(15 days)
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.
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.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The document primarily focuses on demonstrating substantial equivalence to a predicate device (BladderScan™ BVI 6100) and proving the accuracy of the new "bladder wall mass" measurement. The core of the acceptance criteria for this new feature is explicitly stated as accuracy when compared to known dimensions of phantoms.
| Acceptance Criteria (Implicit for Bladder Wall Mass) | Reported Device Performance |
|---|---|
| Accuracy of BladderMass BVM™ 6500 in measuring bladder wall mass compared to known dimensions (as claimed in 0270-1238-xx-55, though specific values are not provided in this extract). | The BladderMass BVM™ 6500 Ultrasound System's measurements of bladder wall mass were compared to "expected results derived from the NIST traceable measurements" of tissue-equivalent phantoms. Additionally, these measurements were compared with those obtained from "standard ultrasound systems, such as the Sonosite 180." The overall conclusion states: "Accuracy has been demonstrated by comparing CIRS measurements to the measurements of the Diagnostic Ultrasound BladderMass BVM™ 6500 Ultrasound System." While specific numerical performance (e.g., mean absolute error, percentage deviation) is not provided in this summary, the statement "Accuracy has been demonstrated" indicates that it met the (unspecified) acceptance threshold for this new functionality. |
| Substantial Equivalence to Predicate Device (Diagnostic Ultrasound BladderScan™ BVI 6100) for bladder volume and imaging. | "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." This implies that the device met the performance and safety characteristics of the predicate for its shared intended uses. |
Study Information
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of phantoms. The study used "different urine volumes and thus different bladder wall thickness measurements" created by filling balloons with varying amounts of urine mimicking material.
- Data Provenance: The test set data was generated in a controlled laboratory setting using "tissue equivalent phantoms with known dimensions" built by a third-party vendor, Computerized Imaging Reference Systems (CIRS), which is stated to be known for supplying medical imaging phantoms. This is a prospective method using manufactured phantoms, not human data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The ground truth was established by NIST traceable measurements of the physical phantoms themselves. No human experts were involved in defining the ground truth for this specific test.
- Qualifications of Experts: Not applicable.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The ground truth was based on physical measurements of the phantoms, not human interpretations requiring adjudication. The device's measurements were then compared directly to these known physical measurements.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. The study described focuses on the standalone performance of the device's bladder wall mass measurement capability against phantoms. No human readers or AI assistance for human readers are mentioned.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes. The described study is a standalone performance evaluation. The device (BladderMass BVM™ 6500) automatically computes the bladder volume and bladder wall mass. Its measurements are then compared directly to the known "ground truth" of the phantoms.
- The text explicitly states: "The Diagnostic Ultrasound BladderMass BVM™ 6500 Ultrasound System takes measurements of the bladder wall and calculates the bladder wall mass." This confirms a standalone algorithm performance evaluation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used was physical measurements of high-precision, NIST-traceable phantoms. These phantoms were designed to mimic the bladder and surrounding tissue, with exact dimensions known from the manufacturing process.
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The sample size for the training set:
- Not specified. The document does not provide details about a training set for the algorithm, only the testing methodology. As the device was approved in 2003, it's possible its algorithms were based on more traditional signal processing and image analysis techniques rather than machine learning requiring large, dedicated training datasets as understood today.
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How the ground truth for the training set was established:
- Not specified, as no training set details are provided in this summary.
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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 6100is intended to project ultrasound energythrough the lower abdomen of thenonpregnant patient to obtain an image ofthe bladder and uses that image tocalculate the bladder volumenoninvasively. The BladderScan BVI6100 is contraindicated for fetal use andfor use on pregnant patients. | New device: The BladderMass™ BVM6500 is intended to project ultrasoundenergy through the lower abdomen of thenonpregnant patient to obtain an image ofthe bladder and uses that image tocalculate the bladder volume and bladderwall mass noninvasively. TheBladderMass BVM 6500 iscontraindicated for fetal use and for useon pregnant patients. |
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510(k) Summary
(As required by 21 CFR 807.92(a))
.
