(213 days)
No
The document describes a standard fluoroscopic C-arm system with image processing capabilities, but there is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The C-arm is used for "general fluoroscopic visualization... for diagnostic, surgical, and critical emergency care procedures," which are diagnostic imaging purposes, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed to provide physicians with general fluoroscopic visualization... including but not limited to, diagnostic, surgical, and critical emergency care procedures." The "Device Description" also mentions its use during "diagnostic, treatment and surgical procedures."
No
The device description clearly outlines a physical C-arm system with an X-ray source, detector, and workstation, indicating it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
- The OrthoScan TAU Mini C-arm is an imaging device that uses X-rays to visualize anatomical structures within the patient's body. It does not analyze biological samples.
The description clearly states its purpose is to provide "general fluoroscopic visualization... of a patient" and describes its use in procedures involving imaging limbs, extremities, and shoulders. This is consistent with an in-vivo imaging device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OrthoScan TAU Mini C-arm is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including pediatic populations when imaging limbs/extremities, shoulders; at locations including but not limited to, hospitals, ambulatory surgery, emergency, traumatology, orthopedic, critical care, or physician office environments.
Product codes
OXO, JAA, MQB
Device Description
The OrthoScan TAU Mini C-Arm is a mobile fluoroscopic mini Carm system that provides fluoroscopic images of patients of all ages during diagnostic, treatment and surgical procedures involving anatomical regions such as but not limited to that of extremities, limbs, shoulders, knees, and Hips. The system consists of C-arm support attached to the image workstation. The proposed device provides the option of three CMOS flat panel detector sizes and identical X-ray source HVPS monoblock generator assembly with continuous or pulsed operation for image acquisition.
The C-arm supports the CMOS FPD, X-Ray controls, collimator, high voltage generator with a fixed SID imaging. The C-arm and support arm which is connected to the mobile workstation platform are mechanically balanced allowing the operator precise positioning and locking of the vertical, horizontal, orbital and rotational movements at various angles and distances when imaging the patient's anatomical structures.
The main workstation platform that supports the C-arm assembly contains the power control system, image processing system, system software, monitor display control and main user interface controls. The combination of C-Arm and workstation provides the clinician with a stable platform to obtain precise angles for localizing the patient's anatomical structures and visualization of pathology during live fluoroscopic imaging.
The touch screen interface and keyboard provide user concise selectable imaging, X-ray technique control, entry of patient demographics and related procedural information. The workstation supports both an optional wired or wireless fluoroscopic footswitch allowing optimal positioning for the clinician. The optional connector interface panel of the OrthoScan TAU Mini C-Arm provides convenient connection of peripheral devices such as thermal video printers, image storage devices (USB) and DICOM fixed wire and wireless network interfaces.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy, X-Ray
Anatomical Site
Limbs/extremities, shoulders, knees, and Hips.
Indicated Patient Age Range
All ages including pediatric populations.
Intended User / Care Setting
Physicians; hospitals, ambulatory surgery, emergency, traumatology, orthopedic, critical care, or physician office environments.
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
Anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms were employed. Images were taken by both the new TAU Mini C-arm and predicate device OrthoScan FD (K133174) and the Ziehm Solo FD (K161976). Image comparison sets taken were representative of both the adult and pediatric populations. A Radiologist performed an assessment of 330 individual images arranged in 20 groups of image sets.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-clinical image and dose Lab testing, image comparison study.
Sample Size: 330 individual images arranged in 20 groups of image sets.
