(121 days)
No
The document does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No
The device is described as a "diagnostic ultrasound system" intended for "clinical diagnosis of patients" and to "make a diagnosis". It does not describe treating or curing a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids." and "It can be used in hospitals... for clinical diagnosis of patients." The "Device Description" also refers to it as a "diagnostic ultrasound system" and mentions that it "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" and mentions "probes" in the intended use, indicating it includes hardware components for acquiring ultrasound data.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "diagnostic ultrasound system and probes" designed to "obtain ultrasound images and analyze body fluids." While it mentions analyzing body fluids, the primary function and the detailed description of its modes of operation (2D, Doppler, M mode, etc.) are all related to ultrasound imaging.
- Intended Use: The intended use focuses on obtaining ultrasound images for clinical diagnosis across various anatomical sites.
- Lack of IVD-Specific Information: The document does not mention any specific tests performed on biological samples, reagents used, or any other characteristics typical of an IVD.
The mention of "analyze body fluids" is a bit ambiguous in the context of an ultrasound system. It's possible this refers to analyzing the characteristics of fluids within the body using ultrasound (e.g., blood flow analysis with Doppler), rather than analyzing samples taken from the body. However, the overwhelming focus of the description is on imaging.
Therefore, based on the provided information, this device is a diagnostic ultrasound system, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The diagnostic ultrasound 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, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Peripheral vessel and Lung.
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 (includes emergency room), 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 HM70 EVO is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging(S-Harmonic). Tissue Doppler imaging, Tissue Doppler Wave, Panoramic Imaging, Freehand 3D, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HM70 EVO 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 HM70 EVO has 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
Not Found
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, Peripheral vessel and Lung.
Indicated Patient Age Range
Not Found
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 (includes emergency room), 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, HM70 EVO, is not required clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
July 9, 2021
Image /page/0/Picture/1 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 in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Samsung Medison CO., LTD. % Jee Young Ju Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, Gangwon-do 25108 REPUBLIC OF KOREA
Re: K210713
Trade/Device Name: HM70 EVO 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: June 7, 2021 Received: June 10, 2021
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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.
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
K210713
Device Name HM70 EVO Diagnostic Ultrasound System
Indications for Use (Describe)
The diagnostic ultrasound 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, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Peripheral vessel and Lung.
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 (includes emergency room), 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) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
SAMSUNG MEDISON Co., Ltd.
510(k) Premarket Notification – Traditional
K210713
5. 510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
- Date Prepared March 05, 2021 1.
-
- Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108, REPUBLIC OF KOREA
- Primary Contact Person 3. Jee Young Ju Regulatory Affairs Specialist Phone: +82.2.2194.0861 Fax: +82.2.556.9537 Email: jee.ju@samsungmedison.com
-
- Secondary Contact Person Ninad Gujar Vice President of Regulatory & Quality Phone: +1.978.564.8632 Fax: +1.978.564.8677 Email: ngujar@neurologica.com
-
- Proposed Device
- Proprietary Name: HM70 EVO Diagnostic Ultrasound System
- Common Name: System, Imaging, Pulsed Doppler, Ultrasonic System, Imaging, Pulsed Echo, Ultrasonic Transducer, Ultrasonic, Diagnostic
- Classification: 21 CFR 892.1550 Ultrasonic pulsed doppler imaging system 21 CFR 892.1560 Ultrasonic pulsed echo imaging system
- 21 CFR 892.1570 Diagnostic ultrasonic transducer
- Product Code(s): IYN, IYO, ITX
- Predicate Device 6.
| HS40 Diagnostic Ultrasound System (K200339) | - Primary Predicate |
|---|---|
| HM70A Diagnostic Ultrasound System (K182894) | - Reference Device |
| UGEO PT60A Diagnostic Ultrasound System(K142466) | - Reference Device |
-
- Device Description
The HM70 EVO is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging(S-Harmonic). Tissue Doppler imaging, Tissue Doppler Wave, Panoramic Imaging, Freehand 3D, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a
- Device Description
4
SAMSUNG MEDISON Co., Ltd.
510(k) Premarket Notification - Traditional
combination of these modes. The HM70 EVO 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 HM70 EVO has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
-
- Indications for Use
The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids.
- Indications for 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, Peripheral vessel and Lung.
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 (includes emergency room), 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.
-
- Technology
The HM70 EVO employs the same fundamental scientific technology as its predicate devices.
- Technology
-
- Determination of Substantial Equivalence
Comparison to Predicates: The HM70 EVO is substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.
- Determination of Substantial Equivalence
-
The systems are all intended for diagnostic ultrasound imaging and fluid flow . analysis
-
The proposed HM70 EVO and predicates HS40(K200339), HM70A(K182894) . have the same clinical intended use, imaging modes and modes of operation.
-
. The proposed HM70 EVO has added the CA4-10M of new transducer.
-
. The proposed HM70 EVO has added the lung application already cleared in UGEO PT60A(K142466).
-
. The system is manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
5
SAMSUNG MEDISON Co., Ltd.
510(k) Premarket Notification – Traditional
- The system has acoustic power levels which are below the applicable FDA limits. ●
- The proposed HM70 EVO and predicate HS40(K200339), HM70A(K182894), . have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
- . The proposed HM70 EVO and predicates have been designed in compliance with approved electrical and physical safety standards.
-
- Summary of Non-Clinical Test
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 HM70 EVO 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 | 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
The subject of this premarket submission, HM70 EVO, is not required clinical studies to support substantial equivalence.
- Summary of Clinical Tests
-
- Conclusion
Since the predicates device and subject device have a similar intended use and kev technological features, the non-clinical data support the safety of the device and demonstrate that the HM70 EVO 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 devices that are currently marketed for the same intended use.
- Conclusion
-
END of 510(k) Summary i