(140 days)
Not Found
No
The summary describes standard image processing techniques for X-ray images and does not mention any AI or ML components.
No
The device is described as a mobile fluoroscopic X-ray system that provides X-ray images for diagnosis and surgical guidance, not for direct therapeutic treatment of a condition. Its primary function is image acquisition.
Yes
The device provides X-ray images of a patient's anatomy during surgery or treatment and explicitly states that it helps medical staff in diagnosis by saving and transmitting images to the PACS system in the hospital.
No
The device description explicitly lists hardware components such as an X-ray tube, flat panel detector, collimator, generator, touch panel, foot switch, hand switch, monitor, thermal transfer printer, mouse, and keyboard, indicating it is a physical medical device 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 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 EXTRON 5 and EXTRON 7 are described as mobile fluoroscopic X-ray systems. They use X-rays to create images of the patient's internal anatomy during surgery or treatment. This is an in vivo (within the living body) imaging technique, not an in vitro test.
- Intended Use: The intended use clearly states that the device provides X-ray images of the patient's anatomy during surgery or treatment to help medical staff in diagnosis. This involves direct imaging of the patient, not testing of samples.
Therefore, the EXTRON 5 and EXTRON 7 fall under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
EXTRON5 and EXTRON 7 are a mobile fluoroscopic X-ray system with high output capacity, high thermal capacity and high resolution image processing system, which provides X-ray images of the patient's anatomy during surgery or treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, surgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis. Examples of a clinical application may include: Neurosurgery, Orthopedics, Anesthesiology, Urology, Internal Medicine (※ This device is not intended for mammography applications.)
Product codes (comma separated list FDA assigned to the subject device)
OWB, OXO, JAA
Device Description
EXTRON 5 and EXTRON 7 are mobile fluoroscopic X-ray systems with high output capacity, high thermal capacity, and high-resolution image processing systems that provide X-ray images of the patient's anatomical structures during surgery or treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, neurosurgery surgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis.
The EXTRON 5 and EXTRON 7 are composed of a C-arm main body and a monitor cart. The Carm main body is composed of an X-ray tube, a flat panel detector, a collimator, a generator, a touch panel, foot switch, hand switch and an XConsoleOP program, while the monitor cart is composed of a monitor, a thermal transfer printer, a mouse, a keyboard and an XConsole program.
The operating principle of the device is designed to expose the patient to X-ray beams. The range of X-ray irradiation are adjusted by the collimator.
X-rays can penetrate into the human body through a two-step conversion process.
X-ray photons are converted into light. The light is then converted into electrical signals through the sensor. The electrical charges are transmitted as the sensor output and converted into signals. These signals are digitized and captured by memory. The captured images are processed and displayed on the monitor. The displayed images can be saved or transmitted to an external storage device, such as a network printer.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
patient's anatomy
Indicated Patient Age Range
Adults and Pediatrics
Intended User / Care Setting
Not Found
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)
Phantom images of various body parts for both the proposed devices, EXTRON 5 and EXTRON 7, and the predicate device, Veradius Unity, have been taken. These images have been reviewed and compared by qualified clinical experts. As a result of this evaluation, it has been confirmed that the EXTRON 5 and EXTRON 7 devices provide equivalent image quality to the predicate device (Veradius Unity).
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
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
August 17, 2023
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.
DRTECH Corporation % Kim Minjeong Manager Suite No. 1, 2 Floor/Suite No. 2, 3 Floor, 29, Dunchon-Daero 541 Beon-Gil, Jungwon-Gu Seongnam-si. Gyeonggi-do 13216 SOUTH KOREA
Re: K230871
Trade/Device Name: Extron 5, Extron 7 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, OXO, JAA Dated: March 31, 2023 Received: July 21, 2023
Dear Kim Minjeong:
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 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) K230871
Device Name EXTRON 5, EXTRON 7
Indications for Use (Describe)
EXTRON5 and EXTRON 7 are a mobile fluoroscopic X-ray system with high output capacity, high thermal capacity and high resolution image processing system, which provides X-ray images of the patient's anatomy during surgery or treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, surgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis. Examples of a clinical application may include: Neurosurgery, Orthopedics, Anesthesiology, Urology, Internal Medicine
(※ This device is not intended for mammography applications.)
