(22 days)
Not Found
No
The document describes a digital X-ray sensor and its physical characteristics, focusing on image acquisition and ergonomics. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
Explanation: The device is described as a "digital sensor which is indicated for acquiring dental intra-oral radiography images." It is used for image acquisition and does not provide any treatment or therapy.
Yes
The device is indicated for "acquiring dental intra-oral radiography images," which serve as a basis for diagnosis by healthcare professionals. While the device itself doesn't interpret the images, it provides the primary data for diagnosis.
No
The device description explicitly states that the FS Ergo is a "USB-driven sensor designed to capture intraoral digital dental x-ray images" and describes its physical features and components (sensor unit, sensor holders, hygienic covers, cable). This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to acquire dental intra-oral radiography images. This is a medical imaging device used for diagnostic purposes, but it does not involve testing samples taken from the human body in vitro (outside the body).
- Device Description: The device is a digital sensor that captures X-ray images. This aligns with medical imaging, not in vitro diagnostics.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
The device is clearly a medical imaging device used for diagnostic purposes, but it falls under the category of radiology or medical imaging equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The FS Ergo sensor is a digital sensor which is indicated for acquiring dental intra-oral radiography images. The FS Ergo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intraoral radiographs.
Product codes (comma separated list FDA assigned to the subject device)
MUH
Device Description
The FS Ergo is a USB-driven sensor designed to capture intraoral digital dental x-ray images. FS Ergo can be used with any X-ray units intended for dental intraoral purposes. When connected to a computer with an appropriate image capturing software application, images are automatically acquired when the FS Ergo sensor receives a perceptible X-ray dose. The FS Ergo sensor is designed with advanced ergonomic principles. It has a bendable sensor housing together with other physical features supporting advanced erqonomics: small diameter flexible cable, 32 degrees' cable exit and sensor dimensions that fit all needs (size 1.5). Comfort is achieved in with large corner chamfers, rounded edges, and thicker sensor structure.
The basic system of the FS Ergo consists of senor unit, sensor holders and hygienic covers (which are medical devices separately cleared by the FDA). A connection to a computer is required but the computer is provided by the users e.q. the computer is not part of the sensor system itself.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Dental intra-oral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals, who are educated and competent to perform the acquisition of dental intraoral radiographs.
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)
Bench test images of skull phantoms were acquired using FS Ergo sensor, the images were reviewed by qualified external clinician to be of acceptable quality for the proposed intended use. Bench testing for the FS Ergo sensor was performed as recommended by the FDA's Guidance for the Submission of 510(k)s for Solid State X-Ray Imaging Devices. Bench testing results indicate substantial equivalence to the predicate device Snapshot.
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
§ 872.1800 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.
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December 19, 2017
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
PaloDEx Group Oy % Anni Lundholm Regulatory Manager Nahkelantie 160 Tuusula 04300 FINLAND
Re: K173646
Trade/Device Name: FS Ergo Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: November 10, 2017 Received: November 27, 2017
Dear Anni Lundholm:
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 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
1
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert Oolo
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K173646
Device Name FS Ergo
Indications for Use (Describe)
The FS Ergo sensor is a digital sensor which is indicated for acquiring dental intra-oral radiography images. The FS Ergo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intraoral radiographs.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
