(24 days)
No
The summary describes hardware and software updates focused on image processing and system performance, but does not mention AI or ML.
No
The device is a mini C-arm X-ray system used for diagnostic imaging, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is designed for "diagnostic" visualization.
No
The device description clearly states it is a "mobile fluoroscopic mini C-arm system" and includes hardware components such as a C-arm support, image workstation, Flat Panel Detector (FPD), image processing board, and power manager board. While it includes software modifications, it is not solely software.
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 Orthoscan TAU Mini C-arm is an imaging device that uses fluoroscopic X-rays to visualize internal structures of the body in real-time. It does not analyze biological samples.
- Intended Use: The intended use clearly states "general fluoroscopic visualization... of a patient" for diagnostic, surgical, and critical emergency care procedures. This involves imaging the patient directly, not analyzing samples from the patient.
- Device Description: The description reinforces that it's a "mobile fluoroscopic mini C-arm system that provides fluoroscopic images of patients."
The device is a medical imaging device, specifically a fluoroscopic X-ray system, 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 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 proposed modifications to Orthoscan, Inc. TAU Mini C-Arm series (which we will refer to internally and in this submittal as Orthoscan TAU 2.0, for distinction from predicate Orthoscan TAU) retain identical function as the predicate TAU Mini C-arm (K183220) as a mobile fluoroscopic mini C-arm 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 changes to the Orthoscan TAU series of Mini C-arm X-ray systems represent a modification of our presently legally marketed device Orthoscan TAU mini C-Arm K183220. The proposed modifications to the predicate encompass the implementation of an optional IGZO 15 cm x 15 cm Flat Panel Detector (FPD) in the 15x12cm and 15x15cm device detector sizes, a new LINUX based operating system and related software, image processing board revisions and a revised Power Manager Board for AC to DC conversion that will distribute 24Vdc via a medical grade DC power supply. The proposed device incorporates software architecture and other improvements that replicate the features and functions of the predicate device and improve image clarity without increasing dose levels.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Pulsed or continuous 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 modified and the predicate device Orthoscan, Inc. TAU (K183220). Numerous Image comparison sets were taken and a Radiologist performed an assessment of individual images arranged in groups of image sets.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Bench testing, image comparison study.
Sample Size: Not specified, "Numerous Image comparison sets".
Key Results: Radiologist concluded that the image quality at same or similar patient dose rates will result in a slight improvement in patient care (images) for the proposed modified TAU device over the Predicate device. The complete system works as intended and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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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October 21, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Orthoscan, Inc. % Mr. Kevin Bridgman Director of Regulatory Affairs and Quality Assurance 14555 N. 82nd Street SCOTTSDALE AZ 85260
Re: K213113
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, MQB Dated: September 21, 2021 Received: September 27, 2021
Dear Mr. Bridgman:
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
1
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 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) K213113
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 when imaging limbs/extremities, 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/1 description: The image shows the logo for Orthoscan. The logo consists of a stylized letter "C" in blue, followed by a vertical blue line. To the right of the line is the word "ORTHOSCAN" in black, with each letter evenly spaced.
U.S. Food and Drug Administration Center for Devices and Radiological Health Document Mail Center -W066-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002
Volume 005 Special 510(k) Summary
Special 510 (k) Premarket Notification Submission- Orthoscan, Inc. TAU Mini C-Arm
Date: September 21, 2021
In accordance with the requirements of 21 CFR §807.92 the following Special 510(k) summary of information is provided:
| Submitter Address: | Orthoscan, Inc.