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
[As required by 21 CFR 807.92]
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92
1. Date Prepared [21 CFR 807.92(a) (1)]
03/31/2023
●
2. Submitter's Information [21 CFR 807.92(a) (1)]
- Name of Sponsor: . DRTECH Corporation
- Suite No.1, 2 Floor / Suite No. 2, 3 Floor, 29, Dunchon-daero541 beon-gil, Address: Jungwon-gu, Seongnam-si, Gyeonggi-do, 13216, Republic of Korea
- Contact Name: Minjeong Kim
- Telephone No.: + 82-31-779-7783 ●
- Fax No.: + 82-31-779-7790
- Email Address : drtechra@drtech.com ●
- Registration Number: 3005172103 ●
- . Name of Manufacturer: Same as Sponsor
3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]
| • Trade Name: | EXTRON 5, EXTRON 7 |
|---|---|
| • Common Name: | Mobile Fluoroscopic X-ray System |
| • Classification Name: | Image-intensified fluoroscopic x-ray system |
| • Classification Panel: | Radiology |
- Classification Regulation: 21 CFR 892.1650 ●
- Product Code: OWB, OXO, JAA
- Device Class: ● II
4
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
- 510(k) Number: K142708 ●
- Applicant: ● GENERAL ELECTRIC COMPANY
- Trade Name: VERADIUS UNITY
- Classification Name: Image-intensified fluoroscopic x-ray system ●
- Classification Panel: Radiology
- Classification Regulation: 21 CFR 892.1650
- Product Code: OWB, JAA, OXO ●
- Device Class: ● II
5. Description of the Device [21 CFR 807.92(a) (4)]
EXTRON 5 and EXTRON 7 are mobile fluoroscopic X-ray systems with high output capacity, high thermal capacity, and high-resolution image processing systems that provide X-ray images of the patient's anatomical structures during surgery or treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, neurosurgery surgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis.
The EXTRON 5 and EXTRON 7 are composed of a C-arm main body and a monitor cart. The Carm main body is composed of an X-ray tube, a flat panel detector, a collimator, a generator, a touch panel, foot switch, hand switch and an XConsoleOP program, while the monitor cart is composed of a monitor, a thermal transfer printer, a mouse, a keyboard and an XConsole program.
The operating principle of the device is designed to expose the patient to X-ray beams. The range of X-ray irradiation are adjusted by the collimator.
X-rays can penetrate into the human body through a two-step conversion process.
X-ray photons are converted into light. The light is then converted into electrical signals through the sensor. The electrical charges are transmitted as the sensor output and converted into signals. These signals are digitized and captured by memory. The captured images are processed and displayed on the monitor. The displayed images can be saved or transmitted to an external storage device, such as a network printer.
6. Indication for Use [21 CFR 807.92(a)(5)]
EXTRON5 and EXTRON 7 are a mobile fluoroscopic X-ray system with high output capacity, high thermal capacity and high resolution image processing system, which provides X-ray images of the patient's anatomy during surgery or treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, neurosurgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis.
Examples of a clinical application may include: Neurosurgery, Orthopedics, Anesthesiology, Urology, Gynecology, Internal Medicine
(※ This device is not intended for mammography applications.)
5
7. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device [21 CFR 807.92(a)(6), 21 CFR 807.92(b)]
The EXTRON 5 and EXTRON 7 are designed as a combination of components, including a C-arm, X-ray tube and housing, flat panel detector, digital imaging system, collimator, generator, and monitor cart. Its purpose is to provide X-ray images of a patient's anatomy during surgery or treatment.
