BladderScan Prime PLUS System
Device Facts
| Record ID | K172356 |
|---|---|
| Device Name | BladderScan Prime PLUS System |
| Applicant | Verathon Incorporated |
| Product Code | IYO · Radiology |
| Decision Date | Sep 15, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | AI/ML, Pediatric, 3rd-Party Reviewed |
Intended Use
The BladderScan® PRIME PLUS system is an ultrasound device intended to be used for measuring urine volume of the bladder non-invasively.
Device Story
BladderScan PRIME PLUS is a portable, battery-operated ultrasound device for non-invasive bladder volume measurement. It uses a mechanical sector probe (13 mm diameter, 1 element) to acquire ultrasound images of the bladder. The system employs patented neural network technology to process these images and calculate bladder volume. It features a touchscreen interface for real-time feedback, directional aiming, and display of volume, battery status, and usage rate. Used by medical professionals in clinical settings, the device provides automated volume measurements to assist in clinical decision-making regarding bladder management. It includes data connectivity via USB and SD card and supports an attached printer. The device is non-sterile and intended for abdominal use.
Clinical Evidence
No clinical data was required or provided. Substantial equivalence was supported by non-clinical bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), acoustic output (IEC 60601-2-37), and biocompatibility (ISO 10993).
Technological Characteristics
Portable ultrasound system; mechanical sector probe (13mm, 1 element); 2.49/1.72 MHz nominal frequencies; 120-degree sector angle; 12 scan planes. Patient contact material: Lexan Polycarbonate Plastic HP1-1H112. Power: Lithium-ion battery. Connectivity: USB, SD card. Software: Neural network-based volume calculation. Standards: IEC 60601-1, IEC 60601-2-37, ISO 10993, ISO 14971, ISO 13485.
Indications for Use
Indicated for measuring urine volume of the bladder non-invasively in male, female, and pediatric patients. Contraindicated for fetal use, pregnant patients, patients with ascites, or patients with open skin or wounds in the suprapubic region.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- BladderScan® PRIME System (K153101)
Related Devices
- K153101 — BladderScan Prime System · Verathon Incorporated · Nov 19, 2015
- K130229 — PALM BLADDER SCANNER · Mianyang Meike Electronic Equipment Co., Ltd. · Mar 20, 2013
- K113304 — BLADDER SCANNER · MEDA Co., Ltd. · Mar 23, 2012
- K111021 — CUBESCAN / BIOCON-700 · Mcube Technology Co., Ltd. · Apr 27, 2011
- K091518 — CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM · Mcube Technology Co., Ltd. · Jun 18, 2009
Submission Summary (Full Text)
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Public Health Service
Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2017
Verathon Incorporated % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO MN 55313
Re: K172356
Trade/Device Name: BladderScan® PRIME PLUS system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: September 5, 2017 Received: September 6, 2017
Dear Mr. Job:
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 (reporting of medical device
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Robert Ochs
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)
K172356
Device Name BladderScan® PRIME PLUS system
Indications for Use (Describe)
The BladderScan® PRIME PLUS system is an ultrasound device intended to be used for measuring urine volume of the bladder non-invasively.
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: BladderScan® PRIME PLUS system Transducer: N/A
| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| (Track 1 Only) | (Tracks 1 & 3) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | P | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Bladder) | P | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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
### All items marked "P" were previously cleared in 510(k) K153101
Prescription Use (21 CFR 801.109)
| (Division Sign-Off) | |
|-----------------------------------------|--|
| Division of Reproductive, Abdominal and | |
| Radiological Devices | |
| 510(k) Number | |
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# Diagnostic Ultrasound Indications for Use Form
System: BladderScan® Prime PLUS System Transducer: 2.49 MHz / 1.72 MHz
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| (Track 1 Only) | (Tracks 1 & 3) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | P | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Bladder) | P | | | | | | |
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
#### All items marked "P" were previously cleared in 510(k) K153101
Prescription Use (21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices Radiological Bookscal Be
Verathon042 510(k) Number
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Image /page/5/Picture/0 description: The image contains the text "verathon.com". The text is in a light color, possibly white or light gray, against a green background. The text appears to be a website address.
Image /page/5/Picture/1 description: The image shows the logo for Verathon, a medical solutions company. The logo features a stylized "V" shape in green and blue, with the company name "VERATHON" in blue, bold letters. Below the company name is the tagline "Trusted and Enduring Medical Solutions" in a smaller font size. The logo is clean and professional, conveying a sense of trust and reliability.
