(33 days)
The EXSYS DEXi is a diagnostic X-ray system intended for use in generating radiographic images of human anatomy for general purpose. The system obtains necessary information of patient's anatomical structure by an image processing (workstation) after process of examination using radiation exposure with DR. This system is not intended for mammography applications.
The EXSYS DEXi is a diagnostic X-ray system intended for use in generating radiographic images of human anatomy for general purpose. The system obtains necessary information of patient's anatomical structure by an image processing (workstation) after process of examination using radiation exposure with DR. This system is not intended for mammography applications.
The EXSYS DEXi composed of a x-ray generator, tube, collimator, tube stand, bucky stand, patient table, flat panel detector and console.
This FDA 510(k) summary does not contain information about acceptance criteria and device performance as it pertains to AI/ML or image analysis aspects. The document focuses on the substantial equivalence of the modified EXSYS DEXi diagnostic X-ray system to a previously cleared predicate device (K233530) based on hardware and software updates, and compliance with general safety and performance standards for X-ray systems.
Specifically, the document refers to non-clinical data and verification and validation testing demonstrating compliance with various international and FDA-recognized consensus standards (e.g., IEC 60601 series for medical electrical equipment, ISO 14971 for risk management, IEC 62304 for medical device software, UL ANSI 2900-1 and IEC 81001-5-1 for cybersecurity). It states, "The test results support that all the specifications have met the acceptance criteria. Verification and validation testing were found acceptable to support the claim of substantial equivalence." However, it does not provide a table of acceptance criteria with reported device performance metrics in an AI/ML context, nor does it describe specific studies that would typically prove such performance (e.g., standalone performance studies, MRMC studies, details on ground truth establishment for a diagnostic algorithm, sample sizes for test/training sets relevant to AI performance).
The "technological characteristics" table (Table 1) compares design parameters of the subject device (new models of EXSYS DEXi) with the predicate device, highlighting additions like new collimators, mechanical parts, detectors, and software (EConsole2). The discussion column for these additions generally states, "The system has been tested and there is 'No negative impact on safety or efficacy' and there are no new potential or increased safety risks concerning this difference." This refers to overall system safety and performance in line with a general X-ray system, not specific AI/ML diagnostic performance.
Therefore, based on the provided document, the following information cannot be extracted:
- A table of acceptance criteria and the reported device performance (for AI-specific functions): Not provided. The document states general compliance with standards and "test results support that all the specifications have met the acceptance criteria," but does not detail these criteria or performance metrics specific to an AI component's diagnostic accuracy, sensitivity, specificity, etc.
- Sample size used for the test set and the data provenance: Not provided for AI/ML performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided for AI/ML performance evaluation.
- Adjudication method for the test set: Not provided for AI/ML performance evaluation.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
- If a standalone (algorithm only without human-in-the-loop performance) was done: Not mentioned.
- The type of ground truth used: Not specified for AI/ML performance evaluation.
- The sample size for the training set: Not provided for AI/ML performance evaluation.
- How the ground truth for the training set was established: Not provided for AI/ML performance evaluation.
The document states, "Clinical studies are unnecessary to validate the safety and effectiveness of the Stationary x-ray system, EXSYS DEXi, the subject of this 510(k) notification," further indicating that specific performance data from clinical trials or detailed AI algorithm validation studies (which typically involve such criteria) are not included in this submission summary. The software updates mentioned (EConsole2) were previously cleared via K240243, suggesting that any specific performance data for that software might be found in its own 510(k) submission, but not in this document.
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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 & 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.
October 23, 2024
DRTECH Corporation % Hanbyul Kim Assistant 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: K242847
Trade/Device Name: EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA); EXSYS DEXi (EXSYS DEXi-D503T-FRA) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR Dated: September 20, 2024 Received: September 20, 2024
Dear Hanbyul Kim:
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 (the 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 available 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
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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.
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 OS 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 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 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.
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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 Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM): EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM): EXSYS DEXi (EXSYS DEXi-D401P-FRM): EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM): EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXI (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA); EXSYS DEXi (EXSYS DEXi-D503T-FRA)
Indications for Use (Describe)
The EXSYS DEXi is a diagnostic X-ray system intended for use in generating radiographic images of human anatomy for general purpose. The system obtains necessary information of patient's anatomical structure by an image processing (workstation) after process of examination using radiation exposure with DR. This system is not intended for mammography applications.
