(25 days)
The KA6 is a portable X-ray system for diagnostic imaging of body extremities.
The Remex KA6 is a handheld battery-operated x-ray system intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. The subject device is designed as an x-ray source to take diagnostic x-rays as radiographic images. The x-ray tube by Canon (tube voltage 40-70kV with 0.4 mm focal spot) is located inside the handheld device. The device is used with a Flat Panel X-ray Detector(FXRD), not part of the system, which is attached to a computer with imaging software to enable image capture, display, manipulation, storage, and transmission. The device is not designed to be used with a radiographic grid.
The provided text lacks the detailed information required to fill out all the sections of the request regarding acceptance criteria and the study proving the device meets them. The document primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and general safety tests, rather than a specific clinical performance study with defined acceptance criteria for diagnostic accuracy.
Here's an attempt to extract and present the available information, with many sections marked as "Not Applicable" or "Information Not Provided" due to the nature of the given text:
Acceptance Criteria and Study for Remex KA6
The document primarily describes a substantial equivalence determination for the Remex KA6 mobile X-ray system, comparing it to the predicate device MinXray TR90BH. The focus is on demonstrating that the Remex KA6 is at least as safe and effective as the predicate, rather than meeting specific diagnostic performance acceptance criteria in a clinical study with detailed metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Software Validation | "met all requirements of the standard [ISO 14971]" | "Remex KA6 completed software validation and was determined to be a moderate level of concern software. The risk management test was performed in accordance with ISO 14971 and met all requirements." |
| Electrical Safety | "met all requirements for electrical safety" (for standards: 60601-1, 60601-1-3, 60601-1-6, 60601-2-28, 60601-2-54) | "KCTL Inc. performed tests for 60601-1, 60601-1-3, 60601-1-6, and 60601-2-28, and 60601-2-54 and met all requirements for electrical safety." |
| Electromagnetic Compatibility (EMC) | "met all requirements for safety" (for standard: 60601-1-2) | "KCTL performed tests for 60601-1-2 and met all requirements for safety." |
| Radiation Protection (Bench Testing) | "met the test requirements" | "Performance tests for radiation protection in x-ray equipment was completed by an outside laboratory, KCTL, and met the test requirements." |
| Diagnostic Quality (Clinical Evaluation) | "were approved for diagnostic quality" | "Images from the Remex KA6 were evaluated for diagnostic quality by a board certified radiologist and were approved for diagnostic quality." |
2. Sample size used for the test set and the data provenance
- Sample Size: Information not provided. The term "images" is used without a specific count.
- Data Provenance: Information not provided, but implicitly, as it's a clinical evaluation, the images would be derived from human subjects. Whether they were retrospective or prospective, or from a specific country, is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: "a board certified radiologist" (singular).
- Qualifications: "board certified radiologist". No specific experience level (e.g., "10 years of experience") is provided.
4. Adjudication method for the test set
- Adjudication Method: "None" or "Not Applicable" as only one expert was used for evaluation. The document states "Images from the Remex KA6 were evaluated for diagnostic quality by a board certified radiologist and were approved for diagnostic quality." This implies a single-reader assessment.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned or performed. The document describes an evaluation of device-generated images for diagnostic quality, not a comparative study of human readers with and without AI assistance.
- Effect Size: Not Applicable, as no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not Applicable. The Remex KA6 is a mobile X-ray system that produces images; it is not an AI algorithm. The diagnostic quality of the images generated by the device was evaluated by a human radiologist.
7. The type of ground truth used
- Ground Truth: "Expert consensus" in a very limited sense, as it was a single "board certified radiologist" who "approved for diagnostic quality." This is closer to expert opinion on image quality rather than a true ground truth established by pathology or long-term outcomes.
8. The sample size for the training set
- Training Set Sample Size: Not Applicable. The Remex KA6 is an X-ray imaging device, not an AI or machine learning algorithm that undergoes a training phase with a dataset.
9. How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Not Applicable, as there is no training set for this type of device.
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August 3, 2021
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Remedi Co. Ltd. % Mr. W. Lee Strong Quality Systems Manager 510K FDA, Inc. 100 E Granada Blvd. Suite 219 ORMOND BEACH FL 32176
Re: K212144
Trade/Device Name: Remex KA6 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: July 6, 2021 Received: July 9, 2021
Dear Mr. Strong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212144
Device Name REMEX KA6
Indications for Use (Describe)
The KA6 is a portable X-ray system for diagnostic imaging of body extremities.
