(145 days)
Not Found
No
The 510(k) summary describes a fluorescence-based dental camera and detection device with different modes for diagnosis and treatment aid. There is no mention of AI, ML, image processing beyond basic visualization, or any data-driven algorithms for analysis or decision support. The device appears to rely on fluorescence properties of dental tissues and user interpretation.
No
The device is indicated as an aid in diagnosis and for visualization, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the SOPROLIFE is "indicated as an aid in the diagnosis of dental caries".
No
The device description clearly states it is a fluorescence detector housed in a dental handpiece and includes a control unit, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, the SOPROLIFE is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- SOPROLIFE's Function: The SOPROLIFE is used directly on the patient's hard dentinal tissues (teeth) to aid in the diagnosis of dental caries and visualize anatomical details. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's an "aid in the diagnosis of dental caries" and an "intra oral camera," both of which are direct clinical applications, not laboratory testing of specimens.
Therefore, the SOPROLIFE falls under the category of a medical device used for direct patient examination and diagnosis, not an IVD.
N/A
Intended Use / Indications for Use
The SOPROLIFE is indicated as an aid in the diagnosis of dental caries and as an intra oral camera to visualize anatomical details invisible to the naked eye or with mirror.
Product codes (comma separated list FDA assigned to the subject device)
NBL
Device Description
The SOPROLIFE is a fluorescence caries detection device. This device is a fluorescence detector housed in a dental handpiece, and a control unit that performs device calibration, as well as variable tone emitting and fluorescence measurement functions.
The handbiece can be connected with 5 different control units : Dock M VIDEO Dock M USB2. Dock MU VIDEO, Dock MU USB2, Dock USB2.
The SOPROLIFE is a device used in clinical dental applications to observe the condition of hard dentinal tissues.
As the SOPROLIFE can be adapted to the most complex of clinical situations, it quickly helps the dentist to get a complete analysis as it adjusts treatment options in Diagnosis aid mode. In Treatment aid mode, the SOPROLIFE facilitates observation of the dentinal tissue condition in progress and at the end of the treatment. In daylight mode the SOPROLIFE enables the dentist to visualize anatomical details invisible to the naked eye or with mirror like an intra oral camera SOPRO 595.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluorescence detector, intra oral camera
Anatomical Site
Hard dentinal tissues (dental)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physicians in dentistry
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.
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
§ 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.
0
1822
12. Summary of Safety and Effectiveness - "510(k) Summary"
- A. Submitter Information
l
i
SOPRO ZAC Athélia Avenue des Genévriers 13705 La Ciotat Cedex FRANCE
JAN 1 8 2010
Telephone: 33 (0) 442 98 01 01 Fax: 33 (0) 442 71 76 90
- Contact Person: Rick Rosati SOPRO c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Tel: 800 289-6367 Ext. 39 Fax: 856 222-4726 E-mail: Rick.Rosati@us.acteongroup.com
Date Prepared:
August 19, 2009
B. Device Identification
Classification Name:
Laser, Fluorescence Caries Detection
Common Usual Name:
DENTAL FLUORESCENCE EXAMINATION DEVICE
Proprietary Name:
SOPROLIFE
C. Identification of Predicate Device
| Device | Applicant | 510(k) No. | Date Cleared |
|---|---|---|---|
| INSPEKTOR PRO | INSPEKTOR Dental Care BV | K040063 | June 24, 2004 |
| SOPRO 595 | SOPRO | K012505 | October 5, 2004 |
The SOPROLIFE is substantially equivalent to the predicate device by INSPEKTOR DENTAL CARE BV, the INSPEKTOR PRO (K040063), and to the predicate device by SOPRO, the SOPRO 595 (K012505), which both have been previously cleared by the FDA and currently being marketed.
1
D. Device Description
The SOPROLIFE is a fluorescence caries detection device . This device is a fluorescence detector housed in a dental handpiece, and a control unit that performs device calibration, as well as variable tone emitting and fluorescence measurement functions.
The handbiece can be connected with 5 different control units : Dock M VIDEO Dock M USB2. Dock MU VIDEO, Dock MU USB2, Dock USB2.
The SOPROLIFE is a device used in clinical dental applications to observe the condition of hard dentinal tissues.
As the SOPROLIFE can be adapted to the most complex of clinical situations, it quickly helps the dentist to get a complete analysis as it adjusts treatment options in Diagnosis aid mode. In Treatment aid mode, the SOPROLIFE facilitates observation of the dentinal tissue condition in progress and at the end of the treatment. In daylight mode the SOPROLIFE enables the dentist to visualize anatomical details invisible to the naked eye or with mirror like an intra oral camera SOPRO 595.
E. Intended Use
This SOPRO product is intended to be used by qualified physicians in dentistry as an aid in the diagnosis of dental caries, and as an intra oral camera to visualize anatomical details invisible to the naked eve or with a mirror
F. Indications for use
The SOPROLIFE is indicated as an aid in the diagnosis of dental cares and as an intra oral camera to visualize anatomical details invisible to the naked eye or with mirror.
G. Substantial Equivalence
The SOPROLIFE (in Diagnosis aid mode and in Treatment aid mode) and the predicate device. INSPEKTOR PRO (K040063), are both fluorescence caries detection device for use in dentistry by qualified physicians, to aid in the diagnosis of dental caries by measuring increased induced fluorescence. The SOPROLIFE (in Daylight mode) and the predicate device SOPRO 595 (K012505) are both intra oral camera to visualize anatomical details invisible to the naked eve or with mirror.
Differences that exist between the SOPROLIFE and the predicate devices relating to technical specifications and performances are minor and do not affect the safety and effectiveness of the SOPROLIFE.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, on the right side. On the left side, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
SOPRO C/O Mr. Rick Rosati Quality Manager Acteon, Incorporated 124 Gaither Drive, Suite 140 Mount Laurel, New Jersey 08054
JAN 1 3 2010
Re: K092583
Trade/Device Name: SOPROLIFE Regulation Number: 21CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: II Product Code: NBL Dated: January 7, 2010 Received: January 8, 2010
Dear Mr. Rosati:
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.
3
Page 2- Mr. Rosati
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours,
ph for
Anthony D. Watson, BS, MS, MBA Director Division of Anesthesiology, General Hospital, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number :
Device Name: SOPROLIFE
Indications For Use :
The SOPROLIFE is indicated as an aid in the diagnosis of dental caries and as an intra oral camera to visualize anatomical details invisible to the naked eye or with mirror.
Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Keri Hulley for HSR
Division Sign-Off) Jivision Sign-Off/
vision of Anesthesiology, General Hospital rection Control, Dental Devices
510(k) Number: K 092583