(57 days)
The Bladder Scanner (Models: M2, M2-W, M1, M1-W) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The M2, M2-W, M1, M1-W Bladder Scanner projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder Volume noninvasively. The M2, M2-W, M1, M1-W Bladder Scanner is intended to be used only by qualified medical professionals.
The M Series Bladder Scanner manufactured by Suzhou Lischka Medtech Co., Ltd. provides noninvasive volume bladder measurement utilizing real-time ultrasound imaging and measurement. The equipment consists of the main unit, 3D probe (M2, M2-W)/2D probe (M1, M1-W), battery and Charger. It features:
- Two Operation Modes: Expert Mode and Easy Mode .
- Non-invasive, comfortable, correct, reliable, fast and simple operation .
- Printouts with ultrasound images and various parameters through PC software .
- . Touch screen keyboard operation
- . Voice input and play functions
- Multi-language selection .
- Information storage •
- . Information printing
- . built-in battery
The difference between these models is that the model of the probe is different. M2, M2-W is 3D probe .M1,M1-W is 2D probe. M2-W, M1-W have WIFI connection function, M2, M1 do not have WIFI connection function.
The provided document focuses on the FDA 510(k) clearance of the Suzhou Lischka Medtech Co., Ltd. Bladder Scanners (Models: M2, M2-W, M1, M1-W) and primarily outlines conformance to general standards rather than specific clinical performance studies with detailed acceptance criteria and expert reviews.
Based on the available text, here's an analysis:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Volume Measurement Accuracy (M2/M2-W) | Better than or equal to predicate device (±15%, ±15ml) | ±7%, ±7ml |
| Volume Measurement Accuracy (M1/M1-W) | Better than or equal to predicate device (±15%, ±15ml) | ±14%, ±14ml |
| Electrical Safety | Compliance with IEC 60601-1: 2012 | Complied |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2: 2014 | Complied |
| Biocompatibility | Compliance with ISO 10993-1, -5, -10 | Complied |
| Acoustic Output | Compliance with NEMA UD 2 and FDA guidelines (Sep 9, 2008) | Complied |
| WIFI and Bluetooth Functionality Safety | Compliance with FCC CFR TITLE 47 PART 15 SUBPART C SECTION 15.247 | Complied |
Study Proving Device Meets Acceptance Criteria:
The document states: "Clinical testing is not required."
Instead, the submission relies on non-clinical data, including:
- Safety Standards: Compliance with electrical safety (ES60601-1), EMC (IEC 60601-1-2), and specific ultrasound safety (IEC 60601-2-37).
- Performance Standards: Compliance with NEMA UD 2 for real-time display of thermal and mechanical acoustic output, and FDA guidelines for acoustic output testing.
- Biocompatibility Standards: Compliance with ISO 10993-1, -5, -10.
- Wireless Communication Standards: Compliance with FCC CFR TITLE 47 PART 15 SUBPART C SECTION 15.247 for WIFI and Bluetooth.
The comparison table on pages 7-8 explicitly notes that the subject device's volume measurement accuracy (±7%, ±7ml for M2/M2-W and ±14%, ±14ml for M1/M1-W) is "more accurate than the predicate device" (which was ±15%, ±15ml). This direct comparison constitutes a performance claim relative to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
Since the document explicitly states "Clinical testing is not required," there is no information provided about a "test set" in the context of human clinical data or diagnostic performance on a dataset of patient scans. The performance data discussed (e.g., volume measurement accuracy) is likely derived from phantom testing or in-vitro validation. The document does not specify the sample size for these non-clinical tests or their provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable, as clinical testing and the establishment of ground truth by experts for a diagnostic performance test set are not described as part of this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring expert adjudication is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a bladder scanner for volume calculation, not an AI-assisted diagnostic imaging interpretation tool for human readers. No MRMC study is mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself is an "algorithm only" device in the sense that it automatically calculates bladder volume. However, the FDA submission doesn't describe a formal "standalone performance study" in the way it might for a sophisticated AI algorithm interpreting medical images. The accuracy metrics (e.g., ±7%, ±7ml) represent the device's inherent performance.