14555 N 82nd St.
Scottsdale, AZ 85260
Phone: (480) 503-8010
Fax: (480) 503-8011 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Kevin Bridgman
14555 N 82nd St.
Scottsdale, AZ 85260
Cell: (909) 262-9930
Phone: (480) 503-8010
Fax: (480) 503-8011 |
| Secondary Contact
Person: | Brenda Sparks
14555 N 82nd St.
Scottsdale, AZ 85260
Phone: (480) 503-8010
Fax: (480) 503-8011 |
4
ORTHOSCAN
Proposed Device:
Device Trade Name: 510(k) Number: Common /Usual Names:
Device Class: Classification(s): Classification Names: Device: Product Code:
21CFR 807.92(a)(2)
21 CFR 807.92(a)(3)
Orthoscan, Inc. TAU Mini C-Arm Unknown at this time Fluoroscopic X-Ray System, Mobile Mini Mobile C-arm, Mini C-arm Class II 21CFR 892.1650 image-intensified fluoroscopic x-ray system, mobile Image-intensified fluoroscopic x-ray system. OXO, JAA, MQB
Predicate Device:
Device Identification: Classification(s): Device Class: Classification Names: Regulation Description: Product Codes:
General Description:
Orthoscan, Inc. TAU Mini C-Arm (K183220) 21CFR 892.1650 Class II Image-intensified fluoroscopic x-ray system, mobile Image-intensified fluoroscopic x-ray system OXO, JAA, MQB
The proposed modifications to Orthoscan, Inc. TAU Mini C-Arm series (which we will refer to internally and in this submittal as Orthoscan TAU 2.0, for distinction from predicate Orthoscan TAU) retain identical function as the predicate TAU Mini C-arm (K183220) as a mobile fluoroscopic mini C-arm 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 changes to the Orthoscan TAU series of Mini C-arm X-ray systems represent a modification of our presently legally marketed device Orthoscan TAU mini C-Arm K183220. The proposed modifications to the predicate encompass the implementation of an optional IGZO 15 cm x 15 cm Flat Panel Detector (FPD) in the 15x12cm and 15x15cm device detector sizes, a new LINUX based operating system and related software, image processing board revisions and a revised Power Manager Board for AC to DC conversion that will distribute 24Vdc via a medical grade DC power supply. The proposed device incorporates software architecture and other improvements that
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Image /page/5/Picture/0 description: The image shows the logo for Orthoscan. The logo consists of a stylized letter "C" in blue, followed by a vertical blue line. To the right of the line is the word "ORTHOSCAN" in black sans-serif font.
replicate the features and functions of the predicate device and improve image clarity without increasing dose levels.
For both the predicate and proposed device, the following are unchanged; Identical C-arm support and mechanical connections, balancing, locking, rotations, work-station platform, monitor display and main user interface controls, touch screen interface, selectable imaging, X-ray technique control, entry of patient information, wired or wireless footswitch operation, interface connection panel and DICOM fixed wire and wireless network interfaces.
The proposed modifications to Orthoscan, Inc. TAU Mini C-Arm series do not change the identical intended use. Intended use is the same as the predicate device TAU (K183220) Mini C-Arm.
Indications for Use: The Orthoscan TAU Mini C-arm is designed to provide physicians with general fluoroscopic visualization, usinq 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, emergency, traumatology, orthopedic, critical care, or physician office environments.
The proposed modifications to Orthoscan, Inc. TAU Mini C-Arm series do not change the indications for use. The indications for use are the same as the predicate device TAU (K183220) Mini C-Arm.
Technology: The changes to proposed device Orthoscan TAU 2.0 series of Mini C-arm X-ray systems represent a modification of our presently legally marketed device Orthoscan TAU Mini C-Arm K183220. The proposed device will provide an option in supplier of detectors. The optional IGZO Solid-State X-ray Imagers (SSXI) provide newer technology in the Flat Panel Detectors (FPD). The inclusion of IGZO detector size 15cmx15cm in the 15cmx15cm sized Orthoscan device will also be fitted into the smaller active field
Intended Use:
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model 15cmx12cm sized device with minor mechanical modifications.
The proposed modified TAU 2.0 will be equipped with a revised Power Manager Board for AC to DC conversion that will distribute 24vdc via a new medical grade DC power supply. This supply will power all electronic sub-assemblies. The AC to DC conversion will provide intrinsic value through risk reduction such as leakage, while standardizing distribution of 24Vdc.
