(268 days)
No
The description focuses on the hardware components and fixed operational parameters of a portable X-ray system, with no mention of AI, ML, or advanced image processing beyond basic X-ray generation and control.
No
The device is an X-ray system used for generating images for diagnosis, not for therapy or treatment.
Yes
The device description explicitly states: "It uses X light source to produce X-ray images of human anatomical structures for diagnosis." This directly indicates its use in diagnostic processes.
No
The device description explicitly lists multiple hardware components, including an X-ray module, oscillating circuit board, control board, beam limiting device, LCD screen, extension wire control, and rechargeable battery. It is a physical X-ray system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The ERI Portable X-ray System is an imaging device that produces X-ray images of the human body (specifically extremities) for diagnostic purposes. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for producing X-ray images of extremities using CR or DR detectors. This is a form of medical imaging, not in vitro testing.
Therefore, the ERI Portable X-ray System falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
ERI Portable X-ray System is a portable x-ray source with a fixed tube current and voltage for producing x-ray images of extremities using computed radiography (CR) detection plate or digital radiography (DR) detector, and the applicable objects are adults. This product is for use by qualified personnel.
It is not intended to replace a radiographic system with variable tube current and voltage (kVp) which may be required for full optimization of image quality and radiation exposure for different exam types.
Product codes
IZL
Device Description
ERI Portable X-ray System generates and controls X-ray with a fixed tube current and voltage (kV). It uses X light source to produce X-ray images of human anatomical structures for diagnosis, and the applicable objects are adults. It operates on 14.4VDC supplied by a rechargeable Lithium-Ion Polymer battery pack.
The ERI Portable X-ray System, is a portable x-ray device that comes in three models: CVX-air, CVX-lite and CVX-E. The differences is as follows:
- Diversity Description: CVX-air, CVX-lite, CVX-E
- X-ray tube voltage: 70kV, 67 kV, 60 kV
- X-ray tube current: 1mA, 0.8mA, 0.6mA
- Power Consumption: 70 W, 53.6 W, 36W
- Others are the same as CVX-air
The main model and series models have the same internal and external appearance, only the X-ray irradiation parameter settings are different.
The X-ray tube head, X-ray controls and power source are assembled in a portable case. The ERI Portable X-ray System is comprised of the following components:
- (1) X-ray module
- (2) Oscillating circuit board
- (3) Control board
- (4) Beam limiting device
- (5) LCD screen
- (6) Extension wire control
- (7) rechargeable battery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
extremities, human anatomical structures
Indicated Patient Age Range
adults
Intended User / Care Setting
qualified personnel
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)
The ERI Portable X-ray System has undergone comprehensive non-clinical design verification and validation testing, including assessments of Electrical Safety and performance. The results confirm that the device's design is appropriate and effective for its intended use. Additionally, clinical trials were conducted to compare the imaging results of the ERI Portable X-ray System with those obtained from commercially available X-ray devices. These trials demonstrated that the image quality produced by the ERI system is on part with that of the comparison devices, supporting its substantial equivalence as a portable X-ray system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
September 20, 2024
Energy Resources International Co., Ltd. % Pearl Tsai QA & RA Specialist 2F .- 5, No.6-1, Sec.2, Shengyi Rd., Zhubei City Hsinchu County, 302058 TAIWAN
Re: K234108
Trade/Device Name: ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: December 22, 2023 Received: December 27, 2023
Dear Pearl Tsai:
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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
2
assistance/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 Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite);
ERI Portable X-ray System (CVX-E)
Indications for Use (Describe)
ERI Portable X-ray System is a portable x-ray source with a fixed tube current and voltage for producing x-ray images of extremities using computed radiography (CR) detection plate or digital radiography (DR) detector, and the applicable objects are adults. This product is for use by qualified personnel.
It is not intended to replace a radiographic system with variable tube current and voltage (kVp) which may be required for full optimization of image quality and radiation exposure for different exam types.
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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4
The assigned 510(K) number: K234108 Date Prepared: 07/22/2024
Submitter Information I.
