ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE)

K961073 · Atlantis Diagnostics Intl., Inc. · IYO · Feb 19, 1997 · Radiology

Device Facts

• Record ID: K961073
• Device Name: ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE)
• Applicant: Atlantis Diagnostics Intl., Inc.
• Product Code: IYO · Radiology
• Decision Date: Feb 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Atlas 2.0 / Hitachi 2.0 are intended for cardiac, peripheral vascular, fetal imaging and other, and ophthalmic intended uses as defined FDA guidance documents. Typical examinations shall include: - General abdominal and pelvic studies including organ surveys and retro-peritoneal cavity studies. - Study of small parts including breasts, penis, testes, thyroid/parathyroid and the abdominal wall. - Pediatric scans of organs. - Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery. - Monitoring procedures for infertility applications. - First, second and third trimester pregnancy studies. - Prostate, prostate biopsy guidance, and rectal wall studies. - Neonatal cephalic studies. - Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries. - Cardiac studies in adults and children. - Biopsy guidance for tissue or fluid sampling. - Ophthalmic studies of the eye and surrounding structures and studies to obtain blood flow information in the eye and surrounding structures.

Device Story

Mobile, software-controlled diagnostic ultrasound system; acquires ultrasound data via piezoelectric scanheads (linear, curved, phased arrays; 2.0-10.0 MHz). Transforms reflected sound waves into 2-D, M-mode, Color Flow Doppler, Color M-mode, Color Power Angio, and Pulsed (PW) Doppler images/audio. Used in clinical settings by healthcare professionals. System software automatically optimizes operating conditions (frame rate, line density, frequency) based on user inputs (field of view, focal depth). Provides anatomical measurements and analysis packages for clinical diagnosis. Includes on-screen display of thermal/mechanical bioeffect indices (TIS/TIB/TIC, MI) per AIUM/NEMA standards. Output assists clinicians in diagnostic decision-making and procedural guidance.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, adherence to electromechanical safety standards (IEC 601-1, UL 2601-1, C22.2 No. 601.1, IEC 601-1-2), and compliance with acoustic output declaration standards (CEI/IEC 1157:1992, AIUM/NEMA 1992).

Technological Characteristics

Piezoelectric transducer technology; 2.0-10.0 MHz frequency range. Modes: 2-D, M-mode, Color Flow, Color M-mode, Color Power Angio, Pulsed Doppler. Software-controlled parameter optimization (frame rate, line density, center frequency). Standards: IEC 601-1, UL 2601-1, C22.2 No. 601.1, IEC 601-1-2, CEI/IEC 1157:1992, AIUM/NEMA 1992. Mobile form factor; supports two simultaneous scanheads.

Indications for Use

Indicated for diagnostic ultrasound imaging and blood flow analysis in adults and children, including cardiac, peripheral vascular, fetal, abdominal, pelvic, small parts, pediatric, neonatal, transcranial, and ophthalmic applications, as well as biopsy guidance.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• ATL HDI 3000
• ATL Ultramark® 9 HDI™
• Atlantis Atlas 1.0
• Storz Renaissance A/B Scan

Submission Summary (Full Text)

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02-13-1997 04:05PM
31 3014804224
P.03
510(k) Premarket Notification
K961073
Atlantis Atlas 2.0 / Hitachi 2.0 Ultrasound Systems
Revision - February 13, 1997
K961073

# SECTION 10
## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

FEB 19 1997

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 name, address, telephone number, contact person:

Terrence J. Sweeney
Director, Worldwide Quality and Regulatory Affairs
Atlantis Diagnostics International, Inc. (ADII)
19015 North Creek Parkway, Suite 105
Bothell WA 98011
[phone]

Date prepared: February 13, 1997

2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:

Common/Usual Name

Diagnostic Ultrasound System with Accessories

Proprietary Name

Atlas 2.0 Diagnostic Ultrasound System

Hitachi 2.0 Diagnostic Ultrasound System

Classification Names:

Ultrasonic Pulsed Doppler Imaging System, Product Code 90 IYN, 21 CFR 892.1550
Diagnostic Ultrasonic Scanhead, Product Code 90 ITX, 21 CFR 892.1570
Ultrasonic Pulsed Echo Imaging System, Product Code 90IYD, 21 CFR 892.1560

3) Identification of the predicate or legally marketed device:

ADII believes that Atlas 2.0 / Hitachi 2.0 are substantially equivalent to the currently-marketed ATL HDI 3000 diagnostic ultrasound system. ATL Ultramark® 9 HDI™ diagnostic ultrasound system, Atlantis Atlas 1.0 system and Storz Renaissance A/B Scan.

