The BladderManager® PC1 5000(+) is intended to project ultrasound energy through r he bladenwanager of the non-pregnant in order to obtain an image of the bladder that is used to determine bladder volume non-invasively. This capability is provided in 2 fundamental modes; 1) hand held probe, aimed by user to obtain reading and 2) Automatically monitor bladder volume via a garment-held probe on non-mobile, supine patient. Patients and/or caregivers are alerted visually and/or audibly when the bladder volume exceeds a pre-programmed threshold.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the BladderManager® Personal Care Instrument PCI 5000:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Primary Goal: Substantial equivalence to predicate device (BladderManager PCI 5000, K955840) for intended use and technological characteristics. This encompasses:	The study data and analyses demonstrated that "the BladderManager PCI 5000 used to measure bladder volume in autoscan mode is substantially equivalent to the BladderManager PCI 5000 used in manual mode." This directly addresses the substantial equivalence for the new autoscan feature to the previously cleared manual mode.
1. Ability to non-invasively monitor bladder volume (manual mode, as per predicate).	The device in manual mode is the predicate, and its performance is established. The study implicitly confirms the new autoscan mode performs equivalently.
2. Ability of new "autoscan mode" to track bladder filling and emptying.	The clinical study was performed "to assess the capability of the BladderManager PCI 5000 to automatically track the bladder filling and emptying in a supine adult." The stated conclusion is that the autoscan mode is substantially equivalent to the manual mode, implying successful tracking.
3. Ability of new "autoscan mode" to alarm at a specific bladder volume.	The study explicitly aimed "to alarm at a specific bladder volume." The conclusion states, "The study also showed that the device can accurately alarm at a preset volume to allow the patient or caregiver time to manage the urological needs of the patient."
4. Safety profile equivalent to predicate device.	The submission states: "All safety testing reported in the previous model BladderManager PCI 5000 510(k) submission is applicable." And "the differences are minor and do not raise new questions of safety and effectiveness."

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

Sample Size: 40 subjects.
Data Provenance: The study was conducted at "two sites." The document does not specify the country of origin of the data, but given the US regulatory context (FDA), it's highly probable the study was conducted in the United States.
Retrospective or Prospective: This was a prospective clinical study, as it "was performed to assess the capability of the BladderManager PCI 5000 to automatically track the bladder filling and emptying." Subjects were enrolled and data was collected specifically for the purpose of this evaluation.

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

The document does not explicitly state the number of experts or their qualifications for establishing ground truth. The "ground truth" for directly comparing bladder volume measurements appears to be derived from the device itself (manual mode readings and voided volume measurement). The post-void residual volume was "manually measured and recorded," implying a clinical measurement rather than an expert consensus on interpreting images.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set in the traditional sense of multiple reviewers resolving discrepancies. The comparison was statistical: "bladder volume measured in autoscan mode was compared to volume measured in the manual mode, and to voided volume." The "post void residual volume was then manually measured and recorded." This suggests direct comparison of objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The study compared different measurement modes of the same device (autoscan vs. manual) and against a physical measurement (voided volume, post-void residual volume). It did not evaluate human readers' improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a way, the evaluation of the "autoscan mode" can be considered a standalone performance assessment of the algorithmic feature. While a human sets the device and observes the alarm, the autoscan function itself is an automated process without continuous human intervention during the measurement cycles. The comparison of autoscan volume to manual mode volume (which is also a device measurement) and voided volume directly assesses the accuracy of the automated function.

7. The Type of Ground Truth Used

The ground truth used was a combination of:

Reference Device Measurement: Bladder volume measured in "manual mode" of the BladderManager PCI 5000 (which is itself the predicate device and considered reliable).
Physical Measurement/Outcomes Data: "Voided volume" (measured into a graduated receptacle) and "post void residual volume" (manually measured). These are objective physiological measurements.

8. The Sample Size for the Training Set

The document does not provide any information about a training set size. This device is an ultrasound instrument (hardware) with a minor software update. It's likely that developmental testing and calibration of the algorithms within the device (even for the manual mode) happened internally, but explicit "training set" data, as understood in modern AI/machine learning contexts, is not described in this 1998 submission.

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

As no training set is described, there is no information on how its ground truth was established.

Summary

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JAN 25 1999

510(k) Summary

BladderManager® Personal Care Instrument PCI 5000

Common/Classification Name: Ultrasonic Bladder Volume Instrument/ Pulsed Echo Ultrasonic Imaging System as classified under 21 CFR 892.1560

Diagnostic Ultrasound Corporation. 18109 NE 76th Street Redmond, Washington 98052

Phone	(206) 867-1348
Facsimile	(206) 883-2896

Gerald McMorrow, MSEE Contact:

Prepared: July 14, 1998

A. Legally Marketed Predicate Devices

The BladderManager PCI 5000 is substantially equivalent to Diagnostic Ultrasound Corporation's previous model BladderManager PCI 5000 (K955840).

