OXI TEMP by BCI INTL., INC. | FDA 510(k) Summary

The OxiTemp provides fast, reliable SpO2, pulse rate and temperature measurements. It can be used in the hospital or clinical environment, and during emergency air or land transport. The oximeter will operate accurately over an ambient temperature range of 32 to 110° F (0 to 43° C). The IR ear thermometer uses a patented ambient temperature compensation technique that allows it to provide accurate patient temperatures over the ambient temperature range 60 to 110° F (16 to 43° C). Below 16°C (60°F) a low ambient message is displayed.

The oximeter works with all BC1 oximetry probes providing SpO2 and pulse rate on all patients from neonate to adult. The IR ear thermometer must seal the ear canal opening and look into the ear canal to provide an accurate temperature measurement. Therefore the adult size temperature probe (3340 series) is restricted to patients over two years of age. The pediatric size temperature probe (3341 series) is restricted to patients over one month of age.

Device Description

The 3301T Oxitemp, with the 3341 series pediatric temperature probes, is an updated version of the existing 3301T OxiTemp, with the 3340 series adult temperature probes, legally marketed by BCI International. The updated device provides all the features of the 3301T plus provides pediatric IR ear temperature measurement.

AI/ML Overview

Table of Acceptance Criteria and Reported Device Performance:

Test Type	Acceptance Criteria	Reported Device Performance
Bench Test 1 (3341 vs. LTXP-1)	Largest difference <= 0.4°F	Largest difference between measurements was 0.2°F
Bench Test 2 (3341 vs. 3340 adult)	Largest difference <= 0.4°F	Largest difference between measurements was 0.1°F
Ear-to-Ear (Initial User Test)	Ear-to-ear difference <= 0.5°F	All but one measurement met criteria (max 0.6°F)
Device-to-Device (3341 vs. LTXP-1)	Ear-to-ear & device-to-device difference <= 0.5°F	All measurement differences were 0.5°F or less
Device-to-Device (3341 vs. 3340 adult, children)	Ear-to-ear & device-to-device difference <= 0.5°F	All measurement differences were 0.5°F or less
Device-to-Device (3341 vs. 3340 adult, adults)	Ear-to-ear (adult probe) <= 0.5°F;	All ear-to-ear (adult probe) were < 0.5°F;
	Device-to-device (pediatric probe) <= 1.0°F	Max difference (pediatric probe) was 0.8°F, meeting criteria

Sample sizes used for the test set and the data provenance:
- Bench Tests: The specific number of measurements or "samples" for the bench tests is not explicitly stated, but they involved comparing the device against "two targets" (floating black body, plastic block) for one test and a "floating black body" for another.
- Clinical Tests (Ear-to-Ear & Device-to-Device):
  - Initial Ear-to-Ear: 24 children (ages 6 months to 10 years).
  - Device-to-Device (3341 vs. LTXP-1): 11 children (ages 1 to 9 years).
  - Device-to-Device (3341 vs. 3340 adult, children): 9 children (ages 7 to 13 years).
  - Device-to-Device (3341 vs. 3340 adult, adults): 15 adults (all > 20 years of age).
- Data Provenance: The document does not explicitly state the country of origin. It appears to be prospective testing conducted for regulatory submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- No external experts were used to establish ground truth in the traditional sense. The "ground truth" for the bench tests was a "floating black body" or a "black plastic block" with known temperature characteristics, and for clinical tests, it was the measurements from predicate devices (OtoTemp LighTouch LTXP-1 and the 3301T with adult probe), implying these are accepted standards. The "user" for the clinical tests was described as "recently trained," but their specific qualifications beyond that are not mentioned.
Adjudication method for the test set:
- No adjudication method (like 2+1 or 3+1) was mentioned. The performance was directly compared against the predicate devices or expected temperature ranges/differences.
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:
- This is not an AI-enabled device. Therefore, no MRMC study, AI assistance, or effect size related to human reader improvement is applicable or mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is a physical medical device (temperature thermometer), not an algorithm. The reported performance is the standalone performance of the device, with human operation being part of its intended use.
The type of ground truth used:
- Bench Tests: Physical temperature standards (floating black body, black plastic block with controlled temperatures).
- Clinical Tests: Comparative measurements against legally marketed predicate devices (Exergen LTXP-1 and the BCI 3301T with 3340 adult probe) which serve as the "standard" or reference. "Ear-to-ear" measurements also serve as a measure of repeatability and user technique.
The sample size for the training set:
- This document describes performance testing for a physical device, not development of a machine learning model. Therefore, there is no explicit "training set" in the context of AI/ML. All samples mentioned are for testing and validation of the device's performance against established standards.
How the ground truth for the training set was established:
- As there is no training set for an AI/ML model, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for BCI International. The logo consists of a circle on the left side, with vertical lines inside. To the right of the circle are the letters BCI in bold, black font. Below the letters is the word "INTERNATIONAL" in a smaller, sans-serif font.