## 510(k) Summary of Safety and Effectiveness
This summary of Safety and Effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR 807, Subpart E, section 807.92.
#### Date Prepared: June 29, 2017
- 1. Submitter's name, address, telephone number, contact person:
Verathon Inc. 20001 North Creek Parkway Bothell, WA 98011 USA
### Corresponding Official:
Mary K. Moore Vice President, Regulatory Affairs and Quality Assurance Phone: 425.629.5754 Email: Mary.Moore@verathon.com
#### Alternate Contact:
Swapna Chirala Regulatory Compliance Engineer, Regulatory Affairs and Quality Assurance Phone: 425.629.5582 Email: Swapna.Chirala@verathon.com
- 2. Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
| Common Name: | Diagnostic Ultrasound System with accessories |
|-------------------------|-----------------------------------------------|
| Proprietary/Trade name: | BladderScan® PRIME PLUS system |
| Device Class: | Class II |
| Review Panel: | Radiology |
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Image /page/6/Picture/1 description: The image shows the logo for Verathon, a medical solutions company. The logo features a stylized green and blue graphic to the left of the company name, which is written in blue, sans-serif font. Below the company name is the tagline "Trusted and Enduring Medical Solutions" in a smaller, sans-serif font.
#### Classification Information:
| Name | CFR Section | Product Code |
|---------------------------------------|-----------------|--------------|
| Ultrasonic Pulsed Echo Imaging System | 21 CFR 892.1560 | IYO |
| Diagnostic Ultrasound Transducer | 21 CFR 892.1570 | ITX |
#### 3. Identification of the predicate or legally marketed device:
BladderScan® PRIME System K153101
#### 4. Device Description:
The BladderScan" PRIME PLUS system provides non-invasive measurement of urinary bladder volume. The system calculates the bladder volume using patented neural network technology. Volume measurements made with this technology are based on a more complex, multifaceted image of the bladder.
Bladder volume, directional aiming with real-time feedback, battery status and usage rate indicators are displayed on the LCD display. The system operates using a battery which includes a charging cradle.
#### 5. Intended Use:
The BladderScan" PRIME PLUS System is an Ultrasound device intended to be used for measuring urine volume of the bladder non-invasively.
Clinical Application: Abdominal B-Mode (Bladder)
#### 6. Technological Characteristics:
The BladderScan" PRIME PLUS system and the predicate are both Track 1 devices that employ the same fundamental technology. The comparison table is provided below.
| Comparison Category | Verathon BladderScan® PRIME<br>PLUS System<br>(This submission) | Predicate Verathon BladderScan®<br>PRIME System<br>(K153101) |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison Overview | | |
| FDA Ultrasound Guidance Track | Identical to predicate | Track 1 |
| Comparison Category | Verathon BladderScan® PRIME<br>PLUS System<br>(This submission) | Predicate Verathon BladderScan®<br>PRIME System<br>(K153101) |
| Device Classification Name | Identical to predicate | System, Imaging, Pulsed Echo,<br>Ultrasonic |
| Intended Use/Indications For<br>Use | Identical to predicate | The BladderScan® Prime System is<br>an ultrasound device intended to<br>be used for measuring the urine<br>volume in the bladder non-<br>invasively. |
| Contraindications | Identical to predicate | The BladderScan® Prime System is<br>not intended for fetal use or for use<br>on pregnant patients, patients with<br>ascites, or patients with open skin<br>or wounds in the suprapubic<br>region. |
| Patient/User Characteristics | | |
| Target Population | Identical to predicate | Male, Female, and Pediatric<br>patients |
| Anatomical Site | Identical to predicate | Bladder |
| Users | Identical to predicate | Physicians/Medical Professionals |
| Technological Characteristics and Performance | | |
| Patient Contact Material | Identical to predicate | Lexan Polycarbonate Plastic HP1-<br>1H112 (colorant: PCM 84907 Dark<br>Gray 424C) |
| Sterility | Identical to predicate | Non-sterile |
| Power Source | Identical to predicate | Electrical (Lithium-ion battery) |
| Energy Delivered | Identical to predicate | Ultrasound |
| Measurement Accuracy | $0-100mL = \pm7.5mL$<br>$100-999 mL = \pm7.5%$ | $\pm 15% \pm 15mL$ |
