(238 days)
Not Found
No
The device description details a volume integral algorithm based on ultrasonic distance measurements and mechanical sector scans, with no mention of AI or ML techniques.
No.
The device's stated intended use is to "measure the urine volume in human bladder," which is a diagnostic function, not a therapeutic one. It does not treat or prevent disease.
Yes
The device measures urine volume in the human bladder, providing quantitative information that can be used by trained professionals in medical settings to assess a patient's condition, which aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a "hand-held device which utilizes ultrasonic distance measuring principle" and "takes mechanical sector scan by 2.5MHz ultrasonic waves," indicating it includes hardware components for ultrasonic scanning.
Based on the provided information, the MD-6000P Bladder Scanner is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- MD-6000P Function: The MD-6000P Bladder Scanner uses ultrasound to directly measure the volume of urine within the human bladder. It does not analyze a specimen taken from the body.
Therefore, the MD-6000P Bladder Scanner falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MD-6000P Bladder Scanner is intended to measure the urine volume in human bladder.
The device is intended to be used in medical and nursing care institutions. It should be operated by trained professionals. The device is not intended for use on pregnant women. It cannot be used on wounded skin.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Other (Bladder)
Product codes
IYO, ITX
Device Description
MD-6000P Bladder Scanner is a hand-held device which utilizes ultrasonic distance measuring principle to calculate urine volume in the bladder.
The device takes mechanical sector scan by 2.5MHz ultrasonic waves and recognizes the reflected waves of the front and back walls of bladder to get the area of bladder section; then it makes 12 scans at an interval of 15° and calculates the urine volume in human bladder with volume integral algorithm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic
Anatomical Site
human bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical and nursing care institutions. It should be operated by trained professionals.
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
Bench Testing:
Measurement accuracy of ±15% or ±15ml within the measurement range of 20-999ml
For the measurement range of 100-999ml, use MD-6000P Bladder Scanner to make scan on the phantom and compare the measurement value and the nominal value, the measurement accuracy met the requirements of ±15%.
For the measurement range of 20-100ml, use MD-6000P Bladder Scanner to make scan on the test object of water sac with known volume, the measurement accuracy met the requirements of ±15ml.
Clinical Testing:
The MD-6000P Bladder Scanner, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.
Key Metrics
Accuracy: ±15% or ±15ml (take the maximum value)
Measuring Range: 20ml - 999ml
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
MEDA Co., Ltd. % Kai Chen President Meditech International, Inc. (United States Designated Agent of MEDA Co., Ltd) 13505 Broadfield Drive POTOMAC MD 20854
Re: K182460
Trade/Device Name: MD-6000P Bladder Scanner Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO, ITX Dated: April 8, 2019 Received: April 10, 2019
Dear Kai Chen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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 of medical device-related adverse events) (21 CFR 803) for
May 6, 2019
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182460
Device Name MD-6000P Bladder Scanner
Indications for Use (Describe)
MD-6000P Bladder Scanner is intended to measure the urine volume in human bladder.
The device is intended to be used in medical and nursing care institutions. It should be operated by trained professionals. The device is not intended for use on pregnant women. It cannot be used on wounded skin.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Submission of MEDA. CO., LTD
Diagnostic Ultrasound Indications for Use Format
System: MD-6000P Bladder Scanner
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Fetal Imaging | ||||||||
| & Other | Small Organ (Specify) | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Bladder) | P | |||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; 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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510(k) SUMMARY
Submitter Information 1.
| Name: | MEDA Co., Ltd. | ||||
|---|---|---|---|---|---|
| Address: | F2C, F3D, F4C, F5, F6C, Building C2, Xinmao Science Skill Park, | ||||
| Huayuan Industry Development Area, Tianjin 300384, P. R. China | |||||
| Phone: | +86-22-83713808 | ||||
| Fax: | +86-22-83713880 | ||||
| Contact person: | |||||
| Medtech International, Inc. and | |||||
| United States Designated Agent of MEDA Co., Ltd. | |||||
| Address: 13505 Broadfield Drive, Potomac, MD 20854 | |||||
| Tel: 240 888 4001 | |||||
| Fax: 301 251 2881 | |||||
| Email: Drkaichen@gmail.com |
Date Prepared: August 15, 2018
2. Device Information
Trade Name/Common Name: MD-6000P Bladder Scanner
| | Classification Name: Ultrasonic Pulsed Echo Imaging System (IYO)
Diagnostic Ultrasound Transducer (ITX) |
|--------------------|---------------------------------------------------------------------------------------------------------------|
| Regulatory Class: | Class II |
| Regulation Number: | 892.1560; 892.1570 |
| Product Code: | IYO; ITX |
3. Predicate Devices
Manufacturer: MEDA CO., LTD
Device Name: MD-6000 Bladder Scanner
510(k) Number: K113304
4. Device Description
MD-6000P Bladder Scanner is a hand-held device which utilizes ultrasonic distance measuring principle to calculate urine volume in the bladder.
