ARIETTA Prologue is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of following clinical applications: FETAL; ABDOMINAL - (Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis)); INTRA-OPERATIVE (SPEC.)-(Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures)); INTRA-OPERATIVE (NEURO); LAPAROSCOPIC; PEDIATRIC; SMALL ORGAN (SPEC.)-(Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy): NEONATAL CEPHALIC: ADULT CEPHALIC; TRANS-RECTAL - (Includes imaging for guidance of trans-rectal biopsy); TRANS-VAGIAL -(Includes imaging for guidance of trans-vaginal biopsy); TRANS-ESOPHAGEAL (NON-CARDIAC & CARDIAC) -ADULT/PEDIATRIC; MUSCULOSKELETAL (CONVENT./SUPERFIC.); Other (spec.) -WOUND (Includes imaging for Cavernous/Non-Cavernous wounds); Other (spec) - GYNECOLOGICAL; CARDIAC: ADULT/ PEDIATRIC and PERIPHERAL VESSEL.

Device Description

An ultrasound diagnostic system with the following features:

Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the reflected echoes
Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) in various modes of operation
A computer system to control the transducer and analyze the signals resulting from the reflected echoes
A video monitor with optional image recorder to display the computed image or derived Doppler data

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the ARIETTA Prologue Diagnostic Ultrasound System and Transducers. It focuses on demonstrating substantial equivalence to a predicate device (Noblus K142368, and K134016 for some indications) and does not contain detailed information about specific performance acceptance criteria or a dedicated study proving performance against such criteria in the way a clinical trial for an AI/CADe device would.

Instead, the document asserts substantial equivalence based on similarities in intended use, clinical applications, modes of operation, technology, and adherence to safety standards. The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical testing performed to ensure the device is safe and effective as per FDA regulations for ultrasound devices, rather than a clinical performance study with specific quantifiable metrics.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative performance acceptance criteria (e.g., sensitivity, specificity, accuracy) for an AI/CADe component, as it is a diagnostic ultrasound system, not an AI/CADe device with specific diagnostic algorithms being validated. The acceptance criteria described are broadly related to safety and effectiveness compared to a predicate device.

Acceptance Criteria (Stated Requirements for Equivalence)	Reported Device Performance (as stated in the conclusion for substantial equivalence)
Indicated for diagnostic ultrasound imaging and fluid flow analysis.	The subject and predicate device(s) are both indicated for diagnostic ultrasound imaging and fluid flow analysis.
Same gray scale and Doppler capabilities.	The subject and predicate device(s) have the same gray scale and Doppler capabilities.
Same essential technology for imaging, Doppler functions, and signal processing.	The subject and predicate device(s) have the same essential technology for imaging, Doppler functions, and signal processing.
Acoustic level below Track 3 FDA limits.	The subject and predicate device(s) have acoustic level below the Track 3 FDA limits.
Manufactured in accordance with FDA 21 CFR 820 Quality System Regulations.	The subject and predicate device(s) are manufactured in accordance to FDA 21 CFR 820 Quality System Regulations.
Designed and manufactured to the same electrical and physical safety standards.	The subject and predicate device(s) are designed and manufactured to the same electrical and physical safety standards.
Materials tested in accordance with ISO 10993-1 for biocompatibility.	The subject and predicate device(s) are manufactured with materials that have been tested in accordance to ISO 10993-1; all biocompatibility testing has been conducted in accordance to each component material characterization, type of body contact, and duration contact risk profile.
Designed to be re-usable and provide instructions for cleaning, disinfection, and sterilization.	The subject and predicate device(s) are designed to be re-usable and provide instructions for cleaning, disinfection, and sterilization in the Ultrasound system and transducer manuals.
Non-clinical testing for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, electrical, and mechanical safety.	The subject device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards.

2. 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 describe a test set or data provenance in the context of a performance study for an AI/CADe device. The evaluations conducted were non-clinical tests (acoustic output, biocompatibility, EMC, electrical/mechanical safety) which typically involve testing the physical device and its components according to engineering standards, rather than analyzing clinical data.

3. 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 this is not a study for an AI/CADe device requiring expert-established ground truth from clinical data. The "ground truth" for the non-clinical tests would be the established engineering standards and specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical data test set or adjudication method is mentioned.

