HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System
Device Facts
| Record ID | K192319 |
|---|---|
| Device Name | HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System |
| Applicant | Samsung Medison Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Dec 10, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
Device Story
Mobile, software-controlled diagnostic ultrasound system; acquires ultrasound data via various transducers; displays images in multiple modes (B-mode, M-mode, PW/CW/Color/Tissue Doppler, 3D/4D, Elastoscan+, etc.). Used in clinical settings by healthcare professionals to visualize anatomical structures and analyze body fluids. Provides real-time acoustic output (MI/TI) and measurement/analysis packages to assist clinical diagnosis. Subject device adds three transducers and nine biopsy kits to predicate HERA W10 platform; no software modifications. System supports standard clinical workflows for imaging and measurement; output aids clinicians in diagnostic decision-making; benefits include non-invasive visualization and assessment of patient anatomy and pathology.
Clinical Evidence
No clinical data required; substantial equivalence supported by bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal/electromagnetic/mechanical safety testing.
Technological Characteristics
Mobile ultrasound system; 192 transmit/receive channels; 1.0-20.0 MHz frequency range. Includes LED-backlit LCD monitor. Biocompatibility per ISO 10993-1. Safety compliance per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37. Connectivity includes digital storage/transfer, WLAN, and ECG. Software-controlled with various imaging modes (B, M, Doppler, 3D/4D, Elastoscan+).
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid analysis in patients requiring fetal/obstetric, abdominal, gynecological, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, urological, cardiac, and peripheral vessel examinations.
Regulatory Classification
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.
Predicate Devices
- HERA W10 Diagnostic Ultrasound System (K182595)
Submission Summary (Full Text)
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December 10, 2019
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Samsung Medison Co., Ltd. % Ji Yea Lee Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108 REPUBLIC OF KOREA
# Re: K192319
Trade/Device Name: HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: October 31, 2019 Received: November 4, 2019
Dear Ji Yea Lee:
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
510(k) Number (if known)
K192319
Device Name HERA W9 Diagnostic Ultrasound System HERA W10 Diagnostic Ultrasound System
Indications for Use (Describe)
The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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# 6. 510(K) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
- Date Prepared August 23, 2019 1.
- 2. Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108, REPUBLIC OF KOREA
- 3. Primary Contact Person Ji Yea Lee Regulatory Affairs Specialist Phone: +82.2.2194.1594 Fax: +82. 31.8017.9573 Email: jiyea722.lee@samsungmedison.com
- 4. Proposed Device
- Common/Usual Name: Diagnostic Ultrasound System and Accessories
- Proprietary Name: HERA W9, HERA W10 Diagnostic Ultrasound System
- Common Name: Diagnostic Ultrasound System
- Classification Names: system, imaging, pulsed doppler, ultrasonic -
- Product Code: IYN, IYO, ITX ၊
- Regulation: 892.1550 i
- 5. Predicate Device
- HERA W10 Diagnostic Ultrasound System (K182595) ।
- · Common/Usual Name: Diagnostic Ultrasound System and Accessories
- · Proprietary Name: HERA W10 Diagnostic Ultrasound System
- · Common Name: Diagnostic Ultrasound System
- · Classification Names: system, imaging, pulsed doppler, ultrasonic
- · Product Code: IYN, IYO, ITX
- · Regulation number : 892.1550
- · Class : Class II
- 6. Device Description
The HERA W9/ HERA W10 are general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound dasta and to display the data as B-mode, M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Amplitude Doppler, Pulse Inversion Harmonic Imaging (S-Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, Elastoscan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode or as a combination of these modes.
The HERA W9/HERA W10 also give the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HERA W9/HERA W10 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
As compared with predicate device(HERA W10, K182595), the subject device has added new three transducers(EV2-10A, EA2-11AV and EA2-11AR) and nine biopsy kits (BP-KIT-079, BP-KIT-080, BP-KIT-081, BP-KIT-082, BP-KIT-085, BP-KIT-086, BP-KIT-089 and BP-KIT-089 and BP-KIT-090) and the product name of HERA W9. There are no change and new software features from the predicate device. The HERA ultrasound system is supported by software and the software is not modified for the subject system.
