(344 days)
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No
The document describes a standard diagnostic ultrasound system with various imaging modes and analysis packages, but there is no mention of AI or ML in the device description, intended use, or any other section. The system optimizes settings based on user input, which is a common feature of modern medical devices and does not necessarily indicate AI/ML.
No
The device is described as a "diagnostic ultrasound system" and its function is to "acquire ultrasound data and display it on a monitor" and "measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis". It is intended for imaging and diagnosis, not for treating conditions.
Yes
The device description explicitly states, "Level 10 HDI is a general purpose, mobile, software-controlled, diagnostic ultrasound system." It also mentions that it "offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals."
No
The device description explicitly states it is a "diagnostic ultrasound system" that "acquire[s] ultrasound data" and is "designed to accept a large selection of scanheads." This indicates it includes hardware components for generating and receiving ultrasound waves, which is not characteristic of a software-only medical device.
Based on the provided information, this 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 Level 10 HDI is a diagnostic ultrasound system. It uses sound waves to create images of internal body structures. It does not analyze samples taken from the body.
- Intended Use: The intended uses listed are all related to imaging internal anatomy and blood flow, not analyzing biological samples.
- Device Description: The description focuses on the ultrasound technology, image processing, and display of anatomical structures and blood flow.
Therefore, the Level 10 HDI falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Level 10 HDI is intended for cardiac, peripheral vascular, fetal imaging and other, and ophthalmic intended uses as defined FDA guidance documents.
Typical examinations using Level 10 HDI are:
- General abdominal and pelvic studies including organ surveys, blood flow assessment, and retroperitoneal cavity studies.
- Study of small parts and superficial structures including breasts, shoulders, thyroid/parathyroid, and the abdominal wall.
- Pediatric scans of organs, superficial, and bony structures.
- Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery.
- Monitoring procedures for infertility studies (other than in vitro fertilization).
- First, second and third trimester pregnancy studies.
- Prostate, prostate biopsy guidance, and rectal wall studies.
- Neonatal head studies.
- Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries.
- Cardiac studies in adults and children.
- Monitoring of cardiac function during procedures using transesophageal echocardiography.
- Biopsy guidance for tissue or fluid sampling.
- Assessment of cardiac muscle, coronary arteries and great vessels during cardiac surgery
- Study of myocardial function in adults
- Study of eye anatomy including blood flow in retinal vessels and branches
- Study of the esophagus, stomach, biliary sytem, pancreas and gastrointestinal tract using endoscopic probe
- Study of abdominal and pelvic organs and masses using laparoscopic probe
- Examination of organs, masses and vessels during surgical procedures
- Study of muscles, ligaments, nerve bundles and connective tissue.
Product codes (comma separated list FDA assigned to the subject device)
90 IYN, 90 ITX, 90MD, 901YO
Device Description
Level 10 HDI is a general purpose, mobile, software-controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and display it on a monitor in 2D, M-mode, 2D Color Doppler, Mmode Color Doppler, Continuous Wave Doppler (CW), Pulsed (PW) Doppler, Color Power Angio (CPA) or in a combination of modes. Level 10 HDI also gives the opertor the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. Level 10 HDI has an output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The Level 10 HDI system is designed to accept a large selection of scanheads with up to three array scanheads and one static probe being connected to the system at any one time. The operator may select among the 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 Level 10 HDI system is designed to accept scanheads of the following types and frequency:
frequency range: 2.0 - 10.0 MHz
scanhead types: Linear array Curved linear array Phased array Static probes
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.
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, fetal, ophthalmic, general abdominal, pelvic, small parts, superficial structures (breasts, shoulders, thyroid/parathyroid, abdominal wall), pediatric organs, superficial structures, bony structures, carotid arteries, legs, arms, feet, penile artery, prostate, rectal wall, neonatal head, middle cerebral arteries, internal carotid artery, vertebral arteries, esophagus, stomach, biliary system, pancreas, gastrointestinal tract, muscles, ligaments, nerve bundles, connective tissue.
