(97 days)
No reference devices were used in this submission.
No
The summary describes a standard X-ray source and its components. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies. The performance studies focus on electrical safety, software validation, and mechanical testing, not algorithmic performance metrics.
No
The device is described as an X-ray source intended for diagnostic imaging of body extremities and the cervical spine, not for treatment or therapy.
No.
Explanation: This device is an X-ray source, which is used to generate X-ray images. It does not interpret or analyze these images to provide a diagnosis; rather, it is a tool for image acquisition.
No
The device description explicitly lists multiple hardware components (shell case, control panel, DCDC riser, power panel, ESU energy storage capacitor, high voltage TANK, collimator, Lithium battery), indicating it is a physical medical 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 clearly states that the device is an X-ray source used for imaging body extremities and the cervical spine on patients. This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (which is the definition of an IVD).
- Device Description: The description details the components of an X-ray source, not a device for analyzing biological samples.
- Input Imaging Modality: The input is X-ray, which is an imaging modality, not a method for analyzing biological samples.
IVD devices are used to perform tests on samples like blood, urine, tissue, etc., to diagnose diseases or conditions. This device is used to generate images of the body.
N/A
Intended Use / Indications for Use
The Combined High Frequency X-ray Source is intended for use by a qualified/trained technician on both adult and pediatric subjects for body extremities and cervical spine exclusively. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
Product codes
IZL
Device Description
PSM-PD series combined high frequency X-ray source is an advanced high frequency X-ray source, which is mainly composed of shell case, control panel mounting assembly, DCDC riser mounting assembly, power panel mounting assembly, ESU energy storage capacitor mounting assembly, high voltage TANK, collimator, Lithium battery. The product is small in size, light in weight and high in power density, which can meet the needs of outdoor portability. At the same time, we provide battery-powered solutions to meet customers' diversified demands for product functions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Body extremities and cervical spine
Indicated Patient Age Range
Adult and pediatric subjects
Intended User / Care Setting
Qualified/trained technician. Not specified, but inferred from "emergency rescue occasions" and "portable" that it might be used in various settings including non-clinical environments.
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)
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the Powersite device, consisting of shell case, control panel mounting assembly, DCDC riser mounting assembly, power panel mounting assembly, ESU energy storage capacitor mounting assembly, high voltage TANK, collimator, Lithium battery. The device complies with the IEC 60601-1, IEC 60601-1-3 and IEC 60601-2-54 standards for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw in the software could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.
Mechanical and acoustic testing:
- Acoustic Testing
- Elongation of the bending cable
- Crimp assembly, cable tensile strength, cable flexibility, minimum bending radius of the cables
- Simulated use testing
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.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name reads "U.S. Food & Drug Administration".
November 1, 2022
Suzhou Powersite Electric Co., Ltd. % Xinyue Lu Regulatory Engineer Building 5, No.188 Fuchunjiang Road, Suzhou New District Suzhou. Jiangsu Province 215151 CHINA
Re: K222258
Trade/Device Name: Combined High Frequency X-ray Source Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: July 18, 2022 Received: September 6, 2022
Dear Xinyue Lu:
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,
For
Laurel Burk, 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) K22258
Device Name Combined High Frequency X-ray Source
Indications for Use (Describe)
The Combined High Frequency X-ray Source is intended for use by a qualified/trained technician on both adult and pediatric subjects for body extremities and cervical spine exclusively. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
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
510(k) Summary
510(k) Submission Number: K222258
I. SUBMITTER
Suzhou Powersite Electric Co., Ltd Building 5, No.188 Fuchunjiang Road, Suzhou New District, Suzhou, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA
Phone: +86-0512-62913368
Contact Person: Yanyan Cui Phone: +86-13771842733 E-mail: may cui@powersite-group.com
Primary correspondent Name: Xinyue Lu Title: Regulatory Engineer Phone: +86-13722611742 E-mail: xinyue lu@powersite-group.com
Date Prepared: June 15, 2022
II. DEVICE
Name of Device: Combined High Frequency X-ray Source Model: PSM-PD5.6CPL, PSM-PD5.6CPLG, PSM-PD4CPL, PSM-PD4CPLG, PSM-PD3.5CPL, PSM-PD3.5CPLG, PSM-PD5.6CPE, PSM-PD5.6CPEG, PSM-PD4CPE, PSM-PD4CPEG, PSM-PD3.5CPE, PSM-PD3.5CPEG Common or Usual Name: Combined High Frequency X-ray Source Classification Name: System, X-Ray, Mobile (21 CFR 892.1720) Regulatory Class: II Product Code: IZL Regulation Medical Specialty: Radiology
4
III. PREDICATE DEVICE
Device Classification Name: system, x-ray, mobile 510(k) Number: K103522 Device Name: SEDECAL Proprietary-Trade Name: Sedecal SPL-HF-4.0 (and SPL-HF-2.0) Common/Usual Name: Mobile Diagnostic X-Ray System Applicant: SEDECAL S.A. 8870 RAVELLO NAPLES, FL 34114 Regulation Name and Number: 21 CFR 892.1720 Device Class: 2 Classification Product Code: IZL Requlation Medical Specialty: Radiology
This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
PSM-PD series combined high frequency X-ray source is an advanced high frequency X-ray source, which is mainly composed of shell case, control panel mounting assembly, DCDC riser mounting assembly, power panel mounting assembly, ESU energy storage capacitor mounting assembly, high voltage TANK, collimator, Lithium battery. The product is small in size, light in weight and high in power density, which can meet the needs of outdoor portability. At the same time, we provide battery-powered solutions to meet customers' diversified demands for product functions.