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| Difference | HERA W10 | HERA W9 | |
|------------|-------------------------|------------------------------------|----------------------------------|
| Software | QuickPrep. | Supported | Not Supported |
| Hardware | Internal DVD | Included | Not Included |
| | Caster size | 6" | 5" |
| | Active array probe port | 4 port | 3 port (default), 4 port(option) |
| | Main monitor | default: 21.5", option: 23", 23.8" | default: 21.5", option: 23.8" |
Also, the differences between HERA W10 and HERA W9 in the subject device are as below.
#### 7. Intended Uses
The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
- 8. Technology
The HERA W9/ HERA W10 employ the same fundamental scientific technology as its predicate device.
- 9. Determination of Substantial Equivalence
The proposed HERA W9/ HERA W10 are substantially equivalent to the predicate device with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness.
As compared with predicate device(HERA W10, K182595), the subject device has added new three transducers(EV2-10A, EA2-11AV and EA2-11AR) and nine biopsy kits (BP-KIT-079, BP-KIT-080, BP-KIT-081, BP-KIT-082, BP-KIT-085, BP-KIT-086, BP-KIT-089 and BP-KIT-089 and BP-KIT-090) and the product name of HERA W9.
| Feature | HERA W9/ HERA W10<br>(Under Review) | HERA W10<br>(K182595) |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | SAMSUNG MEDISON CO.,LTD | SAMSUNG MEDISON CO.,LTD |
| Intended Use | The HERA W9/ HERA W10<br>Diagnostic Ultrasound System and<br>transducers are intended for diagnostic<br>ultrasound imaging and fluid analysis<br>of the human body. | The HERA W10 Diagnostic<br>Ultrasound System and transducers are<br>intended for diagnostic ultrasound<br>imaging and fluid analysis of the<br>human body. |
| Clinical<br>Application | - Fetal/Obstetrics<br>- Abdominal<br>- Gynecology<br>- Pediatric<br>- Small Organ<br>- Neonatal Cephalic<br>- Adult Cephalic<br>- Trans-rectal<br>- Trans-vaginal<br>- Muscular-Skeletal (Conventional, | - Fetal/Obstetrics<br>- Abdominal<br>- Gynecology<br>- Pediatric<br>- Small Organ<br>- Neonatal Cephalic<br>- Adult Cephalic<br>- Trans-rectal<br>- Trans-vaginal<br>- Muscular-Skeletal (Conventional, |
| Feature | HERA W9/ HERA W10<br>(Under Review) | HERA W10<br>(K182595) |
| | Superficial)<br>- Urology<br>- Cardiac Adult<br>- Cardiac Pediatric<br>- Peripheral vessel | Superficial)<br>- Urology<br>- Cardiac Adult<br>- Cardiac Pediatric<br>- Peripheral vessel |
| Scanhead Types | - Linear Array<br>- Curved Linear Array<br>- Endocavity<br>- Phased Array | - Linear Array<br>- Curved Linear Array<br>- Endocavity<br>- Phased Array |
| Scanhead<br>Frequency | 1.0 ~ 20.0 MHz | 1.0 ~ 20.0 MHz |
| Acoustic Output<br>Display & FDA<br>Limits | - Display Feature for Higher Output-<br>Track3<br>- MI Output Display<br>- TI Output Display | - Display Feature for Higher Output-<br>Track3<br>- MI Output Display<br>- TI Output Display |