Indicated Patient Age Range
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Intended User / Care Setting
Competent health care professionals
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
SECTION 8 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
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, contact person: 1)
Terrence J. Sweeney Director, Worldwide Quality and Regulatory Affairs Advanced Technology Laboratories, Inc. P.O. Box 3003 Bothell, WA 98041-3003 (206) 487-7602
Date prepared: April 10, 1996
- Name of the device, including the trade or proprietary name if 2) applicable, the common or usual name, and the classification name, if known:
Common/ Usual Name
Diagnostic Ultrasound System with Accessories
Proprietary Name
Level 10 HDI 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 90MD, 21 CFR America 901YO 892.1560 3/11/97
Identification of the predicate or legally marketed device: 3)
Advanced Technology Laboratories, Inc. believes that Level 10 HDI is substantially equivalent to the currently marketed ATL HDI 3000 diagnostic ultrasound system and Storz Renaissance A/B Scan.
1
4) Device Description:
Level 10 HDI is a general purpose, mobile, software-controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and display it on a monitor in 2D, M-mode, 2D Color Doppler, Mmode Color Doppler, Continuous Wave Doppler (CW), Pulsed (PW) Doppler, Color Power Angio (CPA) or in a combination of modes. Level 10 HDI also gives the opertor the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. Level 10 HDI has an output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The Level 10 HDI system is designed to accept a large selection of scanheads with up to three array scanheads and one static probe being connected to the system at any one time. The operator may select among the 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 Level 10 HDI system is designed to accept scanheads of the following types and frequency:
frequency range: 2.0 - 10.0 MHz
scanhead types: Linear array Curved linear array Phased array Static probes
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.
Level 10 HDI has 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 .
2
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:
Level 10 HDI is intended for cardiac, peripheral vascular, fetal imaging and other, and ophthalmic intended uses as defined FDA guidance documents.
Typical examinations using Level 10 HDI are:
- General abdominal and pelvic studies including organ surveys, ● blood flow assessment, and retroperitoneal cavity studies.
- Study of small parts and superficial structures including breasts, . shoulders, thyroid/parathyroid, and the abdominal wall.
- Pediatric scans of organs, superficial, and bony structures. .
- Peripheral vascular applications including carotid arteries, legs, . arms, feet, and penile artery.
- Monitoring procedures for infertility studies (other than in vitro ● fertilization).
- First, second and third trimester pregnancy studies. ●
- Prostate, prostate biopsy guidance, and rectal wall studies. ●
- Neonatal head studies. .
- Transcranial studies of middle cerebral arteries, internal carotid ● artery, and vertebral arteries.
- Cardiac studies in adults and children. .
- Monitoring of cardiac function during procedures using . transesophageal echocardiography.
- Biopsy guidance for tissue or fluid sampling. ●
- Assessment of cardiac muscle, coronary arteries and great vessels ● during cardiac surgery
- Study of myocardial function in adults ●
- Study of eye anatomy including blood flow in retinal vessels and ● branches
- Study of the esophagus, stomach, biliary sytem, pancreas and ● gastrointestinal tract using endoscopic probe
- Study of abdominal and pelvic organs and masses using ● laparoscopic probe
- Examination of organs, masses and vessels during surgical
3
procedures
- Study of muscles, ligaments, nerve bundles and connective tissue .
Technological Characteristics: ୧)
This device operate identical to the predicate devices in that piezoelectric 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 a 2D and M-mode images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (2D, M-mode, Color Flow, Color Mmode. Color Power Angio, and Pulsed Doppler) are the same as predicate devices identified in item 3. Scanhead patient contact materials are biocompatible.
This device conforms 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:
| ISPTAd | 720 mW/cm2 | (Maximum) |
|---|---|---|
| TIS/TIB/TIC | 0.1 - 4.0 | (Range) |
| Mechanical Index (MI) | 1.9 | (Maximum) |
| ISPPAd | 0 - 700 W/cm2 | (Range) |
Ophthalmic Applications:
| ISPTAd | 50 mW/cm² | (Maximum) |
|---|---|---|
| TIS at Surface / | ||
| 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.