Lilium a-200E

{0}------------------------------------------------ December 7, 2017 Image /page/0/Picture/1 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. Lilium Otsuka Co., Ltd. % Kathryn Coressel, RAC Senior Regulatory Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 AUSTIN TX 78746 Re: K170046 Trade/Device Name: Lilium α-200E Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: October 30, 2017 Received: November 3, 2017 Dear Ms. Coressel: 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 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. {1}------------------------------------------------ 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. O'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K170046 Device Name Lilium a-200E Indications for Use (Describe) Lilium a-200E, using ultrasound, is intended to provide the diagnostic information of the visualized urine dynamics acquired from the volume of the urinary bladder. Clinical Application: Track 1 Only, Other- Abdominal Mode of Operation: Mode A | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| < 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}------------------------------------------------ # Diagnostic Ultrasound Indications For Use (Per Appendix G, FDA Ultrasound Guidance) # 510(k) Number: TBD Device Name: Lilium α-200E Ultrasound System Intended Use: Lilium α-200E, using ultrasound, is intended to provide the diagnostic information of the visualized urine dynamics acquired from the volume of the urinary bladder. | Clinical Application | | Mode of Operation | | | | | | | | |--------------------------|---------------------------------|----------------------------|---|---|-----|-----|---------------|-----------------------|--------------------| | | General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color Doppler | Combined<br>(Specify) | Other*<br>(A-Mode) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal Imaging<br>& Other | Fetal | | | | | | | | | | | Abdominal | | | | | | | | | | | Intra-operative (Specify) | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | Laparoscopic | | | | | | | | | | | Pediatric | | | | | | | | | | | Small Organ (Specify) | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | Trans-rectal | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | Trans-urethral | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | | Intravascular | | | | | | | | | | | Other (Bladder) | | | | | | | N | | | Cardiac | Cardiac Adult | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | Other (Specify) | | | | | | | | | | Peripheral<br>vessel | Peripheral Vessel | | | | | | | | | | | Other (Specify) | | | | | | | | | N = new indication; P = previously cleared by FDA; E = added under this appendix * Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging. {4}------------------------------------------------ # 510(k) Summary # Lilium α-200E K 170046 # 1. Submission Sponsor Lilium Otsuka Co., Ltd. 4-12-6, Chiyoda Chuo-ku, Sagamihara City, Kanagawa 252-0237 JAPAN Hiroaki Takahashi Manager Email: htakahashi@liotsuka.com Office number: +81-42-704-3822 # 2. Submission Correspondent Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327.9997 Contact: Kathryn A Coressel, RAC Title: Senior Consultant, RA #### 3. Date Prepared 12/29/2016 #### 4. Device Identification Trade/Proprietary Name: Lilium α-200E Common/Usual Name: IYO: Ultrasonic pulsed echo imaging system ITX: Diagnostic ultrasonic transducer {5}------------------------------------------------ | Regulation Number: | IYO: 21 CFR 892.1560<br>ITX: 21 CFR 892.1570 | |-----------------------|----------------------------------------------| | Product Code: | IYO and ITX | | Device Class: | Class II | | Classification Panel: | Radiology | # 5. Legally Marketed Predicate Device(s) K071217, BladderScan® BVI 9400 Ultrasound System, Verathon Inc. # 6. Indication for Use Statement Lilium α-200E, using ultrasound, is intended to provide the diagnostic information of the visualized urine dynamics acquired from the volume of the urinary bladder. # 7. Device Description Lilium α-200E is a portable, battery powered, software controlled ultrasound system used to acquire and display real time A-mode images of the bladder. The Lilium device consists of a main body and an ultrasonic probe. Lilium device is used to measure urine volume inside the bladder non-invasively. In addition, it provides urine volume in the bladder at regular intervals and graphically displays the gradual increase of urine collection. It alerts when a set volume is attained. The device retains history. This information aids healthcare professionals, patients, and caregivers in providing proper continence care for those with urination difficulties. The device has wireless capabilities. The Lilium device measures urine volume by means of a probe that has four ultrasound sensors aligned vertically. The sensor aligned side is applied to outside the abdomen wall so the probe can emit ultrasound (Mode A) toward the bladder and receive the echoed signals. The device the signal intensity to measure the height and depth of the bladder. These measurements determine the size of the bladder and quantify the filling of the bladder (urine volume is displayed on the screen. The system also includes indicator lights to indicate for urine volume and for correct positioning of the device. The operating principle of the device is as follows: An ultrasonic probe in which ultrasound transducers are arranged is placed on the abdominal surface, above the pubic bone, along the extending direction of the urinary bladder. When the ultrasound is transmitted from the probe, transducers put on the base part of the bladder detect echoes or ultrasonic reflections first when the urine begins to accumulate. As the bladder volume increases, transducers on the upper bladder detect echoes. {6}------------------------------------------------ # 8. Substantial Equivalence Discussion The following table compares the Lilium α-200E to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device. | Manufacturer<br>Trade Name | Lilium α-200E | Verathon. Inc.