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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510(k) Summary
[As required by 21 CFR 807.92]
510(k) Number: K242847
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)]
09/20/2024
●
2. Submitter's Information [21 CFR 807.92(a) (1)]
- Name of Sponsor: DRTECH Corporation ●
- Address: Suite No.1, 2 Floor / Suite No. 2, 3 Floor, 29, Dunchon-daero541 beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, 13216, Republic of Korea
- Contact Name: Hanbyul Kim
- Telephone No.: + 82-31-779-7720 ●
- 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(Brand) Name: ● EXSYS DEXi Device(Model) Name : ● EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA); EXSYS DEXi (EXSYS DEXi-D503T-FRA);
- Common Name: Diagnosis X-Ray System ●
- . Classification Name: Stationary x-ray system
- Classification Panel: ● Radiology
- Classification Regulation: 21 CFR 892.1680 ●
- . Product Code: KPR
- Device Class: II ●
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4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
- 510(k) Number: ● K233530
- Applicant: DRTECH Corporation
- Trade(Brand) Name: EXSYS DEXi
- Device(Model) Name : EXSYS DEXi (EXSYS DEXi-D401S-FRM); ● EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM);
- Classification Name: Stationary x-ray system .
- Classification Panel: Radiology
- Classification Regulation: 21 CFR 892.1680 ●
- Product Code: KPR
- Device Class: . II
5. Description of the Device [21 CFR 807.92(a) (4)]
The EXSYS DEXi is a diagnostic X-ray system intended for use in generating radiographic images of human anatomy for general purpose. The system obtains necessary information of patient's anatomical structure by an image processing (workstation) after process of examination using radiation exposure with DR. This system is not intended for mammography applications.
The EXSYS DEXi composed of a x-ray generator, tube, collimator, tube stand, bucky stand, patient table, flat panel detector and console.
Although it shares the same brand name as the predicate device EXSYS DEXi (K233530), a model name has been added with the following modifications:
-
- Addition of collimator
-
- Addition of mechanical parts (tube stand, bucky stand, patient table)
-
- Addition of a detector
-
- Addition of software
-
- Update of software
6. Indication for Use [21 CFR 807.92(a)(5)]
The EXSYS DEXi is a diagnostic X-ray system intended for use in generating radiographic images of human anatomy for general purpose. The system obtains necessary information of patient's anatomical structure by an image processing (workstation) after process of examination using radiation exposure with DR. This system is not intended for mammography applications.
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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 EXSYS DEXi composed of a x-ray generator, tube stand, bucky stand, bucky stand, patient table, flat panel detector and console.
It is a diagnostic X-ray system intended for use in generating radiographic images of human anatomy for general purpose. The system obtains necessary information of patient's anatomical structure by an image processing (workstation) after process of examination using radiation exposure with DR. This system is not intended for mammography applications.
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 | K233530 | N/A |
| Manufacturer | DRTECH Corporation | DRTECH Corporation | N/A |
| Device/Brand Name | EXSYS DEXi | EXSYS DEXi | N/A |
| Model Name | EXSYS DEXi-A401S-FRMEXSYS DEXi-A402S-FRMEXSYS DEXi-A401P-FRMEXSYS DEXi-A402P-FRMEXSYS DEXi-A503T-FRMEXSYS DEXi-D401S-FRMEXSYS DEXi-D402S-FRMEXSYS DEXi-D401P-FRMEXSYS DEXi-D402P-FRMEXSYS DEXi-D503T-FRMEXSYS DEXi-D401S-FRAEXSYS DEXi-D402S-FRAEXSYS DEXi-D401P-FRAEXSYS DEXi-D402P-FRAEXSYS DEXi-D503T-FRA | EXSYS DEXi-A401S-FRMEXSYS DEXi-A402S-FRMEXSYS DEXi-A401P-FRMEXSYS DEXi-A402P-FRMEXSYS DEXi-A503T-FRMEXSYS DEXi-D401S-FRMEXSYS DEXi-D402S-FRMEXSYS DEXi-D401P-FRMEXSYS DEXi-D402P-FRMEXSYS DEXi-D503T-FRM | Model names havebeen added due to theaddition of productconfigurations.The system has beentested and there is "Nonegative impact onsafety or efficacy" andthere are no newpotential or increasedsafety risks concerningthis difference. |
| ClassificationName | Stationary x-ray system | Stationary x-ray system | Identical |
| ClassificationRegulation | 21 CFR 892.1680 | 21 CFR 892.1680 | Identical |
| Product Code | KPR | KPR | Identical |
| Device Class | Class II | Class II | Identical |
| Intended Use | The EXSYS DEXi is adiagnostic X-ray systemintended for use in generatingradiographic images ofhuman anatomy for generalpurpose. The system obtainsnecessary information ofpatient's anatomical structureby an image processing | The EXSYS DEXi is adiagnostic X-ray systemintended for use in generatingradiographic images ofhuman anatomy for generalpurpose. The system obtainsnecessary information ofpatient's anatomical structureby an image processing | Identical |
