OrthoScan TAU Mini C-Arm

K183220 · Orthoscan, Inc. · OXO · Jun 21, 2019 · Radiology

Device Facts

• Record ID: K183220
• Device Name: OrthoScan TAU Mini C-Arm
• Applicant: Orthoscan, Inc.
• Product Code: OXO · Radiology
• Decision Date: Jun 21, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

Intended 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/extremittes, 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 visualization of patient anatomy (limbs, extremities, shoulders). System comprises C-arm support, CMOS flat panel detector (FPD), X-ray source, and mobile workstation. Operator uses touch screen/keyboard to control X-ray technique, image acquisition, and processing. Features include pulsed/continuous fluoroscopy, variable beam limiting, and pediatric dose reduction (IDR) filters. Used in hospitals, ORs, and clinics by physicians/technicians. Output displayed on monitor for live visualization of pathology/anatomy during procedures. Benefits include precise anatomical localization and reduced radiation dose via IDR technology. Optional UPS ensures data integrity during power loss.

Clinical Evidence

Bench testing only. No human clinical studies conducted. Performance validated using anthropomorphic (PMMA) and anatomical simulation phantoms. A board-certified radiologist assessed 330 images across 20 sets, comparing the subject device to predicates. Results demonstrated equivalent image quality with reduced patient entrance dose.

Technological Characteristics

Mobile fluoroscopic X-ray system. Materials: CsI(Tl)/CMOS solid-state X-ray detector. Energy: Pulsed/continuous X-ray generator (40-78 kVp). Connectivity: DICOM 3.0, IEEE 802.11 (Wi-Fi), USB. Software: Windows 8.1 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 of patients of all ages, including pediatric populations, during diagnostic, surgical, and critical emergency care procedures involving limbs, extremities, and shoulders in clinical 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 FD Mini C-Arm (K133174)
• Ziehm Solo FD (K161976)

Submission Summary (Full Text)

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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

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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) 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*)

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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<br>14555 N 82nd St.<br>Scottsdale, AZ 85260<br>Phone: [phone]<br>Fax: [phone] |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Richard Westrich<br>14555 N 82nd St.<br>Scottsdale, AZ 85260<br>Cell: [phone]<br>Phone: [phone]<br>Fax: [phone] |
| Secondary Contact Person: | Steve Seeman<br>14555 N 82nd St.<br>Scottsdale, AZ 85260<br>Phone: [phone]<br>Fax: [phone] |

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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

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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<br>employs the same fundamental control, and scientific technology<br>as that of our predicate devices OrthoScan FD Mini C-arm<br>(K133174) and the Ziehm Solo FD (K161976). |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The radiation control, HVPS X-Ray monoblock generator, power<br>supplies as well as our advanced imaging system are identical to<br>the predicate OrthoScan FD Mini C-arm (K133174). |
| | Software architecture design is identical to that of the predicate<br>device OrthoScan FD Mini C-arm (K133174) with modification of<br>the software to support pediatric indication of use, low dose<br>functionality, processing applications related to the optional<br>range of FPD sizes, Variable beam limiting device, and device<br>specific features. |
| | The primary modifications of the C-Arm include a larger but<br>virtually the same medical grade CsI(T1)/CMOS solid state X-ray<br>detector as that of the predicate OrthoScan FD Mini C-Arm<br>(K133174) and the Ziehm Solo FD (K161976). A variable beam<br>limiting device for precise collimating to anatomical structures,<br>new pre-filter for pediatric imaging, touch control monitor,<br>optional UPS power supply, incorporation of mechanical design<br>improvements in the C-Arm and mobile workstation balancing,<br>locks, and maneuverability improving operator workflow during<br>extended procedures while keeping the essential smaller profile<br>of our predicate OrthoScan FD Mini C-arm (K133174). |
| Summary of Technological<br>Characteristics: | The following table provides a comparison of the technological<br>characteristics of the proposed device OrthoScan TAU Mini C-Arm<br>to that of the predicate device demonstrates that the scientific<br>and technology characteristics are substantial equivalence to the<br>predicate device OrthoScan FD mini C-Arm (K133174). |

| Differences<br>Features/Technology: | New Device<br>OrthoScan TAU Mini C-Arm<br>TAU 1512 -1000-0015,<br>TAU 1515- 1000-0016,<br>TAU 2020- 1000-0017 | Predicate Device<br>OrthoScan FD 1000-<br>0004<br>(K133174) | 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<br>system, mobile | Identical |
| Regulation Description | Image-intensified<br>fluoroscopic x-ray system. | Image-intensified<br>fluoroscopic x-ray<br>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<br>at this time | K133174 | OrthoScan TAU unknown<br>at this time |
| Detector Specifications | | | |
| CMOS Flat Panel<br>Detector/Image Receptor | medical grade<br>CsI(T1)/CMOS solid state<br>X-ray detector | medical grade<br>GadOx (T1)/CMOS solid<br>state X-ray detector | All Detectors of the TAU<br>Mini C-Arm are of similar<br>design Technology and<br>Scientific principal to that<br>of the Predicate<br>(K133174) They share the<br>advantages of SSXI image<br>receptors. |
| Detector Resolution | TAU 2020 = 2.0k x 2.2 k | 1.5 k x 1.5 k | Substantially Equivalent.<br>The proposed device has<br>added the ability of a |
| | TAU 1515 = 1.5 k x 1.5 k | | larger FOV for Physician.<br>These changes do not<br>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.<br>The proposed device has |
| | TAU 1515 = 5.5" x 5.5" | | added the ability of a<br>larger FOV for Physician.<br>These changes do not |
| | TAU 1512 = 5.5" x 4.3" | | raise new safety or<br>effectiveness concerns. |
| Field of View (Collimated Mag<br>Mode) | TAU 2020 = 4" x 4" | 4.3" x 4.3" | Substantially Equivalent.<br>The proposed device has |
| | TAU 1515 = 4.3" x 4.3" | | added the ability of a<br>larger Field of view for the<br>Physician. |
| | TAU 1512 = 4.3" x 3.3" | | These changes do not<br>raise new safety or<br>effectiveness concerns. |
| Detector Size | TAU 2020 = 20 x 20 cm | 15.0 x 15.0 (cm) | Substantially Equivalent.<br>The proposed device has<br>added the ability of a |
| | TAU 1515 = 15 x 15 cm | | larger Field of view for the<br>Physician. |
| | TAU 1512 = 15 x 12 cm | | The difference does not<br>affect the safety or<br>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<br>added the ability of a<br>larger Field of view for the<br>Physician. |
| | TAU 1512 = 15 x 12 cm | | The difference does not<br>affect the safety or<br>efficacy of the device. |
| | TAU 2020 = 99 microns | | Substantially Equivalent |
| Pixel Spacing | TAU 1515 = 100 microns | 100 microns | The difference does not<br>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<br>affect the safety or |
| | TAU 1512 = 70 dB | | efficacy of the device. |
| DQE | TAU 2020 = 70% | | Identical |
| | TAU 1515 = 70% | | The difference does not<br>affect the safety or |
| | TAU 1512 = 70% | | efficacy of the device. |
| Grayscale Resolution | 16 bit (65,536 shades of<br>gray) | 16 bit (65,536 shades of<br>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<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 (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-<br>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…