The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic. Adult Cephalic. Trans-rectal. Trans-vaginal. Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

Device Description

The HS40 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color M mode, Anatomical mode, Color Doppler mode, Pulsed Wave (PW) Spectral Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, Power Doppler (PD) mode, ElastoScan Mode, 3D/4D/XI STIC imaging mode, Freehand 3D mode, Dual mode, Dual live mode, Quad mode, Combined mode, Simultaneous mode and Zoom mode. The HS40 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HS40 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Samsung Medison HS40 Diagnostic Ultrasound System. This document asserts substantial equivalence to a predicate device rather than presenting a study demonstrating acceptance criteria being met for a novel device. Therefore, much of the requested information regarding acceptance criteria and performance studies for a new device is not applicable or not provided in this specific filing.

However, based on the provided text, I can infer and extract some relevant information.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on demonstrating "substantial equivalence" to a legally marketed predicate device (HS50/HS60 Diagnostic Ultrasound System, K170493) in terms of safety, effectiveness, and functionality. The "reported device performance" is the assertion that the HS40 meets these criteria by having equivalent or similar functionality and adherence to safety standards.

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (HS40)
Safety: Compliance with applicable medical device safety standards.	Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, NEMA UD 2-2004, NEMA UD 3-2004.
Effectiveness: Similar intended uses and clinical applications.	Supports all clinical applications of the predicate device: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
Functionality: Similar technological characteristics and modes of operation.	Possesses all key features and modes of operation (e.g., B-mode, M-mode, PW Spectral Doppler, Color Doppler, Tissue Harmonic Imaging, 3D/4D imaging) present in the predicate device (HS50/HS60). No new functionality compared to the predicate.

2. Sample Size for the Test Set and Data Provenance

The document explicitly states: "Summary of Clinical Tests: Not applicable. The subject of this submission, HS40, did not require clinical studies to support substantial equivalence." This indicates that there was no specific test set of patient data used for clinical evaluation of the HS40's performance against defined acceptance criteria because clinical studies were not required for this type of submission (510(k) for an ultrasound system). The equivalence is largely based on technical specifications and adherence to standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable, as no clinical test set requiring expert ground truth was performed for the HS40 in this submission.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was performed for the HS40 in this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The filing explicitly states that no clinical studies were required or performed. Therefore, no MRMC study comparing human readers with and without AI assistance was conducted for this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is a diagnostic ultrasound system, not an AI-powered diagnostic algorithm in the typical sense that would undergo standalone performance evaluation. The device's performance is tied to its imaging capabilities, which are considered substantially equivalent to the predicate.

7. Type of Ground Truth Used

Not applicable, as no clinical studies with ground truth were conducted for this submission. The "ground truth" in a 510(k) context for an ultrasound system like this is primarily its adherence to safety standards and demonstration of equivalent technical and functional characteristics to a predicate, not clinical diagnostic accuracy against a reference standard.

8. Sample Size for the Training Set

Not applicable. This document describes a general-purpose diagnostic ultrasound system that acquires images, not an AI/ML algorithm that is trained on a specific dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set for an AI/ML algorithm for this device.

Summary

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Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a symbolic graphic. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion. The graphic features a stylized representation of three human profiles, one behind the other, suggesting a sense of community and support.

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

August 8, 2017

Samsung Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313

Re: K172129

Trade/Device Name: HS40 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: July 12, 2017 Received: July 14, 2017

Dear Mr. Job:

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 of medical device

{1}------------------------------------------------

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/ResourcesforYou/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,

Michael D. 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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Indications for Use

510(k) Number (if known) K172129

Device Name

HS40 Diagnostic Ultrasound System

Indications for Use (Describe)

The HS40 diagnostic ultrasound system and probes were designed for obtaining ultrasound images and analyzing bodv fluid.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) No.:

