(100 days)
Not Found
Yes
The document explicitly mentions "deep learning based segmentation algorithm" and "deep learning based view recognition algorithm" which are forms of machine learning. It also refers to "BiometryAssist (AI version)" and "ViewAssist (AI version)".
No
The device is described as a "Diagnostic Ultrasound System" intended for "diagnostic ultrasound imaging and fluid analysis," and its purpose is to "acquire ultrasound data and to display the data" and "measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis". It does not describe any therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states "The Diagnostic Ultrasound System... are intended for diagnostic ultrasound imaging and fluid analysis of the human body." It further clarifies its purpose for "clinical diagnosis of patients." The "Device Description" also refers to the devices as "general purpose, mobile, software controlled, diagnostic ultrasound system."
No
The device description explicitly states that the HERA W9/HERA W10 are "diagnostic ultrasound system," which are hardware devices that acquire ultrasound data. While the system is software-controlled and includes AI features, it is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging and fluid analysis of the human body." This describes an imaging system that uses ultrasound waves to visualize internal structures and analyze fluids within the body.
- Device Description: The description details how the system acquires and displays ultrasound data in various modes. It also mentions analysis packages that provide information for diagnosis, but this information is derived from the ultrasound images, not from testing samples outside the body.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) obtained from the human body to provide information for diagnosis, monitoring, or screening. This document does not mention the collection or analysis of any such specimens.
The device is a diagnostic ultrasound system, which is a medical device used for imaging, but it does not fit the definition of an In Vitro Diagnostic device.
No
The input explicitly states "Control Plan Authorized (PCCP) and relevant text: Not Found", meaning the letter does not confirm FDA's review and approval or clearance of a PCCP for this device.
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, 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+TM Mode, Combined modes, Multi-Image modes (Dual, Quad), 3D/4D modes.
Product codes
IYN, IYO, ITX
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 Bmode, 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.
Mentions image processing
Acquire ultrasound data and to display the data as Bmode, 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.
Mentions AI, DNN, or ML
Yes, AI appears in "BiometryAssist (AI version)" and "ViewAssist (AI version)".
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel. (also Trans-vaginal in the 510(k) Summary)
Indicated Patient Age Range
Adult, Pediatric, Neonatal (Cephalic), Fetal
Intended User / Care Setting
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. The document only specifies "Data used for training, tuning and validation purpose are completely separated from the ones during training process and there is no overlap between the three."
Description of the test set, sample size, data source, and annotation protocol
BiometryAssist:
- Sample Size: 320 fetal biometry images
- Data Source: Collected at two hospitals (South Korea and United States). Mix of data from retrospective data collection and prospective data collection in clinical practice. Acquired with SAMSUNG MEDISON's ultrasound systems (W10, W9).
- Annotation Protocol ("Truthing" process): All acquired images for training, tuning and validation were first classified into the correct views by three participating experts. Afterwards, corresponding anatomy areas were manually drawn for each of the image. The participating experts were composed of an obstetrician with more than 20 years of experience and two sonographers with more than 10 years of experience, all in fetal cardiology. The entire process was supervised by another obstetrician with more than 25 years of experience.
- Independence of test data: Data used for training, tuning and validation purpose are completely separated from the ones during training process and there is no overlap between the three.
ViewAssist:
- Sample Size: 1,320 fetal heart and fetal biometry images
- Data Source: Collected at two hospitals (South Korea and United States). Mix of data from retrospective data collection and prospective data collection in clinical practice. Acquired with SAMSUNG MEDISON's ultrasound systems (W10, W9).
- Annotation Protocol ("Truthing" process): All acquired images for training, tuning and validation were first classified into the correct views by three participating experts. Afterwards, corresponding anatomy areas were manually drawn for each of the image. The participating experts were composed of an obstetrician with more than 20 years of experience and two sonographers with more than 10 years of experience, all in fetal cardiology. The entire process was supervised by another obstetrician with more than 25 years of experience.
- Independence of test data: Data used for training, tuning and validation purpose are completely separated from the ones during training process and there is no overlap between the three.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Test
[The Summary of Testing for BiometryAssist]
- Study Type: Validation of deep learning based algorithms for segmentation and size measurement.
- Sample Size: 320 fetal biometry images.
- Key Results:
- Segmentation test:
- A deep learning based segmentation algorithm was validated.
- The average dice-score is 0.91 (threshold 0.8).
- Size measurement test:
- The error rate of circumference measured value is 8% or less.
- The error rate of distance measured value is 4% or less.
- The error rate of NT measured value is 1mm or less.
- Segmentation test:
[The Summary of Testing for ViewAssist]
- Study Type: Validation of deep learning based algorithms for view recognition and anatomy annotation (segmentation).
- Sample Size: 1,320 fetal heart and fetal biometry images.
- Key Results:
- View recognition test:
- A deep learning based view recognition algorithm was validated.
