(242 days)
The Bladder Scanner (Model Name:MS) is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease.
Mode of operation: B-mode.
Intended user population: Trained and qualified healthcare professionals.
Intended use environment:Professional health care facilities.
The Bladder Scanner (model:M5) designed and manufactured by SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO., LTD. is a kind of B mode noninvasive bladder volume measurement and bladder wall thickness measurement based on ultrasonic imaging and measurement principle. The Bladder Scanner (model:M5) is composed of main device, probe, trolley and upper computer software. The main device and probe measure bladder wall thickness, and thickness, and they can transmit the patient information and measurement result to upper computer running upper computer software by WIFI or USB to manage and process patient's data, and the main device include print function.
The provided 510(k) summary for the Bladder Scanner (Model Name: M5) by Suzhou Peaksonic Medical Technology Co., Ltd. does not include a specific study detailing acceptance criteria and reported device performance in the format requested.
The document focuses on demonstrating substantial equivalence to a predicate device (Wireless Probe Type Ultrasound Scanner, Model: BProbe, K172750) through a comparison of technological characteristics and compliance with various international standards for safety, EMC, biocompatibility, and software.
While there is a mention of "Performance verification" with an "Internal verification protocol," the details of this protocol, including specific acceptance criteria and the results of the performance are not explicitly provided in the summary. The summary states that there are "slight difference in measurement range, measurement accuracy, and acoustic output, the subject device has wider measurement range and more accurate measurement accuracy, the measurement range and accuracy were verified." However, the actual acceptance criteria and the verified performance values are not tabulated.
Therefore, many parts of your request for specific details of the acceptance criteria and the study that proves the device meets them cannot be fully answered from the provided text.
Based on the available information, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with "acceptance criteria" and "reported device performance" in the typical sense of a clinical or performance study with quantified metrics and thresholds. Instead, it refers to the device having a "wider measurement range" and "more accurate measurement accuracy" than the predicate, and states that these were "verified."
Measurement Accuracy (Compared to Predicate):
| Criterion (Implicit) | Reported Device Performance (M5) | Predicate Device Performance (K172750) |
|---|---|---|
| Bladder Volume Measurement Accuracy (for 10-999ml) | ±7%, ±7ml | ±10% |
Measurement Range (Compared to Predicate):
| Criterion (Implicit) | Reported Device Performance (M5) | Predicate Device Performance (K172750) |
|---|---|---|
| Volume Measurement Range | 10-999ml | 10-999ml (No difference stated, but "wider measurement range" is claimed in "Note 3") |
Other Performance-Related Characteristics (not explicit acceptance criteria, but comparisons):
| Characteristic | Proposed Device (Bladder Scanner, M5) | Predicate Device (Wireless Probe Type Ultrasound Scanner, BProbe) |
|---|---|---|
| Transducer Frequency | 2.5 MHz | 3.5MHz |
| Penetration Depth | 190mm | ≥150mm |
| Maximum MI | 0.8 | 0.47 |
| Maximum TIS | 0.06 | 0.037 |
2. Sample Size for the Test Set and Data Provenance
The document states: "Clinical testing is not required" and mentions "Internal verification protocol 1" for performance verification. This implies that the performance data for the "more accurate measurement accuracy" was likely derived from internal testing, possibly using phantoms or simulated data, rather than a clinical human test set.
- Sample Size for Test Set: Not specified.
- Data Provenance: Likely internal verification, not specified as human clinical data. No country of origin is mentioned for specific test data, apart from the manufacturer being in China.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Given the statement "Clinical testing is not required," there is no indication of experts being used to establish ground truth for a clinical test set. If the performance verification involved phantoms or other non-clinical methods, the "ground truth" would be the known properties of those phantoms.
4. Adjudication Method
Not applicable, as no clinical test set with expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or presented. The submission focuses on substantial equivalence based on technical specifications and international standard compliance, not a comparative effectiveness study with human readers.
6. Standalone Performance
The claimed "measurement accuracy" of ±7%, ±7ml refers to the standalone performance of the device's volume calculation algorithm. Details of the study or verification that quantified this accuracy are not provided beyond the mention of an "Internal verification protocol."