5. 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

Not applicable. The document describes a diagnostic ultrasound system, not an AI-assisted diagnostic tool subject to MRMC studies comparing human readers with and without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a diagnostic ultrasound system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical testing, the "ground truth" would be engineering specifications, applicable safety standards (e.g., IEC 60601-1, IEC 62304, ISO 10993-1), and FDA guidance documents. There is no mention of clinical ground truth (like pathology or outcomes data) being used for performance evaluation in this 510(k) submission.

8. The sample size for the training set

Not applicable. This is not an AI/CADe device, and no training set for an algorithm is mentioned.

9. How the ground truth for the training set was established

Not applicable, as there is no training set mentioned for an AI/CADe algorithm.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles, with flowing lines suggesting movement or energy. The figure is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

December 15, 2016

Hitachi, Ltd. % Ms. Angela Van Arsdale RA/QA Manager 10 Fairfield Boulevard WALLINGFORD CT 06492

Re: K162902

Trade/Device Name: ARIETTA Prologue Diagnostic Ultrasound System and Transducers Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 13, 2016 Received: October 18, 2016

Dear Ms. Van Arsdale:

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.

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

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

{2}------------------------------------------------

Indications for Use

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

510(k) Number (if known)

K162902

Device Name

ARIETTA Prologue Diagnostic Ultrasound System and Transducers

Indications for Use (Describe)

The Modes of Operation are B mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Dopler), Color Doppler, Amplitude Doppler (Color Flow Angiography) and TDI (Tissue Doppler Imaging), Omni Directional M mode.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Device Name: ARIETTA Prologue

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

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spe	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P
Fetal Imaging& Other	Abdominal	Pa	Pa	Pa	Pa	Pa	Pa	Pa
	Intra-operative (Spec.)	Pb	Pb	Pb		Pb	Pb	Pb
	Intra-operative (Neuro.)	P	P	P		P	P	P
	Laparoscopic	P	P	P		P	P	P
	Pediatric	P	P	P	P	P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd		Pd	Pd	Pd
	Neonatal Cephalic	P	P	P		P	P	P
	Adult Cephalic	P	P	P	P	P	P	P
	Trans-rectal	Pe	Pe	Pe		Pe	Pe	Pe
	Trans-vaginal	Pf	Pf	Pf		Pf	Pf	Pf
	Trans-urethral
	Trans-esoph. (non-Card.)	Pg	Pg	Pg	Pg	Pg	Pg	Pg
	Musculo-skel. (Convent.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)	P	P	P		P	P	P
	Intra-luminal
	Other (Wound)	Ph	Ph	Ph		Ph	Ph	Ph
	Other (Gynecological)	P	P	P		P	P	P
	Cardiac Adult	P	P	P	P	P	P	P
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (Adult/Pediatric)	Pg	Pg	Pg	Pg	Pg	Pg	Pg
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	P	P
	Other (spec.)

N = new indication; P = previously cleared in K134016, K142368

Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/CW, CFM-B/CFM-N, CFM-B/PW, CFM-B/CW

** Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode, Trapezoid mode

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"

Prescription Use Only (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

Page 2 of 18

510(K) Premarket Notification - ARIETTA Prologue

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

Device Name: ARIETTA Prologue
Transducer: C22P
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
Fetal Imaging& Other	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N = new indication; P = previously cleared in K142368

Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"

Prescription Use Only (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

Page 3 of 18

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

Device Name: ARIETTA Prologue
Transducer: C251
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spe)	Other**(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal	P	P	P		P	P	P
	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd		Pd	Pd	Pd
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N = new indication; P = previously cleared in K142368

Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/CFM-M, CFM-B/PW

**Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"

Prescription Use Only (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

Page 4 of 18

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

Device Name: ARIETTA Prologue
Transducer: C25P
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation

Clinical Application			Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spe)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
Fetal Imaging& Other	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N = new indication; P = previously cleared in K142368

Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"

Prescription Use Only (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

Page 5 of 18

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

Device Name: ARIETTA Prologue
Transducer: C35
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spe.)	Other**(Spec.)
	Ophthalmic
Fetal Imaging& Other	Fetal	P	P	P		P	P	P
	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd		Pd	Pd	Pd
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N = new indication; P = previously cleared in K142368

Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/CFM-M, CFM-B/PW

**Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"

Prescription Use Only (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

Page 6 of 18

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

Device Name: ARIETTA Prologue
Transducer: C41B
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal	P	P	P			P	P
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	Pe	Pe	Pe		Pe	Pe	Pe
	Trans-vaginal	Pf	Pf	Pf		Pf	Pf	Pf
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)	P	P	P			P	P
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N = new indication; P = previously cleared in K142368

Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"

Prescription Use Only (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

Page 7 of 18

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

Device Name: ARIETTA Prologue
Transducer: C41V1
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spe)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
Fetal Imaging& Other	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	Pe	Pe	Pe		Pe	Pe	Pe
	Trans-vaginal	Pf	Pf	Pf		Pf	Pf	Pf
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)	P	P	P		P	P	P
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N = new indication; P = previously cleared in K142368

Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"

Prescription Use Only (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

Page 8 of 18

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

Device Name: ARIETTA Prologue
Transducer: C42K
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spe.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging& Other	Abdominal
	Intra-operative (Spec.)	Pb	Pb	Pb		Pb	Pb	Pb
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)	Pd	Pd	Pd		Pd	Pd	Pd
	Neonatal Cephalic	P	P	P		P	P	P
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
Cardiac	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N = new indication; P = previously cleared in K142368

Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"

Prescription Use Only (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

Page 9 of 18

{11}------------------------------------------------

Device Name: ARIETTA Prologue
Transducer: L44
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation

Clinical Application		B	M	PWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
General(Track I only)	Specific(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging& Other	Abdominal	Pa	Pa	Pa	Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd	Pd	Pd	Pd
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P	P	P	P
	Musculo-skel. (Superfic.)	P	P	P	P	P	P
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P	P	P	P
Vessel	Other (spec.)

N = new indication; P = previously cleared in K142368

Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/CFM-M, CFM-B/PW

**Power Doppler (Color Flow Angiography), Free Angular M-mode, Trapezoid mode

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"

Prescription Use Only (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

Page 10 of 18

{12}------------------------------------------------

Device Name: ARIETTA Prologue
Transducer: L441
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd		Pd	Pd	Pd
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)	P	P	P		P	P	P
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P
	Other (spec.)

N = new indication; P = previously cleared in K142368

Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode, Trapezoid mode

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"

Prescription Use Only (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

Page 11 of 18

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

Device Name: ARIETTA Prologue
Transducer: L44LA
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spe	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging& Other	Abdominal
	Intra-operative (Spec.)	P	P	P		P	P	P
	Intra-operative (Neuro.)
	Laparoscopic	P	P	P		P	P	P
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N = new indication; P = previously cleared in K142368

Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode, Trapezoid mode

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"

Prescription Use Only (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

Page 12 of 18

{14}------------------------------------------------

Device Name: ARIETTA Prologue
Transducer: L53K
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
(1iminal American	Mode of Overention

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spe)	Other**(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal
	Intra-operative (Spec.)	Pb	Pb	Pb		Pb	Pb	Pb
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N = new indication; P = previously cleared in K142368

Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode, Trapezoid mode

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"

Prescription Use Only (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

Page 13 of 18

{15}------------------------------------------------

Device Name: ARIETTA Prologue
Transducer: L55
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd		Pd	Pd	Pd
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)	P	P	P		P	P	P
	Intra-luminal
	Other (Wound)	Ph	Ph	Ph		Ph	Ph	Ph
	Other (Gynecological)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P		P	P	P
Vessel	Other (spec.)

N = new indication; P = previously cleared in K142368

Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode, Trapezoid mode

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"

Prescription Use Only (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

Page 14 of 18

{16}------------------------------------------------

Device Name:	ARIETTA Prologue
Transducer:	L64
Intended use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spe)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging& Other	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd		Pd	Pd	Pd
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)	P	P	P		P	P	P
	Intra-luminal
	Other (Wound)	Ph	Ph	Ph		Ph	Ph	Ph
	Other (Gynecological)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P		P	P	P
Vessel	Other (spec.)

N = new indication; P = previously cleared in K142368

Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode, Trapezoid mode

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"

Prescription Use Only (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

Page 15 of 18

{17}------------------------------------------------

Device Name: ARIETTA Prologue
Transducer: S211
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Clinical Application						Mode of Operation
	General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spe	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal		P	P	P	P	P	P	P
Fetal Imaging& Other	Abdominal		P	P	P	P	P	P	P
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric		P	P	P	P	P	P	P
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic		P	P	P	P	P	P	P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
	Cardiac Adult		P	P	P	P	P	P	P
Cardiac	Cardiac Pediatric		P	P	P	P	P	P	P
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
PeripheralVessel	Peripheral vessel		P	P	P	P	P	P	P
	Other (spec.)

