(28 days)
No
The description focuses on the hardware components and the RSA technique, which is a traditional stereophotogrammetric method. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The software mentioned (RSA-CMS) is cleared under an older K number (K042383), suggesting it predates widespread AI/ML adoption in medical imaging.
No.
The device is an x-ray system used for diagnostic imaging, specifically for Roentgen Stereophotogrammetric Analysis (RSA), which measures the stability of joint replacements. It does not actively treat or alleviate a medical condition.
Yes
The device is an x-ray system that produces images for Roentgen Stereophotogrammetric Analysis (RSA), which is used to precisely measure joint replacement stability. This measurement provides information about a patient's medical condition related to their joint stability, indicating a diagnostic function.
No
The device description explicitly lists multiple hardware components (Stand, Tube housings, Collimators, Reference Box Cover, SR reference box, Detector Plates, SR Support Arm) and describes their integration and function in acquiring X-ray images. While it mentions using previously cleared software (K042383, the RSA-CMS), the device itself is a physical X-ray system with associated hardware.
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 description clearly states this is a "stationary digital x-ray system for general radiography and RSA (Roentgen Stereophotogrammetric Analysis procedures)." It uses X-rays to image the internal structures of the body.
- Intended Use: The intended use is for imaging various anatomical sites in adult and pediatric subjects. This is a diagnostic imaging device, not a device that analyzes biological samples.
- Device Description: The components listed are typical of an X-ray system (stand, tube housings, detectors, etc.). The RSA functionality is a specific imaging technique, not an in vitro test.
Therefore, this device falls under the category of medical imaging devices, 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
KPR, MQB, LLZ
Device Description
The Halifax SR Suite is compromised of two regulatory approved 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 components are: 1: Stand. 2: Tube housings, 3: Collimators, 4: Reference Box Cover, 5: SR reference box, 6: Detector Plates, 7: SR Support Arm. The SR Suite employs the software cleared in K042383, the RSA-CMS.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts.
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained doctor or technician
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
Internal laboratory testing was performed to determine Effective Doses for RSA Examinations and RSA precision, including bench testing that was performed using phantoms to evaluate variables in the image acquisition (e.g., scatter, setup, marker size) that could impact the system performance. The precision was evaluated using a stationary carbon fiber phantom box and a rotating carbon fiber plate. Translational precision was evaluated by taking 10 repeated measures of the carbon fiber phantom box containing two grids of 26 tantalum beads, and by calculating the standard deviation of the repeated measurements of the inter-bead distance.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing including precision studies using phantoms. Translational precision was found to be x = 0.0018mm, y = 0.0017mm, and z =0.0039 mm. A combined precision was calculated using a rotating carbon fiber plate containing 47 tantalum beads, and was found to be 0.005mm. Software validation and risk analysis was performed. Clinical images were obtained to validate total system performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Translational Precision: x = 0.0018mm, y = 0.0017mm, z = 0.0039 mm.
Combined Precision: 0.005mm.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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510(k) Summary K121345 Halifax Biomedical Inc. 11493 Route 19, Mabou Nova Scotia, Canada, BOE 1XO +1 902 945 2762 Phone Fax +1 902 945 2324 Contact: Chad Munro, CEO President Date Prepared: June 1, 2012
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- Identification of the Device: Proprietary-Trade Name: SR Suite 1.0 Classification Name: Stationary X-ray system, Product Codes Product Codes KPR, MQB, and LLZ Common/Usual Name: Diagnostic X-ray Units with Digital X-ray receptor panel.
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- Indications for Use (intended use): This is a stationary digital x-ray system for general radiography and RSA (Roentgen Stereophotogrammetric Analysis procedures). Not for mammography.
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- Description of the Device: The Halifax SR Suite is compromised of two regulatory approved 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 components are: 1: Stand. 2: Tube housings, 3: Collimators, 4: Reference Box Cover, 5: SR reference box, 6: Detector Plates, 7: SR Support Arm. The SR Suite employs the software cleared in K042383, the RSA-CMS.
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The key difference between the Halifax SR Suite 1.0 and the predicate Sedecal Millennium is the use of 5. two generators, tube heads, collimators, and detector panels in order to be able to take simultaneous images from two angles as shown in the illustration above. This allows for the RSA-CMS software cleared in K042383. The SR Suite employs the RSA-CMS software cleared in K042383.
