(79 days)
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal; Pediatric, Small Organ (breast, testes, thyroid); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Peripheral Vascular (PV); and Urology (including prostate).
minisono product is an ultrasound imaging system for medical diagnosis. This device is available for portable and tablet PC (Microsoft corp., Surface pro). Also, this innovative system platform provides optimal patient diagnosis workflow with the tablet PC, optimal image quality.
- Signal Mode: B(2D) mode, M mode, Pulsed Wave Doppler(PWD) mode, Color Doppler, Power Doppler, Tissue Harmonic Imaging
- Combination Mode: B/Color Doppler, B/PWD, B/Color Doppler/PWD
The Alpinion Medical Systems Co., Ltd. minisono is an ultrasound imaging system for medical diagnosis. It is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in various clinical applications including Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Musculo-skeletal (Conventional and Superficial), Peripheral Vascular (PV), and Urology (including prostate).
This document does not contain details of a study with acceptance criteria and reported device performance in the format of a table, efficacy data, or diagnostic performance metrics typically associated with AI/ML devices. Instead, it is a 510(k) premarket notification for a medical device that argues for substantial equivalence to a predicate device, the E-CUBE i7 Diagnostic Ultrasound System (K153444).
Therefore, specific information regarding the acceptance criteria and study proving the device meets them, as requested in the prompt, cannot be fully extracted in the requested format for a diagnostic AI/ML device. However, based on the provided text, here is a summary of the information related to the device's validation and comparison to a predicate:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table of acceptance criteria and reported device performance in the context of diagnostic accuracy or clinical efficacy for an AI/ML component. The submission focuses on substantial equivalence to a predicate device based on similar indications for use, technological characteristics, and compliance with safety standards.
The acceptance criteria for this submission appear to be demonstrating that the minisono system possesses the same fundamental scientific technology, intended use, and similar technological characteristics as the predicate device (E-CUBE i7), and that any differences do not raise new questions of safety or effectiveness.
The document lists the following as "reported device performance" indirectly by comparing features to the predicate:
| Feature/Criterion | Proposed minisono Performance | Predicate E-CUBE i7 Performance |
|---|---|---|
| Indications for Use | Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Peripheral Vessel (PV); Urology (including prostate). | Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Adult Cephalic; Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac (Adult); Cardiac (Pediatric); Peripheral Vessel (PV); Urology (including prostate). |
| Imaging Modes | 2D (B) mode, M mode, Color Flow Doppler (CF) mode, Power Doppler (PD) mode, Pulsed wave Doppler (PWD) mode, Tissue Harmonic Imaging mode. | 2D (B) mode, M mode, Anatomical M, Color Flow Doppler (CF) mode, Power Doppler (PD) mode, Directional PD, Pulsed wave Doppler (PWD) mode, Continuous wave Doppler (CWD) mode, Tissue Harmonic Imaging mode. |
| Image Processing Technology | Xpeed™, SRI™, Spatial Compounding Image (SCI). | Xpeed™, Full SRI™, Spatial Compounding Image (SCI). |
| Software Features | Needle Vision™ Plus. | Panoramic, Needle Vision™ /Needle Vision™ Plus, Cube View™. |
| Thermal, mechanical and electrical safety | Conforms to NEMA UD2, UD3, AIUM Medical Ultrasound Safety, IEC60601-1, IEC60601-1-2, IEC60601-2-37, IEC60601-1-6, ISO10993-1, ISO10993-5, ISO10993-10, ISO14971. | Conforms to NEMA UD2, UD3, AIUM Medical Ultrasound Safety, IEC60601-1, IEC60601-1-2, IEC60601-2-37. |
| Transducer C1-6 Frequency | 1~6MHz | Not explicitly listed for predicate, but predicate's indications suggest comparable transducers. |
| Transducer L3-12 Frequency | 3~12MHz | Not explicitly listed for predicate, but predicate's indications suggest comparable transducers. |
| Scanning Depth (C1-6) | 300mm | Not explicitly listed for predicate. |
| Scanning Depth (L3-12) | 100mm | Not explicitly listed for predicate. |
| Total Number of Elements | 128 (for both C1-6 and L3-12) | Not explicitly listed for predicate. |
| Electrical Power | Voltage: 5Vdc, 1A | Voltage: 19V, 10.53A; Frequency: 50/60Hz; Power: 200W Max. |
The "acceptance criteria" here is primarily the demonstration of substantial equivalence to the predicate device in terms of intended use, technology, and compliance with safety standards, rather than a specific performance metric like sensitivity or specificity for a diagnostic algorithm.