| Measurement Range | Identical to predicate | 0 to 999 mL |
| Variable Acoustic Output<br>Settings | Identical to predicate | No |
| Controls to Change Acoustic<br>Output During Scan | Identical to predicate | No |
| Modes of Operation | Identical to predicate | B-mode |
| Transducer Type | Identical to predicate | Mechanical Sector Probe |
| Transducer Diameter | Identical to predicate | 13 mm |
| Number of Elements | Identical to predicate | 1 |
| Comparison Category | Verathon BladderScan® PRIME<br>PLUS System<br>(This submission) | Predicate Verathon BladderScan®<br>PRIME System<br>(K153101) |
| Transducer Resonant Frequency | Identical to predicate | 2.95 MHz |
| Nominal Acoustic Output<br>Frequencies | Identical to predicate | 2.49 / 1.72 MHz |
| Sector Angle | Identical to predicate | 120 degrees |
| Number of Scan Planes | Identical to predicate | 12 |
| Design and Usability Features | | |
| Portable | Identical to predicate | Yes |
| Display | Identical to predicate | LCD |
| Scan Button | Identical to predicate | Yes |
| Touchscreen Operation | Identical to predicate | Yes |
| Selectable Unit Orientation<br>(Patient Right/Left) | Identical to predicate | Yes |
| Live Scan Image | Identical to predicate | Yes |
| Procedure Type selection on<br>user interface | Single mode of operation<br>accommodating<br>Male/Female/Small child | Male/Female/Small Child mode<br>selection screen and If female:<br>Uterus or no uterus selection |
| Calibration | No Calibration recommended | Annual Calibration recommended |
| Data Connections | Identical to predicate | USB, SD card |
| Attached Printer | Identical to predicate | Yes |
| Accessories | Identical to predicate | Printer, battery, battery charger,<br>power cord, mobile cart |
| Safety Standards | | |
| Acoustic Output: Maximum<br>Mechanical Index (MI) | Identical to predicate | 0.424 |
| Acoustic Output: Maximum<br>Thermal Index (TI) | Identical to predicate | ≤ 1.0 |
| Acoustic Output: Intensity,<br>Spatial Peak Temporal Average<br>(ISPTA) | Identical to predicate | ≤ 1.0 mW/cm² |
| Acoustic Output: Intensity,<br>Spatial Peak Pulse Average (ISPPA) | Identical to predicate | ≤ 12.0 W/cm² |
| Biocompatibility Standard<br>Compliance | Identical to predicate | ANSI/AAMI/ISO 10993-1:2009,<br>ANSI/AAMI/ ISO 10993-5:2009, ISO<br>10993-10:2010, ANSI/AAMI/ISO<br>10993-12:2012 |
| Comparison Category | Verathon BladderScan® PRIME<br>PLUS System<br>(This submission) | Predicate Verathon BladderScan®<br>PRIME System<br>(K153101) |
| Electrical Safety Standard<br>Compliance | AAMI/ANSI ES 60601-<br>1:2005/(R)2012 and A1:2012,<br>IEC 60601-2-37:2007 | IEC 60601-1:2005, IEC 60601-2-<br>37:2007 |
| Electromagnetic Compatibility<br>Standard Compliance | Identical to predicate | IEC 60601-1-2: 2007 |
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Image /page/7/Picture/0 description: The image shows the logo for Verathon, a medical solutions company. The logo features a stylized green and blue graphic to the left of the company name, which is written in blue, sans-serif font. Below the company name is the tagline "Trusted and Enduring Medical Solutions" in a smaller font size.
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Image /page/8/Picture/0 description: The image contains the text "verathon.com". The text is in a sans-serif font and is light gray in color. The background is a light green color.
Image /page/8/Picture/1 description: The image shows the logo for Verathon, a medical solutions company. The logo features a stylized "V" shape in blue and green, followed by the word "VERATHON" in blue, all caps. Below the company name is the tagline "Trusted and Enduring Medical Solutions" in a smaller font.
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Image /page/9/Picture/0 description: The image shows the text "verathon.com". The text is written in a light color, possibly white or light green. The background is a darker shade of green. The text appears to be a website address.
Image /page/9/Picture/1 description: The image shows the logo for Verathon. The logo consists of a stylized green checkmark-like symbol on the left, followed by the word "VERATHON" in blue, all caps. Below the company name is the tagline "Trusted and Enduring Medical Solutions" in a smaller font size.
