(51 days)
Not Found
No
The document describes a portable X-ray unit and its basic functions, focusing on hardware and software for controlling the X-ray source. There is no mention of AI or ML in the device description, intended use, or performance studies. The software is described as "Moderate level of concern" and not based on the predicate, but this doesn't imply AI/ML.
No
The device is described as a diagnostic X-ray system intended for producing diagnostic x-ray images, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The HyperLight Portable X-ray Unit is a diagnostic X-ray system which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors." Additionally, the "Device Description" mentions it is "designed for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure".
No
The device description explicitly states it is a "handheld x-ray device" and mentions hardware components like an "x-ray source, a tube, is located inside the handheld device." While software supports the functions, it is not the primary or sole component.
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 HyperLight Portable X-ray Unit is an imaging device that uses X-rays to produce diagnostic images of the teeth, jaw, and oral structure. It does not analyze biological samples.
- Intended Use: The intended use clearly states it's for producing diagnostic X-ray images using intra-oral receptors. This is an imaging function, not an in vitro diagnostic test.
Therefore, the HyperLight Portable X-ray Unit falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The HyperLight Portable X-ray Unit is a diagnostic X-ray system which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors. Its use is intended for both adults and pediatric subjects.
Intended as extraoral x-ray sources to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians.
Product codes (comma separated list FDA assigned to the subject device)
EHD
Device Description
HyperLight Portable X-ray Unit of Changzhou Sifary Medical Technology Co., Ltd., is a handheld x-ray device. The technology of portable x-ray devices was originally developed in the 1950s and was originally designed to be used in situations where there was no access to fixed x-ray units. With new technological possiblities arising, the use of portable handheld devices are becoming more mainstream.
The subject device is designed for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure by exposing an x-ray image receptor to ionizing radiation. The x-ray source, a tube, is located inside the handheld device. All three conventional types of intraoral receptors can be used with this device-analog x-ray film, digital phosphorous plates, and digital x-ray sensors. The intraoral x-ray detectors are not part of the subject device. The functions of the HyperLight Portable device are supported by software. The software package is of Moderate level of concern and it's not based on the predicate system.
This device is used in general dentistry and is supplied with an internal timer to control the duration of the x-ray source to the patient. The handheld x-ray device is a choice model to assist doctors with special need patients, nursing home patients in the office that cannot be easily moved, as well as other special situations. The choice of an x-ray generator is a matter of functional utility in the dental operatory and personal preference by the medical professional.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Teeth, jaw, and oral structure
Indicated Patient Age Range
Adults and pediatric subjects.
Intended User / Care Setting
Trained dentists and dental technicians.
General dentistry office, nursing home, special situations where patients cannot be easily moved.
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)
Non-Clinical Performance Data:
- Electrical Safety and EMC
- Software Validation
- Biocompatibility
- Usability
- Clinical Comparison
- Risk Assessment
All tests were performed in accordance with ISO standards and tests are recognized by FDA. Conformity with all standards was determined by the device manufacturer, Changzhou Sifary Medical Technology Co., Ltd. Electrical tests performed by TÜV Rheinland (Shanghai) Co., Ltd.
The subject device was tested to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-65, IEC 62304, IEC 62366, ISO 14971, IEC 61223-3-4.
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.
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA. To the right of that is the logo for the U.S. Food & Drug Administration. The FDA logo is in blue and white.
September 1, 2023
Changzhou Sifary Medical Technology Co., Ltd. % Mr. Lee W. Strong Regulatory Dept Manager 510k FDA Inc. 156 E. Granada Blvd. ORMOND BEACH FL 32176
Re: K232068
Trade/Device Name: HyperLight Portable X-ray Unit Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: EHD Dated: July 7, 2023 Received: July 12, 2023
Dear Mr. Strong:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K232068
Device Name HyperLight Portable X-ray Unit
Indications for Use (Describe)
The HyperLight Portable X-ray Unit is a diagnostic X-ray system which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors. Its use is intended for both adults and pediatric subjects.
| 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) |
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3
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510k FDA Consulting
Medical Device Clearances
156 East Granada Blvd.
Ormond Beach, FL 32176
386-506-8711
510(k) Summary - K232068
Submitter/Applicant
Changzhou Sifary Medical Technology Co., Ltd No.99 Qingyang Road, Xuejia County, Xinbei District Changzhou, Jiangsu, China 213000
Phone: + 86-186-02591004 Contact: Tao Huan, Head of Firm (simon@sifary.com)
Date Prepared: July 10, 2023
Preparer/Consultant
510K FDA Inc. 156 East Granada Blvd. Ormond Beach, FL 32176
Phone:
386-506-8711 Fax: (386) 675-4621 Lee Strong, Regulatory Dept. Mgr (lee@510kfda.com) Primary Contact: Secondary Contacts: Claude Berthoin, CEO (claude@denterpriseintl.com).