2. Sample Size for the Test Set and Data Provenance
The document explicitly states: "The subject of this premarket submission, minisono, did not require clinical studies to support substantial equivalence."
Therefore, there is no test set, sample size, or data provenance related to clinical performance or diagnostic accuracy provided. The evaluation was based on non-clinical tests demonstrating biocompatibility, acoustic output, and thermal, electrical, electromagnetic, and mechanical safety according to applicable medical device safety standards.
3. Number of Experts and Qualifications for Ground Truth
Since no clinical studies were conducted to support substantial equivalence, there were no experts used to establish ground truth for a test set in the context of diagnostic performance. The evaluation was based on engineering and safety standards.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used for diagnostic performance evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. The document states that clinical studies were not required, and there is no mention of an MRMC study or evaluation of human reader improvement with AI assistance. The device is an ultrasound imaging system, not an AI-assisted diagnostic tool in the sense of image interpretation.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is an ultrasound imaging system, not an algorithm being deployed in a standalone capacity for diagnostic interpretation. Its "software" features are related to image processing and user interface, not automated diagnostic algorithms.
7. Type of Ground Truth Used
Not applicable for diagnostic performance. For safety and functional aspects, the "ground truth" would be established by validated test methods and compliance with recognized standards (e.g., IEC, ISO, AIUM/NEMA).
8. Sample Size for the Training Set
Not applicable, as this is not an AI/ML-driven diagnostic device that would require a "training set" in the conventional sense. The device's "software" features are implemented based on established imaging principles and signal processing, not statistical learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are displayed side-by-side.
Alpinion Medical Systems Co., Ltd. Boyeon CHO QARA Manager 5fl, i dong, 77, heungan-daero 81 beon-gil dongan-gu Anyang-si, Gyeonggi-do, 14117 REPUBLIC OF KOREA
Re: K182845
Trade/Device Name: minisono Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: November 30, 2018 Received: December 3, 2018
Dear Boyeon CHO:
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 mav, 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 avare 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.
December 27, 2018
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D.'Hara For
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K182845
Device Name minisono
Indications for Use (Describe)
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal; Pediatric, Small Organ (breast, testes, thyroid); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Peripheral Vascular (PV); and Urology (including prostate).
