(80 days)
K 915436
K 915436
No
The summary describes a standard ultrasound device for bladder volume measurement and does not mention any AI/ML components or algorithms. The image processing mentioned is likely traditional image analysis for volume calculation.
No
The device is used to determine bladder volume non-invasively by obtaining an image, which is a diagnostic function, not a therapeutic one. It does not treat a condition.
Yes
The device is described as obtaining an image of the bladder to determine bladder volume non-invasively, which is a measurement used to provide information about a patient's physiological state.
No
The device description explicitly states it is a "portable, battery-powered ultrasound instrument," indicating it is a hardware device that uses ultrasound technology.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device function: The BladderManager PCI 5000 and BladderScan BVI 5000 use ultrasound energy projected through the lower abdomen to image the bladder and determine its volume. This is a non-invasive method that does not involve analyzing samples taken from the body.
Therefore, based on the provided information, the device falls under the category of a medical imaging device, not an In Vitro Diagnostic.
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
89 KET
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
Preliminary clinical testing of the BladderManager PCI 5000 and the BladderScan BVI 5000 was performed on adult ambulatory volunteers.
Clinical testing of the BladderManager PCI 5000 was performed at three independent clinical sites using adult spinal cord diseased patients, as well as healthy volunters.
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 volunters. 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
K955942 Puc 1 y3
Image /page/0/Picture/1 description: The image shows the logo and address of Diagnostic Ultrasound Corporation. The logo consists of the letters "DU" in a bold, stylized font, with the letter "X" placed below. The text "Diagnostic Ultrasound" is written in a clear, sans-serif font, followed by "CORPORATION" and the address "P.O. Box 818, Redmond, WA 98073-0818 USA".
MAR 1 5 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: | (206) 867-1348 |
|---|---|
| Facsimile: | (206) 883-2896 |
| Contact Person: | Gerald McMorrow, MSEE |
Date Prepared: December 22, 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)
Cornorate Hear 18109 NF 76th Redmond I 906 867-134 200 221-0317
Canadian Office
3500 Maycrest Way, Suite 140
Richmond, BC V6V 2N8
CANADA
604 244-5814
800 765-7733
European Office
Lagedijk 14
3401 RG Ijsselstein
THE NETHERLANDS
31 3068 70570
31 3068 70510 Fax
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 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 PCI 5000, the BladderScan BVI 5000, and their predicate device, 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.
2
Clinical testing of the BladderManager PCI 5000 was performed at three independent clinical sites using adult spinal cord diseased patients, as well as healthy volunters. 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 as safe, as effective, and performs as well as the legally marketed predicate device. The BladderManager PCI 5000 and the BladderScan BVI 5000 are substantially equivalent to the BladderScan BVI 2500 with respect to intended use, technological characteristics, and performance.