(338 days)
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No
The document describes a standard diagnostic ultrasound system and does not mention AI, ML, or any related technologies in its description or intended use.
No
The device is described as a "diagnostic ultrasound system" and its function is to "acquire ultrasound data and display it" and provide "measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnostic purposes." There is no mention of it being used for treatment.
Yes
The "Device Description" explicitly states, "Atlas 2.0 / Hitachi 2.0 are general purpose, mobile, software-controlled, diagnostic ultrasound systems..." and later, "The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnostic purposes."
No
The device description explicitly states that the device is a "software-controlled, diagnostic ultrasound system" and is "designed to accept a large selection of scanheads". This indicates the device includes hardware components (the system itself and scanheads) in addition to software.
Based on the provided information, the Atlas 2.0 / Hitachi 2.0 device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Atlas 2.0 / Hitachi 2.0 is a diagnostic ultrasound system. It uses sound waves to create images of internal structures of the body.
- Intended Use: The intended uses listed are all related to in vivo imaging (imaging within the living body) of various anatomical sites. There is no mention of analyzing samples taken from the body.
Therefore, the device falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Atlas 2.0 / Hitachi 2.0 are intended for cardiac, peripheral vascular, feval imaging and other, and ophthaimic 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 aneries, 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.
Product codes (comma separated list FDA assigned to the subject device)
90 IYN, 90 ITX, 90IYD
Device Description
Atlas 2.0 / Hitachi 2.0 are general purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-scroen display for thermal and mechanical values related to potential biocffect mechanisms. There function is to acquire ultrasound data and display it on a monitor in 2-D, M-mode, 2-D Color Flow Doppier, Color M-mode, Color Power Angio, Pulsed (PW) Doppier or in a combination of modes. An audio 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 scanneads by means of a control located on the system control panel. All actions affecting the performance of the scanhead from the main system control panel.
The Atlas 2.0 / Hitachi 2.0 system is designed to accept scanneads of the following types and frequency:
frequency range: 2.0 - 10.0 MHz scanhead types: fiat linear array curved linear array phased array
Specific operating conditions (frame rate, line density, center frequency, number of active clements etc.) are automatically optimized by the system software in response to user inputs such as ficid of view, focal depth, image quality, power etc.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac, peripheral vascular, feval, ophthaimic, abdominal and pelvic, retro-peritoneal cavity, small parts (breasts, penis, testes, thyroid/parathyroid, abdominal wall), pediatric organs, carotid arteries, legs, arms, feet, penile artery, prostate, rectal wall, neonatal cephalic, middle cerebral aneries, internal carotid artery, vertebral arteries, eye and surrounding structures.
Indicated Patient Age Range
Adults, children, pediatric, neonatal
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
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.(b)
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.
0
510(k) Premarket Notification K961073
Atlantis Atlan 2.0 / Hitachi 2.0 Ultrasound Systems Revision - February 13, 1997
SECTION 10 510(k) SUMMARY OF SAFETY AND EFFECTIVEN
FEB 1 9 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.
- Submitter's name, address, telephone number, consact person:
Terrence J. Sweeney Director, Worldwide Quality and Regulatory Affairs Atlantis Diagnostics International, Inc. (ADI) 19015 North Creek Parkway, Suite 105 Bothell WA 98011 (206) 487-7602
Date prepared: February 13, 1997
- Name of the device, including the trade or propriesary name if applicable, the common or 2) 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
-
- Identification of the predicate or legally marketed device:
ADII believes that Atlas 2.0 / Hirachi 2.0 are substantially equivalent to the currentlymarketed ATL HDI 3000 diagnostic ultrasound system. ATL Ultramark® 9 HDI™ diagnostic ultrasound system, Atlantis Atlas 1.0 system and Storz Renaissance A/B Scan.
- Identification of the predicate or legally marketed device:
4) Device Description:
Atlas 2.0 / Hitachi 2.0 are general purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-scroen display for thermal and mechanical values related to potential biocffect mechanisms. There function is to acquire ultrasound data and display it on a monitor in 2-D, M-mode, 2-D Color Flow Doppier, Color M-mode, Color Power Angio, Pulsed (PW) Doppier or in a combination of modes. An audio
1
510{k} Premarkel Notification K961073
Atlantis Allas 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 scanneads by means of a control located on the system control panel. All actions affecting the performance of the scanhead from the main system control panel.
The Atlas 2.0 / Hitachi 2.0 system is designed to accept scanneads of the following types and frequency:
frequency range: 2.0 - 10.0 MHz scanhead types: fiat linear array curved linear array phased array
Specific operating conditions (frame rate, line density, center frequency, number of active clements etc.) are automatically optimized by the system software in response to user inputs such as ficid 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 Blectrical Equipment
- · UL 2601-1, Underwriters Laboratories Standards, Medical Eloctrical Equipment
- C22.2 No. 601.1, Canadian Standards Association, Medical Blectrical Bquipment
- CEVIEC 1157:1992, International Electrolechnical Commission. Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment
- IEC 601-1-2, Collateral Standard: Electromagnetic Compatibility .
2) Intended Use:
Atlas 2.0 / Hitachi 2.0 are intended for cardiac, peripheral vascular, feval imaging and other, and ophthaimic 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 aneries, internal carotid artery, and vertebral . arteries.
- Cardiac studies in adults and children. .
- · Biopsy guidance for tissue or fluid sampling.
510(k) Summary of Safety and Effectiveness
2
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.
Technological Characteristics: ର)
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 itom 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 (AIUMNEMA, 1992) for an on-sereen 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 ourput in accordance with the ALARA (as low as reasonably achievable) principle.
The device's acoustic output limits are:
All Applications Other Than Ophthalmic:
| ISPTAG | 720 mW/cm2 | (Maximum) |
|---|---|---|
| TIS/TIB/TIC | 0.1 - 4.0 | (Range) |
| Mechanical Index (MI) | 1.9 | (Maximum) |
| Isppad | 0 - 700 W/cm2 | (Range) |
| ISPTAd | 50 mW/cm2 | (Maximum) |
| Thermal Index (TIC) | 0.1 - 1.0 | (Range) |
| Mechanical Index (MI) | .23 | (Maximum) |
| IsppAd | 0 - 50 W/cm2 | (Range) |
The limits are same as predicate Track 3 devices.