The Ultrasound System SONIMAGE HS1 and its transducers are products designed to collect ultrasonic image data of the human body for diagnostic purposes. The system employs the ultrasonic pulse-echo method to visualize the anatomic structures, characteristics, and dynamics of the human body, and using an image display, Doppler display and/or Doppler sound, offers a procedure applied to the human body for medical diagnosis or examination. The range of intended clinical applications is same as other conventional ultrasound imaging systems for general purpose, such as small parts, abdomen, obstetrics, gynecology, musculoskeletal (soft tissue), peripheral vascular, and Cardiac.

Device Description

The Ultrasound System SONIMAGE HS1 is a portable ultrasound system for general purposes. The system provides ultrasound imaging information such as used for the purpose of diagnosing the human body, which visually represents the internal geometry, characteristics and dynamics of the human body, and transmits / receives ultrasound waves to obtain image data of the visual representation. This system provides ultrasound images in all its modes of B-mode, M-mode, Color Doppler-mode, PW Doppler-mode, and Elastography-mode. It is also capable with Anatomical M-mode, CW Doppler-mode and CF/PW-TDI-mode with Sector transducer. The optional items are available, such as a Pole Cart with storage basket, a power extension unit, and a foot switch with dual/triple pedals. The system can be connected to LAN through the wired Ethernet and, is also capable of wireless LAN with the OTS USB-WiFi adapter supporting security of WPA/WPA2 and WEP. This system conforms to Real Time Display of Thermal and Mechanical Output Indices on Diagnostic Ultrasound Equipment (Track 3). Transducers have their own characteristic applications, and are brought into contact with the body surface.

AI/ML Overview

The provided text describes the Konica Minolta Ultrasound System SONIMAGE HS1 and focuses on demonstrating its substantial equivalence to previously cleared predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical setting. Therefore, many of the requested details about a study evaluating performance metrics (like sample size, data provenance, expert ground truth, adjudication, MRMC studies, or standalone performance) are not present in this document.

However, I can extract information related to the device's technical acceptance and the basis for its clearance.

Acceptance Criteria and Reported Device Performance

The document states that the system's geometric accuracy, elastography position, and the accuracy of position and velocity for various Doppler modes were tested. The "acceptance criteria" here refer to meeting the expectations for these technical characteristics, aligning with existing standards and predicate devices, rather than predefined clinical performance thresholds.

Acceptance Criteria Category	Reported Device Performance
Geometric Accuracy (B-mode)	Comprehensively tested with successful results.
Elastography Position	Comprehensively tested with successful results.
Accuracy of Position & Velocity (Color Doppler, PW/CW Doppler, TDI)	Comprehensively tested with successful results.
Accuracy of Time (PW/CW Doppler, ECG trace)	Comprehensively tested with successful results.
Quantitative Doppler Sensitivity	Not applicable; the proposed system and predicate systems do not have quantitative claims of sensitivity regarding Color Doppler, TDI, and PW/CW Doppler modes.
Compliance with Standards	Conforms to AAMI/ANSI ES 60601-1, IEC 60601-1-6, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 10993-1, NEMA UD 2-2004, NEMA UD 3-2004, and displays thermal and mechanical output indices (Track 3) in real time.
Biocompatibility	All patient contact materials conform to ISO 10993 and are determined acceptable. Achieves the same acceptance level as predicate devices.
Risk Analysis	All verification activities as required by the risk analysis were performed, and predetermined acceptance criteria were met.

Regarding a "study that proves the device meets the acceptance criteria":

The document explicitly states: "The clinical studies are not required to support substantial equivalence for these conventional ultrasound diagnostic equipment."

Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices through technological characteristic comparison and non-clinical testing. The "study" aspects mentioned are primarily non-clinical bench tests.

Here's what can be inferred about the "study" (non-clinical testing) from the provided text:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify a "sample size" for a test set in the context of clinical images or patient data. The evaluations were "bench-tests," implying controlled laboratory settings rather than patient data.
- Data provenance is not mentioned, but given it's a submission by KONICA MINOLTA, INC. from Japan, the testing would likely have been conducted internally or by relevant testing facilities. The tests are non-clinical, so "retrospective or prospective" is not applicable in the patient data sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. As the testing involved "geometric accuracy verification," "position for Elastography-mode," and "accuracy verification of the position and the velocity for Color Doppler-mode, PW/CW Doppler-mode and TDI-mode," the "ground truth" would be established by engineering specifications, calibrated phantoms, and measurement standards, not by human experts interpreting clinical images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of clinical data, which was not the nature of these non-clinical bench tests.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This is a conventional ultrasound system, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical imaging device operated by a human, not a standalone algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The ground truth for the non-clinical tests would be based on physical and engineering measurements against established standards and validated test methods (e.g., using phantoms for spatial accuracy, calibrated flow models for Doppler velocity accuracy).
The sample size for the training set:
- Not applicable. This document describes a medical device clearance based on substantial equivalence and non-clinical engineering tests, not an AI/machine learning model that requires a training set.
How the ground truth for the training set was established:
- Not applicable (see point 7).

