(16 days)
No
The description focuses on the synchronization of two x-ray systems for RSA procedures and does not mention any AI or ML components for image analysis, processing, or other functions.
No
The device is described as a stationary digital x-ray system for general radiography and Roentgen Stereophotogrammetric Analysis (RSA) procedures. Its primary function is to acquire x-ray images to enable precise measurements of joint replacement stability, which is a diagnostic capability, not a therapeutic intervention.
Yes
Explanation: The device is described as a stationary digital x-ray system used for general radiography and Roentgen Stereophotogrammetric Analysis (RSA) procedures. RSA is a stereo x-ray technique that enables precise measurements of joint replacement stability. The output of the device (X-ray images and RSA measurements) provides information about a patient's health status, specifically related to joint replacement stability, which aligns with the definition of a diagnostic device.
No
The device description explicitly details hardware components such as X-Ray imaging systems, synchronization switches, control modules, detectors, workstations, and cabinets. It describes the integration and synchronization of these physical components.
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 Halifax SR Suite and Imaging Kit are imaging systems that use digital x-rays to create images of the inside of the body. They are used for general radiography and Roentgen Stereophotogrammetric Analysis (RSA), which is a technique for measuring the stability of joint replacements based on these x-ray images.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. Its function is to generate images using external energy (x-rays).
Therefore, the device falls under the category of medical imaging equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
This is a stationary digital x-ray system for general radiography and RSA (Roentgen Stereophotogrammetric Analysis procedures). Not for mammography.
Product codes (comma separated list FDA assigned to the subject device)
KPR, MQB, LLZ
Device Description
The Halifax SR Suite consists of two X-Ray imaging systems; the two systems are integrated through a synchronization switch. The switch allows the two X-Ray imaging systems to fire simultaneously, providing a pair of X-Ray images from different perspectives to be taken at the exact same time. This process allows for Roentgen Stereophotogrammetric Analysis (RSA). RSA is a stereo x-ray technique that enables measurements more precise than single plane radiography based on phantom precision studies. The resulting level of precision provides measurements of joint replacement stability.
The Halifax Imaging Kit is part of the SR Suite product line and provides an alternative path to creating an SR Suite. The Halifax Imaging Kit consists of FDA cleared and/or certified X-Ray components integrated into an existing digital radiography room already containing an FDA cleared x-ray imaging system to form an SR Suite. The exposures of the Halifax Imaging Kit and the existing Digital Radiography (DR) system are synchronized by replacing the trigger switches of the two systems with either the Universal Synchronization Switch or the Imaging Kit Control Module (IKCM).
The Universal Synchronization Switch or IKCM ensures the two X-Ray imaging systems fire simultaneously, therefore providing a pair of X-Ray images from two different perspectives taken at the exact same time. There are two versions of the Halifax Imaging Kits:
a) UNIVERSAL SYNCHRONIZATION (NON-GE BASED CONFIGURATION) The Universal Synchronization Switch synchronizes two independent X-ray systems as accurately as possible by using the manual pushbutton interface of each X-ray system. This replaces the synchronization switch that was described in our predicate K121345.
b) IMAGING KIT CONTROL MODULE (GE BASED CONFIGURATION) The general purpose of the IKCM is to coordinate and control the activities of the detector and workstation with the activities of the generator, as well as coordinate the exposures between the client's clinical system and the Halifax Imaging Kit for RSA exposures. The current version of the IKCM is designed specifically for interfacing with the following components:
•GEHC WDR1 Upgrade Kit which consists of a 'Flashpad' detector, a workstation named 'MagicPC', and a 'Cabinet' for power distribution and communication control. Integrating with a pre-existing system (GEHC Discovery XR656 Plus).
· EMD Technologies Epsilon Series generator. (Or generators already on site)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
Bench testing and standards testing indicates that the new device is as safe and effective as the predicate device. Risk analysis has been performed.
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.
K092429, K141602, K111682, K102012, K131106, K102116
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
§ 892.1680 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.
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Image /page/0/Picture/0 description: The image contains two logos. The first logo is the Department of Health & Human Services - USA logo, which features a stylized human figure. The second logo is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the administration in blue text to the right of the square.
