Planmed Verity

K143435 · Planmed OY · OAS · May 14, 2015 · Radiology

Device Facts

• Record ID: K143435
• Device Name: Planmed Verity
• Applicant: Planmed OY
• Product Code: OAS · Radiology
• Decision Date: May 14, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

Planmed Verity is intended to be used for X-ray computed tomography imaging of anatomies within upper and lower extremities and maxillofacial area. The device is to be operated and used by legally qualified health care professionals.

Device Story

Planmed Verity is a compact, stand-alone Cone Beam Computed Tomography (CBCT) system. It utilizes a flat panel detector and an X-ray tube that performs a single rotation around the target anatomy to acquire snapshot X-ray images. The system features a motorized gantry with adjustable height and tilt, supporting both non-weight-bearing and weight-bearing imaging (patient standing inside the gantry). The device is operated by qualified healthcare professionals in a clinical setting. It manages the entire imaging workflow, including patient information, acquisition, processing, and archiving. The system applies calibration corrections to raw data before reconstruction via a dedicated engine. The resulting high-resolution volumetric images assist clinicians in diagnostic assessment of extremities and the maxillofacial area.

Clinical Evidence

Clinical study evaluated image quality of the maxillofacial area using images from routine clinical practice at a university hospital. Results demonstrated that the device's patient positioning provides clinically sufficient image quality. Non-clinical evidence included physical laboratory testing comparing imaging performance, image quality, and dose levels against the predicate device.

Technological Characteristics

CBCT system with flat panel detector; motorized gantry with adjustable height/tilt; supports weight-bearing and non-weight-bearing imaging; pulsed X-ray radiation; dedicated reconstruction engine and algorithm; stand-alone unit.

Indications for Use

Indicated for X-ray computed tomography imaging of upper and lower extremities and maxillofacial area in patients requiring diagnostic imaging. To be used by qualified healthcare professionals.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Xoran xCAT (K061834)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 14, 2015

Planmed Ov % Lars Moring Regulatory Affairs Manager Sorvaaiankatu 7 Helsinki, 00880 FINLAND

Re: K143435

Trade/Device Name: Planmed Verity Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS, JAK Dated: April 24, 2015 Received: April 29, 2015

Dear Lars Moring:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K143435

Device Name Planmed Verity

Indications for Use (Describe)

Planmed Verity is intended to be used for X-ray computed tomography imaging of anatomies within upper and lower extremities and maxillofacial area.

The device is to be operated and used by legally qualified health care professionals.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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ENCLOSURE 2 P. 2-1

# 510(K) SUMMARY

DATE April 24th, 2015

#### PRODUCT, CLASSIFICATION NAME

Trade Name: Planmed Verity Common Name: Computed Tomography X-ray System Classification Name: Computed Tomography X-ray System Product codes: OAS (primary), JAK (secondary) Class: II Regulation: 21 CFR 892.1750

## MANUFACTURER

Planmed Oy Sorvaajankatu 7 00880 Helsinki, Finland Phone: [phone] Fax: [phone] Contact person: Lars Moring

#### UNITED STATES SALES REPRESENTATIVE (U.S. DESIGNATED AGENT)

Planmed USA Inc. 100 North Gary Avenue, Suite A Roselle, IL 60172 Phone: [phone] Fax: [phone] Contact person: Bob Pienkowski

#### INTENDED USE

Planmed Verity is intended to be used for X-ray computed tomography imaging of anatomies within upper and lower extremities and maxillofacial area.

The device is to be operated and used by legally qualified health care professionals.

#### PRODUCT DESCRIPTION

Planmed Verity utilizes the CBCT (Cone Beam Computed Tomography) technology with a flat panel detector to provide high resolution volumetric images. During image acquisition the detector and X-ray tube perform a single rotation around the target of imaging, during which an amount of snapshot X-ray images are acquired. The X-ray radiation is pulsed so that it is active only when data is collected for the projection images. Before reconstruction, calibration corrections are applied to the image data. The reconstruction is then performed using a dedicated reconstruction engine and algorithm.

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# ENCLOSURE 2

P. 2-2

The system is designed as a compact, stand-alone unit from which the whole imaging procedure from patient information management to image acquisition, processing and archiving can be performed.

The unit provides a motorized gantry with adjustable height and tilt for the best possible extremity and maxillofacial area positioning. The construction also enables a weight-bearing option, in which the patient stands inside the gantry during image acquisition. Weight-bearing imaging of the extremity shows the anatomy under natural load.

#### PREDICATE DEVICE

We consider this product to be similar in design, composition to the following device introduced into commercial distribution after May 28. 1976:

510(k) # K061834 Xoran xCATTM

#### SUBSTANTIAL EQUIVALENCE

The intended use of Planmed Verity and the predicate device is similar. Planmed Verity is intended to be used for imaging anatomies within upper and lower extremities and maxillofacial area. Intended use of the predicate device covers these same areas. Planmed Verity and the predicate device both utilize cone beam computed tomography technology with substantially equivalent technical characteristics for acquiring 3D image data sets of these anatomical areas.

Non-clinical physical laboratory testing studies were completed for the product to compare the imaging performance of Planmed Verity and the predicate device. This testing included a wide range of different physical evaluations for performance, image quality and dose levels. All results were equivalent or slightly better in Planmed Verity than in the predicate device.

A clinical study was completed to evaluate the image quality of Planmed Verity's maxillofacial area. The images for this clinical study were selected from patients imaged as part of normal clinical routine in a university hospital in Finland. The results show that the imaging position, which is different from the one in the predicate device, gives a clinically sufficient image quality.

The safety of selected patient positioning has been analyzed as a part of the risk analysis. As an outcome it is concluded that the selected design methods ensure that the selected patient positioning for head area imaging is safe when used as labeled. The sitting position and open design of Planmed Verity makes it also easy for the patient to move away from the device whenever needed.

## CONCLUSIONS

The intended use and technical characteristics are basically the same for both compared devices. The most evident difference is the patient positioning, which has, however, no notable effects on achieved imaging performance characteristics. Both devices are safe when used as labelled.

Based on the non-clinical and clinical studies the imaging performance of Planmed Verity was found both substantially equivalent to the predicate device and sufficient for clinical use.

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Image /page/5/Picture/0 description: The image shows the word "Planned" in large, bold, black font at the top. Below that, in a smaller font, is the text "ENCLOSURE 2" on one line and "P. 2-3" on the next line. The text is centered on the image.

The comparison demonstrates that Planmed Verity is as safe and effective as the predicate device.