Low Dose Lung Screening Option

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Canon Medical Systems Corporation % Mr. Paul Biggins Senior Director Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780 Re: K190505 Trade/Device Name: Low Dose CT Lung Cancer Screening Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: May 17, 2019 Received: May 20, 2019 Dear Mr. Biggins: 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. 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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 June 5, 2019 {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 mediation-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) #### K190505 Device Name Low Dose CT Lung Cancer Screening Option #### Indications for Use (Describe) The Low Dose CT Lung Cancer Screening Option for Canon/Toshiba CT systems is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body, a professional medical society and/or Canon. Information from professional societies related to lung cancer screening can be found, but is not limited to: American College of Radiology® (ACR)-resources and technical specification; accreditation American Association of Physicists in Medicine (AAPM) - Lung Cancer Screening Protocols; radiation management. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 PRAStaff(@fda.hhs.gov "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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Canon Medical Systems USA, Inc. The word "Canon" is in red, and the rest of the text is in black. The text is aligned to the left and is in a sans-serif font. The logo is simple and professional. #### 510(k) SUMMARY # Made For life ## K190505 ## 1. SUBMITTER'S NAME: Canon Medical Systems Corporation 1385 Shimoishigami Otawara, Japan 324-8550 ## 2. OFFICIAL CORRESPONDENT: Naofumi Watanabe - 3. ESTABLISHMENT REGISTRATION: 9614698 ## 4. CONTACT PERSON: Paul Biggins Senior Director Regulatory Affairs/U.S. Agent Canon Medical Systems USA, Inc. 2441 Michelle Drive, Tustin, CA 92780 714-669-7808 ## 5. DATE PREPARED: May 31, 2019 ## 6. TRADE NAME(S): Low Dose CT Lung Cancer Screening Option ## 7. COMMON NAME: System, X-ray, Computed Tomography ## 8. DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1750) ## 9. PRODUCT CODE / DESCRIPTION: JAK - System, Computed Tomography ## 10. PERFORMANCE STANDARD: This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020] ## 11. PREDICATE DEVICE: | Product | Marketed by | 510(k) Number | Clearance Date | |--------------|------------------------------------|---------------|----------------| | Aquilion RXL | Toshiba America<br>Medical Systems | K121553 | July 26, 2012 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Canon Medical Systems USA, Inc. The word "Canon" is in red, and the rest of the text is in black. The text is left-aligned and the font is sans-serif. The logo is simple and professional. **Made For life** ## 12. REASON FOR SUBMISSION: Modification of a cleared device ## 13. DEVICE DESCRIPTION: The low dose lung cancer screening option is an indication being added to the following existing, previously FDA-cleared scanners: | 510(K) NUMBER | PRODUCT Family – Aquilion TSX-101 | |---------------|------------------------------------------------------------------------------| | K033418 | AQUILION MULTISLICE CT SCANNERS (TSX-101A/A AND TSX-101A/C) | | K051833 | AQUILION 64 SP CT SCANNER; AQUILION 32 SP CT SCANNER (TSX-101A/H, TSX-101A/I | | K080211 | AQUILION 32/64 SP CT SYSTEM (TSX-101A/H, TSX-101A/I) | | K112989 | AQUILION CXL (TSX-101A/Q) | | K121553 | AQUILION RXL (TSX-101A/R) | | 510(K) NUMBER | PRODUCT Family – Lightning TSX-035/TSX-036 | | K151833 | Aquilion Lightning (TSX-035A/2 V7.0) | | K153263 | Aquilion Lightning (TSX-035A/4 and /5 V7.0) | | K170019 | Aquilion Lightning (TSX-036A/1 V8.4) | | 510(K) NUMBER | PRODUCT Family – Aquilion ONE TSX-301/TSX-305 | | K063189 | AQUILION ONE CT SYSTEM (TSX-301A) | | K072606 | AQUILION ONE CT SYSTEM (TSX-301A/2) | | K083282 | AQUILION ONE CT SYSTEM (TSX-301B) | | K093891 | AQUILION ONE VERSION 4.6 W/DUAL ENERGY (TSX-301A/2) | | K113466 | AQUILION ONE (TSX-301A) | | K120546 | AQUILION ONE PREMIUM (TSX-301B) | | K122109 | AQUILION ONE VISION V4.90 (TSX-301C) | | K132222 | AQUILION ONE VISION V6.0 (TSX-301C) | | K133497 | AQUILION ONE VISION (TSX-301C) | | K142465 | Aquilion ONE Vision v7.0 (TSX-301C) | | K160587 | Aquilion ONE GENESIS V7.3 (TSX-305A/3) | | K161009 | Aquilion ONE Vision with FIRST 2.0 V7.4 (TSX-301C) | | K170177 | Aquilion ONE GENESIS V8.3 with FIRST 2.1 (TSX-305A/3) | | 510(K) NUMBER | PRODUCT Family – Prime TSX302/TSX-303 | | K110066 | AQUILION PRIME (TSX-302A) | | K120710 | AQUILION PRIME (TSX-302A) | | K130645 | AQUILION PRIME V5.00 (TSX-303A) | | K141741 | AQUILION PRIME V6.00 (TSX-303A) | | K172188 | Aquilion Prime SP v8.4 (TSX-303B/1) | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for Canon Medical Systems USA, INC. The word "Canon" is in red, and the rest of the text is in black. The text is left-aligned and appears to be a company logo or branding element. **Made For life** No functional, performance, feature, or design changes are being made to the devices that will be indicated for low dose lung cancer screening. The devices already include low dose lung screening protocols, intended for use in the review of thoracic CT images within the established inclusion criteria of programs/protocols that have been approved and published by either a governmental body or professional medical society: Please refer to clinical literature that includes the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. #### 14. INDICATIONS FOR USE: The Low Dose CT Lung Cancer Screening Option for Canon/Toshiba CT systems is indicated for using low dose CT for lung cancer screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body, a professional medical society and/or Canon. Information from professional societies related to lung cancer screening can be found, but is not limited to: American College of Radiology® (ACR) – resources and technical specification; accreditation American Association of Physicists in Medicine (AAPM) – Lung Cancer Screening Protocols; radiation management. *Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. #### 15. SUBSTANTIAL EQUIVALENCE: Following FDA recommendations during the October 8, 2014 meeting with MITA, Toshiba