7. The Type of Ground Truth Used
For the key performance metric (volume measurement accuracy), the ground truth for non-clinical testing would typically be established using precisely known volumes in phantoms or calibrated fluid measurements. The document does not explicitly state how the ground truth for their accuracy claims was established, but given it's a bladder volume device and clinical testing was not done, this would be the most common method.
8. The Sample Size for the Training Set
Not applicable. This device, as described, is a pulsed-echo ultrasound device for volume calculation, not a machine learning model that requires a distinct "training set." Its functionality is based on established ultrasound physics and algorithms, not trained on large datasets.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a training set for a machine learning model.
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Suzhou Lischka Medtech Co., Ltd. % Shi Jing R&D Manager NO.999 Quija Road, Qiandeng Town Kunshan, Jiangsu 215341 CHINA
Re: K190769
Trade/Device Name: Bladder Scanner (Models: M2, M2-W, M1, M1-W) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: March 26, 2019 Received: March 26, 2019
Dear Shi Jing:
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. 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
May 22, 2019
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/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,
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
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Indications for Use
510(k) Number (if known)
K190769
Device Name Bladder Scanner (Models : M2, M2-W, M1, M1-W)
Indications for Use (Describe)
The Bladder Scanner (Models: M2, M1, M1-W) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The M2, M2-W, M1, M1-W Bladder Scanner projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder Volume noninvasively. The M2, M2-W, M1, M1-W Bladder Scanner is intended to be used only by qualified medical professionals.
| 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 Form
System: M2
Transducer: H3D-1
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging& Other | Fetal / Obstetrics | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Bladder) | N | |||||||
| Cardiac | Adult Cardiac | |||||||
| Pediatric Cardiac | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | |||||||
| vascular | Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
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System: M1 Transducer: HD2-1
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PW | CW | Color | Combined (Specify) | Other (Specify) | ||
| General | Specific | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| FetalImaging& Other | Small Organ (Specify) | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Bladder) | N | |||||||
| Cardiac | Adult Cardiac | |||||||
| Pediatric Cardiac | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheralvascular | Peripheral vascular | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
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510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 10 March 2019
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | Suzhou Lischka Medtech Co., Ltd. |
|---|---|
| Address: | 2F,BuildingG4, Kunshan Hi-Tech Medical DeviceIndustrial Park, NO.999 Qujia Road, QiandengTown, Kunshan City, Jiangsu Prov. 215341,China |
| Contact person: | Shi Jing |
| Title: | R&D manager |
| E-mail: | shi.jing@lischka.cn |
| Tel: | +86- 512-36692288-831 |
2. Device Identification
| Trade/Device Name: | Bladder Scanner |
|---|---|
| Models: | M2, M2-W, M1, M1-W |
| Regulation Number: | 21 CFR 892.156021 CFR 892.1570 |
| Regulation Name: | Ultrasonic, Pulsed echo, ImagingTransducer, Ultrasonic, Diagnostic |
| Regulation Class: | Class II |
| Product Code: | IYO, ITX |
3. Predicate Device
| 510(K) number: | K131227 |
|---|---|
| Device Name: | PadScan HD series Bladder Scanner |
| Manufacturer: | Caresono Technology Co., Ltd |
| Regulation Number: | 21 CFR 892.156021 CFR 892.1570 |
| Regulation Name: | Ultrasonic, Pulsed echo, ImagingTransducer, Ultrasonic, Diagnostic |
| Regulation Class: | Class II |
| Product Code: | IYO, ITX |
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4. Device Description
The M Series Bladder Scanner manufactured by Suzhou Lischka Medtech Co., Ltd. provides noninvasive volume bladder measurement utilizing real-time ultrasound imaging and measurement. The equipment consists of the main unit, 3D probe (M2, M2-W)/2D probe (M1, M1-W), battery and Charger. It features:
- Two Operation Modes: Expert Mode and Easy Mode .
- Non-invasive, comfortable, correct, reliable, fast and simple operation .
- Printouts with ultrasound images and various parameters through PC software .
- . Touch screen keyboard operation
- . Voice input and play functions
- Multi-language selection .
