← Product Code [DQA](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA) · K960058

# OXITEMP, 3301T SA (K960058)

_Bci Intl., Inc. · DQA · May 15, 1996 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K960058

## Device Facts

- **Applicant:** Bci Intl., Inc.
- **Product Code:** [DQA](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA.md)
- **Decision Date:** May 15, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2700
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **Attributes:** Pediatric

## Indications for Use

The 3301T 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 3301T SA OxiTemp extends the ambient temperature range the device can operate in up to 130°F (54°C) and down to 32°F (0°C). The oximeter works with all BCI oximetry probes providing SpO2 and pulse rate on all patients from neonate to adult (see the section CHOOSE THE PROBE under USING THE OXIMETER in the operations manual). For the 3301T the IR ear thermometer must seal the ear canal opening and look into the ear canal to provide an accurate temperature measurement. Therefore, it is restricted to patients over two years of age. The 3301T SA provides tympanic temperature measurements. The probe must be able to fit into the ear canal for proper operation. Therefore, it is restricted to patients over three years of age.

## Device Story

Pulse oximeter and infrared (IR) ear thermometer; provides SpO2, pulse rate, and tympanic temperature. Used in hospitals, clinics, and emergency transport. Operates via BCI oximetry probes and IR temperature sensor. Features ambient temperature compensation for accurate readings in environments ranging from 32°F to 130°F. Output displayed on device screen for clinician use to support clinical decision-making. Benefits include reliable monitoring in extreme ambient conditions.

## Clinical Evidence

Bench testing only. Environmental chamber testing confirmed oximeter and thermometer operation at 32°F and 130°F. Comparative study on 34 subjects evaluated tympanic temperature accuracy against Exergen OtoTemp HTTS-3000-SD. Results showed performance within 1.0°F (2 SD, 95.45% population) specification.

## Technological Characteristics

Pulse oximeter with integrated IR ear thermometer. Features ambient temperature compensation circuitry. Operates in ambient range 32°F to 130°F. Form factor: portable monitor. Connectivity: compatible with BCI oximetry probes.

## Regulatory 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.

## Predicate Devices

- BCI 3301T OxiTemp
- Exergen Ototemp

## Reference Devices

- Exergen OtoTemp HTTS-3000-SD

## Submission Summary (Full Text)

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100

BCI INTERNATIONAL

K960058

MAY 15 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: December 15, 1995

Proprietary Name: OxiTemp, 3301T SA
Common/Classification Name: Oximeter with Ear Thermometer
Predicate Devices: BCI 3301T OxiTemp and Exergen Ototemp

## New Device Description:

The Oxitemp, 3301T SA, pulse oximeter is an updated version of existing 3301T OxiTemp legally marketed by BCI International. The updated device provides all the features of the 3301T plus provides tympanic temperature measurement and extends the ambient operating temperature range.

## Intended Use

The 3301T 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 3301T SA OxiTemp extends the ambient temperature range the device can operate in up to 130°F (54°C) and down to 32°F (0°C).

The oximeter works with all BCI oximetry probes providing SpO2 and pulse rate on all patients from neonate to adult (see the section CHOOSE THE PROBE under USING THE OXIMETER in the operations manual). For the 3301T the IR ear thermometer must seal the ear canal opening and look into the ear canal to provide an accurate temperature measurement. Therefore, it is restricted to patients over two years of age. The 3301T SA provides tympanic temperature measurements. The probe must be able to fit into the ear canal for proper operation. Therefore, it is restricted to patients over three years of age.

BCI International
W238 N1650 Rockwood Drive
Waukesha, WI 53188-1199 USA
Phone: 414/542-3100 Fax: 414/542-0718
5

{1}

# Performance Data:

Testing of the 3301T SA OxiTemp and the predicate devices ( BCI 3301T oximeter and the Exergen OtoTemp HTTS-3000-SD ) was done to show that the performance of the 3301T SA was equivalent to the predicate devices. The first test showed that the oximeter portion of the OxiTemp would operate properly at a temperature of $130^{\circ}\mathrm{F}$. The device was put into an oven for almost eight hours. Approximately 4.5 hours were spent at $130^{\circ}\mathrm{F}$.

The second test showed that the 3301T SA would correctly operate and track the temperature of a target up to $130^{\circ}\mathrm{F}$. The ambient and target temperatures were the same. The 3301T SA was in the environmental chamber during the entire test.

The third test showed that the 3301T SA would read a patient (target) temperature of approximately $98.6^{\circ}\mathrm{F}$ in ambient temperatures up to $130^{\circ}\mathrm{F}$.

The fourth test showed that the 3301T SA would read a patient (target) temperature of approximately $98.6^{\circ}\mathrm{F}$ in an ambient temperature of $32^{\circ}\mathrm{F}$.

The fifth test showed that the 3301T SA would measure a target temperature over the specified range of $65^{\circ}\mathrm{F}$ to $110^{\circ}\mathrm{F}$. It was compared to the predicate device, the OtoTemp HTTS-3000-SD.

The last test was comparing readings between the two devices on 34 people. The first comparison was on ear to ear measurements for the 3301T SA. The last test also compared the OxiTemp and an OtoTemp in reading temperature on the right ear. The device performed within the $1.0^{\circ}\mathrm{F}$ (two standard deviation, $95.45\%$ population) specification for both comparisons. Statistical methods were used because of the technique sensitivity of tympanic temperature measurements.

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,

![img-0.jpeg](img-0.jpeg)

Donald Alexander
VP Regulatory Affairs

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K960058](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K960058)

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