Device Classification
| Trade/Model Names: | HyperLight Portable X-ray Unit |
|---|---|
| Common Name: | Portable X-ray System |
| Regulation Name: | Extra-oral Source X-ray System |
| Regulation Number: | 21 CFR 872.1800 |
| Primary Product Code: | EHD |
| Classification Name: | Unit, X-ray, Extraoral with Timer |
| Regulatory Class: | II |
| 510k Review Panel: | Dental |
4
Predicate Device
The subject device claims equivalence to the following legally marketed predicate:
| 510(k) Number: | K180561 |
|---|---|
| Applicant: | MobileX Portable X-ray System (Model T-100). |
| Date Cleared: | April 4, 2018 |
| Regulation Name: | Extra-oral Source X-ray System |
| Regulation Number: | 21 CFR 872.1800 |
| Primary Product Code: | EHD |
| Classification Name: | Unit, X-ray, Extraoral with Timer |
| Regulatory Class: | II |
| 510k Review Panel: | Dental |
Indications for Use
The device is a diagnostic X-ray system which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors. Its use is intended for both adults and pediatric subjects.
Intended Use
Intended as extraoral x-ray sources to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians.
Device Description
HyperLight Portable X-ray Unit of Changzhou Sifary Medical Technology Co., Ltd., is a handheld x-ray device. The technology of portable x-ray devices was originally developed in the 1950s and was originally designed to be used in situations where there was no access to fixed x-ray units. With new technological possiblities arising, the use of portable handheld devices are becoming more mainstream.
The subject device is designed for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure by exposing an x-ray image receptor to ionizing radiation. The x-ray source, a tube, is located inside the handheld device. All three conventional types of intraoral receptors can be used with this device-analog x-ray film, digital phosphorous plates, and digital x-ray sensors. The intraoral x-ray detectors are not part of the subject device. The functions of the HyperLight Portable device are supported by software. The software package is of Moderate level of concern and it's not based on the predicate system.
This device is used in general dentistry and is supplied with an internal timer to control the duration of the x-ray source to the patient. The handheld x-ray device is a choice model to assist doctors with special need patients, nursing home patients in the office that cannot be easily moved, as well as other special situations. The choice of an x-ray generator is a matter of functional utility in the dental operatory and personal preference by the medical professional.
5
Comparison of Technological Characteristics with Predicate
| Device
Characteristic | Subject Device
HyperLight Portable
X-ray Unit | Predicate Device Mobile-
X Portable X-ray System
(K180561) | Comparison |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| 510(k) Owner | Changzhou Sifary Medical
Technology Co., Ltd.
(China) | Denterprise International,
Inc.
(USA) | NA |
| Classification &
Product Code | 872.1800; EHD | 872.1800; EHD | Similar |
| Intended Use | Intended as extraoral x-ray
sources to be used with
intraoral image receptors for
diagnostic imaging by
dentists or dental
technicians. | Intended as extraoral x-ray
sources to be used with
intraoral image receptors for
diagnostic imaging by
dentists or dental
technicians. | Similar |
| Indication for Use | The device is a diagnostic
X-ray system which is
intended to be used by
trained dentists and dental
technicians as an extra-oral
X-ray source for producing
diagnostic x-ray images
using intra-oral receptors.
Its use is intended for both
adults and pediatric
subjects. | The device is a diagnostic
X-ray system, which is
intended to be used by
trained dentists and dental
technicians as an extra-oral
X-ray source for producing
diagnostic x-ray images
using intra-oral receptors.
Its use is intended for both
adults and pediatric
subjects. | Similar |
| Size | 11.85" x 4.58" x 9.97" | 6.5" x 6.0" x 10.5" | Difference of
design, size |
| Source to Skin
Distance | 20 cm | 20.5 cm | Difference .5 cm |
| Cone diameter | 5.7 cm | 6.0 cm | Difference .3 cm |
| Device
Characteristic | Subject Device
HyperLight Portable
X-ray Unit | Predicate Device Mobile-
X Portable X-ray System
(K180561) | Comparison |
| User interface | Up-down buttons for
exposure time selection
with timer display.
