(15 days)
The provided text does not contain any K/DEN numbers under the "Reference Device(s)" section. It explicitly states "Not Found".
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard ultrasound technology and image processing for volume calculation, not advanced AI/ML techniques.
No
The device is described as an ultrasound system used to acquire and display real-time B-mode images of the bladder to calculate bladder volume and wall mass noninvasively, which are diagnostic functions, not therapeutic.
Yes
The device is described as "Diagnostic Ultrasound BladderMass" and its intended use is to obtain an image of the bladder and use that image to calculate bladder volume and bladder wall mass noninvasively. This aligns with the definition of a diagnostic device, as it provides information about a patient's health status.
No
The device description explicitly states it is a "hand-held, battery powered, software controlled ultrasound system" and mentions projecting ultrasound energy, indicating it includes hardware components beyond just software.
Based on the provided information, the BladderMass™ BVM 6500 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- BladderMass BVM 6500 Function: The BladderMass BVM 6500 uses ultrasound energy projected through the lower abdomen to image the bladder and calculate its volume and wall mass. This is a non-invasive procedure performed on the patient's body, not on a sample taken from the body.
The device is a diagnostic ultrasound system, which falls under a different regulatory category than in vitro diagnostics.
N/A
Intended Use / Indications for Use
New device: The BladderMass™ BVM 6500 is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume and bladder wall mass noninvasively. The BladderMass BVM 6500 is contraindicated for fetal use and for use on pregnant patients.
Product codes
90-IYO, 90-ITX
Device Description
The Diagnostic Ultrasound BladderMass BVMTM 6500 Ultrasound System is a hand-held, battery powered, software controlled ultrasound system used to acquire and display real time B-mode images of the bladder. The system is intended to non invasively monitor bladder volume on an intermittent basis. The system is an effective, low cost, simple option for use in a clinical hospital or nursing home setting or for home use under medical supervision.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Bladder
Indicated Patient Age Range
Nonpregnant patient (contraindicated for fetal use and for use on pregnant patients)
Intended User / Care Setting
clinical hospital or nursing home setting or for home use under medical supervision.
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
The BladderMass Phantom is essentially a balloon which gets filled with urine mimicking material and then the filled balloon is surrounded with tissue mimicking material. Both the tissue and urine mimicking material have been used by CIRS for many years in bladder volume phantoms. The balloon is injected molded to have a thickness of approximately 3mm when relaxed, due to the precision of the injection molded process this thickness does not vary by more than +/- 0.25 mm across the surface of the balloon.
Different urine volumes and thus different bladder wall thickness measurements can be made by filling the balloon with different amounts of urine mimicking material. Since the same mold is used for both balloons, the balloon mass will be relatively constant between phantoms while the bladder wall thickness and urine volume can change significantly.
During the manufacturing process, CIRS measures 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 Diagnostic Ultrasound BladderMass BVM™ 6500 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 mass measurements.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All clinical and non clinical testing of the Diagnostic Ultrasound BladderMass BVM™ 6500 Ultrasound System indicate that the Diagnostic Ultrasound BladderMass BVM™ 6500 Ultrasound System is substantially equivalent to the Diagnostic Ultrasound BladderScan™ BVI 6100 Ultrasound System, and all acoustic measurements remain within Preamendment limits.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy has been demonstrated by comparing CIRS measurements to the measurements of the Diagnostic Ultrasound BladderMass BVM™ 6500 Ultrasound System.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR 2 6 2003
SECTION 4.2.14 510(K) SUMMARY
| PREDICATE DEVICE | New DEVICE |
|---|---|
| Diagnostic Ultrasound BladderScan™ | |
| BVI 6100 Ultrasound System | Diagnostic Ultrasound BladderMass™ |
| BVM 6500 Ultrasound System | |
| Predicate: The BladderScan™ BVI 6100 | |
| is intended to project ultrasound energy | |
| through the lower abdomen of the | |
| nonpregnant patient to obtain an image of | |
| the bladder and uses that image to | |
| calculate the bladder volume | |
| noninvasively. The BladderScan BVI | |
| 6100 is contraindicated for fetal use and | |
| for use on pregnant patients. | New device: The BladderMass™ BVM |
| 6500 is intended to project ultrasound | |
| energy through the lower abdomen of the | |
| nonpregnant patient to obtain an image of | |
| the bladder and uses that image to | |
| calculate the bladder volume and bladder | |
| wall mass noninvasively. The | |
| BladderMass BVM 6500 is | |
| contraindicated for fetal use and for use | |
| on pregnant patients. |
1
510(k) Summary
(As required by 21 CFR 807.92(a))
.
