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.

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.

AI/ML Overview

Here’s an analysis of the acceptance criteria and supporting study for the Agfa Skintell OCT system, based on the provided 510(k) summary:

The 510(k) summary for Agfa Skintell (K132800) is a substantial equivalence submission, meaning it aims to demonstrate that the new device is as safe and effective as a legally marketed predicate device (Michelson Diagnostics VivoSight Topical OCT System, K093520). Therefore, the "acceptance criteria" are primarily defined by the performance of the predicate device and relevant product safety/quality standards. The "study" largely consists of verification and validation testing, including comparative evaluations with the predicate and histological analysis.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a substantial equivalence submission relying heavily on a predicate device, the "acceptance criteria" are implicit in demonstrating performance that is equivalent or superior in key aspects, while adhering to relevant standards. The performance aspects are compared directly to the predicate.

Acceptance Criteria (Implicit from Predicate & Standards)	Reported Device Performance (Agfa Skintell)
Functional Equivalence to Predicate K093520	Provides volume and cross-sectional imaging, high resolution rendering of structures, geometrical length-measurements.
Optical Resolution (Predicate: < 7.5 µm lateral, < 5 µm axial)	3 µm lateral and axial (Superior to predicate). The filing implicitly states this is an improvement that yields "sharper and clearer images."
Image Depth (Predicate: Up to 2.0 mm)	Up to 1.0 mm (Less than predicate). The filing argues this shallower depth is still suitable as significant structures are often within this range, and the improved resolution at this depth compensates for the reduced penetration.
Scanning Range (Predicate: 5mm x 5mm)	1.8mm x 1.5mm (enface) (Less than predicate). The filing states the probe is movable, allowing the smaller field of view to be positioned as needed, implying this difference does not impact safety or effectiveness.
Image Quality & Visualization of Skin Structures	"Produces sharper and clearer images than the Michelson device." "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."
Compliance with Product Standards (e.g., IEC 60601-1, IEC 60601-1-2, EN 1041)	Device "conforms to product safety, radiology, and imaging standards." Specifically lists compliance with IEC 60601-1: 2005, IEC 60601-1-2: 2007, EN 1041:2008.
Compliance with Quality Management & Biocompatibility Standards (e.g., ISO 14971, ISO 13485, ISO 10993 series)	"Conforms to product safety, radiology, and imaging standards." Specifically lists compliance with ISO 14971:2007, ISO 13485:2003, ISO 10993-1:2009, ISO10993-5: 2009, ISO10993-10: 2010, ISO10993-12: 2007. Also states "Biocompatibility tests" were performed.
Safety and Effectiveness (Compared to Predicate)	"Differences in devices do not alter the intended therapeutic/diagnostic effect." "Differences are minor and would not be expected to impact safety and effectiveness."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document simply states "Images were taken using both the slice and enface modes of the Skintell device and anlaysed histopathologically." It does not specify the number of images, cases, or subjects used for this analysis.
Data Provenance: Not explicitly stated, but the submission is from Agfa HealthCare N.V. (Belgium). The study involved "histopathologically analyzed" images, suggesting human tissue samples. It is not specified if the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: The document mentions "external and internal experts" comparing Agfa's Skintell device to the predicate for image quality evaluations. It does not specify the number of experts involved.
Qualifications of Experts: The qualifications of these experts are not provided.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method for reconciling varying expert opinions, if multiple experts were indeed used for image quality evaluation. It broadly mentions "image quality evaluations with external and internal experts."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not explicitly mentioned or performed in the context of human readers improving with AI vs. without AI assistance. This submission is for an imaging device (OCT system), not an AI-powered diagnostic algorithm. The comparison was primarily between the new device and a predicate device, and the demonstration of image quality and ability to visualize structures.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, this is not applicable. The Agfa Skintell is an imaging device, not an algorithm. Its "performance" refers to its ability to acquire high-quality images and show anatomical structures, not to an automated diagnostic output. The evaluation focused on the physical characteristics of the images produced by the device and their correlation with histopathology.

7. Type of Ground Truth Used

The primary ground truth used for evaluating the Skintell device's ability to visualize skin structures was histopathology (standard HE stained histopathology section). The document states: "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."