December 19, 2017
510(k) SUMMARY for FS Ergo
Submitter Information
| Name: | Palodex Group Oy |
|---|---|
| Address: | Nahkelantie 160 |
| FI-04300 Tuusula | |
| Finland | |
| Contact Person: | Anni Lundholm |
| Email: | regulatory@kavokerr.com |
| Telephone Number: | +358 10 270 2000 |
| Fax Number: | +358 10 270 2230 |
Device Name
Proprietary Name: FS Ergo Common Name: Digital intraoral sensor system Classification Name: System, X-Ray, Extraoral source, Digital FDA CDRH Panel: Radiology Product Code: MUH Requlation Number: 21 CFR 872.1800 Device Class: Class 11
Primary Predicate Device
| Proprietary Name: | Snapshot |
|---|---|
| 510(k) Number: | K081925 |
| Manufacturer: | Instrumentarium Dental, PaloDEX Group Oy |
| Regulation Number: | 21 CFR 872.1800 |
| Regulation Name: | Extraoral source x-ray system |
| Product Code: | MUH |
| Device Class: | II |
Reference Predicate Device
| Proprietary Name: | EzSensor Soft (EzSensor Soft, EzSensor Soft i, EzSensor Bio and EzSensor Bio I) | ||
|---|---|---|---|
| 510(k) Number: | K151707 | ||
| Manufacturer: | Rayence Co., Ltd. | ||
| Regulation Number: | 21 CFR 872.1800 | ||
| Regulation Name: | Extraoral source x-ray system | ||
| Product Code: | MUH | ||
| Device Class: | II |
Description of the Device
The FS Ergo is a USB-driven sensor designed to capture intraoral digital dental x-ray images. FS Ergo can be used with any X-ray units intended for dental intraoral purposes. When connected to a computer with an appropriate image capturing software application, images are automatically acquired when the FS Ergo sensor receives a perceptible X-ray dose. The FS Ergo sensor is designed with advanced ergonomic principles. It has a bendable sensor housing together with other physical
4
features supporting advanced erqonomics: small diameter flexible cable, 32 degrees' cable exit and sensor dimensions that fit all needs (size 1.5). Comfort is achieved in with large corner chamfers, rounded edges, and thicker sensor structure.
The basic system of the FS Ergo consists of senor unit, sensor holders and hygienic covers (which are medical devices separately cleared by the FDA). A connection to a computer is required but the computer is provided by the users e.q. the computer is not part of the sensor system itself.
Indications for Use
The FS Ergo sensor is a digital sensor which is indicated for acquiring dental intra-oral radiography images. The FS Ergo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intraoral radiographs.
Description of Substantial Equivalence
The substantial equivalence of the FS Ergo is demonstrated by two predicate devices: primary predicate device Snapshot cleared under K081925 and manufactured by Instrumentarium Dental, Palodex Group Oy and secondary predicate device EzSensor Soft cleared under K151707 and manufactured by Rayence Co., Ltd. Indications for use of the FS Erqo and the predicate devices Snapshot (K081925) and EzSensor Soft (K151707) are not identical but they include the same fundamental elements of producing x-ray radiography images for professional use.
Snapshot (K081925) is the primary predicate device since its technological characteristics is most similar to the FS Ergo. EzSensor Soft (K151707) is the secondary predicate device since its structure (sensor head) is soft like the FS Ergo. EzSensor Soft is not, however, available for technical testing and image quality comparison.
Technical characteristics of the FS Ergo sensor and the predicate devices Snapshot cleared under K081925 and EzSensor Soft cleared under K151707 are described in the table 7-1 below.
| Characteristics | Primary Predicate Device
Snapshot
(K081925) | Secondary Predicate Device
EzSensor Soft
(K151707) | Subject Device
FS Ergo |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Snapshot is
intended to be used
by dentists and
other qualified
professional for
producing diagnostic
x-ray radiographs of
definition, jaws and
other oral
structures. | EzSensor Soft,
EzSensor Soft i,
EzSensor Bio and
EzSensor Bio i
Digital Dental Intra
Oral Sensors are
intended to collect
dental x-ray
photons and convert
them into electronic | The FS Ergo sensor
is a digital sensor
which is indicated
for acquiring dental
intra-oral
radiography images.
The FS Ergo sensor
shall be operated by
healthcare
professionals, who |
Table 7-1. Significant characteristics comparison table.