- The average recognition accuracy is 94.70% (threshold 89%).
- Anatomy annotation (segmentation) test:
- A deep learning based segmentation algorithm was validated.
- The average dice-score is 0.875 (threshold 0.8).
- View recognition test:
Summary of Clinical Tests
The subject of this premarket submission, HERA W9/ HERA W10, did not require clinical studies to demonstrate the substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
BiometryAssist:
- Segmentation test: average dice-score is 0.91 (threshold 0.8)
- Size measurement test:
- error rate of circumference measured value is 8% or less.
- error rate of distance measured value is 4% or less.
- error rate of NT measured value is 1mm or less.
ViewAssist:
- View recognition test: average recognition accuracy is 94.70% (threshold 89%)
- Anatomy annotation (segmentation) test: average dice-score is 0.875 (threshold 0.8)
Predicate Device(s)
HERA W9. HERA W10 Diagnostic Ultrasound System (K220043)
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.
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April 21, 2023
SAMSUNG MEDISON CO., LTD. % So-Yeon Jang Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, Gangwon-do 25108 SOUTH KOREA
Re: K230084
Trade/Device Name: HERA W10 Diagnostic Ultrasound System: HERA W9 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: March 8, 2023 Received: March 14, 2023
Dear So-Yeon Jang:
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
1
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 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,
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230084
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, 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+TM 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) |
---|---|
----------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------- |
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SAMSUNG
510(k) Summarv
In accordance with 21 CFR 807.92 the following summary of information is provided:
-
- Date Prepared - January 05, 2023
-
- Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do, 25108, REPUBLIC OF KOREA
-
- Primary Contact Person So-Yeon Jang Regulatory Affairs Specialist Phone: +82.2.2194.0875 Fax: +82. 2.2194.0278 Email: sy24.jang@samsungmedison.com
-
- Secondary Contact Person Ninad Gujar Vice President Phone: +1.978.564.8632 Fax: +1.978.564.8677 Email: ngujar@neurologica.com
- న్. 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, 892.1560, 892.1570
-
- Predicate Device
- HERA W9. HERA W10 Diagnostic Ultrasound System (K220043) Primary Predicate –
-
- 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 Bmode, 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.
4
Image /page/4/Picture/0 description: The image contains the word "SAMSUNG" in all capital letters. The word is written in a bold, sans-serif font. The color of the text is blue.
8. 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.
-
- Technology
The HERA W9/ HERA W10 employ the same fundamental scientific technology as its predicate devices.
- Technology
-
- 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.
- Determination of Substantial Equivalence
| Feature | HERA W9/HERA W10
(Under Review) | HERA W9/HERA W10 (K220043)
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 | 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 |
| Feature | HERA W9 /HERA W10
(Under Review) | HERA W9/HERA W10 (K220043)
Primary Predicate |
| | - 3D MagiCut
- Volume Calculation
- (VOCAL, XI VOCAL) XI STIC
- HDVI
- Realistic Vue
- 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 | - 3D MagiCut
- Volume Calculation
- (VOCAL, XI VOCAL) XI STIC
- 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 |
| Transducers | - HeartAssist * - ViewAssist
- 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
- PA1-5A | - HeartAssist *
- View Assist
- 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
- PA1-5A |
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- Note : This 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 (K220043) have the same clinical intended use, imaging modes and modes of operation.
- . The proposed HERA W9/ HERA W10 have expanded the measurement parts of
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Image /page/6/Picture/0 description: The image shows the word "SAMSUNG" in all capital letters. The word is written in a bold, sans-serif font. The color of the text is blue, and the background is white.
BiometryAssist (AI version) in the previously cleared HERA W9/ HERA W10 (K220043).
- . 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 (K220043)
- The proposed HERA W9/ HERA W10 have included a new transducer EV2-12. Biocompatibility has been evaluated and image performance tests have been conducted.
- . The proposed HERA W9/ HERA W10 have added a 27 inch OLED monitor to the main monitors.
- . The proposed HERA W9/ HERA W10 and predicate HERA W9/ HERA W 10(K220043) 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(K220043) have been designed in compliance with approved electrical and physical safety standards.
- . The systems are manufactured with materials that 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 limit defined by FDA.
Difference | HERA W9 | HERA W10 | |
---|---|---|---|
Software | CrystalVue Flow | Not Supported | Supported |
MPI+ | Not Supported | Supported | |
HeartAssist | Not Supported | Supported | |
Internal DVD | Not Included | Included | |
Hardware | Caster size | 5" | 6" |
Active array probe port | 3 port (default), | ||
4 port(option) | 4 port | ||
Main monitor | 21.5"/ 23.8" / 27" | 21.5"/ 23" / 23.8" / 27" |
The differences between HERA W9 and HERA W10 in the subject device are as below
-
- Summary of Non-Clinical Test
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, 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 the following FDA-recognized standards.