1
This software was designed specifically to perform Roentgen Stereophotogrammetric Analysis.
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- Testing summary: External laboratory safety and EMC testing was performed to standards IEC 60601 + Am1& 2 and IEC 60601-1-2. Internal laboratory testing was performed to determine Effective Doses for RSA Examinations and RSA precision, including bench testing that was performed using phantoms to evaluate variables in the image acquisition (e.g., scatter, setup, marker size) that could impact the system performance. The precision was evaluated using a stationary carbon fiber phantom box and a rotating carbon fiber plate. Translational precision was evaluated by taking 10 repeated measures of the carbon fiber phantom box containing two grids of 26 tantalum beads, and by calculating the standard deviation of the repeated measurements of the inter-bead distance. Translational precision was found to be x = 0.0018mm, y = 0.0017mm, and z =0.0039 mm. In the same manner, a combined precision was calculated using a rotating carbon fiber plate containing 47 tantalum beads. The combined precision was found to be 0.005mm. Software validation and risk analysis was performed. Clinical images were obtained to validate total system performance.
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- Safety and Effectiveness, comparison to predicate device. The results of bench, clinical, and standards testing indicates that the new device is as safe and effective as the predicate devices. Risk analysis has been performed.
| Characteristic | Sedecal Millennium Digital K090279 | Halifax SR Suite 1.0 |
|---|---|---|
| Intended Use: | These Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. | This is a stationary digital x-ray system for general radiography and RSA (Roentgen Stereophotogrammetric Analysis procedures.) Not for mammography. |
| Generator | Sedecal SHF635RF | Sedecal SHF635RF (Two used) |
| Maximum output | 50 kW to 80 kW. | 64 kW (Two used) |
| Stand | Supplied by Sedecal | Sedecal and Acceleray |
| Image Acquisition | Digital or Film | Digital, dual panels. |
| Digital Panel Size | 17 x 17 | 17 x 17 |
| Digital Panel | ||
| Supplier | Canon panels, multiple models: 50C, 50G, 40C & 40G | Canon CXDI-50RF (Two used, cleared in K092429) |
| Digital Resolution | Pixel size 160 × 160 $ μ $ m | |
| Image matrix size 2208 × 2688 pixels | ||
| Number of pixels Approx. 5.9 million pixels | Pixel size 160 × 160 $ μ $ m | |
| Image matrix size 2208 × 2688 pixels | ||
| Number of pixels Approx. 5.9 million pixels . | ||
| Software | DICOM, via O&R software cleared in K091364 | The SR Suite employs the software cleared in K042383, the RSA-CMS. The software was designed specifically to perform Roentgen Stereophotogrammetric Analysis. |
| Acquisition | ||
| Software | The Sedecal Millenium employs the acquisition softare cleared in the Canon digital panels: K023750, K031337, and K060433, | SR Suite 1.0 employs the acquisition software cleared in K092429 for the digital panel. |
| Collimator | Ralco or Heustis | Ralco R225 |
| Safety | UL. listed | UL, listed |
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- Substantial Equivalence Chart, Halifax SR Suite 1.0
Conclusion: After analyzing bench, clinical, risk analysis, and standards testing data; it is the 9. conclusion of Halifax Biomedical that the SR Suite 1.0 X-Ray System is as safe and effective as the predicate devices, has no significant technological differences, and has no new indications for use, (In fact USING the predicate devices) thus rendering it substantially equivalent to the predicate devices.
- Substantial Equivalence Chart, Halifax SR Suite 1.0
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Image /page/2/Picture/0 description: The image contains a logo for the Department of Health & Human Services USA. The logo features a stylized eagle or bird-like symbol with three distinct strokes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol, indicating the organization it represents.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
JUN - 1 2012
Halifax Biomedical, Inc. % Daniel Kamm. P.E. Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114
Re: K121345
Trade/Device Name: SR SUITE 1.0 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, LLZ, and MQB Dated: May 2, 2012 Received: May 4, 2012
Dear Mr. 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. 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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11 you don't the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):K12J345
Device Name: SR SUITE 1.0
Indications For Use:
This is a stationary digital x-ray system for general radiography and RSA (Roentgen Stereophotogrammetric Analysis procedures.) Not for mammography.
Prescription Use X (Part 21 CFR 801 Subpart D)
510K
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safoty
K121345
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