PALM BLADDER SCANNER

K130229 · Mianyang Meike Electronic Equipment Co., Ltd. · IYO · Mar 20, 2013 · Radiology

Device Facts

• Record ID: K130229
• Device Name: PALM BLADDER SCANNER
• Applicant: Mianyang Meike Electronic Equipment Co., Ltd.
• Product Code: IYO · Radiology
• Decision Date: Mar 20, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Palm Bladder Scanner-PBSV 4.1 is a portable diagnostic ultrasound system for non-invasive bladder volume measurement. Device utilizes a 2.6MHz mechanical sector scan probe to project ultrasound energy through the lower abdomen. Echo signals are transmitted to an embedded computer system for image processing, edge identification, and volume calculation. Results are displayed on a color LCD and can be printed via a built-in printer. Operated by healthcare professionals in clinical settings. Provides rapid bladder volume assessment to assist in clinical decision-making regarding urinary retention or post-void residual volume. Benefits include non-invasive monitoring, reducing need for catheterization.

Clinical Evidence

No clinical tests were included. Safety and effectiveness were established through non-clinical bench testing, including biocompatibility (ISO 10993-5, ISO 10993-10), electromagnetic compatibility (IEC 60601-1-2), and ultrasound-specific safety standards (IEC 62359, IEC 60601-2-37).

Technological Characteristics

2.6MHz mechanical sector scan transducer (SD2-001). Power source: 7.4v Li-Ion rechargeable battery. Display: Color LCD. Operating conditions: +5°C to +40°C, humidity ≤70%, 700-1060hPa. Compliance with IEC 60601-1-2, IEC 62359, and IEC 60601-2-37. Biocompatibility per ISO 10993-5 and 10993-10.

Indications for Use

Indicated for non-pregnant adult and pediatric patients for non-invasive bladder imaging and volume calculation via lower abdominal ultrasound. Contraindicated for fetal use, pregnant patients, patients with abdominal wounds or skin diseases, and patients allergic to coupling agents.

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

• Verathon BladderScan BVI 9400 Ultrasound System (K071217)

Submission Summary (Full Text)

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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: [phone]
- · Fax: [phone]
- E-mail: [e-mail]
- · 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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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 | <3 seconds |
| | Penetration Depth | ≥140mm | ≥150mm |
| Range of Measurement | | 0-999ml | Adult: 0-999ml<br>Small Child: 0-200ml |
| Accuracy | | • ± 25% (60ml≤ volume ≤150ml)<br>• ± 15% (150ml≤volume ≤999ml) | ±15%, ±15ml |

## 5.3 Comparison of Required Technology Characteristics:

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| | | Mianyang Meike Electronic Equipment Co., Ltd. | |
|-----------------------|------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Power Supply | | 7.4v Li Ion Rechargeable | 11.1v Li Ion Rechargeable |
| Screen Display | | Color LCD | Color LCD |
| Operation Condition | | •Temperature: +5°C~+<br>40°C<br>• Humidity Rate: ≤70%<br>•Atmospheric Pressure:<br>700hPa~1060hPa | •Temperature: +10°C~+40°C<br>• Humidity Rate: 30%~75%<br>•Atmospheric Pressure:<br>700hPa~1060hPa |
| Acoustic | Maximum MI | 0.89 | 0.95 |
| Output<br>Maximum TIS | | 0.98 | 4.0 |
| Target Population | | Adult and Children | Adult and Children |
| Anatomical Sites | | Abdomen | Abdomen |

The PBSV4.1 incorporates the same fundamental technologies, such as the mode of operation, transducer type, anatomical sites and range of measurement, with the predicate device. Then though the subject device and the predicate device differ in the specific transducer specification and acoustic output parameters, such differences will not influence the major function of the subject device and cause safety and effectiveness concerns. Besides, the subject device has been tested as Track 3 Device per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued on September 9, 2008 and its acoustic output are within the Pre-amendment limit.

#### 5.4 Discussion of Tests Performed

- · Clinical Tests:
No clinical tests were included.

