(88 days)
HERA W9/ HERA W10 Diagnostic Ultrasound System (K192319)
No
The document does not mention AI, ML, or related terms like deep learning or neural networks in the device description or intended use.
No.
The device is explicitly stated to be for "diagnostic ultrasound imaging and fluid analysis of the human body" and its purpose is "to make a diagnosis," not to treat conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The HS50 / HS60 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body." Additionally, the "Device Description" mentions, "Its function is to acquire ultrasound data and to display the data... The HS50 / HS60 also gives 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."
No
The device description explicitly states it is a "Diagnostic Ultrasound System," which inherently includes hardware components (transducers, system unit) to acquire ultrasound data, in addition to the software that controls it and processes the data.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the HS50 / HS60 is a diagnostic ultrasound system. It acquires ultrasound data and displays it as images and measurements of the human body. It does not analyze samples taken from the body.
- Intended Use: The intended use describes imaging and fluid analysis of the human body, not analysis of samples from the human body.
- Modes of Operation: The modes of operation are all related to ultrasound imaging and Doppler techniques, not laboratory analysis of biological samples.
Therefore, the HS50 / HS60 Diagnostic Ultrasound System falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The HS50 / HS60 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, Trans-esophageal(Cardiac) and peripheral vessel.
If is intended for use by, or by the order of, and under the supervision of, a licensed physician 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 mode(Dual, Quad), 3D/4D mode.
Product codes
IYN, IYO, ITX
Device Description
The HS50 / HS60 are a 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. Color M mode. Anatomical mode. Color Doppler mode, Pulsed Wave (PW) Spectral Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, Power Doppler (PD) mode, ElastoScan Mode, 3D/4D/XI STIC imaging mode, Dual mode, Quad mode, Combined mode, Simultaneous mode and Zoom mode. The HS50 / HS60 also gives 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 HS50 / HS60 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 B mode, M mode. Color M mode. Anatomical mode. Color Doppler mode, Pulsed Wave (PW) Spectral Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, Power Doppler (PD) mode, ElastoScan Mode, 3D/4D/XI STIC imaging mode, Dual mode, Quad mode, Combined mode, Simultaneous mode and Zoom mode.
LumiFlow™ visualizes blood flow in three dimensional-like to help understand the structure of blood flow and small vessels intuitively.
Slab 3D is a volume rendering technology that visuals cross-sectional images near each plane as a thick slice by post-processing an acquired volume data.
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Ultrasound
Anatomical Site
Human body for general diagnostic ultrasound imaging and fluid analysis. 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, Trans-esophageal(Cardiac) and peripheral vessel.
Indicated Patient Age Range
Not specified (covers Neonatal Cephalic, Adult Cephalic, Pediatric, Adult).
Intended User / Care Setting
Intended for use by, or by the order of, and under the supervision of, a licensed physician 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 proposed device HS50 / HS60 Ultrasound System did not require clinical studies to demonstrate substantial equivalence. Non-clinical testing for acoustic output, biocompatibility, software function, cleaning and disinfection effectiveness, and thermal, electrical, electromagnetic and mechanical safety were performed and found to conform with applicable FDA guidance and medical device safety standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found.
Predicate Device(s)
HS50 / HS60 Diagnostic Ultrasound System (K192505)
Reference Device(s)
HERA W9/ HERA W10 Diagnostic Ultrasound System (K192319)
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
April 9, 2021
Image /page/0/Picture/1 description: The image contains 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 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. % Scully Kim Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, Gangwon-do 25108 REPUBLIC OF KOREA
Re: K210068
Trade/Device Name: HS50 Diagnostic Ultrasound System. HS60 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: February 19, 2021 Received: February 22, 2021
Dear Scully Kim:
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- 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.
Michael D. O'Hara
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
Indications for Use
Device Name HS50 / HS60 Diagnostic Ultrasound System
Indications for Use (Describe)
The HS50 / HS60 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, Trans-esophageal(Cardiac) and peripheral vessel.
If is intended for use by, or by the order of, and under the supervision of, a licensed physician 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 mode(Dual, Quad), 3D/4D mode.
| 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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510(K) Summary:
In accordance with 21 CFR 807.92 the following summary of information is provided:
- Date Prepared January 08, 2021 1.
-
- Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do, Republic of Korea
-
- Primary Contact Person Scully Kim Regulatory Affairs Specialist Phone: +82.2.2194.1312 Fax: +82. 2.2194.0273 Email: scully.kim(@samsungmedison.com
-
- Secondary Contact Person Ninad Gujar Director of Regulatory & Quality Phone: +1.978.564.8632 Fax: +1.978.564.8677 Email: ngujar@neurologica.com
- Proposed Device 5.
