NICAL SMART MICRO CR system for intraoral dental images

• K Number: K143703
• Device Name: NICAL SMART MICRO CR system for intraoral dental images
• Manufacturer: NICAL SPA
• Date Cleared: 2015-03-18 ( 79 days)
• Product Code: MUH
• Regulation Number: 872.1800

Intended Use

NICAL SMART MICRO CR system for intraoral dental images is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media.

Device Description

The NICAL/SMART MICRO is a Computed Radiography System which produces the Xray diagnostic image in digital format instead of using traditional screens and film. This device utilizes reusable X-ray storage phosphor plate (IP) that is sensitive to X-ray and stores latent image when it is exposed to X-ray. After X-ray exposure to the X-ray storage phosphor plate, X-ray storage phosphor plate is scanned by means of laser in the device. Latent image in the X-ray storage phosphor plate is released in a form of light by laser scanning. Then the light is collect and converted into a form of digital image. The signal processing is made to the digital image data such as the digital filtering, the gain & offset correction and flat fielding. The image can then be viewed on a computer workstation, adjusted if necessary, then stored locally, sent to an archive, printed or sent to PACS system. After acquisition of the latent image from the X-ray storage phosphor plate, it is erased thoroughly to be reused.

Predicate Devices

K131442

Reference Devices

K131442

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions standard digital image processing techniques (filtering, gain/offset correction, flat fielding) but does not mention AI, ML, or any related concepts like neural networks or deep learning.

Therapeutic

No

This device is a computed radiography system used for capturing, digitizing, and processing intraoral X-ray images for diagnostic purposes, not for treating any medical condition.

Diagnostic

No

This device is a Computed Radiography System that produces X-ray diagnostic images in digital format. It captures and processes images but does not interpret or diagnose conditions, which are functions of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components like an X-ray storage phosphor plate, a laser scanning mechanism, and components for collecting and converting light into a digital image. While it includes software for image processing, it is an integral part of a larger hardware system.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The NICAL SMART MICRO CR system is designed to capture, digitize, and process intraoral x-ray images. This is an imaging system that works with the patient's body directly (using X-rays) and processes the resulting image data. It does not analyze biological samples taken from the body.
• Intended Use: The intended use clearly states it's for capturing and processing intraoral x-ray images, which is a form of medical imaging, not in vitro testing.

Therefore, the device falls under the category of medical imaging equipment, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

NICAL SMART MICRO CR system for intraoral dental images is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media.

Product codes

MUH

Device Description

The NICAL/SMART MICRO is a Computed Radiography System which produces the Xray diagnostic image in digital format instead of using traditional screens and film. This device utilizes reusable X-ray storage phosphor plate (IP) that is sensitive to X-ray and stores latent image when it is exposed to X-ray. After X-ray exposure to the X-ray storage phosphor plate, X-ray storage phosphor plate is scanned by means of laser in the device. Latent image in the X-ray storage phosphor plate is released in a form of light by laser scanning. Then the light is collect and converted into a form of digital image. The signal processing is made to the digital image data such as the digital filtering, the gain & offset correction and flat fielding. The image can then be viewed on a computer workstation, adjusted if necessary, then stored locally, sent to an archive, printed or sent to PACS system. After acquisition of the latent image from the X-ray storage phosphor plate, it is erased thoroughly to be reused. Details: A laser diode is focused on the plate with a diameter of 30 µm, total power is 35 mW (CW) at wavelength from 620 to 650 µm. The blue light (400 nm) is collected from a light guide (NICAL patent) and sent to a Hamamatzu photomultiplier (PMT). Wavelength (Peak): 420 nm. The signal output from PMT is digitized from a 16 bit A/D converter. The 16 bit digitized imaging signal is sent to an FTDI 2232HL IC that contains all the logic to interface to USB2 standard. The time to read a full image depends on the size of the plate: size 0: 5 seconds; size 3: 9 seconds.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

intra oral

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)

Software validation and risk analysis was performed. Electrical safety and EMC testing was performed by a qualified testing laboratory according to IEC 60601-1 and IEC 60601-1-2. A verification report on image testing was performed to check image quality and resolution. A quality assurance procedure has been established for the incoming inspection of the imaging plates. Biocompatibility of the hygienic envelopes has been verified. Clinical Images were reviewed by a Board Certified US based radiologist and were found to be of excellent quality, suitable for the intended use. These images were not necessary to establish substantial equivalence based on the comparison to the predicate device (Note: X-ray storage phosphor plate that is identical to the predicate image plate) but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

FireCR Dental:
MTF: 70 kV 0.08sec dose.
55% 1 lp/mm
11% 3 lp/mm

NICAL/SMART MICRO Dental Imaging System:
MTF: 65Kv 0,1 sec dose.
100%. 1 lp/mm
95%. 3 lp/mm
80%. 5 lp/mm
30%. 10 lp/mm

Predicate Device(s)

K131442

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design that resembles a wing or a wave.

