Ultrasound System SONIMAGE HS1

• K Number: K151060
• Device Name: Ultrasound System SONIMAGE HS1
• Manufacturer: KONICA MINOLTA, INC.
• Date Cleared: 2015-06-05 ( 46 days)
• Product Code: IYO ITX IYN
• Regulation Number: 892.1560

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 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, 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, Mmode, Color Doppler-mode, and PW/CW Doppler-mode. The optional items are available, such as a Pole Cart with storage basket, a power extension unit, and a foot switch with dual pedals. 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.

Predicate Devices

K142197 - Ultrasound System SONIMAGE HS1, K061605 - Nemio XG, SSA-580A

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a conventional ultrasound system and does not mention AI, ML, or any related technologies in its description, intended use, or performance studies.

Therapeutic

No
The description explicitly states its purpose for "diagnostic purposes" and "medical diagnosis or examination," and does not mention any therapeutic functions.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed to collect ultrasonic image data of the human body for diagnostic purposes."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "portable ultrasound system" that "transmits / receives ultrasound waves" and includes "transducers," which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided text, the device described is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD devices are used to examine specimens taken from the human body. The description clearly states that the Ultrasound System SONIMAGE HS1 and its transducers are used to collect ultrasonic image data of the human body by applying a procedure to the human body.
• The device uses an ultrasonic pulse-echo method to visualize internal structures. This is a non-invasive imaging technique applied directly to the patient, not a method for analyzing biological samples.
• The intended use is for diagnostic imaging of various anatomical sites within the body. This aligns with the function of an ultrasound machine, not an IVD device.

Therefore, the Ultrasound System SONIMAGE HS1 is a medical imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 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, musculoskeletal (soft tissue), peripheral vascular, and Cardiac.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: As shown in tables in the document on pages 3-6.

Product codes (comma separated list FDA assigned to the subject device)

IYO, IYN, ITX

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, Mmode, Color Doppler-mode, and PW/CW Doppler-mode.

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

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic pulse-echo method

Anatomical Site

Small parts, abdomen, musculoskeletal (soft tissue), peripheral vascular, Cardiac.
Specific applications include Ophthalmic, Fetal, Intra-operative (Specify), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (includes thyroid and breast), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Intravascular, Cardiac Adult, Cardiac Pediatric, Intravascular (Cardiac), Trans-esoph. (Cardiac), Intra-cardiac, Peripheral vessel.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The geometric accuracy verification in B-mode and the accuracy verification of the position and the velocity for Color Doppler-mode and PW/CW Doppler-mode, and the time for PW/CW Doppler-mode are comprehensively tested as Bench-tests except quantitative Doppler sensitivity. The both systems do not have a quantitative claims of sensitivity regarding Color Doppler-mode and PW/CW Doppler-mode.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K142197 - Ultrasound System SONIMAGE HS1, K061605 - Nemio XG, SSA-580A

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

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 is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with a design that resembles an abstract bird or wing shape above them. The logo is black and white.

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

June 5, 2015

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

Re: K151060

Trade/Device Name: Ultrasound System SONIMAGE HS1 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, ITX Dated: April 17, 2015 Received: April 20, 2015

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

Robert A Ochs

Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number:	K151060
Device Number:	Ultrasound System SONIMAGE HS1
Indications for 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 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, musculoskeletal (soft tissue), peripheral vascular, and Cardiac.

Type of Use (Select one or both, as applicable)

Prescription Use	X	OR	Over-The-Counter Use
(Per 21 CFR 801 Subpart D)			(Per 21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Ultrasound System SONIMAGE HS1 System:

Transducer:

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

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal
	Abdominal	P	P	P	N	P	Note1	Note2
	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	N	N	N	N	N	Note1	Note2
	Cardiac Pediatric	N	N	N	N	N	Note1	Note2
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note1	Note2
	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

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Ultrasound System SONIMAGE HS1 System: L18-4 Transducer:

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

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& 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)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note1	Note2
	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

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Ultrasound System SONIMAGE HS1 System: C5-2 Transducer:

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

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
Fetal	Fetal
Imaging
& Other	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
Vessel	Peripheral vessel
	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)

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Ultrasound System SONIMAGE HS1 System: S4-2 Transducer:

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

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal
	Abdominal	N	N	N	N	N	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	N	N	N	N	N	Note1	Note2
	Cardiac Pediatric	N	N	N	N	N	Note1	Note2
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	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)

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Chapter 4. 510(k) Summary

Submitter's Name:	KONICA MINOLTA, INC.
Address:	1 Sakura-machi,
Hino-shi, 191-8511 Japan
Contact:	Shigeyuki Kojima
Telephone:	[phone]
Date:	April 17, 2015
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):	K142197 - Ultrasound System SONIMAGE HS1,
Konica Minolta, Inc.
K061605 - Nemio XG, SSA-580A,
Toshiba America Medical Systems, Inc.

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

8

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, Mmode, Color Doppler-mode, and PW/CW Doppler-mode.

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

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 C1:2009 and A2:2010; IEC 60601-1-6: 2013; IEC 60601-1-2: 2007; IEC 60601-2-37: 2007; IEC 62304: 2006; ISO 10993-1:2009; ISO 10993-5:2009; ISO 10993-10:2010; 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 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, musculoskeletal (soft tissue), peripheral vascular and cardiac.

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This system is contraindicated for an eyeball examination or any other examination that may require the passage of an ultrasound beam 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 (K142197). The additional predicate device for the Cardiac usage including CW Doppler and Sector probe is Nemio XG SSA-580A system (K061605). The comparisons of technological characteristics for both systems are provided as follows;

Intended Use:

The additional intended use of the system and supporting clinical application is Cardiac that is the same as K061605.

The systems are intended to be used with a conventional extracorporeal transducers, which types are Linear, Convex and Sector as partially same as those of the predicate devices.

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 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 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 and the accuracy verification of the position and the velocity for Color Doppler-mode and PW/CW Doppler-mode, and the time for PW/CW Doppler-mode are

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comprehensively tested as Bench-tests except quantitative Doppler sensitivity. The both systems do not have a quantitative claims of sensitivity regarding Color Doppler-mode and PW/CW Doppler-mode.

Safety:

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

Biocompatibility:

The patient contact materials of human body surface are evaluated under ISO 10993 and determined as acceptable for these usage. The both 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 predicate devices that have already been cleared for USA distribution with 510(k) premarket notification numbers K142197 and K061605.