In summary, the provided information outlines a regulatory submission where the Ultrasound System SONIMAGE HS1 demonstrated substantial equivalence to predicate devices through non-clinical bench testing, ensuring adherence to technical specifications, safety standards, and performance characteristics consistent with its intended use as a conventional ultrasound imaging system. Clinical studies were explicitly stated as not required.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 19, 2016

KONICA MINOLTA, INC. % Mr. Russell D. Munves Official Correspondent Storch Amini & Munves PC 140 east 45th Street, 25th Floor NEW YORK NY 10017

Re: K162065

Trade/Device Name: Ultrasound System SONIMAGE HS1 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: July 25, 2016 Received: July 26, 2016

Dear Mr. Munves:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael O'Hara

For

Robert 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

510(k) Number (if known)

K162065

Device Name Ultrasound System SONIMAGE HS1

Indications for Use (Describe)

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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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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Ultrasound System SONIMAGE HS1 System:

Transducer:

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal	N	N	N	N	N	Note1	Note2
	Abdominal	P	P	P	P	P	Note1	Note2,4
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Note3)	P	P	P		P	Note1	Note2, 5
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	N	N	N	N	N	Note1	Note2
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P		P	Note1	Note2, 5
	Musculo-skeletal (Superficial)	P	P	P		P	Note1	Note2, 5
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult	P	P	P	P	P	Note1	Note2,4
	Cardiac Pediatric	P	P	P	P	P	Note1	Note2,4
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note1	Note2, 5
	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Combined mode BM (B + M), BD (B + Pulse Doppler), BcMc (Color Doppler + M Color Doppler) and BcD (B Color Doppler + Pulse Doppler)

Note 2: Other mode Mc (M Color Mode)

Note 3: Small organ includes thyroid and breast

Note 4: Other mode CF-TDI(Color Flow - Tissue Doppler Imaging) and PW-TDI(Pulse Doppler - Tissue Doppler Imaging)

Note 5: Other mode Elastography

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Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Note3)	P	P	P		P	Note1	Note2, 4
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P		P	Note1	Note2, 4
	Musculo-skeletal (Superficial)	P	P	P		P	Note1	Note2, 4
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note1	Note2, 4
	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Combined mode BM (B + M), BD (B + Pulse Doppler), BcMc (Color Doppler + M Color Doppler) and BcD (B Color Doppler + Pulse Doppler)

Note 2: Other mode Mc (M Color Mode)

Note 3: Small organ includes thyroid and breast

Note 4: Other mode Elastography

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Ultrasound System SONIMAGE HS1 System: Transducer: C5-2

Clinical Application				Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal	N	N	N		N	Note1	Note2
	Abdominal	P	P	P		P	Note1	Note2
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Combined mode BM (B + M), BD (B + Pulse Doppler), BcMc (Color Doppler + M Color Doppler) and BcD (B Color Doppler + Pulse Doppler)

Note 2: Other mode Mc (M Color Mode)

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Ultrasound System SONIMAGE HS1 System: Transducer: S4-2

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
Fetal	Fetal
Imaging	Abdominal	P	P	P	P	P	Note1	Note2,3
& Other	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult	P	P	P	P	P	Note1	Note2,3
	Cardiac Pediatric	P	P	P	P	P	Note1	Note2,3
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Combined mode BM (B + M), BD (B + Pulse Doppler), BcMc (Color Doppler + M Color Doppler) and BcD (B Color Doppler + Pulse Doppler)

Note 2: Other mode Mc (M Color Mode)

Note 3: Other mode CF-TDI(Color Flow - Tissue Doppler Imaging) and PW-TDI(Pulse Doppler - Tissue Doppler Imaging)

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Ultrasound System SONIMAGE HS1 System: Transducer: L14-4