Key Results: The Radiologist's conclusion was that the image quality combined with a reduced patient dosage would result in a significant improvement in patient care for the TAU device over the Predicate device. OrthoScan believes the TAU Mini C-arm image quality, safety and effectiveness to be substantially equivalent to that of the predicate devices at a lower entrance dose level.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
OrthoScan FD Mini C-Arm (K133174), Ziehm Solo FD (K161976)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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, there 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. Below the square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
June 21, 2019
Orthoscan, Inc. % Mr. Steve D. Seeman Director of Quality Assurance and Regulatory Affairs 14555 N. 82nd St. SCOTTSDALE AZ 85260
Re: K183220
Trade/Device Name: OrthoScan TAU Mini C-Arm Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OXO, JAA and MQB Dated: June 3, 2019 Received: June 4, 2019
Dear Mr. Seeman:
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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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 medical devices and radiation-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
2
Indications for Use
510(k) Number (if known) K183220
Device Name OrthoScan TAU Mini C-Arm
Indications for Use (Describe)
The OrthoScan TAU Mini C-arm is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including pediatic populations when imaging limbs/extremittes, shoulders; at locations including but not limited to, hospitals, ambulatory surgery, emergency, traumatology, orthopedic, critical care, or physician office environments.
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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Image /page/3/Picture/0 description: The image is a logo for OrthoScan Imaging Excellence. The logo features a blue square on the left with a white abstract design inside. To the right of the square is the word "ORTHOSCAN" in large, bold, black letters. Below the word "ORTHOSCAN" is the phrase "IMAGING EXCELLENCE" in smaller, blue letters.
510(k) Summary
510 (k) Premarket Notification Submission- OrthoScan TAU Mini C-Arm
In accordance with the requirements of 21 CFR §807.92 the following 510(k) summary of information is provided:
| Submitter Address: | OrthoScan
14555 N 82nd St.
Scottsdale, AZ 85260
Phone: (480) 503-8010
Fax: (480) 503-8011 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Richard Westrich
14555 N 82nd St.
Scottsdale, AZ 85260
Cell: (909) 262-9930
Phone: (480) 503-8010
Fax: (480) 503-8011 |
| Secondary Contact Person: | Steve Seeman
14555 N 82nd St.
Scottsdale, AZ 85260
Phone: (480) 503-8010
Fax: (480) 503-8011 |
4
Image /page/4/Picture/0 description: The image shows the logo for OrthoScan Imaging Excellence. The logo features a blue square on the left with a white abstract image inside. To the right of the square is the word "OrthoScan" in a bold, black font. Below "OrthoScan" is the phrase "Imaging Excellence" in a smaller, blue font.
Proposed Device:
Device Trade Name: 510(k) Number: Common Names:
Device Class: Regulation Number: Regulation Name: Product Code:
Primary Predicate Device:
Device Identification: Requlation Number: Device Class: Requlation Name: Product Codes:
Secondary Predicate Device:
Device Identification: Regulation Number: Device Class: Requlation Name: Product Codes:
General Description:
21CFR 807.92(a)(2)
OrthoScan TAU Mini C-Arm K183220 Fluoroscopic X-Ray System, Mobile Mini Mobile C-arm, Mini C-arm Class II 21CFR 892.1650 image-intensified fluoroscopic x-ray system OXO, JAA, MQB
21 CFR 807.92(a)(3)
OrthoScan FD Mini C-Arm (K133174) 21CFR 892.1650 Class II Image-intensified fluoroscopic x-ray system OXO, JAA, MQB
21 CFR 807.92(a)(3)
Ziehm Solo FD (K161976) 21CFR 892.1650 Class II Image-intensified fluoroscopic x-ray system OXO, JAA, MQB
The OrthoScan TAU Mini C-Arm is a mobile fluoroscopic mini Carm system that provides fluoroscopic images of patients of all ages during diagnostic, treatment and surgical procedures involving anatomical regions such as but not limited to that of extremities, limbs, shoulders, knees, and Hips. The system consists of C-arm support attached to the image workstation. The proposed device provides the option of three CMOS flat panel detector sizes and identical X-ray source HVPS monoblock generator assembly with continuous or pulsed operation for image acquisition.