The working flow of combined high-frequency X-ray source is as follows:
Input single-phase alternating current, through the filter circuit, reduce the influence of 1) harmonics on mains power supply, APFC circuit will change AC into DC, improve the power factor of the product, through the filter circuit to reduce AC ripple.
The DC inverter is converted into high-frequency alternating current by the inverter, and 2) the high-frequency low voltage is boosted into high-frequency high voltage by the boost transformer, and the AC is converted into high-voltage DC by the voltage multiplier, and finally the smooth high voltage is loaded at both ends of the ball tube through filtering.
-
Set different parameters and working modes through DSP+FPGA control unit.
-
Provide serial communication and wireless remote control functions.
Provide LCD operation and upper computer software control of two parameters, working 5) mode setting.
5
Our company provides Combined High Frequency X-ray Source to the complete machine manufacturer. Then the complete machine manufacturers assemble the complete machine with our product and sell the complete machine to the hospital or others.
The associated consumables include:
- . Mains power supply cord
- . Hand switch control line
- Serial port transfer wiring .
- . Fuse(0215016.MXP)
- Fuse(8020.0604) .
- . Cross countersunk head screw(SUS304, M3*6)
- Cross flat head screw(SUS304, M3*8, head diameter 6mm) .
- USB flash disk .
- Automatic test report .
V. INDICATIONS FOR USE
The Combined High Frequency X-ray Source is intended for use by a qualified/trained technician on both adult and pediatric subjects for body extremities and cervical spine exclusively. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
The Indications for Use statement for the Powersite device is not identical to the predicate device; however, the differences do not alter the intended diagnostic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use for X-ray photography of human limb joints and cervical spine in emergency rescue occasions, by cooperating with X-ray imaging device.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE
PREDICATE DEVICE
At a high level, the subject and predicate devices are based on the following same technological elements:
The working flow of combined high-frequency X-ray source is as follows:
Input single-phase alternating current, through the filter circuit, reduce the influence of 1) harmonics on mains power supply, APFC circuit will change AC into DC, improve the power
6
factor of the product, through the filter circuit to reduce AC ripple.
-
The DC inverter is converted into high-frequency alternating current by the inverter, and the high-frequency low voltage is boosted into high-frequency high voltage by the boost transformer, and the AC is converted into high-voltage DC by the voltage multiplier, and finally the smooth high voltage is loaded at both ends of the ball tube through filtering.
-
Set different parameters and working modes through DSP+FPGA control unit.
-
Provide serial communication and wireless remote control functions.
Provide LCD operation and upper computer software control of two parameters, working 5) mode setting.
7
The following technological differences exist between the subject and predicate devices:
Table 1 Comparison Table
| Comparison
item | The subject product | The predicate device(K103522) | Difference | Overview of
supporting
materials |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Common/Usual
Name of Device | Combined High Frequency X-ray Source | Mobile Diagnostic X-ray System | SE | User manual |
| Model
Specification | PSM-PD5.6CPL、PSM-PD5.6CPLG、
PSM-PD4CPL、PSM-PD4CPLG、
PSM-PD3.5CPL、PSM-PD3.5CPLG、
PSM-PD5.6CPE、PSM-PD5.6CPEG、
PSM-PD4CPE、PSM-PD4CPEG、
PSM-PD3.5CPE、PSM-PD3.5CPEG | Sedecal SPL-HF-4.0 (and SPL-HF-2.0) | SE | User manual |
| Indications for
use | The Combined High Frequency X-ray
Source is intended for use by a
qualified/trained technician on both adult
and pediatric subjects for body extremities
and cervical spine exclusively. Applications
can be performed with the patient sitting,
standing, or lying in the prone or supine
position. (Not for mammography) | Intended for use by a qualified/trained
doctor or technician on both adult and
pediatric subjects for taking diagnostic
radiographic exposures of the skull,
spinal column, chest, abdomen,
extremities, and other body parts.