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| Characteristics | Primary Predicate
Device
Snapshot
(K081925) | Secondary
Predicate Device
EzSensor Soft
(K151707) | Subject Device
FS Ergo |
|------------------------------------------|------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| | | impulses that may
be stored, viewed
and manipulated for
diagnostic use by
dentists. | are educated and
competent to
perform the
acquisition of dental
intraoral
radiographs. |
| Sensor type | Intra-oral | Intra-oral | Intra-oral |
| Sensor
Dimensions
(mm) | Size 1: 37 x 26
Size 2: 42 x 31 | Size 1.0: 38 x 27
Size 1.5: 41 x 31
Size 2.0: 44 x 33 | Size 1.5: 40 x 30 |
| Sensor
Thickness (mm) | 12 | 5.5 | 8.5 |
| Sensor Shape | Rectangular, four
rounded corners | Rectangular, four
rounded corners | Rectangular, four
rounded corners |
| Resolution –
Pixel Size ( μm) | 19 x 19 | 14.8 x 14.8 | 17 x 17 |
| Theoretical
Resolution | 26.3 lp/mm | 33.78 lp/mm | 29.4 lp/mm |
| Sensor Active
Area (mm) | Size 1: 30 x 20
Size 2: 36 x 26 | Size 1.0: 30 x 20
Size 1.5: 33 x 24
Size 2.0: 36 x 26 | Size 1.5: 32 x 25 |
| Sensor Housing | Rigid, polyamide
(PA) | Soft, silicone with
urethane coating | Soft, silicone with
urethane coating |
| Connection to
PC | USB 2.0 | USB 2.0 | USB 2.0 |
| Electrical Rating | 5 Vdc / 500 mA | 5 Vdc / 500 mA | 5 Vdc / 500 mA |
| IP Classification | Sensor: IP67 | Sensor: IP68 | Sensor: IP68 |
| Mode of
Operation | Continuous mode | Continuous mode | Continuous mode |
| Electrical Safety | IEC 60601-1:1998 | IEC 60601-1:2015 | IEC 60601-1:2015 |
Principle of Operation
The FS Ergo sensor is automatically powered when connected to the USB port on a workstation. No power switch is needed. User activates image capturing from an image capturing software installed on the connected workstation. The sensor detects x-ray exposure automatically and transfers the image to the software without additional user interaction. The FS Ergo can be used with any x-ray units intended for dental intraoral purposes in the range of 60 to 70 kV and at minimal 40 µGy incident dose.
After transmitting the image, the sensor is ready for the next exposure. A full mouth s series of image can be easily captured by sequentially activating the sensor from the software application. Image capture session can be terminated from the software application.
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Non-Clinical Performance Data
The FS Ergo sensor has successfully passed internal design verification and validation.
Electrical, mechanical, safety and performance testing according to standards IEC 60601-1:2005, IEC 60601-1-6:2013, IEC 62366:2014 and IEC 62304:2006 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2:2014. Testing was completed by 3rd party test house, and the FS Ergo sensor has passed all tests.
Biocompatibility evaluation was conducted on patient contacting accessory parts and the materials. The parts are found to be in conformance with ISO 10993-1:2009.
Bench test images of skull phantoms were acquired using FS Ergo sensor, the images were reviewed by qualified external clinician to be of acceptable quality for the proposed intended use. Bench testing for the FS Ergo sensor was performed as recommended by the FDA's Guidance for the Submission of 510(k)s for Solid State X-Ray Imaging Devices. Bench testing results indicate substantial equivalence to the predicate device Snapshot.
Clinical Performance Data
Clinical data was not needed to support substantial equivalence.
Conclusion as to Substantial Equivalence
Based on the substantial equivalence comparison of intended use, design, technological characteristics, performance, labeling, biocompatibility, standards, and other characteristics, there are no significant differences found between the FS Ergo and the predicate devices Snapshot (cleared under K081925) and EzSensor Soft (cleared under K151707). Minor differences have not been shown to raise new concerns for the proposed indications for use.
The device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantially equivalent to the predicate device. All internal verification and validation has been completed successfully.
In summary, FS Ergo sensor described in this submission is substantially equivalent to the Snapshot (cleared under K081925) and the EzSensor Soft (cleared under K151707) and satisfies all criteria of substantial equivalence.