With the introduction of a Linux based operating system (OS) an open source highly secure OS, and revisions to the image processing board, software architecture design has been improved and functions are identical to that of the predicate device Orthoscan, Inc. TAU Mini C-arm (K183220).
Summary of Technological Characteristics: The comparisons of the proposed modifications to Orthoscan, Inc. TAU Mini C-Arm demonstrate that the scientific and technology characteristics indicate substantial equivalence to the predicate device Orthoscan, Inc. TAU Mini C-Arm (K183220). The following table provides a comparison of the technology characteristics.
| Differences
Features/Technology: | Modified Device Orthoscan,
Inc. TAU 2.0 Mini C-Arms
model#/sizes, serial
number prefix:
1000-0015, 15x12cm,
Serial No. sequence
5Txxx
1000-0016, 15x15cm,
Serial No. sequence
5Uxxx
1000-0017, 20x20cm,
Serial No. sequence
5Vxxx | Predicate Device Orthoscan,
Inc. TAU Mini C-Arms
model#/sizes, and serial
number prefix;
1000-0015, 15x12cm,
Serial No. sequence
5Nxxx
1000-0016, 15x15cm,
Serial No. sequence
5Pxxx
1000-0017, 20x20cm,
Serial No. sequence
5Rxxx
(K183220) | 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 | New Proposed Device -
unknown at this time | K183220 | New Proposed Device -
unknown at this time |
| Detector Specifications | | | |
| CMOS and IGZO Flat Panel
Detector/Image Receptor | CsI(T1)/ solid state X-ray
detector
20x20cm remains CMOS
same as predicate.
15x12cm and 15x15cm
will be CMOS or optional
IGZO | CsI(T1)/ solid state X-ray
detector
20x20cm, 15x15cm and
15x12cm are CMOS | Substantially Equivalent.
The introduction of the
optional IGZO technology
was found to be equal in
safety and effectiveness
including image quality
(Essential Performance).
IGZO sensor technology
demonstrates equal/
better image quality to
that of the predicate. The
IGZO detector features
the same scintillator
technology and equal or
improved active area,
pixel pitch, frame rate, X-
Ray energy, power
specifications and
mechanical dimensions,
and also has identical
image processing features
as the predicate.
IGZO based detectors are
manufactured using
processes that are similar
to CMOS detectors. The
slight differences in used
sensor glass technology
does not have influence
on safety & effectiveness
of the product and
provides slightly improved
image quality at equal
dose values as the
predicate. |
| Detector Resolution | TAU 2.0 2020 =2.0k x
2.2k
TAU 2.0 1515 =1.5 k x
1.5k
TAU 2.0 1512 =2.0 k x
1.5k | TAU 2020 =2.0k x 2.2 k
TAU 1515 =1.5k x 1.5k
TAU 1512 =2.0 x 1.5k | Identical |
| Field of View (Full) | TAU 2.0 2020 = 8" x 8"
TAU 2.0 1515 = 5.5" x
5.5"
TAU 2.0 1512 = 5.5" x
4.3" | TAU 2020 = 8" x 8"
TAU 1515 = 5.5" x 5.5"
TAU 1512 = 5.5" x 4.3" | Substantially Equivalent.
The 15x12cm model will
be mechanically modified
to house the 15x15cm
IGZO Flat Detector for a
useful array area
15x12cm. The difference
does not affect the safety
or efficacy of the device |
| Field of View (Collimated Mag
Mode) | TAU 2.0 2020 = 4" x 4"
TAU 2.0 1515 = 4.3" x
4.3"
TAU 2.0 1512 = 4.3" x
3.3" | TAU 2020 = 4" x 4"
TAU 1515 = 4.3" x 4.3"
TAU 1512 = 4.3" x 3.3" | Identical to predicate |
| Detector Size | TAU 2.0 2020 = 20 x
20cm
TAU 2.0 1515 = 15 x
15cm
TAU 2.0 1512 = 15 x
15cm | TAU 2020 = 20 x 20 cm
TAU 1515 = 15 x 15 cm
TAU 1512 = 15 x 12 cm | Substantially Equivalent.