Clinical Application				Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Note3)	P	P	P		P	Note1	Note2
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P		P	Note1	Note2
	Musculo-skeletal (Superficial)	P	P	P		P	Note1	Note2
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note1	Note2
	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Combined mode BM (B + M), BD (B + Pulse Doppler), BcMc (Color Doppler + M Color Doppler) and BcD (B Color Doppler + Pulse Doppler)

Note 2: Other mode Mc (M Color Mode)

Note 3: Small organ includes thyroid and breast

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Ultrasound System SONIMAGE HS1 System: Transducer: EC9-3

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
Fetal	Fetal	N	N	N		N	Note1	Note2
Imaging	Abdominal
& Other	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	N	N	N		N	Note1	Note2
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Combined mode BM (B + M), BD (B + Pulse Doppler), BcMc (Color Doppler + M Color Doppler) and BcD (B Color Doppler + Pulse Doppler)

Note 2: Other mode Mc (M Color Mode)

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Ultrasound System SONIMAGE HS1 System: Transducer: L11-3

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Note3)	N	N	N		N	Note1	Note2, 4
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	N	N	N		N	Note1	Note2, 4
	Musculo-skeletal (Superficial)	N	N	N		N	Note1	Note2, 4
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	N	N	N		N	Note1	Note2, 4
	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Combined mode BM (B + M), BD (B + Pulse Doppler), BcMc (Color Doppler + M Color Doppler) and BcD (B Color Doppler + Pulse Doppler)

Note 2: Other mode Mc (M Color Mode)

Note 3: Small organ includes thyroid and breast

Note 4: Other mode Elastography

{10}------------------------------------------------

Ultrasound System SONIMAGE HS1 System: Transducer: MC10-3

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
Imaging& Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Note3)	N	N	N		N	Note1	Note2
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	N	N	N		N	Note1	Note2
	Musculo-skeletal (Superficial)	N	N	N		N	Note1	Note2
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel	N	N	N		N	Note1	Note2
Vessel	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Combined mode BM (B + M), BD (B + Pulse Doppler), BcMc (Color Doppler + M Color Doppler) and BcD (B Color Doppler + Pulse Doppler)

Note 2: Other mode Mc (M Color Mode)

Note 3: Small organ includes thyroid and breast

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Ultrasound System SONIMAGE HS1 System: Transducer: HL18-4

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Note3)	N	N	N		N	Note1	Note2
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	N	N	N		N	Note1	Note2
	Musculo-skeletal (Superficial)	N	N	N		N	Note1	Note2
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel
	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Combined mode BM (B + M), BD (B + Pulse Doppler), BcMc (Color Doppler + M Color Doppler) and BcD (B Color Doppler + Pulse Doppler)

Note 2: Other mode Mc (M Color Mode)

Note 3: Small organ includes thyroid and breast

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510(k) Summary

Submitter's Name:	KONICA MINOLTA, INC.
Address:	1 Sakura-machi,Hino-shi, 191-8511 Japan
Contact:	Tsutomu Fukui
Telephone:	+81 42 589 8429
Date:	July 25, 2016
Trade Name:	Ultrasound System SONIMAGE HS1
Model No:	SONIMAGE HS1
Common Name:	Ultrasound Imaging System
Classification Name(s):	Ultrasonic Pulsed Doppler Imaging System (21 CFR 892.1550)Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560)Diagnostic Ultrasound Transducer (21 CFR 892.1570)
Classification Number(s):	90-IYN; 90-IYO; 90-ITX
Regulatory Class:	Class II
Predicate Device(s):	K152577 - Ultrasound System SONIMAGE HS1, Konica Minolta, Inc.K061605 - Nemio XG, SSA-580A, Toshiba America Medical Systems, Inc.K142368 - Noblus Ultrasound Diagnostic System, Hitachi Aloka Medical,Ltd.
Device Description:	The Ultrasound System SONIMAGE HS1 is a portable ultrasound systemfor general purposes. The system provides ultrasound imaginginformation such as used for the purpose of diagnosing the human body,which visually represents the internal geometry, characteristics anddynamics of the human body, and transmits / receives ultrasound wavesto obtain image data of the visual representation.
	This system provides ultrasound images in all its modes of B-mode, M-mode, Color Doppler-mode, PW Doppler-mode, and Elastography-mode.

{13}------------------------------------------------

It is also capable with Anatomical M-mode, CW Doppler-mode and CF/PW-TDI-mode with Sector transducer.

The optional items are available, such as a Pole Cart with storage basket, a power extension unit, and a foot switch with dual/triple pedals.

