K Number

Device Name

ULTRASOUND SYSTEM SONIMAGE HS 1

Manufacturer

KONICA MINOLTA, INC.

Date Cleared

2015-10-08

(29 days)

Product Code

IYN ITX IYO

Regulation Number

892.1550

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

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K151060, K061605

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a conventional ultrasound system and does not mention AI, ML, or related concepts.

Therapeutic

No.
The device is described as being for "diagnostic purposes" and the "collection of ultrasonic image data," not for treatment.

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" and "offers a procedure applied to the human body for medical diagnosis or examination." Additionally, the Device Description states it is "used for the purpose of diagnosing the human body."

SaMD (Software as a Medical Device)

The device description explicitly states it is a "portable ultrasound system" that "transmits / receives ultrasound waves," indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that the Ultrasound System SONIMAGE HS1 uses the ultrasonic pulse-echo method to visualize the internal structures and dynamics of the human body directly. It transmits and receives ultrasound waves to create images.
No Sample Analysis: There is no mention of analyzing samples taken from the body. The diagnostic information is obtained by interacting with the body itself.

Therefore, this device falls under the category of medical imaging devices rather than in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

IYN, IYO, ITX

Device Description

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Small parts, abdomen, musculoskeletal (soft tissue), peripheral vascular, and Cardiac.

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)

Non-clinical test: The geometric accuracy verification in B-mode 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 Dopplermode and ECG trace 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, TDImode and PW/CW Doppler-mode.

Safety: The system is in conformance with the standards described above, which are same standards to those of the primary predicate device (K151060). The both systems conform to real time display of thermal and mechanical output indices under Track 3.

Biocompatibility: The all patient contact materials, including material of an acoustic standoff, 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.

Design Control as per 21CFR 820.30: The proposed device has been verified to meet design specification. The Risk Analysis for the SONIMAGE HS1 has been conducted in accordance with the SOP conforming to ISO14971:2007. The risks associated with all of the identified hazards were reduced to an acceptable level by the risk control measures as shown in Risk Assessment Record. 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.

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.

K151060, K061605

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

§ 892.1550 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.

Summary

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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a ribbon-like shape representing the snake.

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

October 8, 2015

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

Re: K152577

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: September 8, 2015 Received: September 9, 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.

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,

Robert Ochs

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

Enclosure

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K152577

Device Name Ultrasound System SONIMAGE HS1

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal
	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
	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	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)
Peripheral
Vessel	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

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

Ultrasound System SONIMAGE HS1 System: Transducer: L18-4

Clinical Application	Mode of Operation
	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
General
(Track 1 Only)	Specific
(Tracks 1 & 3)
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	P	P	P		P	Note1	Note2
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	P	P	P		P	Note1	Note2
	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)

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

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	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal
	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)

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)

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	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal
	Abdominal	P	P	P	P	P	Note1	Note2,3
	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
Vessel	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: Other mode CF-TDI(Color Flow - Tissue Doppler Imaging) and PW-TDI(Pulse Doppler - Tissue Doppler Imaging)

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	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
Fetal
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
Vessel	Peripheral vessel	N	N	N		N	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

510(k) Summary

Submitter's Name:	KONICA MINOLTA, INC.
Address:	1 Sakura-machi,
Hino-shi, 191-8511 Japan
Contact:	Shigeyuki Kojima
Telephone:	+81 42 589 8429
Date:	September 8, 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):	K151060 – Ultrasound System SONIMAGE HS1,
Konica Minolta, Inc.
K061605 - Nemio XG, SSA-580A,
Toshiba America Medical Systems, Inc.
Modification Description:	The proposed submission is consisting in several modifications to the
Ultrasound System SONIMAGE HS1 referencing as K151060. The
modifications are as shown below;
✓ Introducing a new transducer and an acoustic standoff
✓ Additional options/accessories such as Wireless LAN capability
✓ Modifications of system software with regards to the imaging
modes (CF(2D)-TDI, PW-TDI, Anatomical-M, and etc.) and the
enhancement of measurement and report function
This proposed submission also includes minor design changes.

Device Description:

The Ultrasound System SONIMAGE HS1 is a portable ultrasound system The system provides ultrasound imaging for general purposes. 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 Doppler-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.

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: 2010; 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.

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 (K151060). The imaging hardware is identical to the primary predicate device (K151060). For the functions other than K151060's, the other predicates are referenced such as the Nemio XG SSA-580A system (K061605). The comparisons of technological characteristics for the proposed device and the predicate systems are provided as follows;

Intended Use

The Indications for Use Statement is identical to the primary predicate device. The intended use of the system and supporting clinical application operating with a conventional extracorporeal transducers are the same as the predicate devices (K151060 and K061605) that support Linear, Convex and Sector type of ultrasound transducers.

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 modifications enhancing the features and the functions are achieved by the system software. No additional hardware is employed to add modes of CF(2D)-TDI, PW-TDI, and Anatomical-M to the primary predicate device (K151060), and those modes operate as same as the other predicates. The wireless connectivity through supporting the OTS USB-WiFi adapter are newly introduced comparing to the predicates, but the complete evaluation as required by the risk analysis has been properly done.

The enhancement of application measurement and report functions by the software modification does not introduce new features other than the traditional items for the conventional ultrasound systems. All referenced literatures are listed in the user manual as same manner as the predicate devices.

The proposed new linear transducer is a conventional extracorporeal transducer, and it employs the same fundamental scientific technologies as the sector transducer of primary predicate device (K151060).

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, PW/CW Doppler-mode and TDI-mode, and the time for PW/CW Dopplermode and ECG trace 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, TDImode and PW/CW Doppler-mode.

Safety

The system is in conformance with the standards described above, which are same standards to those of the primary predicate device (K151060). The both systems conform to real time display of thermal and mechanical output indices under Track 3.

Biocompatibility

The all patient contact materials, including material of an acoustic standoff, 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.

Design Control as per 21CFR 820.30

The proposed device has been verified to meet design specification. The Risk Analysis for the SONIMAGE HS1 has been conducted in accordance with the SOP conforming to ISO14971:2007. The risks associated with all of the identified hazards were reduced to an acceptable level by the risk control measures as shown in Risk Assessment Record. 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.

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.