Applications can be performed with the
patient sitting, standing, or lying in the
prone or supine position. (Not for
mammography) | SE | User manual |
| Basic principle
(Working | The working flow of combined high-
frequency X-ray source is as follows: | The working flow of combined high-
frequency X-ray source is as follows: | SE | User manual |
| principle / Action mechanism) | | | | |
| 1. Input single-phase alternating current,
through the filter circuit, reduce the
influence of harmonics on mains power
supply, APFC circuit will change AC into
DC, improve the power factor of the
product, through the filter circuit to reduce
AC ripple.
2. The DC inverter is converted into high-
frequency alternating current by the
inverter, and the high-frequency low voltage
is boosted into high-frequency high voltage
by the boost transformer, and the AC is
converted into high-voltage DC by the
voltage multiplier, and finally the smooth
high voltage is loaded at both ends of the
ball tube through filtering.
3. Set different parameters and working
modes through DSP+FPGA control unit.
4. Provide serial communication and
wireless remote control functions.
5. Provide LCD operation and upper
computer software control of two
parameters, working mode setting. | 1. Input single-phase alternating current,
through the filter circuit, reduce the
influence of harmonics on mains power
supply, APFC circuit will change AC into
DC, improve the power factor of the
product, through the filter circuit to
reduce AC ripple.
2. The DC inverter is converted into
high-frequency alternating current by the
inverter, and the high-frequency low
voltage is boosted into high-frequency
high voltage by the boost transformer,
and the AC is converted into high-
voltage DC by the voltage multiplier, and
finally the smooth high voltage is loaded
at both ends of the ball tube through
filtering.
3. Set different parameters and working
modes through DSP+FPGA control unit.
4. Provide serial communication and
wireless remote control functions.
5. Provide LCD operation and upper
computer software control of two
parameters, working mode setting. | Difference:
- The structure | User manual | |
| Structural composition | Combined High Frequency X-ray Source | The predicate device consists of the | | |
| | product consists of the control software
(Release version: V1.0) and the host of
Combined High Frequency X-ray Source.
The host of Combined High Frequency X-ray Source is mainly composed of shell case, control panel mounting assembly, DCDC riser mounting assembly, power panel mounting assembly, ESU energy storage capacitor mounting assembly, high voltage TANK, collimator, Lithium battery. | control software and the host of
Combined High Frequency X-ray Source.
The host of the predicate device is composed of a control panel with a display, a power module, a high voltage tank (TANK), a collimator, a handswitch, and a mobile column with an articulated arm and a cassette basket. | composition is
different. The
predicate device is
accompanied with a
mobile column with
articulated arm and
cassette basket,
which the subject
device does not
have. | |
| Basic parameter | 1. AC power input
100V240VAC, ±10%240VAC, ±10% VAC,
50Hz/60Hz±1Hz | 1. AC power input
100
50/60Hz | | User manual |
| | 2. DC power input
48VDC/2A | 2. DC power input
48VDC/2A | | |
| | | | | |
8
9
10
| 3. Maximum nominal electrical power
PSM-PD3.5CPL/CPLG
PSM-PD3.5CPE/CPEG
PSM-PD4CPL/CPLG
PSM-PD4CPE/CPEG
PSM-PD5.6 CPL/CPLG
PSM-PD5.6CPE/CPEG | 3.2kW
4.0kW
5.6kW | 3. Maximum nominal electrical power
SPL-HF4: 4kW |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4. Maximum output electric power
PSM-PD3.5CPL/CPLG
PSM-PD3.5CPE/CPEG
PSM-PD4CPL/CPLG
PSM-PD4CPE/CPEG
PSM-PD5.6 CPL/CPLG
PSM-PD5.6CPE/CPEG | 3.6kW
4.0kW
5.6kW | 4. Output power:
SPL-HF4: 4kW |
| | | Difference:
2) The maximum nominal electric power and the maximum output electric power are different. The maximum nominal electric power and the maximum output electric power in the model declared by the subject device are 5.6kW. While the maximum nominal electric power and the maximum output electric power in the model declared by the predicate device are 4kW. |
11
| Normal
operating
condition | 1. Temperature:
035°C (AC supply )40°C (only for battery discharging)
0
2. Relative humidity:
95%, non-condensing;
3. Atmospheric pressure:
700hPa1060hPa. | 1. Temperature:40°C
0
2. Relative humidity:
95%, non-condensing;
3. Atmospheric pressure:
700hPa1060hPa. | SE | User manual | | | | | | | | |125kV, 1kV step size, tube voltage
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|----|-------------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|-------------|
| Performance
requirements | 1. X-ray tube voltage
a) Tube voltage regulation range:
40kV
can be set according to power.
