(24 days)
The BladderScan® Prime system is an ultrasound device intended to be used for measuring the urine in the bladder non-invasively.
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,
The provided text is a 510(k) summary for the BladderScan® Prime System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (BladderScan® BVI 9400), rather than outlining a standalone clinical study with detailed acceptance criteria and performance data for a new device's accuracy against a ground truth.
Therefore, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an accuracy study (e.g., against a ground truth). It primarily details the technological characteristics, intended use, and safety standards compliance to show equivalence.
However, it does provide one quantitative metric which can be interpreted as an acceptance criterion for measurement accuracy based on the predicate device's performance.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate) | Reported Device Performance (BladderScan® Prime) |
|---|---|
| Measurement Accuracy: ± 15% ± 15mL | Measurement Accuracy: ± 15% ± 15mL |
| Measurement Range: 0 to 999 mL | Measurement Range: 0 to 999 mL |
Note: The document states that the proposed device (BladderScan® Prime) intends to meet the same accuracy and range specifications as the predicate. It does not provide new, independent study results to prove this for the BladderScan® Prime specifically. It relies on the assertion that "The BladderScan® Prime system and BladderScan® BVI 9400 system are both Track 1 devices that employ the same fundamental technology." implying similar performance.
Missing Information (not found in the provided text):
- 2. Sample size used for the test set and the data provenance: Not mentioned. The document primarily discusses comparisons of technical specifications and safety standards, not a specific clinical test set for accuracy.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as a clinical accuracy study with ground truth establishment is not described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an ultrasound system for measuring bladder volume, not an AI-assisted diagnostic imaging device for human reader improvement studies.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is an algorithm for calculating bladder volume from ultrasound data. Its performance is stated to be "± 15% ± 15mL", but no specific study demonstrating this standalone performance for the Prime system is detailed. It is inherited from the predicate.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not detailed. For bladder volume measurement, the gold standard for ground truth often involves catheterization or direct measurement during surgery, but no such method is described for validating the new device. The document implies that the "NeuralHarmonics technology" provides a more complex, three-dimensional image of the bladder, leading to more accurate volume measurements, but it doesn't describe the validation process.
- 8. The sample size for the training set: Not applicable. This is not an AI/ML device in the modern sense that learns from a training set. It's an ultrasound device applying a specific calculation algorithm.
- 9. How the ground truth for the training set was established: Not applicable.
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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 (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
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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)
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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."
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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 | |||||||
| FetalImaging& 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) | ||||||||
| PeripheralVessel | 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 | ColorDoppler | Combined(Specify) | Other*(Specify) |
| (Track 1 Only) | (Tracks 1 & 3) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging& 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) | ||||||||
| PeripheralVessel | 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, PulsedEcho, Ultrasonic | System, Imaging, PulsedEcho, Ultrasonic |
| Intended Use/Indications For Use | The BladderScan Primesystem is an ultrasounddevice intended to beused for measuring theurine volume in thebladder non-invasively. | The BladderScan® BVI9400 is intended toproject ultrasound energythrough the lowerabdomen of thenonpregnant patient toobtain an image of thebladder and uses thatimage to calculate thebladder volumenoninvasively. |
| Contraindications | The BladderScan Primesystem is not intendedfor fetal use or for use onpregnant patients,patients with ascites, orpatients with open skinor wounds in thesuprapubic region. | The BladderScan BVI 9400is not intended for fetaluse or for use onpregnant patients. Do notuse the BladderScan BVI9400 on: A patient whohas open skin or woundsin the suprapubic area. Apatient with ascites. Apregnant patient. |
| Patient/User Characteristics | ||
| Target Population | Male, Female, andPediatric patients | Male, Female, andPediatric patients |
| Anatomical Site | Bladder | Bladder |
| Users | Physicians/MedicalProfessionals | Physicians/MedicalProfessionals |
| Technological Characteristics and Performance | ||
| Patient Contact Material | Lexan PolycarbonatePlastic HP1-1H112(colorant: PCM 84907Dark Gray 424C) | Low Density PolyethylenePlastic (LDPE) Dow 955i(colorant: Techmer PM84149 Cool Grey 4C) |
| Sterility | non-sterile | non-sterile |
| Power Source | electrical (lithium-ionbattery) | electrical (lithium-ionbattery) |
| 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 DuringScan | 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 (PatientRight/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, batterycharger, power cord,mobile cart | ultrasound gel, battery,battery charger, powercord, calibration tank,mobile cart |
| Safety Standards | ||
| Acoustic Output: Maximum MechanicalIndex (MI) | 0.42 | 0.95 |
| Acoustic Output: Maximum Thermal Index(TI) | ≤ 1.0 | ≤ 1.0 |
| Acoustic Output: Intensity, Spatial PeakTemporal Average (ISPTA) | ≤ 1.0 mW/cm² | ≤ 1.0 mW/cm² |
| Acoustic Output: Intensity, Spatial PeakPulse Average (ISPPA) | ≤ 12.0 W/cm² | ≤ 10.0 W/cm² |
| Biocompatibility Standard Compliance | ANSI/AAMI/ISO 10993-1:2009, ANSI/AAMI/ ISO10993-5:2009, ISO10993-10:2010,ANSI/AAMI/ISO 10993- | ISO 10993-1:2009 |
| Electrical Safety Standard Compliance | IEC 60601-1:2005, IEC60601-2-37:2007 | IEC 60601-1:2005, IEC60601-2-37:2007 |
| Electromagnetic Compatibility StandardCompliance | 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 essentialperformance-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.
§ 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.