N = new indication; P = previously cleared in K142368

Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW, CFM-B/CW

**Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Includes imaging for guidance of trans-vaginal biopsy. Subscript "f":

Subscript "g": For Adult and pediatric patients

Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds

Prescription Use Only (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

Page 16 of 18

510(K) Premarket Notification - ARIETTA Prologue

{18}------------------------------------------------

Device Name: ARIETTA Prologue
Transducer: S31KP
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application						Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging& Other	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)	P	P	P		P	P	P
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N = new indication; P = previously cleared in K134016

Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and pediatric patients

Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"

Prescription Use Only (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

Page 17 of 18

{19}------------------------------------------------

Device Name: ARIETTA Prologue
Transducer: S3ESEL
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		B	M	PWD	CWD	ColorDoppler	Combined*(Spe)	Other**(Spec.)
General(Track I only)	Specific(Tracks I & III)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)	Pg	Pg	Pg	Pg	Pg	Pg	Pg
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Wound)
	Other (Gynecological)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Adult/Pediatric)	Pg	Pg	Pg	Pg	Pg	Pg	Pg
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N = new indication; P = previously cleared in K142368

Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW, CFM-B/CW

**Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

Subscript "b": Includes imaging of organs and structures exposed during neurosurgery and laparoscopic procedures).

Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.

Subscript "e": Includes imaging for guidance of trans-rectal biopsy

Includes imaging for guidance of trans-vaginal biopsy. Subscript "f":

Subscript "g": For Adult and pediatric patients

Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds

Prescription Use Only (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

Page 18 of 18

510(K) Premarket Notification - ARIETTA Prologue

{20}------------------------------------------------

510(k) Summary of Safety and Effectiveness in accordance with 21 CFR Part 807, Subpart E, Section 807.92.

21 CFR 807.92, Subsection a

1. Submitter's Information

Hitachi Aloka Medical America, Inc. 10 Fairfield Boulevard Wallingford, CT 06492-5903

On behalf of Hitachi, Ltd. Tokyo, Japan

Primary Contact Person: Angela Van Arsdale R.A. / Q.A. Manager Telephone: (203) 269-5088 Ext: 346 Fax Number: (203) 269-6075

Date Prepared: September 7, 2016

Device / Common / Classification Name / Classification / Product Code:

Device Proprietary Name – ARIETTA Prologue Diagnostic Ultrasound system and Transducers Common name - Diagnostic Ultrasound System and Transducers Classification name - System, Imaging, Pulsed Doppler, Ultrasonic Classification: Class II Product Code: 90-IYN 892.1550 Ultrasonic Pulsed Imaging System 90-IY0 892.1560 Ultrasonic Pulsed Echo Imaging System 90-ITX 892.1570 Diagnostic Ultrasound Transducer

1. Legally Marketed Predicate Device(s): NOBLUS (K142368)
1. Device Description:

An ultrasound diagnostic system with the following features:

Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the reflected O echoes
Ultrasound transducer accessories (standard and optional) to maximize functional usage of O transducer(s) in various modes of operation
A computer system to control the transducer and analyze the signals resulting from the reflected O echoes
A video monitor with optional image recorder to display the computed image or derived Doppler O data

5. Indication for Use:

ARIETTA Prologue is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of following clinical applications: FETAL; ABDOMINAL - (Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis)); INTRA-OPERATIVE (SPEC.) - (Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures)); INTRA-OPERATIVE (NEURO.); LAPAROSCOPIC; PEDIATRIC; SMALL ORGAN (SPEC.) - (Includes thyroid, breast, scrotum, penis and imaging for guidance of biopsy); NEONATAL CEPHALIC; ADULT CEPHALIC; TRANS-RECTAL - (Includes imaging for guidance of trans-rectal biopsy); TRANS-VAGINAL - (Includes imaging for guidance of trans-vaginal biopsy); TRANS-ESOPHAGEAL ( Non-Cardiac & Cardiac) - Adult/Pediatric; MUSCULOSKELETAL (CONVENT./SUPERFIC.); Other (spec.) -WOUND (Includes imaging for Cavernous/Non-Cavernous wounds); Other (spec) - GYNECOLOGICAL; CARDIAC ADULT / PEDIATRIC; PERIPHERAL VESSEL.