7. Type of Ground Truth Used
For the accuracy claim, the ground truth would likely be the known volumes of phantoms or carefully measured fluid volumes if internal verification protocols were used. The document does not specify the exact nature of the ground truth used for this verification.
8. Sample Size for the Training Set
The document does not mention any machine learning or AI components that would require a dedicated training set. The device is described as operating based on "ultrasonic imaging and measurement principle" and "complex algorithm is used to calculate the bladder volume." If these algorithms involve learning, the training set size is not disclosed.
9. How Ground Truth for the Training Set Was Established
Not applicable, as no training set is explicitly mentioned for algorithm development.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
July 1, 2022
Suzhou Peaksonic Medical Technology Co., Ltd. Calvin Ma GM 2A, West Side of Building G4, Kunshan Hi-Tech Medical Device Industrial Park Qiandeng, Kunshan Suzhou, Jiangsu 215341 CHINA
Re: K213488
Trade/Device Name: Bladder Scanner, Model Name:M5 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO, ITX Dated: May 5, 2022 Received: May 19, 2022
Dear Calvin Ma:
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
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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 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
Michael D. O'Hara, Ph.D. Deputy Director DHT 8C: Division of Radiological Imaging and Radiation Therapy OHT8: Office of 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) K213488
Device Name Bladder Scanner, Model Name:M5
Indications for Use (Describe)
The Bladder Scanner (Model Name:MS) is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease.
Mode of operation: B-mode.
Intended user population: Trained and qualified healthcare professionals.
Intended use environment:Professional health care facilities.
| 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)
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510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: June 29,2022
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO., LTD. |
|---|---|
| Address: | 2A, West Side of Building G4, Kunshan Hi-Tech Medical DeviceIndustrial Park Qiandeng, Kunshan, Suzhou, Jiangsu 215341China |
| Contact person: | Calvin Ma |
| Title: | GM |
| E-mail: | service@peaksonic.com.cn |
| Tel: | 86-512-36693388 |
2. Device Identification
| 510(K) number: | K213488 |
|---|---|
| Trade/Device Name: | Bladder Scanner |
| Models: | M5 |
| Common name: | System, Imaging, Pulsed Echo, UltrasonicTransducer, Ultrasonic, Diagnostic |
| Regulation Number: | 21 CFR 892.156021 CFR 892.1570 |
| Regulation Name: | Ultrasonic pulsed echo imaging systemDiagnostic ultrasonic transducer |
| Regulation Class: | Class II |
| Panel: | Radiology |
| Product Code: | IYO,ITX |
3. Predicate Device
| 510(K) number: | K172750 |
|---|---|
| Device Name: | Wireless Probe Type Ultrasound Scanner (Model: BProbe) |
| Manufacturer: | Guangzhou Sonostar Technologies Co., Ltd. |
| Common name | System, Imaging, Pulsed Echo, UltrasonicTransducer, Ultrasonic, Diagnostic |
| Regulation Number: | 21 CFR 892.156021 CFR 892.1570 |
| Regulation Name: | Ultrasonic pulsed echo imaging system |
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| Diagnostic ultrasonic transducer | ||
|---|---|---|
| Regulation Class: | Class II | |
| Panel: | Radiology | |
| Product Code: | IYO,ITX |
4. Device Description
The Bladder Scanner (model:M5) designed and manufactured by SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO., LTD. is a kind of B mode noninvasive bladder volume measurement and bladder wall thickness measurement based on ultrasonic imaging and measurement principle. The Bladder Scanner (model:M5) is composed of main device, probe, trolley and upper computer software. The main device and probe measure bladder wall thickness, and thickness, and they can transmit the patient information and measurement result to upper computer running upper computer software by WIFI or USB to manage and process patient's data, and the main device include print function.
The Bladder Scanner (model:M5) has the following characteristics:
·There are three operation modes for bladder volume measurement: Expert mode, simple mode and intelligent mode. In expert mode, real-time two-dimensional B-ultrasound image is displayed. The operator can judge whether the measurement position and measurement result are correct according to the displayed bladder section image. In the simple mode, there is no real-time two-dimensional scanning image, and the operator is guided by the instrument to move the probe to find the correct position for measurement. In the intelligent mode, in the pre scanning stage, only the real-time projection position map of the bladder scanning surface appears. Before the scanning, the position of the bladder is accurately located, and the positioning is carried out before scanning.
