Access CT

K191136 · Philips Healthcare (Suzhou) Co., Ltd. · JAK · Jul 29, 2019 · Radiology

Device Facts

• Record ID: K191136
• Device Name: Access CT
• Applicant: Philips Healthcare (Suzhou) Co., Ltd.
• Product Code: JAK · Radiology
• Decision Date: Jul 29, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The Access CT scanner system can be used as a Whole Body (except cardiac) Computed Tomography X-ray System featuring a continuously rotating X-ray tube and detector array with multislice capability up to 6/16 slices simultaneously. The acquired X-ray transmission data is reconstructed by computer into cross-sectional images of the same axial plane taken at different angles. The system is suitable for all patients.

Device Story

Access CT is a whole-body (non-cardiac) CT scanner; utilizes continuously rotating X-ray tube and detector array; acquires X-ray transmission data; reconstructs data into cross-sectional images; used in clinical settings by trained physicians; provides diagnostic information regarding tissue density (bone and soft tissue); supports clinical decision-making through visualization of internal structures; benefits patients by enabling non-invasive diagnostic imaging.

Clinical Evidence

No clinical site testing performed. Evidence consists of bench-level design verification and validation, including image quality verification, risk analysis, and simulated use testing for clinical workflow, service, and manufacturing validation.

Technological Characteristics

System includes gantry (stator, rotor, X-ray tube, detector array), patient couch, and console. Detectors: NanoPanel Elite (GOS solid scintillator). X-ray tube: CTR1735. Connectivity: DICOM compliant. Software: iDose4 iterative reconstruction. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-44, IEC 62304, IEC 62366-1, ISO 14971, NEMA XR 25/28/29.

Indications for Use

Indicated for whole body (except cardiac) CT imaging. Suitable for all patients requiring cross-sectional diagnostic imaging.

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

• PHILIPS MX 16 SLICE (K091195)

Reference Devices

• Philips Ingenuity CT (K160743)
• Philips Incisive CT (K180015)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Philips Healthcare (Suzhou) Co., Ltd. Ray Sun Regulatory Affairs Engineer No.258, ZhongYuan Road, Suzhou Industrial Park SUZHOU, 215024 CHINA

Re: K191136

Trade/Device Name: Access CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: May 5, 2019 Received: May 7, 2019

Dear Ray Sun:

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.

July 29, 2019

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

{1}------------------------------------------------

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

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

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia 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}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K191136

Device Name Access CT

Indications for Use (Describe)

The Access CT scanner system can be used as a Whole Body (except cardiac) Computed Tomography X-ray System featuring a continuously rotating X-ray tube and detector array with multislice capability up to 6/16 slices simultaneously. The acquired X-ray transmission data is reconstructed by computer into cross-sectional images of the same axial plane taken at different angles. The system is suitable for all patients.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: underline;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

*[e-mail]*

*"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."*

FORM FDA 3881 (7/17)

PSC Publishing Services [phone] EF

Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd. Access CT

CONFIDENTIAL Section 4-Indications For Use Statement page 2 of 2

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are all capitalized and evenly spaced. The font is sans-serif and the overall impression is clean and modern.

## 510(k) Summary of Safety and Effectiveness

[As required by 21 CFR 807.92(c)]