Device Name: HS40 Diagnostic Ultrasound System

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	N	N	N		Note 15	Note 1	Note 2, 7, 8, 9, 11
	Abdominal (See Note 10)	N	N	N		Note 15	Note 1	Note 2, 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	N	N	N		Note 15	Note 1	Note 2, 7, 8, 9, 11
	Small Organ (See Note 5)	N	N	N		Note 15	Note 1	Note 2, 7, 9, 11, 12
	Neonatal Cephalic	N	N	N		Note 15	Note 1	Note 8, 9, 11
	Adult Cephalic	N	N	N	N	Note 15	Note 1	Note 7
	Trans-rectal	N	N	N		Note 15	Note 1	Note 2, 7, 8, 9, 12
	Trans-vaginal	N	N	N		Note 15	Note 1	Note 2, 7, 8, 9, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	N	N	N		Note 15	Note 1	Note 2, 7, 8, 9, 11, 12
	Musculo-skel. (Superfic.)	N	N	N		Note 15	Note 1	Note 2, 7, 9, 11
	Intra-luminal
	Other (See Note 13)	N	N	N		Note 15	Note 1	Note 2, 7, 9, 12
	Cardiac Adult	N	N	N	N	Note 15	Note 1	Note 4, 7, 14, 16
Cardiac	Cardiac Pediatric	N	N	N	N	Note 15	Note 1	Note 4, 7, 14, 16
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	N	N	N	N	Note 15	Note 1	Note 2, 7, 8, 9, 11
	Other (spec.)

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

Additional Comments:

Note 1: B+M, B+PW, B+CV, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, B+PPJ, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: Tissue Doppler Imaging (TDI)
Note 15: Color Doppler includes Power (Amplitude) Doppler
Note 16: Contrast

{4}------------------------------------------------

510(k) No.:

Device Name: LA3-16AD for use with HS40

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	N	N	N		Note 15	Note 1	Note 2, 7, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	N	N	N		Note 15	Note 1	Note 2, 7, 9, 11
	Small Organ (See Note 5)	P	P	P		Note 15	Note 1	Note 2, 7, 9, 11, 12
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		Note 15	Note 1	Note 2, 7, 9, 11, 12
	Musculo-skel. (Superfic.)	P	P	P		Note 15	Note 1	Note 2, 7, 9, 11
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		Note 15	Note 1	Note 2, 5, 7, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K153408; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+CV, B+C, B+PD, B+Elastoscan, B+C+PW, B+DD+PW, B+DPD+PW, B+C+M, B+C+CW, B+PPJ, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

Note 15: Color Doppler includes Power (Amplitude) Doppler

{5}------------------------------------------------

510(k) No.:

Device Name: CA2-8AD for use with HS40

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		Note 15	Note 1	Note 2, 7, 9, 11
	Abdominal (See Note 10)	P	P	P		Note 15	Note 1	Note 2, 7, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	N	N	N		Note 15	Note 1	Note 2, 7, 9, 11
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	N	N	N		Note 15	Note 1	Note 2, 7, 9, 11
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	N	N	N		Note 15	Note 1	Note 2, 7, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K143264; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+CV, B+C, B+PD, B+Elastoscan, B+C+PW, B+DD+PW, B+DPD+PW, B+C+M, B+C+CW, B+PPJ, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

Note 15: Color Doppler includes Power (Amplitude) Doppler

{6}------------------------------------------------

510(k) No.:

Device Name: CF4-9 for use with HS40

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		Note 15	Note 1	Note 8, 9, 11
	Abdominal (See Note 10)	P	P	P		Note 15	Note 1	Note 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		Note 15	Note 1	Note 8, 9, 11
	Small Organ (See Note 5)
	Neonatal Cephalic	P	P	P		Note 15	Note 1	Note 8, 9, 11
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	N	N	N		Note 15	Note 1	Note 8, 9, 11
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		Note 15	Note 1	Note 8, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K133505; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+CV, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, B+PPJ, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

Note 15: Color Doppler includes Power (Amplitude) Doppler

Note 16: Strain+

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)

{7}------------------------------------------------

510(k) No.:

