(97 days)
Not Found
No
The summary describes a device that uses patented Vmode® technology and constructs a finite element model for calculations, but there is no mention of AI or ML.
No
The device is described as a diagnostic ultrasound device used for measuring bladder volume and aortic diameter, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows". The device measures bladder volume and aortic diameter, which are diagnostic measurements used to assess physiological conditions.
No
The device is described as a portable, battery-operated B-mode ultrasonic instrument that projects ultrasound energy and includes a transducer, LCD display, and thermal printer, indicating it is a hardware device with integrated software.
Based on the provided information, the Verathon Inc. BladderScan® BVI 9600 with AortaScan® Mode is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes.
- Device Function: The BladderScan® BVI 9600 with AortaScan® Mode is an ultrasound device that uses energy projected into the body to obtain images and measurements of internal organs (bladder and aorta). It does not analyze specimens derived from the body.
- Intended Use: The intended use is for diagnostic ultrasound imaging and fluid flow analysis of the human body, specifically for measuring bladder volume and aortic diameter. This is an in vivo (within the living body) diagnostic process, not an in vitro (in glass/outside the body) process.
Therefore, the device falls under the category of medical imaging devices used for in vivo diagnosis, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
- Abdomen, B-Mode, per Indications for Use Ultrasound Form
- The Verathon Inc. BladderScan® BVI 9600 with AortaScan® Mode is a user selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorfa for aorlic diameter measurement.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: General (Track I only)
Specific (Tracks I & III): Abdominal, Other (Abdominal Aorta Measurement), Other (Bladder)
Mode of Operation: B
Product codes (comma separated list FDA assigned to the subject device)
90-1YO, 90-ITX
Device Description
The BVI9600, with AortaScan®, is a B-mode ultrasonic instrument that is portable and battery operated. The BVI 9600 has two user controlled modes of operation; (1) - Bladder Volume Measurement and (2)- Abdominal Aortic Measurement, both noninvasive. Either bladder volume or aortic diameter measurement functions can be chosen by a button press. When the scan button is pressed the BVI9600 uses patented Vmode® technology to measure ultrasonic reflections on multiple planes inside the body to produce a 3dimensional image. Based on these images and the mode of operation chosen, the BV19600 either calculates and displays the bladder volume (BladderScan® mode) or calculates and displays the abdominal aortic diameter (AortaScan® mode). The 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. Bladder volume (in BladderScan® mode), aortic diameter (in AortaScan® mode), mode selection, directional aiming, battery status, and usage rate indicators are all displayed on the BV19600 LCD display. The instrument contains a thermal printer that allows the user to print exams with a single button click.
New device: The Verathon Inc. BladderScan® BVI 9600 with AortaScan® is a user selectable dual function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume or the mid abdomen to obtain an image of the abdominal aorta for aortic diameter measurement.
The Verathon Inc. BladderScan® BVI 9600, with AortaScan®, and its integrated 3.0 MHz mechanical sector transducer operate only in B-mode to locate and automatically measure bladder volume (in BladderScan® Mode) or abdominal aortic diameter (in AortaScan® Mode). The same transducer is driven at 1.74 MHz to obtain a second harmonic for enhanced bladder wall detection. Bladder volume (in BladderScan® Mode), aortic diameter (in AortaScan® Mode), patient gender, non optimal directional aiming, battery status, and usage rate indicators are all displayed on the Verathon Inc. BladderScan® BVI 9600 Ultrasound System scanner. The ultrasonic power transmitted from the system is not user adjustable.
The portable Verathon Inc. BladderScan® BVI 9600 Ultrasound System with AortaScan® is applied to the patient's abdomen along with Sontac Ultrasound Coupling Gel to obtain aortic measurement. The BladderScan® BVI 9600 Ultrasound System transducer collects cross- sectional images of the bladder or aorta from twelve (12) scan planes. From this information, the Verathon Inc. BladderScan® BVI 9600 Ultrasound System constructs a finite element model of the bladder (in BladderScan® Mode) or aorta (in AortaScan® Mode) and automatically computes the volume of urine via volumetric integration (for the bladder measurement) or the diameter of the aorta (for aortic measurement), depending on the mode of operation chosen (AortaScan® or BladderScan®).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Lower abdomen (bladder), Mid-abdomen (abdominal aorta)
Indicated Patient Age Range
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Two third-party vendors were contracted to build tissue equivalent phantoms with known dimensions:
The AortaScan® phantom: a tube with a bulge representing an aortic aneurysm, filled with blood mimicking material surrounded by tissue mimicking material. Known diameters of the tube were compared to the AortaScan® measurements from the BVI 9600.