The C-arm supports the CMOS FPD, X-Ray controls, collimator, high voltage generator with a fixed SID imaging. The C-arm and support arm which is connected to the mobile workstation platform are mechanically balanced allowing the operator precise positioning and locking of the vertical, horizontal, orbital and
5
Image /page/5/Picture/0 description: The image is a logo for OrthoScan Imaging Excellence. The logo features a blue square on the left with a white abstract design inside. To the right of the square is the word "ORTHOSCAN" in large, bold, black letters. Below the word "ORTHOSCAN" is the phrase "IMAGING EXCELLENCE" in smaller, blue letters.
rotational movements at various angles and distances when imaging the patient's anatomical structures.
The main workstation platform that supports the C-arm assembly contains the power control system, image processing system, system software, monitor display control and main user interface controls. The combination of C-Arm and workstation provides the clinician with a stable platform to obtain precise angles for localizing the patient's anatomical structures and visualization of pathology during live fluoroscopic imaging.
The touch screen interface and keyboard provide user concise selectable imaging, X-ray technique control, entry of patient demographics and related procedural information. The workstation supports both an optional wired or wireless fluoroscopic footswitch allowing optimal positioning for the clinician. The optional connector interface panel of the OrthoScan TAU Mini C-Arm provides convenient connection of peripheral devices such as thermal video printers, image storage devices (USB) and DICOM fixed wire and wireless network interfaces.
OrthoScan TAU Mini C-Arm is intended to provide fluoroscopic images of the patient including but not limited to, diagnostic, surgical, and critical emergency care procedures during diagnostic or therapeutic treatment/surgical procedures of the upper and lower extremities.
Indications for Use: The OrthoScan TAU Mini C-Arm is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including pediatric populations when imaging limbs/extremities, shoulders; at locations including but not limited to, hospitals, ambulatory surgery, eemergency, traumatology, orthopedic, critical care, or physician office environments.
Intended Use:
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Image /page/6/Picture/0 description: The image shows the logo for OrthoScan. The logo consists of a blue square on the left with a white abstract design inside. To the right of the square is the word "OrthoScan" in a large, bold, serif font. Below "OrthoScan" is the phrase "IMAGING EXCELLENCE" in a smaller, sans-serif font.
| Technology: | The proposed modified device OrthoScan TAU Mini C-arm
employs the same fundamental control, and scientific technology
as that of our predicate devices OrthoScan FD Mini C-arm
(K133174) and the Ziehm Solo FD (K161976). |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The radiation control, HVPS X-Ray monoblock generator, power
supplies as well as our advanced imaging system are identical to
the predicate OrthoScan FD Mini C-arm (K133174). |
| | Software architecture design is identical to that of the predicate
device OrthoScan FD Mini C-arm (K133174) with modification of
the software to support pediatric indication of use, low dose
functionality, processing applications related to the optional
range of FPD sizes, Variable beam limiting device, and device
specific features. |
| | The primary modifications of the C-Arm include a larger but
virtually the same medical grade CsI(T1)/CMOS solid state X-ray
detector as that of the predicate OrthoScan FD Mini C-Arm
(K133174) and the Ziehm Solo FD (K161976). A variable beam
limiting device for precise collimating to anatomical structures,
new pre-filter for pediatric imaging, touch control monitor,
optional UPS power supply, incorporation of mechanical design
improvements in the C-Arm and mobile workstation balancing,