#### 7. Determination of Substantial Equivalence:
#### Summary of Non-Clinical Tests:
The BladderScan" PRIME PLUS system has been evaluated for electrical, thermal, mechanical and EMC safety. Additionally, cleaning/disinfection, biocompatibility, and acoustic output have been evaluated, and the device has been found to conform to applicable voluntary medical device safety standards. Assurance of quality was established by employing the following elements for product development: Design Reviews, Risk Assessment, Development of Requirements and Software Verification, Hardware Verification, and Safety Compliance Verification. Patient contact materials are biocompatible.
The BladderScan" PRIME PLUS system is designed to comply with the following standards:
| Reference No. | Title |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-1:2009 | ISO 10993-1:2009/R(2013) Biological Evaluation of Medical Devices. Part 1:<br>Evaluation and Testing |
| ISO 10993-5:2009 | AAMI / ANSI / ISO 10993-5:2009/(R)2014, Biological Evaluation Of Medical<br>Devices - Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility) |
| ISO 10993-10:2010 | ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation of Medical<br>Devices - Part 10: Test for Irritation and Skin Sensitization.<br>(Biocompatibility) |
| ANSI/AAMI/ISO 10993-<br>12:2012 | AAMI / ANSI / ISO 10993-12:2012, Biological Evaluation Of Medical Devices -<br>Part 12: Sample Preparation And Reference Materials. (Biocompatibility) |
| IEC 60601-<br>1:2005/A1:2012 | AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And<br>A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1:<br>General Requirements For Basic Safety And Essential Performance (IEC<br>60601-1:2005, Mod). (General II (ES/EMC)) |
| IEC 60601-1-2:2007 | AAMI / ANSI / IEC 60601-1-2:2007(R)2012, Medical Electrical Equipment -<br>Part 1-2: General Requirements for Basic Safety and Essential Performance<br>– Collateral Standard: Electromagnetic Compatibility - Requirements and<br>Tests (Edition 3) |
#### FDA Consensus Standards
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Image /page/10/Picture/0 description: The image shows the text "verathon.com". The text is written in a light color, possibly white or a light shade of green. The background is a solid, darker shade of green, providing contrast for the text to be visible.
Image /page/10/Picture/1 description: The image shows the logo for Verathon, a medical solutions company. The logo features a stylized checkmark symbol in blue and green, followed by the company name "VERATHON" in large, bold, blue letters. Below the company name is the tagline "Trusted and Enduring Medical Solutions" in a smaller font size.
| IEC 60601-2-37:2007 | IEC 60601-2-37:2007 Medical Electrical Equipment. Part 2-37: Particular<br>Requirements for the Basic Safety and Essential Performance of Ultrasonic<br>Medical Diagnostic and Monitoring Equipment. |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AIUM/NEMA UD-2:2004 | Standard for Real Time Display of Thermal and Mechanical Acoustic output<br>Indices on Diagnostic Ultrasound Equipment. |
| AIUM AOMS:2004 | Acoustic Output Measurement Standard for Diagnostic Ultrasound<br>Equipment. |
| ISO 14971:2007 | AAMI / ANSI / ISO 14971:2007/(R) 2010 (Corrected 4 October 2007),<br>Medical Devices - Applications of Risk Management to Medical<br>Devices. (General I (QS/RM)) |
#### Miscellaneous Standards
| Reference No. | Title | |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-<br>6:2010/A1:2013 | IEC 60601-1-6 Edition 3.1 2013-10, Medical Electrical Equipment – Part 1-6:<br>General Requirements for Basic Safety and Essential Performance –<br>Collateral Standard: Usability. (General I (QS/RM)) | |
| | AAMI HE 75:2009 | AAMI/ANSI HE75:2009/(R)2013, Human Factors Engineering – Design of<br>Medical Devices. (General I (QS/RM)) |
| | | IEC 62366-1:2015 |
| ISO 13485:2003 | ISO 13485:2003, Medical Devices Quality Management System -<br>Requirements for Regulatory Purposes | |
#### Summary of Clinical Tests:
The BladderScan® PRIME PLUS System, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.
#### 8. Conclusion
The intended use and other key features are consistent with traditional clinical practice and FDA guidance. The BladderScan® PRIME PLUS system and the predicate device conform to applicable electro-medical device safety standards with compliance verified through independent evaluation. The BladderScan® PRIME PLUS system and the predicate meet FDA requirements for Track 1 devices, share indications for use, have biosafety equivalence and are manufactured using ISO 13485 quality management system. Verathon Inc. believes that the BladderScan" PRIME PLUS system is substantially equivalent with regard to safety and effectiveness to the legally marketed predicate device.