The TAU 2.0 (15x12cm)
model will be
mechanically modified to
house the 15x15cm IGZO
Flat Detector for a useful
array area 15x12cm. The
difference does not affect
the safety or efficacy of
the device. |
| Useful Array | TAU 2.0 2020 = 20 x
20cm
TAU 2.0 1515 = 15 x
15cm
TAU 2.0 1512 = 15 x
15cm | TAU 2020 = 20 x 20 cm
TAU 1515 = 15 x 15 cm
TAU 1512 = 15 x 12 cm | Substantially Equivalent.
The TAU 2.0 (15x12cm)
model will be
mechanically modified to
house the 15x15cm IGZO
Flat Detector for a useful
array area 15x12cm. The
difference does not affect
the safety or efficacy of
the device. |
| Pixel Spacing | TAU 2.0 2020 = 99
microns
TAU 2.0 1515 = same for
CMOS or 100microns for
IGZO detector
TAU 2.0 1512 = same for
CMOS or 100microns for
IGZO detector | TAU 2020 = 99 microns
TAU 1515 = 100 microns
TAU 1512 = 75 microns | Substantially Equivalent.
The difference for the
TAU 2.0 15x12 cm IGZO
detector pixel spacing
does not affect the
safety or efficacy of the
device. |
| Dynamic Range | TAU 2.0 same for CMOS
or >69dB for IGZO | TAU 2020 = 71 dB
TAU 1515 = 71 dB
TAU 1512 = 70 dB | Substantially Equivalent
The difference in dynamic
range for the IGZO
detector does not affect
the safety or efficacy of
the device. |
| DQE | TAU 2.0 2020 = 70%
TAU 2.0 1515 = same for
CMOS or 65% for IGZO
TAU 2.0 1512 = same for
CMOS or 65% for IGZO | TAU 2020 = 70%
TAU 1515 = 70%
TAU 1512 = 70% | Substantially Equivalent.
The difference in DQE for
the IGZO detector does
not affect the safety or
efficacy of the device. |
| A/D Conversion | 16 bit | 16 bit | 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
Brightness/Contrast Control | 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 | YES | Identical |
| Adult Dose Reduction IDR | YES | YES | Identical |
| Software | | | |
| Software Architecture | OrthoTouch Application | OrthoMini Application | Software architecture design is Substantially Equivalent to that of the predicate device Orthoscan, Inc. TAU Mini C-arm (K183220). The OrthoTouch Application provides the main user interface to Orthoscan fluoroscopic X-Ray products, identical to OrthoMini, application. OrthoTouch on LINUX operating system performs equal to OrthoMini. |
| Graphical User Interface (GUI) | OrthoTouch Application | OrthoMini Application | Substantially Equivalent GUI application are nearly Identical in workflows to achieve the same basic functionality with new proposed device software application. During verification and validation activities this change did not raise any safety and/or effectiveness concerns. The difference does not affect the safety or efficacy of the device. |
| Operating system | LINUX Ubuntu 16.04, Embedded | Windows 8.1 Embedded | Substantially Equivalent operating system was shown to support nearly identical workflows to achieve the same basic functionality with new proposed device software application. During verification and validation activities this change did not raise any safety and/or effectiveness concerns. The difference does not affect the safety or efficacy of the device. |
| Pediatric Workflow Support | Yes | Yes | Identical |
| Measurement | Yes | Yes | Identical |
| 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 | Yes | Identical |
| HVL Filter | 2.5mm
(Al Equivalent) | 2.5mm
(Al Equivalent) | Identical |
| Magnification Mode | Yes | Yes | 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) | 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) | Identical |
| Physical Dimensions: | | | |
| Source to Image | 17.7" (45cm) | 17.7" (45cm) | Identical |
| Free space | 13.8" | 13.8" | Identical |
| Arc Depth | 20" | 20" | Identical |
| Pivot | 430° | 430° | Identical |
| Lateral Rotation
B + Y axis (Wig-Wag) | 320° | 320° | Identical |
| Orbital Rotation | 160° | 160° | Identical |
| 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 | 475lb | Identical |
| Height | 49" | 49" | Identical |
| Footprint | 28" x 33" | 28" x 33" | Identical |
| Power System | | | |
| Input Power | 250W AC to DC 24Vdc,
90-264 VAC @ 50/60Hz
power supply medical
grade. | 90-253 VAC @ 47-63 Hz | Substantially equivalent. |
| EMI Filter | Yes | FN2060B-6-06 | Substantially Equivalent.
