(81 days)
Yes
The summary explicitly mentions "NerveTrack based on AI" and "A deep learning based segmentation algorithm" for UterineAssist, along with descriptions of training and test data for these features.
No
The device is described as a diagnostic ultrasound system intended for obtaining images and analyzing body fluids to aid in clinical diagnosis, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The HS40 diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids." and "...for clinical diagnosis of patients." The "Device Description" also mentions its function "...to make a diagnosis by competent health care professionals."
No
The device is described as a "diagnostic ultrasound system" and includes mentions of probes and acquiring ultrasound data, which are hardware components. While it is software-controlled and includes software features like AI algorithms, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is designed to "obtain ultrasound images and analyze body fluids." While it mentions analyzing body fluids, the primary function and the detailed clinical applications listed are all related to imaging and diagnosis based on those images.
- Device Description: The device description focuses entirely on the ultrasound system's capabilities for acquiring and displaying ultrasound data in various modes and providing measurement and analysis packages for diagnosis.
- Lack of In Vitro Testing: The description of the device, its operation, and the performance studies provided do not mention any components, processes, or tests that involve analyzing samples outside of the body (in vitro). The "analysis of body fluids" mentioned in the intended use is likely referring to the ability to visualize and potentially measure fluid collections within the body using ultrasound, not laboratory-style testing of collected fluid samples.
- Focus on Imaging and Anatomical Structures: The clinical applications and the performance studies (NerveTrack and UterineAssist) are all centered around visualizing and analyzing anatomical structures within the body using ultrasound.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. This device's function is to generate images of the inside of the body using ultrasound waves.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The HS40 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 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.
Product codes
IYN, IYO, ITX
Device Description
The HS40 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 HS40 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 HS40 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
Yes
Mentions AI, DNN, or ML
Yes
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. Specific nerves (Elbow : MN, UN, RN / Neck&Shoulder : ISBP, SCBP, AxBP), Uterus.
Indicated Patient Age Range
Age range: 22~68 for NerveTrack testing.
Gender: Female. Age: Reproductive age, specific age not collected for UterineAssist testing.
Intended User / Care Setting
It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients.
Description of the training set, sample size, data source, and annotation protocol
The training data used for the training of the NerveTrack algorithm are independent of the data used to test the NerveTrack algorithm.
Data used for test/training validation purpose are completely separated from the ones during training process and there is no overlap between the two.
Description of the test set, sample size, data source, and annotation protocol
NerveTrack:
Testing Data Information:
Number of Subjects: 18 (13 Females, 5 Males)
Number of Images: 2,146 (1,168 Females, 978 Males)
Age range: 2268 (3268 Females, 2250 Males)31.5 (16~27.1 Females, 31.5 Males)
Average age: 42.7 (45.7 Females, 35.0 Males)
BMI range: 16
Average BMI: 21.5 (20.5 Females, 31.5 Males)
Ethnicity: All Koreans
Data acquisition: All the nerve data were acquired on Samsung ultrasound devices including HS40. When collecting scan data, the speed of the probe varies from about 1cm to 5cm per second. The orientation of the probe was short-axis imaging and perpendicular to the skin, obtained by sliding the probe in both the proximal and distal directions.
Annotation protocol: Ten anesthesiologists and five sonographers with more than 10 years of experience participated to establish the ground truth (GT) for the location of 8 different kinds of nerves. One anesthesiologist who scanned the ultrasound directly drew the GT of nerve location, and two or more other anesthesiologists and sonographers reviewed and confirmed that it was correct. If there was any mistake during the review, it was revised again.
UterineAssist:
Segmentation test: 450 sagittal uterus images and 150 transverse uterus images collected at three hospitals.
Feature points extraction test: 45 sagittal and 41 transverse plane images of uterus collected at three hospitals.
Demographic distribution: Gender: Female, Age: Reproductive age, specific age not collected, Ethnicity/Country: All Koreans.
