COZUMEL DIAGNOSTIC ULTRASOUND SYSTEM

• K Number: K981505
• Device Name: COZUMEL DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer: SONOSITE,INC.
• Date Cleared: 1998-05-08 ( 14 days)
• Product Code: IYO , ITX , IYN
• Regulation Number: 892.1560
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal OB/GYN
Abdominal
Intraoperative (abdominal organs and vascular)
Small Organs (breast, thyroid, testicle)
Pediatric
Transvaginal
Peripheral Vessel
Cardiac
Musculo-skeletal (conventional)
Neonatal Cephalic

Typical examinations performed using Cozumel system 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, and the abdominal wall.
Pediatric scans of organs, superficial, and bony structures.
Monitoring procedures for infertility studies (other than in vitro fertilization).
First, second and third trimester pregnancy studies.
Neonatal head studies.
General cardiac studies in adults.

Device Description

Cozumel is a general purpose, highly portable, software-controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and display it on a monitor in 2D, M-mode, and Color Power Angio (CPA) or in a combination of modes. Cozumel also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information used for clinical diagnostic purposes. Cozumel has an output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

The Cozumel system is designed to accept a curved or linear scanhead. All actions affecting the performance of the scanhead are activated from the main system control panel.

The Cozumel system is designed to accept scanheads of the following types and frequency:
frequency range: 2.0 - 7.0 MHz
scanhead types: Linear array Curved linear 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, gain etc.

AI/ML Overview

The Cozumel Ultrasound System is a diagnostic ultrasound system intended for various clinical applications. The submission's focus is on establishing substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and results for the device itself.

Acceptance Criteria and Device Performance:

The document does not explicitly state quantitative acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) or provide a direct performance study comparing the Cozumel system against such criteria. The "performance" described is largely related to its technical specifications and compliance with safety and acoustic output standards.

The acceptance criteria are implicitly met by demonstrating substantial equivalence to existing legally marketed predicate devices (ATL HDI® 5000, Medison SA600, and ATL Ultramark® 4) and by conforming to relevant safety and acoustic output standards.

Implicit "Acceptance Criteria" based on the submission:

Category	Acceptance Criteria	Reported Device Performance (Cozumel Ultrasound System)
Technical Equivalence	Functionality of acquiring ultrasound data and displaying it in 2D, M-mode, and Color Power Angio (CPA) or combinations thereof, with measurement and analysis packages for clinical diagnostic purposes.	Operates identically to predicate devices, using piezoelectric material in the transducer to transmit and receive sound waves. Displays 2D, M-mode, and Color Power Angio. Includes anatomical measurement and analysis packages.
Operating Modes	Provision of 2D, M-mode, and Color Power Angio.	Same as predicate devices (2D, M-mode, and Color Power Angio).
Frequency Range	Ability to accept scanheads within a specified frequency range.	Designed to accept scanheads with a frequency range of 2.0 - 7.0 MHz.
Scanhead Types	Ability to accept common ultrasound scanhead types.	Designed to accept Linear array and Curved linear array scanheads.
Automatic Optimization	Automatic optimization of operating conditions (frame rate, line density, center frequency, number of active elements) in response to user inputs.	Operating conditions are automatically optimized by the system software in response to user inputs (e.g., field of view, focal depth, image quality, gain).
Biocompatibility	Patient contact materials for scanheads must be biocompatible.	Scanhead patient contact materials are biocompatible.
Electromechanical Safety	Compliance with specified international and national electromechanical safety standards (e.g., EN 60601-1, UL 2601-1, C22.2 No. 601.1, EN 60601-1-2).	Designed to meet EN 60601-1 (IEC 601-1), UL 2601-1, C22.2 No. 601.1, and EN 60601-1-2 (IEC 601-1-2).
Acoustic Output Standards	Conformance to the AIUM/NEMA standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices and compliance with specified acoustic output limits.	Conforms to AIUM/NEMA (1992) for on-screen display of acoustic output indices. Acoustic output limits are: ISPTAd 720 mW/cm², TIS/TIB/TIC 0.1-4.0 (Range), MI 1.9 (Maximum), ISPPAd 0-700 W/cm² (Range). It states these limits are the same as predicate Track 3 devices.
Intended Use	The device's intended uses align with FDA guidance documents and cover a range of typical examinations, including specific clinical applications for the system and its transducers (C7-4 MHz IVT, L7-3 MHz Linear Array, C4-2 MHz Curved Array), potentially including "new indications" (N) where noted on the indications for use forms which represents new applications for the device not typically available on the predicates.	Intended uses include Fetal OB/GYN, Abdominal, Intraoperative, Small Organs, Pediatric, Transvaginal, Peripheral Vessel, Cardiac, Musculo-skeletal (conventional), Neonatal Cephalic. Each transducer has specific confirmed clinical applications including some new (N) applications.

Study Information:

1. Sample Size used for the test set and the data provenance:

   • The submission does not describe a specific clinical performance study with a "test set" in the context of diagnostic accuracy. The primary means of demonstrating performance and safety is through comparison to predicate devices and adherence to recognized standards. Therefore, no explicit sample size for a test set or data provenance (country, retrospective/prospective) is provided for algorithm performance.
   • The FDA's approval letter mentions a requirement for a post-clearance special report that should contain "complete information, including acoustic output measurements based on production line devices." This indicates that some form of testing would be conducted on physical devices, but it's related to manufacturing and safety specifications rather than clinical performance.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Since no clinical performance study with a "test set" for diagnostic accuracy is described, there are no experts mentioned for establishing ground truth related to diagnostic performance.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable, as no clinical performance study with a test set is detailed.

4. 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 MRMC comparative effectiveness study is mentioned. This is a 1998 submission for a general diagnostic ultrasound system; AI/ML assistant technologies were not a focus at this time.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable, as this device predates the widespread concept of standalone AI algorithms in medical imaging as seen today. The "algorithm" here refers to the software controlling the ultrasound system's operation and image generation, not a diagnostic AI tool.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the safety and performance claims made, the "ground truth" is largely defined by industry standards and regulatory requirements (e.g., IEC 601-1 for electrical safety, AIUM/NEMA for acoustic output). For the "intended uses," the ground truth is established by the successful history of use and accepted clinical practice for predicate ultrasound devices.

7. The sample size for the training set:

   • Not applicable. This device is an ultrasound system, not an AI algorithm trained on a dataset. The software within the system is developed through traditional software engineering, not machine learning model training as understood in current AI contexts.

8. How the ground truth for the training set was established:

   • Not applicable, as no AI training set is involved.

Regulation Number and Section

§ 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.