(22 days)
No
The document describes a portable ultrasound device for measuring bladder volume and a new hydrogel pad accessory. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the physical properties and biocompatibility of the gel pad and the basic ultrasound functionality.
No.
The device is used to non-invasively determine bladder volume, which is a diagnostic function, not a therapeutic one. It provides information rather than treatment.
Yes
The device "project[s] ultrasound energy...to obtain an image of the bladder that is used to determine bladder volume non-invasively." Obtaining an image of the bladder and determining its volume are diagnostic functions.
No
The device description clearly states it is a portable, battery-powered ultrasound instrument with a scanhead and hydrogel pad, indicating it is a hardware device, not software-only.
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 non-invasively determine bladder volume. This is an in vivo (within the living body) measurement, not an in vitro test on a sample.
- Intended Use: The intended use clearly states "project ultrasound energy through the lower abdomen... to obtain an image of the bladder that is used to determine bladder volume non-invasively." This describes a non-invasive imaging and measurement technique applied directly to the patient.
The device is an ultrasound imaging and measurement device used for non-invasive assessment of bladder volume.
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."
This statement of intended use is unchanged with the DxU Gel Pad.
Product codes (comma separated list FDA assigned to the subject device)
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. For both instruments, the scanhead is applied to the patient's abdomen with a hydrogel pad providing ultrasound transmission coupling between the scanhead and the patient's body. Standard ultrasound gel can also be used by itself or in addition to the hydrogel pad, depending on patient preference. The hydrogel pad used in the original 510(k) submission, the Koolgel gel pad, is composed of water and polyethylene oxide, manufactured with the identical formulation as a previously cleared device (Ad-Heal wound dressing, K881731). The object of this submission, the DxU Gel Pad, is composed of distilled water, glycerol, gracillaria agar, carrageenan, methyl paraben, and propyl paraben.
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
patient/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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing included density, speed of sound, and acoustic impedance measurements, and biocompatibility testing. All non-clinical testing demonstrated that the subject device accessory is substantially equivalent to the predicate device accessory in terms of safety, effectiveness, and performance.
Clinical testing of the DxU gel pad with the BVI/PCI 5000 was performed on healthy volunteers, as well as actual spinal cord injured subjects familiar with the instrument. No significant adverse effects or complications were noted. The results demonstrate that the device accessory is substantially equivalent to the predicate gel pad in terms of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Koolgel wound dressing (K881731)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo for Diagnostic Ultrasound Corporation. The logo features the letters "DUX" in a bold, stylized font. Below the letters, the word "CORPORATION" is written in a smaller font. The address "P.O. Box 818 Redmond, WA 98073-0818" is also included.
OCT 1 1996
510(k) SUMMARY
Diagnostic Ultrasound Corporation Gel Pad (DxU Gel Pad) Accessory for Use With the BladderScan™ Bladder Volume Instrument BVI 5000 (K955840)
BladderManager™ Personal Care Instrument PCI 5000 (K955942)
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: | September 6, 1996 |
Name of Device and Name/Address of Sponsor:
Diagnostic Ultrasound Gel Pad, for use with the BladderScan™ Bladder Volume Instrument BVI 5000 (K955840) BladderManager™ Personal Care Instrument PCI 5000 (K955942)
Diagnostic Ultrasound Corporation 18109 NE 76th Street Redmond. WA 98052
Common or Usual Name
Ultrasonic Bladder Volume Instrument
orporate Headquarters 18109 NE 76th Stree edmond. WA http://www.dxu.co
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Canadian Office
1 519 885-0722
1 800 252-1021
1 519 746-9399 Fax
uropean Office THE NETHER ANDS
1
K963585 p. 2 of 3
Image /page/1/Picture/1 description: The image shows the logo for Diagnostic Ultrasound Corporation. The logo consists of the letters "DUX" in a bold, stylized font. Below the letters, the words "Diagnostic Ultrasound" are written in a smaller font, followed by the word "CORPORATION". The address "P.O. Box 818 Redmond, WA 98073-0818" is printed below the company name.
Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
Predicate Device
Koolgel wound dressing (K881731), for use with the BladderScan™ Bladder Volume Instrument BVI 5000 (K955840) BladderManager™ Personal Care Instrument PCI 5000 (K955942)
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. For both instruments, the scanhead is applied to the patient's abdomen with a hydrogel pad providing ultrasound transmission coupling between the scanhead and the patient's body. Standard ultrasound gel can also be used by itself or in addition to the hydrogel pad, depending on patient preference. The hydrogel pad used in the original 510(k) submission, the Koolgel gel pad, is composed of water and polyethylene oxide, manufactured with the identical formulation as a previously cleared device (Ad-Heal wound dressing, K881731). The object of this submission, the DxU Gel Pad, is composed of distilled water, glycerol, gracillaria agar, carrageenan, methyl paraben, and propyl paraben.
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 unchanged with the DxU Gel Pad.
Technological Characteristics Comparison
The DxU Gel Pad accessory to the BladderManager PCI 5000 and BladderScan BVI 5000 is substantially equivalent to the Koolgel gel pad used in the original 510(k) submission for these two devices. The DxU Gel Pad and its predicate gel pad are both semisolid compounds
Corporate Headquarters 18109 NE 76th Street Redmond, WA 98059 206 867-1348 800 331-2313 206 883 2896 Fax http://www.dxu.com
♦
anadian Office 519 885-0799 800 252-1021 1 519 746-9392 Fax
European Office Lagediik 14 3401 RG IJsselstein THE NETHERLANDS 31 3068 70570 31 3068 70512 Fax
2
K963585 p.3/13
Image /page/2/Picture/1 description: The image shows the logo for Diagnostic Ultrasound Corporation. The logo consists of the letters "DU" in a bold, stylized font, with the letter "X" placed below and slightly to the right of the "D". To the right of the letters, the words "Diagnostic Ultrasound" are written in a clear, sans-serif font. Below the company name, the address "P.O. Box 818 Redmond, WA 98073-0818 USA" is printed.
designed to provide ultrasonic coupling between the instruments' ultrasound transducer and the skin of the patient. The instruments themselves are pulsed echo ultrasonic imaging instruments dedicated to non-invasive measurement of urinary bladder volume. Although there are some technological differences between the DxU Gel Pad and its predicate accessory, 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 DxU Gel Pad differs from the Koolgel gel pad in composition of materials, however, accepted scientific methods for biocompatibility testing and clinical performance testing demonstrated that the subject device accessory is substantially equivalent to the predicate device accessory in terms of safety. Also, accepted scientific methods for bench testing and clinical performance testing demonstrated that the subject device accessory is substantially equivalent to the predicate device accessory in terms of effectiveness.
Performance Data
Non-clinical testing included density, speed of sound, and acoustic impedance measurements, and biocompatibility testing. All non-clinical testing demonstrated that the subject device accessory is substantially equivalent to the predicate device accessory in terms of safety, effectiveness, and performance.
Clinical testing of the DxU gel pad with the BVI/PCI 5000 was performed on healthy volunteers, as well as actual spinal cord injured subjects familiar with the instrument. No significant adverse effects or complications were noted. The results demonstrate that the device accessory is substantially equivalent to the predicate gel pad in terms of safety and effectiveness.
Conclusion
Non-clinical and clinical testing methods demonstrate that the device accessory is as safe. as effective, and performs as well as the legally marketed predicate device accessory. The DxU Gel Pad is substantially equivalent to the Koolgel gel pad with respect to intended use, technological characteristics, and clinical performance.
Corporate Headquarters 18109 NE 76th Street Redmond, WA 98052 USA 1 206 867-1348 1 800 331-2313 1 906 883 9896 Fax http://www.dxu.com
♦
anadian Office 510 885-0799 1 800 959-1091 1 519 746-9392 Fax
uropean Office lagediik 14 3401 RG IJsselstein THE NETHERLANDS 31 3068 70519 Fax