Information about clinical subgroups and confounders present in the dataset: Sagittal uterus images divided into 4 phases: early proliferative, peri-ovulatory, secretory, and post-menopause based on endometrium shape. Differentiation made between good image quality and challenging image quality dataset.
Information about equipment and protocols used to collect images: Data set acquired with 4 SAMSUNG MEDISON's ultrasound systems and probes to secure diversity. 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): Segmentation of the ground truth was generated by three participating OB/GYN experts with more than 10 years' experience. The set of images (uterus and endometrium) were divided into 3 subsets and the three participating OB/GYN experts each drew the ground truths for one of the subsets. The ground truths drawn by an expert were cross-checked by the other two experts. Any images that do not meet the inclusion/exclusion criteria were excluded from the set of images.
Summary of Performance Studies
NerveTrack:
Study type: Validation for expansion of the detection nerve of NerveTrack based on AI.
Acceptance Criteria:
Accuracy (%): (Number of correctly detected frames / Total number of frames with nerve) x 100 ≥ 80%
Speed (FPS): 1000 / Average latency time of each frame (msec) ≥ 2 FPS
Summary Performance data:
Accuracy (%): Average 91.7, Standard Deviation 5.6, 95% CI 89.5 to 93.9
Speed (FPS): Average 7.93, Standard Deviation 1.11, 95% CI 7.04 to 8.82
Key results: The standalone performance of NerveTrack was evaluated for BMI (Body Mass Index) subgroups. We evaluated the performance for the four groups (underweight, healthy weight, overweight, obesity) and observed very good generalizability for BMI. Because the average accuracy of all subgroups are included within the confidence interval of the accuracy for the full dataset. The depth range was set 2.5cm to 4.5cm and the maximum depth of the detected nerve was 3.31 cm from skin. When we calculate the relationship between BMI and the maximum depth of nerves, it shows a low correlation and no significant difference of NerveTrack performance according to the patient's BMI information. So, we believe that our model is robust even if the cases with various BMI information exist.
UterineAssist:
Study type: Summary of Testing for UterineAssist, three areas tested: image segmentation, feature points extraction, and size measurement.
Segmentation test:
Average dice-score of uterus is 96%
Average dice-score of endometrium is 92%
Feature points extraction test:
Errors of uterus feature points are 5.8 mm or less
Errors of endometrium feature points are 4.3 mm or less
Size measurement test:
Errors of Measurements performance are 2.0 mm or less
Key Metrics
NerveTrack:
Accuracy (%): 91.7 (Average)
Speed (FPS): 7.93 (Average)
UterineAssist:
Dice-score of uterus: 96% (average)
Dice-score of endometrium: 92% (average)
Error of uterus feature points: 5.8 mm or less
Error of endometrium feature points: 4.3 mm or less
Errors of Measurements performance: 2.0 mm or less
Predicate Device(s)
HS40 Diagnostic Ultrasound System (K210426)
Reference Device(s)
HM70 EVO Diagnostic Ultrasound System (K220269)
V8 Diagnostic Ultrasound System (K211945)
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
August 22, 2022
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Samsung Medison Co., Ltd. % Jee Young Ju Regulatory Affairs Specialist 3366. Hanseo-ro. Nam-myeon Hongcheon-gun, Gangwon-do 25108 KOREA
Re: K221599
Trade/Device Name: HS40 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: August 2, 2022 Received: August 10, 2022
Dear Jee Young Ju:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
For
Michael D. O'Hara, Ph.D. Deputy 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
2
Indications for Use
510(k) Number (if known) K221599
Device Name HS40 Diagnostic Ultrasound System
Indications for Use (Describe)
The HS40 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 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.
| 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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3
510(k) Premarket Notification – Traditional
K221599
5. 510(K) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
- Date Prepared May 31, 2022 1.
