(51 days)
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, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal(Cardiac) and Peripheral vessel.
The Diagnostic Ultrasound System 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.
The HS70A 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, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS70A 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 HS70A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
This document is a 510(k) Premarket Notification for the Samsung Medison HS70A Diagnostic Ultrasound System. It aims to demonstrate substantial equivalence to previously cleared predicate devices.
Summary of Acceptance Criteria and Device Performance:
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing specific quantitative acceptance criteria or a dedicated study with performance metrics against those criteria for the new device features. Instead, it states that the device was evaluated against existing standards and guidance, and that migrated software functionality was tested to ensure image quality was not compromised.
The comparison table in the document indicates that the HS70A (Under Review) is largely "Same to predicate" for various features, including:
- Intended Use and Clinical Applications: Identical to predicate devices (Fetal/Obstetrics, Abdominal, Gynecology, etc.).
- Fundamental Technology: Employs the same as predicate devices.
- Operating Modes: Identical (B-mode, M-mode, PW Doppler, CW Doppler, Color Doppler, Power Amplitude Doppler, S-Harmonic, 3D imaging, ElastoScan, Combined modes).
- Scanhead Types and Frequency: Identical.
- Acoustic Output Display & FDA Limits: Identical.
- Transmit/Receive Channels: Identical (192).
- System Characteristics: Mostly identical, with an addition of a 23.8-inch monitor option (predicate had 23-inch).
- Product Safety Certification: Conforms to IEC 60601-1, CSA C22.2 No.601.1, IEC 60601-2-37.
- EMC Compliance: Conforms to IEC60601-1-2: 2014(4th Edition).
- Acoustic Output Display Standard: Track 3.
- Biocompatibility Compliance: Conforms to ISO10993-1.
- Software Functionality: Many features are "Same to predicate" (e.g., Q Scan, ClearVision, MultiVision, Auto IMT+, Strain+, S-Detect for Breast/Thyroid, 3D Imaging features, HDVI, RealisticVue, CEUS+, 5D NT, 5D LB, 5D CNS, ElastoScan, E-Thyroid, E-Breast, ArterialAnalysis).
New Features and their Predicate Clearance:
The document highlights the addition of new software features and one new transducer, which are cleared based on their presence in the second predicate device (HERA W9/W10, K192319), indicating that these features themselves have undergone prior FDA review and clearance.
| Feature | Reference in Document | Predicate Clearance |
|---|---|---|
| IOTA-ADNEX | K192319 | Same (Refer to SE analysis 1) |
| BiometryAssist | K192319 | Same (Refer to SE analysis 2) |
| CrystalVueFlow | K192319 | SE (Refer to SE analysis 3) |
| 5D Heart | K192319 | SE (Refer to SE analysis 4) |
| EV2-10A Transducer | K192319 | Same (Refer to SE analysis 5) |
This implies that the acceptance criteria for these specific features were met in their previous 510(k) clearances.
Details of the Study (as described in the document):
The document explicitly states: "The subject of this premarket submission, HS70A, is not required clinical studies to support substantial equivalence."
Instead, the submission relies on:
- Non-Clinical Tests: Evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety, conforming with applicable medical device safety standards (e.g., ISO 14971, ANSI AAMI ES60601-1, IEC60601-1-2, ISO 10993-1, IEC60601-2-37, NEMA UD 2-2004).
- Software Functionality Evaluation: "All migrated software functionality was evaluated using the same test criteria as the predicates for all applicable imaging modes to ensure that migration into a new system design did not compromise image quality with respect to the intended use of each feature." This evaluation followed the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2005."
Based on the provided text, the following information is not available or not applicable:
- Sample Size Used for the Test Set and Data Provenance: Not specified for performance of new features or overall substantial equivalence, as clinical studies were not required. The non-clinical evaluations likely used test equipment and phantom data.
- Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts: Not applicable, as expert-driven ground truth for performance studies is not described.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not done.
- Standalone (algorithm only without human-in-the-loop performance) Study: Not explicitly described in terms of separate performance metrics, but the software functionality evaluation would implicitly be a standalone test for the algorithm's output.
- Type of Ground Truth Used: For non-clinical tests, physical measurements and engineering specifications would serve as ground truth (e.g., Acoustic Output, EMC, Electrical Safety). For the software functionality evaluation, the "same test criteria as the predicates" implies comparison against established performance levels or outputs of the predicate versions.
