(242 days)
Not Found
No
The document mentions "complex image processing technology" and "complex algorithm" for volume calculation, but does not explicitly mention AI, ML, or related terms like neural networks or deep learning. The description focuses on traditional ultrasound imaging and measurement principles.
No
The device is used to image and measure bladder volume and wall thickness, which are diagnostic purposes, not therapeutic. It does not treat or alleviate any condition.
Yes
The device obtains an image of the bladder and calculates its volume non-invasively, which provides information for diagnosis or monitoring of bladder related conditions. It also measures bladder wall thickness.
No
The device description explicitly states that the Bladder Scanner is composed of a "main device, probe, trolley and upper computer software," indicating it includes hardware components in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Bladder Scanner (Model Name:MS) uses ultrasound energy applied externally to the lower abdomen to image and calculate bladder volume. It does not analyze samples taken from the body.
- Intended Use: The intended use is to non-invasively measure bladder volume and wall thickness using ultrasound imaging. This is a diagnostic imaging procedure, not an in vitro test.
Therefore, the Bladder Scanner is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
IYO,ITX
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
•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.
Mentions image processing
Yes
The complex image processing technology is used to restore the three dimensional image, and the complex algorithm is used to calculate the bladder volume and display the results.
The corresponding image processing was used to separate the information of bladder wall from the image and calculate the thickness of bladder wall.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
lower abdomen, bladder
Indicated Patient Age Range
Adults and Pediatrics
Intended User / Care Setting
Trained and qualified healthcare professionals, Professional health care facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Volume measurement accuracy: ±7%, ±7ml
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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
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 Device |
| Industrial Park Qiandeng, Kunshan, Suzhou, Jiangsu 215341 | |
| China | |
| 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, Ultrasonic |
| Transducer, Ultrasonic, Diagnostic | |
| Regulation Number: | 21 CFR 892.1560 |
| 21 CFR 892.1570 | |
| Regulation Name: | Ultrasonic pulsed echo imaging system |
| Diagnostic 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, Ultrasonic |
| Transducer, Ultrasonic, Diagnostic | |
| Regulation Number: | 21 CFR 892.1560 |
| 21 CFR 892.1570 | |
| Regulation Name: | Ultrasonic pulsed echo imaging system |
4
| 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
5
•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:
| SE
Comparisons | Proposed Devices
Bladder Scanner
(model:M5)
K213488 | Predicate Device
K172750 | Similarities/
Differences |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Classification | Class II
IYO, ITX | Class II
IYO, ITX | Same |
| Indication for
use | It 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 | It 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. | Same |
| | and skin disease. | | |
| | Mode of operation: B-mode.
Intended user population:
Trained and qualified
healthcare professionals. | | |
| | Intended use environment:
Professional health care
facilities. | | |
| Patient Population | Adults and Pediatrics | Adults and Pediatrics | Same |
| Acoustic output level | Track 1 | Track 3 | Different
Note 9 |
| Modes of operation | B | B | Same |
| Number of elements | 1 | 1 | Same |
| Transducer
Resonant
Frequency | 2.5 MHz
Mechanical Sector Scan | 3.5MHz Mechanical
Sector Scan | Different
Note 2 |
| Sector Angle | 120° | / | Different
Note 1 |
| Penetration
Depth | 190mm | ≥150mm | Different
Note 1 |
| Volume
measurement
range | 10-999ml | 10-999ml | Same |
| Volume
measurement
accuracy | ±7%, ±7ml | ±10% | Different
Note 3 |
| Acoustic Output | Maximum
MI:0.8
Maximum
TIS:0.06 | Maximum
MI:0.47
Maximum
TIS:0.037 | Different Note 3 |
| Anatomical
Sites | Abdomen | Abdomen | Same |
| Display | Main device:10.1" TFT-LCD | IPAD or IPHONE | Different
Note 4 |
| Probe
Connection to
Display | Wired | Wireless | Different
Note 5 |
| Main device
connects to PC | USB or WIFI | / | Different
Note 6 |
| | AC/DC Adapter: | DC3.8V 4200mA | |
| Power | Input: AC100-240V, 50/60Hz, | | Different
Note 7 |
| | Output: DC13.5V Battery: Li-
ion rechargeable | lithium battery | |
| operating system | Android
Upper computer software
operates on windows PC | IPAD or IPHONE | Different Note 8 |
| Patient-
Contacting
Materials | Evaluated according to
ISO 10993-5 and ISO
10993-10 | Evaluated according to
ISO 10993-5 and ISO
10993-10 | Same |
| Electrical Safety | Evaluated according to
IEC 60601-1 | Evaluated according to
IEC 60601-1 | Same |
| EMC | Evaluated according to
IEC 60601-1-2 | Evaluated according to
IEC 60601-1-2 | Same |
| Performance
Safety | Evaluated according to
IEC 62359:2017 and IEC
60601-2-37 | Evaluated according to
IEC 60601-2-37 | Different Note 9 |
| FCC Radio
Frequency
Testing | Tested to FCC
requirements and found
to comply with the
requirements of FCC
CFR Title 47 Part 15
Subpart C Section
15.247. | Tested to FCC
requirements and found
to comply with the
requirements of FCC
CFR Title 47 Part 15
Subpart C Section
15.247. | Same |
6
7
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
8
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.
9
- 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.