(251 days)
Not Found
No
The description focuses on standard ultrasound technology and signal processing, with no mention of AI or ML.
No.
The device description and intended use clearly state that the ZONCARE-M5 Ultrasound system is for evaluations, diagnosis, and generating images, not for treating conditions.
Yes
The device is an ultrasound system that analyzes returned signals to generate images and offers analysis packages to provide information used by healthcare professionals to make a diagnosis. The predicate device is also named a "Diagnostic Ultrasound System."
No
The device description explicitly states that the system consists of a "main system along with associated transducers" and describes the hardware components and processes involved in generating and receiving ultrasonic waves. It also mentions "hardware buttons for the User Interface." This indicates it is a hardware-based ultrasound system with integrated software, not a software-only device.
Based on the provided information, the ZONCARE-M5 Ultrasound system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- ZONCARE-M5 Function: The description clearly states that the ZONCARE-M5 system uses ultrasound waves transmitted through body tissues to generate images and conduct Doppler processing. It analyzes signals returned from within the body, not from specimens taken from the body.
- Intended Use: The intended use is for ultrasound evaluations of various anatomical sites within the body.
Therefore, the ZONCARE-M5 Ultrasound system is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ZONCARE-M5 Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include: Abdominal Gynecology(including endovaginal) Obstetric Cardiac Small parts(Breast,Testes,Thyroid,etc.) Urology Musculoskeletal Peripheral vascular
Intended use:Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The ZONCARE-M5 Ultrasound system consists of a main system along with associated transducers.
The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The waves are then reflected within the body and detected by the transducer, which then converts back to an electrical signal. The ZONCARE-M5 system then analyzes the returned signal to generate an image or conduct Doppler processing.
The ZONCARE-M5 system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis.
The system provides hardware buttons for the User Interface.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Gynecology (including endovaginal), Obstetric, Cardiac, Small parts (Breast, Testes, Thyroid, etc.), Urology, Musculoskeletal, Peripheral vascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physician or allied health professional
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)
Clinical test: Clinical testing is not required
Non-clinical test: The ZONCARE-M5 Ultrasound System complies with (1)AAMI/ANSI ES60601-1 Electrical Safety (2) IEC 60601-1-2 Electromagnetic Compatibility (3) Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008. The following biocompatibility standards are conducted on the subject device: (1) ISO 10993-1, ISO 10993-5 and ISO 10993-10. The tests were selected to show substantial equivalence between the subject device and the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Wuhan Zoncare Bio-medical Electronics Co., Ltd. % Long Yang, COO Shenzhen Hlongmed Biotech Co., Ltd. 1002, 10th Floor, Zhongxing Administrative Building Zhongxing Industrial Zone, Chuangye Road, Nanshan Shenzhen, Guangdong 518054 CHINA
July 10, 2019
Re: K183041
Trade/Device Name: Full Digital Colour Doppler Ultrasonic Diagnostic System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: May 31, 2019 Received: June 5, 2019
Dear Long Yang:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Section 10
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Full Digital Colour Doppler Ultrasound Diagnostic System
Indications for Use (Describe)
The ZONCARE-M5 Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include:
Abdominal Gynecology(including endovaginal) Obstetric Cardiac Small parts(Breast,Testes,Thyroid,etc.) Urology Musculoskeletal Peripheral vascular
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Full Digital Color Doppler Ultrasonic Diagnostic System
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track1 Only) | Specific | ||||||||
| (Track 1&3) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (Specify) | Other | ||||||||