The subject device has the same fundamental scientific technologies as the predicate devices. The technological comparison table below demonstrates the comparability of the technological characteristics of the new device and the currently cleared predicate devices. The Technological differences do not affect the intended use of the device.
The table 1 below compares the main performance data of the subject device with the predicate devices to substantiate equivalence of the subject device and predicates.
| Parameter | Subject Device | Predicate Device | Discussion |
|---|---|---|---|
| 510(K) | |||
| Number | Unknown | K142708 | - |
| Manufacturer | DRTECH Corporation | Philips Medical Systems | |
| Nederland B.V. | - | ||
| Model Name | EXTRON 5, EXTRON 7 | Veradius Unity | - |
| Classification | |||
| Name | Image-intensified | ||
| fluoroscopic x-ray system | Image-intensified | ||
| fluoroscopic x-ray system | Identical | ||
| Classification | |||
| Panel | Radiology | Identical | |
| Classification | |||
| Regulation | 21 CFR 892.1650 | 21 CFR 892.1650 | Identical |
| Product Code | OWB, OXO, JAA | OWB, OXO, JAA | Identical |
| Device Class | Class II | Class II | Identical |
| Intended Use | EXTRON5 and EXTRON 7 | ||
| are a mobile fluoroscopic X- | |||
| ray system with high output | |||
| capacity, high thermal | |||
| capacity and high resolution | |||
| image processing system, | |||
| which provides X-ray | |||
| images of the patient's | |||
| anatomy during surgery or | |||
| treatment. This device plays | |||
| an important role in | |||
| emergency injury treatment, | |||
| orthopedic surgery, | |||
| neurosurgery surgery, bone | |||
| surgery, etc. This device has | |||
| a function to save important | |||
| a specific images as records, | |||
| so you can easily search for | |||
| the images and transmit it to | |||
| the PACS system in the | |||
| hospital to help the medical | |||
| staff in diagnosis. | The proposed Veradius | ||
| Unity device is intended to | |||
| be used and operated by: | |||
| adequately trained, | |||
| qualified, and authorized | |||
| health care professionals | |||
| such as physicians, | |||
| surgeons, cardiologists, | |||
| radiologists, and | |||
| radiographers, who have full | |||
| understanding of the safety | |||
| information and emergency | |||
| procedures as well as the | |||
| capabilities and functions of | |||
| the device. | |||
| The device is used for | |||
| radiological guidance and | |||
| visualization during | |||
| diagnostic, interventional, | |||
| and surgical procedures on | |||
| all patients except neonates | |||
| (birth to one month), within | Identical | ||
| Examples of a clinical | |||
| application may include: | |||
| Neurosurgery, Orthopedics, | |||
| Anesthesiology, Urology, | |||
| Gynecology, Internal | |||
| Medicine | |||
| (※ This device is not | |||
| intended for mammography | |||
| applications.) | the limits of the device. The | ||
| device is to be used in | |||
| healthcare facilities both | |||
| inside and outside the | |||
| operating room, in sterile as | |||
| well as non-sterile | |||
| environments, in a variety of | |||
| procedures. | |||
| Applications | |||
| • Orthopedic | |||
| • Neuro | |||
| • Abdominal | |||
| • Vascular | |||
| • Thoracic | |||
| • Cardiac | |||
| Target | |||
| population | Patients who need X-ray | ||
