CARIESCAN PRO

• K Number: K090598
• Device Name: CARIESCAN PRO
• Manufacturer: CARIESCAN LTD.
• Date Cleared: 2009-12-15 ( 285 days)
• Product Code: NBL
• Regulation Number: 872.1745

Intended Use

For use by dental professionals as an aid in the diagnosis and monitoring of dental caries.

Device Description

This submission is for a handheld dental caries detection device which uses the AC impedance spectroscopy technique (ACIST). Single use disposal sensors are connected to the handheld device. The sensor is placed on the tooth site to be measured and a metal lip hook is placed on the patients lip, a small electrical current is passed between the sensor and the lip hook, the signals returned indicate any mineral changes in the tooth structure.

Predicate Devices

K983658, K071133

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the AC impedance spectroscopy technique and electrical signal analysis, with no mention of AI or ML.

Therapeutic

No
The device is described as an aid in diagnosis and monitoring, and it provides signals that indicate mineral changes, which are diagnostic indicators, not a treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" states, "For use by dental professionals as an aid in the diagnosis and monitoring of dental caries."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "handheld dental caries detection device" and mentions "single use disposal sensors are connected to the handheld device" and a "metal lip hook." These are physical hardware components, not solely software.

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: This device directly interacts with the tooth structure in vivo (within the living body) using electrical impedance. It does not analyze a sample taken from the body.
• Intended Use: The intended use is "as an aid in the diagnosis and monitoring of dental caries," which is a direct assessment of the tooth itself.

Therefore, while it's a diagnostic device, it falls under the category of a medical device rather than an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For use by dental professionals as an aid in the diagnosis and monitoring of dental caries.

Product codes

NBL

Device Description

This submission is for a handheld dental caries detection device which uses the AC impedance spectroscopy technique (ACIST). Single use disposal sensors are connected to the handheld device. The sensor is placed on the tooth site to be measured and a metal lip hook is placed on the patients lip, a small electrical current is passed between the sensor and the lip hook, the signals returned indicate any mineral changes in the tooth structure.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Teeth

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dental Professionals / Dental Surgery

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

Performance: 92.5 % sensitivity 92.5% specificity

Key Metrics

92.5 % sensitivity 92.5% specificity

Predicate Device(s)

K983658, K071133

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.1745 Laser fluorescence caries detection device.

(a)
Identification. A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.(b)
Classification. Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
(2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and
(3) The labeling must include detailed use instructions with precautions that urge users to:
(i) Read and understand all directions before using the device,
(ii) Store probe tips under proper conditions,
(iii) Properly sterilize the emitter-detector handpick before each use, and
(iv) Properly maintain and handle the instrument in the specified manner and condition.

Summary

0

K090598

CarieScan PRO 510(k) Submission

25 February 2009

5 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter Details 5.1

CarieScan Ltd Prospect Business Centre The Technology Park Dundee DD2 1SW വി Tel: [phone] Fax: [phone] www.cariescan.com

EC 1 5 2009

5.2 Official Contact

Nikola Skelly, Quality & Regulatory Manager Tel: [phone] Fax: [phone] Email: [e-mail]

Submission date: February 25th 2009

5.3 Device Details

Proprietary / Trade Name:	CarieScan PRO
Classification Name:	Laser Fluorescence Caries Detection Device
Product Codes:	NBL
Common / Usual Name:	Dental Caries Detection Device.

5.4 Equivalent legally marketed devices

Performance	- DIAGNOdent® 2095	K983658.
Safety	- Apex NRG XFR, Electronic Apex Locator	K071133.

5.5 Indications for Use (Intended Use)

For use by dental professionals as an aid in the diagnosis and monitoring of dental caries.

5.6 Device Description

This submission is for a handheld dental caries detection device which uses the AC impedance spectroscopy technique (ACIST). Single use disposal sensors are connected to the handheld device. The sensor is placed on the tooth site to be measured and a metal lip hook is placed on the patients lip, a small electrical current is passed between the sensor and the lip hook, the signals returned indicate any mineral changes in the tooth structure.

1

CarieScan PRO 510(k) Submission

Comparison of Technological Characteristics 5.7

5.7.1 Performance

. . .

r

With respect to performance, the CarieScan PRO is substantially equivalent to the predicate device, DIAGNOdent 2095. The devices are used in the same way for the same purpose, however the technology used is different. The DIAGNOdent uses laser fluorescence, while the CarieScan PRO uses AC impedance spectroscopy.

5.7.2 Safety

A second predicate device has been selected for safety comparison, this is the Apex NRG - Electronic Apex Locator which also uses an impedance technique.

	Candidate Device	Predicate Devices
Device
Characteristics		Performance	Safety
	CarieScan PRO	DIAGNOdent	Apex NRG
Intended Use /
Indications for
Use	For use by dental
professionals as an aid in
the diagnosis and
monitoring of dental
caries.	For use as an aid in
the diagnosis of dental
caries.	To measure the length of
the root canal for the
purpose of performing
root canals and related
dental procedures for use
by a trained professional
in general dentistry.
Target population	Dental Professionals	SAME	SAME
Anatomical Sites	Teeth	SAME	SAME
Where Used	Dental Surgery	SAME	SAME
Energy used
and/or delivered	Electrical Impedance	Laser Fluorescence	Electrical Impedance
Power Source	Lithium Polymer
Rechargeable Battery	5- AA Alkaline Battery	1- AA Battery
Measurement
Method	Comparison of
impedance at multi
frequencies	Light fluorescence	Comparison of impedance
at multi frequencies
Frequencies used
for comparison	3kHz - 20kHz	N/A	6.5kHz - 1.3 kHz
Performance*	92.5 % sensitivity
92.5% specificity	80% sensitivity
52% specificity	N/A
Max Applied
Current