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.

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.

AI/ML Overview

This document describes the DxU Gel Pad, an accessory for the BladderScan™ BVI 5000 and BladderManager™ PCI 5000 ultrasonic bladder volume instruments. The submission is a 510(k) summary, aiming to demonstrate substantial equivalence to a predicate device, the Koolgel wound dressing.

It's important to note that this is a medical device accessory submission focusing on the gel pad itself, not the core ultrasonic imaging device. Therefore, the "device performance" in this context refers to the performance of the gel pad in enabling the ultrasonic instruments to function effectively, rather than the performance of an AI algorithm making diagnoses or measurements. Because it is a medical device, AI is not a relevant consideration and thus cannot be included in the response.

Here's a breakdown of the requested information based on the provided text, focusing on the gel pad's performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the gel pad's performance in terms of specific numerical thresholds for accuracy, sensitivity, or specificity. Instead, the acceptance is based on demonstrating "substantial equivalence" to the predicate device in terms of safety, effectiveness, and performance.

Acceptance Criteria (Implied for Gel Pad)	Reported Device Performance (DxU Gel Pad)
Safety: Biocompatibility, no significant adverse effects or complications.	Biocompatibility testing demonstrated substantial equivalence to the predicate. Clinical testing noted "no significant adverse effects or complications."
Effectiveness: Ability to provide effective ultrasonic coupling for accurate bladder volume measurement.	Bench testing (density, speed of sound, acoustic impedance) and clinical performance testing demonstrated substantial equivalence to the predicate in terms of effectiveness.
Performance: Overall functionality commensurate with the predicate device in supporting bladder volume instruments.	Demonstrated substantial equivalence to the predicate gel pad based on non-clinical and clinical testing.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document mentions clinical testing was "performed on healthy volunteers, as well as actual spinal cord injured subjects." However, it does not specify the sample size (number of volunteers or subjects) used for this clinical testing.
Data Provenance: The document does not explicitly state the country of origin for the data. The submission is from Diagnostic Ultrasound Corporation, located in Redmond, WA, USA, suggesting the clinical testing likely occurred in the USA. The study design (retrospective or prospective) is also not explicitly stated, but clinical testing on "volunteers" and "subjects" usually implies a prospective study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Given that this is a 510(k) submission for a gel pad accessory, and the "performance" relates to enabling an ultrasonic instrument, the concept of "ground truth" as established by experts (e.g., radiologists interpreting images) for diagnostic accuracy is not directly applicable in the same way it would be for an AI-driven diagnostic device.

The "ground truth" in this context would likely be the accurate bladder volume measurements obtained by the BladderScan/BladderManager instruments when used with the gel pad, validated against established methods (which are not detailed here for the predicate device either, as it's an accessory submission). The document does not mention the use of experts to establish a "ground truth" for the gel pad's performance in a diagnostic sense.

4. Adjudication Method for the Test Set

As the "ground truth" by expert consensus (e.g., 2+1, 3+1) is not explicitly established for this accessory, an adjudication method is not applicable and therefore not described in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study, typically used to evaluate the impact of an AI algorithm on human reader performance, is not relevant for this submission. This document describes an accessory (gel pad) for an ultrasonic device, not an AI-powered diagnostic tool. Therefore, no such study was performed or reported.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This submission is for a gel pad, which is a passive accessory and does not involve an algorithm or AI. Therefore, a standalone performance study (algorithm only) is not applicable and was not performed.

7. Type of Ground Truth Used

The "ground truth" in the context of this submission (gel pad facilitating ultrasonic measurement) would be the accurate bladder volume measurements obtained by the ultrasonic instrument, likely verified by the instrument itself when functioning correctly. The specifics of how this "ground truth" was established for the fundamental bladder volume measurement (e.g., catheterization, other imaging modalities) are outside the scope of this accessory submission and are not detailed here. The submission uses the term "effectiveness" which implies that the gel pad allowed the BVI/PCI 5000 to function as intended, determining bladder volume non-invasively.

8. Sample Size for the Training Set

Since this is a submission for a physical accessory (gel pad) and not an AI algorithm, there is no concept of a "training set" as would be used to train a machine learning model. Therefore, no training set sample size is reported.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an AI algorithm, the question of how its ground truth was established is not applicable to this submission.

Summary

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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

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 Corporation18109 NE 76th StreetRedmond, 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

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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

Intended Use

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

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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

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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

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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

Regulation Number and Section

§ 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.