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K Number
K160182
Device Name
LOGIQ S7 Expert
Manufacturer
GE Healthcare
Date Cleared
2016-02-26

(30 days)

Product Code
IYN,ITX,IYO
Regulation Number
892.1550
Type
Special
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The device is intended for use by a qualified physician for ultrasound evaluation of Obstetrics (Fetal); Abdominal (includes renal, GYN/Pelvic); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vasculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal: Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular).

Device Description

The LOGIQ S7 Expert is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 530mm (Caster), 520mm (Keyboard), 565mm (Monitor) wide, 865mm deep and 1760mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.1-inch LCD touch screen and color 23-inch LCD widescreen monitor.

AI/ML Overview

The provided document is a 510(k) Premarket Notification Submission for the GE LOGIQ S7 Expert diagnostic ultrasound system. It outlines the device's indications for use and states its substantial equivalence to previously cleared devices. It explicitly mentions that clinical studies were NOT required to support substantial equivalence for this submission. Therefore, the document does not contain information about acceptance criteria for device performance based on a clinical study, nor does it present the results of such a study.

The submission focuses instead on demonstrating substantial equivalence through:

  • Comparison to Predicate Devices: Showing that the LOGIQ S7 Expert shares the same fundamental scientific technology, clinical intended use, imaging modes, and similar capabilities (measurements, digital image capture, reviewing/reporting) as its predicate devices (K141261 LOGIQ S7 Expert, K152195 LOGIQ S8, K141639 Voluson S8, K143452 Logiq P9).
  • Safety and Performance Testing: Confirming compliance with various safety standards related to acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety.
  • Software Features Migration: Listing new software features (STIC, OmniView, Cardiac AFI, Email2MMS) that were previously cleared on other GE ultrasound systems.
  • Transducer Equivalence: Confirming that new transducers (C1-6-D, C3-10-D, P8D, BE9CS-D) are already cleared on predicate devices (LOGIQ S8), and a new S2-5-D probe is an incremental improvement to an existing one (3Sp-D) and deemed equivalent.

Since no clinical study was conducted as part of this submission, the following information cannot be extracted from the provided text:

  1. A table of acceptance criteria and the reported device performance: Not available as no clinical study was performed for this 510(k).
  2. Sample size used for the test set and the data provenance: Not applicable as no clinical test set was used.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  4. Adjudication method: Not applicable.
  5. 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: Not applicable. The device is a diagnostic ultrasound system, not explicitly described as having AI features that would necessitate an MRMC study for improved reader performance. Even if it had such features, no clinical study was performed.
  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

§ 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.