Aloka Arietta 850

K183456 · Hitachi Healthcare Americas · IYN · Jan 28, 2019 · Radiology

Device Facts

• Record ID: K183456
• Device Name: Aloka Arietta 850
• Applicant: Hitachi Healthcare Americas
• Product Code: IYN · Radiology
• Decision Date: Jan 28, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ALOKA ARIETTA 850 is intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intraoperative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous/Non-Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel, Endoscopy clinical applications.

Device Story

ALOKA ARIETTA 850 is a multi-functional, fully digitalized ultrasound diagnostic scanner. It processes ultrasound echoes received via linear, convex, radial, or phased array probes to generate diagnostic images. The system supports B-mode, M-mode, PW/CW Doppler, Color Doppler, Power Doppler (Color Flow Angiography), Tissue Doppler Imaging (TDI), and 3D/4D imaging. It is operated by trained clinicians (physicians, sonographers) in clinical settings. The device uses adaptive filters (HI REZ) to enhance image quality. Clinicians view the output on a display to evaluate anatomy and blood flow, aiding in clinical decision-making and patient diagnosis. The system is based on PC technology using the Windows operating system.

Clinical Evidence

Bench testing only. No clinical data was required for this submission. The device conforms to applicable safety standards including AAMI ANSI ES60601-1, IEC 60601-2-37, IEC 60601-1-2, ISO 10993 series, and NEMA UD 2/UD 3.

Technological Characteristics

Fully digitalized ultrasound system; supports linear, convex, radial, and phased array probes. PC-based architecture (Windows OS). Modes: B, M, PW/CW Doppler, Color/Power Doppler, TDI, 3D/4D. Conforms to IEC 60601-1, IEC 60601-2-37, and ISO 10993 standards.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body in fetal, abdominal, intra-operative, laparoscopic, pediatric, small organ, cephalic, trans-rectal, trans-vaginal, trans-urethral, trans-esophageal, musculoskeletal, wound, gynecological, endoscopic, cardiac, and peripheral vessel applications.

Regulatory Classification

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.

Predicate Devices

• ALOKA ARIETTA 850 (K173739)

Reference Devices

• NOBLUS Ultrasound Diagnostic System (K160559)
• ARIETTA Precision (K163505)
• ARIETTA 70 (K134016)
• PROSOUND F75 Diagnostic Ultrasound System (K140639)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 28, 2019

Hitachi Healthcare Americas % Mr. Dennis Domoracki Senior Regulatory Affairs Specialist 1959 Summit Commerce Park TWINSBURG OH 44087

Re: K183456

Trade/Device Name: ALOKA ARIETTA 850 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: December 13, 2018 Received: December 13, 2018

Dear Mr. Domoracki:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Hsl 2. Nils

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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| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------------|-------------------|--------|--------|--------|------------------|----------------------|--------------------|
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| | 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 | P |
| | Musculo-skel. (Superfic.) | P | P | P | P | P | P | P |
| | Other (Wound) | Ph | Ph | Ph | Ph | Ph | Ph | Ph |
| | Other (Gynecological) | P | P | P | P | P | P | |
| | Other (Endoscopic) | Pi, Pj | Pi, Pj | Pi, Pj | Pi, Pj | Pi, Pj | Pi, Pj | |
| | Cardiac Adult | P | P | P | P | P | P | P |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P |
| Peripheral Vessel | Trans-esophageal (Adult/Pediatric) | Pg | Pg | Pg | Pg | Pg | Pg | Pg |
| | Peripheral vessel | P | P | P | P | P | P | P |

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| | runn-sessophi. (non-Car | | | | | | | | |
| | usculo-skel. (Convert | | | | | | | | |
| | ວັນາອຸດົ…