Device Name: PN2-4 for use with HS40

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P		Note 15	Note 1	Note 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	P	P	P		Note 15	Note 1	Note 7
	Trans-rectal (See Note 13)
	Trans-vaginal (See Note 13)
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult	P	P	P		Note 15	Note 1	Note 4, 7, 14, 16
	Cardiac Pediatric	P	P	P		Note 15	Note 1	Note 4, 7, 14, 16
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K133505; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+CV, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, B+PPJ, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: Tissue Doppler Imaging (TDI)
Note 15: Color Doppler includes Power (Amplitude) Doppler

Note 7: Tissue Harmonic Imaging (THI)

{8}------------------------------------------------

510(k) No.:

Device Name: EVN4-9 for use with HS40

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		Note 15	Note 1	Note 2, 7, 9
	Abdominal (See Note 10)	P	P	P		Note 15	Note 1	Note 2, 7, 9
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		Note 15	Note 1	Note 2, 7, 9, 12
	Trans-vaginal	P	P	P		Note 15	Note 1	Note 2, 7, 9, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) (See Note 13)	P	P	P		Note 15	Note 1	Note 2, 7, 9, 12
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K153408; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+CV, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, B+PPJ, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: Tissue Doppler Imaging (TDI)
Note 15: Color Doppler includes Power (Amplitude) Doppler

Note 16: Strain+

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)

{9}------------------------------------------------

510(k) No.:

Device Name: VN4-8 for use with HS40

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		Note 15	Note 1	Note 2, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P		Note 15	Note 1	Note 2, 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		Note 15	Note 1	Note 2, 7, 8, 9, 11
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by K153408; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+CV, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, B+PPJ, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

Note 15: Color Doppler includes Power (Amplitude) Doppler

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

510(k) No.:

Device Name: V5-9 for use with HS40

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		Note 15	Note 1	Note 2, 7, 8, 9
	Abdominal (See Note 10)	P	P	P		Note 15	Note 1	Note 2, 7, 8, 9
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
&Other	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		Note 15	Note 1	Note 2, 7, 8, 9, 12
	Trans-vaginal	P	P	P		Note 15	Note 1	Note 2, 7, 8, 9, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	P	P	P		Note 15	Note 1	Note 2, 7, 8, 9, 12
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K153408; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+CV, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, B+PPJ, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: Tissue Doppler Imaging (TDI) Note 15: Color Doppler includes Power (Amplitude) Doppler

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510(k) No.:

Device Name: DP2B for use with HS40

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic				P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult				P
	Cardiac Pediatric				P
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel				P
	Other (spec.)

N= new indication; P= previously cleared by FDA K143264; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+CV, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, B+PPJ, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: Tissue Doppler Imaging (TDI)
Note 15: Color Doppler includes Power (Amplitude) Doppler

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.

1. Submitter's Information: 21 CFR 807.92(a)(1)

SAMSUNG MEDISON CO., LTD. 42, Teheran-ro 108-gil, Gangnam-gu, Seoul, Korea

Contact Person:

Jiyeon, Cho Regulatory Affairs Specialist

Telephone:	82.2.2194.5431
Facsimile:	82.2.556.3974

Data Prepared: Apr 13, 2017

2. Name of the device:

Common/Usual Name:
Diagnostic Ultrasound System and Accessories
Proprietary Name:
HS40 Diagnostic Ultrasound System
Classification Names:	FR Number	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	IYN
Ultrasound Pulsed Echo Imaging System	892.1560	IYO
Diagnostic Ultrasound Transducer	892.1570	ITX

3. Identification of the predicate or legally marketed device:

-HS50 / HS60 Diagnostic Ultrasound System (K170493)

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4. Device Description:

5. Intended Uses:

The HS40 diagnostic ultrasound system and probes were designed for obtaining ultrasound images and analyzing body fluid.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

6. Technological Characteristics:

The HS40 are substantially equivalent with respect to safety, effectiveness, and functionality to the HS50 / HS60 (K170493). There is no new functionality that of predicate device of HS40.

All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All system allow for specialized measurements of structures and flow, and calculations.