| (Specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal/Obstetrics | N | N | N | N | |||||
| Abdominal | N | N | N | N | N | N | |||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro | |||||||||
| logical) | |||||||||
| Fetal | |||||||||
| Imaging | |||||||||
| & other | Laparoscopic | ||||||||
| Pediatric | |||||||||
| Small Organ(Specify)* | N | N | N | N | |||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | N | N | N | N | |||||
| Trans-vaginal | N | N | N | N | |||||
| Trans-urethral | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | N | N | N | N | |||||
| Musculo-skeletal | |||||||||
| (Superficial) | N | N | N | N | |||||
| Intravascular | |||||||||
| Other(Specify)** | N | N | N | N | |||||
| Adult Cardiac | N | N | N | N | N | N | |||
| Pediatric Cardiac | |||||||||
| Cardiac | Intravascular(cardiac) | ||||||||
| Trans-esoph.(cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| vascular | Peripheral vascular | N | N | N | N | ||||
| Other(Specify) | |||||||||
| Clinical Application | Mode of | ||||||||
| Operation | |||||||||
| General | Specific | B | M | PWD | CWD | Color | Combined | Other | |
| (Track1 Only) | (Track 1&3) | Doppler | (Specify) | (Specify) | |||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal/Obstetrics | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro | |||||||||
| logical) | |||||||||
| Fetal | Laparoscopic | ||||||||
| Imaging | Pediatric | ||||||||
| & other | Small Organ(Specify)* | N | N | N | N | N | N | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Musculo-skeletal | N | N | N | N | N | N | |||
| (Conventional) | |||||||||
| Musculo-skeletal | N | N | N | N | N | N | |||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other(Specify)** | |||||||||
| Adult Cardiac | |||||||||
| Pediatric Cardiac | |||||||||
| Cardiac | Intravascular(cardiac) | ||||||||
| Trans-esoph.(cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | Peripheral vascular | N | N | N | N | N | N | ||
| vascular | Other(Specify) | ||||||||
| Clinical Application | Mode of Operation | ||||||||
| General | |||||||||
| (Track1 Only) | Specific | ||||||||
| (Track 1&3) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (Specify) | Other | ||||||||
| (Specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal/Obstetrics | N | N | N | N | |||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neurological) | |||||||||
| Fetal | |||||||||
| Imaging | |||||||||
| & other | Laparoscopic | ||||||||
| Pediatric | |||||||||
| Small Organ(Specify)* | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | N | N | N | N | |||||
| Trans-vaginal | N | N | N | N | |||||
| Trans-urethral | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other(Specify)** | |||||||||
| Adult Cardiac | |||||||||
| Pediatric Cardiac | |||||||||
| Cardiac | Intravascular(cardiac) | ||||||||
| Trans-esoph.(cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| vascular | Peripheral vascular | ||||||||
| Other(Specify) | |||||||||
| Clinical Application | Mode of Operation | ||||||||
| General | |||||||||
| (Track1 Only) | Specific | ||||||||
| (Track 1&3) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (Specify) | Other | ||||||||
| (Specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal/Obstetrics | N | N | N | N | N | ||||
| Abdominal | N | N | N | N | N | ||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | |||||||||
| Imaging | |||||||||
| & other | Pediatric | ||||||||
| Small Organ(Specify)* | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other(Specify)** | N | N | N | N | N | ||||
| Adult Cardiac | |||||||||
| Pediatric Cardiac | |||||||||
| Cardiac | Intravascular(cardiac) | ||||||||
| Trans-esoph.(cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| vascular | Peripheral vascular | ||||||||
| Other(Specify) |
Intended use:Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix Additional comments: Combined mode: B+M
Note: * Small organ includes Thyroid, Testes, Breast
4
ZONCARE-M5 with TL40 Transducer
Intended use:Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note:* Small organ includes Thyroid, Testes, Breast
5
ZONCARE-M5 with TC10 Transducer
Intended use:Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix Additional comments: Combined mode: B+M
Note:* Small organ includes Thyroid, Testes, Breast
** Other use includes Urology, Gynecology of the county of the comment of the
6
ZONCARE-M5 with TC50 Transducer