TAU 2.0 consist of an AC
to DC 24vdc power
supply with in line filter
and isolation. |
| AC Power Cord | Retractable (25ft) | Retractable (25ft) | Identical |
| Isolation Transformer | Yes | Yes | Substantially Equivalent.
TAU 2.0 consist of an AC
to DC 24vdc power supply
with in line filter and
isolation. |
| UPS (Battery Backup) | TAU 2020 Optional
TAU 1515 Optional
TAU 1512 Optional | TAU 2020 Optional
TAU 1515 Optional
TAU 1512 Optional | Identical |
| 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 shows the logo for Orthoscan. The logo consists of a stylized letter "C" in blue, followed by a vertical blue line. To the right of the line is the word "ORTHOSCAN" in black, with each letter evenly spaced.
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Image /page/8/Picture/0 description: The image shows the word "ORTHOSCAN" in a simple, sans-serif font. To the left of the word is a blue vertical line and a blue abstract symbol that resembles a stylized letter "C". The overall design is clean and modern, with a focus on simplicity and readability.
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Image /page/9/Picture/0 description: The image shows the logo for Orthoscan. The logo consists of a stylized letter "C" in blue, followed by a vertical blue line. To the right of the line is the word "ORTHOSCAN" in black sans-serif font.
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Image /page/10/Picture/0 description: The image shows the word "ORTHOSCAN" in a sans-serif font. The letters are spaced out evenly and are all uppercase. To the left of the word is a blue graphic that looks like a stylized letter "C" and a vertical line.
11
O R T H O S C A N
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Image /page/12/Picture/0 description: The image shows the logo for Orthoscan. The logo consists of a stylized blue "C" shape on the left, followed by a vertical blue line. To the right of the line is the word "ORTHOSCAN" in a simple, sans-serif font.
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Image /page/13/Picture/0 description: The image shows the logo for Orthoscan. The logo consists of a stylized letter 'e' in blue, followed by a vertical blue line. To the right of the line is the word 'ORTHOSCAN' in all capital letters.
Conclusion of Table Information:
The changes and differences of the proposed Orthoscan, Inc. TAU Mini C-Arm described in the table do not change the control mechanism, operating principle, energy type, or intended use found on the predicate device Orthoscan, Inc. TAU Mini C-Arm (K183220).
| Adverse Effects on Health: | The proposed modified Orthoscan, Inc. 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, Inc. 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: Annex II of the European Medical Devices Directive (MDD) 93/42/EEC.
Please see EC Certificate for predicate devices EC Declaration of Conformity in VOL 009 FILES 003 and FILE 009
EN ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes. Date: 2016. Please see Certificate in Volume 009 File 013
IEC 60601-1 Medical Electrical Equipment, General Requirements for Safety IEC 60601-1:200 5 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint). No Recognized Conformance Standard but is general basis of AAMI/ANSI ES60601-1 conformance standard 19-4.
