(15 days)
No
The description details standard ultrasound technology and image processing techniques (finite element model, volumetric integration) for calculating bladder volume. There is no mention of AI, ML, or related concepts.
No.
The device's intended use is to obtain an image of the bladder and calculate bladder volume and bladder wall mass non-invasively, which are diagnostic functions, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states "Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application: Other (Bladder)". The device is also described as calculating bladder volume and bladder wall mass.
No
The device description explicitly states it is a "portable, battery powered, software controlled ultrasound system" and mentions an "integrated 3.0 MHz mechanical sector transducer," indicating it includes hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- BladderScan BVI 9400 Function: The BladderScan BVI 9400 uses ultrasound energy applied to the body (non-invasively) to image the bladder and calculate its volume. It does not analyze any specimens taken from the patient.
The device description clearly states it's a "portable, battery powered, software controlled ultrasound system used to acquire and display real time B-mode images of the bladder." This is consistent with an in vivo (within the living body) diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
New device: 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. The BladderScan® BVI 9400 is contraindicated for fetal use and for use on pregnant patients.
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 and bladder wall mass noninvasively.
Contraindications: The BladderScan® BV19400 is contraindicated for fetal use and for use on pregnant patients.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application: Other (Bladder), Mode of Operation: N (new indication)
Clinical Application: Abdominal, Mode of Operation: P (previously cleared by FDA (K022153))
Product codes
90-IYO, 90-ITX
Device Description
The Verathon Inc. BladderScan® BVI 9400 Ultrasound System is a portable, battery powered, software controlled ultrasound system used to acquire and display real time B-mode images of the bladder. The system is intended to non invasively monitor bladder volume on an intermittent basis. The system is an effective, low cost, simple to use option for use in a clinical hospital or nursing home setting or for home use under medical supervision.
The Verathon Inc. BladderScan® BVI 9400 Ultrasound System and its integrated 3.0 MHz mechanical sector transducer operate only in B-mode to locate and automatically measure bladder volume. The same transducer is driven at 1.74 MHz to obtain a second harmonic for enhanced bladder wall detection. Bladder volume, patient gender, non optimal directional aiming, battery status, and usage rate indicators are all displayed on the Verathon Inc. BladderScan® BVI 9400 Ultrasound System scanner. The ultrasonic power transmitted the system is not user adjustable. The portable Verathon Inc. BladderScan® BVI 9400 Ultrasound System is applied to the patient's abdomen with a single patient use Sontac® hydrogel pad, manufactured by Verathon Inc. BladderScan® BVI 9400 Ultrasound System. The transducer collects cross-sectional images of the bladder from twelve (12) scan planes. From this information, the Verathon Inc. BladderScan® BVI 9400 Ultrasound System constructs a finite element model of the bladder and automatically computes the volume of urine via volumetric integration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Lower abdomen (bladder)
Indicated Patient Age Range
Nonpregnant patients (contraindicated for fetal use and pregnant patients).
Intended User / Care Setting
Used in a clinical hospital or nursing home setting or for home use under medical supervision.
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
Accurate bladder volume measurement has been demonstrated by comparing CIRS measurements (NIST traceable measurements from tissue equivalent phantoms with known dimensions provided by Computerized Imaging Reference Systems (CIRS)) to the measurements obtained by the Verathon Inc. BladderScan® BVI 9400 Ultrasound System. Additional measurements were taken by standard ultrasound systems such as the Sonosite 180 to compare bladder mass measurements.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All clinical and non clinical testing of the Verathon Inc. BladderScan® BVI 9400 Ultrasound System indicate that the Verathon Inc. BladderScan® BVI 9400 Ultrasound System is substantially equivalent to the Verathon Inc. BladderScan® BVI 6100 Ultrasound System, and all acoustic measurements remain within Preamendment limits.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Verathon BladderScan® BVI 6100 Ultrasound System (K022153)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAY 1 7 2007
.