·The instrument is non-invasive and comfortable for patients when measuring bladder volume. When the user releases the scan key, it can obtain multiple two-dimensional plane ultrasound images in the body within a few seconds. The complex image processing technology is used to restore the threedimensional image, and the complex algorithm is used to calculate the bladder volume and display the results.
• Two-dimensional plane scanning was used, and two-dimensional B-ultrasound images were displayed on the screen. After locating the position of bladder wall, the image was frozen by pressing the button on the probe. The corresponding image processing was used to separate the information of bladder wall from the image and calculate the thickness of bladder wall.
• The bladder volume measurement can print two orthogonal images + projection, patient information and volume value; bladder wall thickness measurement can print a B-ultrasound image, patient information and wall thickness value.
· Touch screen keyboard operation is adopted
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•Multi language choice
· Information management, storage, printing, deletion and uploading.
- The probe is equipped with a display screen to guide the user to move the probe
- •The instrument is composed of injection molding shell host, probe and trolley
- •The display adopts 10.1 inch LCD (1280 * 800) pixels
•Power supply mode: AC power supply or battery power supply.
5. Indication for use
The Bladder Scanner (Model Name:M5) is intended to project ultrasound energy through the lower abdomen of the non-pregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease.
Mode of operation: B-mode.
Intended user population: Trained and qualified healthcare professionals.
Intended use environment: Professional health care facilities.
6. Technological Characteristics Comparison
Compared to the predicate device, the subject device has the same intended use, similar product design, and similar performance as the predicate device, the summarized comparison information is listed in the following table:
| SEComparisons | Proposed DevicesBladder Scanner(model:M5)K213488 | Predicate DeviceK172750 | Similarities/Differences |
|---|---|---|---|
| Classification | Class IIIYO, ITX | Class IIIYO, ITX | Same |
| Indication foruse | It is intended to projectultrasound energy throughthe lower abdomen of thenon-pregnant patient toobtain an image of thebladder and uses that imageto calculate the bladdervolume non-invasively. It iscontraindicated for fetal useand for use on pregnantpatients. And it should not beused by those who areallergic to coupling agent andwho have abdomen wound | It is intended to projectultrasound energy throughthe lower abdomen of thenon-pregnant patient toobtain an image of thebladder and uses that imageto calculate the bladdervolume non-invasively. It iscontraindicated for fetal useand for use on pregnantpatients. And it should not beused by those who are allergicto coupling agent and whohave abdomen wound andskin disease. | Same |
| and skin disease. | |||
| Mode of operation: B-mode.Intended user population:Trained and qualifiedhealthcare professionals. | |||
| Intended use environment:Professional health carefacilities. | |||
| Patient Population | Adults and Pediatrics | Adults and Pediatrics | Same |
| Acoustic output level | Track 1 | Track 3 | DifferentNote 9 |
| Modes of operation | B | B | Same |
| Number of elements | 1 | 1 | Same |
| TransducerResonantFrequency | 2.5 MHzMechanical Sector Scan | 3.5MHz MechanicalSector Scan | DifferentNote 2 |
| Sector Angle | 120° | / | DifferentNote 1 |
| PenetrationDepth | 190mm | ≥150mm | DifferentNote 1 |
| Volumemeasurementrange | 10-999ml | 10-999ml | Same |
| Volumemeasurementaccuracy | ±7%, ±7ml | ±10% | DifferentNote 3 |
| Acoustic Output | MaximumMI:0.8MaximumTIS:0.06 | MaximumMI:0.47MaximumTIS:0.037 | Different Note 3 |
| AnatomicalSites | Abdomen | Abdomen | Same |
| Display | Main device:10.1" TFT-LCD | IPAD or IPHONE | DifferentNote 4 |
| ProbeConnection toDisplay | Wired | Wireless | DifferentNote 5 |
| Main deviceconnects to PC | USB or WIFI | / | DifferentNote 6 |
| AC/DC Adapter: | DC3.8V 4200mA | ||
| Power | Input: AC100-240V, 50/60Hz, | DifferentNote 7 | |
| Output: DC13.5V Battery: Li-ion rechargeable | lithium battery | ||
| operating system | AndroidUpper computer softwareoperates on windows PC | IPAD or IPHONE | Different Note 8 |
| Patient-ContactingMaterials | Evaluated according toISO 10993-5 and ISO10993-10 | Evaluated according toISO 10993-5 and ISO10993-10 | Same |