=
- Common/Usual Name : Diagnostic Ultrasound System and Accessories ਸ ਵੀ
- Proprietary Name : HS50 Diagnostic Ultrasound System
- HS60 Diagnostic Ultrasound System
- Proprietary Name : HS50 Diagnostic Ultrasound System
: Ultrasonic pulsed doppler imaging system
- -Regulation Name
- -Regulatory Class : Class II
- ह Product Code : IYN, IYO, ITX
- Regulation Number : 21 CFR 892.1550, 892.1560, 892.1570 -
-
- Predicate Devices
-
- Device Description
The HS50 / HS60 are a 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. Color M mode. Anatomical mode. Color Doppler mode, Pulsed Wave (PW) Spectral Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, Power Doppler (PD) mode, ElastoScan Mode, 3D/4D/XI STIC imaging mode, Dual mode, Quad mode, Combined mode, Simultaneous mode and Zoom mode. The HS50 / HS60 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information
4
that is used to make a diagnosis by competent health care professionals. The HS50 / HS60 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
-
- Intended Use
The HS50 / HS60 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
- Intended Use
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Transesophageal(Cardiac) and peripheral vessel.
It is intended for use by, or by the order of, and under the supervision of, a licensed physician 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 mode(Dual, Quad), 3D/4D mode.
- Technological Comparison to Predicate Devices 9. The HS50 / HS60 employ the same fundamental scientific technology as its predicate device HS50/ HS60 (K192505).
-
- Determination of Substantial Equivalence
Comparison to Predicate: The HS50/ HS60 are substantially equivalent to the predicate devices with regard to intended use. imaging capabilities, technological characteristics and safety and effectiveness.
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. The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
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. The proposed HS50/ HS60 and predicate HS50/ HS60 (K192505) have the same clinical intended use.
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. The proposed HS50/ HS60 and predicate HS50/ HS60 (K192505) have the same imaging modes and modes of operation.
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. The proposed HS50/ HS60 migrated new SW features MV-Flow™, LumiFlow™, S-Detect™ for Thyroid, Slab 3D from predicates HERA W9/HERA W10 (K192319).
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MV-Flow™ visualizes microcirculatory and slow blood flow to display the intensity of blood flow in color.
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LumiFlow™ visualizes blood flow in three dimensional-like to help understand the structure of blood flow and small vessels intuitively.
-
S-Detect™ for Thyroid analyzes selected lesions in the thyroid ultrasound study and shows the analysis data, provides standardized reporting based on the K-
5
TIRADS guidelines
-
Slab 3D is a volume rendering technology that visualizes cross-sectional images near each plane as a thick slice by post-processing an acquired volume data.
-
. The proposed HS50/ HS60 improved some of cleared SW functions.
- Added Zoom Box Reference Position
- UI improvement of Patient registration menu
- Increase the number of 2D Follicle detection from 30 to 50
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The proposed HS50/ HS60 and predicate HS50/ HS60 (K192505) have same . capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
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The proposed HS50/ HS60 and predicate HS50/ HS60 (K192505) have been . designed in compliance with approved electrical and physical safety standards.
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The system is manufactured with materials which have been evaluated and found . to be safe for the intended use of the device.
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. The system has acoustic power levels which are below the applicable FDA limits.
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- Summary of Non-Clinical Testing
The device has been evaluated for acoustic output, biocompatibility, software function, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable FDA guidance and medical device safety standards. The HS50/ HS60 and its applications comply with the following FDA-recognized standards.
| Reference No. | Title |
|---|---|
| IEC 60601-1 | AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 |
| and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment |
- Part 1: General requirements for basic safety and essential performance
(IEC 60601-1:2005, MOD) |
| IEC 60601-1-2 | IEC60601-1-2: 2014(4th Edition), Medical electrical equipment - Part 1-
2: General requirements for basic safety and essential performance -
EMC |
| IEC 60601-2-37 | IEC 60601-2-37 Edition 2.0 2007, Medical electrical equipment – Part 2-
37: Particular requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and monitoring equipment |
| ISO10993-1 | AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of
medical devices - Part 1: Evaluation and testing within a risk
management process |
| ISO14971 | ISO 14971:2007, 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 |
- Summary of Clinical Tests
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The proposed device HS50 / HS60 Ultrasound System did not require clinical studies to demonstrate substantial equivalence.
13. Conclusion
Since the predicate devices and subject device have a similar intended use and key technological features, the non-clinical data support the safety of the device and demonstrate that the HS50 / HS60 Ultrasound System should perform as intended in the specified use conditions. Therefore, SAMSUNG MEDISON CO., LTD. concludes that the performance of the subject device is as safe and effective, and is therefore substantially equivalent, to the predicate device(s) that are currently marketed for the same intended use.