| A. | Submitter Information | Compay: Diagnostic Ultrasound21222 30th Drive SE, Suite 120Bothell, WA 98041Phone: 425-867-1348 ext.1667Fax: 425-883-2896Email: ngertlar@dxu.comContact: Nancy J. Gertlar, RACDirector, Regulatory AffairsDate: March 5, 2003 |
|---|---|---|
| B. | Device Information | |
| Trade/Proprietary Name: | Diagnostic Ultrasound BladderMass BVMTM6500 Ultrasound System | |
| Common Name: | Diagnostic Ultrasound System with Accessories | |
| Classification Name: | Regulatory Class: IIReview Category: Tier IIClassification Panel: RadiologyUltrasonic Pulsed Echo Imaging System• FR Classification 892.1560• Product Code 90-IYODiagnostic Ultrasound Transducer• FR Classification 892.1570• Product Code 90-ITX | |
| Predicate Device: | Diagnostic Ultrasound BladderScan BVI 6100Ultrasound System, K022153 | |
| Device Description: | The Diagnostic Ultrasound BladderMass BVMTM6500 Ultrasound System is a hand-held, batterypowered, software controlled ultrasound systemused to acquire and display real time B-modeimages of the bladder. The system is intended tonon invasively monitor bladder volume on anintermittent basis. The system is an effective, lowcost, simple option for use in a clinical hospital or | |
| system is an effective, low cost, simple optionfor use in a clinical hospital or nursing homesetting or for home use under medicalsupervision. | ||
| Intended Use: | New device: The BladderMass™ BVM 6500 isintended to project ultrasound energy throughthe lower abdomen of the nonpregnant patient toobtain an image of the bladder and uses thatimage to calculate the bladder volume andbladder wall mass noninvasively. TheBladderMass 6500 is contraindicated for fetaluse and for use on pregnant patients. | |
| C. | Comparison of RequiredTechnologicalCharacteristics: | The Diagnostic Ultrasound BladderMassBVM™ 6500 Ultrasound System and itsintegrated 3.7 MHz mechanical sectortransducer operate only in B-mode to locate andautomatically measure bladder volume. Bladdervolume, patient gender, non optimal directionalaiming, battery status, and usage rate indicatorsare all displayed on the Diagnostic UltrasoundBladderMass BVM™ 6500 Ultrasound Systemscanner. The ultrasonic power transmitted thesystem is not user adjustable.The hand-held Diagnostic UltrasoundBladderMass BVM™ 6500 Ultrasound Systemis applied to the patient's abdomen with a singlepatient use Sontac® hydrogel pad,manufactured by Diagnostic Ultrasound tooptimize the performance of the DiagnosticUltrasound BladderMass BVM™ 6500Ultrasound System. The transducer collectscross- sectional images of the bladder fromtwenty four (24) scan planes. From thisinformation, the Diagnostic UltrasoundBladderMass BVM™ 6500 Ultrasound Systemconstructs a finite element model of the bladderand automatically computes the volume of urinevia volumetric integration and the bladder wallmass.In order to demonstrate the BladderMassaccuracy claimed in 0270-1238-xx-55, a thirdparty 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, andcalculate the expected bladder wall mass. | ||
|---|---|---|
| The Diagnostic Ultrasound BladderMassBVM™ 6500 Ultrasound System takesmeasurements of the bladder wall and calculatesthe bladder wall mass. | ||
| Accuracy has been demonstrated by comparingCIRS measurements to the measurements of theDiagnostic Ultrasound BladderMass BVM™6500 Ultrasound System. | ||
| A Calibration Targeting System, consisting of aheli-coil shaped calibration target along with aspecially designed container, allows the user toeasily scan a known geometrically shapedtarget. Data may be optically transmitted to aremote location when connected to theclinician's personal computer via acommunication cradle. Connection to thiscommunication cradle allows for batterycharging, remote calibration, usage monitoring,software updates, and data transfer through aweb-based interface, referenced as"ScanPoint™". The Diagnostic UltrasoundBladderMass BVM™ 6500 Ultrasound Systemalso includes a universal charger cradle for thenon replaceable lithium ion battery incorporatedinto the hand held instrument. | ||
| D. | Summary and Conclusionof Non Clinical and | All clinical and non clinical testing of theDiagnostic Ultrasound BladderMass BVM™ |
| Clinical Testing | 6500 Ultrasound System indicate that theDiagnostic Ultrasound BladderMass BVM™6500 Ultrasound System is substantiallyequivalent to the Diagnostic UltrasoundBladderScan™ BVI 6100 Ultrasound System,and all acoustic measurements remain withinPreamendment 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(Track Ionly) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) |
| FetalImaging& Other | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | P | |||||||
| Intra-operative(Abdominal organs andvascular) | ||||||||
| 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.) | ||||||||
| PeripheralVessel | 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
§ 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.