Feature /Characteristics	The subject device	The predicate device.
	HS40	HS50 / HS60(K170493)
Indications for use
Fetal/Obstetrics	V	V
Abdominal	V	V
Gynecology	V	V
Pediatric	V	V
Small Organ	V	V
Neonatal Cephalic	V	V
Adult Cephalic	V	V
Trans-rectal	V	V
Trans-vaginal	V	V
Musculo-skeletal(Conventional)	V	V
Musculo-skeletal(Superficial)	V	V
Urology	V	V
Cardiac Adult	V	V
Cardiac Pediatric	V	V
Peripheral vessel	V	V
Scanhead Types
Linear Array	V	V
Curved Linear Array	V	V
Feature /Characteristics	The subject deviceHS40	The predicate device.HS50 / HS60(K170493)
Endocavity	✓	✓
Phased Array	✓	✓
Static Probes	✓	✓
Scanhead Frequency1.0 ~ 20.0 MHz	✓	✓
Modes of Operation
B-mode	✓	✓
M-mode	✓	✓
Pulsed wave (PW)Spectral Doppler	✓	✓
Continuous wave (CW)Doppler	✓	✓
Color Doppler	✓	✓
Power AmplitudeDoppler	✓	✓
Tissue HarmonicImaging	✓	✓
3D/4D imaging mode	✓	✓
Combined modes	✓	✓
Safety & EMC
Compliance
IEC 60601-1UL 60601-1CSA C22.2 No.601.1	✓	✓
IEC 60601-2-37	✓	✓
IEC 60601-1-2	✓	✓
Acoustic Output Display Standard
Track 3	✓	✓
Patient Contact Materials
Tested to ISO 10993-1	✓	✓
Functionality
Quick Scan(Q Scan)	✓	✓
ClearVision	✓	✓
MultiVision	✓	✓
Needle Mate+	✓	✓
Auto IMT+	✓	✓
Strain+	✓	✓
Elastoscan	✓	✓
Panoramic	✓	✓
3D Imaging (VolumeData Acquisition)	✓	✓
3D Imaging presentation3D Cine/4D Cine	✓	✓
3D Rendering MPR	✓	✓
3D XI	✓	✓
3D MSV/Oblique View	✓	✓
3D MXI VolumeSlice/Mirror View	✓	✓
Volume CT	✓	✓
3D MagiCut	✓	✓
Volume Calculation(VOCAL,XI VOCAL)	✓	✓
XI STIC	✓	✓
Realistic Vue	✓	✓
Ez Exam+	✓	✓
Feature /Characteristics	The subject device	The predicate device.
	HS40	HS50 / HS60(K170493)
5D Follicle	V	V

510(k) Summary / Statement Certification

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7. A brief discussion of the bench and non-clinical tests conducted on the subject device

The device has been evaluated for acoustic output, biocompatibility effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform to applicable medical device safety standards.

The HS40 and their applications comply with voluntary standards as below:

Reference No.	Title
IEC 60601-1	AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 andA2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2	AAMI / ANSI / IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance – Collateral standard:Electromagnetic compatibility - Requirements and tests (Edition 3)
IEC 60601-2-37	IEC 60601-2-37:2007 Edition 2.0 2007-08, Medical electrical equipment – Part 2-37:Particular requirements for the basic safety and essential performance of ultrasonicmedical diagnostic and monitoring equipment
ISO10993-1	AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process
ISO14971	ISO 14971:2007, Medical devices - Application of risk management to medicaldevices
NEMA UD 2-2004	NEMA UD 2-2004 (R2009)Acoustic Output Measurement Standard for Diagnostic Ultrasound EquipmentRevision 3
NEMA UD 3-2004	NEMA UD 3-2004 (R2009)Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indiceson Diagnostic Ultrasound Equipment, Revision 2

Summary of Clinical Tests:

Not applicable. The subject of this submission, HS40, did not require clinical studies to support substantial equivalence.

8. Conclusion

Intended uses and other key features are consistent with traditional clinical practices and FDA guidelines. The design, development and quality process of the manufacturer confirms with 21 CFR 820 and ISO 13485. The device is designed to conform to applicable medical device safety standards and compliance. Therefore, SAMSUNG MEDISON CO., LTD. considers the HS40 to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

END of 510(K) Summary

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.