4) Device Description:

Atlas 2.0 / Hitachi 2.0 are general purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical values related to potential bioeffect mechanisms. There function is to acquire ultrasound data and display it on a monitor in 2-D, M-mode, 2-D Color Flow Doppler, Color M-mode, Color Power Angio, Pulsed (PW) Doppler or in a combination of modcs. An audio

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02-13-1997 04:05PM FROM: REGULATORY

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510(k) Premarket Notification K981073

Atlantis Atlas 2.0 / Hitachi 2.0 Ultrasound Systems Revision - February 13, 1997

presentation of pulsed Doppler information is also available on the systems. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnostic purposes.

The Atlas 2.0 / Hitachi 2.0 systems are designed to accept a large selection of scanheads with up to two being connected to the system at any one time. The operator may select between the two scanheads by means of a control located on the system control panel. All actions affecting the performance of the scanhead are activated from the main system control panel.

The Atlas 2.0 / Hitachi 2.0 system is designed to accept scanheads of the following types and frequency:

frequency range: 2.0 - 10.0 MHz

scanhead types: flat linear array
curved linear array
phased array

Specific operating conditions (frame rate, line density, center frequency, number of active elements etc.) are automatically optimized by the system software in response to user inputs such as field of view, focal depth, image quality, power etc.

Atlas 2.0 / Hitachi 2.0 have been designed to meet the following electromechanical safety standards:

- IEC 601-1, International Electrotechnical Commission, Medical Electrical Equipment
- UL 2601-1, Underwriters Laboratories Standards, Medical Electrical Equipment
- C22.2 No. 601.1, Canadian Standards Association, Medical Electrical Equipment
- CEI/IEC 1157:1992, International Electrotechnical Commission, Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment
- IEC 601-1-2, Collateral Standard: Electromagnetic Compatibility

## 5) Intended Use:

Atlas 2.0 / Hitachi 2.0 are intended for cardiac, peripheral vascular, fetal imaging and other, and ophthalmic intended uses as defined FDA guidance documents.

Typical examinations shall include:

- General abdominal and pelvic studies including organ surveys and retro-peritoneal cavity studies.
- Study of small parts including breasts, penis, testes, thyroid/parathyroid and the abdominal wall.
- Pediatric scans of organs.
- Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery.
- Monitoring procedures for infertility applications.
- First, second and third trimester pregnancy studies.
- Prostate, prostate biopsy guidance, and rectal wall studies.
- Neonatal cephalic studies.
- Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries.
- Cardiac studies in adults and children.
- Biopsy guidance for tissue or fluid sampling.

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02-13-1997 04:06PM FROM ATL REGULATORY
114804224 P.05
510(k) Premarket Notification
K961073
Atlantis Atlas 2.0 / Hitachi 2.0 Ultrasound Systems
Revision - February 13, 1997

- Ophthalmic studies of the eye and surrounding structures and studies to obtain blood flow information in the eye and surrounding structures.

## 6) Technological Characteristics:

These devices operate identical to the predicate devices in that piezo material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2-D and M-mode images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of these devices (2-D, M-mode, Color Flow, Color M-mode, Color Power Angio, and Pulsed Doppler) are the same as predicate devices identified in item 3. Scanhead patient contact materials are biocompatible and are also the same as the identified predicate devices.

These devices conform to the Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (AIUM/NEMA, 1992) for an on-screen display feature that provides information on potential thermal and cavitation bioeffect mechanisms. A user education program provides additional information so users may moderate the system's acoustic output in accordance with the ALARA (as low as reasonably achievable) principle.

The device's acoustic output limits are:

All Applications Other Than Ophthalmic:

| I_{SPTA4} | 720 mW/cm2 | (Maximum) |
| --- | --- | --- |
| TIS/TIB/TIC | 0.1 - 4.0 | (Range) |
| Mechanical Index (MI) | 1.9 | (Maximum) |
| I_{SPPA4} | 0 - 700 W/cm2 | (Range) |

Ophthalmic Applications:

| I_{SPTA4} | 50 mW/cm² | (Maximum) |
| --- | --- | --- |
| Thermal Index (TIC) | 0.1 - 1.0 | (Range) |
| Mechanical Index (MI) | .23 | (Maximum) |
| I_{SPPA4} | 0 - 50 W/cm² | (Range) |

The limits are same as predicate Track 3 devices.

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