and record body part data. The device uses input from the Structure Sensor camera to accurately capture and construct a 3D model of a patient's anatomy. It is intended for trained and qualified healthcare professionals, who are trained in its use. The 3D Measuring Tool is to be used on a patient population that includes non-pregnant female or male adults. The 3D Measuring Tool is intended to be used in any environment where health care is provided by a qualified health care professional. The 3D Measuring Tool does not provide a diagnosis or therapy. # Substantial Equivalence An overview comparison of the LymphaTech Mobile 3D Measuring Tool (subject device) compared to the predicate device is presented in the table below. The reference device (decimal3D) uses the same high-accuracy off-the-shelf long-wave infrared camera for a different intended use. {5} K251255 510(k) Summary Traditional 510(k) -LymphaTech LymphaTech Mobile 3D Measuring Tool Table 1: Device Comparison | | | Subject Device: LymphaTech Mobile 3D Measuring Tool | Predicate Device: WoundVision Scout | Comparison | | --- | --- | --- | --- | --- | | Regulatory information | Manufacturer | LymphaTech | WoundVision LLC | N/A | | | Product Code | SFG | FXN | A new product code | | | Regulation Number | 21 CFR 878.4160 | 21 CFR 878.4160 | Identical. | | | Device Classification Name | Camera, Surgical, Measurement | Tape, Camera, Surgical | Similar - Both for measurement | | | Device Classification | 1 | 1 | Identical. | | | Indication for Use | The LymphaTech Mobile 3D Measuring Tool is a software application that uses input from the Structure Sensor, an off-the-shelf long-wave infrared camera, to measure the diameter, surface area, volume, and perimeter/circumference of a part of the body. The 3D Measuring Tool is non-contact with respect to the patient and provides an adjunctive tool to help a qualified health care professional measure and record body part data. The device uses input from the Structure Sensor camera to accurately capture and construct a 3D model of a patient's anatomy. It is intended for trained and qualified healthcare professionals, who are trained in its use. The 3D Measuring Tool is to be used on a patient population that includes non-pregnant female or male adults. The 3D Measuring Tool is intended to be used in any environment where | The Scout is a combination digital camera and long-wave infrared camera. The digital camera is indicated for the use of capturing visual images to measure the diameter, surface area, and perimeter of a part of the body or two body surfaces. The long-wave infrared camera is indicated for the use of capturing thermal images to measure the thermal intensity data of a part of the body or two body surfaces. Both components of the Scout are non-contact with respect to the patient and provide an adjunctive tool to help a trained and qualified health care professional measure and record external wound and body surface data. Intended for qualified healthcare | Similar- Both devices measure the diameter, surface area, and perimeter of a part of the body. The subject device also measures volume. The predicate device measures temperature. | {6} K251255 510(k) Summary Traditional 510(k) –LymphaTech LymphaTech Mobile 3D Measuring Tool | | | Subject Device: LymphaTech Mobile 3D Measuring Tool | Predicate Device: WoundVision Scout | Comparison | | --- | --- | --- | --- | --- | | | | health care is provided by a qualified health care professional. The 3D Measuring Tool does not provide a diagnosis or therapy. | professionals who are trained in its use, the Scout is a non-invasive and non-radiating device. The Scout is to be used on a patient population that includes non-pregnant female or male patients 18 years of age or older. The Scout is intended to be used in hospital, acute and sub-acute care settings, long term care, surgery, health care practitioner facilities, outpatient, home healthcare, or in any environment where health care is provided by a qualified health care professional. The Scout does not provide a diagnosis or therapy. | | | | Rx or OTC | Rx Only | Rx Only | Identical. | | Principles of Operation | | The subject device is software only. | The predicate device is a digital and thermal long-wave infrared camera that measures the desired body part. | Similar- Both devices record measurements. | | Setting of Use | | Clinical setting | Clinical setting | Identical. | | User | | Clinician | Clinician | Identical. | | Patient Contact | | Non-patient contacting | Non-patient contacting | Identical. | | Measurements | | Measure the diameter, surface area, volume and perimeter/circumference of a part of the body. | Measure the diameter, surface area, and perimeter of a part of the body or the distance | Similar- physical measurements. The subject device measures volume and does not | 3 {7} K251255 510(k) Summary Traditional 510(k) –LymphaTech LymphaTech Mobile 3D Measuring Tool | | | Subject Device: LymphaTech Mobile 3D Measuring Tool | Predicate Device: WoundVision Scout | Comparison | | --- | --- | --- | --- | --- | | | | | between two body surfaces. Measures temperature. | measure temperature. | | Testing | | Bench testing and clinical usability testing. | Bench testing and clinical usability testing. | Identical types of testing. | | Software and Connectivity | Storage of data | Electronically records and stores source data . | Electronically records and stores source data. | Identical. | | | Device connectivity | None required. Measurements and images remain on iPad. | Measurements and images can be updated to electronic medical records and are stored in the cloud. Connects to a portal and EMR. | Different- The predicate device requires connectivity to access data. | | Hardware | Long-wave Infrared Camera | Measures infrared radiation on objects. | Measures infrared radiation on objects. | Identical. | | | Computing Device | Off-the-Shelf iPad running iPad iOS 14 or higher. | N/A- No iPad or mobile device is required for the predicate device. | Different computing devices. | ## Performance Testing Performance testing of the subject device was conducted on humans to show usability and accuracy of the software. There are no device-specific guidance documents, special controls document, and/or requirements in a device-specific regulation that is applicable to the subject device. A list of the testing for the LymphaTech Mobile 3D Measuring Tool is listed below: - Software Verification Testing - Cybersecurity Testing - Usability Testing - Non-Clinical Bench Performance Testing including linear diameter and length accuracy testing, circumference and surface area testing, volume accuracy testing as compared to water displacement and perometry, and inter-operator variability assessment. ## Conclusion The LymphaTech Mobile 3D Measuring Tool is substantially equivalent to the legally marketed predicate device as demonstrated by the similar indication for use, similar technologies and performance data, and does not raise different questions of safety and effectiveness.