← Product Code [PSN](/submissions/SU/subpart-e%E2%80%94surgical-devices/PSN) · K230448 # DeepX DermoSight Dermatoscope (K230448) _Deepx Health, LLC · PSN · May 17, 2023 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PSN/K230448 ## Device Facts - **Applicant:** Deepx Health, LLC - **Product Code:** [PSN](/submissions/SU/subpart-e%E2%80%94surgical-devices/PSN.md) - **Decision Date:** May 17, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4580 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended Use The DeepX DermoSight Dermatoscope is a non-invasive skin imaging system, which acquires white light dermatoscopic images and clinical photographs of the skin. These can be stored, retrieved, displayed and reviewed by trained medical practitioners. ## Device Story Hand-held dermatoscope (camera) with LED light source; acquires white light dermatoscopic images (contact mode) and clinical photographs (15cm distance); connects via USB to PC workstation; images/data transmitted to cloud-based software application; used in professional medical environments; enables storage, retrieval, and review of skin images/patient data by medical practitioners; supports clinical documentation and workflow; aids in visual assessment of skin lesions. ## Clinical Evidence Bench testing only. No clinical data provided. Performance verified through hardware/software validation, usability evaluation, biocompatibility testing (ISO 10993), and electrical/electromagnetic safety testing (IEC 60601). ## Technological Characteristics Hand-held camera with 5MP CMOS sensor (2592 x 1944); white light LED illumination; USB connectivity to PC; cloud-based software for storage/retrieval; contact-mode dermatoscopy and non-contact clinical photography; biocompatible nose piece/spacer (ISO 10993); IEC 60601-1/1-2 compliant. ## Regulatory Identification A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient. ## Special Controls *Classification.* Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. ## Predicate Devices - Demetra BDEM-01 ([K192829](/device/K192829.md)) ## Reference Devices - MicroDERM® Model/Version 3.5 ([K040171](/device/K040171.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 17, 2023 DeepX Health LLC % Howard Schrayer Official Correspondent 8 Lookout Hilton Head Island, South Carolina 29928 Re: K230448 Trade/Device Name: DeepX DermoSight Dermatoscope Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: PSN Dated: February 20, 2023 Received: February 21, 2023 Dear Howard Schrayer: 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 {1}------------------------------------------------ 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 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 medical devices and radiation-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, Jessica Carr -S Jessica Carr, Ph.D. Acting 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K230488 Device Name DeepX DermoSight Dermatoscope Indications for Use (Describe) The DeepX DermoSight Dermatoscope is a non-invasive skin imaging system, which acquires white light dermatoscopic images and clinical photographs of the skin. These can be stored, retrieved, displayed and reviewed by trained medical practitioners. | 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." {3}------------------------------------------------ # Exhibit E - 510(k) Summary | Contact: | Howard Schrayer
DeepX Health LLC
2101 L Street, NW Suite 300
Washington, DC 20037

Telephone: 609-273-7350
hs.ss@lucidmedical.net | |-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared: | February 20, 2023 | | Device Trade Name: | DermoSight Dermatoscope | | Manufacturer: | DeepX Health LLC
2101 L Street, NW Suite 300
Washington, DC 20037 | | Common Name: | Light Based Imaging - Surgical Lamp | | Classification: | Class II | | Product Code: | PSN | | Regulation: | 21 CFR 878.4580 | | Predicate Devices:
Primary Predicate | Demetra BDEM-01
Surgical Lamp
[510(k) K192829] | | Reference Predicate | Visiomed AG
MicroDERM® Model/Version 3.5
[510(k) K040171] | {4}------------------------------------------------ #### Indications for Use: The DeepX DermoSight Dermatoscope is a non-invasive skin imaging system. which acquires white light dermatoscopic images and clinical photographs of the skin. These can be stored, retrieved, displayed and reviewed by trained medical practitioners. #### Device Description: The DeepX Health DermoSight Dermatoscope is designed to acquire images of the skin and optimize the imaging storage and documentation workflow. The DeepX Health DermoSight Dermatoscope system consists of a hardware device and a software application. The hardware device is a hand-held, dermatoscope (camera) for acquiring and transmitting images of the skin. The hand-held, portable unit includes an LED light-source, a digital camera and a USB cable to transfer images to a standard PC workstation. The device acquires optical dermatoscopic images in a contact mode (acquired with the device in contact with the skin). In addition, the device can also acquire a clinical close-up image, when it is positioned 15cm from the skin. The stand-alone software application is cloud-based software with a related web application. The cloud software allows for storage and retrieval of