- Information storage •
- . Information printing
- . built-in battery
The difference between these models is that the model of the probe is different. M2, M2-W is 3D probe .M1,M1-W is 2D probe. M2-W, M1-W have WIFI connection function, M2, M1 do not have WIFI connection function.
5. Intended use
The Bladder Scanner (Models: M2, M2-W, M1, M1-W) projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder volume noninvasively. The Bladder Scanner is intended to be used only by qualified medical professionals.
6. Indication for use
The Bladder Scanner (Models: M2, M1, M1-W) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The M2, M2-W, M1, M1-W Bladder Scanner projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder Volume noninvasively. The M2, M2-W, M1, M1-W Bladder Scanner is intended to be used only by qualified medical professionals.
Contraindications:
Do not use the Bladder Scanner on following cases:
- a) Fetal use or pregnant patients.
- b) Patients with ascites.
- c) Patients with open or damaged skin.
- d) Wounds in the suprapubic region.
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7. Comparison to Predicate Device
Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table
| SE Comparisons | Bladder Scanner(Models: M2, M2-W,M1, M1-W) | PadScan HD seriesBladder Scanner | Note |
|---|---|---|---|
| Manufacturer/K# | Suzhou Lischka/Presentapplication | Caresono/K131227 | -- |
| Trade name andmodel | Bladder Scanner(Models: M2, M2-W,M1, M1-W) | PadScan HD seriesBladder Scanner(Models: HD5, HD3) | |
| Classificationsname andRegulation Name | Regulation Number:21 CFR 892.156021 CFR 892.1570Regulation Name:Ultrasonic, Pulsedecho, ImagingTransducer,Ultrasonic, DiagnosticProduct Code: IYO,ITX | Regulation Number:21 CFR 892.156021 CFR 892.1570Regulation Name:Ultrasonic, Pulsedecho, ImagingTransducer, Ultrasonic,DiagnosticProduct Code: IYO, ITX | Same |
| Intended Use | The Bladder Scanner(Models: M2, M2-W,M1, M1-W) projectsultrasound energythrough the lowerabdomen of thepatient to obtainimages of the bladderwhich is used tocalculate bladdervolume noninvasively.The Bladder Scanneris intended to be usedonly by qualifiedmedical professionals. | The PadScan HDseries Bladder Scannerprojects ultrasoundenergy through thelower abdomen of thepatient to obtain imagesof the bladder which isused to calculatebladder volumenoninvasively. ThePadScan HD seriesBladder Scanner isintended to be usedonly by qualifiedmedical professionals. | Same |
| Contraindications | Do not use theBladder Scanner onfollowing cases: | Do not use thePadScanHD Bladder Scanner onfollowing cases: | Same |
| a) Fetal use orpregnant patientsb) Patients withascitesc) Patients with openordamaged skin.d) Wounds in thesuprapubic region | a) Fetal use or pregnantpatientsb) Patients with ascitesc) Patients with open ordamaged skin.d) Wounds in thesuprapubic region | ||
| Modes ofoperation | B mode | B mode | Same |
| SystemCharacteristics | PortableLCD DisplayThermal PrinterPower source: Battery | PortableLCD DisplayThermal PrinterPower source: BatteryorAC-DC adapter | Different, but both ourdevice and predicate devicemet the requirements of IEC60601-1. The differencedoes not affect the safetyand performance. |
| Display | M2: 2.4" TFT-LCDM1: 2.4" TFT-LCD | PadScan HD2: 2.5"TFT-LCDPadScan HD5: 8" TFT-LCD | Different,The size of the display isdifferent and does not affectproduct safety andperformance. |
| Controls forChange ofacoustic outputduring scan | No | No | Same |
| Transducer Type | Mechanical SectorProbe | Mechanical SectorProbe | Same |
| Measurementplace | Abdomen | Abdomen | Same |
| TransducerResonantFrequency | 3.5Mhz or 2.5Mhz | 2.5Mhz | Basically the same |
| Number ofelements | 1 | 1 | Same |
| Sector Angle | 120° | 120° | Same |
| Number of ScanPlanes | M2, M2-W-12 ,M1, M1-W-1 | PadScan HD5-12,PadScan HD2-1 | Same |
| PatientContactingMaterial | PE (skin contact) | PE (skin contact) | Same |
| Volumemeasurementrange | 0ml-999ml | 0ml-999ml | Same |