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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510k FDA Consulting
Medical Device Clearance
100 East Granada Blvd., Suite 219 Ormond Beach, FL 32176
386-506-8711
510(k) Summary
K212144
Submitter
Remedi Co., Ltd. #1409, IS BIZ Tower, 26 Yangpyeong-ro 21 Seoul, Republic of Korea 072NN
+82-(0)2-2135-5879 Tel: +82-(0)2-2135-5889 Fax: Gyuun Choi, Regulatory Manager(gyuun.choi@remedihc.com ) Contact: Date: July 6, 2021
Consultant
510K FDA, Inc. 100 East Granada Blvd., Suite 219 Ormond Beach, FL 32176
| Phone: | 386-506-8711 |
|---|---|
| eFax: | 855-235-7902 |
| Primary Contact: | W. Lee Strong, Quality Systems Manager () |
| Secondary Contact: | Claude Berthoin, President (Claude@510kfda.com) |
Device Classification
| Trade Names: | Remex KA6 |
|---|---|
| Common Name: | Mobile X-Ray System |
| Regulation Name: | Mobile X-Ray System |
| Regulation Number: | 21 CFR 892.1720 |
| Medical Specialty: | Radiology |
| Regulatory Class: | II |
| Product Code: | IZL |
| Submission Type: | 510(k) |
| Regulatory Class: | 2 |
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Predicate Devices
The following predicates are legally marketed, post-amendment devices:
| 510(k) Number: | K182207 |
|---|---|
| Clearance Date: | December 14, 2018 |
| 510(k) Trade Name: | MinXray TR90BH |
| Submitters: | Mikasa X-Ray Co., Ltd. (Tokyo, Japan)MinXray, Inc. (Northbrook, Illinois, USA) |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 892.1720 |
| Regulation Name: | Mobile X-Ray System |
| Product Code: | IZL |
Device Description
The Remex KA6 is a handheld battery-operated x-ray system intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.
The subject device is designed as an x-ray source to take diagnostic x-rays as radiographic images. The x-ray tube by Canon (tube voltage 40-70kV with 0.4 mm focal spot) is located inside the handheld device. The device is used with a Flat Panel X-ray Detector(FXRD), not part of the system, which is attached to a computer with imaging software to enable image capture, display, manipulation, storage, and transmission. The device is not designed to be used with a radiographic grid.
The operator controls three key variables to obtain the best image at minimal exposure:
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- X-Ray Exposure Intensity can be changed from 40 kV to 70 kV in 1 kV increments.
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- X-Ray Exposure Dosage can be changed from 2mA 6mA in 1mA increments.
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- X-Ray Exposure Time can be changed from 0.06 sec 2.00 sec in 0.01 increments.
Indications for Use
The KA6 is a handheld portable X-ray system for diagnostic imaging of body extremities.
The device was previously submitted to the FDA in submission number K202559 and found not-substantially equivalent (NSE). The Remex KA6 is being re-submitted with an adjusted IFU statement.
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Comparison of Technological Characteristics with Predicates
The following table compares technological and other characteristics of the subject and predicate devices.
| Characteristic | Remex KA6(K212144) | MinXray TR90BH(K182207) |
|---|---|---|
| Intended Use | Intended for use by aqualified/trained physician ortechnician on both adult and pediatricsubjects for taking diagnostic x-rays. | Intended for use by aqualified/trained physician ortechnician on both adult and pediatricsubjects for taking diagnostic x-rays. |
| Indications forUse | The KA6 is a portable X-ray systemfor diagnostic imaging of bodyextremities. | The TR90BH is a portable X-raysystem with following limitations ofuse:The device may be used for handhelddiagnostic imaging of bodyextremities.The device may be used for standmounted diagnostic imaging of head,abdomen, or extremities.The device may be used for standmounted imaging of the chest whenused without a grid.- Not to be used on bariatric patients,unless imaging body extremities.- Not for mammography use- The TR90BH is not intended toreplace a stationary radiographicsystem, which may be required forfull optimization of image quality andradiation exposure for different examtypes. |
| Comment onIndications | Certain limitations apply because ofthe lower maximum kVp output ascompared to the predicate. Seeindications above. | Original Indications |
| Characteristic | Remex KA6(K212144) | MinXray TR90BH(K182207) |
| Size: Body | 165 x 176 x 255 mm | 219 x 442 x 190 mm |
| Weight | 2.4 kg (including cone 190g) | 7.5kg |
| Energy Source | Lithium Polymer RechargeableBattery (22.2 VDC), 300 exposuresper charge | Lithium-ion Rechargeable Battery(57.6 VDC), 300 exposures percharge. |
| Mountingmethod | Unit is usually handheld, or mountedon optional arms or tripod | Unit is usually mounted to a MinXrayXGS MKIII Portable Stand |
| User Interface | Up-Down pushbuttons for selectionof exposure time, kVp, and mA, withLED indicators | Up-Down pushbuttons for kVpselections and exposure timeselections with LED indicators |
| Exposure switch | Dual-stage, deadman type | Dual-stage, deadman type |
| Controls | Built-in SoftwareS/W name: RPG-F-0706S/W version: 1.00 | Analog/digital, no software |