B. 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.

C. Indications for Use

ﻟﺔ

The BladderManager PCI 5000 projects 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.

D. Substantial Equivalence Summary

The predicate device also provides the same function and technological characteristics as described above for the new model BladderManager PCI 5000. The two models have the same indication for use and use the same mechanical sector scanning transducer to obtain the necessary data.

The new model is nearly identical to the predicate BladderManager PCI 5000 (K955840) with the following exceptions: the new model can be worn continually

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K982568 p. 2 of 3

by the patient with use of a garment, and can be set to automatically measure bladder volume at preset time intervals. Although there are some technological differences (software) incorporated to provide these features, the differences are minor and do not raise new questions of safety and effectiveness. In addition, accepted scientific methods exist for assessing the effects of the technological differences.

Technological Characteristics E.

The ultrasonic and electrical properties of the device are unchanged. The only modification is the addition of the autoscan mode, and the ability to wear the device with a garment. All safety testing reported in the previous model BladderManager PCI 5000 510(k) submission is applicable.

The hardware of the BladderManager PCI 5000 is unchanged. All testing reported in K955840 is applicable to this model.

A minor software change initiates the scan automatically at preset time intervals. Other than this change, the software for the current model is unchanged from the predicate model.

Testing F.

A clinical study was performed to assess the capability of the BladderManager PCI 5000 to automatically track the bladder filling and emptying in a supine adult, and to alarm at a specific bladder volume. In this study, bladder volume measured in autoscan mode was compared to volume measured in the manual mode, and to voided volume.

Forty subjects were enrolled at two sites. Subjects were trained in the use of the device and fitted with the garment. The instrument was set to scan every 15 minutes and the alarm was set to 250 cc.

When the alarm sounded, the autoscan volume was recorded. The instrument was then placed in manual mode and the bladder volume was measured manually and recorded. The subject was then asked to void into a graduated receptacle. The voided volume was measured, and the post void residual volume was then manually measured and recorded.

These data and analyses demonstrate that the BladderManager PCI 5000 used to measure bladder volume in autoscan mode is substantially equivalent to the BladderManager PCI 5000 used in manual mode. The study also showed that the device can accurately alarm at a preset volume to allow the patient or caregiver time to manage the urological needs of the patient.

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K982564 p.3d 3

. .

G. Conclusions

Diagnostic Ultrasound Corporation has demonstrated through its comparison of performance with the predicate device that the BladderManager PCI 5000 is equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 25 1999

Gerald McMorrow President and CEO Diagnostic Ultrasound Corp. 18109 NE 76th St. Redmond, WA 98052

K982568 Re: BladderManager™ PCI 5000 and BladderManager™ PCI 5000+ with option of garment held probe and automatic monitoring Regulatory class: II/21 CFR 892.1560 and 21 CFR 892.1570 Procode: 90 IYO and 90 ITX Dated: November 12, 1998 Received: November 13, 1998

Dear Mr. McMorrow:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranion.

This determination of substantial equivalence applies to the following transducers intended for use with the BladderMananger™ PCI 5000 and the BladderManager™ PCI 5000+, as described in your premarket notification:

Transducer Model Number

2 MHz scanhead

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

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Page 2 -- Gerald McMorrow

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

If you have any questions regarding the content of this letter, please contact Paul Gammell, Ph.D.at (301) 594-1212.

Sincerely yours,

David G. Slosky, MD

Capt. Daniel G. S Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and ... . . . . Radiological Health

Enclosure

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I of I Page

510(k) Number (if known):	K982568
Device name:	BLADDER MANAGER ® PCI 5000

AND
BLADDER MANAGER® PCI5000+
Indications For Use:The BladderManager® PC1 5000(+) is intended to project ultrasound energy through r he bladenwanager of the non-pregnant in order to obtain an image of the bladder that is used to determine bladder volume non-invasively. This capability is provided in 2 fundamental modes; 1) hand held probe, aimed by user to obtain reading and 2) Automatically monitor bladder volume via a garment-held probe on non-mobile, supine patient. Patients and/or caregivers are alerted visually and/or audibly when the bladder volume exceeds a pre-programmed threshold.

(PI EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEE: JED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K982568

Pre: cription Use OR Over-The-Counter Use
(Pe 21 CFR 801.109) (Optional Format 1-2-96)

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קאות/

K982568
BLADDER MANAGER® PCI 5000

Appendix F

BLADDER MANAGER® PCI5000 t
	Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

life and the out of the but one of the human body as tollow analysis of the human body as follows:
Int

Int nded use: Diagnostic ultrasound imaging

Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic
Fetal
At lominal		X
In-operative (specify)
In: apperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
Prescription Use (Per 21 CFR 801.109) F-3 510(k) Number K982568

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.