(50 days)
Not Found
No
The description mentions "computer identifies the edge of image and volume calculation" which is standard image processing, not necessarily AI/ML. There is no mention of AI, ML, deep learning, neural networks, or any related terms. The performance studies listed are standard safety and performance tests, not studies evaluating AI/ML performance.
No
The device is described as a diagnostic tool used to measure bladder volume, not to provide therapy or treatment.
Yes
The device is described as "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 non-invasively." The calculation of bladder volume provides information about a patient's condition, which aligns with the definition of a diagnostic device. Furthermore, performance studies mention tests for "medical diagnostic ultrasonic fields" and "ultrasonic medical diagnostic and monitoring equipment," explicitly indicating its diagnostic purpose.
No
The device description explicitly states it consists of "host and probe," indicating it includes hardware components beyond just software.
No, this device 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.
- Device Function: The PBSV4.1 bladder scanner uses ultrasound energy applied externally to the body to image the bladder and calculate its volume. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it "project[s] ultrasound energy through the lower abdomen... to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively." This is an external imaging and measurement process.
- Device Description: The description reinforces this by explaining it uses "B-mode ultrasound technology" and "scan of probe connected with the device" to detect signals and process images.
The device is a medical imaging device, specifically an ultrasound system, used for non-invasive measurement of bladder volume. It does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
PBSV4.1 bladder scanner 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 non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease.
Product codes
IYO,ITX
Device Description
Palm bladder scanner is a medical device with high performance combined with modern B-mode ultrasound technology and computer technology. The device consists of host and probe, it can speedily complete the detection of bladder area through scan of probe connected with the device, and transmit B ultrasound echo signal detected to embedded computer system after processing before computer identifies the edge of image and volume calculation, realizes the measurement of bladder volume, displays and prints out the relative information through LED/built-in printer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
B-Mode
Anatomical Site
Abdomen
Indicated Patient Age Range
Adult and Children
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)
Non-clinical Tests:
The subject device was tested to evaluate its safety and effectiveness, including the followings:
a. AAMI/ANSI/ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity. (Biocompatibility)
b. AAMI/ANSI/ISO 10993-10:2010, Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization. (Biocompatibility)
c. AAMI/ANSI/IEC 60601-1-2:2007. Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-collateral standard: Electromagnetic compatibility-Requirements and tests (Edition 3). (General)
d. IEC 62359 Edition 2.0 2010-10-10, Ultrasonics- Field characterization Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields. (Radiology)
e. IEC 60601-2-37 Edition 2.0 2007-08, Medical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. (Radiology)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy:
• ± 25% (60ml≤ volume ≤150ml)
• ± 15% (150ml≤volume ≤999ml)
Predicate Device(s)
Verathon BladderScan® BVI 9400 Ultrasound System (K071217)
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
美科
Meike ®
MAR 20 201
Section 5 510(k) Summary
5.1 Submitter Information
- · Company: Mianyang Meike Electronic Equipment Co.,Ltd.
- · Address: No.238, Middle Section of Chuanye Road, Kechuang-yuan Zone,
Mianyang City, Sichuan Province, South-West of China
- Phone: 086-816-6355076
- · Fax: 086-816-6355070
- E-mail: whkItzlb@163.com
- · Contact: Wenjun Zhao, General Manager
- Date: November 20, 2012
5.2 Device Information
- · Trade/Proprietary Name: Palm Bladder Scanner-PBSV 4.1
- · Common Name: Diagnostic Ultrasound System with Accessories
- · Classification Name(s): Device Class: 2
Review Panel: Radiology
Ultrasonic Pulsed Echo Imaging System
- · Regulation Number 892.1560
- Product Code: IYO
Diagnostic Ultrasound Transducer
- · Regulation Number 892.1570
- Product Code: ITX
· Predicate Device: Verathon BladderScan® BVI 9400 Ultrasound System (K071217)
· Device Description
Palm bladder scanner is a medical device with high performance combined with modern B-mode ultrasound technology and computer technology. The device consists of host and probe, it can
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Image /page/1/Picture/0 description: The image shows the word "Meike" in English and Chinese. The Chinese characters are above the English word. There is a registered trademark symbol to the right of the English word.
speedily complete the detection of bladder area through scan of probe connected with the device, and transmit B ultrasound echo signal detected to embedded computer system after processing before computer identifies the edge of image and volume calculation, realizes the measurement of bladder volume, displays and prints out the relative information through LED/built-in printer.
• Intended Use:
New Device: PBSV4.1 bladder scanner 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 non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease.
| Item | Subject Device | Predicate Device | |
|---|---|---|---|
| PBSV4.1 | BV1 9400 (K071217) | ||
| Mode of Operation | B | B | |
| Transducer Characteristics | Type | 2.6MHz Mechanical | 3.0MHz and 1.74 MHz |
| Sector Scan | Mechanical Sector Scan | ||
| Time from 3D Scan Initiation to Result Display | 4 seconds |