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6. Comparison to predicate device:

	Subject:ARIETTA Prologue Diagnostic systemand Transducers	Predicate:Noblus [K14268]
CLINICAL APPLICATIONS:	Fetal; Abdominal; Intra-operative (Spec.);Intra-operative (Neuro.); Laparoscopic;Pediatric; Small Organ (Spec.); NeonatalCephalic; Adult Cephalic; Trans-rectal;Trans-Vaginal; Trans-esophageal (Non-Cardiac & Cardiac) - Adult/Pediatric;Musculoskeletal (Convent./Superfic.);Wound (Cavernous/Non-Cavernous);Gynecological; Cardiac Adult / Pediatricand Peripheral Vessel	Fetal; Abdominal; Intra-operative (Spec.);Laparoscopic; Pediatric; Small Organ(Spec.); Neonatal Cephalic; Adult Cephalic;Trans-rectal; Trans-vaginal; Trans-esophageal (Non-Cardiac & Cardiac) -Adult/Pediatric; Musculoskeletal(Convent./Superfic.);Wound(Cavernous/Non-Cavernous); Gynecology;Cardiac; Peripheral vessel, Biopsy,Endoscopy, Intra-luminal, Urology
TRACK	3	3
PROBE TYPES	Convex, Linear, Sector	Convex, Linear, Sector, 4D, Other, EUS, Broncho
TRANSMIT
Transmit channel	64	64
Transmit power level	0 ~ 100% (1% steps)	5 ~ 100% (5% steps)
Transmit frequency	Selectable in 4 steps	Selectable in 5 steps
Transmit focus	Max 8 steps electric focusing	Max 10 steps electric focusing
RECEIVE
Number of receive beam	2 beam	2 beam (as 64 channels)
Receive focus	Continuously variable aperturedynamic focus	Continuously variable aperturedynamic focus
DISPLAY MODES	B, M, PW, CW and combinations	B, M, PW, CW and combinations
Physiological signal display	N/A	Applicable
DICOM	Applicable	Applicable
DICOM SR	Applicable	Applicable
DICOM QR	Applicable	Applicable
Automated IMT Measurement	Applicable	Applicable
Automated NT Measurement(Cleared via K140639, K140443, K134016)	Applicable	N/A
EFV (Extended Field of View)	Applicable	Applicable (Wide View function)
HI REZ / AIP	Applicable (AIP/SIP)	Applicable (HI REZ)
DSD (Dynamic Slow Motion Display)(Cleared via K140639, K140443, K134016)	Applicable	N/A
Real-Time Doppler Auto Trace	Applicable	Applicable
Spatial Compound	Applicable	Applicable
FAM (Free Angular M-mode)	Applicable	Applicable (ODM function)
Measurement Function	Applicable	Applicable
Trapezoid	Applicable	Applicable
TDI	Applicable	Applicable
Color Flow
Reference frequency	2.0~8MHz	2.0~10MHz
PRF	120Hz~20kHz	120Hz~20kHz
Linear oblique scan angle	0°, ±10°, ±15°, ±20° (depending probe)	0°, ±10°, ±15°, ±20° (depending probe)
Color Flow Angiography	Available	Available
Built-in Battery	Applicable	Applicable
Wireless equipment	Applicable	N/A

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21 CFR Part 807.92, Section b

1. Non-clinical Testing

No new hazards were identified with the subject device. The subject device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards.

2. Clinical testing:

None required

3. Conclusions:

The Hitachi, Ltd. ARIETTA Prologue Diagnostic Ultrasound system and Transducers is substantially equivalent in safety and effectiveness to the predicate device;

The subject and predicate device(s) are both indicated for diagnostic ultrasound imaging and fluid flow analysis.
. The subject and predicate device(s) have the same gray scale and Doppler capabilities.
트 The subject and predicate device(s) have the same essential technology for imaging, Doppler functions, and signal processing.
. The subject and predicate device(s) have acoustic level below the Track 3 FDA limits.
트 The subject and predicate device(s) are manufactured in accordance to FDA 21 CFR 820 Quality System Regulations.
. The subject and predicate device(s) are designed and manufactured to the same electrical and physical safety standards.
. The subject and predicate device(s) are manufactured with materials that have been tested in accordance to ISO 10993-1; all biocompatibility testing has been conducted in accordance to each component material characterization, type of body contact, and duration contact risk profile.
. The subject and predicate device(s) are designed to be re-usable and provide instructions for cleaning, disinfection, and sterilization in the Ultrasound system and transducer manuals.

END OF 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.