the acquired images and patient data for review by medical professionals. DeepX Health DermoSight Dermatoscope software is a stand-alone application to be accessed via a standard computer connected to the hospital/clinic server or directly to the internet. The software displays the patient demographic and identification information (e.g., date of image acquisition and anatomic location of photographed site). The images and identification data may be output to the computer used for image acquisition or downloaded to an alternate computer or storage device identified by the user. ### Substantial Equivalence and Predicate Devices: The device was shown to be substantially equivalent to a previously cleared light based imaging devices, specifically including the Demetra BDEM-01 system [510(k) K192829] predicate and the Visiomed AG MicroDERM® Model/Version 3.5 [510(k) K040171]. {5}------------------------------------------------ ### Performance Testing: The following documentation was submitted in the 510(k). Hardware Requirements Level of Concern Statement Software Description Software Architecture Specification User Manual and Instructions for Use Software Design Specification Risk Analysis Traceability Matrix Software Validation Report Usability Evaluation Report Software Development and Lifecycle Plan Unresolved Anomalies Cybersecurity Electromagnetic Compatibility and Safety Biocompatibility Data #### Predicate Comparison Table | Manufacturer | DeepX Health LLC | Demetra | |-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | DeepX Health
DermoSight Dermatoscope | Demetra BDEM-01 | | 510(k) Number | Subject Device - TBD | K192829 | | Regulatory Class | Class II | Class II | | Regulation | 21 CFR 878.4580 | 21 CFR 878.4580 | | Type of Device/
Product Code /
Regulation | Light Based Imaging
Surgical Lamp
PSN
21 CFR 878.4580 | Light Based Imaging
Surgical Lamp
PSN
21 CFR 878.4580 | | Indications for
Use | The DeepX DermoSight
Dermatoscope is a non-invasive
skin imaging system, which
acquires white light
dermatoscopic images and
clinical photographs of the skin.
These can be stored, retrieved,
displayed and reviewed by
trained medical practitioners. | The Barco DermoSight
Dermatoscope is a noninvasive
skin imaging
system, which acquires
multispectral and white light
dermatoscopic images and
clinical photographs of the skin.
These can be stored, retrieved,
displayed and reviewed by
trained medical practitioners. | | Intended Use
(From Regulation) | A surgical lamp (including a
fixture) is a device intended to
be used to provide visible | A surgical lamp (including a
fixture) is a device intended to
be used to provide visible | | | illumination of the surgical field
or the patient.
Emission and collection of light
to create an image for medical
purposes | illumination of the surgical field
or the patient.
Emission and collection of light
to create an image for medical
purposes | | Intended Users | Trained medical practitioners | Trained medical practitioners | | Mechanism of Action | Acquire and display of digital
video images | Acquire and display of digital
video images | | Form of Hardware
Component of
Device | The hardware device is a
portable, battery powered
medical device for acquiring and
visualizing images of the skin. | The hardware device is a
portable, battery powered
medical device for acquiring and
visualizing images of the skin. | | DermoSight
Camera
Resolution | 5mp 2592 x 1944
CMOS sensor | 8mp 3840 x 2160
CMOS sensor | | Light Source | White light LEDs | White light LEDs
Multispectral LEDs | | Data transfer | Camera to PC via USB cable | FCC compliant wireless | | Software location | Cloud based | Cloud based | | Functions | Image acquisition
Image transfer
Image and patient data storage
and retrieval
Image display and comparison | Image acquisition
Image transfer
Image and patient data storage
and retrieval
Image display and comparison | | Use environment | Professional medical
environment | Professional medical
environment | | Hardware
Location | PC inserted between image
source (camera) and internet
connection | PC inserted between image
source (camera) and internet
connection | | Body contact | Unbroken skin | Unbroken skin | | User interface | Proprietary software for entry
and retrieval of patient
identification, lesion location and
images | Proprietary software for entry
and retrieval of patient
identification, lesion location and
images | | Biocompatibility | ISO 10993 for tissue contact
nose piece and spacer | ISO 10993 for tissue contact
nose piece | | Environmental
compatibility | IEC 60601-1-2:2014 and EN
60601-1-2:2015 compliant | IEC 60601-1-2:2014 and EN
60601-1-2:2015 compliant | | Electrical safety | IEC 60601 compliant | IEC 60601 compliant | {6}------------------------------------------------ {7}------------------------------------------------ ### Conclusion The DeeX Health DermoSight Dermatoscope system is substantially equivalent to the previously cleared Demetra BDEM-01 Image Processing System with respect to intended use, general technological characteristics and performance. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PSN/K230448](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PSN/K230448) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com