- Sample Size for the Training Set: Not applicable, as the submission focuses on substantial equivalence based on existing technology and non-clinical testing, not on developing a new AI/ML model that requires a distinct training set. The software is largely inherited or based on previously cleared modules.
- How the Ground Truth for the Training Set Was Established: Not applicable.
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Samsung Medison Co., Ltd. % Ji Yea Lee Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, Gangwon-do 25108 REPUBLIC OF KOREA
Re: K200699
Trade/Device Name: HS70A 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 13, 2020 Received: March 17, 2020
Dear Ji Yea Lee:
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
May 7, 2020
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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
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Indications for Use
510(k) Number (if known) K200699
Device Name HS70A 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, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal(Cardiac) and Peripheral vessel.
The Diagnostic Ultrasound System 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.
| Type of Use (Select one or both, as applicable) | Remediation Use (Part 21 CFR 201.3 Labeling) Over-The-Counter Use (OTC) | Remediation Use (Part 21 CFR 201.3 Labeling) | Over-The-Counter Use (OTC) |
|---|---|---|---|
| Remediation Use (Part 21 CFR 201.3 Labeling) | |||
| Over-The-Counter Use (OTC) |
| > Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Premarket Notification - Traditional
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5. 510(K) Summarv: K200699
In accordance with 21 CFR 807.92 the following summary of information is provided:
- Date Prepared March 13, 2020 1.
-
- Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108, Republic of Korea
3. Contact Person
Primary contact Ji Yea Lee Regulatory Affairs Specialist Phone: +82.2.2194.1594 Fax: +82.31.8017.9576 Email: iivea722.lee@samsungmedison.com
Secondary Contact Ninad Gujar Director of Regulatory & Quality Phone: +1.978.564.8632 Fax: +1.978.564.8677 Email: ngujar@neurologica.com
4. Proposed Device
- Common/Usual Name: Diagnostic Ultrasound System and Accessories
- Proprietary Name: HS70A Diagnostic Ultrasound System
- Regulation Name: Ultrasound pulsed Doppler imaging system
- Panel/ Requlatory Class: Radiology / II
- Product Code: IYN, IYO, ITX
- Regulation : 21 CFR 892.1550, 892.1560, 892.1570
-
- Predicate Device: HS70A Diagnostic Ultrasound System (K173713) Second Predicate Device:
HERA W9/HERA W10 Diagnostic Ultrasound System (K192319)
Device Description 6.
The HS70A 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, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS70A 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 HS70A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
7. Indications for Use
The Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound
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510(k) Premarket Notification - Traditional
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imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Sketal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal(Cardiac) and Peripheral vessel.
The Diagnostic Ultrasound System 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.
8. Technology
The HS70A employs the same fundamental scientific technology as its predicate devices.
9. Determination of Substantial Equivalence
The proposed HS70A is similar to the predicate device with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness. A comparison of the proposed device to the currently marketed predicates is provided in the table below.
| HS70A | Addition of V2.02 | Remarks | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical application | - No addition | |||||||||||
| Operation of modes | - No addition | |||||||||||
| Applied transducers | - EV2-10A | Transducer 510(k) Clearance EV2-10A K192319 | ||||||||||