October 31, 2018
Halifax Biomedical, Inc. % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES, FL 34114
Re: K182880
Trade/Device Name: Halifax Imaging Kit Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB, LLZ Dated: October 11, 2018 Received: October 15, 2018
Dear Daniel Kamm:
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Hole 2. Nils
for Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182880
Device Name Halifax Imaging Kit
Indications for Use (Describe)
This is a stationary digital x-ray system for general radiography and RSA (Roentgen Stereophotogrammetric Analysis procedures). Not for mammography.
| 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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Image /page/3/Picture/0 description: The image shows the text "510(k) Summary K182880" at the top. Below that is the logo for Halifax Biomedical Inc. The logo includes a square with arrows pointing inward and the company name in two lines, with "Halifax" in a larger, orange font and "Biomedical Inc." in a smaller, blue font.
11493 Route 19, Mabou Nova Scotia, Canada, BOE 1X0 Phone +1 902 945 2762 Fax +1 902 945 2324 Chad Munro, CEO, President Date Prepared: October 30, 2018
1. Identification of the Device:
Proprietary-Trade Name: Halifax Imaging Kit Regulation Number: 892.1680 Regulation Name: Stationary x-ray system. Regulatory Class: II Product Codes: KPR, MQB, LLZ Common/Usual Name: Stationary X-Ray System
- Equivalent legally marketed device: Halifax SR Suite 1.0, K121345 Regulation Number: 892.1680 Regulation Name: Stationary x-ray system. Regulatory Class: II Product Codes: KPR, MQB, LLZ Common/Usual Name: Stationary X-Ray System
3. Contact:
Daniel Kamm, P.E., Tel 239-234-1735, Email fda.help.now@gmail.com
-
- Indications for Use: This is a stationary digital x-ray system for general radiography and RSA (Roentgen Stereophotogrammetric Analysis procedures). Not for mammography.
-
- Description of the Device: The Halifax SR Suite consists of two X-Ray imaging systems; the two systems are integrated through a synchronization switch. The switch allows the two X-Ray imaging systems to fire simultaneously, providing a pair of X-Ray images from different perspectives to be taken at the exact same time. This process allows for Roentgen Stereophotogrammetric Analysis (RSA). RSA is a stereo x-ray technique that enables measurements more precise than single plane radiography based on phantom precision studies. The resulting level of precision provides measurements of joint replacement stability.
The Halifax Imaging Kit is part of the SR Suite product line and provides an alternative path to creating an SR Suite. The Halifax Imaging Kit consists of FDA cleared and/or certified X-Ray components integrated into an existing digital radiography room already containing an FDA cleared x-ray imaging system to form an SR Suite. The exposures of the Halifax Imaging Kit and the existing Digital Radiography (DR) system are synchronized by replacing the trigger switches of the two systems with either the Universal Synchronization Switch or the Imaging Kit Control Module (IKCM).
4
The Universal Synchronization Switch or IKCM ensures the two X-Ray imaging systems fire simultaneously, therefore providing a pair of X-Ray images from two different perspectives taken at the exact same time. There are two versions of the Halifax Imaging Kits:
a) UNIVERSAL SYNCHRONIZATION (NON-GE BASED CONFIGURATION) The Universal Synchronization Switch synchronizes two independent X-ray systems as accurately as possible by using the manual pushbutton interface of each X-ray system. This replaces the synchronization switch that was described in our predicate K121345.
b) IMAGING KIT CONTROL MODULE (GE BASED CONFIGURATION) The general purpose of the IKCM is to coordinate and control the activities of the detector and workstation with the activities of the generator, as well as coordinate the exposures between the client's clinical system and the Halifax Imaging Kit for RSA exposures. The current version of the IKCM is designed specifically for interfacing with the following components:
•GEHC WDR1 Upgrade Kit which consists of a 'Flashpad' detector, a workstation named 'MagicPC', and a 'Cabinet' for power distribution and communication control. Integrating with a pre-existing system (GEHC Discovery XR656 Plus).
· EMD Technologies Epsilon Series generator. (Or generators already on site)
Image /page/4/Picture/5 description: The image shows a diagram of a setup with two cameras positioned at an angle of 30 degrees relative to a central point. The cameras are mounted above a black platform, and the distance from the cameras to the platform is labeled as 150 cm. The cameras are pointed downwards, and their fields of view converge on the platform, which has two objects with red lines and crosshairs on them.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench and standards testing indicates that the new device is as safe and effective as the predicate device. Risk analysis has been performed.
