← Product Code [IYO](/productcode/IYO) · K963585 # BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000 (K963585) _Diagnostic Ultrasound Corp. · IYO · Oct 1, 1996 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K963585 ## Device Facts - **Applicant:** Diagnostic Ultrasound Corp. - **Product Code:** [IYO](/productcode/IYO.md) - **Decision Date:** Oct 1, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1560 - **Device Class:** Class 2 - **Review Panel:** Radiology ## 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.” ## Device Story DxU Gel Pad is a hydrogel accessory for BladderScan BVI 5000 and BladderManager PCI 5000 ultrasound instruments. Acts as acoustic coupling medium between ultrasound transducer and patient skin; facilitates transmission of ultrasound energy for non-invasive bladder volume measurement. Used by clinicians or patients in clinical or home settings. Replaces or supplements standard ultrasound gel. Composed of distilled water, glycerol, gracillaria agar, carrageenan, and parabens. Ensures signal integrity for bladder imaging. ## Clinical Evidence Clinical testing performed on healthy volunteers and spinal cord injured subjects familiar with the instrument. No significant adverse effects or complications reported. Results demonstrate safety and effectiveness equivalent to the predicate gel pad. ## Technological Characteristics Semisolid hydrogel pad. Composition: distilled water, glycerol, gracillaria agar, carrageenan, methyl paraben, propyl paraben. Function: ultrasonic coupling medium. Bench testing included density, speed of sound, and acoustic impedance measurements. ## Regulatory 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 - Koolgel wound dressing ([K881731](/device/K881731.md)) ## Reference Devices - BladderScan™ Bladder Volume Instrument BVI 5000 ([K955840](/device/K955840.md)) - BladderManager™ Personal Care Instrument PCI 5000 ([K955942](/device/K955942.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} DU Diagnostic Ultrasound CORPORATION P.O. Box 818 Redmond, WA 98073-0818 USA OCT 1 1996 K963585 # 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 Corporate Headquarters 18109 NE 76th Street Redmond, WA 98052 USA 1 206 867-1348 1 800 331-2313 1 206 883 2896 Fax http://www.dxu.com Canadian Office 1 519 885-0722 1 800 252-1021 1 519 746-9392 Fax European Office Lagedijk 14 3401 RG IJsselstein THE NETHERLANDS 31 3068 70570 31 3068 70512 Fax {1} K963585 p. 2 of 3 # RU Diagnostic Ultrasound CORPORATION P.O. Box 818 Redmond, WA 98073-0818 USA ## 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 98052 USA 1 206 867-1348 1 800 331-2313 1 206 883 2896 Fax http://www.dxu.com Canadian Office 1 519 885-0722 1 800 252-1021 1 519 746-9392 Fax European Office Lajjedijk 14 3401 RG IJsselstein THE NETHERLANDS 31 3068 70570 31 3068 70512 Fax {2} K963585p.3/3 DU Diagnostic Ultrasound CORPORATION P.O. Box 818 Redmond, WA 98073-0818 USA 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 1 206 883 2896 Fax http://www.dxu.com Canadian Office 1 519 885-0722 1 800 252-1021 1 519 746-9392 Fax European Office Lagedijk 14 3401 RG IJsselstein THE NETHERLANDS 31 3068 70570 31 3068 70512 Fax --- **Source:** [https://fda-staging.innolitics.com/device/K963585](https://fda-staging.innolitics.com/device/K963585) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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