| A. | Submitter Information | Compay: Diagnostic Ultrasound
21222 30th Drive SE, Suite 120
Bothell, WA 98041
Phone: 425-867-1348 ext.1667
Fax: 425-883-2896
Email: ngertlar@dxu.com
Contact: Nancy J. Gertlar, RAC
Director, Regulatory Affairs
Date: March 5, 2003 |
|----|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. | Device Information | |
| | Trade/Proprietary Name: | Diagnostic Ultrasound BladderMass BVMTM
6500 Ultrasound System |
| | Common Name: | Diagnostic Ultrasound System with Accessories |
| | Classification Name: | 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: | Diagnostic Ultrasound BladderScan BVI 6100
Ultrasound System, K022153 |
| | Device Description: | The Diagnostic Ultrasound BladderMass BVMTM
6500 Ultrasound System is a hand-held, battery
powered, software controlled ultrasound system
used to acquire and display real time B-mode
images of the bladder. The system is intended to
non invasively monitor bladder volume on an
intermittent basis. The system is an effective, low
cost, simple option for use in a clinical hospital or |
| | | system is an effective, low cost, simple option
for use in a clinical hospital or nursing home
setting or for home use under medical
supervision. |
| | Intended Use: | New device: The BladderMass™ BVM 6500 is
intended to project ultrasound energy through
the lower abdomen of the nonpregnant patient to
obtain an image of the bladder and uses that
image to calculate the bladder volume and
bladder wall mass noninvasively. The
BladderMass 6500 is contraindicated for fetal
use and for use on pregnant patients. |
| C. | Comparison of Required
Technological
Characteristics: | The Diagnostic Ultrasound BladderMass
BVM™ 6500 Ultrasound System and its
integrated 3.7 MHz mechanical sector
transducer operate only in B-mode to locate and
automatically measure bladder volume. Bladder
volume, patient gender, non optimal directional
aiming, battery status, and usage rate indicators
are all displayed on the Diagnostic Ultrasound
BladderMass BVM™ 6500 Ultrasound System
scanner. The ultrasonic power transmitted the
system is not user adjustable.
The hand-held Diagnostic Ultrasound
BladderMass BVM™ 6500 Ultrasound System
is applied to the patient's abdomen with a single
patient use Sontac® hydrogel pad,
manufactured by Diagnostic Ultrasound to
optimize the performance of the Diagnostic
Ultrasound BladderMass BVM™ 6500
Ultrasound System. The transducer collects
cross- sectional images of the bladder from
twenty four (24) scan planes. From this
information, the Diagnostic Ultrasound
BladderMass BVM™ 6500 Ultrasound System
constructs a finite element model of the bladder
and automatically computes the volume of urine
via volumetric integration and the bladder wall
mass.
In order to demonstrate the BladderMass
accuracy claimed in 0270-1238-xx-55, a third
party vendor was contracted to build tissue |
36
:
:
2
、
3
equivalent phantoms with known dimensions. The suppliers, Computerized Imaging Reference Systems (CIRS) is known for supplying medical imaging phantoms to the medical marketplace.
The BladderMass Phantom is essentially a balloon which gets filled with urine mimicking material and then the filled balloon is surrounded with tissue mimicking material. Both the tissue and urine mimicking material have been used by CIRS for many years in bladder volume phantoms. The balloon is injected molded to have a thickness of approximately 3mm when relaxed, due to the precision of the injection molded process this thickness does not vary by more than +/- 0.25 mm across the surface of the balloon.
Different urine volumes and thus different bladder wall thickness measurements can be made by filling the balloon with different amounts of urine mimicking material. Since the same mold is used for both balloons, the balloon mass will be relatively constant between phantoms while the bladder wall thickness and urine volume can change significantly.
During the manufacturing process, CIRS measures 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 Diagnostic Ultrasound BladderMass BVM™ 6500 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 mass measurements.
The traditional method of measuring bladder mass is to use a standard ultrasound system,
4
| | | make random bladder wall measurements, and
calculate the expected bladder wall mass. |
|----|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | The Diagnostic Ultrasound BladderMass
BVM™ 6500 Ultrasound System takes
measurements of the bladder wall and calculates
the bladder wall mass. |
| | | Accuracy has been demonstrated by comparing
CIRS measurements to the measurements of the
Diagnostic Ultrasound BladderMass BVM™
6500 Ultrasound System. |
| | | A Calibration Targeting System, consisting of a
heli-coil shaped calibration target along with a
specially designed container, allows the user to
easily scan a known geometrically shaped
target. Data may be optically transmitted to a
remote location when connected to the
clinician's personal computer via a
communication cradle. Connection to this
communication cradle allows for battery
charging, remote calibration, usage monitoring,
software updates, and data transfer through a
web-based interface, referenced as
"ScanPoint™". The Diagnostic Ultrasound
BladderMass BVM™ 6500 Ultrasound System
also includes a universal charger cradle for the
non replaceable lithium ion battery incorporated
into the hand held instrument. |
| D. | Summary and Conclusion
of Non Clinical and | All clinical and non clinical testing of the
Diagnostic Ultrasound BladderMass BVM™ |
| | Clinical Testing | 6500 Ultrasound System indicate that the
Diagnostic Ultrasound BladderMass BVM™
6500 Ultrasound System is substantially
equivalent to the Diagnostic Ultrasound
BladderScan™ BVI 6100 Ultrasound System,
and all acoustic measurements remain within
Preamendment limits. |
·
5
Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Diagnostic Ultrasound Corporation % Mr. Heinz Joerg Steneberg Responsible Third Party TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
MAR 2 6 2003
Re: K030763 Trade/Device Name: Diagnostic Ultrasound BladderMass BVM 6500 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic trensducer Regulatory Class: II Product Code: 90 IYO and ITX Dated: March 7, 2003 Received: March 11, 2003
Dear Mr.Steneberg:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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.
6
This letter will allow you to begin marketing your device as described in your Section 510(k) 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 the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM System: BladderMass™ BVM 6500 Ultrasound System
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I | ||||||||
| only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Ophthalmic | |||||||
| 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 (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; P= previously cleared by FDA (K022153)
Prescription Use (Per 21 CFR 801.109)
David A. Bergman
(Division Sign-Off Division of Reproductive, A 000045 and Radiological Devi 510(k) Number