510(K) SUMMARY (As required by 21 CFR 807.92(a))
| A. Submitter Information | Company:Verathon Inc.21222 30th Drive SE, Suite 120Bothell, WA 98041Phone:425-867-1348 ext.1350Fax:425-883-2896Email:rgarrison@verathon.comContact:Russ GarrisonActing Director, Regulatory AffairsDate:April 19, 2007 | Company: | Verathon Inc. | 21222 30th Drive SE, Suite 120 | Bothell, WA 98041 | Phone: | 425-867-1348 ext.1350 | Fax: | 425-883-2896 | Email: | rgarrison@verathon.com | Contact: | Russ Garrison | Acting Director, Regulatory Affairs | Date: | April 19, 2007 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Company: | Verathon Inc. | ||||||||||||||||||||||||
| 21222 30th Drive SE, Suite 120 | |||||||||||||||||||||||||
| Bothell, WA 98041 | |||||||||||||||||||||||||
| Phone: | 425-867-1348 ext.1350 | ||||||||||||||||||||||||
| Fax: | 425-883-2896 | ||||||||||||||||||||||||
| Email: | rgarrison@verathon.com | ||||||||||||||||||||||||
| Contact: | Russ Garrison | ||||||||||||||||||||||||
| Acting Director, Regulatory Affairs | |||||||||||||||||||||||||
| Date: | April 19, 2007 | ||||||||||||||||||||||||
| B. Device Information | Trade/Proprietary Name:Verathon Inc. BladderScan® BVI 9400 Ultrasound SystemCommon Name:Diagnostic Ultrasound System with AccessoriesClassification Name(s):Regulatory Class: IIReview Category: Tier IIClassification Panel: RadiologyUltrasonic Pulsed Echo Imaging SystemFR Classification 892.1560Product Code 90-IYODiagnostic Ultrasound TransducerFR Classification 892.1570Product Code 90-ITXPredicate Device:Verathon BladderScan® BVI 6100 Ultrasound System (K022153) | Trade/Proprietary Name: | Verathon Inc. BladderScan® BVI 9400 Ultrasound System | Common Name: | Diagnostic Ultrasound System with Accessories | Classification Name(s): | Regulatory Class: II | Review Category: Tier II | Classification Panel: Radiology | Ultrasonic Pulsed Echo Imaging System | FR Classification 892.1560 | Product Code 90-IYO | Diagnostic Ultrasound Transducer | FR Classification 892.1570 | Product Code 90-ITX | Predicate Device: | Verathon BladderScan® BVI 6100 Ultrasound System (K022153) | ||||||||
| Trade/Proprietary Name: | Verathon Inc. BladderScan® BVI 9400 Ultrasound System | ||||||||||||||||||||||||
| Common Name: | Diagnostic Ultrasound System with Accessories | ||||||||||||||||||||||||
| Classification Name(s): | Regulatory Class: II | ||||||||||||||||||||||||
| Review Category: Tier II | |||||||||||||||||||||||||
| Classification Panel: Radiology | |||||||||||||||||||||||||
| Ultrasonic Pulsed Echo Imaging System | |||||||||||||||||||||||||
| FR Classification 892.1560 | |||||||||||||||||||||||||
| Product Code 90-IYO | |||||||||||||||||||||||||
| Diagnostic Ultrasound Transducer | |||||||||||||||||||||||||
| FR Classification 892.1570 | |||||||||||||||||||||||||
| Product Code 90-ITX | |||||||||||||||||||||||||
| Predicate Device: | Verathon BladderScan® BVI 6100 Ultrasound System (K022153) |
:
1
| Device Description: | The Verathon Inc. BladderScan® BVI 9400 Ultrasound
System is a portable, battery powered, software
controlled ultrasound system used to acquire and display
real time B-mode images of the bladder. The system is
intended to non invasively monitor bladder volume on an
intermittent basis. The system is an effective, low cost,
simple to use option for use in a clinical hospital or
nursing home setting or for home use under medical
supervision. |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | New device: 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. The BladderScan® BVI 9400 is
contraindicated for fetal use and for use on pregnant
patients. |
| Comparison of Required
Technological
Characteristics: | The Verathon Inc. BladderScan® BVI 9400 Ultrasound
System and its integrated 3.0 MHz mechanical sector
transducer operate only in B-mode to locate and
automatically measure bladder volume. The same
transducer is driven at 1.74 MHz to obtain a second
harmonic for enhanced bladder wall detection. Bladder
volume, patient gender, non optimal directional aiming,
battery status, and usage rate indicators are all displayed
on the Verathon Inc. BladderScan® BVI 9400
Ultrasound System scanner. The ultrasonic power
transmitted the system is not user adjustable.
The portable Verathon Inc. BladderScan® BVI 9400
Ultrasound System is applied to the patient's abdomen
with a single patient use Sontac® hydrogel pad,
manufactured by Verathon Inc. BladderScan® BVI 9400
Ultrasound System. The transducer collects cross-
sectional images of the bladder from twelve (12) scan
planes. From this information, the Verathon Inc.
