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K Number
K962127
Device Name
OHMEDA 3800 PULSE OXIMETER
Manufacturer
OHMEDA MEDICAL
Date Cleared
1996-10-10

(129 days)

Product Code
DQA
Regulation Number
870.2700
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Ohmeda Model 3800 Pulse Oximeter is a noninvasive, arterial oxygen saturation and pulse rate monitor.

Device Description

The Ohmeda Model 3800 Pulse Oximeter is a noninvasive, arterial oxygen saturation and pulse rate monitor. It features two easy-to-read displays that present patient data and status information: a numeric LED (light-emitting diode) display that shows the SpO2 and pulse rate values, and a plethysmographic LCD (liquid crystal display) that shows the waveform, the current high and low SpO2 and pulse rate limit settings, and messages as appropriate.

AI/ML Overview

The provided text is a 510(k) summary for the Ohmeda 3800 Pulse Oximeter, asserting its substantial equivalence to previously marketed Ohmeda pulse oximeters. It describes the device's features, compliance with standards, and its intended use. However, it does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and performance study specifics as it relates to medical device regulatory submissions and AI/ML evaluation.

Specifically, the document does not include:

  1. A table of acceptance criteria and reported device performance for metrics like sensitivity, specificity, accuracy, or other benchmarked values.
  2. Details about sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for ground truth establishment.
  3. Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
  4. Specifics on the type of ground truth used (e.g., pathology, outcomes data).
  5. Sample size for the training set or how ground truth was established for the training set.

The document focuses on:

  • Substantial Equivalence: Stating that the Ohmeda 3800 Pulse Oximeter is substantially equivalent to the Ohmeda 3760 Pulse Oximeter and the Ohmeda Handheld Pulse Oximeter.
  • Device Description: Describing its features as a noninvasive arterial oxygen saturation and pulse rate monitor.
  • Software Development: Mentioning that the software followed "a rigorous software development process and has been fully specified and validated by Ohmeda."
  • Standards Compliance: Listing several CSA, IEC, ISO, and UL standards with which the device complies.

Therefore, I cannot populate the table or provide the requested study details based solely on the provided text. The information required for such an analysis is typically found in the more detailed sections of a 510(k) submission, such as performance testing reports, clinical data summaries, or validation studies, which are not present in this summary document.

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).