LogoFDA 510(k) Search
K Number
K220043
Device Name
HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System
Manufacturer
Samsung Medison Co., LTD
Date Cleared
2022-04-05

(90 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The diagnostic ultrasound system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. 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. It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients. Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan+™ Mode, Combined modes, Multi-Image modes (Dual, Quad), 3D/4D modes.
Device Description
The HERA W9/ HERA W10 are general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Tissue Doppler Imaging (TDD), 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 W10 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
More Information

K211824

K211824

Yes
The document explicitly mentions "BiometryAssist (AI version)" and "ViewAssist (AI version)" as features of the device, indicating the incorporation of AI technology.

No.
The device's intended use is explicitly stated as "diagnostic ultrasound imaging and fluid analysis," and it is used to "make a diagnosis," not to treat or cure a condition.

Yes

The "Intended Use / Indications for Use" section explicitly states, "The diagnostic ultrasound system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body." Additionally, the "Device Description" refers to it as a "general purpose, mobile, software controlled, diagnostic ultrasound system."

No

The device description explicitly states it is a "diagnostic ultrasound system," which inherently includes hardware components (transducers, processing unit, display, etc.) to acquire and display ultrasound data. While it is software-controlled and utilizes AI features, it is not solely software.

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

  • IVDs analyze samples taken from the human body (like blood, urine, tissue). This device is a diagnostic ultrasound system, which uses sound waves to create images of the human body. It performs imaging and fluid analysis within the body, not on samples taken from it.
  • The intended use and device description clearly state it's for diagnostic ultrasound imaging and fluid analysis of the human body. This is a key characteristic of imaging devices, not IVDs.
  • The clinical applications listed are all related to imaging different parts of the body.

While the device is used for diagnosis, the method of diagnosis (ultrasound imaging) falls outside the definition of an In Vitro Diagnostic.

No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The "Control Plan Authorized (PCCP)" section is "Not Found".

Intended Use / Indications for Use

The diagnostic ultrasound system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

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.

It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients.

Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan+™ Mode, Combined modes, Multi-Image modes (Dual, Quad), 3D/4D modes.

Product codes

IYN, ITX, IYO

Device Description

The HERA W9/ HERA W10 are general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Tissue Doppler Imaging (TDD), 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 W10 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

  • The proposed HERA W9/ HERA W10 have expanded the measurement parts of BiometryAssist . (AI version) in the previously cleared HERA W9/ HERA W10 (K211824).
  • . The proposed HERA W9 HERA W10 have expanded the view recognition and the annotation of ViewAssist (AI version) in the previously cleared HERA W9/ HERA W10 (K211824)

Input Imaging Modality

Ultrasound

Anatomical Site

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.

Indicated Patient Age Range

Adult, Pediatric, Neonatal.

Intended User / Care Setting

It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients.

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)

The subject of this premarket submission, HERA W9/ HERA W10, did not require clinical studies to support substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

HERA W9, HERA W10 Diagnostic Ultrasound System (K211824)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Samsung Medison Co., LTD % Jee Young Ju Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, Gangwon-do 25108 KOREA

April 5, 2022

Re: K220043

Trade/Device Name: HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Diagnostic Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, ITX, IYO Dated: December 30, 2021 Received: January 5, 2022

Dear Jee Young Ju:

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 mediation-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,

Jessica Lamb, Ph.D. Assistant Director Mammography Ultrasound and Imaging Software Branch 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

Indications for Use

510(k) Number (if known) K220043

Device Name

HERA W9, HERA W10 Diagnostic Ultrasound System

Indications for Use (Describe)

The diagnostic ultrasound system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

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.

It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients.

Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan+™ Mode, Combined modes, Multi-Image modes (Dual, Quad), 3D/4D modes.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

SAMSUNG

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

  • Date Prepared December 30, 2021 1.
  • Manufacturer 2. SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108, REPUBLIC OF KOREA
    1. Primary Contact Person Jee Young Ju Regulatory Affairs Specialist Phone: +82.2.2194.0861 Fax: +82. 2.2194.0278 Email: jee.ju@samsungmedison.com

Secondary Contact Person Ninad Gujar Vice President Phone: +1.978.564.8632 Fax: +1.978.564.8677 Email: ngujar@neurologica.com

    1. 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 i
    • Product Code: IYN, IYO, ITX
    • Regulation: 892.1550, 892.1560, 892.1570
    1. Predicate Device
  • HERA W9, HERA W10 Diagnostic Ultrasound System (K211824) Primary Predicate -
    1. Device Description

The HERA W9/ HERA W10 are general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Tissue Doppler Imaging (TDD), 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 W10 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

4

Image /page/4/Picture/0 description: The image shows the word "SAMSUNG" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the image space.

Indications for Use 7.

The diagnostic ultrasound system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

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.

It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients.

Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan+™ Mode, Combined modes, Multi-Image modes (Dual, Quad), 3D/4D modes.

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.

| Feature | HERA W9 /HERA W10
(Under Review) | HERA W9/HERA W10 (K211824)
Primary Predicate |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | SAMSUNG MEDISON CO.,LTD | SAMSUNG MEDISON CO.,LTD |
| Intended Use | The HERA W9/ HERA W10 Diagnostic
Ultrasound System and transducers are
intended for diagnostic ultrasound imaging
and fluid analysis of the human body. | The HERA W9/ HERA W10 Diagnostic
Ultrasound System and transducers are
intended for diagnostic ultrasound imaging
and fluid analysis of the human body. |
| Functionality | - Q Scan

  • ClearVision
  • MultiVision
  • Panoramic
  • NeedleMate+
  • AutoIMT+
  • Elastoscan+
  • E-Thyroid
  • E-Breast
  • E-Strain
  • S-Detect for Breast
  • S-Detect for Thyroid
  • ADVR
  • 3D Imaging
    (Volume Data Acquisition)
  • 3D Imaging presentation
  • 3D Cine/4D Cine
  • 3D Rendering MPR
  • 3D XI MSV/Oblique View
  • Volume CT
  • 3D MagiCut
  • Volume Calculation
    (VOCAL, XI VOCAL)
  • XI STIC | - Q Scan
  • ClearVision
  • MultiVision
  • Panoramic
  • NeedleMate+
  • AutoIMT+
  • Elastoscan+
  • E-Thyroid
  • E-Breast
  • E-Strain
  • S-Detect for Breast
  • S-Detect for Thyroid
  • ADVR
  • 3D Imaging
    (Volume Data Acquisition)
  • 3D Imaging presentation
  • 3D Cine/4D Cine
  • 3DRendering MPR
  • 3D XI MSV/Oblique View
  • Volume CT
  • 3D MagiCut
  • Volume Calculation
    (VOCAL, XI VOCAL)
  • XI STIC |
    | Feature | HERA W9 /HERA W10
    (Under Review) | HERA W9/HERA W10 (K211824)
    Primary Predicate |
    | | HDVI
    RealisticVue
    CEUS+
    HQ-Vision
    MV-Flow
    CrystalVue
    CrystalVue Flow*
    5D CNS+
    5D Follicle
    5D Heart Color
    5D Limb Vol
    5D LB
    5D NT
    2D NT
    IOTA-ADNEX
    BiometryAssist
    E-Cervix
    LumiFlow
    ShadowHDR
    MPI+*
    Slice A
    HeartAssist *
    ViewAssist | HDVI
    RealisticVue
    CEUS+
    HQ-Vision
    MV-Flow
    CrystalVue
    CrystalVue Flow*
    5D CNS+
    5D Follicle
    5D Heart Color
    5D Limb Vol
    5D LB
    5D NT
    2D NT
    IOTA-ADNEX
    BiometryAssist
    E-Cervix
    LumiFlow
    ShadowHDR
    MPI+*
    Slice A
    HeartAssist *
    ViewAssist |
    | Transducers | L3-12A
    LA2-9A
    LA4-18B
    CA1-7A
    CA2-9A
    CA3-10A
    CF4-9
    E3-12A
    EA2-11B
    VR5-9
    PA4-12B
    PA3-8B
    PM1-6A
    CV1-8A
    EV3-10B
    EV2-10A
    EA2-11AV
    EA2-11AR
    LA2-14A | L3-12A
    LA2-9A
    LA4-18B
    CA1-7A
    CA2-9A
    CA3-10A
    CF4-9
    E3-12A
    EA2-11B
    VR5-9
    PA4-12B
    PA3-8B
    PM1-6A
    CV1-8A
    EV3-10B
    EV2-10A
    EA2-11AV
    EA2-11AR
    LA2-14A |

