Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)

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December 5, 2023 Precision Healing LLC % Christine Brauer Regulatory Affairs Consultant Brauer Device Consultants, LLC 7 Trail House Court Rockville, MD 20850 Re: K230734 Trade/Device Name: Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009) Regulation Number: 21 CFR 878.4165 Regulation Name: Wound Autofluorescence Imaging Device Regulatory Class: Class I Product Code: OCR, FXN Dated: November 3, 2023 Received: November 6, 2023 Dear Christine Brauer: 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 (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/cdrb/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. {1}------------------------------------------------ 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 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-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 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. 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-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). {2}------------------------------------------------ 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/deviceadvice-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. Tanisha L. Tanisha L. Hithe -S 2023.12.05 Hithe -S 11:33:57 -05'00' 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}------------------------------------------------ ### Indications for Use Submission Number (if known) K230734 Device Name Multispectral Imager Kit (MSI Kit) (300-00015): Multispectral Imager (MSI) (300-00009) Indications for Use (Describe) The MSI is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds to: · View and digitally record images of a wound. · Measure and digitally record the size of a wound. - · View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light. · View and digitally record thermal images of a wound. The MSI does not diagnose or treat skin wounds. 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 Applicant Information | Applicant/<br>510(k) Owner: | Precision Healing, Inc.<br>1200 Summit Avenue, Suite 414<br>Fort Worth, Texas 76102 | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Robert Brik, Director of Product Engineering<br>Precision Healing, LLC<br>1200 Summit Ave, Suite 414<br>Fort Worth, TX 76102<br>Telephone: 804.370.0291<br>Email: rbrik@dxwound.com | Date of Preparation: 30 November 2023 510(k) Number: K230734 ### Device and Classification Information | Trade Name: | Multispectral Imager Kit (MSI Kit) (PN 300-00015)<br>Multispectral Imager (MSI) (PN 300-00009) | |----------------------------|--------------------------------------------------------------------------------------------------------------| | Common Name: | Autofluorescence imager<br>Thermal imager | | Classification Regulation: | 21 CFR 878.4165 – Wound Autofluorescence Imaging Device<br>21 CFR 878.4160 – Surgical Camera and Accessories | | Product Code: | QCR - Wound Autofluorescence Imaging Device<br>FXN - Tape, Camera, Surgical | | Class: | I<br>I | | Panel: | General and Plastic Surgery | Device Description The MSI Kit includes the following: the MSI, a Universal Serial Bus (USB-C) cable, a wall adapter, and a carrying case. {5}------------------------------------------------ The MSI captures and processes optical data of an imaged wound. The MSI consists of three imaging modalities: white light, autofluorescence and thermal. The MSI has 395nm excitation LEDs for autofluorescence imaging, a sensor for measuring distance to the wound, and a thermal sensor for capturing temperature gradients. The MSI is powered by an onboard rechargeable battery and has a USB-C connection for uploading images to a computer. The manual provides users of the MSI with detailed instructions for proper use, maintenance, and storage. ### Indication for Use The indication for use is shown below. The MSI is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds to: - . View and digitally record images of a wound. - Measure and digitally record the size of a wound. ● - . View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light. - . View and digitally record thermal images of a wound. The MSI does not diagnose or treat skin wounds. ### Predicate Device Identification for Substantial Equivalence Comparison For purposes of demonstrating substantial equivalence, the following predicate devices were selected: - > MolecuLight i:X by MolecuLight, Inc. authorized via DEN180008 - > WoundVision Scout ("WoundVision") by WoundVision LLC cleared via K131596 Two predicate devices were selected in accordance with the guidance document entitled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] -Guidance for Industry and Food and Drug Administration Staff" document issued on July 28, 2014. The MSI combines the intended use and imaging capabilities of each predicate device into a single device for user convenience without altering the fundamental intended use or risk profile of either device. To the best of the applicant's knowledge, both predicate devices have been authorized for marketing, are legally marketed and have not been subject to a design-related recall. {6}------------------------------------------------ Comparison