Intended use:Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix Additional comments: Combined mode: B+M
Note:* Small organ includes Thyroid, Testes, Breast
7
ZONCARE-M5 with TP16 Transducer
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track1 Only) | Specific | |||||||
| (Track 1&3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & other | Fetal/Obstetrics | |||||||
| Abdominal | N | N | N | N | N | N | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ(Specify)* | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other(Specify)** | ||||||||
| Cardiac | Adult Cardiac | N | N | N | N | N | N | |
| Pediatric Cardiac | ||||||||
| Intravascular(cardiac) | ||||||||
| Trans-esoph.(cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Peripheral | ||||||||
| vascular | Peripheral vascular | |||||||
| Other(Specify) |
Intended use:Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix Additional comments: Combined mode: B+M
Note:* Small organ includes Thyroid, Testes, Breast
8
ZONCarE中旗
Section 9
510(k) Summary
(as required by 807.92(c))
The assigned 510(K) number is:_ K183041
Date of Summary:
1. Submitter information
Manufacturer Name: Wuhan Zoncare Bio-medical Electronics Co., Ltd
Address:Zoncare Building,#380,High-tech 2ND Road,Eastlake high-tech district ,Wuhan,
Hubei , China
Contact Person and Title: Chenglin Tian/Manager of Medical Regulation
Tel: (86)-27-86637765
Fax: (86)-27-87174399
Email: fda ce@zoncae.cn
2. Contact person
2.1 Primary Contact Person
Long Yang (COO)
Shenzhen Hlongmed Biotech Co.,Ltd
1002, 10th Floor, Zhongxing Administrative Building, Zhongxing Industrial Zone,
Chuangye Road, Nanshan, Shenzhen, P.R.China
Tel: 0086-755-86664986
Fax: 0086-755-86664933
E-mail: yanglong@hlongmed.com
2.2 Secondary Contact Person
9
ZONCarE中旗
Chenglin Tian/Manager of Medical Regulation
Wuhan Zoncare Bio-medical Electronics Co., Ltd
Zoncare Building, #380, High-tech 2ND Road, Eastlake high-tech district ,Wuhan,
Hubei , China
Tel: (86)-27-86637765
3. Device information
Device name: Full Digital Colour Doppler Ultrasonic Diagnostic System
Model:ZONCARE-M5
Common Name:Diagnostic Ultrasound System with Accessories
Classification Name and Product Code:
21 CFR 892.1550 System, Imaging, Pulsed Doppler, Ultrasonic
Product code: IYN
21 CFR 892.1560 Ultrasonic, Pulsed echo, Imaging
Product code: IYO
21 CFR 892.1570 Transducer, Ultrasonic, Diagnostic
Product code: ITX
Regulatory Class: class II
4. Predicate device information
Manufacturer:Edan Instruments, Inc.
Address:3/F-B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou,
Nanshan Shenzhen, 518067 P.R. China
Device name:Acclarix Diagnostic Ultrasound System
510(k)number:K150999
5. Indications for Use
The ZONCARE-M5 Ultrasound system is intended for use by a qualified physician or
10
ZONCarE中旗
allied health professional for ultrasound evaluations. Specific clinical applications include:
- Abdominal Gynecology (including endovaginal) Obstetric Cardiac Small parts(Breast, Testes, Thyroid, etc.) Urology Musculoskeletal Peripheral vascular
6. Device Description
The ZONCARE-M5 Ultrasound system consists of a main system along with associated transducers.
The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The waves are then reflected within the body and detected by the transducer, which then converts back to an electrical signal. The ZONCARE-M5 system then analyzes the returned signal to generate an image or conduct Doppler processing.
The ZONCARE-M5 system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis.
The system provides hardware buttons for the User Interface.
7. Comparison to Predicate Devices
Wuhan Zoncare Bio-medical Electronics Co., Ltd believes the ZONCARE-M5 Ultrasound System described in this submission is substantially equivalent to the
11
predicate device as follow:
Acclarix AX8 Diagnostic Ultrasound System(K150999)
The following table shows similarities and differences between our device and the
predicate devices.
| Item | Proposed Device | Predicate Device |
|---|---|---|
| Trade name | Full Digital Colour Doppler | |
| Ultrasound Diagnostic System | Acclarix Diagnostic Ultrasound | |
| System | ||
| Model | ZONCARE-M5 | AX8 |
| 510k | ||
| submitter | Wuhan Zoncare Bio-medical | |
| Electronics Co.,Ltd. | Edan Instruments,Inc | |
| 510K Number | / | K150999 |
| Intended use | Diagnostic ultrasound imaging or | |
| fluid flow analysis of the human | ||
| body | Diagnostic ultrasound imaging or | |
| fluid flow analysis of the human | ||
| body | ||
