The BVI 6100 System is intended to project ultrasound energy through the lower abdomen of a nonpregnant patient to obtain an image of the bladder and measure urinary bladder volume non-invasively on an intermittent basis. The indications for use are the same as for Diagnostic Ultrasound's predicate devices. The BladderScan BVI 6100 is contraindicated for fetal use and for use on pregnant patients.

Device Description

The BladderScan™ BVI 6100 Ultrasound System is a hand-held, batterypowered, 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 option for use in a clinical hospital or nursing home setting or for home use under medical supervision.

AI/ML Overview

The provided text describes the BladderScan™ BVI 6100 Ultrasound System, an ultrasound device for non-invasively monitoring bladder volume. However, the document does not contain information about specific acceptance criteria related to device performance (e.g., accuracy, precision of bladder volume measurement) or a study proving it meets those criteria.

The document primarily focuses on:

Device Description and Intended Use: The device is a hand-held, battery-powered ultrasound system for acquiring real-time B-mode images of the bladder and measuring urinary bladder volume in non-pregnant patients.
Compliance with Standards: A list of international and national standards the device is designed to comply with (e.g., EN 60601-1, IEC 61000-4-2, CISPR11). These standards relate to safety, EMC, and acoustic output, not clinical performance metrics.
Predicate Devices: Identification of similar legally marketed devices (BladderManager™ BVI 5000 System, BladderScan™ BVI 2500 System, and SonoSite™ Hand-Carried Ultrasound System).
FDA Clearance: Notification of FDA's determination of substantial equivalence (K022153) to predicate devices, allowing it to be marketed. A post-clearance special report for acoustic output measurements based on production line devices was requested.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about a study proving it meets those criteria, as this information is not present in the provided text.

Specifically, the following points from your request cannot be answered based on the provided document:

A table of acceptance criteria and the reported device performance: No specific performance metrics (like accuracy or precision for volume measurement) are mentioned along with their acceptance criteria or achieved values.
Sample size used for the test set and the data provenance: No performance study is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No performance study is described.
Adjudication method for the test set: No performance study is described.
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: No such study is mentioned. This device is a standalone measurement device, not an AI assistance tool for human readers in the context of the document.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: While the device is "standalone" in that it performs the measurement, no specific study evaluating its standalone performance against a ground truth is described.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No performance study is described.
The sample size for the training set: No information is provided about any training sets for an algorithm.
How the ground truth for the training set was established: No information is provided about any training sets for an algorithm.

The only "study" mentioned is the compliance with various standards related to safety and electromagnetic compatibility, and a general statement that the device "meets the FDA's pre-amendment acoustic output limits." These are not performance studies in the sense of clinical accuracy or precision.

Summary

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KD221LB

AUG 1 5 2002

DIAGNOSTIC ULTRASOUND

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, Part 807, Subpart E, Section 807.92.

Submitter's name, address, telephone number, contact person: 1)

Russ Garrison Senior Vice President, Operations Diagnostic Ultrasound Corporation 21222 30th Drive SE, Suite 120 Bothell, WA 98021

Phone: (425) 867-1348 x1350

E-mail: rgarrison@dxu.com

Date prepared: August 1, 2002

1. Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
  Common/ Usual Name

Diagnostic Ultrasound System with Accessories

Proprietary Name

BladderScan™ BVI 6100

Classification Names

Ultrasonic Pulsed Echo Imaging System (892.1560; 90-IYO) Diagnostic Ultrasound Transducer (892.1570; 90-ITX)

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Identification of the predicate or legally marketed device: 3)

Diagnostic Ultrasound believes that the BVI 6100 System is substantially the previously cleared Diagnostic Ultrasound equivalent to BladderManager™ BVI 5000 System (K955850), Diagnostic Ultrasound BladderScan™ BVI 2500 System (K915436), and the SonoSite™ Hand-Carried Ultrasound System (K990806).

4) Device Description:

The BVI 6100 System is designed to comply with the standards listed below.