Submitter: ENERGY RESOURCES INTERNATIONAL CO., LTD. Address: 2F .- 5, No.6-1, Sec.2, Shengvi Rd., Zhubei City, Hsinchu County 302058, Taiwan (R.O.C) Phone Number: +886-3-6585156 Fax Number: +886-3-6585802
Primary Contact Person: Pearl Tsai Email: pearl.tsai@eriray.com Phone Number: +886-3-6585156 ext.112 Fax Number: +886-3-6585802
Secondary Contact Person: Robert Yang
Email: robert@eriray.com Phone Number: +886-3-6585156 ext.100
Fax Number: +886-3-6585802
Subject Device II.
Trade Name: ERI Portable X-ray System (CVX-air),
ERI Portable X-ray System (CVX-lite),
ERI Portable X-ray System (CVX-E)
Model: CVX-air, CVX-lite, and CVX-E
Common Name and Classification:
| No. | Product
Code | Common Name | Regulator
y Class | Regulation Number | Panel |
|-----|-----------------|---------------------|----------------------|-------------------|-----------|
| 1 | IZL | Mobile x-ray system | II | 21 CFR 892.1720 | Radiology |
III. Predicate Device
| Predicate Device | |||
|---|---|---|---|
| Subject Device | Predicate Device | Submitter/510(k) | |
| Holder | 510(k) Number | ||
| EZER Portable X-ray System | Livermoretech | K193535 |
IV. Device Description
ERI Portable X-ray System generates and controls X-ray with a fixed tube current and voltage (kV). It uses X light source to produce X-ray images of human anatomical structures for diagnosis, and the applicable objects are adults. It operates on 14.4VDC supplied by a rechargeable Lithium-Ion Polymer battery pack.
The ERI Portable X-ray System, is a portable x-ray device that comes in three models: CVX-air, CVX-lite and CVX-E. The differences is as follows:
5
| Diversity Description | Main Model | Series Model | |
|---|---|---|---|
| CVX-air | CVX-lite | CVX-E | |
| X-ray tube voltage | 70kV | 67 kV | 60 kV |
| X-ray tube current | 1mA | 0.8mA | 0.6mA |
| Power Consumption | 70 W | 53.6 W | 36W |
| Others are the same as CVX-air | |||
| The main model and series models have the same internal and external appearance, only the |
| X-ray irradiation parameter settings are different
The X-ray tube head, X-ray controls and power source are assembled in a portable case. The ERI Portable X-ray System is comprised of the following components:
- (1) X-ray module
- (2) Oscillating circuit board
- (3) Control board
- (4) Beam limiting device
- (5) LCD screen
- (6) Extension wire control
- (7) rechargeable battery.
V. Indications for Use
ERI Portable X-ray System is a portable x-ray source with a fixed tube current and voltage for producing x-ray images of extremities using computed radiography (CR) detection plate or digital radiography (DR) detector, and the applicable objects are adults. This product is for use by qualified personnel.
It is not intended to replace a radiographic system with variable tube current and voltage (kVp) which may be required for full optimization of image quality and radiation exposure for different exam types.
VI. Comparison of Technology Characteristics with the Predicate Device
Energy Resources International claims that the ERI Portable X-ray System is substantially equivalent to the EZER Portable X-ray System cleared by the FDA in K193535. Energy Resources International claims substantial equivalence because the CVX-air, CVX-lite and CVX-E has a similar intended use, operating principles, and operational specifications as compared to the predicate device.
The specific details regarding the similarities and differences between the ERI Portable X-ray System and EZER Portable X-ray System have been identified and explained in the Comparison Table, see table below. A summary of these similarities and differences is included below. These differences do not present any new issues related to safety and effectiveness.
| Device name | EZER Portable X-ray System
(Predicate Device: K193535) | ERI Portable X-ray System
(Proposed Device) |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification,
regulation
number, product
code | Mobile x-ray system,
21 CFR 892.1720,
IZL | Mobile x-ray system,
21 CFR 892.1720,
IZL |
| Indications for
Use/Intended
Use | EZER Portable X-Ray system is a
portable x-ray source with a fixed
tube current and voltage for
producing diagnostic x-ray images
of extremities using digital or film
image receptors. Its use is
intended to be used by trained
clinician or technicians for both
adult and pediatric subjects age 2
and above.