| radiography or fluoroscopy | |||
| images | |||
| Adults and Pediatrics | Patients who need | ||
| diagnostic, interventional | |||
| and surgical procedures, | |||
| except neonates (birth to one | |||
| month) | Identical | ||
| Mobile | |||
| Platform | Yes | Yes | Identical |
| Max. Output | |||
| Power | EXTRON 5: 4.8kW | ||
| EXTRON 7: 15kW | 15kW | Equivalent : | |
| The specifications | |||
| have been | |||
| enhanced to enable | |||
| operation at power | |||
| levels up to 4.8kW. | |||
| That does not give | |||
| rise to any novel | |||
| concerns regarding | |||
| safety and | |||
| effectiveness. | |||
| X-ray tube | Rotating Anode | Rotating Anode | Identical |
| Radiographic | |||
| Mode | kV Range : 40 to 120kV | ||
| mA Range : Up to 150mA | |||
| ※ EXTRON 7 only | kV Range : 40 to 120kV | ||
| mA Range : Up to 125mA | Equivalent : | ||
| Alteration in the | |||
| mA does not give | |||
| rise to any novel | |||
| concerns regarding | |||
| safety and | |||
| effectiveness. | |||
| Fluoroscopic | |||
| Mode | kV Range : 40 to 120kV | ||
| mA Range : | |||
| EXTRON 5 - Up to 40mA | |||
| EXTRON 7 - Up to 60mA | kV Range : 40 to 120kV | ||
| mA Range : 1 to 60mA | Equivalent : | ||
| Alteration in the | |||
| mA does not give | |||
| rise to any novel | |||
| concerns regarding | |||
| safety and | |||
| effectiveness. | |||
| Dimension | Immersion Depth : 74cm | Immersion Depth : 73cm | Equivalent : |
| Free Space : 80cm | |||
| Orbital movement : 165° | Free Space : 77cm | ||
| Orbital movement : 145° | Alteration in the | ||
| dimension does not | |||
| give rise to any | |||
| novel concerns | |||
| regarding safety | |||
| and effectiveness. | |||
| Additionally, due to | |||
| the greater scope of | |||
| movement, the | |||
| Subject device | |||
| offers a higher | |||
| degree of | |||
| convenience | |||
| compared to the | |||
| Predicate device. | |||
| Laser Guide | Yes | Yes | Identical |
| Foot Switch | Wired Foot Switch | ||
| Wireless Foot Switch | Wired Foot Switch | ||
| Wireless Foot Switch | Identical | ||
| Detector pixels | EXPD 2121P : 1500 x 1500 pixels | ||
| EXPD 3030P : 2048 x 2048 pixels | 1560 x 1420 pixels | Equivalent : | |
| Alteration in the | |||
| detector pixels do | |||
| not give rise to any | |||
| novel concerns | |||
| regarding safety | |||
| and effectiveness. |
Table 1. Comparison of the Subject Device (EXTRON 7) to the Predicate Device (Veradius Unity)Substantial Equivalence
6
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7
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The predicate devices (K142708) and the subject device, EXRON 7 are equivalent in terms of the following matters:
- Intended Use
- Target population
- Mobile Platform
- X-ray tube
- Laser Guide
- Foot Switch
A few differences are as follows:
- Max. Output Power
- Radiographic Mode
- · Fluoroscopic Mode
- Dimension
- Detector pixels
There are no significant differences between the EXTRON 7 and the predicate device that would have a negative impact on the product's use. Therefore, the subject device is considered substantially equivalent to the predicate device.
8
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9. Summary of Non-Clinical Data [21 CFR 807.92(b)(1)]
The EXTRON 5 and EXTRON 7 comply with the following international and FDA-recognized consensus standards list in Table 2.