- · 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)

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- 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)

## 5.5 Conclusion

From the above comparison table and relative tests that have been conducted, it is reasonable to conclude that the subject device - PBS V 4.1 is as safe and effective as the predicate device - BVI 9400, that they are substantially equivalent.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, at the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 20, 2013

Mianyang Meike Electronic Equipment Co., Ltd. % Ms. Helen Nan General Manager . Wenzhou Cytech Information Service Co., Ltd. Room 404, Bldg 7, Jinhuichang Homeland. Liuhonggiao Road Wenzhou City, Zhejiang Province, 325000 CHINA

Re: K130229

Trade/Device Name: PBSV4.1 Palm Bladder Scanner Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Codes: IYO, ITX Dated: January 10, 2013 Received: February 12, 2013

Dear Ms. Nan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

This determination of substantial equivalence applies to the following transducers intended for use with the PBSV4.1 Palm Bladder Scanner, as described in your premarket notification:

Transducer Model Number

SD2-001

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Section 4 Indications for Use Statement

510(k) Number (if known): Device Name: PBSV4.1 Palm Bladder Scanner

#### Indications for Use:

· Abdomen, B-Mode, per Indications for Use Ultrasound Form

· 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.

### Contradictions:

· PBSV4.1 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.

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 OF NEEDED)

Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR)

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(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health K130229 510(k)

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# DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM 1

System: PBSV 4.1 Palm Bladder Scanner

Transducer: 2.6MHz High-Frequency Focused Transducer – SD2-001

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|------------------------------|------------------------------|-------------------|---|-----|-----|------------------|-----------------------|-------------------------|
| General<br>(Track 1<br>Only) | Specific<br>(Track 1&3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify<br>) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative<br>(Specify) | | | | | | | |
| | Intra-Operative<br>(Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>&Other | Pediatric | | | | | | | |
| | Small Organ<br>(Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.<br>(non-Card) | | | | | | | |

2

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| Mianyang Meike Electronic Equipment Co., Ltd. | | | | | | |
|-----------------------------------------------|-------------------------------------|---|--|--|--|--|
| | Musculo-skeletal<br>(Conventional) | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | |
| | Intravascular | | | | | |
| | Other(Specify) | | | | | |
| | Cardiac Adult | | | | | |
| | Cardiac Pediatric | | | | | |
| | Intravascular<br>(Cardiac) | | | | | |
| Cardiac | Trans-epoph.<br>(Cardiac) | | | | | |
| | Intra-cardiac | | | | | |
| | Other(Specify) | | | | | |
| Peripheral<br>vessel | Peripheral vessel<br>Other(Bladder) | P | | | | |

N=new indication; P=previously cleared by FDA (K071217);

E=added under this appendix

*Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging,

Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

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美科
Meike ®

## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM 2

System: PBSV4.1 Palm Bladder Scanner

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|------------------------------|------------------------------|-------------------|---|-----|-----|------------------|-----------------------|-------------------------|
| General<br>(Track 1<br>Only) | Specific<br>(Track 1&3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify<br>) |
| | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>&Other | Fetal | | | | | | | |
| | Abdominal | P | | | | | | |
| | Intra-operative<br>(Specify) | | | | | | | |
| | Intra-Operative<br>(Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ<br>(Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.<br>(non-Card) | | | | | | | |
| | Musculo-skeletal | | | | | | | |

4

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| | Mianyang Meike Electronic Equipment Co., Ltd. | | | | |
|----------------------|-----------------------------------------------|--|--|--|--|
| Cardiac | (Conventional) | | | | |
| | Musculo-skeletal | | | | |
| | (Superficial) | | | | |
| | Intravascular | | | | |
| | Other(Specify) | | | | |
| | Cardiac Adult | | | | |
| | Cardiac Pediatric | | | | |
| | Intravascular | | | | |
| | (Cardiac) | | | | |
| | Trans-epoph. | | | | |
| | (Cardiac) | | | | |
| | Intra-cardiac | | | | |
| | Other(Specify) | | | | |
| Peripheral<br>vessel | Peripheral vessel | | | | |
| | Other | | | | |

N=new indication; P=previously cleared by FDA (K071217);

E=added under this appendix

*Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging,

Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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(Division Sign Off) Division of Radiological Health Office of In I'itro Diagnostic and Radiological Health K130229 210(k)