| SW Features | - Addition of predicate S/W features:: IOTA-ADNEX, BiometryAssist, 5D Heart, CrystalVue Flow- Improvement of cleared S/W functions:: Measurement, Setup&Preferences, Utility, DICOM, 5D Follicle, Sonoview | SW Features 510(k) clearance IOTA-ADNEX K192319 BiometryAssist K192319 5D Heart K192319 CrystalVue Flow K192319 | ||||||||||
| HW Features | - 23.8 inch Monitor |
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510(k) Premarket Notification – Traditional
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| HS70A(Under Review) | HS70A(K173713) | HERA W9/HERA W10(K192319) | Note | |
|---|---|---|---|---|
| Device name | The subject device | Primary Predicate | Second Predicate | |
| Manufacturer | SAMSUNG MEDISON. | SAMSUNG MEDISON. | SAMSUNG MEDISON. | |
| Regulation No. | 892.1550892.1560892.1570 | 892.1550892.1560892.1570 | 892.1550892.1560892.1570 | |
| Product Code | IYN, IYO, ITX | IYN, IYO, ITX | IYN, IYO, ITX | Same to predicate |
| Intended Use | The Diagnostic UltrasoundSystem and transducers areintended for diagnosticultrasound imaging and fluidanalysis of the human body. | The Diagnostic UltrasoundSystem and transducers areintended for diagnosticultrasound imaging and fluidanalysis of the human body. | The Diagnostic UltrasoundSystem and transducers areintended for diagnosticultrasound imaging and fluidanalysis of the human body. | |
| clinical Application | - Fetal/Obstetrics | - Fetal/Obstetrics | Fetal/Obstetrics | Same to predicate |
| - Abdominal | - Abdominal | Abdominal | Same to predicate | |
| - Gynecology | - Gynecology | Gynecology | Same to predicate | |
| - Intra-operative | - Intra-operative | Same to predicate | ||
| - Pediatric | - Pediatric | Pediatric | Same to predicate | |
| - Small Organ | - Small Organ | Small Organ | Same to predicate | |
| - Neonatal Cephalic | - Neonatal Cephalic | Neonatal Cephalic | Same to predicate | |
| - Adult Cephalic | - Adult Cephalic | Adult Cephalic | Same to predicate | |
| - Trans-rectal | - Trans-rectal | Trans-rectal | Same to predicate | |
| - Trans-vaginal | - Trans-vaginal | Trans-vaginal | Same to predicate | |
| - Trans-esophageal(Cardiac) | - Trans-esophageal(Cardiac) | Same to predicate | ||
| - Muscular-Skeletal(Conventional, Superficial) | - Muscular-Skeletal(Conventional, Superficial) | Muscular-Skeletal(Conventional, Superficial) | Same to predicate | |
| - Urology | - Urology | Urology | Same to predicate | |
| - Cardiac Adult | - Cardiac Adult | Cardiac Adult | Same to predicate | |
| - Cardiac Pediatric | - Cardiac Pediatric | Cardiac Pediatric | Same to predicate | |
| - Peripheral vessel | - Peripheral vessel | Peripheral vessel | Same to predicate | |
| Scanhead Types | - Linear Array | - Linear Array | Linear Array | Same to predicate |
| Device name | HS70A(Under Review) | HS70A(K173713) | HERA W9/HERA W10(K192319) | Note |
| The subject device | Primary Predicate | Second Predicate | ||
| - Curved Linear Array | - Curved Linear Array | Curved Linear Array | Same to predicate | |
| - Endocavity | - Endocavity | Endocavity | Same to predicate | |
| - Phased Array | - Phased Array | Phased Array | Same to predicate | |
| - Static Probes | - Static Probes | Static Probes | Same to predicate | |
| ScanheadFrequency | 1.0 ~ 20.0 MHz | 1.0 ~ 20.0 MHz | 1.0 ~ 20.0 MHz | Same to predicate |
| Acoustic OutputDisplay & FDALimits | - Display Feature for HigherOutput-Track3- MI Output Display- TI Output Display | - Display Feature for HigherOutput-Track3- MI Output Display- TI Output Display | - Display Feature for HigherOutput-Track3- MI Output Display- TI Output Display | Same to predicate |
| Modes of Operation | - B-mode | - B-mode | B-mode | Same to predicate |
| - M-mode | - M-mode | M-mode | Same to predicate | |
| - Pulsed wave (PW)Doppler | - Pulsed wave (PW) Doppler | Pulsed wave (PW) Doppler | Same to predicate | |
| - Continuous wave (CW)Doppler | - Continuous wave (CW)Doppler | Continuous wave (CW)Doppler | Same to predicate | |
| - Color Doppler | - Color Doppler | Color Doppler | Same to predicate | |
