DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM
Device Facts
| Record ID | K030763 |
|---|---|
| Device Name | DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM |
| Applicant | Diagnostic Ultrasound Corp. |
| Product Code | IYO · Radiology |
| Decision Date | Mar 26, 2003 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Indications for Use
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.
Device Story
Hand-held, battery-powered ultrasound system; acquires real-time B-mode images of bladder via 3.7 MHz mechanical sector transducer. Applied to abdomen using hydrogel pad. Collects cross-sectional images from 24 scan planes; constructs finite element model of bladder; automatically computes urine volume via volumetric integration and bladder wall mass. Used in clinical, hospital, nursing home, or home settings under medical supervision. Data transferable via communication cradle to PC for remote calibration, usage monitoring, and software updates via ScanPoint™ web-based interface. Assists clinicians in monitoring bladder health; provides noninvasive alternative to traditional ultrasound bladder wall measurement methods.
Clinical Evidence
Bench testing only. Accuracy of bladder wall mass measurement demonstrated by comparing device output to NIST-traceable measurements from tissue-equivalent phantoms. Additional validation performed by comparing results against measurements taken by standard ultrasound systems (e.g., Sonosite 180).
Technological Characteristics
Hand-held ultrasound system; 3.7 MHz mechanical sector transducer; B-mode operation only. Non-adjustable ultrasonic power. Powered by non-replaceable lithium-ion battery. Connectivity via communication cradle to PC (ScanPoint™ web interface). Single-patient use hydrogel pad. Software-controlled volumetric integration and finite element modeling.
Indications for Use
Indicated for nonpregnant patients requiring noninvasive bladder volume and bladder wall mass monitoring. Contraindicated for fetal use and pregnant patients.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Diagnostic Ultrasound BladderScan™ BVI 6100 Ultrasound System (K022153)
Reference Devices
- Sonosite 180
Submission Summary (Full Text)
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K030763
MAR 2 6 2003
## SECTION 4.2.14 510(K) SUMMARY
| PREDICATE DEVICE | New DEVICE |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Diagnostic Ultrasound BladderScan™<br>BVI 6100 Ultrasound System | Diagnostic Ultrasound BladderMass™<br>BVM 6500 Ultrasound System |
| Predicate: The BladderScan™ BVI 6100<br>is intended to project ultrasound energy<br>through the lower abdomen of the<br>nonpregnant patient to obtain an image of<br>the bladder and uses that image to<br>calculate the bladder volume<br>noninvasively. The BladderScan BVI<br>6100 is contraindicated for fetal use and<br>for use on pregnant patients. | New device: The BladderMass™ BVM<br>6500 is intended to project ultrasound<br>energy through the lower abdomen of the<br>nonpregnant patient to obtain an image of<br>the bladder and uses that image to<br>calculate the bladder volume and bladder<br>wall mass noninvasively. The<br>BladderMass BVM 6500 is<br>contraindicated for fetal use and for use<br>on pregnant patients. |
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## 510(k) Summary
(As required by 21 CFR 807.92(a))
.
| A. | Submitter Information | Compay: Diagnostic Ultrasound<br>21222 30th Drive SE, Suite 120<br>Bothell, WA 98041<br>Phone: 425-867-1348 ext.1667<br>Fax: 425-883-2896<br>Email: ngertlar@dxu.com<br>Contact: Nancy J. Gertlar, RAC<br>Director, Regulatory Affairs<br>Date: March 5, 2003 |
|----|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. | Device Information | |
| | Trade/Proprietary Name: | Diagnostic Ultrasound BladderMass BVMTM<br>6500 Ultrasound System |
| | Common Name: | Diagnostic Ultrasound System with Accessories |
| | Classification Name: | Regulatory Class: II<br>Review Category: Tier II<br>Classification Panel: Radiology<br>Ultrasonic Pulsed Echo Imaging System<br>• FR Classification 892.1560<br>• Product Code 90-IYO<br>Diagnostic Ultrasound Transducer<br>• FR Classification 892.1570<br>• Product Code 90-ITX |
| | Predicate Device: | Diagnostic Ultrasound BladderScan BVI 6100<br>Ultrasound System, K022153 |
| | Device Description: | The Diagnostic Ultrasound BladderMass BVMTM<br>6500 Ultrasound System is a hand-held, battery<br>powered, software controlled ultrasound system<br>used to acquire and display real time B-mode<br>images of the bladder. The system is intended to<br>non invasively monitor bladder volume on an<br>intermittent basis. The system is an effective, low<br>cost, simple option for use in a clinical hospital or |
| | | system is an effective, low cost, simple option<br>for use in a clinical hospital or nursing home<br>setting or for home use under medical<br>supervision. |