| Modes of<br>Operation | - B-mode<br>- M-mode<br>- Pulsed wave (PW) Doppler<br>- Continuous wave (CW) Doppler<br>- Color Doppler<br>- Tissue Doppler Imaging (TDI)<br>- Tissue Doppler Wave (TDW)<br>- Power Amplitude Doppler<br>- Pulse Inversion Harmonic Imaging<br>(S-Harmonic)<br>- Directional Power Doppler (S-Flow)<br>- Color M-Mode<br>- 3D Imaging Mode<br>- 4D Imaging Mode<br>- Elastoscan+TM Mode<br>- MV-Flow Mode<br>- Tissue Harmonic Imaging<br>- Combination Modes | - B-mode<br>- M-mode<br>- Pulsed wave (PW) Doppler<br>- Continuous wave (CW) Doppler<br>- Color Doppler<br>- Tissue Doppler Imaging (TDI)<br>- Tissue Doppler Wave (TDW)<br>- Power Amplitude Doppler<br>- Pulse Inversion Harmonic Imaging<br>(S-Harmonic)<br>- Directional Power Doppler (S-Flow)<br>- Color M-Mode<br>- 3D Imaging Mode<br>- 4D Imaging Mode<br>- Elastoscan+TM Mode<br>- MV-Flow Mode<br>- Tissue Harmonic Imaging<br>- Combination Modes |
| #Transmit<br>Channels | 192 | 192 |
| #Receive<br>Channels | 192 | 192 |
| System<br>Characteristics: | - Beamformer 192<br>- Mobile cart<br>- LCD Monitor (LED Backlight unit)<br>- 256 gray shades on monitor<br>- 100-240VAC, 1100VA, 50/60Hz | - Beamformer 192<br>- Mobile cart<br>- LCD Monitor (LED Backlight unit)<br>- 256 gray shades on monitor<br>- 100-240VAC, 1100VA, 50/60Hz |
| Product Safety<br>Certification | - IEC 60601-1<br>- IEC 60601-1-2-37 | - IEC 60601-1<br>- IEC 60601-1-2-37 |
| Feature | HERA W9/ HERA W10<br>(Under Review) | HERA W10<br>(K182595) |
| | - CSA C22.2 No.601.1 | - CSA C22.2 No.601.1 |
| EMC Compliance | IEC 60601-1-2 | IEC 60601-1-2 |
| Acoustic Output<br>Display Standard | Track 3 | Track 3 |
| Biocompatibility<br>Compliance | ISO10993-1 | ISO10993-1 |
| Functionality | - Q Scan | - Q Scan |
| | - ClearVision | - ClearVision |
| | - MultiVision | - MultiVision |
| | - Panoramic | - Panoramic |
| | - NeedleMate+ | - NeedleMate+ |
| | - AutoIMT+ | - AutoIMT+ |
| | - Elastoscan+ | - Elastoscan+ |
| | - E-Thyroid | - E-Thyroid |
| | - E-Breast | - E-Breast |
| | - E-Strain | - E-Strain |
| | - S-Detect for Breast | - S-Detect for Breast |
| | - S-Detect for Thyroid | - S-Detect for Thyroid |
| | - ADVR | - ADVR |
| | - 3D Imaging | - 3D Imaging |
| | - (Volume Data Acquisition) | - (Volume Data Acquisition) |
| | - 3D Imaging presentation | - 3D Imaging presentation |
| | - 3D Cine/4D Cine | - 3D Cine/4D Cine |
| | - 3D Rendering MPR | - 3D Rendering MPR |
| | - 3D XI MSV/Oblique View | - 3D XI MSV/Oblique View |
| | - Volume CT | - Volume CT |
| | - 3D MagiCut | - 3D MagiCut |
| | - Volume Calculation | - Volume Calculation |
| | - (VOCAL, XI VOCAL) | - (VOCAL, XI VOCAL) |
| | - XI STIC | - XI STIC |
| | - HDVI | - HDVI |
| | - RealisticVue | - RealisticVue |
| | - CEUS+ | - CEUS+ |
| | - HQ-Vision | - HQ-Vision |
| | - MV-Flow | - MV-Flow |
| | - CrystalVue | - CrystalVue |
| | - CrystalVue Flow | - CrystalVue Flow |
| | - 5D CNS+ | - 5D CNS+ |
| | - 5D Follicle | - 5D Follicle |
| | - 5D Heart Color | - 5D Heart Color |
| | - 5D Limb Vol | - 5D Limb Vol |
| | - 5D LB | - 5D LB |
| | - 5D NT | - 5D NT |
| | - 2D NT | - 2D NT |
| | - IOTA-ADNEX | - IOTA-ADNEX |
| Feature | HERA W9/ HERA W10<br>(Under Review) | HERA W10<br>(K182595) |
| | - BiometryAssit | - BiometryAssit |
| | - E-Cervix | - E-Cervix |
| | - LumiFlow | - LumiFlow |
| | - ShadowHDR | - ShadowHDR |
| | - MPI+ | - MPI+ |
| Transducers | - L3-12A | - L3-12A |
| | - LA2-9A | - LA2-9A |
| | - LA4-18B | - LA4-18B |
| | - CA1-7A | - CA1-7A |
| | - CA2-9A | - CA2-9A |
| | - CA3-10A | - CA3-10A |
| | - CF4-9 | - CF4-9 |
|…
