MicroDERM® is intended for the acquisition and storage of images of skin surfaces. These images can then be retrieved, printed, reviewed and displayed.

Device Description

MicroDERM® is a digital dermascope and software system, which captures images of skin surfaces for physician diagnostic review and referral purposes. These images can be sent to other computers using a modem or network card. It consists of the MicroDERM® camera, MicroDERM® software, and a frame grabber card. The MicroDERM® software runs under the Microsoft® Windows 2000 operating system. MicroDERM is not intended as a diagnostic device.

AI/ML Overview

This document is a 510(k) premarket notification for the MicroDERM® device, which is a digital dermascope and software system. The document states that the device is not intended as a diagnostic device, but rather for the acquisition and storage of images of skin surfaces. Therefore, the acceptance criteria and related studies provided are focused on performance standards for medical devices generally, rather than diagnostic accuracy metrics.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria / Performance Standard	Reported Device Performance
ISO 9001:1994 Quality Systems	The MicroDERM System has been tested to and meets this standard.
ISO 13485 Quality Systems, Medical Devices- Particular application to the Requirements of 90001	The MicroDERM System has been tested to and meets this standard.
EN 14971 Risk Analysis	The MicroDERM System has been tested to and meets this standard.
EN 46001 Quality Systems Application of 9001 to Medical devices	The MicroDERM System has been tested to and meets this standard.
IEC 10918-1 Information technology -- Digital compression and coding of continuous-tone still images: Requirements and guidelines	The MicroDERM System has been tested to and meets this standard. (Indicates images are saved using standard JPEG compression algorithms).
IEC 60601- Electrical Safety and Electromagnetic Compatibility	The MicroDERM System has been tested to and meets this standard.
21CFR820 Quality System Regulation	The MicroDERM System has been tested to and meets this standard.
FDA ODE Guidance on the Content of Pre-market submissions for devices containing Software: 1998	The MicroDERM System has been tested to and meets this standard.
FDA Guidance of use of Off The Shelf Software in Medical Devices; 1997	The MicroDERM System has been tested to and meets this standard.
FDA Guidance for the Submission of Pre-Market Notification for Medical Image Management Devices: 2000	The MicroDERM System has been tested to and meets this standard.
21CFR1020.10 As applicable to Video Monitors	The MicroDERM System has been tested to and meets this standard.
21CFR1040.10 As applicable to Optical Storage Devices	The MicroDERM System has been tested to and meets this standard.
21CFR810 Labeling	The MicroDERM System has been tested to and meets this standard.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document primarily focuses on compliance with general medical device standards and does not detail a clinical test set or data provenance for evaluative purposes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. Since the device is not intended for diagnosis, the concept of "ground truth" for patient outcomes or conditions in a clinical study is not applicable in the context of the provided information.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided in the document. The MicroDERM is described as an image acquisition and storage device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance evaluation related to diagnostic accuracy or clinical outcomes was not performed, nor is it relevant given the stated indications for use. The "Performance Standards" listed are for medical device quality systems, electrical safety, and image handling, not for AI algorithm performance. The device is explicitly stated as "not intended as a diagnostic device."

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not provided and is not applicable in the context of the device's stated purpose as an image acquisition and storage system, rather than a diagnostic tool.

8. The sample size for the training set

This information is not provided in the document. Since the device is not an AI-based diagnostic tool, a "training set" in that sense would not be relevant.

9. How the ground truth for the training set was established

This information is not provided and is not applicable as there is no indication of an AI-based diagnostic algorithm requiring a training set with established ground truth.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 10. 2017 Visiomed AG c/o Mr. John Greenbaum Generic Devices Consulting 20310 SW 48th Street

Fort Lauderdale, Florida 33332

Re: K040171

Trade/Device Name: MicroDERM® Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: PSN Dated: April 26, 2004 Received: April 27, 2004

Dear Mr. Greenbaum

This letter corrects our substantially equivalent letter of June 8, 2004.

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. 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 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

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Page 2 - Mr. John Greenbaum

CFR Part 807); labeling (21 CFR Part 801 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _ K040171

Device Name: MicroDERM

Indications for Use:

MicroDERM® is intended for the acquisition and storage of images of skin surfaces. These images can then be retrieved, printed, reviewed and displayed.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

miriam C. Provost (Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number_________________________________________________________________________________________________________________________________________________________________

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040171 1/2

JUN - 8 2004

510(k) Summary

Submitter: Visiomed AG. 160 Universitätsstr. 160 Bochum, Germany 01730 Phone: + 49 (234) 9787 76 Fax: + 49 (234) 9787 75

Contact: Thomas Schnepple

510(k) Numbers and Product Codes of equivalent devices.

Apax Pacs System 510(k) Number: #K032760 Product Code: LLZ CFR Section: 892.2050 Tis, Inc., Seoul Korea

Indications for Use and Intended Population

MicroDERM® is intended for the acquisition and storage of images of skin surfaces. These images can then be retrieved, printed, reviewed and displayed.

Device Description

Physical/Technical Characteristics

MicroDERM® can digitize, display, store, retrieve and import images using the digital dermatoscopic, software and supporting PC hardware. Images are saved in a database using the standard JPEG image compression algorithms. Images can be exported to other devices (e.g. other MicroDERM systems) via a DICOM export function.

Performance Standards

The MicroDERM System has been tested to and meets the following Performance Standards:

Visiomed AG MicroDERM 510(K) Pre-market Submission; Amended Section 4.0 - 510K Summary Page 9 Confidential and Proprietary Information of Visiomed AG

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040171 2/2

ISO 9001:1994 Quality Systems .
ISO 13485 Quality Systems, Medical Devices- Particular application to the � Requirements of 90001
EN 14971 Risk Analysis ●
EN 46001 Quality Systems Application of 9001 to Medical devices .
IEC 10918-1 Information technology -- Digital compression and coding of . continuous-tone still images: Requirements and guidelines
IEC 60601- Electrical Safety and Electromagnetic Compatibility .
21CFR820 Quality System Regulation .
FDA ODE Guidance on the Content of Pre-market submissions for devices containing . Software: 1998
FDA Guidance of use of Off The Shelf Software in Medical Devices; 1997 .
FDA Guidance for the Submission of Pre-Market Notification for Medical Image ● Management Devices: 2000
21CFR1020.10 As applicable to Video Monitors .
21CFR1040.10 As applicable to Optical Storage Devices .
21CFR810 Labeling .

Conclusion

There are more similarities than differences between the predicate device and the Visiomed AG MicroDERM System. When used in according with the directions for use, by qualified personnel, the Visiomed AG MicroDERM System is safe and effective, as indicated, for its intended use. No new issues of risk, safety or effectiveness are introduced with the Visiomed AG MicroDERM System when compared with the predicate device.

Regulation Number and Section

§ 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.