| Date Prepared: | March 5 2019 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd.<br>No. 258, Zhongyuan Road, Suzhou Industrial Park,<br>Suzhou Jiangsu, CHINA, 215024<br>Establishment Registration Number: 3009529630 |
| Primary Contact<br>Person: | Ray Sun<br>Regulatory Affair Engineer<br>Phone: [phone]<br>E-mail: [e-mail] |
| Secondary Contact<br>Person | Shiguang An<br>Regulatory Affair Engineer<br>Phone: [phone]<br>E-mail: [e-mail] |
| Device Name: | Access CT |
| Classification: | Classification name: Computed tomography x-ray system<br>Classification Regulation: 21CFR 892.1750<br>Classification Panel: Radiology<br>Device Class: Class II<br>Primary Product Code: JAK |
| Predicate Device: | Trade name: PHILIPS MX 16 SLICE<br>Manufacturer: Philips Medical Systems (Cleveland), Inc.<br>510(k) Clearance: K091195<br>Classification Regulation: 21CFR 892.1750<br>Classification name: Computed tomography x-ray system<br>Classification Panel: Radiology<br>Device class: Class II<br>Product Code: JAK |
| Reference Device: | Trade name: Philips Ingenuity CT<br>Manufacturer: Philips Medical Systems (Cleveland), Inc.<br>510(k) Clearance: K160743<br>Classification Regulation: 21CFR 892.1750<br>Classification name: Computed tomography x-ray system<br>Classification Panel: Radiology<br>Device class: Class II<br>Product Code: JAK |
| Reference Device: | Philips Incisive CT |
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd. |
| 510(k) Clearance: | K180015 |
| Classification Regulation: | 21CFR 892.1750 |
| Classification name: | Computed tomography x-ray system |
| Classification Panel: | Radiology |
| Device class | Class II |
| Product Code: | JAK |
| Device Description: | The proposed <b>Access CT</b> is currently available in two system configurations, 6 slices and 16 slices.<br><br>The <b>Access CT</b> system is used clinically as a diagnostic patient imaging device that produces images that correspond to tissue density. The quality of the images depends on the level and amount of X-ray energy delivered to the tissue. CT imaging displays both high-density tissue, such as bone, and soft tissue. When interpreted by a trained physician, CT images yield useful diagnostic information. The system is intended for use in the head and whole body.<br><br>The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the <b>Access CT</b> have the same fundamental design characteristics and are based on comparable technologies as the predicate.<br><br>The main system modules and functionalities are:<br>1. Gantry. The Gantry consists of 4 main internal units:<br>a. Stator – a fixed mechanical frame that carries HW and SW.<br>b. Rotor – A rotating circular stiff frame that is mounted in and supported by the stator.<br>c. X-Ray Tube (XRT) and Generator – fixed to the Rotor frame.<br>d. Data Measurement System (DMS) – a detectors array, fixed to the Rotor frame.<br>2. Patient Support (Couch) – carries the patient in and out through the Gantry bore synchronized with the scan.<br>3. Console - Containing a Host computer and display that is the primary user interface.<br><br>In addition to the above components and the software operating them, each system includes hardware and software for data acquisition, display, manipulation, storage and filming as well as post-processing into views other than the original axial images. Patient supports (positioning aids) are used to position the patient. |
| Indications for Use: | The Access CT Scanner System can be used as a whole<br>body (except cardiac) computed tomography X-ray system<br>featuring a continuously rotating X-ray tube and detector<br>array with multi-slice capability up to 6/16 slices<br>simultaneously. The acquired X-RAY transmission data is<br>reconstructed by computer into cross-sectional images of the<br>body from the same axial plane taken at different angles. The<br>system is suitable for all patients. |
| Fundamental<br>Scientific<br>Technology: | The proposed Access CT is an advanced continuous-<br>rotation computed tomography systems suitable for a wide<br>range of computed tomographic (CT) applications.<br><br>The proposed Access CT is used clinically as a diagnostic<br>patient imaging device that produces images that<br>correspond to tissue density. The quality of the images<br>depends on the level and amount of X-ray energy delivered<br>to the tissue. CT imaging displays both high-density tissue,<br>such as bone, and soft tissue.<br><br>The principal technological components (rotating x-ray tube,<br>detector and gantry) of the proposed Access CT is<br>substantially equivalent to the currently marketed predicate<br>Philips MX 16 SLICE (K091195, 05/27/2009).<br><br>Based on the information provided above, the proposed<br>Access CT does not raise different questions of safety and<br>effectiveness compare to the currently marketed predicate<br>Philips MX 16 SLICE (K091195, 05/27/2009). |
| Summary of Non-<br>Clinical Performance<br>Data: | The proposed Access CT complies with the following<br>international and FDA-recognized consensus standards:<br><br>• AAMI / ANSI ES60601-1:2005/(R) 2012 and A1:2012,<br>C1:2009/(R) 2012 and A2:2010/(R) 2012 (Consolidated<br>Text) Medical Electrical Equipment - Part 1: General<br>Requirements For Basic Safety And Essential Performance<br>(IEC 60601-1:2005, MOD).<br>FDA/CDRH recognition number 19-4<br><br>• IEC 60601-1-2:2014, Medical electrical equipment - Part<br>1-2: General requirements for basic safety and essential<br>performance - Collateral Standard: Electromagnetic<br>disturbances - Requirements and tests<br>FDA/CDRH recognition number 19-8<br><br>• IEC 60601-1-3:2013 Medical electrical equipment -- Part<br>1-3: General requirements for basic safety - Collateral |
| standard: Radiation protection in diagnostic X-ray<br>equipment<br>FDA/CDRH recognition number 12-269 | |
| • IEC 60601-1-6:2013 Medical electrical equipment -- Part<br>1-6: General requirements for basic safety and essential<br>performance – Collateral standard: Usability<br>FDA/CDRH recognition number 5-89 | |
| • IEC 60601-2-44:2016 Medical electrical equipment - Part<br>2-44: Particular requirements for the basic safety and<br>essential performance of x-ray equipment for computed<br>tomography<br>FDA/CDRH recognition number 12-302 | |
| • IEC 62304:2006 Medical device software -- Software life<br>cycle processes<br>FDA/CDRH recognition number 13-32 | |
| • IEC 62366-1:2015 Medical devices - Part 1: Application of<br>usability engineering to medical devices<br>FDA/CDRH recognition number 5-114 | |
| • ISO14971 Medical devices – Application of risk<br>management to medical devices (Ed. 2.0, 2007)<br>FDA/CDRH recognition number 5-40 | |
| • NEMA XR 25-2011 Computed Tomography Dose Check<br>FDA/CDRH recognition number 12-225 | |
| • NEMA XR 28-2013 Supplemental Requirements for User<br>Information and System Function Related to Dose in CT<br>FDA/CDRH recognition number 12-287 | |
| • NEMA XR 29-2013 Standard Attributes on CT Equipment<br>Related to Dose Optimization and Management | |
| • Guidance for Industry and FDA Staff – Guidance for the<br>Content of Premarket Submissions for Software Contained<br>in Medical Devices (issued May 11, 2005, document<br>number 337). | |
| • Guidance for Industry and FDA Staff – Content of<br>Premarket Submissions for Management of Cybersecurity in<br>Medical Devices (issued October 2, 2014) | |
| • Guidance for Industry and FDA Staff – Use of International | |
| | |
| | Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (issued June 16, 2016)<br>• Guidance for Industry and FDA Staff – Information to Support a Claim of Electromagnetic Compatibility (EMC) of |
| | Electrically-Powered Medical Devices (issued July 11, 2016)<br>The systems comply with industry guidance and<br>performance standards for Computed Tomography (CT)<br>Equipment and Laser products (21 CFR 1020.33 and 21…