Please see CB test report in VOL_017_EMC-Eectrical Safety FILE007
IEC 60601-1-2 MEDICAL ELECTRICAL EQUIPMENT - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-2:2014 Conformance Standard #19-8
Please see CB test report in VOL_017_FILE017 and FILE019
14
ORTHOSCAN
IEC 60601-1-3
Medical Electrical Equipment, Radiation Protection in Diagnostic X-ray Equipment
Edition 2.1, Date: 2013 Conformance Standard #12-269 Please see CB test report in VOL017 EMC-Eectrical Safety_FILE009
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
Please see CB test report in VOL017 EMC-Electrical Safety FILE011
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 1.1, 2015 #12-296
Please see CB test report in VOL017_EMC-Electrical Safety FILE013
Orthoscan understands that the FDA will accept declarations of conformity, in support of premarket submissions, to [Rec # 12-296] until September 28, 2021. After this transition period, declarations of conformity to [Rec # 12-296] will not be accepted.
IEC 60825-1
Safety of laser products, Equipment Safety, requirements, and user guide
Edition 2.0, Date: 2007-03-30 Conformance Standard #12-273
See predicate (K183220) Test reports VOL 018 Performance testing
ISO 14971
Medical devices - Application of risk management to medical devices
Edition 2.0, Date: 2007-03-01 Conformance Standard #5-40
Compliance is shown by risk management and software Verification and Validation documentation see Volume 016_Software.
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Image /page/15/Picture/0 description: The image shows the logo for Orthoscan. The logo consists of a stylized letter "C" in blue, followed by a vertical blue line. To the right of the line is the word "ORTHOSCAN" in black, all caps.
Determination of Substantial Equivalence:
Summary Bench Testing
Verification and Validation including hazard mitigations executed resulted in demonstrated system that met Design Input and user needs.
The device was tested by notified test laboratory resulting in device being certified compliant with 60601-1 ED 3 series, including IEC 60601-2-54. Further, the device met all applicable sections of 21 CFR Subchapter J performance standards.
The proposed modified Orthoscan, Inc. 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 Analvsis
- Required reviews ●
- Design reviews ●
- Component testing ●
- Integration testing ●
- . Performance testing
- Safety testing ●
- . Product use testing
Performance bench testing included:
Non-clinical testing methods specific to quidance for submission of 510(k)s for Solid State X-Ray Imaging Devices (SSXI); demonstrating system, and imaging performance. 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 modified and the predicate device Orthoscan, Inc. TAU (K183220). Numerous Image comparison sets were taken and a Radiologist performed an assessment of individual images arranged in groups of image sets. His conclusion was the image quality at same or similar patient dose rates will result in a slight improvement in patient care (images) for the proposed modified TAU device over the Predicate device. Therefore, Orthoscan, Inc. believes the TAU Mini C-arm image quality, safety and effectiveness to be substantially equivalent to that of the predicate device Orthoscan, Inc. TAU (K183220).
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Image /page/16/Picture/0 description: The image shows the logo for Orthoscan. The logo consists of a stylized letter "C" in blue, followed by a vertical blue line. To the right of the line is the word "ORTHOSCAN" in black, with each letter evenly spaced.
Summary of Clinical Test Data:
Orthoscan, Inc. TAU mobile fluoroscopic Mini C-arm system did not require live human clinical studies to support substantial equivalence in accordance with the TAU 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, Inc. 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, Inc. TAU Mini C-Arm in comparison to the predicate Orthoscan, Inc. TAU Mini C-Arm (K183220). Evaluation of the images was conducted by a board-certified Radiologist. His conclusion was the image quality at the same or equivalent patient dosage will result in a slight improvement in patient care (images) for the proposed modified TAU device over the Predicate 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.
Conclusion:
Orthoscan, Inc. considers the proposed modified Orthoscan, Inc. TAU Mini C-arm to be as safe, as effective, and performs substantially equivalent to the predicate device Orthoscan, Inc. TAU Mini C-arm (K183220) in accordance with its labeling.