(178 days)
Not Found
No
The summary describes a standard OCT imaging device with image processing capabilities for visualization and measurement, but there is no mention of AI or ML being used for image analysis, interpretation, or any other function. The performance studies focus on image quality and comparison to a predicate device, not on the performance of an AI/ML algorithm.
No.
The device is an imaging system designed for diagnosis and visualization, not for treating or providing therapy.
No
The provided text indicates the device is an imaging system used to visualize external tissues and skin structures and provides measurements, but it does not state that it analyzes or interprets these images to provide a medical diagnosis. The performance studies mention linking device images to histopathological patterns but do not describe the device itself making a diagnosis.
No
The device description explicitly states it is an "optical coherence tomography imaging device (OCT) weighing approximately 105kg," indicating it is a physical hardware system, not software only.
Based on the provided information, Agfa's Skintell is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Skintell's Function: Skintell is an in-vivo imaging system. It directly images external tissues of the human body (skin) without requiring the collection and analysis of a specimen taken from the body.
- Intended Use: The intended use clearly states "real-time imaging of external tissues of human body," which is consistent with an in-vivo imaging device.
- Device Description: The description reinforces that it "is used to create images of non-open wounded human skin and the corresponding close-to-surface tissue," again indicating direct imaging of the body.
Therefore, because Skintell operates by directly imaging the body rather than analyzing a specimen taken from the body, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Agfa's Skintell is an Optical Coherence Tomography (OCT) system indicated for use in two-dimensional, cross-sectional, real-time imaging of external tissues of human body.
Product codes (comma separated list FDA assigned to the subject device)
NQQ
Device Description
Agfa's Skintell is an optical coherence tomography imaging device (OCT) weighing approximately 105kg. It is used to create images of non-open wounded human skin and the corresponding close-to-surface tissue.
Skintell offers users the following functions:
- volume and cross-sectional imaging .
- high resolution rendering of structures .
- . geometrical length- measurements
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT)
Anatomical Site
external tissues of human body (non-open wounded human skin and the corresponding close-to-surface tissue)
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)
The device has completed verification and validation testing to confirm it meets specifications and operates as planned. Tests included standard workflow tests, biocompatibility tests, and image quality evaluations with external and internal experts comparing Agfa's Skintell device to the Michelson Diagnostics VivoSight Topical OCT (K093520) predicate device.
Images were taken using both the slice and enface modes of the Skintell device and anlaysed histopathologically. Typical patterns of normal skin as well as typical patterns of lesions itself visible on the standard HE stained histopathology section can be linked to image patterns visible in the slice- and enface-images of the Skintell device. Thus, Skintell offers the possibility to visualize skin-structures in-vivo.
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.
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
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
MAR - 3 2014
510(K) SUMMARY
Agfa Skintell - Optical Coherence Tomography (OCT) System
Common Name: Optical Coherence Tomography (OCT) System Classification Name: System, Imaging, Optical Coherence Tomography (OCT) Regulatory Classification: 21 CFR 892.1560 Product Code: NOQ Proprietary Name: Skintell Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Koen Vervoort, Prepared: September 6, 2013 Telephone: +32-34444-7368
A. LEGALLY MARKETED PREDICATE DEVICES
This is a 510(k) for Agfa's Skintell which is an optical coherence tomography (OCT) imaging device. It is substantially equivalent to the system with Michelson Diagnostics VivoSight Topical OCT System (K093520).
DEVICE DESCRIPTION B.
Agfa's Skintell is an optical coherence tomography imaging device (OCT) weighing approximately 105kg. It is used to create images of non-open wounded human skin and the corresponding close-to-surface tissue.
Skintell offers users the following functions:
- volume and cross-sectional imaging .
- high resolution rendering of structures .
- . geometrical length- measurements
C. INTENDED USE
Agfa's Skintell is an Optical Coherence Tomography (OCT) system indicated for use in twodimensional, cross-sectional, real-time imaging of external tissues of human body.
D. SUBSTANTIAL EQUIVALENCE SUMMARY
Agfa's Skintell has an Indications For Use statement identical to the statement for the predicate device, K093520. Intended uses are the same. The devices have the same technological characteristics. Descriptive characteristics and performance data are adequate to ensure equivalence.
1
t
| PRODUCT COMPARISON TABLE | ||
|---|---|---|
| Skintell | ||
| (New Device) | Michelson VivoSight Topical OCT | |
| (PREDICATE-K093520) | ||
| Network Connectivity | Same as predicate | Ethernet |
| Scanning Technology | Same as predicate | Ultrasound, Near Infra-Red (NIR) Light |
| Laser Center Wavelength | Same as predicate | 1300 nm |
| Optical Resolution | 3 um lateral and axial | 6 fps (5 mm scan width / 1.250 A-line) |
20 fps ( 1 mm scan width / 250 A-line)
35 fps (0.2 mm scan width / 50 A-line) |
| Image Depth | Up to 1.0mm | Up to 2.0 mm |
| Power Supply | 115-120/230V 50-60 Hz | 110-132 V 50-60 Hz |
| Weight | Same as predicate | 105 kg |
| Image Presentation | Same as predicate | Vertical B Scan, En-face, 3D |
| Image Formats | Same as predicate | DICOM and TIFF Stack |
| Operating System | Windows XP | Windows 7 |
| Display System | Same as predicate | Standard PC display or separately cleared
medical display |
Differences in devices do not alter the intended therapeutic/diagnostic effect.
E. TECHNOLOGICAL CHARACTERISTICS
Agfa's Skintell is an optical coherence tomography (OCT) imaging device. Principles of operation and technological characteristics of the new and predicate device are largely the same as other optical coherence tomography systems.
The Agfa Skintell system is identical to the Michelson Diagnostic VivoSight Topical OCT system (K093520) with the exception of the following:
- Optical resolution of 3 um lateral and axial
- . Scanning range of 1.8 mm x 1.5 mm (enface)
- . Image depth of up to 1.0 mm
The differences of the devices are optical resolution of Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Date: 2014.03.03 0 | Date: 2014.05.0.
01 10:25:31 -05'00'