(53 days)
Esaote's Model 7300 (MyLab30) is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative: Abdominal, and Other: Urologic.
Esaote's Model 7350 (MyLab50) is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative: Abdominal, and Other: Urologic.
Esaote's Model 6150 (MyLab70) is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative: Abdominal, and Other: Urologic.
Esaote's Model 6100 (MyLab90) is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Adult Cephalic, Laparoscopic, Intraoperative: Abdominal, and Other: Urologic.
The 7300 (MyLab30), 7350 (MyLab50), 6150 (MyLab70), and 6100 (MyLab90) system designs remain the same as those previously cleared by FDA via K040596, K050326, K051308, and K051837, respectively. They are ultrasound systems used to perform diagnostic general ultrasound studies. Their primary modes of operation are: B-Mode, M-Mode, Doppler, 3D/4D and Color Flow Mapping and, on lower frequency probes, Tissue Enhancement Imaging (TEI). The systems are equipped with an optional LCD Color Display and can drive phased (PA), convex (CA) and linear array (LA) and Doppler probes.
The 30/50/70/90 systems are able to produce Real Time 2D images and 3D images (in manual mode) with all probes. The systems in combination with the BC431 or BS230 probes, offer the possibility to also produce automatic 3D and Real Time 4D images. The 7300 (MyLab30), 7350 (MyLab50), 6150 (MyLab70), and 6100 (MyLab90) models are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.
The provided text does NOT describe specific acceptance criteria and a study to prove they are met. Instead, it is a 510(k) Summary, which is a premarket notification to the FDA. It outlines the device's characteristics and its substantial equivalence to previously cleared devices.
Therefore, most of the requested information cannot be extracted from this document, as a 510(k) summary primarily focuses on demonstrating equivalence rather than detailing rigorous performance studies with specific statistical metrics and ground truth establishment.
Here's what can be inferred or explicitly stated based on the provided text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance metrics against defined acceptance criteria. The tables in the original text show which modes and applications are "new" (N) or "previously cleared" (P) for different models and transducers, comparing them to predicate devices, but do not contain numerical performance data or acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not present. No details about a specific test set, its sample size, or data provenance (country, retrospective/prospective) are mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not present. Establishing ground truth is typically part of a performance study, which is not detailed here.
4. Adjudication Method
This information is not present.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not present. There is no mention of a comparative effectiveness study, nor any effect sizes for human reader improvement with or without AI.
6. Standalone (Algorithm Only) Performance Study
This information is not present. The device is an ultrasound imaging system, not a standalone algorithm in the AI sense. Its "performance" would relate to image quality and diagnostic capability, which are typically assessed through clinical use and comparison to established methods, rather than an "algorithm only" study.
7. Type of Ground Truth Used
This information is not present.
8. Sample Size for the Training Set
This information is not present. The document does not describe the development or training of any AI/algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not present.
Summary of Device and Equivalence Claim:
The document describes the MyLab30, 50, 70, 90 Systems by Esaote, S.p.A. as ultrasound imaging systems. The 510(k) submission aims to gain clearance for these systems, specifically for the addition of certain functionalities and transducers.
The core of the submission is to demonstrate substantial equivalence to several predicate devices, including:
- K040596: 7300 (MyLab30)
- K050326: 7350 (MyLab50)
- K051308: 6150 (MyLab70)
- K051837: 6100 (MyLab90)
- K043455: 8000Live (Medison)
- K022567: Sequoia Signature II (Siemens)
The new elements for which clearance is sought are primarily:
- The addition of 3D/4D imaging capabilities.
- The addition of specific transducers (BC431 and BS230) and biopsy accessories for them.
- New "Urological" indication for some models.
The tables indicate which functionalities are "new" (N) to the specific model/transducer combination being reviewed in this 510(k) and which were "previously cleared" (P) by the FDA on other models or previous submissions. The substantial equivalence claim is based on the device having the same intended use, similar technological characteristics, and being as safe and effective as the predicate devices. The FDA's letter (sections 3-5) confirms the determination of substantial equivalence for the specified models with the added transducers.
§ 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.