| (workstation) after process ofexamination using radiationexposure with DR. Thissystem is not intended formammography applications. | (workstation) after process ofexamination using radiationexposure with DR. Thissystem is not intended formammography applications. | ||
| High Frequency X-ray Generator | |||
| Output Power | 40kW, 50kW | 40kW, 50kW | Identical |
| Generatormodels | DXG-40SDXG-40PDXG-50T | DXG-40SDXG-40PDXG-50T | Identical |
| Line voltage | DXG-40S, DXG-40P :220~230VACDXG-50T :230/380/400/480VAC | DXG-40S, DXG-40P :220~230VACDXG-50T :230/380/400/480VAC | Identical |
| kV Range | DXG-40S, DXG-40P :40 | DXG-40S, DXG-40P :40 | Identical |
| mA Range | DXG-40S, DXG-40P :10 to 500mADXG-50T :10 to 630mA | DXG-40S, DXG-40P :10 to 500mADXG-50T :10 to 630mA | Identical |
| Image Acquisition | |||
| Detector | Used with DRTECHDetectorK193017 :EVS 4343W, EVS 4343WP,EVS 3643W, EVS 3643WPK192400 :EVS 4343A, EVS 3643AK193031 :EXPD 4343P, EXPD 3643PK223124 :EXPD 86P, EXPD 86PG,EXPD 129P, EXPD 129PGK231959 :EXPD 4357, EXPD 4357PK232082 :EXPD 4343SK232753 :EXPD 3643D, EXPD 4343D | Used with DRTECHDetectorK193017 :EVS 4343W, EVS 4343WP,EVS 3643W, EVS 3643WPK192400 :EVS 4343A, EVS 3643AK193031 :EX PD 4343P, EXPD 3643PK223124 :EXPD 86P, EXPD 86PG,EXPD 129P, EXPD 129PG | 510(k) cleareddetectors have beenadded.The system has beentested and there is “Nonegative impact onsafety or efficacy” andthere are no newpotential or increasedsafety risks concerningthis difference.All the flat paneldetectors have beenpreviously cleared by510(k). |
| Image Management Software | |||
| Software | EConsole1 (K231225)EConsole2 (K240243) | EConsole1 (K231225) | Added our software,EConsole2 (K240243),which was previouslycleared with 510(k).The system has beentested and there is “Nonegative impact onsafety or efficacy” andthere are no newpotential or increased |
| safety risks concerning | |||
| this difference. | |||
| Image viewing | Available | Available | Identical |
| Image search | Available | Available | Identical |
| Image storage | Available | Available | Identical |
| Imageannotation | Available | Available | Identical |
| Imagemeasurement | Available | Available | Identical |
| Imageprocessing | Available | Available | Identical |
| Image stitch | Available | Available | Identical |
| GeneratorControl | Available | Available | Identical |
| X-ray Tube | |||
| Tube models | E7239X, E7242X, E7884X | E7239X, E7242X, E7884X | Identical |
| Max. TubeVoltage | E7239X : 125 kVE7242X : 125 kVE7884X : 150 kV | E7239X : 125 kVE7242X : 125 kVE7884X : 150 kV | Identical |
| Anode HeatCapacity | E7239X : 140 kHUE7242X : 200 kHUE7884X : 300 kHU | E7239X : 140 kHUE7242X : 200 kHUE7884X : 300 kHU | Identical |
| Collimator | |||
| CollimatorModels | M-38R 221/A DHHSR 225 ACS DHHS | M-38 | A new collimator thatoperates manually andanother type thatoperates automaticallyhave been added.We have conductedtests regarding the |
| Adjustmentmethod | Manual, Auto | Manual | addition of thesecollimators, and thereis "no negative impacton safety or efficacy."Furthermore, there areno new potential risksor increased safetyhazards related to thesedifferences. |
| Tube Stand | |||
| Models | DTS-MDTS-A | DTS-M | Motorized tube standhas been added.We have conductedtests regarding thisaddition, and there is |
| OperationMethod | Manual, Auto | Manual | "no negative impact onsafety or efficacy."Furthermore, there areno new potential risksor increased safetyhazards related to thesedifferences. |
| Type | Floor-supported type | Floor-supported type | Identical |
| Tube HeadConsole | Membrane OPLCD Console | Membrane OPLCD Console | Identical |
| Bucky Stand | |||
| Models | DBS-43MLLD 129 With RotationLLD 129 CompactDBS-57MDBS-43ADBS-57A | DBS-43MLLD 129 With RotationLLD 129 Compact | Three Types of buckystands have beenadded.We have conductedtests regarding thisaddition, and there is |
| OperationMethod | Manual, Auto | Manual | "no negative impact onsafety or efficacy."Furthermore, there areno new potential risksor increased safetyhazards related to thesedifferences. |
| Type | Floor-supported type | Floor-supported type | Identical |
| Patient Table | |||
| Models | DPT-4ADPT-6ADPT-4BDPT-6BDPT-6ATDPT-6BT | DPT-4ADPT-6A | Four Types of patienttables have been added.We have conductedtests regarding thisaddition, and there is |
| Type | 4 way : DPT-4A, DPT-4B6 way : DPT-6A, DPT-6B,DPT-6AT, DPT-6BT | 4 way : DPT-4A6 way : DPT-6A | "no negative impact onsafety or efficacy."Furthermore, there areno new potential risksor increased safetyhazards related to thesedifferences. |
| Fixed method | Electromagnet | Electromagnet | Identical |
Table 1. Comparison of the Subject Device to the Predicate Device Substantial Equivalence
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There are no significant differences between the subject Device and the predicate device that would have a negative impact on the product's use. Therefore, the subject device substantially equivalent to the predicate device.