The BladderScan® Phantom: a balloon filled with urine mimicking material, surrounded by tissue mimicking material. The known volume of this balloon was compared to the BladderScan® measurements from the BVI 9600.
Measurements of key physical parts of the phantoms were NIST traceable, and each phantom came with a certification sheet listing the measurements. The results obtained from the Verathon Inc. BladderScan® BVI 9600 Ultrasound System were compared to the expected NIST traceable measurements. Additionally, measurements were taken by standard ultrasound systems, such as the Sonosite 180, for comparison. AortaScan® accuracy was demonstrated by comparing AortaScan® Phantom measurements to the measurements of the Verathon Inc. BladderScan® BVI 9600 Ultrasound System.
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
K082456
pg. 1 of 4
510(K) SUMMARY (As required by 21 CFR 807.92(a))
DEC 0 1 2008
| Submitter Information | Company: Verathon Inc. |
|---|---|
| 20001 North Creek Parkway | |
| Bothell, WA 98011 | |
| Phone: | 425-867-1348 ext.5640 |
| Fax: | 425-883-2896 |
| Email: | rzeine@verathon.com |
| Contact: | Richard A. Zeine |
| Director of Quality Assurance and | |
| Regulatory Affairs | |
| Date: | August 15, 20008 |
| Device Information |
Verathon Inc. BladderScan® BVI 9600 Ultrasound System with AortaScan®
Diagnostic Ultrasound System with Accessories
Common Name:
Classification Name(s):
Trade/Proprietary Name:
Regulatory Class: II Review Category: Tier II Classification Panel: Radiology Ultrasonic Pulsed Echo Imaging System
- FR Classification 892.1560 .
- . Product Code 90-1YO
- Diagnostic Ultrasound Transducer
- FR Classification 892.1570 .
- Product Code 90-ITX .
Verathon BladderScan® BVI 9400 Ultrasound System (K071217)
And SonoSite MicroMaxx High-Resolution Ultrasound System (C3 Series) (K053069)
The BVI9600, with AortaScan®, is a B-mode ultrasonic instrument that is portable and battery operated. The BVI 9600 has two user controlled modes of operation; (1) - Bladder Volume Measurement and (2)- Abdominal Aortic Measurement, both noninvasive. Either bladder volume or aortic diameter measurement functions can be chosen by a button press. When the scan button is pressed the BVI9600 uses patented Vmode® technology to measure ultrasonic
Predicate Device:
Device Description:
A.
1
reflections on multiple planes inside the body to produce a 3dimensional image. Based on these images and the mode of operation chosen, the BV19600 either calculates and displays the bladder volume (BladderScan® mode) or calculates and displays the abdominal aortic diameter (AortaScan® mode). The 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. Bladder volume (in BladderScan® mode), aortic diameter (in AortaScan® mode), mode selection, directional aiming, battery status, and usage rate indicators are all displayed on the BV19600 LCD display. The instrument contains a thermal printer that allows the user to print exams with a single button click.
New device: The Verathon Inc. BladderScan® BVI 9600 with AortaScan® is a user selectable dual function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume or the mid abdomen to obtain an image of the abdominal aorta for aortic diameter measurement.
The BladderScan® BVI 9600 is not intended for fetal use or use on pregnant patients.
The BladderScan® BVI 9600 is not intended for acute events such as aortic dissection, ulcer or rupture.
The Verathon Inc. BladderScan® BVI 9600 Ultrasound System with AortaScan® retains the same bladder volume measurement features of the Verathon inc. BladderScan® BVI 9400 System (K071217). The BVI 9600 is identical to the BVI 9400, with regards to hardware, software, transducer and calibration method.
The Verathon Inc. BladderScan® BVI 9600, with AortaScan®, and its integrated 3.0 MHz mechanical sector transducer operate only in B-mode to locate and automatically measure bladder volume (in BladderScan® Mode) or abdominal aortic diameter (in AortaScan® Mode). The same transducer is driven at 1.74 MHz to obtain a second harmonic for enhanced bladder wall detection. Bladder volume (in BladderScan® Mode), aortic diameter (in AortaScan® Mode), patient gender, non optimal directional aiming, battery status, and usage rate indicators are all displayed on the Verathon Inc. BladderScan® BVI 9600 Ultrasound System scanner. The ultrasonic power transmitted from the system is not user adjustable.
The portable Verathon Inc. BladderScan® BVI 9600 Ultrasound System with AortaScan® is applied to the
Intended Use:
Contraindications (U.S. Only):
Comparison of Required Technological Characteristics:
C.
