Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System

• K Number: K142618
• Device Name: Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System
• Manufacturer: Hitachi Aloka Medical America, Inc.
• Date Cleared: 2014-10-16 ( 30 days)
• Product Code: ITX DEV
• Regulation Number: 892.1570

Intended Use

The Hitachi Aloka Medical, Ltd UST-5310 or UST-5311 or UST-5311-TIP transducers are intended for use with the PROSOUND ALPHA 6, PROSOUND ALPHA 7 and ARIETTA70 Diagnostic Ultrasound systems by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation during intraoperative and Intra-operative (neurosurgery) procedures. This device is not indicated for Ophthalmic applications.

Device Description

Linear Array transducer

Predicate Devices

K140854

Reference Devices

K093488

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasound transducer and system with no mention of AI or ML capabilities in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

Therapeutic

No
The device is described as a "Diagnostic Ultrasound system" used for "diagnostic ultrasound evaluation," indicating its purpose is to diagnose, not treat, conditions.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the transducers are used with "Diagnostic Ultrasound systems by trained personnel... for the diagnostic ultrasound evaluation".

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Linear Array transducer," which is a hardware component of an ultrasound system, not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use clearly states "diagnostic ultrasound evaluation during intraoperative and Intra-operative (neurosurgery) procedures." This describes a procedure performed directly on a patient using imaging, not a test performed on a sample (like blood, urine, or tissue) outside the body.
• Device Description: It's a "Linear Array transducer," which is a component of an ultrasound system used for imaging the inside of the body.
• Input Imaging Modality: It's "Diagnostic ultrasound," which is an imaging technique, not a method for analyzing biological samples.
• Anatomical Site: The specified anatomical sites are internal organs and the brain, which are imaged directly.

IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Hitachi Aloka Medical, Ltd UST-5310 or UST-5311 or UST-5311-TIP transducers are intended for use with the PROSOUND ALPHA 6, PROSOUND ALPHA 7 and ARIETTA70 Diagnostic Ultrasound systems by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation during intraoperative and Intra-operative (neurosurgery) procedures.

This device is not indicated for Ophthalmic applications.

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

ITX

Device Description

Linear Array transducer

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained personnel (doctor, sonographer, etc.)

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

Not Found

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

Not Found

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

Non-clinical Testing: No new hazards were identified with the addition of the UST-5311 transducers to the PROSOUND ALPHA7 & ARIETTA70. The subject systems and the transducers have been evaluated for acoustic output, biocompatibility, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards.
Clinical testing: None required.
Conclusions: The Hitachi Aloka Medical, Ltd. Sterile Transducer is substantially equivalent in safety and effectiveness to the predicate device.

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

Not Found

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

K140854

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

K093488

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

Not Found

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or a cape.

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

Hitachi Aloka Medical America, Inc. % Ms. Angela Van Arsdale RA/QA Manager 10 Fairfield Blvd. WALLINGFORD CT 06492

December 3, 2014

Re: K142618 Trade/Device Name: UST-5310 or UST-5310-TIP / UST-5311 or UST-5311-TIP Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: September 12, 2014 Received: September 16, 2014

Dear Ms. Arsdale:

This letter corrects our substantially equivalent letter of October 16, 2014.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

Robert A Ochs

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K142618

Device Name

UST-5310 or UST-5310-TIP / UST-5311 or UST-5311-TIP

Indications for Use (Describe)

The Hitachi Aloka Medical, Ltd UST-5310 or UST-5311 or UST-5311-TIP transducers are intended for use with the PROSOUND ALPHA 6, PROSOUND ALPHA 7 and ARIETTA70 Diagnostic Ultrasound systems by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation during intraoperative and Intra-operative (neurosurgery) procedures.

This device is not indicated for Ophthalmic applications.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

Device Name: PROSOUND ALPHA 6, PROSOUND ALPHA 7 and ARIETTA 70 Transducer : UST -5310 or UST -5310-TIP 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	Color
Doppler	Combined*
(Specify)	Other**
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)*	P	P	P		P	P	P
	Intra-operative (Neurosurgery)	P	P	P		P	P	P
	Laparoscopic **
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA via K140854

Combination of each operating mode includes:

• 1 Combination of each operating mode- B/M, B/PWD, M/CD, B/CD/PWD

**2 Includes: Mflow, B/Bflow, Power flow.

Intra-operative (Specify)* - (liver, pancreas, gall bladder..)