- Summary of Non-Clinical Test
Reference No. | Title |
---|---|
IEC 60601-1 | ANSI 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 60601-1-2 | IEC60601-1-2: 2020(4.1 Edition), Medical electrical equipment - Part 1-2 |
General requirements for basic safety and essential performance - EMC |
7
IEC 60601-2-37 | IEC60601-2-37:2007 + A1:2015, Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment |
---|---|
ISO10993-1 | ISO 10993-1:2018, Biological evaluation of medical devices -- Part 1 Evaluation and testing within a risk management process. |
ISO14971 | ISO 14971:2019, Medical devices - Application of risk management to medical devices |
NEMA UD 2-2004 | NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 |
[The Summary of Testing for BiometryAssist]
-
Summary test statistics or other test results including acceptance criteria or other information supporting the appropriateness of the characterized performance.
We tested on two areas: Segmentation and Size measurement. -
□ Segmentation test
-
் A deep learning based segmentation algorithm was validated using 320 fetal biometry images collected at two hospitals (South Korea and United States).
-
· The average dice-score is 0.91 (threshold 0.8)
-
□ Size measurement test
-
· We use same datasets of segmentation test.
-
· The error rate of circumference measured value is 8% or less.
-
· The error rate of distance measured value is 4% or less.
-
· The error rate of NT measured value is 1mm or less.
■ Demographic distribution:
- □ Gender: Female
- □ Age: Reproductive age, specific age not collected
- □ Ethnicity/Country: Not Available / United States and South Korea
- Information about clinical subgroups and confounders present in the dataset:
- | | We divided the fetal ultrasound images, depending on the ISUOG and AIUM guidelines, into 8 views.
- Information about equipment and protocols used to collect images
- We acquired the data set with SAMSUNG MEDISON's ultrasound systems (W10, W9) in order to secure diversity of the data set: Mix of data from retrospective data collection and prospective data collection in clinical practice
- Information about how the reference standard was derived from the dataset (i.e. the "Truthing" process):
- | All acquired images for training, tuning and validation were first classified into the correct views by three participating experts. Afterwards, corresponding anatomy areas
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Image /page/8/Picture/0 description: The image shows the word "SAMSUNG" in a bold, sans-serif font. The word is written in blue color. The background is white.
were manually drawn for each of the image.
- The participating experts were composed of an obstetrician with more than 20 years of experience and two sonographers with more than 10 years of experience, all in fetal cardiology. The entire process was supervised by another obstetrician with more than 25 years of experience.
- Description of how the independence of test data from training data was ensured:
- Data used for training, tuning and validation purpose are completely separated from the ones during training process and there is no overlap between the three.
[The Summary of Testing for ViewAssist]
- Summary test statistics or other test results including acceptance criteria or other information supporting the appropriateness of the characterized performance.
We tested on two areas: view recognition and anatomy annotation(segmentation).
□ View recognition test
- · A deep learning based view recognition algorithm was validated using 1,320 fetal heart and fetal biometry images collected at two hospitals (South Korea and United States).
- · The average recognition accuracy is 94.70% (threshold 89%)
- □ Anatomy annotation(segmentation) test
- ் A deep learning based segmentation algorithm was validated using 1,320 fetal heart and fetal biometry images collected at two hospitals.
- · The average dice-score is 0.875 (threshold 0.8)
■ Demographic distribution:
- □ Gender: Female
- □ Age: Reproductive age, specific age not collected
- □ Ethnicity/Country: Not Available / United States and South Korea
■ Information about clinical subgroups and confounders present in the dataset:
- [ We divided the fetal ultrasound images, depending on the ISUOG and AIUM guidelines, into 33 views.
- Information about equipment and protocols used to collect images
- [ We acquired the data set with SAMSUNG MEDISON's ultrasound systems (W10, W9) in order to secure diversity of the data set: Mix of data from retrospective data collection and prospective data collection in clinical practice
- Information about how the reference standard was derived from the dataset (i.e. the "Truthing" process):
- [ All acquired images for training, tuning and validation were first classified into the
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correct views by three participating experts. Afterwards, corresponding anatomy areas were manually drawn for each of the image.
- | | The participating experts were composed of an obstetrician with more than 20 years of experience and two sonographers with more than 10 years of experience, all in fetal cardiology. The entire process was supervised by another obstetrician with more than 25 years of experience.
- Description of how the independence of test data from training data was ensured:
- [] Data used for training, tuning and validation purpose are completely separated from the ones during training process and there is no overlap between the three.
In addition to conformance to the harmonized standards above, 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 .
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- Summary of Clinical Tests
The subject of this premarket submission, HERA W9/ HERA W10, did not require clinical studies to demonstrate the substantial equivalence.
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- 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 subject device to be as safe, as effective, and performance is substantially equivalent to the primary predicate device(K220043) that is currently marketed for the same intended use.
- Conclusion
END of 510(k) Summary