(134 days)
Not Found
No
The description focuses on image acquisition, storage, and basic processing (digitization, display, compression, export) without mentioning any analytical or interpretive functions that would typically involve AI/ML. The device is explicitly stated as "not intended as a diagnostic device," further suggesting the absence of AI/ML for diagnostic support.
No
The document states the device is intended for image acquisition and storage for physician diagnostic review, not for treatment or therapy. It explicitly states it is not a diagnostic device.
No
The "Device Description" explicitly states, "MicroDERM is not intended as a diagnostic device."
No
The device description explicitly states that MicroDERM® consists of a camera, software, and a frame grabber card, indicating it includes hardware components in addition to software.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that MicroDERM® is for the "acquisition and storage of images of skin surfaces" and that these images are for "physician diagnostic review and referral purposes." It does not mention analyzing biological samples or providing diagnostic information based on in vitro testing.
- Device Description: The description reinforces that it "captures images of skin surfaces for physician diagnostic review and referral purposes." Crucially, it also explicitly states: "MicroDERM is not intended as a diagnostic device."
- Lack of IVD Characteristics: IVD devices typically involve analyzing biological specimens (like blood, urine, tissue) to provide information about a patient's health status. This device focuses solely on capturing and managing images of the skin surface.
Therefore, MicroDERM® functions as an image management system for dermatological images, not as a device that performs in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
PSN
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.
Mentions image processing
MicroDERM® is intended for the acquisition and storage of images of skin surfaces. These images can then be retrieved, printed, reviewed and displayed.
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital dermatoscopic
Anatomical Site
skin surfaces
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified personnel
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 MicroDERM System has been tested to and meets the following Performance Standards:
- 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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one behind the other.
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
1
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
2
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
Page lof I
510(k) Number_________________________________________________________________________________________________________________________________________________________________
3
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
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.
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
4
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.