locks, and maneuverability improving operator workflow during
extended procedures while keeping the essential smaller profile
of our predicate OrthoScan FD Mini C-arm (K133174). |
| Summary of Technological
Characteristics: | The following table provides a comparison of the technological
characteristics of the proposed device OrthoScan TAU Mini C-Arm
to that of the predicate device demonstrates that the scientific
and technology characteristics are substantial equivalence to the
predicate device OrthoScan FD mini C-Arm (K133174). |
| Differences
Features/Technology: | New Device
OrthoScan TAU Mini C-Arm
TAU 1512 -1000-0015,
TAU 1515- 1000-0016,
TAU 2020- 1000-0017 | Predicate Device
OrthoScan FD 1000-
0004
(K133174) | Comparison to Predicate,
Comments to Differences |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Codes | | | |
| Device Classification Name | image-intensified
fluoroscopic x-ray system,
mobile | image-intensified
fluoroscopic x-ray
system, mobile | Identical |
| Regulation Description | Image-intensified
fluoroscopic x-ray system. | Image-intensified
fluoroscopic x-ray
system. | Identical |
| Classification Product Code | OXO | OXO | Identical |
| Subsequent Product Code | JAA | JAA | Identical |
| Regulation Number | 892.165 | 892.165 | Identical |
| Device Class | II | II | Identical |
| Non-Contact Device | Non-Contact | Non-Contact | Identical |
| 510(k) Panel Review | Radiology | Radiology | Identical |
| 510(K) Number | OrthoScan TAU unknown
at this time | K133174 | OrthoScan TAU unknown
at this time |
| Detector Specifications | | | |
| CMOS Flat Panel
Detector/Image Receptor | medical grade
CsI(T1)/CMOS solid state
X-ray detector | medical grade
GadOx (T1)/CMOS solid
state X-ray detector | All Detectors of the TAU
Mini C-Arm are of similar
design Technology and
Scientific principal to that
of the Predicate
(K133174) They share the
advantages of SSXI image
receptors. |
| Detector Resolution | TAU 2020 = 2.0k x 2.2 k | 1.5 k x 1.5 k | Substantially Equivalent.
The proposed device has
added the ability of a |
| | TAU 1515 = 1.5 k x 1.5 k | | larger FOV for Physician.
These changes do not
raise new safety or |
| | TAU 1512 = 2.0 k x 1.5 k | | effectiveness concerns. |
| Field of View (Full) | TAU 2020 = 8" x 8" | 5.5" × 5.5" | Substantially Equivalent.
The proposed device has |
| | TAU 1515 = 5.5" x 5.5" | | added the ability of a
larger FOV for Physician.
These changes do not |
| | TAU 1512 = 5.5" x 4.3" | | raise new safety or
effectiveness concerns. |
| Field of View (Collimated Mag
Mode) | TAU 2020 = 4" x 4" | 4.3" x 4.3" | Substantially Equivalent.
The proposed device has |
| | TAU 1515 = 4.3" x 4.3" | | added the ability of a
larger Field of view for the
Physician. |
| | TAU 1512 = 4.3" x 3.3" | | These changes do not
raise new safety or
effectiveness concerns. |
| Detector Size | TAU 2020 = 20 x 20 cm | 15.0 x 15.0 (cm) | Substantially Equivalent.
The proposed device has
added the ability of a |
| | TAU 1515 = 15 x 15 cm | | larger Field of view for the
Physician. |
| | TAU 1512 = 15 x 12 cm | | The difference does not
affect the safety or
efficacy of the device. |
| Useful Array | TAU 2020 = 20 x 20 cm | 15.0 x 15.0 (cm) | Substantially Equivalent. |
| | | | |
| | TAU 1515 = 15 x 15 cm | | The proposed device has
added the ability of a
larger Field of view for the
Physician. |
| | TAU 1512 = 15 x 12 cm | | The difference does not
affect the safety or
efficacy of the device. |
| | TAU 2020 = 99 microns | | Substantially Equivalent |
| Pixel Spacing | TAU 1515 = 100 microns | 100 microns | The difference does not
affect the safety or |
| | TAU 1512 = 75 microns | | efficacy of the device. |
| Dynamic Range | TAU 2020 = 71 dB | | Substantially Equivalent |
| | TAU 1515 = 71 dB | | The difference does not
affect the safety or |
| | TAU 1512 = 70 dB | | efficacy of the device. |
| DQE | TAU 2020 = 70% | | Identical |
| | TAU 1515 = 70% | | The difference does not
affect the safety or |
| | TAU 1512 = 70% | | efficacy of the device. |
| Grayscale Resolution | 16 bit (65,536 shades of