| | Intended Use: | New device: The BladderMass™ BVM 6500 is<br>intended to project ultrasound energy through<br>the lower abdomen of the nonpregnant patient to<br>obtain an image of the bladder and uses that<br>image to calculate the bladder volume and<br>bladder wall mass noninvasively. The<br>BladderMass 6500 is contraindicated for fetal<br>use and for use on pregnant patients. |
| C. | Comparison of Required<br>Technological<br>Characteristics: | The Diagnostic Ultrasound BladderMass<br>BVM™ 6500 Ultrasound System and its<br>integrated 3.7 MHz mechanical sector<br>transducer operate only in B-mode to locate and<br>automatically measure bladder volume. Bladder<br>volume, patient gender, non optimal directional<br>aiming, battery status, and usage rate indicators<br>are all displayed on the Diagnostic Ultrasound<br>BladderMass BVM™ 6500 Ultrasound System<br>scanner. The ultrasonic power transmitted the<br>system is not user adjustable.<br><br>The hand-held Diagnostic Ultrasound<br>BladderMass BVM™ 6500 Ultrasound System<br>is applied to the patient's abdomen with a single<br>patient use Sontac® hydrogel pad,<br>manufactured by Diagnostic Ultrasound to<br>optimize the performance of the Diagnostic<br>Ultrasound BladderMass BVM™ 6500<br>Ultrasound System. The transducer collects<br>cross- sectional images of the bladder from<br>twenty four (24) scan planes. From this<br>information, the Diagnostic Ultrasound<br>BladderMass BVM™ 6500 Ultrasound System<br>constructs a finite element model of the bladder<br>and automatically computes the volume of urine<br>via volumetric integration and the bladder wall<br>mass.<br><br>In order to demonstrate the BladderMass<br>accuracy claimed in 0270-1238-xx-55, a third<br>party vendor was contracted to build tissue |
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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,
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| | | make random bladder wall measurements, and<br>calculate the expected bladder wall mass. |
|----|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | The Diagnostic Ultrasound BladderMass<br>BVM™ 6500 Ultrasound System takes<br>measurements of the bladder wall and calculates<br>the bladder wall mass. |
| | | Accuracy has been demonstrated by comparing<br>CIRS measurements to the measurements of the<br>Diagnostic Ultrasound BladderMass BVM™<br>6500 Ultrasound System. |
| | | A Calibration Targeting System, consisting of a<br>heli-coil shaped calibration target along with a<br>specially designed container, allows the user to<br>easily scan a known geometrically shaped<br>target. Data may be optically transmitted to a<br>remote location when connected to the<br>clinician's personal computer via a<br>communication cradle. Connection to this<br>communication cradle allows for battery<br>charging, remote calibration, usage monitoring,<br>software updates, and data transfer through a<br>web-based interface, referenced as<br>"ScanPoint™". The Diagnostic Ultrasound<br>BladderMass BVM™ 6500 Ultrasound System<br>also includes a universal charger cradle for the<br>non replaceable lithium ion battery incorporated<br>into the hand held instrument. |
| D. | Summary and Conclusion<br>of Non Clinical and | All clinical and non clinical testing of the<br>Diagnostic Ultrasound BladderMass BVM™ |
| | Clinical Testing | 6500 Ultrasound System indicate that the<br>Diagnostic Ultrasound BladderMass BVM™<br>6500 Ultrasound System is substantially<br>equivalent to the Diagnostic Ultrasound<br>BladderScan™ BVI 6100 Ultrasound System,<br>and all acoustic measurements remain within<br>Preamendment limits. |
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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.
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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
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## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM System: BladderMass™ BVM 6500 Ultrasound System
| Clinical Application | | Mode of Operation | | | | | | |
|------------------------------|-------------------------------------------------------|-------------------|---|-----|-----|------------------|---------------------|------------------|
| General<br>(Track I<br>only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Fetal<br>Imaging<br>& Other | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | P | | | | | | |
| | Intra-operative<br>(Abdominal organs and<br>vascular) | | | | | | | |
| | Intra-operative (Neuro.)<br>Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (breast,<br>thyroid, testicles) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | |
| | Musculo-skel.<br>(Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>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
