(43 days)
Not Found
No
The description mentions "patented Vmode® technology" which uses ultrasonic reflections to create a 3D image and calculate volume/mass. While this involves complex processing, there is no mention of AI, ML, or related terms like neural networks, deep learning, or training/test sets, which are typically associated with AI/ML implementations in medical devices. The technology described appears to be based on established ultrasound principles and proprietary algorithms rather than AI/ML.
No
The device is described as a diagnostic ultrasonic instrument intended for obtaining an image of the bladder and measuring bladder volume and mass non-invasively, which are diagnostic functions, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Other (Bladder)". Additionally, the "Device Description" mentions that it "calculates and displays the bladder volume and bladder mass," which are diagnostic measurements.
No
The device description explicitly states it is a "B-mode ultrasonic instrument, portable and battery operated" and includes a "thermal printer," indicating it is a hardware device with integrated software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health.
- Device Function: The BladderScan® BVM 9500 uses ultrasound energy to image and measure the bladder within the body. It does not analyze samples taken from the body.
The device is a diagnostic ultrasound system used for non-invasive imaging and measurement in vivo (within the living body).
N/A
Intended Use / Indications for Use
- Abdomen, B-Mode, per Indications for Use Ultrasound Form .
- The BladderScan® BVM 9500 is intended to project ultrasound energy through . the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass non-invasively.
- The portable Verathon Inc. BladderScan® BVM 9500 Ultrasound System is applied to the patient's abdomen along with Sontac Ultrasound Coupling Gel to obtain bladder volume and bladder mass.
- Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Other (Bladder)
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
The BladderScan® BVM 9500 is a B-mode ultrasonic instrument, portable and battery operated, intended for the noninvasive measurement of urinary bladder volume and bladder mass. The BladderScan® BVM 9500 calculates the bladder volume and mass using patented Vmode® technology. Vmode ultrasound is easy to use and comfortable for the patient. When you release the scan button, within seconds, the Vmode technology measures ultrasonic reflections on multiple planes inside the body and produces a 3-dimensional image. Based on this image, the BladderScan® calculates and displays the bladder volume and bladder mass. Volume measurements made with Vmode ultrasound are more accurate than those from conventional 2-dimensional ultrasound, as they are based on a more complex, 3-D image of the bladder.
Bladder volume and mass, mode (uterus detection or standard BladderScan), directional aiming with real-time feedback, battery status, and usage rate indicators are all displayed on the BladderScan® BVM 9500 LCD display. The instrument contains a thermal printer that will allow the user to print exams with a single button click.
The Verathon Inc. BladderScan® BVM 9500's center section of the transducer is generating higher-frequency ultrasound at 7.3MIIz. This special design is for bladder wall thickness measurement, which can yield higher resolution information and improves the thickness measurement accuracy. The ultrasonic power transmitted from the system is not user adjustable.
The BVM9500 Ultrasound System transducer collects two group of information: Group 1 includes cross-sectional Bmode images from 3MHz signal and the harmonic ratio from 1.74MHz: Group 2 includes the RF signal from higher frequency signal at 7.3MHz. Then the BVM9500 Ultrasound System utilizes the first group information to automatically calculate the urine volume via volumetric integration. At the same time, the 3D bladder surface area is also calculated based on the segmentations from every plane. Bladder wall thickness is measured automatically based on the7.3MHz RF signal in the following step. The higher resolution guarantees the accuracy of the thickness measurement of the thin bladder wall. Lastly, the 3D bladder surface area and the bladder wall thickness are computed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Lower abdomen, bladder
Indicated Patient Age Range
Not Found. Contraindicated for fetal use and for use on pregnant patients.
Intended User / Care Setting
Not Found
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
A third party vendor was contracted to build tissue equivalent phantoms with known dimensions. The supplier of the tissue equivalent phantoms is CIRS and is known for supplying medical imaging phantoms to the medical marketplace.