gray) | 16 bit (65,536 shades of
gray) | Identical |
| Image Processing Features | | | |
| Startup time | 30 sec | 30 sec | Identical |
| Cine Loop Export | Yes | Yes | Identical |
| Fluoroscopy Frame Rate | 30/15/7.5/2 fps | 30/15/7.5/2 fps | Identical |
| Edge Enhancement | Yes | Yes | Identical |
| Post Process
Brightness/Contrast | Yes | Yes | Identical |
| Adaptive Noise Suppression | Automatic | Automatic | Identical |
| Manual Noise Suppression | 3 Modes | 3 Modes | Identical |
| AERC Automatic X-Ray
Technique Control | YES | YES | Identical |
| Adaptive Noise Filter | Noise reduction | Noise reduction | Identical |
| Save and Auto Store | YES | YES | Identical |
| Last image hold | YES | YES | Identical |
| Edge Enhancement | YES | YES | Identical |
| Cine Loop Frame Rate | 30 fps | 30 fps | Identical |
| Snapshot Capabilities | YES | YES | Identical |
| Post Processing (B/C) | YES | YES | Identical |
| Image invert | YES | YES | Identical |
| Image Zoom | YES | YES | Identical |
| Manual Noise Suppression | 4 modes | 4 modes | Identical |
| Image Documentation: | | | |
| Wireless Communication (Wi-
Fi)/(WLAN) | Capable IEEE 802.11 | Capable IEEE 802.11 | Identical |
| DICOM 3 Compliant | Yes | Yes | Identical |
| MPPS | Capable | Capable | Identical |
| RDSR | YES | YES | Identical |
| Image Capacity | 26, 000 | 26, 000 | Identical |
| Video Capacity | 14.4 min | 14.4 min | Identical |
| Cine Loop Export | Yes | Yes | Identical |
| TP Link High Gain Wireless USB | Option | Option | Identical |
| USB Ports | 2 | 2 | Identical |
| Printer option | 2 | 2 | Identical |
| Dose Measurement | | | |
| Air Kerma (US-Standard) | YES | YES | Identical |
| DAP (Optional in the US) | Optional | Optional | Identical |
| Pediatric Features | | | |
| Pediatric Dose Reduction IDR | YES | NO | IDR unique set of features
and functions. Pediatric
Dose reduction and
special features for
pediatric population. Dose
assessment and image
comparison of dose
reduction for pediatric
confirmed similar image
quality with new IDR filter
The difference does not
affect the safety or
efficacy of the device. See
Substantially Equivalent |
| Adult Dose Reduction IDR | YES | NO | IDR unique set of features
and functions for Adult
population. Dose
assessment and image
comparison of dose
reduction confirmed
similar image quality with
new IDR filter
The difference does not
affect the safety or
efficacy of the device.
Substantially Equivalent |
| Software Architecture | OrthoMini Application | OrthoMini Application | Software architecture design is Substantially Equivalent to that of the predicate device OrthoScan FD Mini C-arm (K133174) with modification of the software to support pediatric indication of use, low dose functionality, processing applications related to the optional range of FPD sizes, Variable beam limiting device, and device specific features. |
| Graphical User Interface
(GUI) | OrthoMini Application | OrthoMini Application | Similar operation
however, with new device TAU the software is configured to support pediatric functionality not available be on OrthoScan
FD.
The difference does not affect the safety or efficacy of the device.
Substantially Equivalent |
| Operating system | Windows 8.1 Embedded | Windows 8.1 Embedded | Identical |
| Pediatric Workflow Support | Yes | No | Not available on predicate
The changes to the proposed device do not raise new safety or effectiveness concerns |
| Measurement | Yes | No | Not available on predicate
The changes to the proposed device do not raise new safety or effectiveness concerns |
| X-Ray Generator Specifications | | | |
| Focal Spot | 42.5 microns | 42.5 microns | Identical |
| kV Range | 40 - 78 kVp | 40 - 78 kVp | Identical |
| mA Range | 0.04 - 0.160 mA | 0.04 - 0.160 mA | Identical |
| Operating Mode | Pulse/ Continuous | Pulse/ Continuous | Identical |
| Pulse Rate | 2 to 30 pps | 2 to 30 pps | Identical |
| Beam Pre-filter 0.1mm Cu | Yes | No | Predicate has 2.5mm AL
and complies with the regulations for HVL in x-
ray beam.