Model Tube voltage
regulation
range PSM-PD5.6CPL/CPLG
PSM-PD5.6CPE/CPEG
PSM-PD4CPL/CPLG
PSM-PD4CPE/CPEG
PSM-PD3.5CPL/CPLG 40kV125kV | | | | | 1. X-ray tube voltage125kV, 1kV step size.
a) Tube voltage regulation range:
40
Model Tube voltage
regulation range SPL-HF4 40~125kV
b) Tube voltage deviation: ±(3%+1kV) | | | | | | User manual |
12
PSM-PD3.5CPE/CPEG | ||||
---|---|---|---|---|
b) Tube voltage deviation: | ||||
$\pm$ (3%+1kV) | ||||
2. X-ray tube current | ||||
a) Tube current regulation range | 2. X-ray tube current | |||
a) Tube current regulation range | Difference: | |||
Model | Tube current | |||
regulation | ||||
range | Model | Tube current | ||
regulation range | 3) The number systems | |||
of tube current, | ||||
loading time and | ||||
current time product | ||||
are different. The | ||||
subject device is | ||||
distributed according | ||||
to the R'20 number | ||||
system, and the | ||||
predicate device is | ||||
distributed according | ||||
to the R'10 number | ||||
system and the user- | ||||
defined number | ||||
system. | ||||
PSM-PD3.5CPL/CPLG | 5-63mA | SPL-HF4 | 5~100mA | |
PSM-PD3.5CPE/CPEG | 16 steps, the specific data are: 5, 6.4, 8, | |||
10, 12.5, 16, 20, 25, 32, 40, 50, 64, 80, | ||||
100 mA | ||||
PSM-PD4CPL/CPLG | 5-80mA | |||
PSM-PD4CPE/CPEG | ||||
PSM-PD5.6CPL/CPLG | 5-100mA | b) Tube current deviation: |
13
PSM-PD5.6CPE | $\pm(4% + 1 mA)$ | |
---|---|---|
Increasing according to the number system |
R'20, the specific data are 5、5.6、6.3、
7.1、8、9、10、11、12.5、14、16、18、
20、22、25、28、32、36、40、45、50、
56、63、71、80、90、100。
b) Tube current deviation:
$\pm(4% + 1 mA)$ | | |
| | | |
| 3. Loading time
a) Loading time regulation range:
1ms~10000ms,
Increasing according to the number system
R'20, the specific data are 1、1.1、1.25、
1.4、1.6、1.8、2、2.2、2.5、2.8、3.2、 | 3. Loading time
a) Loading time regulation range:
1 ms~10000ms,
Increase according to the number
system R'10 (in 25% steps), for a total of
41 steps | Difference:
4) The loading time
deviation is different.