The tissue equivalent phantom is essentially a balloon which gets filled with urine mimicking material and then the filled balloon is surrounded with tissue mimicking material. This balloon is a known volume and wall thickness and can be compared to the BladderScan® measurements from the BVM 9500.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bladder volume and mass accuracy have been demonstrated by comparing the bladder mass and bladder volume phantom measurements to the measurements of the Verathon Inc. BladderScan® BVM 9500. The same procedures are used to prove the measurement accuracy of the previously cleared Verathon Inc.BVM 6500 (K030763) during production.
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
§ 892.1560 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
K090214/
17
510(K) SUMMARY (As required by 21 CFR 807.92(a))
MAR 1 3 2009
| Submitter Information | |
|---|---|
| Company: | Verathon Inc. |
| 20001 North Creek Parkway | |
| Bothell, WA 98011 | |
| Phone: | 425-867-1348 ext.5642 |
| Fax: | 425-883-2896 |
| Email: | krisn@verathon.com |
| Contact: | Kristian Nielsen |
| Regulatory Affairs Specialist | |
| Date: | January 29, 2009 |
| Device Information | |
| Trade/Proprietary Name: | Verathon Inc. BladderScan® BVM 9500 Ultrasound System |
| Common Name: | Diagnostic Ultrasound System with Accessories |
| Classification Name(s): | Regulatory Class: II |
| Review Category: Tier II | |
| Classification Panel: Radiology | |
| Ultrasonic Pulsed Echo Imaging System | |
| FR Classification 892.1560 | |
| Product Code 90-IYO | |
| Diagnostic Ultrasound Transducer | |
| FR Classification 892.1570 | |
| Product Code 90-ITX | |
| Predicate Device(s): | Verathon BladderScan® BVI 9400 Ultrasound System (K071217) |
| And | |
| Verathon BladderScan® BVM 6500 Ultrasound System (K030763) | |
| Device Description: | The BladderScan® BVM 9500 is a B-mode ultrasonic |
: : : : :
1
instrument, portable and battery operated, intended for the noninvasive measurement of urinary bladder volume and bladder mass. The BladderScan® BVM 9500 calculates the bladder volume and mass using patented Vmode® technology. Vmode ultrasound is easy to use and comfortable for the patient. When you release the scan button, within seconds, the Vmode technology measures ultrasonic reflections on multiple planes inside the body and produces a 3-dimensional image. Based on this image, the BladderScan® calculates and displays the bladder volume and bladder mass. Volume measurements made with Vmode ultrasound are more accurate than those from conventional 2-dimensional ultrasound, as they are based on a more complex, 3-D image of the bladder.
Bladder volume and mass, mode (uterus detection or standard BladderScan), directional aiming with real-time feedback, battery status, and usage rate indicators are all displayed on the BladderScan® BVM 9500 LCD display. The instrument contains a thermal printer that will allow the user to print exams with a single button click.
(Same as previously cleared Verathon BVM 6500 Ultrasound System): The BladderScan® BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass non-invasively.
The Verathon Inc. BladderScan® BVM 9500 Ultrasound System retains the same bladder volume measurement features of the Verathon inc. BladderScan® BVI 9400 System (K071217), but also has the Bladder mass measurement function and intended use as the previously cleared Verathon Inc. BladderScan® BVM 6500 (K030763).
The BVM 9500 is identical to the BVI 9400, with regards to hardware and calibration method however, the BVM 9500 transducer has been changed to a trifrequency transducer for better bladder detection and measurement.
Intended Use:
Comparison of Required Technological Characteristics:
2
The Verathon Inc. BladderScan® BVM 9500's center section of the transducer is generating higher-frequency ultrasound at 7.3MIIz. This special design is for bladder wall thickness measurement, which can yield higher resolution information and improves the thickness measurement accuracy. The ultrasonic power transmitted from the system is not user adjustable.