of the Indication for Use and Intended Use between MSI and the Predicate Devices The MSI Kit has the same intended use as each predicate device although there are slight differences in the indication for use statement. The MSI Kit and MolecuLight i:X share the same intended use - both devices are intended for use as an adjunctive tool that provides fluorescence and white light images for evaluation by a healthcare professional. Both devices are not intended to provide a diagnosis, but rather the healthcare professional remains responsible for the diagnosis and evaluation of the wound using the device as a tool (see Table 1). Both devices have the same purpose, function, target patient population, users and use environment, demonstrating they have the same intended use. Both the MSI Kit and WoundVision Scout share the same intended use - both devices provide thermal images of a wound for use by healthcare professionals as an adjunctive tool. Both devices provide wound area measurements. Both devices share the same purpose, function, target patient population, users and use environment, demonstrating that they have the same intended use (see Table 2). | Characteristic | MSI Kit<br>MolecuLight i:X | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Precision Healing LLC<br>MolecuLight Inc.<br>DEN180008 | | Regulatory Class: | Class I | | Regulatory Number: | 878.4165 | | Regulation Name: | Autofluorescence detection device<br>for general surgery and<br>dermatological use | | Product Code: | QCR – Wound Autofluorescence<br>Imaging Device | | Indications for Use: | ... is a handheld imaging tool that<br>allows clinicians diagnosing and<br>treating skin wounds to:<br>• View and digitally record<br>images of a wound.<br>• View and digitally record<br>images of fluorescence emitted<br>from a wound when exposed to<br>an excitation light....<br>The MSI does not diagnose or treat<br>skin wounds. | | | ... is a handheld imaging tool that<br>allows clinicians diagnosing and<br>treating skin wounds at point of<br>care, to<br>(i) View and digitally record<br>images of a wound,<br>(ii) View and digitally record<br>images of fluorescence emitted<br>from a wound when exposed to an<br>excitation light. | | Purpose: | An adjunctive tool that provides<br>white light images and<br>fluorescence images of a wound for | | | An adjunctive tool that provides<br>white light images and<br>fluorescence images of a wound for | Table 1. Comparison of the Intended Use of the MSI Kit to the MolecuLight Predicate {7}------------------------------------------------ | Characteristic | MSI Kit<br>Precision Healing LLC | MolecuLight i:X<br>MolecuLight Inc.<br>DEN180008 | |----------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------| | | evaluation by a healthcare<br>professional | evaluation by a healthcare<br>professional | | Function: | Outputs:<br>• White Light Image<br>• Red Fluorescence<br>• Green Fluorescence<br>• Blue Fluorescence | Outputs:<br>• White Light Image<br>• Red Fluorescence<br>• Green Fluorescence | | Target Population: | Adult patients with wounds | Adult patients with wounds | | Prescription Device: | Yes | Yes | | Target Users: | Healthcare professionals who care<br>for and treat patients with wounds | Healthcare professionals who care<br>for and treat patients with wounds | | Use Environment: | Point-of-care with patient (e.g.,<br>office or clinic) | Point-of-care with patient (e.g.,<br>office or clinic) | | | | | Table 2. Comparison of the Intended Use of the MSI Kit to the WoundVision Scout | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | Predicate | | | | | Characteristic | MSI Kit<br>Precision Healing LLC | WoundVision Scout<br>WoundVision LLC<br>K131596 | | | Regulatory Class: | Class I | Class I | | | Regulatory Number: | 878.4160 | 878.4160 | | | Regulation Name: | Surgical Camera and Accessories | Surgical Camera and Accessories | | | Product Code: | FXN - Tape, Camera, Surgical | FXN - Tape, Camera, Surgical | | | Indications for Use: | • Measure and digitally record<br>the size of a wound....<br><br>• View and digitally record<br>thermal images of a wound.<br><br>The MSI does not diagnose or treat<br>skin wounds. | ...capturing thermal images to<br>measure the thermal intensity data<br>of a part of the body or two body<br>surfaces...<br><br>measure and record external<br>wound and body surface data....<br><br>...does not provide a diagnosis or<br>therapy. | | | Purpose: | An adjunctive tool that provides<br>white light images, thermal images<br>and wound area measurements for<br>evaluation by a healthcare<br>professional | An adjunctive tool that provides<br>white light images, thermal images<br>and wound area measurements for<br>evaluation by a healthcare<br>professional | | | Function: | Outputs:<br>• White light image<br>• Thermal image<br>• Wound area measurement | Outputs:<br>• White light image<br>• Thermal image<br>• Wound area measurement | | {8}------------------------------------------------ | Characteristic | MSI Kit<br>Precision Healing LLC | WoundVision Scout<br>WoundVision LLC<br>K131596 | |----------------------|----------------------------------------------------------------------|----------------------------------------------------------------------| | Target