| Exposure times | 0.06 -2.0 sec (0.01 sec. steps) | 0.03-0.2 sec (0.01 sec. Steps)0.2-04 sec ( 0.02 sec. Steps)04-1.0 sec (0.05 sec. Steps)1.0-4.0 sec (0.1 sec. Steps) |
| Tube potential(kVp) | 40 - 70 kVp (1 kVp steps) | 40 - 90 kVp |
| Characteristic | Remex KA6(K212144) | MinXray TR90BH(K182207) |
| Tube current(mA) | 2 mA - 6 mA (1 mA steps) | 20 mA @ 40 kVDC – 60 kVDC (2 kVP steps)15 mA @ 62 kVDC – 80 kVDC (2 kVP steps)10 mA @ 82 kVDC – 90 kVDC (2 kVP steps)High Power Mode15 mA @ 82 kVDC – 90 kVDC (2 kVP steps) |
| Alerts andAlarms | At least three specific alerts and alarms indicate equipment state of readiness to use. | At least two specific alerts and alarms indicate equipment state of readiness to use. |
| X-ray tube | Canon D-041SB | Toshiba D-0814 |
| Focal Spot Size | 0.4 mm | 1.2 mm |
| Total filtration | 1.6 mm Al equivalent | 3.2mm AL equivalent |
| Collimator | Square collimator with LED Light Field Center Indicator | Four manually and steplessly adjustable shutters with light beam type central x-ray indicator (Advantech R72) |
| TriggeringMechanism | Two stage triggering | Two stage triggering |
| Source to SkinDistance (SSD) | 300 mm | 300 mm |
| PerformanceStandard | IEC 60601-1-3:2013IEC 60601-2-28:2017IEC 60601-2-54:2009 | IEC 60601-1-3:2008IEC 60601-1-2-28:2010IEC 60601-2-54:2009 |
| Characteristic | Remex KA6(K212144) | MinXray TR90BH(K182207) |
| Electrical safety | IEC 60601-1:2012 | IEC 60601-1:2012 |
| IEC 60601-1-2:2014 | IEC 60601-1-2:2007 | |
| IEC 60601-1-6:2013 | IEC 60601-1-6:2010 | |
| IEC 62304:2006 | IEC 62304:2006 | |
| IEC 62366:2007 | IEC 62366:2007 |
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Both the subject Remex KA6 and predicate MinXray TR90BH device are intended for mobile x-ray examination of adult and pediatric populations.
The subject device is lightweight and designed for handheld use and transport in a carry case, while the predicates are heavy enough to generally require mounting and transport on a portable stand.
The subject is DC-powered by battery, while the predicate is AC-powered via wall outlet. Both the subject and predicates are operated by push buttons and/or touch screen on the device itself.
The above comparison of technological characteristics shows the Remex KA6 to be smaller, lighter, and less powerful than the predicate, with lower tube voltage and current being the more obvious examples. These variations raise no new issues of safety or effectiveness.
Performance Data
The following performance data were provided in support of the substantial equivalence determination...
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- Software Remex KA6 completed software validation and was determined to be a moderate level of concern software. The risk management test was performed in accordance with ISO 14971 and met all requirements of the standard. These tests were performed by the manufacturer and all requirements were met.
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- Electrical Safety -Accredited Testing Laboratory KCTL Inc. performed tests for 60601-1, 60601-1-3, 60601-1-6, and 60601-2-28, and 60601-2-54 and met all requirements for electrical safety.
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- Electromagnetic Compatibility (EMC)—KCTL performed tests for 60601-1-2and met all requirements for safety.
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- Bench Testing Performance tests for radiation protection in x-ray equipment was completed by an outside laborabory, KCTL, and met the test requirements.
-
- Clinical Evaluation Images from the Remex KA6 were evaluated for diagnostic quality by a board certified radiologist and were approved for diagnostic quality.
Risk Analysis Information
Risks associated with the handheld design include increased operator exposure due to leakage radiation and backscatter radiation. Methods to reduce exposure include proper lead lining around the x-ray source assembly, measurement of a typical exposure near and around the unit, and recommended safety precautions such as wearing personnel monitoring and protective equipment.
NOTE: The use of a tripod stand is recommended if you need the device to be more stable while taking the images to prevent blurry imaging. This is an accessory to the Remex KA6.
The Remex KA6 has a Source-Skin Distance (SSD) cage that is attached to the device to maintain a minimum SSD of 300 mm. Operators are not to remove this cage to bring the device closer to the patient. Images may be taken at a distance greater than the cage to the source, but cannot be taken closer than the cage allows.
The petition was prepared in compliances with the following FDA guidance instructions and documents: "FDA Guidance on Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use. "
Conclusions
The comparison of intended use and technological characteristics shows the subject device to be at least as safe and effective as the predicate, and, furthermore, warrants a finding of substantial equivalence between the Remex KA6 and MinXray TR90BH predicate.
The non-clinical data support the safety of the device and demonstrate that Remex KA6 should perform as intended in the specified use conditions.
Clinical images from the Remex KA6 were evaluated for diagnostic quality by a board certified radiologist and were approved for diagnostic quality.
§ 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.