New Device X-ray beam pre-filter helps reduce |
| | | | skin entrance dose by
adding additional filtration
of Cu. |
| HVL Filter | 2.5mm
(Al Equivalent) | 2.5mm
(Al Equivalent) | Identical |
| Magnification Mode | Yes | Yes | Both support mag modes
of operation nearly
Identical |
| Collimator | TAU 1512 Fixed Aperture
@ Fixed SID
(Normal, Mag)
TAU 1515 Fixed Aperture
@ Fixed SID
(Normal, Mag)
TAU 2020
Stepless Collimator with
Fixed SID
(4 Leaf, 2 Axis) | Fixed Aperture @ Fixed
SID (Normal, Mag) | Although not Identical
both have similar indented
use of collimating X-ray
beam providing
compliance with the
regulations.
Substantially Equivalent |
| Physical Dimensions: | | | |
| Source to Image | 17.7" (45cm) | 17.7" (45cm) | Identical |
| Free space | 13.8" | 13.8" | Identical |
| Arc Depth | 20" | 19" | Substantially Equivalent
Provides more depth for
procedures in clinical
use. The change to the
proposed device does
not raise new safety or
effectiveness concerns |
| Pivot | 430° | 430° | Identical |
| Lateral Rotation
B + Y axis (Wig-Wag) | 320° | 320° | Identical |
| Orbital Rotation | 160° | 150° | Substantially Equivalent
The change to the
proposed device does
not raise new safety or
effectiveness concerns |
| Vertical Range | 26.5" | 26.5" | Identical |
| Distance to Cabinet | max 68" | max 68" | Identical |
| Distance to Wheel base | max 45" | max 45" | Identical |
| Weight | 475lb | 400lb | Substantially Equivalent
The change to the
proposed device does
not raise new safety or
effectiveness concerns |
| Height | 48" | 44.5" | Substantially Equivalent
The change to the
proposed device does
not raise new safety or
effectiveness concerns |
| Footprint | 28" x 33" | 28" x 33" | Identical |
| Power System | | | |
| Input Power | 90-253 VAC @ 47-63 Hz | 90-253 VAC @ 47-63 Hz | Identical |
| EMI Filter | FN2060B-6-06 | FN2060B-6-06 | Identical |
| AC Power Cord | Retractable (25ft) | Retractable (25ft) | Identical |
| Isolation Transformer | Yes | Yes | Identical |
| EMI Filter | Yes | Yes | Identical |
| UPS (Battery Backup) | TAU 2020 Optional
TAU 1515 Optional
TAU 1512 Optional | No | Power system of the
Predicate device and the
new Device TAU are
Substantially Equivalent
The proposed new device
TAU Mini C-arm added
an optional backup
battery (UPS) to protect
the data integrity of the
system if the device
experiences a sudden
loss of power e.g. power
Line outage, accidental
disconnect of power cord
from main power etc.
The UPS allows for
limited additional power
for controllable exit or to
complete a short
duration of in-progress
procedure. Safety
testing confirms this
change did not raise any
new safety and
effectiveness concerns. |
| Laser Alignment: | | | |
| Laser position indicator | Yes | Yes | Identical |
| Surgical Lights: | | | |
| Light bar assemblies | Yes | Yes | Identical |
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Image /page/7/Picture/0 description: The image contains the logo for OrthoScan Imaging Excellence. The logo features a blue square on the left side with a white abstract design inside. To the right of the square, the word "OrthoScan" is written in a bold, black font. Below "OrthoScan", the words "Imaging Excellence" are written in a smaller, blue font.