Population: | Adult patients with wounds | Adult patients with wounds | | Prescription Device: | Yes | Yes | | Target Users: | Healthcare professionals who care for and treat patients with wounds | Healthcare professionals who care for and treat patients with wounds | | Use Environment: | Point-of-care with patient (e.g., office or clinic) | Point-of-care with patient (e.g., office or clinic) | ### Comparison of the Technological Characteristics between the MSI Kit and the Predicate Devices Both the MSI and the MolecuLight i:X share key core fluorescence functionality and technological characteristics (see Table 3). Both devices use overlapping excitation wavelengths to excite naturally occurring fluorophores in the wound and surrounding tissue, which in response emit light that is filtered and measured by a CMOS camera to produce an image. There is substantial overlap between the spectral profiles of the MSI and MolecuLight i:X's excitation LEDs. Specifically, the MSI uses a 395 nm light emitted from LEDs as the fluorescent excitation light whereas the predicate MolecuLight i:X uses a 405 nm light emitted from LEDs. MSI captures emission wavelengths > 450 nm whereas the predicate captures emission wavelengths from 500-545 nm and 600-665 nm. In both devices image processing occurs to produce fluorescence images. White light images are also collected. Any differences in technological characteristics do not raise different questions of safety or effectiveness compared to the predicate device. For thermal imaging, the MSI and the WoundVision Scout predicate share very similar functionality and technological characteristics (see Table 4). Both devices use an infrared sensor to capture a thermal image of the wound. Both devices calculate a central tendency of temperature and use a color-coded display to produce a thermal image. Specifically, the MSI calculates the median temperature, and then uses a color coded scale to display the relative thermal image with a score of -4 to +4 °C from the median. WoundVision Scout calculates the mean temperature (rather than median) and uses a color-coded scale to display the relative thermal image. Both devices also provide white light images, and wound area measurements. Any differences in technological characteristics do not raise different questions of safety or effectiveness compared to the predicate device. {9}------------------------------------------------ | Characteristic | MSI Kit<br>Precision Healing LLC | MolecuLight i:X<br>MolecuLight Inc.<br>DEN180008 | |----------------------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------| | Operating Modes | Fluorescence, white light and thermal imaging | Fluorescence and white light imaging | | Fluorescence Excitation<br>Light | 395 nm light emitted from LEDs | 405 nm light emitted from LEDs | | Captured Emission<br>Wavelength | > 450 nm | 500-545 nm and<br>600-665 nm | | Fluorescence Output | • Red fluorescence<br>• Green fluorescence<br>• Blue fluorescence<br>Images shown individually for<br>each color. | • Red fluorescence<br>• Green fluorescence<br>All fluorescence features appear in<br>the same image. | | White Light Imaging | White light image is collected. | White light image is collected. | | Working Distance | 17-20 cm | 8-12 cm (Fluorescence and<br>Standard Imaging) | | Image Format | JPEG | JPEG | | Power Supply | Battery and wall | Battery and wall | | Display | 5" LCD | 4-inch (diagonal) widescreen<br>display with Multi-Touch IPS<br>technology | | Patient Contacting Materials | Non-patient contacting device | Non-patient contacting device | | Sterile | No | No | | Mechanical Safety | Compliance to IEC 60601-1 | Compliance to IEC 60601-1 | | Electrical Safety | Compliance to IEC 60601-1 | Compliance to IEC 60601-1 | | Electromagnetic<br>Compatibility | Compliance to IEC 60601-1-2 | Compliance to IEC 60601-1-2 | | Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-57<br>IEC 62471<br>IEC 60825 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-57<br>IEC 62471 | Table 3. Comparison of the Technological Characteristics of the MSI Kit to the MolecuLight i:X Predicate {10}------------------------------------------------ | Characteristic | MSI Kit | WoundVision Scout | |-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | | Precision Healing LLC | WoundVision, LLC | | | | K131596 | | Operating Modes | Fluorescence, white light, thermal<br>imaging, and wound area<br>measurement | White light and thermal imaging,<br>and wound area measurement | | | | | | | | | | Infrared Laser Distance<br>Finder Wavelength | 940 nm | 635 nm<br>650 nm | | | | | | Infrared Laser Distance<br>Finder Peak Power Output | < 0.4mW | < 0.4mW | | | | | | Imaging/Optics | Thermal camera used to capture a<br>thermal image of the wound | Thermal camera used to capture a<br>thermal image of the wound | | | | | | Image Processing | Median temperature is found. A<br>color-coded scale is used to display<br>the relative thermal image with a<br>scale of -4 to +4 °C from the<br>median. | Mean temperature is found. A<br>color-coded scale is used to display<br>the relative thermal image. | | | | | | | | | | | | | | | | | | Function | Outputs: | Outputs: | | | • Thermal image<br>• White light image<br>• Wound