(77 days)
Yes
The summary explicitly states that the device includes new software features (NerveTrack and UterineAssist) based on AI.
No
The device is described as a "diagnostic ultrasound system" and its intended use is for "clinical diagnosis of patients," not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "clinical diagnosis of patients" and the "Device Description" states it is a "diagnostic ultrasound system" and that its analysis packages provide information "used to make a diagnosis".
No
The device description explicitly states it is a "diagnostic ultrasound system" and mentions "probes," which are hardware components essential for acquiring ultrasound data. While it is software-controlled and includes software features, it is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Function: The V8 diagnostic ultrasound system is described as acquiring and displaying ultrasound data to create images of internal anatomical structures. It also analyzes body fluids, but the primary function and the majority of the described applications relate to imaging.
- Intended Use: The intended use focuses on obtaining ultrasound images and analyzing body fluids for clinical diagnosis. While analyzing body fluids is mentioned, the context of the device description and applications strongly suggests this is done in conjunction with or as part of the ultrasound examination, not as a standalone in-vitro test.
- Clinical Applications: All listed clinical applications are related to imaging internal body structures using ultrasound.
- Modes of Operation: All listed modes of operation are related to different ways of acquiring and displaying ultrasound data.
- Device Description: The description emphasizes acquiring and displaying ultrasound data as images.
- Lack of Mention of Specimen Analysis: There is no mention of analyzing specimens derived from the human body in a laboratory setting, which is a key characteristic of IVDs.
While the device does analyze body fluids, the overall context and description point to it being a diagnostic imaging device that may incorporate some fluid analysis capabilities within the imaging process, rather than a device primarily designed for in-vitro testing of specimens.
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) and relevant text' section is marked 'Not Found'.
Intended Use / Indications for Use
The V8 diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obsterics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-raginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Trans-esophageal (Cardiac) 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, 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 V8 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, 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. The V8 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 V8 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
- The proposed V8 has migrated new SW feature (NerveTrack) based on AI and new transducer (CA4-10M) from predicate HS40 (K210426).
- The proposed V8 has included new SW feature (UterineAssist) based on AI. The UterineAssist is used for non-invasive processing of ultrasound images to detect, measure and calculate relevant medical parameters of uterus.
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Trans-esophageal (Cardiac) and Peripheral vessel.
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, 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 V8 Ultrasound System did not require clinical studies to demonstrate 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
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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
Samsung Medison Co., Ltd. % Scully KIM Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, Gangwon-do 25108 REPUBLIC OF KOREA
September 8, 2021
Re: K211945
Trade/Device Name: V8 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 22, 2021 Received: June 23, 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); 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
Indications for Use
510(k) Number (if known)
Device Name
V8 Diagnostic Ultrasound System
Indications for Use (Describe)
The V8 diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obsterics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-raginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Trans-esophageal (Cardiac) 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, 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) |
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
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
Traditional 510(k) V8 Diagnostic Ultrasound System
510(K) Summary:
In accordance with 21 CFR 807.92 the following summary of information is provided:
-
Date Prepared June 22, 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 4. Ninad Gujar Vice President Phone: +1.978.564.8632 Fax: +1.978.564.8677 Email: ngujar@neurologica.com
-
- Proposed Device
-
Common/Usual Name : Diagnostic Ultrasound System and Accessories -
-
Proprietary Name : V8 Diagnostic Ultrasound System -
- Regulation Name : Ultrasonic pulsed doppler imaging system
-
Regulatory Class : Class II -
-
Product Code : IYN, IYO, ITX -
-
-Regulation Number : 21 CFR 892.1550, 892.1560, 892.1570
-
Predicate Devices 6.
-
- Device Description
The V8 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, 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. The V8 also gives the operator the ability to measure anatomical structures
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 background is white, which makes the blue letters stand out.
and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The V8 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
- Intended Use 8.
The V8 diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Trans-esophageal (Cardiac) 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 mode(Dual, Quad), 3D/4D mode.
-
- Technological Comparison to Predicate Devices
The V8 employs the same fundamental scientific technology as its predicate device RS85 (K192903) system.
- Technological Comparison to Predicate Devices
-
- Determination of Substantial Equivalence
Comparison to Predicate: The V8 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 V8 and predicate RS85 (K192903) have the same clinical intended use.
-
. The proposed V8 and predicate RS85 (K192903) have the same imaging modes and modes of operation.
-
. The Thoracic application has been included to system indications for use to support Lung scanning which is previously cleared in UGEO PT60A(K142466).
-
. The proposed V8 has migrated new SW feature (NerveTrack) based on AI and new transducer (CA4-10M) from predicate HS40 (K210426).
-
. The proposed V8 has included new SW feature (UterineAssist) based on AI. The UterineAssist is used for non-invasive processing of ultrasound images to detect, measure and calculate relevant medical parameters of uterus. It provides
5
Image /page/5/Picture/0 description: The image shows the word "SAMSUNG" in all capital letters. The font is a bold sans-serif typeface, and the color of the text is a dark blue. The background is plain white, which makes the text stand out.
similar indication for use of LVivo Software Application previously cleared (K200232).
- . The proposed V8 has included two new transducers LA4-18A and LA3-22AI. The Biocompatibility and Image Performance Test have been conducted, and their test reports are included in this submission.
- . The proposed V8 and predicate RS85 (K192903) have same capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
- . The proposed V8 and predicate RS85 (K192903) have been designed in compliance with approved electrical and physical safety standards.
- The system is manufactured with materials which have been evaluated and found ● to be safe for the intended use of the device.
- . The system has acoustic power levels which are below the applicable FDA limits.
-
- 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 V8 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 |
12. Summary of Clinical Tests
The proposed device V8 Ultrasound System did not require clinical studies to demonstrate substantial equivalence.
6
Image /page/6/Picture/0 description: The image shows the word "SAMSUNG" in a bold, sans-serif font. The color of the text is a dark blue. The letters are evenly spaced and the word is centered in the image.
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 V8 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 primary predicate device that is currently marketed for the same intended use.
- END of 510(k) Summary