(366 days)
Not Found
No
The summary describes a device that uses spectrophotometric analysis and digital imaging to visualize skin components. There is no mention of AI, ML, or any related concepts in the intended use, device description, or other sections. The technology described is based on light interaction with tissue and image capture, not algorithmic learning or inference.
No
The device is described as a non-invasive skin analysis system that images skin conditions and displays components of the skin. It does not state that it is used for treatment.
Yes
The device is described as a "skin analysis system" that uses "Spectrophotometric Intracutaneous Analysis" to "identify and display graphically the separate components of the skin," which are actions indicative of a diagnostic purpose.
No
The device description explicitly states it uses a digital camera and light (LEDs) to acquire images, indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro).
- Device Description: The SIAscope is described as a "non-invasive skin analysis system" that "scans the patient's skin." It uses light and a digital camera to analyze the skin in situ (on the body).
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the patient.
Therefore, because the SIAscope analyzes the skin directly on the patient's body and does not involve the examination of specimens outside the body, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SIAscope is a non-invasive skin analysis system, which provides color bitmaps called 'SIAscans' that show the relative location of blood, collagen and pigment.
Product codes (comma separated list FDA assigned to the subject device)
PSN
Device Description
The SIAscope is a quick, non-invasive device for imaging skin conditions. It uses a technique known as 'Spectrophotometric Intracutaneous Analysis' (SIAscopy) to identify and display graphically the separate components of the skin. SIAscopy uses a digital camera and light (both visible and near-infrared) to investigate the skin's interior structure.
The SlAscope operates by illuminating the skin with LEDs and measuring the intensity of remitted light. The intensity of the illumination is similar to the emission from a typical hand held torch or remote control unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
SIAscope II (K023729)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus features a staff with two snakes entwined around it.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2017
Astron Clinica Limited c/o Smith Associates Mr. E.J. Smith 1676 Village Green, Suite A Crofton. Maryland 21114
Re: K062736
Trade/Device Name: SIAscope V Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: PSN Dated: June 15, 2007 Received: June 18, 2007
Dear Mr. Smith:
This letter corrects our substantially equivalent letter of September 14, 2007.
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 CFR Part 807); labeling (21 CFR Part 801 ); medical device reporting (reporting of medical
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Page 2 - Mr. E. J. Smith
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/ReportaProblem/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): K062736
Device Name: SIAscope V
Indications for Use:
The SIAscope is a non-invasive skin analysis system, which provides color bitmaps called 'SIAscans' that show the relative location of blood, collagen and pigment'.
Prescription Use X (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)
| (Division Sig: Off) | Page 1 of 1 |
|---|---|
| Division of General, Restorative, and Neurological Devices | |
| 10(k) Number | L062736 |
3
3
62736
SEP 1 4 2007
510(k) Summary
September 6, 2007
Company Name & Address: Astron Clinica Ltd The Mount Toft Cambridge, United Kingdon CB3 7RL
Contact Name:
E.J. Smith 1676 Village Green, Suite A Crofton, MD 21114 Phone: 888-729-9674 Fax: 410-793-0448 Email: ESmith9746@aol.com
Date Summary Prepared:
August 31, 2006
Device Identification:
| Classification Name: | Light, Surgical, Floor Standing |
|---|---|
| Common/Usual Name: | Skin Analysis System |
| Proprietary Name: | SIAscope |
| Establishment Registration Number: | 3004519907 |
| Regulation Number: | 21 CFR 878.4580 |
| Product Code: | FSS |
| Classification Panel: | General & Plastic Surgery |
| Device Classification: | Class II |
Intended Use
The SIAscope is a non-invasive skin analysis system, which provides color bitmaps called 'SIAscans' that show the relative location of blood, collagen and pigment.
CAUTION : This device should only be used to scan the patient's skin.
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KO62736
Device Overview
The SIAscope is a quick, non-invasive device for imaging skin conditions. It uses a technique known as 'Spectrophotometric Intracutaneous Analysis' (SIAscopy) to identify and display graphically the separate components of the skin. SIAscopy uses a digital camera and light (both visible and near-infrared) to investigate the skin's interior structure.
The SlAscope operates by illuminating the skin with LEDs and measuring the intensity of remitted light. The intensity of the illumination is similar to the emission from a typical hand held torch or remote control unit.
Description of SIAscans
Unlike biopsy, SIAscopy provides an array of readings of the skin that are displayed in graphical form creating a synthesized image called a SIAscan.
Predicate Product Comparison
The SIAscope V operates in a very similar fashion to the predicate device. Where alterations have been make this have been design to improve the imaging performance, reliability and safety of the device over and above the predicate device.
Although the design of the user interface has changed, these changes have been made to make the device easier and more intuitive to use for the clinical practitioner. However, the software algorithms and theory of SIAscopy is the same as found in the predicate device.
We assert that the SIAscope V substantially equivalent to the SIAscope II (K023729)
| Parameter | SIAscope V | SIAscope II (K023729) |
|---|---|---|
| Product Code | FSS | FSS |
| Intended Use | SIAscope is a non-invasive skin | |
| analysis system, which provides | ||
| color bitmaps called 'SIAscans' that | ||
| show the relative location of blood, | ||
| collagen and pigment. | SIAscope is a non-invasive skin | |
| analysis system, which provides a | ||
| synthesized 'image' showing the | ||
| relative location of blood, collagen | ||
| and pigment. | ||
| Illumination For: | Skin | Skin |
| Illumination: | LED | LED |
| Imager Chip: | CMOS | CCD |
Summary comparison of features and specification SIAscope V vs. SIAscope II
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长662736
| Power Source: | USB via PC | AC |
|---|---|---|
| External Materials: | ||
| (Caseworks) | Glass, ABS & TPE Plastics | Glass, Aluminium |
| PC Connection: | USB 2.0 | Proprietary Umbilical Cable |
| Weight: | 250grams | 1Kg |
| Calibration Method: | Factory Calibrated | Factory Calibrated |
| Viewfinder: | Colour (3.2 MegaPixel) | Monochrome (0.7 MegaPixel) |
| Software: | DERMETRICS™ |
- New User Interface
- SIAscopy algorithms unchanged | SIAscope II |
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