The loading time
deviation of the
subject device is
larger than that of the
predicate device. The |
| 3.6、4、4.5、5、5.6、6.3、7.1、8、9、
10、11、12.5、14、16、18、20、22、
25、28、32、36、40、45、50、56、63、
71、80、90、100、110、125、140、
160、180、200、220、250、280、320、
360、400、450、500、630、710、800、
900、1000、1100、1250、1400、1600、
1800、2000、2200、2500、2800、3200、
3600、4000、4500、5000、6300、7100、
8000、900、10000; | b) Loading time deviation:
$\pm$ (2% + 0.1ms) | deviation of the
subject device is
controlled within the
scope of the
international
standard
requirements. |
| b) Loading time deviation:
not greater than
$\pm$ (2%+0.2ms) @ >5ms
$\pm$ (5%+1ms) @ ≤5ms | | |
14
15
| 4. Current time product
a) Current time product regulation range: | 4. Current time product
a) Current time product regulation range: | Difference:
5) The regulation range of current time product is different. The regulation range of current time product of the subject device is larger than that of the predicate device. | | | | | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|
| Model Current time product regulation range PSM-
PD3.5CPL/CPLG
PSM-
PD3.5CPE/CPEG
PSM-
PD4CPL/CPLG
PSM-
PD4CPE/CPEG
PSM-
PD5.6CPL/CPLG
PSM-
PD5.6CPE/CPEG 0.1-320mAs | | | | | Model Current time product regulation range SPL-HF4 0.1 mAs ~ 250 mAs Increase according to the number
system R'10 (in 25% steps), a total of 34 steps
b) Current time product deviation:
$\pm$ (5% + 0.1 mAs) | | | | | |
16
Increasing according to the number system | ||
---|---|---|
R'20, the specific data are 0.1、0.11、 | ||
0.12、0.14、0.16、0.18、0.2、0.22、 | ||
0.25、0.28、0.32、0.4、0.45、0.5、 | ||
0.56、0.63、0.71、0.8、0.9、1、1.1、 | ||
1.25、1.4、1.6、1.8、2、2.2、2.5、2.8、 | ||
3.2、3.6、4、4.5、5、5.6、6.3、7.1、8、 | ||
9、10、11、12.5、14、16、18、20、22、 | ||
25、28、32、36、40、45、50、56、63、 | ||
71、80、90、100、110、125、140、 | ||
160、180、200、220、250、280、320。 | ||
b) Current time product deviation: | ||
± (5% + 0.1 mAs) | ||
5. Operating frequency: | 5. Operating frequency: | |
Maximum operating frequency | Maximum operating frequency | |
300kHz±20kHz | 300kHz |
17
| Functional
requirements | 1. Exposure technology mode
The device should have mA/ms, mAs,
mAs/ms modes.
2. Fault diagnosis and prompt
- During the exposure process, release the
handbrake actively, and an error should be
prompted. - If the internal temperature of the oil tank
of the combined head exceeds the limit, an
error should be prompted. | 1. Exposure technology mode
The device should have mA/ms, mAs
modes.
- Fault diagnosis and prompt
All filament currents display values.
When the range is exceeded, the
exposure is not allowed, a continuous
alarm will sound and the value on the
display will flash. | SE | User manual | |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-------------|
| | Electrical safety | Shall comply with the requirements of IEC
60601-1 and IEC 60601-2-54. | Shall comply with the requirements of
IEC 60601-1 and IEC 60601-2-54. | SE | User manual |
| | EMC | Shall comply with the requirements of IEC
60601-1-2. | Shall comply with the requirements of
IEC 60601-1-2. | SE | User manual |
| | Software
requirements | 1. Basic data configuration - Exposure parameter setting | 1. Basic data configuration
- Exposure parameter setting | SE | User manual |
| | | | | | |
| | It should be able to operate the software to
set the exposure mode, filament, tube
voltage, tube current, loading time and
current time product. - Information indication and fault prompt | It should be able to operate the software
to set the exposure mode, filament, tube
voltage, tube current, loading time and
current time product. - Information indication and fault
prompt | | | |
| Cybersecurity
requirements | Data interface:
There is an RS-232 output interface, and
the RS-232 interface is used for the
communication between the Combined
High Frequency X-ray Source and the
control software of the client X-ray imaging
device to meet the interactive information. | None | Difference:
- Cybersecurity
requirements are
different. The subject
device have been
tested and evaluated
for cybersecurity. We
have not found
information related to
cybersecurity about
the predicate device. | | |
| | | | | User manual | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| Sterilization /
disinfection
method | Not applicable | Not applicable | Neither
sterilization/disinfection is
required. | / | |
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There are 6 differences in comparison items between the subject device and the predicate device of the same type of medical devices:
No. | Different item | Difference description | Detailed description |
---|---|---|---|
1 | Structural | ||
composition | The predicate device | ||
is accompanied with a | |||
mobile column with | |||
articulated arm and | |||
cassette basket, which | |||
the subject device | |||
does not have. | The subject device is an X-ray source which is a | ||
component of the X-ray system and does not | |||
require a mobile column with an articulated arm and | |||
a cassette basket. We sell the subject device to the | |||
complete machine manufacturers, and they might | |||
provide a mobile column with an articulated arm | |||
and a cassette basket, or other accessories | |||
according to their own needs. | |||
2 | Basic | ||
parameter | The maximum nominal | ||
electric power and the | |||
maximum output | |||
electric power in the | |||
model declared by the | |||
subject device are | |||