followed the November 1998 General vs. Specific Guidance document to help establish that the indication for the Low Dose CT Lung Cancer Screening Option does not constitute a new intended use for the device, and that the Option could therefore be further evaluated for substantial equivalence, as per the flowchart found in the July 28, 2014 "Evaluating Substantial Equivalence in Premarket Notifications" guidance document. The NLST made use of the Aquilion 16 scanner. However, because the Aquilion 16 is out of production, and also because FDA has been moving toward restricting predicate devices to devices cleared within the previous ten years, after consulting FDA Canon Medical selected the Aquilion RXL as the predicate device. The Aquilion RXL is the successor 16-row to the Aquilion 16, and therefore offers a higher, more modern standard of image quality to compare against. Canon Medical grouped our CT systems into three different platforms/families based on their technological characteristics: The Aquilion 16/32/64/RXL, PRIME/PRIME SP, ONE/ViSION/Genesis, and Lightning platforms. We have provided bench data from a representative scanner in each family. The NLST data were acquired on scanners from the Aquilion 16/64/RXL family. We therefore selected the RXL as the predicate. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Canon Medical Systems USA, Inc. The word "Canon" is written in a bold, red font. Below the logo, the text "CANON MEDICAL SYSTEMS USA, INC." is written in a smaller, black font. The logo is simple and professional. **Made For life** For one device in each of the families, Canon Medical provided bench testing data to demonstrate performance that was substantially equivalent to the NLST predicate. To demonstrate substantial equivalence of the new LDCT LCS option to the predicate device, Canon Medical is providing bench testing data. The bench testing measured traditional image quality metrics on standard phantoms, and compared to the image quality results from the predicate scanner, which is a contemporary member of the family of Toshiba scanners used in the NLST, with similar technological characteristics as, and performance equivalent to the NLST scanner. To demonstrate substantial equivalence of other CT systems to the predicate device, Canon Medical compared objective image quality bench testing for each subject device to that of the predicate device. Canon Medical has identified the following bench tests as relevant to assessing a CT scanner's low-dose lung-cancer screening performance: | Image Quality Metric | Relevance to low-dose lung cancer screening | |---------------------------------------------|-----------------------------------------------------------------------------| | Modulation Transfer Function<br>(MTF) | Quantifies the in-plane spatial resolution performance of the system. | | Axial Slice Thickness | Quantifies the longitudinal resolution performance of the system. | | Contrast to Noise Ratio (CNR) | Quantifies the signal strength relative to the standard deviation of noise. | | CT number uniformity | Quantifies the stability of the Hounsfield Unit for water across the FOV. | | Noise Performance (Noise<br>Power Spectrum) | Quantifies the noise properties of the system. | To demonstrate substantial equivalence of other CT systems to the predicate device, Canon Medical compared objective image quality bench testing for each subject device to that of the predicate device. ## 16. SAFETY: The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-4, IEC60601-1-6, IEC60601-2-28, IEC60601-2-32, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, NEMA PS 3.1-3.18, NEMA XR-25 NEMA XR-26 and NEMA XR-29. Additionally, this device complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Canon Medical Systems USA, INC. The word "Canon" is in red, and the rest of the text is in black. The text is aligned to the left. **Made For life** ## 17. TESTING Canon Medical grouped our CT systems into three different platforms/families based on their technological characteristics: The Aquilion 16/32/64/RXL, PRIME/PRIME SP, ONE/ViSION/Genesis, and Lightning. We have provided bench data from a representative scanner in each family. The NLST data were acquired on scanners from the Aquilion 16/64/RXL family. We therefore selected the RXL as the predicate. For one device in each of the families, Canon Medical provided bench testing data to demonstrate performance that was substantially equivalent to the NLST predicate. We have additionally provided clinical literature to demonstrate that newer technologies, such as iterative reconstruction, have not negatively affected the devices' safety and effectiveness. #### 18. CONCLUSION Canon Medical has demonstrated, via the criteria in the "General vs. Specific Intended Use" guidance document, that the lung cancer screening indication does not change the intended use of the device. Because the subject and predicate devices are all FDA-cleared for general CT imaging, of which lung cancer screening is a specific application, the different technological characteristics do not raise different questions of safety and effectiveness than the predicate device used in the NLST. To supplement the NLST data, Canon Medical has identified bench data relating to device performance for low-dose lung screening, and provided data demonstrating substantial equivalence. Canon Medical has also identified clinical studies using newer devices than the NLST that demonstrate that the new technological characteristics of post-NLST devices have not negatively impacted their safety and effectiveness. Canon would also respectfully present to FDA that the ACR currently has over 4,000 sites/CT systems that are accredited with respect to the ACR guidelines. Based upon the latest IMV research that the installed base of CT scanners for Canon/Toshiba is approximately 17%. Extrapolation of the ACR database would then infer that over 680 Canon/Toshiba CT scanners are currently accredited for lung screening and there have been no reports of adverse events related to this clinical practice. CT systems that include the lung cancer screening option remain in compliance with the applicable US and international safety and performance standards such as United States Code of Federal Regulations Title 21, Subchapter J – Radiological Health, NEMA, DICOM, and IEC standards.