(24 days)
Not Found
Yes
The device description explicitly mentions "patented NeuralHarmonics technology" and states that it calculates bladder volume based on a "more complex, three-dimensional image." While the term "NeuralHarmonics" isn't a standard AI/ML term, the context of using a complex 3D image and a proprietary "Neural" technology strongly suggests the use of a neural network or similar AI/ML approach for image processing and volume calculation, especially when contrasted with "conventional two-dimensional ultrasound." The lack of detail on training/test sets is common in 510(k) summaries and doesn't negate the potential for AI/ML use.
No
The device measures urine volume in the bladder, which is a diagnostic function, not a therapeutic one. It does not treat or prevent any condition.
No
The device is used for measuring urine volume, which provides data but doesn't interpret or diagnose a medical condition.
No
The device description explicitly states it is an "ultrasound device" and includes hardware components like an instrument, LCD display, and battery charger.
Based on the provided information, the BladderScan® Prime system 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. They are used to provide information for diagnosis, monitoring, or screening.
- BladderScan® Prime System Function: The BladderScan® Prime system uses ultrasound to non-invasively measure the volume of urine within the bladder. It does not analyze a sample taken from the body.
Therefore, since the device operates externally and does not analyze a biological sample, it falls outside the definition of an In Vitro Diagnostic device. It is a medical device used for non-invasive measurement.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The relevant section explicitly states "Control Plan Authorized (PCCP) and relevant text - Not Found."
Intended Use / Indications for Use
The BladderScan® Prime system is an ultrasound device intended to be used for measuring the urine in the bladder non-invasively.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
The BladderScan" Prime system instrument provides noninvasive measurement of urinary bladder volume. The instrument calculates the bladder volume using patented NeuralHarmonics technology, which is easy to use and comfortable for the patient. Volume measurements made with NeuralHarmonics are accurate than those from conventional two-dimensional ultrasound as they are based on a more complex, three-dimensional image of the bladder.
Bladder volume, mode (male, female and small child), directional aiming with real-time feedback, battery status and usage rate indicators are displayed on the LCD display. The system also includes a battery charger for custom, user-replaceable lithium-ion batteries included with the system,
Mentions image processing
Not Found
Mentions AI, DNN, or ML
The instrument calculates the bladder volume using patented NeuralHarmonics technology
Input Imaging Modality
Ultrasound
Anatomical Site
Bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians/Medical Professionals
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 19, 2015
Verathon Incorporated % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313
Re: K153101
Trade/Device Name: BladderScan® Prime System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: November 6, 2015 Received: November 9, 2015
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-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.
1
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 at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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 yours,
Robert Ocks
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name BladderScan® Prime system
Indications for Use (Describe)
The BladderScan® Prime system is an ultrasound device intended to be used for measuring the urine in 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)
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
Diagnostic Ultrasound Indications for Use Form
System: BladderScan® Prime System
Transducer: N/A
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 | Combined | Other* |
| (Track 1 Only) | (Tracks 1 & 3) | Doppler | (Specify) | (Specify) | ||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | N | |||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Bladder) | N |
N = new indication; P = previously cleared; 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
Prescription Use (21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
4
Diagnostic Ultrasound Indications for Use Form
System: BladderScan® Prime System
Transducer: 2.49/1.72 MHz Harmonic Transducer
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 | ||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| (Track 1 Only) | (Tracks 1 & 3) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | N | |||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Bladder) | N |
N = new indication; P = previously cleared; 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
Prescription Use (21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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Image /page/5/Picture/0 description: The image shows the logo for Verathon, a medical solutions company. The logo features a stylized "V" shape in blue and green, with the word "VERATHON" in blue capital letters next to it. Below the company name is the tagline "Trusted and Enduring Medical Solutions" in a smaller font.
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: October 2, 2015
-
- Submitter's name, address, telephone number, contact person:
Verathon Inc. 20001 North Creek Parkway Bothell, WA 98011
- Submitter's name, address, telephone number, contact person:
Corresponding Official:
Rhonda M. Kops, RAC Manager, Regulatory Affairs
Phone: 425-867-1348 ext. 5643 Fax: 425-883-2896 Email: rhonda.kops@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
BladderScan® Prime system Proprietary/Trade name:
Class II Device Class:
Review Panel: Radiology
Classification Information:
| Name | CFR Section | Product Code |
|---|---|---|
| Ultrasonic Pulsed Echo Imaging System | 21 CFR 892.1560 | lında çıxır. Bu və bir və bir və bir və bir və bir və bir və bir və bir və bir və bir və bir və bir və bir və bir və bir və bir və bir və bir və bir və bir və bir və bir və |
| Diagnostic Ultrasound Transducer | 21 CFR 892.1570 |
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Image /page/6/Picture/0 description: The image shows the logo for Verathon, a medical solutions company. The logo features a stylized green and blue symbol to the left of the company name, which is written in blue capital letters. Below the company name is the tagline "Trusted and Enduring Medical Solutions" in a smaller font.