K963496

NOV 26 1996

Summary of Safety and Effectiveness

Submitter:	BCI International, Inc.
Address:	W238 N1650 Rockwood Drive
	Waukesha, WI 53188
Telephone:	(414) 542-3100
Contact:	VP Regulatory Affairs

Prepared:

Proprietary Name: Common/Classification Name: Predicate Devices:

April 12, 1996

OxiTemp, 3301T Oximeter with Ear Thermometer BCI 3301T OxiTemp and Exergen OtoTemp

New Device Description:

Intended Use

BCI International W238 N1650 Rockwood Drive Waukesha, WI 53188-1199 USA Phone: 414/542-3100 Fax: 414/542-0718

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Performance Data:

The first bench test showed that the 3301T with the 3341 series pediatric temperature probe would measure a target temperature over the specified range of 60°F to 110°F. It was compared to the predicate device, the OtoTemp LighTouch LTXP-1. Two targets were used, a floating black body (106°F to 70°F) and a black plastic block that was put in an oven (115°F) then into a refrigerator freezer ( less than 32°F). The measured temperature range of the block was 61.2°F to 109.9ºF. The largest difference between measurements was 0.2ºF with the allowable difference being 0.4°F. This test showed that the 3301T with the pediatric temperature probe would read the same temperature as the Exergen LTXP-1 (the standard).

A second bench test was run comparing the 3301T with the 3341 probe to the other predicate device, the 3301T with the 3340 adult probe. A floating black body was used as the target (109F to 73°F). The largest difference between measurements was 0.1ºF with the allowable difference being 0.4ºF. This test showed that the 3301T with the pediatric temperature probe would read the same temperature as the 3301T with the 3340 adult probe.

The next series of tests were comparing ear to ear & device to device readings using the 3301T with the pediatric temperature probe. Ear to ear measurements are used to verify accurate temperature measurements (repeatability) and proper user technique. The device to device testing was to show that the 3301T with the pediatric temperature probe operated in a similar manner to the predicate devices when used properly.

The first test of ear to ear comparisons was done on 24 children from 6 months to 10 years of age. It was used to determine if the user had enough experience to properly use the device and continue on to the next series of tests. The ear to ear difference should all be in the order of 0.5°F or less. All measurements except one met that criteria, with the maximum difference being 0.6°F. With only one measurement being just out of the desired range it was decided that the user ( recently trained ) had enough experience to continue with the device to device testing.

The first device to device testing compared the 3301T with the pediatric probe to the Exergen LighTouch. The test was run on 11 children, ages 1 to 9 years of age. All ear to ear & device to device (same ear) differences should be 0.5°F or less. All measurement differences, ear to ear & device to device, were 0.5ºF or less.

The next device to device testing compared the 3301T with the pediatric probe to the 3301T with the adult temperature probe. The test was run on 9 children, ages 7 to 13 years of age. All ear to ear & device to device (same ear) differences should

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be 0.5ºF or less. All measurement differences, ear to ear & device to device, were 0.5°F or less.

The last test compared the 3301T with the pediatric probe to the 3301T with the adult temperature probe on adults. The test was run on 15 adults, all greater than 20 years of age. This test was to demonstrate that the probe tip must seal the ear canal and not enter it, with the expected difference criteria going up to 1.0°F. All of the ear to ear measurement differences using the adult probe were less than 0.5°F (as expected). The results with the pediatric probe met the defined criteria (1.0°F differences) with a maximum difference of 0.8°F. It was interesting to note that over half ( 8 of 15 ) subjects had readings that met the previous 0.5°F difference specifications for ear & device to device comparisons (got the same temperature on an adult). One adult had small ears and only allowed the pediatric probe to be used.

This shows that measurements taken with the pediatric 3301T are accurate and repeatable. The pediatric 3301T performed within the expected criteria when compared to the predicate devices.

The Oxitemp passed all the tests.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Respectfully,

Donald Acquina

Donald Alexander VP Regulatory Affairs

Regulation Number and Section

§ 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).