EN 60601-1:1997 .
. EN 60601-1-1:1993
EN 60601-1-2:1998 .
EN 60601-2-37:2001 .
CAN/CSA C22.2, No. 601.1 M90 .
UL 2601-1:1999 .
IEC 61000-4-2:1999 .
. IEC 61000-4-3:1997
IEC 61000-4-4:1995 ●
IEC 61000-4-5:1999 .
. CEI/IEC 61157:1992
. CISPR11:1997
Acoustic Output Measurement Standard for Diagnostic Ultrasound . Equipment. American Institute of Ultrasound in Medicine, 1998.
Acoustic Output Labeling Standard for Diagnostic Ultrasound . Equipment: A Standard for How Manufacturers Should Specify Acoustic Output Data, American Institute of Ultrasound in Medicine, 1998.
Medical Ultrasound Safety, American Institute of Ultrasound in . Medicine (AIUM), 1994
European Medical Device Directive (93/42/EEC) .

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The BVI 6100 is a Track 1 System and meets the FDA's pre-amendment acoustic output limits for "fetal imaging and other" applications.

5) Intended Use:

The intended uses of the BVI 6100 System, as defined by FDA quidance documents, is for Abdominal (Adult and Pediatric) applications.

6) Technological Characteristics:

The BVI 6100 and its integrated 3.7 MHz mechanical sector transducer operate only in B-mode to locate and automatically measure bladder volume. Bladder volume, patient gender, non-optimal directional aiming, battery status, and usage rate indicators are all displayed on the BVI 6100 scanner. The ultrasonic power transmitted by the System is not user adjustable.

The hand-held BVI 6100 is applied to the patient's abdomen with a single patient use Sontac® hydrogel pad, manufactured by Diagnostic Ultrasound to optimize the performance of the BVI 6100. The transducer collects cross-sectional images of the bladder from twelve (12) scan planes. From this information, the BVI 6100 constructs a finite element model of the bladder and automatically computes the volume of urine via volumetric integration.

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 BVI 6100 System also includes a universal charger cradle for the non-replaceable lithium ion batterv incorporated into the handheld instrument.

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Electrostatic Techniques-Section 4.2: Measurement Discharge/Immunity Test-Basic EMC Publication

IEC 61000-4-3:1997, International Electrotechnical Committee, Electromagnetic Compatibility (EMC)-Part 4. Testing and Measurement Techniques-Section 3: Radiated Radio-Frequency, Electromagnetic Field Immunity Test

IEC 61000-4-4:1995, International Electrotechnical Committee, Electromagnetic Compatibility (EMC)-Part 4. Testing and Techniques-Section 4, Measurement Electrical Fast Transient/Burst Immunity Test-Basic EMC Publication

IEC 61000-4-5:1999, International Electrotechnical Committee, Electromagnetic Compatibility (EMC)-Part 4. Testing and Measurement Techniques-Section 5, Surge Immunity Test

CISPR11:1997, International Electrotechnical Commission. International Special Committee on Radio Interference. Industrial, Scientific, and Medical (ISM) Radio-Frequency Equipment Electromagnetic Disturbance Characteristics-Limits and Methods of Measurement

IEC 60601-2-37:2001, International Electrotechnical Commission, Medical Electrical Equipment-Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment

Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (AlUM), 1994

for Acoustic Output Measurement Standard Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine, 1998.

Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment: A Standard for How Manufacturers Should Specify Acoustic Output Data, American Institute of Ultrasound in Medicine, 1998.

The BVI 6100 will be cleared and/or approved by the following agencies:

-U. S. Food and Drug Administration (FDA)

-Canadian Standards Association (CSA)

European Medical Device Directive 93/42/EEC Notified Body ।
Section 4.2, page 3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, arranged in a way that resembles a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.

Public Health Service

AUG 15 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Diagnostic Ultrasound Corporation % Mr. Mark Job Program Manager TÜV Product Service. Inc. 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891

Re: K022153

Trade Name: BladderScan™ BVI 6100 Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYO and ITX Dated: August 5, 2002 Received: August 6, 2002

Dear Mr. Job:

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 6100 Ultrasound System, as described in your premarket notification:

Transducer Model Number

3.7 MHz

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

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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); 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

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Page 3 – Mr. Job

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

David b. Lyman

Morr

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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KC2215,3

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: BladderScan™ BVI 6100 Ultrasound System

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	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal	P
	Intra-operative (Abdominalorgans 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.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA (K955840, K915436)

Prescription Use (Per 21 CFR 801.109)

David E. Seum

(Division Sign-Off) Division It Frenchictive Abdom D. distribut at Devices 510x, Nimmer

000010 Section 4.3, page 2

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.