5

  • Note : SW feature is supported in HERA W10 only.
  • . The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
  • . The proposed HERA W9/ HERA W10 and predicate HERA W9/ HERA W10 (K211824) have the same clinical intended use, imaging modes and modes of operation.
  • The proposed HERA W9/ HERA W10 have expanded the measurement parts of BiometryAssist . (AI version) in the previously cleared HERA W9/ HERA W10 (K211824).
  • . The proposed HERA W9 HERA W10 have expanded the view recognition and the annotation of ViewAssist (AI version) in the previously cleared HERA W9/ HERA W10 (K211824)

6

SAMSUNG

  • . The proposed HERA W9/ HERA W10 have added the 14 inch touch monitor as an option.
  • The proposed HERA W9/ HERA W10 and predicate HERA W9/ HERA W10(K211824) have ● same capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
  • The proposed HERA W9/ HERA W10 and predicate HERA W9/ HERA W10(K211824) have been designed in compliance with approved electrical and physical safety standards.
  • The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
  • . The systems have acoustic power levels which are below the applicable FDA limits.
DifferenceHERA W9HERA W10
SoftwareCrystalVue FlowNot SupportedSupported
MPI+Not SupportedSupported
HeartAssistNot SupportedSupported
HardwareInternal DVDNot IncludedIncluded
Caster size5"6"
Active array probe port3 port (default), 4 port(option)4 port
Main monitor21.5"/ 23.8"21.5"/ 23" / 23.8"

The differences between HERA W9 and HERA W10 in the subject device are as below.

10. Summary of Non-Clinical Test

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The HERA W9/ HERA W10 and its applications comply with voluntary standards.

Reference No.Title
IEC 60601-1ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010
/(R)2012
Medical Electrical Equipment - Part 1: General Requirements for basic safety and
essential performance.
IEC 60601-1-2IEC60601-1-2: 2014(4th Edition), Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance - EMC
IEC 60601-2-37IEC60601-2-37:2007 + A1:2015, Particular requirements for the safety of ultrasonic
medical diagnostic and monitoring equipment
ISO10993-1ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing
within a risk management process.
ISO14971ISO 14971:2007, Medical devices - Application of risk management to medical devices
NEMA UD 2-2004NEMA UD 2-2004 (R2009)
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision
3

In addition to conformance to the above harmonized standards, HERA W9 / HERA W10 quality assurance activities include the following:

  • Risk analysis and mitigation ●
  • . Software verification and validation testing
  • . System verification and validation testing
  • Image quality tests .

7

Image /page/7/Picture/0 description: The image shows the word "SAMSUNG" in all capital letters. The letters are a dark blue color. The background is white.

11. Summary of Clinical Tests

The subject of this premarket submission, HERA W9/ HERA W10, did not require clinical studies to support substantial equivalence.

12. Conclusion

Intended uses and other key features are consistent with traditional clinical practices and FDA guidelines. The design, development and quality process of the manufacturer confirms with 21 CFR 820 and ISO 13485. The device is designed to conform to applicable medical device safety standards and compliance. Therefore, SAMSUNG MEDISON CO., LTD. considers the HERA W9/ HERA W10 to be as safe, as effective, and provide performance substantially equivalent to the primary predicate device(K211824).

END of 510(k) Summary