| Standards development
organization, reference
| number, and date | Standard name |
|---|---|
| ISO 14971: Third Edition | |
| 2019-12 | Medical devices - Application of risk management to medical devices |
| ANSI AAMI ES60601-1:2005/(R)2012 and | |
| A1:2012 | Medical electrical equipment - Part 1: General requirements for basic |
| safety and essential performance (IEC 60601-1:2005, MOD) | |
| 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 | |
| disturbances - Requirements and tests | |
| IEC 60601-1-6 Edition 3.1 | |
| 2013-10 | Medical electrical equipment - Part 1-6: General requirements for basic |
| safety and essential performance - Collateral standard: Usability | |
| IEC 62366-1 Edition 1.1 | |
| 2020-06 | |
| CONSOLIDATED | |
| VERSION | Medical devices - Part 1: Application of usability engineering to |
| medical devices | |
| IEC 60601-1-3 Edition 2.1 | |
| 2013-04 | Medical electrical equipment - Part 1-3: General requirements for basic |
| safety and essential performance - Collateral Standard: Radiation | |
| protection in diagnostic X-ray equipment | |
| IEC 60601-2-28 Edition | |
| 3.0 2017-06 | Medical electrical equipment - Part 2-28: Particular requirements for the |
| basic safety and essential performance of X-ray tube assemblies for | |
| medical diagnosis | |
| IEC 60601-2-54 Edition | |
| 1.2 2018-06 | |
| CONSOLIDATED | |
| VERSION | Medical electrical equipment - Part 2-54: Particular requirements for the |
| basic safety and essential performance of X-ray equipment for | |
| radiography and radioscopy | |
| IEC 60601-2-43 Edition | |
| 2.2 2019-10 | |
| CONSOLIDATED | |
| VERSION | Medical electrical equipment - Part 2-43: Particular requirements for the |
| safety and essential performance of X-ray equipment for interventional | |
| procedures | |
| IEC 62304 Edition 1.1 | |
| 2015-06 | |
| CONSOLIDATED | |
| VERSION | Medical device software - Software life cycle processes |
| ANSI UL 2900-1 First | |
| Edition 2017 | Standard for Safety, Standard for Software Cybersecurity Network- |
| Connectable Products. Part 1: General Requirements |
Table 2. International and FDA-recognized consensus standards
And EXTRON 5 and EXTRON 7 comply with the FDA guidance documents listed in Table 3.
Table 3. FDA Guidance Documents
| Title of Guidance Document | Issue Date |
|---|---|
| Guidance for Industry and Food and Drug Administration Staff: The 510(k) | |
| Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] | July 28, 2014 |
| Guidance for Industry and FDA Staff: Guidance for the Content of Premarket | |
| Submission for Software in Medical Devices | May 11, 2005 |
| Guidance for Industry and Food and Drug Administration Staff: Medical X-Ray | May 8, 2019 |
9
| Title of Guidance Document | Issue Date |
|---|---|
| Imaging Devices Conformance with IEC Standards | |
| Guidance for Industry and FDA Staff: Information to Support a Claim of | |
| Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices | July 11, 2016 |
| Guidance for Industry and FDA Staff: Applying Human Factors and Usability | |
| Engineering to Medical Devices | February 3, 2016 |
| Guidance for Industry and FDA Staff: Content of Premarket Submissions for | |
| Management of Cybersecurity in Medical devices | October 2, 2014 |
Phantom images of various body parts for both the proposed devices, EXTRON 5 and EXTRON 7, and the predicate device, Veradius Unity, have been taken. These images have been reviewed and compared by qualified clinical experts. As a result of this evaluation, it has been confirmed that the EXTRON 5 and EXTRON 7 devices provide equivalent image quality to the predicate device (Veradius Unity).
10. Summary of Clinical Data [21 CFR 807.92(b)(2)]
Not Applicable
Clinical studies were not performed, but phantom images were taken to support SE.
11. Conclusion [21 CFR 807.92(b)(3)]
The EXTRON 5 and EXTRON 7 are substantially equivalent to the currently marketed predicate device (Veradius Unity (K142708)) in terms of design, fundamental scientific technology, and indications for use, safety, and effectiveness.
Substantial equivalence for Mobile fluoroscopic X-ray System(EXTRON 5, EXTRON 7) was demonstrated through the non-clinical performance in compliance with the requirements specified in the international and FDA recognized consensus standards, ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, IEC 60601-2-43, IEC 62304 and ANSI UL 2900-1.
The comparison of technological characteristics, non-clinical performance data and safety testing demonstrate that the EXTRON 7 are substantially equivalent to the predicate devices.