The portable Verathon Inc. BladderScan® BVM 9500 Ultrasound System is applied to the patient's abdomen along with Sontac Ultrasound Coupling Gel to obtain bladder volume and bladder mass. The BVM9500 Ultrasound System transducer collects two group of information: Group 1 includes cross-sectional Bmode images from 3MHz signal and the harmonic ratio from 1.74MHz: Group 2 includes the RF signal from higher frequency signal at 7.3MHz. Then the BVM9500 Ultrasound System utilizes the first group information to automatically calculate the urine volume via volumetric integration. At the same time, the 3D bladder surface area is also calculated based on the segmentations from every plane. Bladder wall thickness is measured automatically based on the7.3MHz RF signal in the following step. The higher resolution guarantees the accuracy of the thickness measurement of the thin bladder wall. Lastly, the 3D bladder surface area and the bladder wall thickness are computed.
In order to demonstrate the BladderScan® accuracy claimed in 0270-0425 -xx-55, a third party vendor was contracted to build tissue equivalent phantoms with known dimensions. The supplier of the tissue equivalent phantoms is CIRS and is known for supplying medical imaging phantoms to the medical marketplace.
The tissue equivalent phantom is essentially a balloon which gets filled with urine mimicking material and then the filled balloon is surrounded with tissue mimicking material. This balloon is a known volume and wall thickness and can be compared to the BladderScan® measurements from the BVM 9500.
3
Bladder volume and mass accuracy have been demonstrated by comparing the bladder mass and bladder volume phantom measurements to the measurements of the Verathon Inc. BladderScan® BVM 9500. The same procedures are used to prove the measurement accuracy of the previously cleared Verathon Inc.BVM 6500 (K030763) during production.
The calibration system for the Verathon Inc. BladderScan® BVM 9500 Ultrasound System is exactly the same as the Verathon Inc. BladderScan® BVI 9400 Ultrasound System (K071217).
Design and testing of the Verathon Inc. BladderScan® BVM 9500 Ultrasound System indicates that the BVM 9500 is substantially equivalent to the Verathon Inc. BladderScan® BVI 9400 Ultrasound System (K071217) for bladder volume measurements and equivalent to the Verathon Inc. BVM 6500 Ultrasound System (K030763) for bladder mass measurements.
All acoustic output measurements for the BladderScan® BVM 9500 Ultrasound System remains within Preamendment limits.
Summary and Conclusion of Non Clinical and Clinical Testing
4
Image /page/4/Picture/16 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles an abstract human figure or a bird-like shape. The logo is presented in black and white.
MAR 17 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kristian Neilsen Regulatory Affairs Specialist Verathon, Inc. Corporate Headquarters 20001 North Creek Parkway BOTHELL WA 98011
Re: K090214
Trade/Device Name: Verathon Inc. BladderScan® BVM 9500 Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: January 29, 2009 Received: January 29, 2009
Dear Mr. Neilsen:
This letter corrects our substantially equivalent letter of March 13, 2009.
We have reviewed your Section 510(k) premarket 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 misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Verathon Inc. BladderScan® BVM 9500 Ultrasound System, as described in your premarket notification:
Transducer Model Number
3.0 / 1.74 Second/ 7.3 MHz Third Harmonic Transducer
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device
5
can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Lauren Hefner at (240) 276-3666.
Sincerely yours,
Hulbert Leeman
ine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
6
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K090214
BladderScan® BVM 9500 Ultrasound System Device Name:________
Indications For Use:
- Abdomen, B-Mode, per Indications for Use Ultrasound Form .
- The BladderScan® BVM 9500 is intended to project ultrasound energy through . the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass non-invasively.
Contraindications:
- The BladderScan® BVM 9500 is contraindicated for fetal use and for use on . pregnant patients.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helus flemen
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Page 1 of 1
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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM System: BladderScan® BVM 9500 Ultrasound System 3.0 / 1.74 Second/ 7.3MHz Third Harmonic Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I | ||||||||
| only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | P | |||||||
| Intra-operative | ||||||||
| (Abdominal organs and | ||||||||
| vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (breast, | ||||||||
| thyroid, testicles) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Convent.) | ||||||||
| Musculo-skel. | ||||||||
| (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (Abdominal Aorta | ||||||||
| Measurement) | ||||||||
| Peripheral vessel | ||||||||
| Other (Bladder) | P |
N= new indication; P= previously cleared by FDA (K071217 & K030763)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number