BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000

K955840 · Diagnostic Ultrasound Corp. · IYO · May 24, 1996 · Radiology

Device Facts

• Record ID: K955840
• Device Name: BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000
• Applicant: Diagnostic Ultrasound Corp.
• Product Code: IYO · Radiology
• Decision Date: May 24, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Indications for Use

project ultrasound energy through the lower abdomen of the non-pregnant patient to obtain an image of the bladder that is used to determine bladder volume non-invasively.

Device Story

Portable, battery-powered pulsed echo ultrasound instruments; PCI 5000 for patient self-use; BVI 5000 for clinician use. Devices project ultrasound energy through lower abdomen to obtain bladder images; calculate bladder volume. BVI 5000 includes docking cradle with onboard computer for hard copy printouts of images and volume. Used to monitor bladder volume intermittently. Output assists clinicians or patients in managing bladder function; non-invasive nature benefits patients by reducing need for catheterization.

Clinical Evidence

Clinical testing performed on adult ambulatory volunteers and patients with spinal cord disease at three independent sites. No significant adverse effects or complications reported. Results demonstrate safety and effectiveness equivalent to the predicate device. Non-clinical testing included acoustic output, thermal, mechanical, electrical safety, electromagnetic compatibility, and biocompatibility testing.

Technological Characteristics

Pulsed echo ultrasonic imaging system. Battery-powered. Includes scanhead, transducer, and (for BVI 5000) docking cradle with onboard computer. Differences from predicate include scanhead shape, scan angle, and transducer model. Biocompatible materials used. Safety testing per standard acoustic and electrical safety protocols.

Indications for Use

Indicated for non-invasive bladder volume measurement in non-pregnant patients, including adult ambulatory volunteers and patients with spinal cord disease.

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 2500 (K915436)

Submission Summary (Full Text)

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955840 P. 1 of 3

DU

Diagnostic

Ultrasound

CORPORATION

P.O. Box 818

Redmond, WA 98073-0818

USA

MAY 24 1996

# 510(k) SUMMARY

## Diagnostic Ultrasound Corporation's
## BladderManager™ Personal Care Instrument PCI 5000
## BladderScan™ Bladder Volume Instrument BVI 5000

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Diagnostic Ultrasound Corporation
18109 NE 76th Street
Redmond, WA 98052

Phone: [phone]
Facsimile: [phone]

Contact Person: Gerald McMorrow, MSEE
Date Prepared: December 21, 1995

## Name of Devices and Name/Address of Sponsor:

BladderManager™ Personal Care Instrument PCI 5000 (PCI 5000)
BladderScan™ Bladder Volume Instrument BVI 5000 (BVI 5000)

Diagnostic Ultrasound Corporation
18109 NE 76th Street
Redmond, WA 98052

## Common or Usual Name

Ultrasonic Bladder Volume Instrument

## Classification Name

System, Imaging, Pulsed Echo, Ultrasonic

## Predicate Device

Diagnostic Ultrasound Corporation's BladderScan™ BVI 2500 (K 915436)

## Corporate Headquarters

18109 NE 76th Street
Redmond, WA 98052

## Canadian Office

13500 May Street
Redmond, BC V6P 7R1E
CANADA
T 604 244 3411
T 800 765 4423
T 604 244 3400

## European Office

Legiedijk 14
3401 RG Ijsselsteen
THE NETHERLANDS
31 3068 70570
31 3068 70512 Fax

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K.55840 1.243

## Device Description

The BladderManager PCI 5000 is a portable, battery-powered ultrasound instrument designed for a patient to non-invasively monitor his or her bladder volume on an intermittent basis. The BladderScan BVI 5000 is similar, except that it is designed for use by the clinician with the added feature of a “docking cradle” containing an onboard computer that provides a hard copy printout of the scan images and the bladder volume.

## Intended Use

The BladderManager PCI 5000 and BladderScan BVI 5000 “project ultrasound energy through the lower abdomen of the non-pregnant patient to obtain an image of the bladder that is used to determine bladder volume non-invasively.”

This statement of intended use is identical to that of the predicate device.

## Technological Characteristics Comparison

The BladderManager PCI 5000 and BladderScan BVI 5000 are substantially equivalent to the other currently marketed BladderScan BVI 2500 which is referenced above. The BladderManager PCI 5000 and BladderScan BVI 5000 and their predicate device are all pulsed echo ultrasonic imaging instruments dedicated to non-invasive measurement of urinary bladder volume. Although there are some technological differences between the BladderManager and its predicate, these differences are minor and raise no new questions of safety and effectiveness. In addition, accepted scientific methods exist for assessing the effects of the technological differences. The BladderManager PCI 5000 and BladderScan BVI 5000 differ from the BladderScan BVI 2500 in scanhead shape, patient contact materials, scan angle, ultrasonic coupling material, lateral resolution, acoustic output, and transducer model number. However, accepted scientific methods for biocompatibility testing, ultrasonic acoustic output testing, and clinical testing demonstrated that the subject devices are substantially equivalent to the predicate device in terms of safety. Also, accepted scientific methods for clinical accuracy testing demonstrated that the subject devices are substantially equivalent to the predicate device in terms of effectiveness.

## Performance Data

Non-clinical testing included acoustic output testing, thermal, mechanical, and electrical safety testing, electromagnetic emissions and immunity testing, and biocompatibility testing. All non-clinical testing demonstrated that the subject devices are substantially equivalent to the predicate device in terms of safety, effectiveness, and performance.

Preliminary clinical testing of the BladderManager PCI 5000 and the BladderScan BVI 5000 was performed on adult ambulatory volunteers. No significant adverse effects or complications were noted. The results demonstrated that the device is substantially equivalent to the predicate device in terms of safety and effectiveness.

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K 955840 P. 3 of 3

Clinical testing of the BladderManager PCI 5000 was performed at three independent clinical sites using adult spinal cord diseased patients, as well as healthy volunteers. No significant adverse effects or complications were noted. The results demonstrated that the device is substantially equivalent to the predicate device in terms of safety and effectiveness.

## Conclusion

Non-clinical and clinical testing methods demonstrate that the device is safe and effective, and performs as well as the legally marketed predicate device.