5.6kW. While the | |||
maximum nominal | |||
electric power and the | |||
maximum output | |||
electric power in the | |||
model declared by the | |||
predicate device are | |||
4kW. | The subject device has more models and various | ||
powers. There is only one model of the predicate | |||
for comparison, and the power data is single. The | |||
range of the subject device applied for is wider and | |||
applicable to more places and body parts. | |||
3 | Performance | ||
requirements | The number systems | ||
of tube current, loading | |||
time and current time | |||
product are different. | The distribution of the subject device is more than | ||
that of the predicate device, and the radiation dose | |||
received by patients is more accurate, so as to | |||
avoid the adverse impact of useless dose on | |||
The subject device is | |||
distributed according | |||
to the R'20 number | |||
system, and the | |||
predicate device is | |||
distributed according | |||
to the R'10 number | |||
system and the user- | |||
defined number | |||
system. | patients. | ||
The loading time | |||
deviation of the subject | The irradiation time of the subject device is 0.1ms | ||
longer than that of the predicate device during one | |||
device is larger than | |||
that of the predicate | |||
device. The deviation | |||
of the subject device is | exposure, which has no effect on the radiation dose | ||
received by the human body. The performance | |||
indicators of the subject device have been verified | |||
by third-party registration testing and meet the | |||
4 | controlled within the | ||
scope of the | |||
international standard | |||
requirements. | |||
5 | The current time product range of the subject | ||
device is larger than that of the predicate device, | |||
The regulation range | and is applicable to a wider range of patient groups, | ||
of current time product | body parts and places. The performance indicators | ||
of the subject device is | of the subject device have been verified by third- | ||
larger than that of the | party registration testing and meet the requirements | ||
predicate device. | of IEC 60601-1 and IEC 60601-2-54. This | ||
difference does not adversely affect the safety and | |||
efficacy of the product. | |||
The control software of the subject device is | |||
6 | Cybersecurity | ||
requirements | The subject device | ||
have been tested and | |||
evaluated for | |||
cybersecurity. We | |||
have not found | |||
information related to | |||
cybersecurity about | |||
the predicate device. | installed on the general computer platform and | ||
configured by the user. The user manual provides | |||
instructions for the installation, operation, | |||
uninstallation and other use of the control software. | |||
The software functions and cybersecurity | |||
requirements have been verified by internal tests | |||
and third-party registration tests to meet the | |||
requirements of clinical application of the product, | |||
which will not adversely affect the safety and | |||
effectiveness of the product. |
Table 2 Comparative Analysis
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Through the above comparative analysis, the differences between Combined High Frequency X-ray Source of our company and the predicate device will not affect the safety and effectiveness of the product.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
N/A.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Powersite device, consisting of shell case, control panel mounting assembly, DCDC riser mounting assembly, power panel mounting assembly, ESU energy storage capacitor mounting assembly, high voltage TANK, collimator, Lithium battery. The device complies with the IEC 60601-1, IEC 60601-1-3 and IEC 60601-2-54 standards for safety and the IEC 60601-1-2 standard for EMC.
22
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw in the software could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.
Mechanical and acoustic testing
- · Acoustic Testing
- · Elongation of the bending cable
· Crimp assembly, cable tensile strength, cable flexibility, minimum bending radius of the cables
· Simulated use testing
Animal Study
N/A.
Clinical Studies
Clinical images are not necessary to demonstrate substantial equivalence, based on the nature of the device (an x-ray generator) and on close similarities to the predicate system. Successful Bench Testing results should be sufficient to show device safety and effectiveness.
Summarv
Based on the basic principle, intended use, performance parameters, operating environment, etc, Powersite Combined High Frequency X-ray Source was found to have a safety and effectiveness profile that is similar to the predicate device.
VIII. CONCLUSIONS
Since the subject device is an integral part of the X-ray imaging system, and similar products are mature and clinical-free products, substantial equivalence can be supported by comparing the basic principles, intended use, performance parameters, operating environment, etc. The
23
safety of the device is supported by non-clinical data, hardware and software verification and validation indicate that Powersite Combined High Frequency X-ray Source should perform as intended under the specified conditions of use. The performance of Powersite Combined High Frequency X-ray Source is equivalent to that of similar devices for the same intended use sold on the market at present.