BLADDERSCAN BVI 9400 ULTRASOUND

• K Number: K071217
• Device Name: BLADDERSCAN BVI 9400 ULTRASOUND
• Manufacturer: VERATHON INCORPORATED
• Date Cleared: 2007-05-17 ( 15 days)
• Product Code: IYO
• Regulation Number: 892.1560
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K022153
• Predicate For: K082456 , K090214 , K091518 , K111021 , K121689 , K130229 , K132736 , K153101 , K160420 , K170046

Intended Use

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
Clinical Application: Abdominal Mode of Operation: P

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

Device: Verathon Inc. BladderScan® BVI 9400 Ultrasound System
Intended Use (from the provided text, specifically page 6 and 7):

• To project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder.
• To calculate the bladder volume and bladder wall mass noninvasively.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary focuses primarily on equivalence to a predicate device and safety, rather than explicit numerical acceptance criteria for accuracy against a gold standard in a clinical setting. However, the mention of "accuracy has been demonstrated by comparing CIRS measurements to the measurements of the Verathon Inc. BladderScan® BVI 9400 Ultrasound System" suggests that the implied acceptance criterion is that the device's measurements are consistent with known measurements from a standardized phantom.

Acceptance Criterion (Implied)	Reported Device Performance
Accuracy of Bladder Volume Measurement: Device's bladder volume measurements should be comparable to known volumes (from NIST traceable measurements or standard ultrasound systems).	"Accuracy has been demonstrated by comparing CIRS measurements to the measurements of the Verathon Inc. BladderScan® BVI 9400 Ultrasound System." "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." (While a specific numerical comparison or percentage accuracy is not given, the claim is that accuracy has been demonstrated against these standards.)
Safety: Acoustic measurements should be within pre-amendment limits.	"all acoustic measurements remain within Preamendment limits."
Substantial Equivalence: Device is substantially equivalent to predicate device.	"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..."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a number of phantoms. The text refers to "tissue equivalent phantoms with known dimensions" and "each phantom comes with a certification sheet listing the measurements." It implies the use of one or more BladderScan Phantoms created by CIRS.
• Data Provenance: The 'data' for the test set is derived from phantom measurements. These phantoms were built by Computerized Imaging Reference Systems (CIRS), a vendor known for supplying medical imaging phantoms. The measurements provided by CIRS are NIST traceable. This is a prospective study design as the phantoms were specifically built for testing this device. There is no mention of human subject data for this specific accuracy assessment, rather a phantom study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. The ground truth for the test set was established by the NIST traceable measurements provided by CIRS when constructing the phantoms.
• Qualifications of Experts: Not applicable. The ground truth relies on physical measurements and established phantom production standards, not human expert consensus.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" (known phantom dimensions/volumes) is inherent in the phantom's construction via NIST traceable measurements. The comparison is between the device's output and these known values, not between human interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, an MRMC study was not done. The study described is a phantom study specifically comparing the device's measurements to known phantom volumes. There is no mention of human readers or AI assistance in this context.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

• Standalone Study: Yes, effectively. The device is designed to automatically compute bladder volume via volumetric integration from collected cross-sectional images. The assessment described (comparing the device's calculation to known phantom volumes) is a standalone performance evaluation of the device's algorithmic capability without human intervention in the measurement process itself.
  • The statement "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" supports that this is a standalone measurement.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used is physical measurements from manufactured phantoms with NIST traceability. The phantoms are designed to mimic bladder and tissue, and their internal volumes and dimensions are known and certified.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not explicitly stated in the provided text. The document describes a performance study for the device, not the development or training of an AI model within the device. The device uses "finite element model" and "volumetric integration," suggesting a rule-based or algorithmic approach rather than a machine learning model that would require a distinct "training set."

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set Establishment: Not applicable. As mentioned, the document does not describe the development or training of a machine learning model, but rather the performance evaluation of a device using an algorithmic approach. Therefore, there is no "training set" or corresponding ground truth establishment process described for such a set.

Summary

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K071217

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:[phone] ext.1350Fax:[phone]Email:[e-mail]: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:	[e-mail]	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:	[e-mail]
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)

:

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Device Description:	The Verathon Inc. BladderScan® BVI 9400 UltrasoundSystem is a portable, battery powered, softwarecontrolled ultrasound system used to acquire and displayreal time B-mode images of the bladder. The system isintended to non invasively monitor bladder volume on anintermittent basis. The system is an effective, low cost,simple to use option for use in a clinical hospital ornursing home setting or for home use under medicalsupervision.
Intended Use:	New device: The BladderScan® BVI 9400 is intended toproject ultrasound energy through the lower abdomen ofthe nonpregnant patient to obtain an image of the bladderand uses that image to calculate the bladder volumenoninvasively. The BladderScan® BVI 9400 iscontraindicated for fetal use and for use on pregnantpatients.
Comparison of RequiredTechnologicalCharacteristics:	The Verathon Inc. BladderScan® BVI 9400 UltrasoundSystem and its integrated 3.0 MHz mechanical sectortransducer operate only in B-mode to locate andautomatically measure bladder volume. The sametransducer is driven at 1.74 MHz to obtain a secondharmonic for enhanced bladder wall detection. Bladdervolume, patient gender, non optimal directional aiming,battery status, and usage rate indicators are all displayedon the Verathon Inc. BladderScan® BVI 9400Ultrasound System scanner. The ultrasonic powertransmitted the system is not user adjustable.The portable Verathon Inc. BladderScan® BVI 9400Ultrasound System is applied to the patient's abdomenwith a single patient use Sontac® hydrogel pad,manufactured by Verathon Inc. BladderScan® BVI 9400Ultrasound System. The transducer collects cross-sectional images of the bladder from twelve (12) scanplanes. From this information, the Verathon Inc.BladderScan® BVI 9400 Ultrasound System constructs afinite element model of the bladder and automaticallycomputes the volume of urine via volumetric integration.In order to demonstrate the BladderScan® accuracyclaimed in 0270-0307 -xx-55, a third party vendor wascontracted to build tissue equivalent phantoms withknown dimensions. The supplier, Computerized

C.

.

.

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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.

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• 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.

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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

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

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

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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

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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 Ionly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal
	Abdominal
	Intra-operative(Abdominal organs andvascular)
	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 Ionly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal
	Abdominal	P
	Intra-operative(Abdominal organs andvascular)
	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.)
PeripheralVessel	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 ________________________________________________________________________________________________________________________________________________________________

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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

Regulation Number and Section

§ 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.