| Volumemeasurementaccuracy | M2/M2-W: ±7%,±7mlM1/M1-W: ±14%,±14ml | ±15%, ±15ml | Different, Our products aremore accurate than thepredicate device, andperformed the accurate test,the performance is betterthan the predicate devicewithout additional risks. |
| Classification ofprotection againstelectric shock | Class II equipment | Class II equipment | Same |
| Applied part type | B type | B type | Same |
| Real-timescanning | Yes (Pre-scan) | Yes (Pre-scan) | Same |
| PC Data Upload | USB connection | Using USB flash disk | Different , Compared to thepredicate devices, the wayof PC Data Upload ischanged from SD card toUSB connectionTransmission. Thedifference does not affectthe Intended Use, it will notraise safety andeffectiveness issue. |
| Power | Lithium battery:URR18650ZY-2600mAh(SNLB-435 )7.4Vd.c. 2600mAhCharger: HXY-084V1500A-ULAC100-240Va | AC/DC Adapter:Input: AC100-240V,50/60Hz,Output: DC14V±0.5VBattery: Li-ionrechargeable | Different, all the electricalsafety testing has beenconducted according to IEC60601-1: 2012, and resultsshowed pass, therefore,difference between inputpower will not reduce thesubject's safety andeffectiveness. Please referto 015 IEC60601-1 testreport of M2,M2-W,M1,M1-W. |
| WIFI | M1, M2 does notcontain WIFIconnectionM1-W, M2-W containWIFI connection | Do not contain WIFIconnection. | Different, Compared withequivalent equipment, ourproducts have added WIFIand bluetooth connectionfunctions. We have testedaccording to FCCrequirements (CFR 47PART 15), which proves thatour products meet therequirements for wirelesssignal function safety, andthere is no unacceptablesafety and performance. |
| Bluetooth | Connect to the printerusing Bluetooth toprint a test image | Do not containBluetooth connection. | requirements (CFR 47PART 15), which proves thatour products meet therequirements for wirelesssignal function safety, andthere is no unacceptablesafety and performance. |
| Standardscompliance | IEC 60601-1:2005+A1:2012IEC 60601-1-2:2014IEC 60601-2-37:2015 | IEC 60601-1:2005+CORR.1(2006)+CORR.2(2007)IEC 60601-1-2:2007IEC 60601-2-37:2007 | Different, We verified theproduct with a newerversion of the standard.Compliance with newstandards does not reducethe subject's safety andeffectiveness. |
| FDA limit | Track 1 | Track 1 | Same |
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Suzhou Lischka
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Suzhou Lischka
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Suzhou Lischka
All the differences don't affect the safety and effectiveness which is concluded after all the required testing, so no safety and effectiveness issues relating to the system come into conclusion.
8. Performance Data
Clinical test:
Clinical testing is not required.
Non-clinical data
The M2, M2-W, M1, M1-W Bladder Scanner comply with: Safety:
-
- ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
-
- IEC 60601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
Performance:
-
- IEC 60601-2-37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
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-
- NEMA UD 2 Standard for real-time display of thermal and mechanical acoustic output indies on diagnostic ultrasound equipment.
-
- Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing
Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.
Biocompatibility:
-
- ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
-
- ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
-
- ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
WIFI and Bluetooth connection:
-
- FCC CFR TITLE 47 PART 15 SUBPART C SECTION 15.247
The tests were selected to show substantial equivalence between the subject device and the predicate.
- FCC CFR TITLE 47 PART 15 SUBPART C SECTION 15.247
9. Conclusion
The M series Bladder Scanner was evaluated with safety, EMC, Biocompatibility and Acoustic Output.
The conclusions drawn from testing of the M series Bladder Scanner demonstrate that the device is as safe and effective as the legally marketed predicate devices.
§ 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.