BladderScan® BVI 9400 Ultrasound System constructs a
finite element model of the bladder and automatically
computes the volume of urine via volumetric integration.
In order to demonstrate the BladderScan® accuracy
claimed in 0270-0307 -xx-55, a third party vendor was
contracted to build tissue equivalent phantoms with
known dimensions. The supplier, Computerized |
C.
.
.
2
Imaging Reference Systems (CIRS) is known for supplying medical imaging phantoms to the medical marketplace.
The BladderScan Phantom is essentially a balloon which gets filled with urine mimicking material and then the filled balloon is surrounded with tissue mimicking material. Both the tissue and urine mimicking material have been used by CIRS for many years in bladder volume phantoms.
During the manufacturing process, CIRS measures key parameters of the physical parts as the parts are constructed. These measurements are all NIST traceable and each phantom comes with a certification sheet listing the measurements.
These results obtained through the Verathon Inc. BladderScan® BVI 9400 Ultrasound System are compared to the expected results derived from the NIST traceable measurements. In addition to these measurements, additional measurements are taken by standard ultrasound systems, such as the Sonosite 180, to compare bladder mass measurements.
Accuracy has been demonstrated by comparing CIRS measurements to the measurements of the Verathon Inc. BladderScan® BVI 9400 Ultrasound System.
A Calibration Targeting System, consisting of a heli-coil shaped calibration target along with a specially designed container, allows the user to easily scan a known geometrically shaped target. Data may be optically transmitted to a remote location when connected to the clinician's personal computer via a communication cradle. Connection to this communication cradle allows for battery charging, remote calibration, usage monitoring, software updates, and data transfer through a web-based interface, referenced as ScanPoint®. The Verathon Inc. BladderScan® BVI 9400 Ultrasound System also includes a universal charger cradle for the replaceable lithium ion battery incorporated into the portable instrument.
3
- D. Summary and Conclusion of Non Clinical and Clinical Testing
All clinical and non clinical testing of the Verathon Inc. BladderScan® BVI 9400 Ultrasound System indicate that the Verathon Inc. BladderScan® BVI 9400 Ultrasound System is substantially equivalent to the Verathon Inc. BladderScan® BVI 6100 Ultrasound System, and all acoustic measurements remain within Preamendment limits.
4
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an eagle emblem, which is a stylized representation of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Verathon, Inc. c/o Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator Medical Device Services Underwriters Laboratories, Inc. 455 East Trimble Road SAN JOSE CA 95131-1230
MAY 1 7 2007
Re: K071217
Trade/Device Name: BladderScan® BVI 9400 Ultrasound System Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: April 30, 2007 Received: May 2, 2007
Dear Mr. Christensen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the BladderScan® BVI 9400 Ultrasound System as described in your premarket notification:
Transducer Model Number
3.0/1.74 MHz Second Harmonic Transducer
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
5
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); 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.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at (240) 276-3666.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
6
Page I of 1
510(k) Number (if known): New Submission
Device Name: Verathon Inc. BladderScan® BVI 9400 Ultrasound System
Indications for Use:
- . Abdomen, B-Mode, per Indications for Use Ultrasound Form
- . 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 and bladder wall mass noninvasively.
Contraindications:
- The BladderScan® BV19400 is contraindicated for fetal use and for use on pregnant . patients.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Nancy Broadron
VA Al 510(k) Num
7
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM System: BladderScan® BVI 9400 Ultrasound System 3.0 / 1.74 MHz Second Harmonic Transducer
. 041214
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I | ||||||||
| only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (Abdominal organs and | ||||||||
| vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (breast, | ||||||||
| thyroid, testicles) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Convent.) | ||||||||
| Musculo-skel. | ||||||||
| (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral vessel | ||||||||
| Other (Bladder) | N | |||||||
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track I | ||||||||
| only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | P | |||||||
| Intra-operative | ||||||||
| (Abdominal organs and | ||||||||
| vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (breast, | ||||||||
| thyroid, testicles) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Convent.) | ||||||||
| Musculo-skel. | ||||||||
| (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA (K022153)
Prescription Use (Per 21 CFR 801.109)
Nancy Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
8
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM System: BladderScan® BVI 9400 Ultrasound System
K071217
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; P= previously cleared by FDA (K022153)
Nancy C. Brogdon
(Division Sign-Off)
Prescription Use (Per 21 CFR 801.109)
ﻴ
(Division Sign-On) ()
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K071217