(85 days)
No
The summary describes a system for image acquisition, storage, and retrieval, with no mention of AI or ML for image analysis or interpretation.
No
The device is a non-invasive skin imaging system designed to acquire and store images for review by medical practitioners, not for treating any medical condition.
Yes
The device acquires dermatoscopic images and clinical photographs of the skin which can be stored, retrieved, displayed, and reviewed by trained medical practitioners. This process aids in the visual assessment and analysis of skin conditions, which is a form of diagnosis.
No
The device description explicitly states that the system consists of both a hardware device (hand-held dermatoscope) and a software application.
Based on the provided information, the DeepX DermoSight Dermatoscope is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The DeepX DermoSight Dermatoscope directly images the skin surface.
- The intended use and device description clearly state that it acquires images of the skin. This is a non-invasive imaging system, not a system for analyzing biological samples.
- There is no mention of analyzing biological specimens or performing tests on samples. The device's function is to capture and manage visual information of the skin.
Therefore, the DeepX DermoSight Dermatoscope falls under the category of a medical imaging device, specifically a dermatoscope, rather than an IVD.
N/A
Intended Use / 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.
Product codes
PSN
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.
Mentions image processing
Acquire and display of digital video images
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
White light dermatoscopic images and clinical photographs.
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners, Professional medical environment
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
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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4580 Surgical lamp.
(a)
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.(b)
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.
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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
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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) |
|---|
| ----------------------------------------------------------------------------------- |
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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] |
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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].
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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 |
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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.