Additionally, several user-
selectable preset times with
patient size, and tooth
selection icons on an LCD
display. | Up-down buttons for
exposure time selection with
timer display. Additionally,
several user-selectable
preset times with patient
size, image-receptor type,
and tooth selection icons on
an LCD display. | Difference;
subject device
does not set
image-receptor
type |
| Backscatter
radiation protection | 159.5mm dia. 13mm thick
Pb-filled acrylic plastic
scatter shield | 153mm dia. 12mm thick
Pb-filled acrylic plastic
scatter shield | 6.5 mm
difference in
diameter and 1
mm difference in
thickness |
| Exposure switch | Exposure trigger at the
lower front area of the main
body or remote switch. | Exposure button at front
cover on right hand side or
remote switch. | Different
location |
| Electrical
Information | | | |
| Exposure time | 0.02 ~ 2.0 seconds
in .01-.40s increments (20
steps) | 0.01 ~ 1.3 seconds in 0.01
or 0.05 increments | Difference;
subject device
has higher
exposure time
|
| Time accuracy | ±5% or ±20ms, whichever is greater | ± (10% +1 ms) | Slight difference |
| mA | 2.5mA | 2mA | Subject has
greater mA |
| kVp | 65kVp | 70kVp | Subject has
lesser kVp |
| Waveform | Constant Potential (DC) | Constant Potential (DC) | Similar |
| Total Filtration | 1.8mmAl | 1.5mmAl | Subject has
greater Total
Filtration |
| Device
Characteristic | Subject Device
HyperLight Portable
X-ray Unit | Predicate Device Mobile-
X Portable X-ray System
(K180561) | Comparison |
| Performance
standards | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-2-65
IEC 62304
IEC 62366
ISO 14971
IEC 61223-3-4 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-2-65
IEC 62304
IEC 62366
ISO 14971 | Difference;
subject device
tested to
IEC61223-3-4 |
The following table compares technological and other characteristics of the subject and predicate device.
6
7
The above comparison shows the subject and predicate devices have substantially similar technological characteristics. Differences show up in the shape, size, design of the device and those are in cm and mm measurements of slight difference. The exposure time is slightly less with the subject device matched to the predicate. The differences of the device are minor and do not raise new issues of safety and effectiveness.
Non-Clinical Performance Data
The following performance was completed on the subject device in support of the substantial equivalence determination of the predicate device. Clinical data was not needed to support substantial equivalence.
- Electrical Safety and EMC
- Software Validation ●
- Biocompatibility ●
- Usability
- Clinical Comparison ●
- Risk Assessment ●
- . All tests were performed in accordance with ISO standards and tests are recognized by FDA.
- None of the standards were adapted for application to the device under . review.
- . There were no requirements of any standard that were not applicable to the device.
8
- No deviations from the standards were applied. ●
- No differences exist between the tested device and the device to be marketed.
- . Conformity with all standards was determined by the device manufacturer, Changzhou Sifary Medical Technology Co., Ltd
- Electrical tests performed by TÜV Rheinland (Shanghai) Co., Ltd.
Specific Guidance Document
There are three FDA Specific Guidance Documents associated with the device:
- Radiation Safety Consideration for X-ray Equipment Designed for Hand-Held . Use. This manufacturer utilized this guidance to develop this device to ensure the safety of this device for both the operators and the patients.
- . Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Details of this guidance are provided within the Software Validation Report.
- Pediatric Information for X-ray Imaging Device Premarket Notifications. The . submission includes pediatric patients in the Indications for Use and labelling.
Labels
The labels on the device show that this device conforms to the following:
21 CFR 1020 Subchapter J: Performance Standards for Ionizing Radiation Emitting Products,
21 CFR 1020.30: Diagnostic x-ray systems and their major components,
21 CFR 1020.31: Radiographic Equipment
Substantial Equivalence
The above comparison chart shows the subject and predicate devices are substantially equivalent in technological characteristics.
Both devices have:
- The same function and used in the same environment.
- The same indications for use and the same intended use. ●
- The same manufacturing process and technological characteristics. ●
- Both devices have completed the ISO standardized testing and have passed ● and the tests are in the comparison chart shown above.
9
Conclusion
The subject and predicate device have the same indications for use, the same intended use and the same technological characteristics. The HyperLight Portable X-ray Unit performs the same identical functions, in the same environment as the predicate device. HyperLight Portable X-ray Unit uses the same technology as the predicate device, based on well-known technology. HyperLight Portable X-ray Unit is as safe and effective as the predicate device. We believe the subject device does not introduce any new safety concerns and is substantially equivalent to the predicate device. In conclusion, the subject device, HyperLight Portable X-ray Unit, is at least as safe and effective as the predicate device and warrants a finding of substantial equivalence to the legally marketed device.