| - Power Amplitude Doppler | - Power Amplitude Doppler | Power Amplitude Doppler | Same to predicate | |
| - Pulse Inversion HarmonicImaging (S-Harmonic) | - Pulse Inversion HarmonicImaging (S-Harmonic) | Pulse Inversion HarmonicImaging (S-Harmonic) | Same to predicate | |
| - 3D imaging mode | - 3D imaging mode | 3D imaging mode | Same to predicate | |
| - ElastoScan Mode | - ElastoScan Mode | ElastoScan Mode | Same to predicate | |
| - Combined modes | - Combined modes | Combined modes | Same to predicate | |
| #Transmit Channels | 192 | 192 | 192 | Same to predicate |
| #Receive Channels | 192 | 192 | 192 | Same to predicate |
| System | - Beamformer 192 | - Beamformer 192 | Beamformer 192 | Same to predicate |
| Characteristics | - Mobile cart | - Mobile cart | Mobile cart | Same to predicate |
| - LCD Monitor (LEDBacklight unit): | - LCD Monitor (LEDBacklight unit): | LCD Monitor (LEDBacklight unit): | Same to predicate | |
| Device name | HS70A(Under Review)The subject device | HS70A(K173713)Primary Predicate | HERA W9/HERA W10(K192319)Second Predicate | Note |
| 23inch, 23.8inch | 23inch | 23inch | ||
| - 256 gray shades onmonitor | - 256 gray shades onmonitor | 256 gray shades on monitor | Same to predicate | |
| - 100-240VAC, 1100VA,- 50/60Hz | - 100-240VAC, 1100VA,- 50/60Hz | 100-240VAC, 1100VA,50/60Hz | Same to predicate | |
| Product SafetyCertification | - IEC 60601-1 | - IEC 60601-1 | IEC 60601-1 | Same to predicate |
| - CSA C22.2 No.601.1 | - CSA C22.2 No.601.1 | CSA C22.2 No.601.1 | Same to predicate | |
| - IEC 60601-2-37 | - IEC 60601-2-37 | IEC 60601-2-37 | Same to predicate | |
| EMC Compliance | - IEC 60601-1-2 | - IEC 60601-1-2 | IEC 60601-1-2 | Same to predicate |
| Acoustic OutputDisplay Standard | - Track 3 | - Track 3 | Track 3 | Same to predicate |
| BiocompatibilityCompliance | - ISO10993-1 | - ISO10993-1 | ISO10993-1 | Same to predicate |
| SoftwareFunctionality | - Q Scan | - Q Scan | - Q Scan | Same to predicate |
| - ClearVision | - ClearVision | - ClearVision | Same to predicate | |
| - MultiVision | - MultiVision | - MultiVision | Same to predicate | |
| - Panoramic | - Panoramic | - Panoramic | Same to predicate | |
| - Needle Mate+ | - Needle Mate | - Needle Mate+ | Same to predicate | |
| - Auto IMT+ | - Auto IMT+ | - Auto IMT+ | Same to predicate | |
| - Strain+ | - Strain+ | Same to predicate | ||
| - Stress Echo | - Stress Echo | Same to predicate | ||
| - E-Strain | - E-Strain | E-Strain | Same to predicate | |
| - S-Shearwave | - S-Shearwave | Same to predicate | ||
| - S-Detect for Breast | - S-Detect for Breast | S-Detect for Breast | Same to predicate | |
| Device name | HS70A(Under Review)The subject device | HS70A(K173713)Primary Predicate | HERA W9/HERA W10(K192319)Second Predicate | Note |
| - S-Detect for Thyroid | - S-Detect for Thyroid | - S-Detect for Thyroid | Same to predicate | |
| - ADVR | - ADVR | - ADVR | Same to predicate | |
| - 3D Imaging (Volume DataAcquisition) | - 3D Imaging (Volume DataAcquisition) | - 3D Imaging (Volume DataAcquisition) | Same to predicate | |
| - 3D Imaging presentation(3D Cine/4D Cine/5D Cine) | - 3D Imaging presentation(3D Cine/4D Cine/5D Cine) | - 3D Imaging presentation(3D Cine/4D Cine/5D Cine) | Same to predicate | |
| -3D Rendering (MPR) | -3D Rendering (MPR) | -3D Rendering (MPR) | Same to predicate | |
| -3D XI (MSV/Oblique View) | -3D XI (MSV/Oblique View) | -3D XI (MSV/Oblique View) | Same to predicate | |
| -3D MXI (Volume Slice,Mirror View) | -3D MXI (Volume Slice,Mirror View) | -3D MXI (Volume Slice,Mirror View) | Same to predicate | |
| - XI Volume CT (VolumeCT) | - XI Volume CT (VolumeCT) | - XI Volume CT (VolumeCT) | Same to predicate | |
| -3D MagiCut | -3D MagiCut | -3D MagiCut | Same to predicate | |
| -Volume Calculation(VOCAL, XI VOCAL) | -Volume Calculation(VOCAL, XI VOCAL) | -Volume Calculation(VOCAL, XI VOCAL) | Same to predicate | |
| - XI STIC | - XI STIC | - XI STIC | Same to predicate | |
| - HDVI | - HDVI | - HDVI | Same to predicate | |
| - RealisticVue | - RealisticVue | - RealisticVue | Same to predicate | |