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

March 18, 2015

NICAL SPA % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K143703

Trade/Device Name: NICAL SMART MICRO CR System for Intraoral Dental Images Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: January 28, 2015 Received: March 6, 2015

Dear Mr. Kamm:

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 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.

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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 [phone] or [phone] 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" (21 CFR 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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

Robert A Ochs

Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Exhibit 4.

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Indications for Use

510(k) Number (if known)

K143703

Device Name NICAL SMART MICRO CR system for intraoral dental images

Indications for Use (Describe)

NICAL SMART MICRO CR system for intraoral dental images is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Exhibit 1. 510(k) SUMMARY

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510(k) Summary, K143703 This 510(k) summary information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date prepared: March 2, 2015

• 1. Company and Correspondent: NICAL SPA Via Soffredini, 43 -20126 Milano Italy Phone [phone] -Fax [phone] www.nical.com Prepared by: Roberto Niccolucci, President
• 2. Device

Trade/Proprietary Name: NICAL/SMART MICRO Common Name: Computed Radiography Scanner System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH

• 3. Predicate Device: FireCR Dental, made by 3D Imaging & Simulations Corp., K131442.
• 4. Indications for Use: The NICAL/SMART MICRO Dental Imaging System is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media.
• 5. Description: The NICAL/SMART MICRO is a Computed Radiography System which produces the Xray diagnostic image in digital format instead of using traditional screens and film. This device utilizes reusable X-ray storage phosphor plate (IP) that is sensitive to X-ray and stores latent image when it is exposed to X-ray. After X-ray exposure to the X-ray storage phosphor plate, X-ray storage phosphor plate is scanned by means of laser in the device. Latent image in the X-ray storage phosphor plate is released in a form of light by laser scanning. Then the light is collect and converted into a form of digital image. The signal processing is made to the digital image data such as the digital filtering, the gain & offset correction and flat fielding. The image can then be viewed on a computer workstation, adjusted if necessary, then stored locally, sent to an archive, printed or sent to PACS system. After acquisition of the latent image from the X-ray storage phosphor plate, it is erased thoroughly to be reused. Details: A laser diode is focused on the plate with a diameter of 30 µm, total power is 35 mW (CW) at wavelength from 620 to 650 µm. The blue light (400 nm) is collected from a light guide (NICAL patent) and sent to a Hamamatzu photomultiplier (PMT). Wavelength (Peak): 420 nm. The signal output from PMT is digitized from a 16 bit A/D converter. The 16 bit digitized imaging signal is sent to an FTDI 2232HL IC that contains all the logic to interface to USB2 standard. The time to read a full image depends on the size of the plate: size 0: 5 seconds; size 3: 9 seconds.
• 6. Comparison with predicate device: The indications for use and the technologies employed are virtually identical to those of the predicate. Imaging plates are exposed to x-rays while in the patient's mouth. The plates are removed and scanned by the scanning device. The resulting images can be viewed by the dentist and stored on a personal computer. The plates are then

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erased and can be reused. Patient cross contamination is prevented by the use of single use barrier envelopes placed over the plates. The imaging plates are identical to those used in the predicate device. Comparison of the test results: The MTF performance (see chart below) is superior on the Nical system as compared to the predicate. The effective pixel pitch is smaller, 30 um vs 35 um giving slightly better overall resolution. This shows up in a comparison of the spatial resolution: 9.0lp/mm @ 35um on the predicate vs. 10.5 lp/mm @ 30um on the Nical device. A detailed comparison table follows.