| 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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Diagnostic Ultrasound Indications for Use
minisono Ultrasound Imaging System: minisono C1-6
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | N | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | ||
| Small Organ | |||||||||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | N | N | N | N | N | N | N | ||
| (Conventional) | |||||||||
| Musculo-skeletal | N | N | N | N | N | N | N | ||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | N | N | N | N | N | N | N | ||
| Urology (including prostate) | N | N | N | N | N | N | N |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
Prescription User (Per 21 CFR 801.109)
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Diagnostic Ultrasound Indications for Use
minisono Ultrasound Imaging System: minisono L3-12
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | N | N | N | N | N | N | N | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | ||
| Small Organ | N | N | N | N | N | N | N | ||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | N | N | N | N | N | N | N | ||
| (Conventional) | |||||||||
| Musculo-skeletal | N | N | N | N | N | N | N | ||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | N | N | N | N | N | N | N | ||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
Prescription User (Per 21 CFR 801.109)
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510(k) Summary
In accordance with 21CFR807.92, the following summary of information is provided;
| Date | Oct. 5th, 2018 |
|---|---|
| Submitter: | ALPINION MEDICAL SYSTEMS Co., Ltd.Address: 5fl, i dong ,77, heungan-daero 81beon-gil, dongan-gu, anyang-si, gyeonggi-do , REPUBLIC OF KOREA, 14117 |
| Primary ContactPerson | Boyeon CHOQuality Management Representative(QMR)Address: 5fl, i dong ,77, heungan-daero 81beon-gil, dongan-gu, anyang-si, gyeonggi-do , REPUBLIC OF KOREA, 14117Phone: +82 70 7465 2104Fax: +82 2 851 5593Email: qa_ra@alpinion.com |
| Secondary ContactPerson | Kevin ChunAddress: 21312 30th Dr SE Ste 100 Bothell, WA 98021, United StatesPhone: 425 949 4904Fax: 425 949 4910Email: kevin.chun@alpinionusa.com |
| Device Trade Name: | minisono |
| Common/UsualName: | Ultrasonic Pulsed Doppler Imaging System |
| Classification Names | System, Imaging, Pulsed Doppler Ultrasonic |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550 90-IYNUltrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYODiagnostic Ultrasound Transducer, 21CFR 892.1570, 90-ITX |
| Primary PredicateDevice | K153424 E-CUBE i7 Diagnostic Ultrasound System |
| Device Description: | minisono product is an ultrasound imaging system for medical diagnosis.This device is available for portable and tablet PC (Microsoft corp.,Surface pro). Also, this innovative system platform provides optimalpatient diagnosis workflow with the tablet PC, optimal image quality. |
| 1. Signal Mode:B(2D) mode, M mode, Pulsed Wave Doppler(PWD) mode, Color Doppler,Power Doppler, Tissue Harmonic Imaging | |
| 2. Combination Mode:B/Color Doppler, B/PWD, B/Color Doppler/PWD |
Acoustic output track: Track 3
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| minisono C1-6 | minisono L3-12 | |
|---|---|---|
| Applicablefrequency | 1~6MHz | 3~12MHz |
| Intended Usage | Fetal,Abdominal,Pediatric,Musculo-skeletal(Conventional)Musculo-skeletal(Superficial)Peripheral vesselUrology (includingprostate) | AbdominalPediatricSmall OrganMusculo-skeletal(Conventional)Musculo-skeletal(Superficial)Peripheral vessel |
| Applicablemode | B mode,M mode,PWD mode,Color DopplerPower DopplerTissue Harmonic ImagingCombined | B mode,M mode,PWD mode,Color DopplerPower DopplerTissue Harmonic ImagingCombined |
| Scanningdepth(mm) | 300 | 100 |
| FOV | 60(°) | N/A |
| Steer Angle | N/A | Max 9(°) |
| Total number ofelement | 128 | 128 |
Types of transducers compatible with the device:
Indications For Use:
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal; Pediatric, Small Organ (breast, testes, thyroid); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Peripheral Vascular (PV); and Urology (including prostate).
