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K Number
K043278
Device Name
TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES
Manufacturer
TERATECH CORP.
Date Cleared
2004-12-13

(17 days)

Product Code
ITX,IYN,IYO
Regulation Number
892.1570
Type
Traditional
Panel
RA
Reference & Predicate Devices
K961459,K991671,K994373,K002003,K011224,K992595,K010883,K012191,K030191,K040840
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The TERATECH Model 8IOC4, 8IOL4, and 10LAP4 Probes are intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this submission.

Device Description

The TERATECH Model 810C4, 81OL4, and 10LAP4 Probes are intended for use with the Model TERATECH2000, a portable ultrasoundimaging system.

AI/ML Overview

The provided text is a 510(k) summary for TERATECH Model 810C4, 810L4, and 10LAP4 Probes. It does not contain information about acceptance criteria or a study proving that the device meets such criteria. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.

The document discusses:

  • Device Name: TERATECH Model 8IOC4, 8IOL4, and 10LAP4 Probes
  • Predicate Devices: Philips LI9-5, Philips CT8-4, Philips LAP L9-5, and TERATECH 10V5 (along with their associated 510(k) clearances).
  • Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body. Specific indications are tabulated for each probe model across various clinical applications and modes of operation (e.g., B-mode, M-mode, PWD, CWD, Color Doppler, Combined Modes, Other).
  • Device Description: Technical specifications (Frequency, # Elements, Array type, Pitch, Elevation width, Geometric focus, Azimuth radius, Azimuth length) for each probe model.
  • Basis for Substantial Equivalence: The subject devices are claimed to be "identical in mechanical design and materials to the respective Philips," and intended for the same clinical applications. The FDA's letter confirms substantial equivalence.

Therefore, I cannot populate the table or answer the questions related to acceptance criteria and performance studies because this information is not present in the provided text. The document is a regulatory submission for substantial equivalence, which does not typically include detailed performance study results against pre-defined acceptance criteria in the way a clinical trial or a more rigorous performance study might.

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.