8. Sample Size for the Training Set

Not applicable. This is an imaging device, not an AI/machine learning algorithm requiring a training set. The device produces images based on physical principles of optical coherence tomography.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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K132800

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.

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.

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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	< 7.5um lateral, < 5 um axial
Lateral Scanning Range	1.8mm x 1.5mm (enface)	5mm x 5mm
Image Acquisition Speed	1 fps - Slice (1.8 mm x 1mm)5 fps - Enface (1.8mm x 1.5mm)3D - 1.8mm x 1.5mm x 1mm	> 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 clearedmedical 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 < 7.5 um for lateral and < 5 um for axial of the Michelson Topical OCT device (K093520) is worse with respect to the resolution 3 um for both lateral and axial of the Agfa Skintell device. However, the penetration depth of the Michelson Topical OCT device (K093520) is about twice of the penetration depth of the Agfa Skintell device. Even though the Michelson device is able to scan images at a deeper depth, the depth resolution declines while the Agfa Skintell images are clearly separable. Therefore, Agfa's Skintell device produces sharper and clearer images than the Michelson device even

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though they are acquired at a shallower depth. Furthermore, this depth of 1.0mm in the epidermal / dermal junction in most cases is where many of the significant changes/structures/lesions are present. The Michelson Topical OCT device (K093520) allows for a wider scanning range of 5mm x 5mm than the Agfa Skintell device which is 1.8mm x 1.5mm (enface). However, the Skintell probe is movable allowing the smaller field of view (scanning range) to be moved to the required section where all the area can be viewed. However, these differences are minor and would not be expected to impact safety and effectiveness.

TESTING F.

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.

The product, manufacturing and development processes have been shown to conform to product safety, radiology, and imaging standards including:

PRODUCT STANDARDS

IEC 60601-1: 2005 Medical Electrical Equipment Part 1: General Requirements for Safety .
. IEC 60601-1-2: 2007 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
EN 1041:2008 Information Supplied by the Manufacturers of Medical Devices .

QUALITY MANAGEMENT STANDARDS

. ISO 14971:2007 Application of Risk Management to Medical Devices
. ISO 13485:2003 Medical Devices - Quality Management Systems - Requirements For Regulatory purposes
ISO 10993-1:2009 Biocompatibility Evaluation and Testing within Risk Management . Process
ISO10993-5: 2009 Biocompatibility: Biological Evaluation of Medical Devices Part 5: . Tests for in virtro Cytotoxicity
ISO10993-10: 2010 Biocompatibility: Tests for Irritation and Skin Sensitation .
ISO10993-12: 2007 Biocompatibility: Sample Preparation and Reference Materials .

NOTE: Agfa recognizes two other standards (AOL 2008 and IEC60601-2-37) associated with

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the product classification NOO: however. Agfa does not feel these standards apply to Skintell and Michelson's VivoSight devices. Please refer to Exhibit 8 for the explanation of this determination.

G. CONCLUSIONS

Agfa's Skintell device has an Indications For Use statement that is identical to the statement for the predicate device, K093520. Intended uses are the same.

Agfa's Skintell system is substantially equivalent to Michelson Diagnostic's VivoSight Topical OCT System (K093520) in that it uses the same technology to create images of non-open wounded human skin and the corresponding close-to-suface tissue. Both Agfa's Skintell device and Michelson Diagnostics VivoSight Topical OCT device (K093520) use the same components including, a non-invasive probe, PC with monitor, and foot pedal. Both the new device and the predicate device weigh 105kg and use a comparable Windows operating system. Agfa's Skintell system and Michelson Diagnostic's VivoSight Topical OCT system (K093520) both offer volume and cross-sectional imaging, high resolution, and geometric length measurements.

This 510(k) has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three wavy lines extending from its base.

Public Health Service

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

March 3, 2014

Agfa HealthCare N.V. % Ms. ShaeAnn Cavanagh AGFA Healthcare 10 South Academy Street Greenville. South Carolina 29601

Re: K132800

Trade/Device Name: Agfa Healthcare N.V Skintell Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: NQQ Dated: January 17, 2014 Received: January 22, 2014

Dear Ms. Cavanagh:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Felipe Aquel

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K132800

Device Name Agfa Healthcare N.V Skintell

Indications for Use (Describe)

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.

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)

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'

Regulation Number and Section

§ 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.