(186 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device and studies does not mention any AI/ML components.
No
The device is described as an ultrasound instrument used to obtain an image of the bladder to determine bladder volume non-invasively, not to treat or cure a disease or condition. Its purpose is monitoring and alerting, not therapy.
No
The device is intended to determine bladder volume non-invasively and alert users when a pre-programmed threshold is exceeded, which is a monitoring function rather than a diagnostic one. While it provides an image of the bladder, its primary goal is to inform about volume changes, not to diagnose a specific condition.
No
The device description explicitly states it is a "portable, battery powered ultrasound instrument" and mentions a "hand held probe" and a "garment-held probe," indicating it includes hardware components for ultrasound imaging.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- BladderManager Function: The BladderManager PCI 5000(+) uses ultrasound energy to non-invasively image the bladder and determine its volume. It does not analyze any specimens taken from the body. It works externally on the patient.
The device is an ultrasound device used for non-invasive bladder volume measurement.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
90 IYO, 90 ITX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Bladder / Lower Abdomen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Patient and/or caregiver
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
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.
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.
Not Found
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
§ 892.1570 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.
0
ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
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
1
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.
2
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.
3
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.
4
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
5
ﺴﺴﻪ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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)
6
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