Orthoscan Tau Mini C-Arm

K213113 · Orthoscan, Inc. · OXO · Oct 21, 2021 · Radiology

Device Facts

• Record ID: K213113
• Device Name: Orthoscan Tau Mini C-Arm
• Applicant: Orthoscan, Inc.
• Product Code: OXO · Radiology
• Decision Date: Oct 21, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Mobile fluoroscopic mini C-arm system; provides real-time X-ray imaging for diagnostic and surgical procedures. Inputs: X-ray radiation passing through patient anatomy; captured by flat panel detector (FPD). Transformation: X-ray signals converted to digital images via image processing board; enhanced by software (OrthoTouch application). Output: Fluoroscopic images displayed on workstation monitor for physician review. Used in OR, clinic, and emergency settings by physicians/technicians. Clinical decision-making: assists in orthopedic/surgical guidance; enables real-time visualization of anatomy/implants. Benefits: improved image clarity at equal or lower dose levels compared to predicate; supports pediatric imaging workflows.

Clinical Evidence

No clinical data; bench testing only. Performance evaluated using anthropomorphic (PMMA) and anatomical simulation phantoms. A board-certified radiologist performed a comparative assessment of image sets from the subject and predicate devices, concluding the subject device provides slight improvement in image quality at equivalent patient dose rates.

Technological Characteristics

Mobile fluoroscopic X-ray system. Detectors: CMOS or optional IGZO (15x15cm, 15x12cm, 20x20cm). Energy: Pulsed/continuous fluoroscopy, 40-78 kVp, 0.04-0.160 mA. Connectivity: DICOM 3 compliant, wired/wireless network, Wi-Fi (IEEE 802.11). Power: 24Vdc medical grade supply. Software: Linux Ubuntu 16.04 embedded. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 60825-1, ISO 14971.

Indications for Use

Indicated for general fluoroscopic visualization (pulsed or continuous) for patients of all ages, including pediatric populations, during diagnostic, surgical, and critical emergency care procedures. Anatomical regions include limbs, extremities, and shoulders. Used in hospitals, ambulatory surgery, emergency, traumatology, orthopedic, critical care, or physician office environments.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Orthoscan, Inc. TAU Mini C-Arm (K183220)

Submission Summary (Full Text)

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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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

. for

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) 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) | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|--|--|
| <span style="font-size:14px;"> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size:14px;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> | | |

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K213113

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.<br>14555 N 82nd St.<br>Scottsdale, AZ 85260<br>Phone: [phone]<br>Fax: [phone] |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Kevin Bridgman<br>14555 N 82nd St.<br>Scottsdale, AZ 85260<br>Cell: [phone]<br>Phone: [phone]<br>Fax: [phone] |
| Secondary Contact<br>Person: | Brenda Sparks<br>14555 N 82nd St.<br>Scottsdale, AZ 85260<br>Phone: [phone]<br>Fax: [phone] |