| | | FireCR Dental
3D Imaging & Simulations
Corp. | NICAL/SMART MICRO Dental Imaging
System |
|------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | | K131442 | K143703 |
| Intended Use | | The FireCR Dental imaging
system is indicated for
capturing, digitization and
processing of intra oral x-
ray images stored in
imaging plate recording
media. | The NICAL/SMART MICRO Dental
Imaging System is indicated for
capturing, digitization and processing of
intra oral x-ray images stored in imaging
plate recording media. |
| Physical
Char. | Overall
Dimensions | Reader
185 x 100 x 293mm | Reader
110x154x270 mm |
| | Imaging Area | Size 0 : 22 x 31mm
Size 1 : 24 x 40mm
Size 2 : 31 x 41mm
Size 3 : 27 x 54mm
Size 4c : 48 x 54mm | Size 0 (22mm x 31mm),
Size 1 (24mm x 40mm),
Size 2 (31mm x 41mm),
Size 3 (27mm x 54mm)
N/A |
| | Effective Pixel
Pitch | 35um, 64um | 30 um. |
| | Spatial
Resolution | 9.0lp/mm @ 35um | 10.5 lp/mm @ 30um |
| | Image Matrix | Size 0
343 x 484 @ 64um
628 x 885 @ 35um
Size 1
375 x 625 @ 64um
685 x 1143 @ 35um
Size 2
484 x 640 @ 64um
886 x 1171 @ 35um
Size 3
421 x 843 @ 64um
771 x 1542 @ 35um
Size 4c
750 x 843 @ 64um
1370 x 843 @ 35um | Size 0
726x1024 pixel 30 um.
Size 1
792x1321 pixel 30 um.
Size 2
1024x1354 pixel 30 um.
Size 3
891x1783 pixel 30 um.
Not applicable |
| | | FireCR Dental
3D Imaging & Simulations
Corp. | NICAL/SMART MICRO Dental Imaging
System |
| | Photo | Image: FireCR Dental 3D Imaging | Image: NICAL/SMART MICRO Dental Imaging System |
| | Weight | 4.7kg | 4.6kg |
| | Imaging
Device | High Sensitivity Photo
Multiplier Tube (s-PMT) | High Sensitivity Photo Multiplier Tube
(s-PMT) |
| Operational
Char | Operating
Condition | Temperature :15-30°C
Humidity: 15%-95% RH | Temperature: 10 - 40 °C
Humidity: 30 - 90% RH |
| | Power | 100 – 240V, 50/60Hz | 100 – 240V, 50/60Hz |
| | Methods of
Exposure | Register Patient ->
X-ray Exposure | Register Patient →
X-ray Exposure |
| | X-ray
Absorber | Imaging plate | Imaging plate |
| Functional
Char. | Output Data | Dicom3.0 Compatible | Dicom3.0 Compatible |
| | Performance | MTF: 70 kV 0.08sec dose.
55% 1 lp/mm
11% 3 lp/mm | MTF: 65Kv 0,1 sec dose.
100%. 1 lp/mm
95%. 3 lp/mm
80%. 5 lp/mm
30%. 10 lp/mm |
| | Defect
Compensation | By Calibration | By Calibration |
| | Dynamic
Range | 16 bit | 16 bit |
| | Image
Processing | Single image processing
parameter is used | Single image processing parameter is
used |
| | FireCR Dental
3D Imaging & Simulations
Corp. | NICAL/SMART MICRO Dental Imaging
System | |
| DICOM
Compatibility | DICOM 3.0 Compliant | DICOM 3.0 Compliant | |

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Imaging Plate Comparison
	FireCR Dental
3D Imaging & Simulations Corp.	NICAL/SMART MICRO Dental Imaging System
510(k) number	K131442	K143703
Imaging Plate Composition	BaSrFBrl:Eu phosphor	BaSrFBrl:Eu phosphor
Plate Sizes	Size 0 : 22 x 31mm	Size 0 (22mm x 31mm)
	Size 1 : 24 x 40mm	Size 1 (24mm x 40mm)
	Size 2 : 31 x 41mm	Size 2 (31mm x 41mm)
	Size 3 : 27 x 54mm	Size 3 (27mm x 54mm)
	Size 4c : 48 x 54mm	N/A
Thickness	Thickness: approx. 350 mm	Thickness: approx. 350 mm
Typical luminescence	400 nm	400 nm
Image Retention	Recommended within 1 hour of exposure. Two hours after exposure 70% of the stored energy still is present with no visible loss of information upon readout. Image retention still exceeds 45% after 24h	Recommended within 1 hour of exposure. Two hours after exposure 70% of the stored energy still is present with no visible loss of information upon readout. Image retention still exceeds 45% after 24h

• 7. Description of non-clinical testing: Software validation and risk analysis was performed. Electrical safety and EMC testing was performed by a qualified testing laboratory according to IEC 60601-1 and IEC 60601-1-2. A verification report on image testing was performed to check image quality and resolution. A quality assurance procedure has been established for the incoming inspection of the imaging plates. Biocompatibility of the hygienic envelopes has been verified.
• 8. Description of clinical testing: Clinical Images were reviewed by a Board Certified US based radiologist and were found to be of excellent quality, suitable for the intended use. These images were not necessary to establish substantial equivalence based on the comparison to the predicate device (Note: X-ray storage phosphor plate that is identical to the predicate image plate) but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended."
• 9. Conclusion: Based on the similarity to the predicate device in terms of technology, performance, and indications for use, we conclude that the Nicro Dental Imaging System is substantially equivalent to the predicate device named above.