The device takes mechanical sector scan by 2.5MHz ultrasonic waves and recognizes the reflected waves of the front and back walls of bladder to get the area of bladder section; then it makes 12 scans at an interval of 15° and calculates the urine volume in human bladder with volume integral algorithm.
5. Indications for Use
MD-6000P Bladder Scanner is intended to measure the urine volume in human bladder.
5
The device is intended to be used in medical and nursing care institutions. It should be operated by trained professionals.
The device is not intended for use on pregnant women. It cannot be used on wounded skin.
Comparison of Technological Characteristics 6.
The subject and the predicate devices are based on the following same technological elements:
- Intended use: measure the urine volume in human bladder
- Mode of operation: B-mode
- Transducer type: mechanical sector probe
- Nominal ultrasound frequency: 2.5MHz
- Total number of elements: Single element
- Volume display resolution: 1ml
- Number of sections in one calculation: 12 sections with an interval of 15 °
- Pre-scan function
- Standards of safety, EMC, biocompatibility: AAMI/ANSI ES60601-1, IEC60601-2-37, UD2-2004 and FDA Guide for Track 1, IEC60601-1-2, ISO10993-5, ISO10993-10
The differences of MD-6000P Bladder Scanner and its predicate device:
| Model | Subject Device | Predicate Device |
|---|---|---|
| ltem | MD-6000P Bladder Scanner | MD-6000 Bladder Scanner |
| Display screen | 1.3" OLED | 6.4" True Color TFT LCD |
| Accuracy | ±15% or ±15ml | |
| (take the maximum value) | ±15% | |
| Appearance | Hand-held | Portable |
| Measuring Range | 20ml - 999ml | 20ml - 999ml |
| Printing | External printer | Built-in printer |
| Pre-scan | Mark on the screen | Image on the screen |
While there are some differences between the MD-6000P Bladder Scanner and its predicate device, they do not affect the safety or effectiveness.
Brief Discussion of Non-clinical Tests 7.
Safety and EMC:
The safety and EMC testing were conducted on the MD-6000P and the testing results comply with the requirements of the following standards:
AAMI/ANSI ES60601-1, Medical Electrical Equipment - Part 1: General Requirements for
6
Safety, 005/(R)2012 And A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment-Part 2-37: Particular requirement for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
IEC 60601-1-2: 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Acoustic output parameters:
The acoustic output parameters comply with the requirements of:
NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3, and
FDA Guidance document "Information for Manufactures Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued in September 2008
Biocompatibility:
The biocompatibility evaluation has been conducted according to ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Tests for in vitro cytotoxicity, skin sensitization and irritation were conducted on the patient-contacting materials according to the requirements of:
ISO 10993-5:2009 Third Edition Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10: 2010 Third Edition Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
FCC Certification:
Tests were conducted on the wireless part of MD-6000P and it complies with the requirements of FCC, CFR, Title 47 - Telecommunications, Chapter I - Federal Communications Commission, Subchapter A - General:
- Subpart J of Part 2 – Frequency Allocations and Radio Treaty Matters; General Rules and Regulations
- Subpart C of Part 15 - Radiofrequency Devices
- Part 18 – Industrial, Scientific, and Medical Equipment
Bench Testing:
Measurement accuracy of ±15% or ±15ml within the measurement range of 20-999ml
For the measurement range of 100-999ml, use MD-6000P Bladder Scanner to make scan on the phantom and compare the measurement value and the nominal value, the measurement accuracy met the requirements of ±15%.
7
For the measurement range of 20-100ml, use MD-6000P Bladder Scanner to make scan on the test object of water sac with known volume, the measurement accuracy met the requirements of ±15ml.
Software:
The software of MD-6000P has passed verification and validation according to the FDA guidance:
"Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005.
Clinical Testing:
The MD-6000P Bladder Scanner, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.
8. Conclusions
The results of non-clinical tests demonstrate that the MD-6000P Bladder Scanner is substantially equivalent in safety and effectiveness to the legally marketed predicate device.