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# 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<br>Features/Technology: | Modified Device Orthoscan,<br>Inc. TAU 2.0 Mini C-Arms<br>model#/sizes, serial<br>number prefix:<br>1000-0015, 15x12cm,<br>Serial No. sequence<br>5Txxx<br>1000-0016, 15x15cm,<br>Serial No. sequence<br>5Uxxx<br>1000-0017, 20x20cm,<br>Serial No. sequence<br>5Vxxx | Predicate Device Orthoscan,<br>Inc. TAU Mini C-Arms<br>model#/sizes, and serial<br>number prefix;<br>1000-0015, 15x12cm,<br>Serial No. sequence<br>5Nxxx<br>1000-0016, 15x15cm,<br>Serial No. sequence<br>5Pxxx<br>1000-0017, 20x20cm,<br>Serial No. sequence<br>5Rxxx<br>(K183220) | Comparison to Predicate,<br>Comments to Differences |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Codes | | | |
| Device Classification Name | image-intensified<br>fluoroscopic x-ray system,<br>mobile | image-intensified<br>fluoroscopic x-ray system,<br>mobile | Identical |
| Regulation Description | Image-intensified<br>fluoroscopic x-ray system. | Image-intensified<br>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 -<br>unknown at this time | K183220 | New Proposed Device -<br>unknown at this time |
| Detector Specifications | | | |
| CMOS and IGZO Flat Panel<br>Detector/Image Receptor | CsI(T1)/ solid state X-ray<br>detector<br>20x20cm remains CMOS<br>same as predicate.<br>15x12cm and 15x15cm<br>will be CMOS or optional<br>IGZO | CsI(T1)/ solid state X-ray<br>detector<br>20x20cm, 15x15cm and<br>15x12cm are CMOS | Substantially Equivalent.<br>The introduction of the<br>optional IGZO technology<br>was found to be equal in<br>safety and effectiveness<br>including image quality<br>(Essential Performance).<br>IGZO sensor technology<br>demonstrates equal/<br>better image quality to<br>that of the predicate. The<br>IGZO detector features<br>the same scintillator<br>technology and equal or<br>improved active area,<br>pixel pitch, frame rate, X-<br>Ray energy, power<br>specifications and<br>mechanical dimensions,<br>and also has identical<br>image processing features<br>as the predicate.<br>IGZO based detectors are<br>manufactured using<br>processes that are similar<br>to CMOS detectors. The<br>slight differences in used<br>sensor glass technology<br>does not have influence<br>on safety & effectiveness<br>of the product and<br>provides slightly improved<br>image quality at equal<br>dose values as the<br>predicate. |
| Detector Resolution | TAU 2.0 2020 =2.0k x<br>2.2k<br>TAU 2.0 1515 =1.5 k x<br>1.5k<br>TAU 2.0 1512 =2.0 k x<br>1.5k | TAU 2020 =2.0k x 2.2 k<br>TAU 1515 =1.5k x 1.5k<br>TAU 1512 =2.0 x 1.5k | Identical |
| Field of View (Full) | TAU 2.0 2020 = 8" x 8"<br>TAU 2.0 1515 = 5.5" x<br>5.5"<br>TAU 2.0 1512 = 5.5" x<br>4.3" | TAU 2020 = 8" x 8"<br>TAU 1515 = 5.5" x 5.5"<br>TAU 1512 = 5.5" x 4.3" | Substantially Equivalent.<br>The 15x12cm model will<br>be mechanically modified<br>to house the 15x15cm<br>IGZO Flat Detector for a<br>useful array area<br>15x12cm. The difference<br>does not affect the safety<br>or efficacy of the device |
| Field of View (Collimated Mag<br>Mode) | TAU 2.0 2020 = 4" x 4"<br>TAU 2.0 1515 = 4.3" x<br>4.3"<br>TAU 2.0 1512 = 4.3" x<br>3.3" | TAU 2020 = 4" x 4"<br>TAU 1515 = 4.3" x 4.3"<br>TAU 1512 = 4.3" x 3.3" | Identical to predicate |
| Detector Size | TAU 2.0 2020 = 20 x<br>20cm<br>TAU 2.0 1515 = 15 x<br>15cm<br>TAU 2.0 1512 = 15 x<br>15cm | TAU 2020 = 20 x 20 cm<br>TAU 1515 = 15 x 15 cm<br>TAU 1512 = 15 x 12 cm | Substantially Equivalent.<br>The TAU 2.0 (15x12cm)<br>model will be<br>mechanically modified to<br>house the 15x15cm IGZO<br>Flat Detector for a useful<br>array area 15x12cm. The<br>difference does not affect<br>the safety or efficacy of<br>the device. |
| Useful Array | TAU 2.0 2020 = 20 x<br>20cm<br>TAU 2.0 1515 = 15 x<br>15cm<br>TAU 2.0 1512 = 15 x<br>15cm | TAU 2020 = 20 x 20 cm<br>TAU 1515 = 15 x 15 cm<br>TAU 1512 = 15 x 12 cm | Substantially Equivalent.<br>The TAU 2.0 (15x12cm)<br>model will be<br>mechanically modified to<br>house the 15x15cm IGZO<br>Flat Detector for a useful<br>array area 15x12cm. The<br>difference does not affect<br>the safety or efficacy of<br>the device. |
| Pixel Spacing | TAU 2.0 2020 = 99<br>microns<br>TAU 2.0 1515 = same for<br>CMOS or 100microns for<br>IGZO detector<br>TAU 2.0 1512 = same for<br>CMOS or 100microns for<br>IGZO detector | TAU 2020 = 99 microns<br>TAU 1515 = 100 microns<br>TAU 1512 = 75 microns | Substantially Equivalent.<br>The difference for the<br>TAU 2.0 15x12 cm IGZO<br>detector pixel spacing<br>does not affect the<br>safety or efficacy of the<br>device. |
| Dynamic Range | TAU 2.0 same for CMOS<br>or >69dB for IGZO | TAU 2020 = 71 dB<br>TAU 1515 = 71 dB<br>TAU 1512 = 70 dB | Substantially Equivalent<br>The difference in dynamic<br>range for the IGZO<br>detector does not affect<br>the safety or efficacy of<br>the device. |
| DQE | TAU 2.0 2020 = 70%<br>TAU 2.0 1515 = same for<br>CMOS or 65% for IGZO<br>TAU 2.0 1512 = same for<br>CMOS or 65% for IGZO | TAU 2020 = 70%<br>TAU 1515 = 70%<br>TAU 1512 = 70% | Substantially Equivalent.<br>The difference in DQE for<br>the IGZO detector does<br>not affect the safety or<br>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<br>Brightness/Contrast | Yes | Yes | Identical |
| Adaptive Noise Suppression | Automatic | Automatic | Identical |
| Manual Noise Suppression | 3 Modes | 3 Modes | Identical |
| AERC Automatic X-Ray<br>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<br>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-<br>Fi)/(WLAN) | Capable IEEE 802.11 | Capable IEEE 802.11 | Identical…