BladderScan Prime System

K153101 · Verathon Incorporated · IYO · Nov 19, 2015 · Radiology

Device Facts

• Record ID: K153101
• Device Name: BladderScan Prime System
• Applicant: Verathon Incorporated
• Product Code: IYO · Radiology
• Decision Date: Nov 19, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The BladderScan® Prime system is an ultrasound device intended to be used for measuring the urine volume in the bladder non-invasively.

Device Story

BladderScan Prime is a portable, battery-powered ultrasound device for non-invasive bladder volume measurement. It utilizes a mechanical sector probe (13 mm diameter, 2.95 MHz resonant frequency) to capture 3D ultrasound data. The system employs patented NeuralHarmonics technology to process 12 scan planes, transforming ultrasound signals into a 3D bladder image and volume calculation. Operated by physicians or medical professionals, the device provides real-time feedback, directional aiming, and volume results on an integrated LCD touchscreen. It features selectable patient orientation and live scan imaging. The output assists clinicians in assessing bladder volume, aiding in clinical decision-making regarding urinary management. The device is intended for use in clinical settings.

Clinical Evidence

Bench testing only. No clinical data provided. Evaluation included electrical, thermal, mechanical, and EMC safety testing, cleaning/disinfection validation, and biocompatibility testing per ISO 10993 standards. Acoustic output was measured per AIUM/NEMA standards. Performance was verified through design reviews, risk assessments, and hardware/software verification.

Technological Characteristics

Mechanical sector probe; 2.95 MHz resonant frequency; 2.49/1.72 MHz nominal acoustic output frequencies; 120-degree sector angle; 12 scan planes. Patient contact material: Lexan Polycarbonate Plastic HP1-1H112. Power: Lithium-ion battery. Connectivity: USB, SD card. Standards: IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2, ISO 10993, ISO 13485.

Indications for Use

Indicated for non-invasive measurement of urine volume in the bladder for 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® BVI 9400 (K071217)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K153101

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.

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# 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<br>Imaging<br>& 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<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) | 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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# 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<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| (Track 1 Only) | (Tracks 1 & 3) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& 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<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) | 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

- 1. Submitter's name, address, telephone number, contact person:
Verathon Inc. 20001 North Creek Parkway Bothell, WA 98011

#### Corresponding Official:

Rhonda M. Kops, RAC Manager, Regulatory Affairs

Phone: [phone] ext. 5643 Fax: [phone] Email: [e-mail]

### 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®<br>Prime<br>(Verathon Inc.) | Predicate BladderScan®<br>BVI 9400<br>(Verathon Inc.) |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison Overview | | |
| FDA 510(k) Number | | K071217 |
| FDA Ultrasound Guidance Track | Track 1 | Track 1 |
| Device Classification Name | System, Imaging, Pulsed<br>Echo, Ultrasonic | System, Imaging, Pulsed<br>Echo, Ultrasonic |
| | | |
| Intended Use/Indications For Use | The BladderScan Prime<br>system is an ultrasound<br>device intended to be<br>used for measuring the<br>urine volume in the<br>bladder non-invasively. | The BladderScan® BVI<br>9400 is intended to<br>project ultrasound energy<br>through the lower<br>abdomen of the<br>nonpregnant patient to<br>obtain an image of the<br>bladder and uses that<br>image to calculate the<br>bladder volume<br>noninvasively. |
| Contraindications | The BladderScan Prime<br>system is not intended<br>for fetal use or for use on<br>pregnant patients,<br>patients with ascites, or<br>patients with open skin<br>or wounds in the<br>suprapubic region. | The BladderScan BVI 9400<br>is not intended for fetal<br>use or for use on<br>pregnant patients. Do not<br>use the BladderScan BVI<br>9400 on: A patient who<br>has open skin or wounds<br>in the suprapubic area. A<br>patient with ascites. A<br>pregnant patient. |
| Patient/User Characteristics | | |
| Target Population | Male, Female, and<br>Pediatric patients | Male, Female, and<br>Pediatric patients |
| Anatomical Site | Bladder | Bladder |
| Users | Physicians/Medical<br>Professionals | Physicians/Medical<br>Professionals |
| Technological Characteristics and Performance | | |
| Patient Contact Material | Lexan Polycarbonate<br>Plastic HP1-1H112<br>(colorant: PCM 84907<br>Dark Gray 424C) | Low Density Polyethylene<br>Plastic (LDPE) Dow 955i<br>(colorant: Techmer PM<br>84149 Cool Grey 4C) |
| Sterility | non-sterile | non-sterile |
| Power Source | electrical (lithium-ion<br>battery) | electrical (lithium-ion<br>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<br>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<br>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<br>charger, power cord,<br>mobile cart | ultrasound gel, battery,<br>battery charger, power<br>cord, calibration tank,<br>mobile cart |
| Safety Standards | | |
| Acoustic Output: Maximum Mechanical<br>Index (MI) | 0.42 | 0.95 |
| Acoustic Output: Maximum Thermal Index<br>(TI) | ≤ 1.0 | ≤ 1.0 |
| Acoustic Output: Intensity, Spatial Peak<br>Temporal Average (ISPTA) | ≤ 1.0 mW/cm² | ≤ 1.0 mW/cm² |
| Acoustic Output: Intensity, Spatial Peak<br>Pulse Average (ISPPA) | ≤ 12.0 W/cm² | ≤ 10.0 W/cm² |
| Biocompatibility Standard Compliance | ANSI/AAMI/ISO 10993-<br>1:2009, ANSI/AAMI/ ISO<br>10993-5:2009, ISO<br>10993-10:2010,<br>ANSI/AAMI/ISO 10993- | ISO 10993-1:2009 |
| Electrical Safety Standard Compliance | IEC 60601-1:2005, IEC<br>60601-2-37:2007 | IEC 60601-1:2005, IEC<br>60601-2-37:2007 |
| Electromagnetic Compatibility Standard<br>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.

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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<br>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.