| - CEUS+ | - CEUS+ | - CEUS+ | Same to predicate | |
| - 5D Follicle | - 5D Follicle | Same to predicate | ||
| - HDVI | - HDVI | Same to predicate | ||
| - 5D NT | - 5D NT | - 5D NT | Same to predicate | |
| - 5D LB | - 5D LB | - 5D LB | Same to predicate | |
| - 5D CNS | - 5D CNS | - 5D CNS | Same to predicate | |
| - Auto NT (Old Name: 2DNT) | - Auto NT (Old Name: 2DNT) | - Auto NT (Old Name: 2DNT) | Same to predicate | |
| - ElastoScan | - ElastoScan | - ElastoScan+ | Same to predicate | |
| - E-Thyroid | - E-Thyroid | - E-Thyroid | Same to predicate | |
| - E-Breast | - E-Breast | - E-Breast | Same to predicate | |
| Device name | HS70A(Under Review)The subject device | HS70A(K173713)Primary Predicate | HERA W9/HERA W10(K192319)Second Predicate | Note |
| - ArterialAnalysis | - ArterialAnalysis | Same to predicate | ||
| - IOTA-ADNEX | - IOTA-ADNEX | Same; refer to SEanalysis 1 | ||
| - BiometryAssist | - BiometryAssist | Same; refer to SEanalysis 2 | ||
| - CrystalVueFlow | - CrystalVueFlow | SE; refer to SEanalysis 3 | ||
| - 5D Heart | - 5D Heart | SE; refer to SEanalysis 4 | ||
| Transducer | - CA1-7A | - CA1-7A | - CA1-7A | Same to predicate |
| - CA2-8A | - CA2-8A | Same to predicate | ||
| - CF4-9 | - CF4-9 | - CF4-9 | Same to predicate | |
| - E3-12A | - E3-12A | - E3-12A | Same to predicate | |
| - VR5-9 | - VR5-9 | Same to predicate | ||
| - CA2-9A | - CA2-9A | Same to predicate | ||
| - CA3-10A | - CA3-10A | - CA3-10A | Same to predicate | |
| - EA2-11B | - EA2-11B | - EA2-11B | Same to predicate | |
| - L3-12A | - L3-12A | - L3-12A | Same to predicate | |
| - LA3-16A | - LA3-16A | Same to predicate | ||
| - LA3-16AI | - LA3-16AI | Same to predicate | ||
| - LA2-9A | - LA2-9A | - LA2-9A | Same to predicate | |
| - LA4-18B | - LA4-18B | - LA4-18B | Same to predicate | |
| - LM4-15B | - LM4-15B | Same to predicate | ||
| - PE2-4 | - PE2-4 | Same to predicate | ||
| - PA3-8B | - PA3-8B | - PA3-8B | Same to predicate | |
| - P4-12B | - P4-12B | Same to predicate | ||
| - PA1-5A | - PA1-5A | Same to predicate | ||
| - MMPT3-7 | - MMPT3-7 | Same to predicate | ||
| - CV1-8A | - CV1-8A | - CV1-8A | Same to predicate | |
| - V5-9 | - V5-9 | Same to predicate | ||
| Device name | HS70A(Under Review)The subject device | HS70A(K173713)Primary Predicate | HERA W9/HERA W10(K192319)Second Predicate | Note |
| - LV3-14A | - LV3-14A | Same to predicate | ||
| - CW4.0 | - CW4.0 | Same to predicate | ||
| - CW6.0 | - CW6.0 | Same to predicate | ||
| - DP2B | - DP2B | Same to predicate | ||
| - DP8B | - DP8B | Same to predicate | ||
| - EV2-10A | - EV2-10A | Same; refer to SEanalysis 5 | ||
| CompatibleBiopsy Guide | - BP-KIT-029 | - BP-KIT-029 | - BP-KIT-029 | 510(k) Exempt |
| - BP-KIT-030 | - BP-KIT-030 | 510(k) Exempt | ||
| - BP-KIT-041 | - BP-KIT-041 | - BP-KIT-041 | 510(k) Exempt | |
| - BP-KIT-043 | - BP-KIT-043 | - BP-KIT-043 | 510(k) Exempt | |
| - BP-KIT-053 | - BP-KIT-053 | 510(k) Exempt | ||
| - BP-KIT-054 | - BP-KIT-054 | - BP-KIT-054 | 510(k) Exempt | |
| - BP-KIT-055 | - BP-KIT-055 | 510(k) Exempt | ||
| - BP-KIT-057 | - BP-KIT-057 | - BP-KIT-057 | 510(k) Exempt | |
| - BP-KIT-058 | - BP-KIT-058 | - BP-KIT-058 | 510(k) Exempt | |
| - BP-KIT-059 | - BP-KIT-059 | - BP-KIT-059 | 510(k) Exempt | |
| - BP-KIT-060 | - BP-KIT-060 | - BP-KIT-060 | 510(k) Exempt | |
| - BP-KIT-065 | - BP-KIT-065 | - BP-KIT-065 | 510(k) Exempt | |
| - BP-KIT-066 | - BP-KIT-066 | - BP-KIT-066 | 510(k) Exempt | |
| - BP-KIT-068 | - BP-KIT-068 | 510(k) Exempt | ||
| - BP-KIT-069 | - BP-KIT-069 | - BP-KIT-069 | 510(k) Exempt | |
| - BP-KIT-071 | - BP-KIT-071 | - BP-KIT-071 | 510(k) Exempt | |
| - BP-KIT-075 | - BP-KIT-075 | 510(k) Exempt | ||
| - BP-KIT-083 | 510(k) Exempt | |||
| - BP-KIT-085 | - BP-KIT-085 | 510(k) Exempt | ||
| - BP-KIT-086 | - BP-KIT-086 | 510(k) Exempt | ||
| DigitalStorage/Transfer | - Foot SwitchECG (defibrillation proof) | - Foot SwitchECG (defibrillation proof) | - Foot SwitchECG (defibrillation proof) | Same to predicate |
| Device name | HS70A(Under Review)The subject device | HS70A(K173713)Primary Predicate | HERA W9/HERA W10(K192319)Second Predicate | Note |
