(336 days)
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.
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.
The provided text describes a 510(k) submission for the Lilium α-200E, an ultrasound system for measuring bladder volume. However, the document explicitly states:
"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."
This means that a clinical study with acceptance criteria and associated performance data as typically sought for AI/ML-based medical devices was not performed for this specific 510(k) submission. The FDA clearance was based on substantial equivalence to a predicate device and extensive non-clinical performance data.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria because such a study was not conducted or presented in this regulatory submission.
The document discusses non-clinical performance data which includes:
- Biocompatibility testing
- Electrical safety testing
- Electromagnetic Disturbance (EMD) testing
- Acoustic Output Measurement
- Thermal Measurement
- Software verification and validation
- Storage and Transport Testing
- Usability engineering
These tests, rather than a clinical performance study with human subjects, formed the basis for demonstrating safety and effectiveness and achieving substantial equivalence.
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December 7, 2017
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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.
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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
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Indications for Use
510(k) Number (if known)
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)
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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(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | Color Doppler | Combined(Specify) | Other*(A-Mode) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging& 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) | |||||||||
| Peripheralvessel | 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.
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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
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| Regulation Number: | IYO: 21 CFR 892.1560ITX: 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.
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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.
| ManufacturerTrade Name | Lilium α-200E | Verathon. Inc.BladderScan® BVI 9400 | Comparison toPredicate |
|---|---|---|---|
| Indications for use: | Lilium α-200E, usingultrasound, is intended toprovide the diagnosticinformation of the visualizedurine dynamics acquiredfrom the volume of theurinary bladder. | The BladderScan® BVI 9400is intended to projectultrasound energy throughthe lower abdomen of thenonpregnant patient toobtain an image of thebladder and uses that imageto calculate the bladdervolume noninvasively. | Minor differencesin wording do notraise any additionalquestions of safetyor efficacy. |
| Contraindications | Lilium α-200E is not intendedfor:1. patients who haveunhealed wounds in thelower abdomen area2. patients for whom aphysician considers the useof the device to beinappropriate3. pregnant patients4. Infants5. patient with ascites | The BladderScan BVI 9400 isnot intended for fetal use orfor use on pregnantpatients. Do not use theBladderScan BVI 9400 on: Apatient who has open skinor wounds in the suprapubicarea. A patient with ascites.A pregnant patient. | Minor wordingdifferences do notraise any additionalquestions of safetyor efficacy. |
| Patient/User Characteristics | |||
| Target Population | Male, Female, andPediatric patients(7 years of age and older) | Same | Same |
| Anatomical Site | Bladder | Same | Same |
| Users | Physicians/MedicalProfessionals | Same | Same |
| Technological Characteristics and Performance | |||
| Patient ContactMaterial | UMGABS AcrylonitrileButadiene Styrene Plastic(ABS) VW800 (colorant:WUA4368A White DIC583) | Low Density PolyethylenePlastic (LDPE) Dow 955i(colorant: Techmer PM84149 Cool Grey 4C) | Biocompatibilitytest results supportthat the material issafe for theintended use |
| ManufacturerTrade Name | Lilium α-200E | Verathon. Inc.BladderScan® BVI 9400 | Comparison toPredicate |
| Power Source | Electrical (AA Battery) | electrical(lithium-ion battery) | Difference incommercial batterytype does not raiseany additionalquestions of safetyor efficacy. |
| Energy Delivered | Ultrasound | Same | Same |
| MeasurementAccuracy | ± (15% ±20mL) | ± 15% ± 15mL | Difference doesnot raise anyadditionalquestions of safetyor efficacy. |
| MeasurementRange | 1 to 999 mL | 0 to 999 mL | Difference doesnot raise anyadditionalquestions of safetyor efficacy. |
| Modes ofOperation | A-mode | B -mode | *See discussionbelow |
| TransducerResonantFrequency | 3MHz +/- 20% | 2.95 MHz | Difference doesnot raise anyadditionalquestions of safetyor efficacy. |
| Center Frequencies | 3MHz | 3.0 / 1.74 MHz | The lowerfrequency for thepredicate does notraise any additionalquestions of safetyor efficacy.Proposed devicemeets FDA'srequirement. |
| Safety Standards | |||
| Acoustic Output:MaximumMechanical Index(MI) | ≤ 1.9 | 0.95 | Difference doesnot raise anyadditionalquestions of safetyor efficacy. |
| Acoustic Output:Intensity, SpatialPeak TemporalAverage (ISPTA) | ISPTA = not more than720mW/cm² | ≤ 1.0 mW/cm² | Difference doesnot raise anyadditionalquestions of safetyor efficacy. |
| ManufacturerTrade Name | Lilium α-200E | Verathon. Inc.BladderScan® BVI 9400 | Comparison toPredicate |
| BiocompatibilityStandardCompliance | ISO 10933-1:2009 | Same | |
| Thermal Safety | IEC60601-2-37:2007 | Same | Same |
| Electrical SafetyStandardCompliance | IEC 60601-1:2005/A1:2012 | Same | |
| ElectromagneticCompatibilityStandardCompliance | IEC 60601-1-2:2007 | Same |
Table 5A – Comparison of Characteristics
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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 ●
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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.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging 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.