<br>BladderScan® BVI 9400 | Comparison to<br>Predicate | |----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use: | Lilium α-200E, using<br>ultrasound, is intended to<br>provide the diagnostic<br>information of the visualized<br>urine dynamics acquired<br>from the volume of the<br>urinary bladder. | The BladderScan® BVI 9400<br>is intended to project<br>ultrasound energy through<br>the lower abdomen of the<br>nonpregnant patient to<br>obtain an image of the<br>bladder and uses that image<br>to calculate the bladder<br>volume noninvasively. | Minor differences<br>in wording do not<br>raise any additional<br>questions of safety<br>or efficacy. | | Contraindications | Lilium α-200E is not intended<br>for:<br>1. patients who have<br>unhealed wounds in the<br>lower abdomen area<br>2. patients for whom a<br>physician considers the use<br>of the device to be<br>inappropriate<br>3. pregnant patients<br>4. Infants<br>5. patient with ascites | The BladderScan BVI 9400 is<br>not intended for fetal use or<br>for use on pregnant<br>patients. Do not use the<br>BladderScan BVI 9400 on: A<br>patient who has open skin<br>or wounds in the suprapubic<br>area. A patient with ascites.<br>A pregnant patient. | Minor wording<br>differences do not<br>raise any additional<br>questions of safety<br>or efficacy. | | Patient/User Characteristics | | | | | Target Population | Male, Female, and<br>Pediatric patients<br>(7 years of age and older) | Same | Same | | Anatomical Site | Bladder | Same | Same | | Users | Physicians/Medical<br>Professionals | Same | Same | | Technological Characteristics and Performance | | | | | Patient Contact<br>Material | UMGABS Acrylonitrile<br>Butadiene Styrene Plastic<br>(ABS) VW800 (colorant:<br>WUA4368A White DIC583) | Low Density Polyethylene<br>Plastic (LDPE) Dow 955i<br>(colorant: Techmer PM<br>84149 Cool Grey 4C) | Biocompatibility<br>test results support<br>that the material is<br>safe for the<br>intended use | | Manufacturer<br>Trade Name | Lilium α-200E | Verathon. Inc.<br>BladderScan® BVI 9400 | Comparison to<br>Predicate | | Power Source | Electrical (AA Battery) | electrical<br>(lithium-ion battery) | Difference in<br>commercial battery<br>type does not raise<br>any additional<br>questions of safety<br>or efficacy. | | Energy Delivered | Ultrasound | Same | Same | | Measurement<br>Accuracy | ± (15% ±20mL) | ± 15% ± 15mL | Difference does<br>not raise any<br>additional<br>questions of safety<br>or efficacy. | | Measurement<br>Range | 1 to 999 mL | 0 to 999 mL | Difference does<br>not raise any<br>additional<br>questions of safety<br>or efficacy. | | Modes of<br>Operation | A-mode | B -mode | *See discussion<br>below | | Transducer<br>Resonant<br>Frequency | 3MHz +/- 20% | 2.95 MHz | Difference does<br>not raise any<br>additional<br>questions of safety<br>or efficacy. | | Center Frequencies | 3MHz | 3.0 / 1.74 MHz | The lower<br>frequency for the<br>predicate does not<br>raise any additional<br>questions of safety<br>or efficacy.<br>Proposed device<br>meets FDA's<br>requirement. | | Safety Standards | | | | | Acoustic Output:<br>Maximum<br>Mechanical Index<br>(MI) | ≤ 1.9 | 0.95 | Difference does<br>not raise any<br>additional<br>questions of safety<br>or efficacy. | | Acoustic Output:<br>Intensity, Spatial<br>Peak Temporal<br>Average (ISPTA) | ISPTA = not more than<br>720mW/cm² | ≤ 1.0 mW/cm² | Difference does<br>not raise any<br>additional<br>questions of safety<br>or efficacy. | | Manufacturer<br>Trade Name | Lilium α-200E | Verathon. Inc.<br>BladderScan® BVI 9400 | Comparison to<br>Predicate | | Biocompatibility<br>Standard<br>Compliance | ISO 10933-1:2009 | Same | | | Thermal Safety | IEC60601-2-37:2007 | Same | Same | | Electrical Safety<br>Standard<br>Compliance | IEC 60601-1:2005/A1:2012 | Same | | | Electromagnetic<br>Compatibility<br>Standard<br>Compliance | IEC 60601-1-2:2007 | Same | | # Table 5A – Comparison of Characteristics {7}------------------------------------------------ {8}------------------------------------------------ # 9. Non-Clinical Performance Data As part of demonstrating safety and effectiveness of Lilium a-200E and in showing substantial equivalence to the predicate device, Lilium Otsuka Co., Ltd. completed a number of non-clinical performance tests. The Lilium α-200E meets all the requirements for overall design, biocompatibility, performance, and electrical safety results confirming that the design output meets the design inputs and specifications for the device. The Lilium α-200E passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device: - Biocompatibility testing per ISO 10993-1 - . Electrical safety testing per IEC 60601-1 and IEC 60601-2-37 - . Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2 - . Acoustic Output Measurement Report 60601-2-37 - . Thermal Measurement Report 60601-2-37 - . Software verification and validation IEC 62304 - . Storage and Transport Testing - . JIS T 1501-General methods of measuring the performance of ultrasonic pulse-echo diagnostic equipment - EN 62366:2008 Usability engineering to medical devices ● {9}------------------------------------------------ # 10. Clinical Performance Data There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device. # 11. Statement of Substantial Equivalence By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device(s). The Lilium α-200E, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.