| Station | - Gel Warmer- Clear Track/ Virtual TrackSystem StandWLAN Card | - Gel Warmer- Clear Track/ Virtual TrackSystem Stand- WLAN Card | - Gel Warmer- Clear Track/ Virtual TrackSystem StandWLAN Card |
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Image /page/6/Picture/1 description: The image shows the SAMSUNG logo. The logo is in a blue oval shape with the word "SAMSUNG" in white letters. The logo is simple and recognizable.
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Image /page/7/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white letters on a blue oval background. The logo is tilted slightly to the right.
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Image /page/8/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The wordmark is placed inside a blue, oval-shaped background.
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Image /page/9/Picture/5 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white letters on a blue oval background. The logo is simple and recognizable.
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Image /page/10/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in a bold, sans-serif font. The word is white and is set against a blue, oval-shaped background. The logo is simple and modern.
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Image /page/11/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The font is sans-serif and bold, and the logo is tilted slightly.
510(k) Premarket Notification – Traditional
10. Summary of Non-Clinical Test
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The HS70A and its applications comply with voluntary standards.
| Test | Standards and FDA Guidance |
|---|---|
| Risk Management | ISO 14971 Second edition 2007 Medical devices - Application of risk management to medical devices |
| Electrical Safety | The HS70A Ultrasound System with defibrillation-proof ECG electrode was evaluated per the followingstandards.ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012Medical Electrical Equipment - Part 1: General Requirements for basic safety and essential performance. |
| ElectromagneticCompatibility | IEC60601-1-2: 2014(4th Edition) Medical Electrical Equipment -- Part 1-2: General Requirements ForBasic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances --Requirements And Tests |
| Biocompatibility | ISO 10993-1 Fourth edition 2009-10-15 Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process. |
| Reprocessing MedicalDevices | FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labelingissued on March 17, 2015, revised June 9, 2017. |
| Software/Firmware-driven Functionality | All migrated software functionality was evaluated using the same test criteria as the predicates for allapplicable imaging modes to ensure that migration into a new system design did not compromise imagequality with respect to the intended use of each feature.Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued onMay 11, 2005 |
| Ultrasound Safety | Marketing Clearance of Diagnostic Ultrasound Systems and Transducers issued June 27, 2019 |
| IEC60601-2-37:2007 + A1:2015, Particular requirements for the safety of ultrasonic medical diagnostic andmonitoring equipment | |
| NEMA UD 2-2004 (R2009)Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 |
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510(k) Premarket Notification – Traditional
Image /page/12/Picture/2 description: The image shows the Samsung logo. The logo is a blue oval with the word "SAMSUNG" in white letters inside. The letters are bold and sans-serif. The logo is simple and recognizable.
-
- Summary of Clinical Tests The subject of this premarket submission, HS70A, is not required clinical studies to support substantial equivalence.
-
- Conclusion
SAMSUNG MEDISON CO., LTD. considers the HS70A to be as safe, as effective, and performance is substantially equivalent to the predicate devices.
-END of 510(K) Summary
§ 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.