area measurement | • Thermal image<br>• White light image<br>• Wound area measurement | | | | | | | | | | Image Format | JPEG | PDF | | Power Supply | Battery and wall | USB power from computer | | Display | 5" LCD on MSI | Displayed on computer | | Patient Contacting Materials | Non-patient contacting device | Non-patient contacting device | | Sterility | No | No | | Mechanical Safety | Compliance to IEC 60601-1 | Compliance to IEC 60601-1 | | Electrical Safety | Compliance to IEC 60601-1 | Compliance to IEC 60601-1 | | Electromagnetic<br>Compatibility | Compliance to IEC 60601-1-2 | Compliance to IEC 60601-1-2 | | Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-57<br>IEC 62471<br>IEC 60825 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60825 | | | | | | | | | | | | | | | | | Table 4. Comparison of the Technological Characteristics of the MSI Kit to the WoundVision Scout Predicate ### Performance Data This 510(k) notification provided performance data to establish the substantial equivalence of the MSI. {11}------------------------------------------------ Reprocessing, Sterility and Shelf-Life: The MSI is not provided sterile and does not have direct patient contact. It is a reusable medical device. Reprocessing validation for cleaning and disinfection of the MSI has been conducted and the validated procedures are provided in the instructions for use. The MSI has undergone climatic conditions and transmit simulation (aka "ship testing") to demonstrate the adequacy of its packaging to protect the device during commercial shipment. Biocompatibility: The MSI does not have direct patient contact. The MSI may contact intact skin surfaces of its users (healthcare professionals) for a limited duration of contact (≤ 24 hours), including repeat use. The MSI materials with potential direct contact of the intact skin of the user have a long history of safe use in medical devices, and pose a very low biocompatibility risk due to their history of safe use in medical devices. Software Verification and Validation: Software verification and validation testing has been performed in accordance with IEC 62304 and the FDA guidance document for software. Verification and validation testing included unit test, system level verification tests (which included functional testing to demonstrate the device meet its requirements), traceability linking and validation testing to ensure the software conforms to user needs and intended uses. Cybersecurity: Cybersecurity information in accordance with the FDA guidance document entitled "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Draft Guidance for Industry and Food and Drug Administration Staff." document issued on April 8, 2022, has been provided to demonstrate cybersecurity risks have been mitigated and that the risk of cybersecurity threats is deemed acceptable. Electrical Safety and EMC Compatibility: The MSI has undergone testing to demonstrate that the device meets the requirements for medical device safety, including mechanical and electrical safety, according to the following international standards: IEC 60601-1, 3™ Edition, Medical electrical equipment - General requirements for basic safety and essential performance. The MSI has undergone testing to demonstrate the device meets the following international standard for EMC compatibility: IEC 60601-1-2, 4.1 Edition, Medical electrical equipment - Part 1-2. General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. Performance Testing - Bench: A series of tests were performed to evaluate the safety and performance of the MSI. Light Sources and Laser: Safety of the light sources (LEDs) and the laser were evaluated in accordance with the following standards: - IEC 62471, First edition, 2006-07 Photobiological safety of lamps and lamp ● svstems - IEC 60825-1: 2014, Edition 3 Safety of laser products Part 1: Equipment . classification, and requirements - IEC 60601-2-57: 2011, Edition 1, Medical electrical equipment Part 2-57: . Particular requirements for the basic safety and essential performance of non-laser {12}------------------------------------------------ light source equipment for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use Visualization Performance Testing: A series of bench studies were conducted to verify the performance of the MSI Kit, including the following: image field uniformity, image distortion, field of view, magnification, geometric resolution, detection limits, linearity, signal-to-noise ratio, accuracy of thermal image data (at varied angles, distances and different cameras) and wound measurement area. A comparison of the performance of the MSI and MolecuLight for in vitro imaging for fluorescence was also performed. Clinical Testing: A clinical study was conducted under anticipated conditions with anticipated users to evaluate the ability of the MSI to detect autofluorescence signals from tissues or structures consistent with the indications for use. These studies demonstrated the quality and consistency of the MSI images for their intended use of visualizing wounds. #### Conclusion The clinical and non-clinical data indicate that the MSI Kit is as safe and effective as the predicate devices for its indications for use, and is substantially equivalent.