| Indication for | ||
| use | The ZONCARE-M5 Ultrasound | |
| system is intended for use by a | ||
| qualified physician or allied health | ||
| professional for ultrasound | ||
| evaluations. | ||
| Specific clinical applications | ||
| include: | ||
| Abdominal | ||
| Gynecology (including endovaginal) | ||
| Obstetric | ||
| Cardiac | ||
| Small parts(Breast, Testes,Thyroid, | ||
| etc.) | The Edan Acclarix AX8 Ultrasound | |
| system is intended for use by a | ||
| qualified physician or allied health | ||
| professional for ultrasound | ||
| evaluations. | ||
| Specific clinical applications | ||
| include: | ||
| Abdominal | ||
| Gynecology(including endovaginal) | ||
| Obstetric | ||
| Cardiac | ||
| Small parts (Breast, Testes,Thyroid, | ||
| etc.) | ||
| Urology | Urology | |
| Musculoskeletal | Musculoskeletal | |
| Peripheral vascular | Peripheral vascular | |
| Intra-operative. | ||
| Installation | ||
| and use | Portable(laptop)Mobile Equipment | Portable(laptop)Mobile Equipment |
| IEC 60601-1, | IEC 60601-1, | |
| IEC 60601-1-2, | IEC 60601-1-2, | |
| Safety | ||
| standards | IEC 60601-2-37, | IEC 60601-2-37, |
| ISO 10993-1,-5,-10,-12 | ISO 10993-1,-5,-10,-12 | |
| NEMA UD2 | AIUM,NEMA | |
| UD2,UD3 | ||
| NEMA UD3 | ||
| Patient contact | ||
| materials | Complies with ISO 10993 | Complies with ISO 10993 |
| General | ||
| Imaging mode | B-Mode,M-Mode,Color,PDI,PW,CW | B-Mode,M-Mode,Color,PDI/DPDI,PW,CW |
| B-Mode:Distance,Circ/Area,Angle, | ||
| Volume,Stenosis | B-Mode:Distance,Circ/Area,Angle, | |
| Volume,Stenosis | ||
| Measurements | M-Mode:Distance, Time,Slope and | |
| Heart Rate | M-Mode:Distance, Time,Slope and | |
| Heart Rate | ||
| D-Mode:Velocity, RI,Time, PI, Heart | ||
| Rate,Auto Trace PG,S/D, | ||
| △V,Acceleration,PHT, VTI | D-Mode:Velocity,RI,Time, PI, Heart | |
| Rate, Auto Trace PG,S/D, | ||
| △V,Acceleration,PHT, VTI | ||
| Principle of | ||
| Operation | Applying high voltage burst to the | |
| Piezoelectric material in the | Applying high voltage burst to the | |
| Piezoelectric material in the | ||
| transducer and detect reflected echo | transducer and detect reflected echo | |
| to construct diagnostic image | to construct diagnostic image | |
| Track 3: MI, TIS, TIC,TIB (TI | Track 3: MI, TIS, TIC,TIB (TI | |
| Range 0-6.0) | Range 0-6.0) | |
| Acoustic | ||
| output | Derated ISPTA: 720W/cm2 | |
| maximum,Mechanic Index ≤1.9 | Derated ISPTA: 720W/cm2 | |
| maximum,Mechanic Index≤1.9 | ||
| maximum or Derated ISPPA 190 | ||
| W/cm² max | maximum or Derated ISPPA 190 | |
| W/cm² max | ||
| Convex Array | Convex Array | |
| Transducer | ||
| Types | Linear Array | Linear Array |
| Phased Array | Phased Array | |
| Micro Convex Array | ||
| Transducer | ||
| Frequency | 2.0-12.0MHz | 2.5-15.0MHz |
| Display | Primary Screen:12.1inch(1024*768) | Primary Screen:15 inch(1920x1080) |
| 370mm(W)*470mm(L)*380mm(H) | 407mm(W)*388mm(L)*77mm(H) | |
| Dimensions/ | ||
| Weight | Weight:nearly 9kg (with | |
| Rechargeable battery, without | ||
| power adaptor or transducers) | Weight: ≤9.1kg(with | |
| Rechargeable battery, without | ||
| power adaptor or transducers) | ||
| Power | ||
| Supply | 100-240V | |
| 50/60Hz | 100-240V | |
| 50/60Hz | ||
| Rechargeable | ||
| battery | Yes | Yes |
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The subject device has same intended use, similar product design, same performance effectiveness, and performance safety as the predicate device.
The differences between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is
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raised regarding to effectiveness and safety.
8. Effectiveness and Safety Considerations
Clinical test:
Clinical testing is not required
Non-clinical test:
The ZONCARE-M5 Ultrasound System complies with
(1)AAMI/ANSI ES60601-1 Electrical Safety
(2) IEC 60601-1-2 Electromagnetic Compatibility
(3) Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.
The following biocompatibility standards are conducted on the subject device:
(1) ISO 10993-1, ISO 10993-5 and ISO 10993-10
The tests were selected to show substantial equivalence between the subject device and the predicate.
9. Substantial Equivalence Conclusion
Verification and validation testing has been conducted on the ZONCARE-M5 Ultrasound System.This premarket notification submission demonstrates that ZONCARE-M5 Ultrasound System is substantially equivalent to the predicate devices.