| Electrical Safety | Evaluated according toIEC 60601-1 | Evaluated according toIEC 60601-1 | Same |
| EMC | Evaluated according toIEC 60601-1-2 | Evaluated according toIEC 60601-1-2 | Same |
| PerformanceSafety | Evaluated according toIEC 62359:2017 and IEC60601-2-37 | Evaluated according toIEC 60601-2-37 | Different Note 9 |
| FCC RadioFrequencyTesting | Tested to FCCrequirements and foundto comply with therequirements of FCCCFR Title 47 Part 15Subpart C Section15.247. | Tested to FCCrequirements and foundto comply with therequirements of FCCCFR Title 47 Part 15Subpart C Section15.247. | Same |
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Note 1: The subject device Bladder Scanner (model:M5) boasts similar technological characteristics with the predicate device K172750, for example, they have the same mode of operation, transducer type (i.e.Mechanical Sector Scan), target population and anatomical sites. Though they differ in transducer specification, range of measurement, accuracy, operation condition and screen display, such slight difference will not affect the core usage of the Bladder Scanner (model:M5), thus will not affecting the substantial equivalence between the two devices.
Note 2: Generally, the frequency of Diagnostic ultrasound is 2-10MHz, subject device's frequency is 2.5MHz, so it is able to measure bladder volume accurately.
Note 3: There are slight difference in measurement range, measurement accuracy, and acoustic output, the subject device has wider measurement range and more accurate measurement accuracy, the measurement range and accuracy were verified. The Acoustic Output is evaluated according to IEC 62359:2017.
Note 4: The display of main device is 10.1" TFT-LCD touch screen, doctor can read and operate easily.
Note 5: The probe of subject device connecting to main device by wire while the connection of probe of predicate device are wireless, obviously, the risk of subject is lower than predicate device.
Note 6: The subject device can transmit patient's data to upper computer by WIFI, its safety has
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been further ensured by FCC requirements, which will not bring new concerns to the subject device's safety and effectiveness
Note 7: The voltage and capacity of battery and output of adaptor are different from predicate device, we evaluated their safety in accordance with IEC 60601-1, test results showed no safety risk.
Note 8: There are some differences in design ideas. The subject device includes two software, one only runs on main device of subject device, the operation system of main device is android, another can run on upper computer, its operation system is windows. All of software are verified and validated, no residual risk.
Note 9: The subject device Bladder Scanner (model:M5) follows Track 1 of FDA ultrasound submission, and the predicate device follows Track 3, but this difference does not raise issues in safety.
To sum up, all the differences don't affect the safety and effectiveness which is concluded affer all the required testing, so it is reasonable to conclude that subject device Bladder Scanner (model:M5) is substantial equivalent with predicate device.
8. Performance Data
Clinical test:
Clinical testing is not required.
Non-clinical data
The subject device Bladder Scanner (model:M5) evaluated:
Safety and Performance:
IEC 60601-1:2012 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
IEC 62359:2017 Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
IEC 60601-2-37:2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment EMC:
IEC 60601-1-2 :2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances -Requirements and tests
Biocompatibility:
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro 1.
- I SO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
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- FCC CFR Title 47 Part 15 Subpart C Section 15.247: Frequency Hopping, Direct Spread Spectrum and Hybrid Systems that are in operation with the bands of 902-928 MHz, 2400-2483.5 MHz, and 5725-5850 MHz
Software verification&validation:
Guidance for the Content of Premarket Submissions for Software Contained in Medical 1. Device
Performance verification
Internal verification protocol 1.
9. Conclusion
The conclusion drawn from the nonclinical tests demonstrate that the subject device in 510(K) submission K213488, Bladder Scanner (Model Name:M5), is as safe, as effective, and performs as well as or better than the predicate device, Wireless Probe Type Ultrasound Scanner (Model: BProbe), cleared under K172750.
§ 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.