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Image /page/8/Picture/0 description: The image shows the logo for OrthoScan. The logo consists of a blue square on the left with a white abstract image inside. To the right of the square is the word "OrthoScan" in large, black, sans-serif font. Below the word "OrthoScan" is the phrase "IMAGING EXCELLENCE" in a smaller, blue, sans-serif font.
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Image /page/9/Picture/0 description: The image shows the logo for OrthoScan Imaging Excellence. The logo features a blue square on the left with a white abstract image of a face. To the right of the square is the word "OrthoScan" in large, black, sans-serif font. Below "OrthoScan" is the phrase "IMAGING EXCELLENCE" in a smaller, blue, sans-serif font.
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Image /page/10/Picture/0 description: The image is a logo for OrthoScan. The logo consists of a blue square on the left with a white abstract design inside, followed by the word "ORTHOSCAN" in large, bold, black letters. Below "ORTHOSCAN" is the phrase "IMAGING EXCELLENCE" in smaller, blue letters.
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Image /page/11/Picture/0 description: The image is a logo for OrthoScan Imaging Excellence. The logo features a blue square on the left with a stylized white image of a face. To the right of the square is the word "OrthoScan" in a large, bold, black font. Below "OrthoScan" is the phrase "IMAGING EXCELLENCE" in a smaller, blue font.
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Image /page/12/Picture/0 description: The image shows the logo for OrthoScan Imaging Excellence. The logo features a blue square on the left with a white abstract image of a face. To the right of the square is the word "ORTHOSCAN" in black, with the words "IMAGING EXCELLENCE" in blue underneath.
Conclusion:
The changes and differences of the proposed OrthoScan TAU Mini C-Arm described in the table do not change the control mechanism, operating principle, energy type, or intended
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Image /page/13/Picture/0 description: The image shows the logo for OrthoScan Imaging Excellence. The logo features a blue square on the left side with a white abstract design inside. To the right of the square is the word "OrthoScan" in large, bold, black letters. Below "OrthoScan" is the phrase "IMAGING EXCELLENCE" in smaller, blue letters.
use found on predicate device OrthoScan FD Mini C-Arm (K133174). In addition, given the high similarity between the legally marketed Solo FD K161976 and the OrthoScan TAU mini C-Arm K183220 we believe that this additional predicate demonstrates that the OrthoScan TAU mini C-Arm K183220 is intended for the same pediatric populations and provide the same intended use and indication for use when imaging all pediatric patient populations
Adverse Effects on Health: The proposed OrthoScan TAU Mini C-arm's potential radiation, mechanical, and electrical hazards are identified and analyzed as part of risk management, and controlled by meeting the applicable CDRH 21CFR subchapter J performance requirements, Recognized Consensus Standards, designing and manufacturing under OrthoScan Quality System, and system verification and validation testing ensure the device performs to the product specifications and its intended use. The adherence to these applicable regulations and certification to Recognized Consensus Standards that apply to this product provides the assurance of device safety and effectiveness.
Applicable Standards:
MDD 93/42/EEC Annex II of the European Medical Devices Directive (MDD) 93/42/EEC.
EN ISO 13485
Medical devices - Quality management systems - Requirements for regulatory purposes
IEC 60601-1 Medical Electrical Equipment, General Requirements for Safety Edition 3.0 (+Corr.1+Corr.2), Date: 2005-12-15
Applicable Standards:
Medical Electrical Equipment, General Requirements for Safety, Electromagnetic Compatibility Edition 3.0, Date: 2007-03-30, Conformance Standard #19-1
IEC 60601-1-3
IEC 60601-1-2
Medical Electrical Equipment, Radiation Protection in Diagnostic X-ray Equipment Edition 2.1, Date: 2013-04 Conformance Standard #12-269
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Image /page/14/Picture/0 description: The image is a logo for OrthoScan. The logo consists of a blue square on the left side with a white abstract image inside. To the right of the square is the word "ORTHOSCAN" in large, black, sans-serif font. Below the word "ORTHOSCAN" is the phrase "IMAGING EXCELLENCE" in a smaller, blue, sans-serif font.