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9. Summary of Non-Clinical Data [21 CFR 807.92(b)(1)]
The EXSYS DEXi comply with the following international and FDA-recognized consensus standards list in Table 2.
| Standards developmentorganization, referencenumber, and date | Standard name |
|---|---|
| ISO 14971: Third Edition2019-12 | Medical devices - Application of risk management to medical devices |
| IEC 60601-1 Edition 3.22020-08CONSOLIDATEDVERSION | Medical electrical equipment - Part 1: General requirements for basicsafety and essential performance |
| IEC 60601-1-2 Edition 4.12020-09CONSOLIDATEDVERSION | Medical electrical equipment - Part 1-2: General requirements for basicsafety and essential performance - Collateral Standard: Electromagneticdisturbances - Requirements and tests |
| IEC 60601-1-6 Edition 3.22020-07CONSOLIDATEDVERSION | Medical electrical equipment - Part 1-6: General requirements for basicsafety and essential performance - Collateral standard: Usability |
| IEC 62366-1 Edition 1.12020-06CONSOLIDATEDVERSION | Medical devices - Part 1: Application of usability engineering tomedical devices |
| IEC 60601-1-3 Edition 2.22021-01CONSOLIDATEDVERSION | Medical electrical equipment - Part 1-3: General requirements for basicsafety and essential performance - Collateral Standard: Radiationprotection in diagnostic X-ray equipment |
| IEC 60601-2-28 Edition3.0 2017-06 | Medical electrical equipment - Part 2-28: Particular requirements for thebasic safety and essential performance of X-ray tube assemblies formedical diagnosis |
| IEC 60601-2-54 Edition1.2 2018-06CONSOLIDATEDVERSION | Medical electrical equipment - Part 2-54: Particular requirements for thebasic safety and essential performance of X-ray equipment forradiography and radioscopy |
| IEC 62304 Edition 1.12015-06CONSOLIDATEDVERSION | Medical device software - Software life cycle processes |
| UL ANSI 2900-1 FirstEdition 2017 | Standard for Safety, Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements |
| IEC 81001-5-1 Edition1.0 2021-12 | Health software and health IT systems safety, effectiveness and securityPart 5.1: Security - Activities in the product life cycle |
Table 2. International and FDA-recognized consensus standards
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And EXSYS DEXi 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 |
| Pediatric Information for X-ray Imaging Device Premarket Notifications,Guidance for Industry and Food and Drug Administration Staff | Nov 28, 2017 |
| Guidance for Industry and Food and Drug Administration Staff: Medical X-RayImaging Devices Conformance with IEC Standards | May 8, 2019 |
| Content of Premarket Submissions for Device Software Functions, Guidance forIndustry and Food and Drug Administration Staff | June 14, 2023 |
| Cybersecurity in Medical Devices Quality System Considerations and Content ofPremarket Submissions | Sep 27, 2023 |
The risk analysis was completed and risk controls were implemented to mitigate identified hazards. The test results support that all the specifications have met the acceptance criteria. Verification and validation testing were found acceptable to support the claim of substantial equivalence.
10. Summary of Clinical Data [21 CFR 807.92(b)(2)]
Not Applicable
Clinical studies are unnecessary to validate the safety and effectiveness of the Stationary x-ray system, EXSYS DEXi, the subject of this 510(k) notification.
11. Conclusion [21 CFR 807.92(b)(3)]
The EXSYS DEXi is substantially equivalent to the currently marketed predicate device (K233530) in terms of technical characteristics, general function, applications for use, safety, and effectiveness.
Substantial equivalence for Stationary X-ray System(EXSYS DEXi) was demonstrated through the non-clinical performance in compliance with the requirements specified in the international and FDA recognized consensus standards, IEC 60601-1, IEC 60601-1-6, IEC 60601-1-6, IEC 62366-1, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, IEC 62304, IEC 81001-5-1 and ANSI UL 2900-1.
The comparison of technological characteristics, non-clinical performance data and safety testing demonstrate that the EXSYS DEXi is substantially equivalent to the predicate devices.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.