2
K082456
Pg. 3 of 4
patient's abdomen along with Sontac Ultrasound Coupling Gel to obtain aortic measurement. The BladderScan® BVI 9600 Ultrasound System transducer collects cross- sectional images of the bladder or aorta from twelve (12) scan planes. From this information, the Verathon Inc. BladderScan® BVI 9600 Ultrasound System constructs a finite element model of the bladder (in BladderScan® Mode) or aorta (in AortaScan® Mode) and automatically computes the volume of urine via volumetric integration (for the bladder measurement) or the diameter of the aorta (for aortic measurement), depending on the mode of operation chosen (AortaScan® or BladderScan®).
In order to demonstrate the BladderScan® accuracy claimed in 0270-0422 -xx-55, two third party vendors were contracted to build tissue equivalent phantoms with known dimensions. The supplier of the aortic phantom, Blue Phantom, is known for supplying medical imaging phantoms to the medical marketplace as is the manufacturer of the bladder phantom, Computer Imaging Reference Systems (CIRS).
The AortaScan® phantom is essentially a tube roughly the length of an adult aorta, with a bulge in the length of the tube that represents an aortic aneurism, filled with blood mimicking material that is surrounded by tissue mimicking material. Known diameters of the tube can then be compared to the AortaScan® measurements from the BVI 9600.
The BladderScan® 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 can be compared to the BladderScan® measurements from the BVI 9600.
During the manufacturing processes, both Blue Phantom and CIRS measure key parameters of the physical parts as the parts are constructed. These measurements are all NIST traceable and each phantom comes with a certification sheet listing the measurements.
These results obtained through the Verathon Inc. BladderScan® BVI 9600 Ultrasound System are compared to the expected results derived from the NIST traceable measurements. In addition to these measurements, additional measurements are taken by standard ultrasound systems, such as the Sonosite 180, to compare bladder volume measurements and aortic measurements.
AortaScan® accuracy has been demonstrated by comparing the AortaScan® Phantom measurements to the measurements of the Verathon Inc. BladderScan® BVI 9600 Ultrasound System.
3
K082454
pg. Hof 4
The calibration system for the Verathon Inc. BladderScan® BVI 9600 Ultrasound System with AortaScan® is exactly the same as the Verathon Inc. BladderScan® BVI 9600 Ultrasound System (K071217).
Summary and Conclusion of Non Clinical and Clinical Testing
Design and testing of the Verathon Inc. BladderScan® BVI 9600 Ultrasound System with AortaScan® indicates that the BVI 9600 is substantially equivalent to the Verathon Inc. BladderScan® BVI 9400 Ultrasound System (K071217) for bladder volume measurements and equivalent to the Sonosite MicroMaxx Ultrasound System (K053069)for aorta scan measurements.
All acoustic output measurements for the BladderScan® BVI 9600 Ultrasound System with AortaScan® are not changed from the BladderScan® BVI 9400 Ultrasound System and remain within Pre-amendment limits.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing the world, representing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard A. Zeine Director of Quality and Regulatory Affairs Verathon Incorporated 20001 North Creek Parkway BOTHELL WA 98011
DEC 0 1 2008
Re: K082456
Trade/Device Name: Verathon Inc. BladderScan® BVI 9600 with AortaScan Ultrasound System Regulation Number: 21 CFR 892.1560
Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: October 7, 2008 Received: October 8, 2008
Dear Mr. Zeine:
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® BVI 9600 with AortaScan Ultrasound System, as described in your premarket notification:
Transducer Model Number3.0/1.74 MHz Second 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 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
5
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.
Jorju M. Whay
Joycé M. Whang, Ph.D. 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): K082456
Device Name: Verathon Inc. BladderScan® BVI 9600 with AortaScan® Ultrasound System
Indications for Use:
- Abdomen, B-Mode, per Indications for Use Ultrasound Form
- The Verathon Inc. BladderScan® BVI 9600 with AortaScan® Mode is a user selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorfa for aorlic diameter measurement.
Contraindications:
- The BladderScan® BVI9600 is contraindicated for fetal use and for use on pregnant patients.
The BladderScan® BVI 9600 is not intended for acute events such as aortic dissection, ulcer or rupture.
Prescription Use × (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)
Hondh Whly
(Division S Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
7
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM System: BladderScan® BVI 9600 Ultrasound System 3.0 / 1.74 MHz Second 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 Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (Abdominal Aorta | ||||||||
| Measurement) | N | |||||||
| Peripheral vessel | ||||||||
| Other (Bladder) | P | |||||||
| N= new indication; P= previously cleared by FDA (K071217) | ||||||||
| (Division Sign-Off) | ||||||||
| Division of Reproductive, Abdominal, and | ||||||||
| Radiological Devices |
108245
510(k) Number_