-
- Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108, REPUBLIC OF KOREA
-
- Primary Contact Person Jee Young Ju Regulatory Affairs Specialist Phone: +82.2.2194.0861 Fax: +82.2.2194.0278
Email: jee.ju(@samsungmedison.com
-
- Secondary Contact Person Ninad Gujar Vice President Phone: +1.978.564.8632 Fax: +1.978.564.8677 Email: ngujar@neurologica.com
5. Proposed Device
- Proprietary Name: HS40 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
6. Predicate Device
| HS40 Diagnostic Ultrasound System (K210426) | – Primary Predicate |
|---|---|
| HM70 EVO Diagnostic Ultrasound System (K220269) | – Reference |
| V8 Diagnostic Ultrasound System (K211945) | – Reference |
-
- Device Description
The HS40 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-
- Device Description
4
510(k) Premarket Notification - Traditional
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 HS40 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 HS40 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 HS40 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-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 mode(Dual, Quad), 3D/4D mode.
-
- Technology The HS40 employs the same fundamental scientific technology as its predicate device(s).
-
- Determination of Substantial Equivalence
Comparison to Predicate: The HS40 is substantially equivalent to the predicate device(s) with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.
- The systems are all intended for diagnostic ultrasound imaging and fluid flow ● analysis
- The proposed HS40 and predicate HS40(K210426) have the same clinical intended . use.
- . The proposed HS40 and predicate HS40(K210426) have the same imaging modes and modes of operation.
- . The proposed HS40 has added the UterineAssist based on AI already cleared in the predicate devce V8(K211945) and expanded the detection nerve type (Elbow : MN, UN, RN / Neck&Shoulder : ISBP, SCBP, AxBP) of NerveTrack based on AI in the
5
510(k) Premarket Notification – Traditional
previously cleared HS40(K210426).
- . The proposed HS40 has added the LA2-9S, PA3-9B, PA1-5A and CA1-7AD transducers from already cleared in predicate device HM70 EVO(K220269).
- The proposed HS40 has changed the housing material of EV2-10A transducer and . specification of caster (4 locking or 3 locking + 1 non-locking type).
- 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. .
- The proposed HS40 and predicate HS40 (K210426) have similar capability in terms ● of performing measurements, capturing digital images, reviewing and reporting studies.
- The proposed HS40 and predicate 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 HS40 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 |
6
510(k) Premarket Notification – Traditional
[ The validation for expansion of the detection nerve of NerveTrack based on AI ]
These are the details on validation of the AI algorithm used for all the new and improved Al-based features that includes expansion of the use of NerveTrack feature and the information about the dataset the device was tested on.
Acceptance Criteria:
| Validation Type | Definition | Acceptance Criteria |
|---|---|---|
| Accuracy (%) | $\frac{\text{Number of correctly detected frames}}{\text{Total number of frames with nerve}} \times 100$ | ≥ 80% |
| Speed (FPS) | $\frac{1000}{\text{Average latency time of each frame (msec)}}$ | ≥ 2 FPS |
Summary Performance data, Standard Deviations & Confidence Intervals:
| Validation Type | Average | Standard Deviation | 95% CI |
|---|---|---|---|
| Accuracy (%) | 91.7 | 5.6 | 89.5 to 93.9 |
| Speed (FPS) | 7.93 | 1.11 | 7.04 to 8.82 |
Testing Data Information:
| Females | Males | Total | |
|---|---|---|---|
| Number of Subjects | 13 | 5 | 18 |
| Number of Images | 1,168 | 978 | 2,146 |
| Age range | 32~68 | 22~50 | 22~68 |
| Average age | 45.7 | 35.0 | 42.7 |
| BMI range | 16~27.1 | 31.5 | 16~31.5 |
| Average BMI | 20.5 | 31.5 | 21.5 |
| Ethnicity | All Koreans |
The standalone performance of NerveTrack was evaluated for BMI (Body Mass Index) subgroups, which are potential subject and image confounder. For subgroup analysis, we divided BMI values into four groups according to the CDC (Centers for Disease Control and Prevention) definition for adult overweight & obesity. They are underweight (BMI