3. Identification of the predicate or legally marketed device:
BladderScan® BVI 9400 K071217
4. Device Description:
The BladderScan" Prime system instrument provides noninvasive measurement of urinary bladder volume. The instrument calculates the bladder volume using patented NeuralHarmonics technology, which is easy to use and comfortable for the patient. Volume measurements made with NeuralHarmonics are accurate than those from conventional two-dimensional ultrasound as they are based on a more complex, three-dimensional image of the bladder.
Bladder volume, mode (male, female and small child), directional aiming with real-time feedback, battery status and usage rate indicators are displayed on the LCD display. The system also includes a battery charger for custom, user-replaceable lithium-ion batteries included with the system,
5. Intended Use:
The BladderScan "Prime system is an ultrasound device intended to be used for measuring the urine volume in the bladder non-invasively.
Clinical Application: Abdominal B-Mode (Bladder)
6. Technological Characteristics:
The BladderScan" Prime system and BladderScan" BVI 9400 system are both Track 1 devices that employ the same fundamental technology. The comparison table is provided below.
| Comparison Category | Proposed BladderScan®
Prime
(Verathon Inc.) | Predicate BladderScan®
BVI 9400
(Verathon Inc.) |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison Overview | | |
| FDA 510(k) Number | | K071217 |
| FDA Ultrasound Guidance Track | Track 1 | Track 1 |
| Device Classification Name | System, Imaging, Pulsed
Echo, Ultrasonic | System, Imaging, Pulsed
Echo, Ultrasonic |
| | | |
| Intended Use/Indications For Use | The BladderScan Prime
system is an ultrasound
device intended to be
used for measuring the
urine volume in the
bladder non-invasively. | The BladderScan® BVI
9400 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
noninvasively. |
| Contraindications | The BladderScan Prime
system is not intended
for fetal use or for use on
pregnant patients,
patients with ascites, or
patients with open skin
or wounds in the
suprapubic region. | The BladderScan BVI 9400
is not intended for fetal
use or for use on
pregnant patients. Do not
use the BladderScan BVI
9400 on: A patient who
has open skin or wounds
in the suprapubic area. A
patient with ascites. A
pregnant patient. |
| Patient/User Characteristics | | |
| Target Population | Male, Female, and
Pediatric patients | Male, Female, and
Pediatric patients |
| Anatomical Site | Bladder | Bladder |
| Users | Physicians/Medical
Professionals | Physicians/Medical
Professionals |
| Technological Characteristics and Performance | | |
| Patient Contact Material | Lexan Polycarbonate
Plastic HP1-1H112
(colorant: PCM 84907
Dark Gray 424C) | Low Density Polyethylene
Plastic (LDPE) Dow 955i
(colorant: Techmer PM
84149 Cool Grey 4C) |
| Sterility | non-sterile | non-sterile |
| Power Source | electrical (lithium-ion
battery) | electrical (lithium-ion
battery) |
| Energy Delivered | ultrasound | ultrasound |
| Measurement Accuracy | $\pm$ 15% $\pm$ 15ml | $\pm$ 15% $\pm$ 15ml |
| Measurement Range | 0 to 999 mL | 0 to 999 mL |
| Variable Acoustic Output Settings | No | No |
| Controls to Change Acoustic Output During
Scan | No | No |
| Modes of Operation | B -mode | B-mode |
| Transducer Type | Mechanical Sector Probe | Mechanical Sector Probe |
| Transducer Diameter | 13 mm | 13 mm |
| Number of Elements | 1 | 1 |
| Transducer Resonant Frequency | 2.95 MHz | 2.95 MHz |
| Nominal Acoustic Output Frequencies | 2.49 / 1.72 MHz | 3.0 / 1.74 MHz |
| Sector Angle | 120 degrees | 120 degrees |
| Number of Scan Plans | 12 | 12 |
| Design and Usability Features | | |
| Portable | Yes | Yes |
| Display | LCD | LCD |
| Scan Button | Yes | Yes |
| Touchscreen Operation | Yes | No |
| Selectable Unit Orientation (Patient
Right/Left) | Yes | No |
| Live Scan Image | Yes | No |
| Data Connections | USB, SD card | Wireless |
| Attached Printer | Yes | Yes |
| Computer Software | No | Yes (ScanPoint) |
| Accessories | Printer, battery, battery
charger, power cord,
mobile cart | ultrasound gel, battery,
battery charger, power
cord, calibration tank,
mobile cart |
| Safety Standards | | |
| Acoustic Output: Maximum Mechanical
Index (MI) | 0.42 | 0.95 |
| Acoustic Output: Maximum Thermal Index
(TI) | ≤ 1.0 | ≤ 1.0 |