It is not intended to replace a
radiographic system with variable
tube current and voltage (kVp)
which may be required for full
optimization of image quality and
radiation exposure for different
exam types. | ERI Portable X-ray System is a
portable x-ray source with a fixed
tube current and voltage for
producing x-ray images of
extremities using computed
radiography (CR) detection plate or
digital radiography (DR) detector,
and the applicable objects are
adults. This product is for use by
qualified personnel.
It is not intended to replace a
radiographic system with variable
tube current and voltage (kVp)
which may be required for full
optimization of image quality and
radiation exposure for different
exam types. |
| TECHNOLOGICAL | | |
| Size: Body | 9.2" L x 6.4" W x 4.6" H | 147(H)×211.1(W)×161.7(D) mm |
| Weight | 2.6 kg | 3.2 kg |
| Source to skin
distance | 30 cm | 45 cm |
| Focal Spot | 1.2 mm | 0.45 mm |
| Collimator | Four manually and steplessly
adjustable shutters with light beam
type central x-ray indicator
(Advantech R72) | Stepless manual button control,
using a motor to drive the light gate
to adjust the X-ray irradiation range. |
| Triggering
Mechanism | Two stage triggering | Two stage triggering |
| User Interface | Up-down push buttons for kVp
selections and exposure time
selections with LED indicators
and mAs indicators. | Up-down push buttons for exposure
time selection to adjust mAs, LED
on/off buttons, and collimator
horizontal/vertical control buttons. |
| Energy Source | Rechargeable 22.2 V DC
Lithium Ion Polymer battery pack | Rechargeable 14.4 V DC
Lithium Ion Polymer battery pack |
| Exposure Time | 0.031.30 seconds in 0.011.00 seconds in 0.01
increments | 0.01
increments |
| mA | 2.0 mA fixed | 1.0 mA fixed / 0.8 mA fixed / 0.6
mA fixed |
| kVp | 60 kVp fixed | 70 kVp fixed / 67 kVp fixed / 60
kVp fixed |
6
The subject device is similar to the predicate device in terms of the indications for use and technological application. Both the subject and predicate devices are portable X-ray system for taking diagnostic X-rays of human anatomy using a fixed tube current and voltage (kVp). Other differences in device design such as exposure time, size, and user interface.
7
VII. Non-clinical Test Data
Testing was performed in accordance with the following international standards:
- IEC 62304 Edition 1.1 [2015-06] Medical device software Software life cycle processes ●
- IEC 60601-1 Edition 3.2 [2020-08 CONSOLIDATED VERSION] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Edition 4.1 [2020-09 CONSOLIDATED VERSION] Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
- IEC 60601-1-3 Edition 2.2 [2021-01 CONSOLIDATED VERSION] Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance -Collateral Standard: Radiation protection in diagnostic X-ray equipment
- IEC 60601-2-54 Edition 2.0 [2022-09] Medical electrical equipment Part 2-54: Particular ● requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
- ISO14971 Third Edition [2019-12] Medical devices - Applications of risk management to medical devices
- 21 CFR 1020.30: Diagnostic x-ray system and their major components ●
- 21 CFR 1020.31: Radiographic Equipment
VIII. Clinical Performance Data
The ERI Portable X-ray System has undergone comprehensive non-clinical design verification and validation testing, including assessments of Electrical Safety and performance. The results confirm that the device's design is appropriate and effective for its intended use. Additionally, clinical trials were conducted to compare the imaging results of the ERI Portable X-ray System with those obtained from commercially available X-ray devices. These trials demonstrated that the image quality produced by the ERI system is on part with that of the comparison devices, supporting its substantial equivalence as a portable X-ray system.
IX. Conclusions
The Energy Resources International ERI Portable X-ray System has the same intended use and same basic technology as the predicate device, thus is able to achieve the same effectiveness and safety as the predicate device. The ERI Portable X-ray System contains in some combination similar features and design as the predicates. Other differences include device design such as exposure time, size and user interface. The subject device is substantially equivalent to the predicate device with its intended use, mechanical and electrical performance as described.