60601-2-28 Edition 2 (2010/03/10) Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis Conformance Standard #12-309
Applicable Standards:
IEC 60601-2-54
Medical electrical equipment, Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy Edition 1.0, Date: 2009-06-29 Conformance Standard #12-274
IEC 60825-1
Safety of laser products, Equipment Safety, requirements, and user quide Edition 2.0. Date: 2007-03-30 Conformance Standard #12-273
ISO 14971
Medical devices - Application of risk management to medical devices Edition 2.0, Date: 2007-03-01 Conformance Standard #5-40
Determination of Substantial Equivalence:
Summary Bench Testing
Verification and Validation including hazard mitigations executed resulted in demonstrated system met Design Input and user needs.
The device was tested by the notified test laboratory resulting in device being certified compliant with 6060-1-1 ED 3 series, including IEC 60601-2-54. Further device met all applicable sections of 21 CFR Subchapter J performance standards.
The OrthoScan TAU Mini C-Arm development occurred under our design control processes, software development processes, and overall quality management system. They included but are not limited to,
- Risk Analysis
- Required reviews
- Design reviews ●
- Component testing
- Integration testing ●
- Performance testing ●
- Safety testing ●
- . Product use testing
Performance bench testing included:
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Image /page/15/Picture/0 description: The image is a logo for OrthoScan Imaging Excellence. The logo features a blue square on the left with a white abstract image of a face. To the right of the square is the word "OrthoScan" in large, bold, black letters. Below "OrthoScan" is the phrase "IMAGING EXCELLENCE" in smaller, blue letters.
Non-clinical testing methods specific to guidance for submission of 510(k)s for Solid State X-Ray Imaging Devices (SSXI); demonstrating system, and imaging performance. Further in line with UCM089742-Premarket Assessment of Pediatric Medical Devices May 24, 2014 and UCM 302938- Pediatric Information for Xray Imaging Device Premarket Notifications Nov 28, 2017. Non-clinical image and dose Lab testing, were employed. Anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms were employed, images were taken by both the new TAU Mini C-arm and predicate device OrthoScan FD (K133174) and the Ziehm Solo FD (K161976). Image comparison sets taken were representative of both the adult and pediatric populations. A Radiologist performed an assessment of 330 individual images arranged in 20 groups of image sets. His conclusion was the image quality combined with a reduced patient dosage will result in a significant improvement in patient care for the TAU device over the Predicate device. Therefore, OrthoScan believes the TAU Mini C-arm image quality, safety and effectiveness to be substantially equivalent to that of the predicate devices at a lower entrance dose level.
OrthoScan TAU mobile fluoroscopic mini C-arm system did not require live human clinical studies to support substantial equivalence in accordance with the FDA quidance Documents, UCM089742- Premarket Assessment of Pediatric Medical Devices May 24, 2014 and UCM 302938- Pediatric Information for X-ray Imaging Device Premarket Notifications Nov 28, 2017. Therefore, OrthoScan conducted a lab test image comparison study employing the use of anthropomorphic phantoms in establishing substantial equivalence based on the modifications to the proposed device and the bench data taken with OrthoScan TAU Mini C-Arm in comparison to the predicate OrthoScan FD Mini C-Arm K133174. Evaluation of the 330 individual images arranged in 20 groups of image sets was conducted by a board-certified Radiologist. His conclusion was the image quality combined with a reduced patient dosage will result in a significant improvement in patient care for the TAU device. His comparison of the dose and images provided further evidence in addition to the laboratory performance data that the complete system works as intended and is substantially equivalent to the predicate device.
Summary of Clinical Test Data:
K183220 510(K) Summary