The system can be connected to LAN through the wired Ethernet and, is also capable of wireless LAN with the OTS USB-WiFi adapter supporting security of WPA/WPA2 and WEP.

This system conforms to Real Time Display of Thermal and Mechanical Output Indices on Diagnostic Ultrasound Equipment (Track 3). Transducers have their own characteristic applications, and are brought into contact with the body surface.

The Ultrasound System SONIMAGE HS1 and its transducers are designed to comply with the following standards:

AAMI / ANSI ES 60601-1: 2005 and A1: 2012, C1:2009 and A2:2010; IEC 60601-1-6: 2010; IEC 60601-1-2: 2007; IEC 60601-2-37: 2007; IEC 62304: 2006; ISO 10993-1:2009; NEMA UD 2-2004; NEMA UD 3-2004;

Intended Use:

The Ultrasound System SONIMAGE HS1 and its transducers are products designed to collect ultrasonic image data of the human body for diagnostic purposes.

The system employs the ultrasonic pulse-echo method to visualize the anatomic structures, characteristics, and dynamics of the human body, and using an image display, Doppler display and/or Doppler sound, offers a procedure applied to the human body for medical diagnosis or examination.

The range of intended clinical applications is same as the predicate device, such as small parts, abdomen, obstetrics, gynecology, musculoskeletal (soft tissue), peripheral vascular, and cardiac.

This system is contraindicated for an eyeball examination or any other examination that may require the passage of an ultrasound beam

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through an eyeball. This system is NOT designed for use in direct contact to central nerves and cardiac systems.

The system should not be used by persons other than fully qualified and certified medical personnel.

Summary of Technological Characteristics

Compared to Predicate Device:

The proposed Ultrasound System SONIMAGE HS1 employs the same fundamental scientific technologies as the primary predicate device (K152577). For the functions other than K152577's, the other predicates are referenced such as the Nemio XG SSA-580A system (K061605) and the Noblus Ultrasound Diagnostic System (K142368). The summary of comparisons of technological characteristics for the proposed device and the predicate systems are provided as follows;

Intended Use

The intended use for the proposed device is essentially the same as the conventional ultrasound diagnostic system for general purpose. The additional clinical applications to the primary predicate device, obstetrics and gynecology, are the same indication for use as other predicate device (K061605).

Operating Principle and designing

The system transmits ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures, characteristics, and dynamics of the human body. The system is designed in laptop shape to be transportable with battery operation. These operating principle and designing are the same as the predicate devices.

The proposed system provide Elastography-mode utilized by same Strain Elastography techniques as the predicate device (K142368). The both systems require to move the ultrasound transducer manually by the operator to provide the information of elasticity of interested tissue as superimposed color image on B-mode image on the display.

The enhancements of measurement and report functions by the software modification from the primary predicate device do not introduce new features other than the traditional items for the conventional diagnostic ultrasound systems.

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The proposed new transducers are a conventional diagnostic ultrasound transducers. All of them employs the same fundamental scientific technologies as the predicate devices.

The proposed system and the predicate devices support the same operating modes and display format, the same measurement functions for anatomic structures, internal geometry, characteristics and dynamics of the human body.

Non-clinical test

The geometric accuracy verification in B-mode, position for Elastographymode, and the accuracy verification of the position and the velocity for Color Doppler-mode, PW/CW Doppler-mode and TDI-mode, and the time for PW/CW Doppler-mode and ECG trace are comprehensively tested as Bench-tests with successful results, except quantitative Doppler sensitivity. The proposed system and the predicate systems do not have a quantitative claims of sensitivity regarding Color Doppler-mode, TDImode and PW/CW Doppler-mode.

All of the verification activities, as required by the risk analysis, for the proposed system was performed and the results demonstrated that the predetermined acceptance criteria were met.

Safety

The system is in conformance with the standards described above, which are same standards to those of the primary predicate device (K152577). The both systems conform to real time display of thermal and mechanical output indices under Track 3.

Biocompatibility

The all patient contact materials of human body surface are evaluated under ISO 10993 and determined as acceptable for these usage. The proposed system and the predicate systems achieve same acceptance level for biocompatibility.

Conclusion:

The clinical studies are not required to support substantial equivalence for these conventional ultrasound diagnostic equipment. In addition to that, as discussed in the above technological comparison, the technological characteristics of the Ultrasound System SONIMAGE HS1 are deemed to be substantially equivalent to the aforementioned predicate devices that have already been cleared for USA distribution with 510(k) premarket notification.

Regulation Number and Section

§ 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.