-
- Substantial Equivalence Chart, Halifax Imaging Kit
5
| Characteristic | Halifax SR Suite 1.0 K121345 | Halifax Imaging Kit Option
*Utilizes existing radiography system
OR new components. |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | This is a stationary digital x-ray system for
general radiography and RSA (Roentgen
Stereophotogrammetric Analysis
procedures.) Not for mammography. | This is a stationary digital x-ray system for
general radiography and RSA (Roentgen
Stereophotogrammetric Analysis
procedures.) Not for mammography. |
| Generator | Sedecal SHF635RF (Two used) | • Sedecal SHF515C or
• Sedecal SHF635RF
• Or equivalent Sedecal Generator
• EMD Epsilon Generator
(Two generators used) |
| Maximum output | 64 kW (Two used) | 45-80 kW depending on model selected
(Two used) or units already in place. |
| Stand | Sedecal and Acceleray | Utilizes existing radiography system OR
SYFM Stand |
| Image Acquisition | Digital, dual panels. | Digital, dual panels. |
| Digital Panel Size | 17 x 17 | 17 x 17 or 14 x 17 or 16 x 16 (Flashpad) |
| Digital Panel
Supplier | Canon CXDI-50RF (Two used, cleared in
K092429) | Two of any of the following (all previously
cleared):
• Agfa DX-D30C or
• Canon CXDI-501G or
• Canon CXDI-70C or
• Canon CXDI-701C or
• GE Flashpad (WDR1 Kit)
• Any imaging panel with 510(k) clearance
which meets Halifax validation criteria. |
| Digital Resolution | Pixel size 160 × 160 µm
Image matrix size 2208 × 2688 pixels
Number of pixels Approx. 5.9 million pixels | Agfa DX-D30C 139 µm 7.9 million pixels
Canon CXDI-501G 125 µm 9.5 million pixels
Canon CXDI-70C 125 um 9.5 million pixels
Canon CXDI-701C 125 µm 9.5 million pixels
200 µm , 4.1 million pixels
GE Flashpad |
| Software | The SR Suite employs the software cleared
in K042383, the RSA-CMS. The software
was designed specifically to perform
Roentgen Stereophotogrammetric Analysis. | Unchanged |
| Acquisition
Software | SR Suite 1.0 employs the acquisition
software cleared in K092429 for the digital
panel. | Unchanged |
| Collimator | Ralco R225 | Ralco R225 Unchanged |
| Safety | UL listings and EMC Tested. | UL listed and EMC tested power supply
used in the Imaging Kit |
Reference to Digital Panel Clearances:
6
8. Summary of Bench Testing and development activities conducted:
The following Risk Management and Risk Analysis documents were created:
Risk Management Plan - Halifax Imaging Kit Risk Management Plan - Imaging Kit Control Module Risk Analysis - Imaging Kit Control Module Risk Analysis - Halifax Imaging Kit - L-Arm Support Fault-Tree Analysis - Imaging Kit Control Module
Design Verification Testing of the Universal Synchronization Switch was performed in order to verify (a) Proper Board level functionality, firmware and (b) Proper Enclosure internal wiring assemblies and connections. Finite element analysis was performed on the support structures followed by design verification reviews.
Verification and Validation reports were executed for the new Imaging Kit, Control Module, and Universal Synchronization Switch.
Labeling: Installation and User Manuals were developed for the modified portions of the system, and the original labeling was updated according to the FDA Guidance on Cybersecurity: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014.
The following reports were prepared documenting bench testing activities:
Design Verification Test, Universal Synchronization Switch
Imaging Kit Control Module Verification Report
Imaging Kit Control Module Validation Test Report
In addition a Requirements Traceability analysis was performed for the Imaging Kit Control Module. The power supply chosen for the Imaging Kit Control Module is UL listed and EMC compliant for medical applications per IEC Standards: IEC 60601-1 and IEC 60601-1-2.
Every installation undergoes a precision validation test prior to turn over to the customer. "The precision of a Radiostereometric Analysis (RSA) System is affected by the components of the RSA System set-up as well as by the features of the individual joint and implant under examination. To validate a new Halifax Imaging Kit at "[Hospital]" in [City] ([Room details]), [State/Province], [Country], a phantom study was undertaken using a small carbon fibre box. Phantom studies, commonly used for RSA validation [1-12], are a technique used to calculate in vitro precision and accuracy of an RSA System."
-
- Summary of Clinical Testing: Clinical testing was not required to establish equivalence because all of the new digital receptor panels already have their own 510(k) clearances.
-
- Conclusion: After analyzing bench testing, standards testing data, and risk analysis it is the conclusion of Halifax Biomedical that the Halifax Imaging Kit Option is as safe and effective as the predicate device, has no significant technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.