(86 days)
The SonoSite NanoMaxx Series Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal; Pediatric; Small Organ (breast, thyroid, testicles, prostate); Peripheral Vessel; Intra-operative (abdominal organs, vascular); Musculoskeletal Conventional & Superficial, Cardiac Adult and Pediatric.
The SonoSite NanoMaxx Series Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, Doppler, Color Power Doppler or in a combination of these modes. The hand-carried system weighs less than 6 pounds and has a touch screen interface with minimal controls to facilitate disinfection and cleaning. The System provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system also includes the ability to measure the intima-media thickness (IMT) of the carotid artery using digital ultrasound images, which is used in conjunction with traditional risk assessment models to assess individual cardiovascular disease risk. The system includes security support to facilitate HIPAA compliance. The system includes a variety of accessories including a stand, dock featuring a video in/out port, a printer port, printer, VESA mounting arm and needle guide kits. The system includes two USB host supports for peripherals such as input devices and storage devices. Input devices include wired and wireless devices such as keyboard, and mouse. Storage devices include devices such as memory sticks, hard drives, and CDs. The system also features SiteLink™ allowing an additional method for the export of patient data. The System/Transducer is capable of exceeding a TI or an MI of 1.0 in certain operating modes or mode combinations. The System monitor displays the current output level in terms of the bioeffects indices ("Mechanical Index [MI]" and "Thermal Index [TI]") in accordance with the AIUM/NEMA Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.
The provided text is a 510(k) Summary for the SonoSite NanoMaxx™ Series Ultrasound System. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed studies demonstrating novel performance against defined acceptance criteria. Therefore, the document does not contain explicit acceptance criteria or detailed study information of the type requested.
The document primarily focuses on:
- Substantial Equivalence: Stating that the device is substantially equivalent to existing SonoSite Maxx Series Ultrasound Systems and Philips Medical Systems HDP 5000 Ultrasound System.
- Device Description: A general overview of the SonoSite NanoMaxx system's features, modes of operation (2D, Doppler, Color Power Doppler), measurement capabilities, and compliance with various medical device standards.
- Intended Use/Indications for Use: Listing the clinical applications for which the device is intended (e.g., Fetal/OB, Abdominal, Cardiac, Vascular, etc.) for the system as a whole and for specific transducers.
- Technological Characteristics: Highlighting acoustic output limits and adherence to bioeffects indices standards.
Therefore, many sections of your requested output table cannot be filled from the provided text. The information below reflects what can be extracted.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|
| Acoustic Output Limits: | Met: |
| - ISPTA (d) Maximum: 720 mW/cm² | - ISPTA (d): 720 mW/cm² (Maximum) |
| - Tis/Tib/Tic Range: 0.0 - 4.0 | - Tis/Tib/Tic: 0.0 - 4.0 (Range) |
| - Mechanical Index (MI) Maximum: 1.9 | - Mechanical Index (MI): 1.9 (Maximum) |
| - ISPPA (d) Range: 0 - 700 W/cm² | - ISPPA (d): 0 - 700 W/cm² (Range) |
| Compliance with Standards: | Met (Implicitly stated by compliance with standards): The system is designed to comply with a range of standards including: |
- AAMI/ANSI/ISO 10993 (Biological evaluation of medical devices)
- IEC 60601-1 (General requirements for safety)
- IEC 60601-2-37 (Safety of ultrasonic medical diagnostic and monitoring equipment)
- NEMA UD 2-2004 (Acoustic Output Measurement Standard)
- NEMA UD 3-2004 (Real-Time Display of Thermal and Mechanical Acoustic Output Indices, explicitly stating adherence to on-screen display feature)
- ISO 9001:2008 (Quality management systems)
- 21 CFR Part 820 (Quality System Regulation)
- EN ISO 13485:2003 (Quality management systems for regulatory purposes)
- EN ISO 14971:2000 (Application of risk management)
- RTCA D160E (Emission of Radio Frequency Energy) |
| Intended Use: (as defined by FDA guidance documents and listed clinical applications; functional equivalence to predicate devices) | Met (Implicitly stated through substantial equivalence to predicate devices and listed indications): The device functions to "acquire and display high-resolution, real-time ultrasound data in 2D, Doppler, Color Power Doppler or in a combination of these modes." It provides "measurement capabilities for anatomical structures and fetal biometry." The listed indications for use are extensive, covering: Fetal/OB, Abdominal, Pediatric, Small Organ, Peripheral Vessel, Musculo-skeletal (Conventional & Superficial), Cardiac (Adult & Pediatric), and Intra-operative (abdominal organs, vascular, spinal cord for nerve blocks). |
| Functional Equivalence: (to predicate devices, meaning it operates in the same way and produces similar diagnostic information capabilities) | Met (Explicitly stated): "This device operates identically 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 2D mages. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (2D, velocity color) are the same as a combination of the predicate devices identified in item 3." It also claims the limits for acoustic output are "the same as predicate Track 3 devices." |
Regarding a "study that proves the device meets the acceptance criteria":
For a 510(k) submission, the "study" is often a comparison to a predicate device, focusing on functional, technological, and safety equivalence rather than a new clinical trial demonstrating efficacy or performance against novel criteria. The document states:
"SonoSite, Inc. believes that the System described in this Submission is substantially equivalent to a combination of the SonoSite Maxx Series Ultrasound System (K071134 and K082098), and the Philips Medical Systems (formerly Advanced Technology Laboratories) HDP 5000 Ultrasound System (K034003 and K011224)."
This implies that the "proof" is based on demonstrating that the NanoMaxx system has the same technological characteristics, intended use, and similar performance to these legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness. The document itself does not describe a specific clinical performance study designed to test specific acceptance criteria on a patient cohort for the purpose of this 510(k). The "studies" primarily referenced are compliance with various engineering, safety, and quality standards.
Filling the additional information points:
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. The document does not describe a test set or clinical study with a specified sample size.
- The "study" here is essentially the comparison of technical specifications and intended uses to predicate devices.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. No test set with ground truth established by experts is described for this 510(k) submission.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set adjudication is described.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a diagnostic ultrasound system, not an AI-assisted interpretation device. The document does not describe any MRMC study or AI components.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a diagnostic ultrasound system requiring a human operator to perform imaging and interpretation.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No specific ground truth establishment is described for performance evaluation beyond general functional equivalence to predicate devices and compliance with technical standards.
-
The sample size for the training set:
- Not applicable. This document is for a conventional ultrasound system and does not mention machine learning or AI models requiring a "training set."
-
How the ground truth for the training set was established:
- Not applicable. As above.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.