(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) Prescription Use Only (Per 21 CFR 801.109)

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

Page 2 of 3

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

Device Name: PROSOUND ALPHA 6, PROSOUND ALPHA 7 and ARIETTA 70 Transducer : UST -5311 or UST -5311-TIP 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	Color
Doppler	Combined*
(Specify)	Other**
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)*	P	P	P		P	P	P
	Intra-operative (Neurosurgery)	P	P	P		P	P	P
	Laparoscopic**
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA via K140854

Combination of each operating mode includes:

*1 Combination of each operating mode- B/M, B/PWD, M/CD, B/CD/PWD

**2 Includes: Mflow, B/Bflow, Power flow.

Intra-operative (Specify)* - (liver, pancreas, gall bladder..)

(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)

Prescription Use Only (Per 21 CFR 801.109)

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

Page 3 of 3

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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

Contact: Angela Van Arsdale RA/OA Manager Telephone: [phone] Ext: 346 Fax Number: [phone]

Manufacturer: Hitachi Aloka Medical, Ltd. 6-22-1 Mure, Mitaka-Shi, 181-8622 Tokyo, Japan

Date Prepared: September 12, 2014

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

Device Proprietary Name - UST-5310 or UST-5310-TIP / UST-5311 or UST-5311-TIP Common name - Diagnostic Ultrasound Transducer Classification name - Diagnostic Ultrasonic Transducer Classification: Class II Product Code: 90-ITX 892.1570 Diagnostic Ultrasonic Transducer

3. Legally Marketed Predicate Device(s):

UST-5310 or UST-5310-TIP / UST-5311 or UST-5311-TIP Intraoperative Ultrasound Transducer for use with PROSOUND ALPHA 6 [K140854].

• 4. Device Description:
     Linear Array transducer
• 5. Indication for Use:
     The Hitachi Aloka Medical, Ltd UST-5310 or UST-5310-TIP / UST-5311-TIP transducers are intended for use with the PROSOUND ALPHA 6, PROSOUND ALPHA 7 and ARIETTA70 Diagnostic Ultrasound systems by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation during intra- operative and Intraoperative (neurosurgery) procedures.

This device is not indicated for Ophthalmic applications.

• 6. Comparison to predicate device:
     The Hitachi Aloka Medical, Ltd. UST-5310 or UST-5310-TIP / UST-5311-TIP Intraoperative transducers cleared via K140854 for use with the PROSOUND ALPHA 6 have not undergone any modifications, therefore there are no changes to either of the two transducers are being added for use with the PROSOUND ALPHA7 and ARIETTA70 Diagnostic Ultrasound systems. The subject systems: PROSOUND ALPHA7 & ARIETTA70 Diagnostic Ultrasound system and predicate system: PROSOUND ALPHA 6 (K093488 / K140854) are track 3 systems that incorporate the same fundamental and scientific technologies. There are no changes to the PROSOUND ALPHA7 and ARIETTA70 Diagnostic Ultrasound scanners with the exception of connection and recognition of the UST-5310 and UST-5311 transducers.

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21 CFR Part 807.92, Section b

• 1. Non-clinical Testing
     No new hazards were identified with the addition of the UST-5311 transducers to the PROSOUND ALPHA7 & ARIETTA70. The subject systems and the transducers have been evaluated for acoustic output, biocompatibility, 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 Aloka Medical, Ltd. Sterile Transducer is substantially equivalent in safety and effectiveness to the predicate device;

• . The subject and predicate device(s) are both indicated for diagnostic ultrasound imaging.

• . The subject and predicate device(s) have the same gray scale and Doppler capabilities.

• . The subject and predicate device(s) have the same essential technology for imaging, Doppler functions, and signal processing.

• 트 The subject and predicate device(s) have acoustic level below the Track 3 FDA limits.

• . The subject and predicate device(s) are manufactured in accordance to FDA 21 CFR 820 Quality System Regulations.

• 트 The subject and predicate device(s) are designed and manufactured to the same electrical and physical safety standards.

• 트 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 predicate transducers [UST-5310 & UST-5311] are sterile single use disposable devices.

END OF SUMMARY