Determination of Comparison with Predicate devices: Substantial : minisono and E-CUBE i7
Equivalence:
| Feature | Proposedminisono | PredicateE-CUBE i7(K153424) |
|---|---|---|
| Indicationsfor use | The device is intended for useby a qualified physician for theevaluation of soft tissue andblood flow in the clinicalapplications; | The device is intended for useby a qualified physician for theevaluation of soft tissue andblood flow in the clinicalapplications; |
| Fetal;Abdominal;Pediatric;Small Organ (breast, testes,thyroid); | Fetal;Abdominal;Pediatric;Small Organ (breast, testes,thyroid);Adult Cephalic;Trans-rectal(TR);Trans-vaginal(TV); | |
| Musculo-skeletal(Conventional);Musculo-skeletal (Superficial); | Musculo-skeletal(Conventional);Musculo-skeletal (Superficial);Cardiac (Adult); |
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| Peripheral Vessel (PV);Urology (including prostate). | Cardiac (Pediatric);Peripheral Vessel (PV);Urology (including prostate). | |
|---|---|---|
| Electricalpower | Voltage: 5Vdc, == 1A | Voltage: 19V, == 10.53AFrequency: 50/60HzPower: 200W Max |
| Imaging | 2D (B) mode | 2D (B) mode |
| modes | M mode | M mode |
| Anatomical M | ||
| Color Flow Doppler (CF) mode | Color Flow Doppler (CF) mode | |
| Power Doppler (PD) mode | Power Doppler (PD) mode | |
| Pulsed wave Doppler (PWD) | Directional PDPulsed wave Doppler (PWD) | |
| mode | mode | |
| Continuous wave Doppler | ||
| (CWD) mode | ||
| Tissue Harmonic Imaging | Tissue Harmonic Imaging | |
| mode | mode | |
| Image | Xpeed™ | Xpeed™ |
| processing | SRI™ | Full SRI™ |
| technology | SpatialCompoundingImage | Spatial CompoundingImage |
| (SCI) | (SCI) | |
| Software | Panoramic | |
| feature | Needle Vision™ | |
| Needle Vision™ Plus | /Needle Vision™ Plus | |
| Cube View™ | ||
| Thermal, | The minisono has been | The E-CUBE i7 has been |
| mechanicaland | designed to conform to thefollowing standards: | designed to conform to thefollowing standards: |
| electrical | - NEMA UD2, UD3 | - NEMA UD2, UD3 |
| safety | - AIUM Medical Ultrasound | - AIUM Medical Ultrasound |
| Safety | Safety | |
| - IEC60601-1 | - IEC60601-1 | |
| - IEC60601-1-2 | - IEC60601-1-2 | |
| - IEC60601-2-37 | - IEC60601-2-37 |
Summary of Non-Clinical Tests:
minisono has been evaluated for biocompatibility, acoustic output as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. minisono and its application comply with voluntary standards as detailed in this premarket submission.
- IEC 60601-1:2005+AMD1:2012 (3.1ed, 2012-08-20 published), + Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC60601-1-2:2014 (4.0ed, 2014-02-25 published), Medical � Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
- � IEC 60601-1-6:2010+AMD1:2013(3.0ed, 2013-10-28), Medical
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electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral standard: Usability
- � IEC60601-2-37:2007(2.0ed. 2007-08-09 published). Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
- ISO10993-1:2009(5.0ed, � 2018-08 published), Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
- � ાડળ 10993-5:2009(3.0ed, 2009-06 published), Biological evaluation of medical devices -- Part 5: Tests for in vitro cvtotoxicity
- � 10993-10:2010(3.0ed, 2010-08 published), ISO Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- � ISO14971:2007(2.0ed, 2007-03 published), Application of risk management to medical devices
- AIUM/NEMA UD 2:2004 (R2009) Rev.3, 2009-08-21 published, � Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
The following quality management system measures were applied to the development of minisono:
- � Medical Device Risk Management
- � Requirements Reviews
- � Desian Reviews
- � Component Verification
- � Integration Review (System Verification)
- � Performance Testing (System Verification)
- � Safety Testing (Compliance Test)
- � Design Validation
Transducer materials and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, minisono, did not require clinical studies to support substantial equivalence.
Discussion:
minisono is a new device and simple diagnostic device. minisono (minisono C1-6 & minisono L3-12) are composed system and USB cable. Software is installed to the tablet PC (Microsoft corp., Surface pro). minisono's functions of imaging/software are same as predicate E-CUBE i7 functions.
Also, the subject device is in conformance with applicable safety standards.
Therefore, the differences between minisono and the predicate devices would not affect the safety, effectiveness and essential performance.
- Conclusion: ALPINION MEDICAL SYSTEMS Co., Ltd. considers minisono to be as safe, as effective. Performance, technology and software are substantially equivalent to the predicate devices.
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ALPINION MEDICAL SYSTEMS Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA or the requirements will be published in guidance documents.
§ 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.