| Acoustic Output: Intensity, Spatial Peak
Temporal Average (ISPTA) | ≤ 1.0 mW/cm² | ≤ 1.0 mW/cm² |
| Acoustic Output: Intensity, Spatial Peak
Pulse Average (ISPPA) | ≤ 12.0 W/cm² | ≤ 10.0 W/cm² |
| Biocompatibility Standard Compliance | ANSI/AAMI/ISO 10993-
1:2009, ANSI/AAMI/ ISO
10993-5:2009, ISO
10993-10:2010,
ANSI/AAMI/ISO 10993- | ISO 10993-1:2009 |
| Electrical Safety Standard Compliance | IEC 60601-1:2005, IEC
60601-2-37:2007 | IEC 60601-1:2005, IEC
60601-2-37:2007 |
| Electromagnetic Compatibility Standard
Compliance | IEC 60601-1-2: 2007 | 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 "V" shape in blue and green, followed by the company name "VERATHON" in blue, all caps. 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 is a logo for Verathon, a medical solutions company. The logo features a stylized "V" symbol in blue and green, followed by the company name "VERATHON" in blue, block letters. Below the company name is the tagline "Trusted and Enduring Medical Solutions" in a smaller, sans-serif font.
9
Image /page/9/Picture/1 description: The image shows the logo for Verathon. The logo features a stylized "V" shape in blue and green, followed by the word "VERATHON" in blue, sans-serif font. Below the company name is the tagline "Trusted and Enduring Medical Solutions" in a smaller, sans-serif font.
7. Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
The BladderScan" Prime 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 system is designed to comply with the following standards.
| Reference No. | Title |
|---|---|
| ANSI/ISO 10993-1:2009 | Biological evaluation of medical devices. Part 1: Evaluation and testing |
| ANSI/ISO 10993-5:2009 | Biological evaluation of medical devices. Part 5: Tests for in vitro cytoxicity. |
| ISO 10993-10:2010 | Biological evaluation of medical devices. Part 10: Tests for irritation and skin sensitization. |
| ANSI/AAMI/ISO 10993-12:2012 | Biological evaluation of medical devices. Part 12: Sample preparation and reference materials. |
| IEC 60601-1:2005 | Medical electrical equipment. Part 1: General requirements for basic safety and essential performance. |
| IEC 60601-1-2:2007 | Medical electrical equipment. Part 1-2: General requirements for basic safety and essential performance-Collateral standard-Electromagnetic compatibility-Requirements and tests. |
| IEC 60601-2-37:2007 | Medical electrical equipment. Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. |
| ALUM/NEMA UD-2:2004 | Standard for real time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment. |
| ALUM AOMS:2004 | Acoustic output measurement standard for diagnostic ultrasound equipment. |
FDA Consensus Standards
Miscellaneous Standards
| Reference No. | Title |
|---|---|
| IEC 60601-1-6:2005 | Medical device equipment. Part 1-6: General requirements for basic safety and essential |
| performance-Collateral standard usability. | |
| AAMI HE75:2009 | Human Factors Engineering- design of medical devices |
| AAMI/IEC 62366:2007 | Medical Devices, Part 1: Application of usability engineering to medical devices. |
| ISO 14971:2012 | Medical Devices-Application of risk management to medical devices. |
| IEC 60950-1 | Information technology equipment- Safety. Part 1: General requirements. |
| ISO 13485:2003 | Medical devices- Quality management systems-requirements for regulatory purposes |
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Image /page/10/Picture/0 description: The image shows the logo for Verathon. The logo consists of a stylized "V" shape in blue and green, with the word "VERATHON" in blue, sans-serif font to the right of the "V". Below the word "VERATHON" is the tagline "Trusted and Enduring Medical Solutions" in a smaller, sans-serif font.
8. Conclusion
The intended use and other key features are consistent with traditional practice and FDA guidance. The BladderScan" Prime system and the predicate device conform to applicable electromedical device safety standards with compliance verified through independent evaluation. The BladderScan Prime system and the predicate meet FDA requirements for Track 1 devices, share indications for ruse, have biosafety equivalence and are manufactured using ISO 13485 quality management system. Verathon Inc. believes that the BladderScan® Prime system is substantially equivalent with regard to safety and effectiveness to the legally marketed device.