(150 days)
K 915436
K 915436
No
The document does not mention AI, ML, deep learning, or any related terms, and the description of the device and testing focuses on standard ultrasound technology and performance metrics.
No
The device is used to determine bladder volume non-invasively through imaging, which is a diagnostic function, not a therapeutic one.
Yes
The device is described as "project[ing] ultrasound energy through the lower abdomen... to obtain an image of the bladder that is used to determine bladder volume non-invasively." The predicate device is also named "Diagnostic Ultrasound Corporation's BladderScan™ BVI 2500," indicating its diagnostic purpose.
No
The device description explicitly states it is a "portable, battery-powered ultrasound instrument" and mentions hardware components like a "docking cradle" and "onboard computer," indicating it is a hardware device that utilizes software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The BladderManager PCI 5000 and BladderScan BVI 5000 use ultrasound energy projected through the lower abdomen to obtain an image and determine bladder volume non-invasively. This means they are interacting with the body externally and not analyzing samples taken from the body.
- Intended Use: The intended use clearly describes a non-invasive method for determining bladder volume.
- Device Description: The description confirms it's a portable ultrasound instrument.
- Input Imaging Modality: Pulsed echo ultrasonic imaging is an external imaging technique.
Therefore, the device falls under the category of medical devices that use imaging techniques to assess internal structures, rather than IVDs which analyze biological samples.
N/A
Intended Use / Indications for 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."
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
lower abdomen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
BladderManager PCI 5000: patient
BladderScan BVI 5000: clinician
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
Not Found
Summary of Performance Studies
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.
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.
Key Metrics
Not Found
Predicate Device(s)
K 915436
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
K955840 P. 1 of 3
Image /page/0/Picture/1 description: The image shows the logo for Diagnostic Ultrasound Corporation. The logo features the letters "DU" in a bold, stylized font, with the "X" symbol placed below the "D". To the right of the letters, the words "Diagnostic Ultrasound" are written in a clear, legible font. Below that is the word "CORPORATION". The image also includes the address "P.O. Box 818 Redmond, WA 98073-0818 USA".
MAY 2 4 1996
510(k) SUMMA KY
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 vith 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: | (206) 867-1348 |
| Facsimile: | (206) 883-2896 |
| 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 30 NF 76th street In on : WA . 8055 06 07 11 14 11 14 1
(0) 13 13 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11
Canadian Office 500 May rest W. hmond, BC VE
European Office agedlik 14 3401 RG lisselsteil THE NETHERI AND
1
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 250() 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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K955'840 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.