(134 days)
BCI 3301T OxiTemp and Exergen Ototemp
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No
The summary describes a pulse oximeter and tympanic thermometer with extended operating temperature range. There is no mention of AI, ML, or related concepts like image processing, training sets, or complex algorithms beyond standard signal processing for vital signs. The performance studies focus on temperature and oximetry accuracy and operating range, not AI/ML model performance.
No
The device is described as providing measurements for SpO2, pulse rate, and temperature, indicating it is a diagnostic or monitoring device, not one that treats or prevents a disease or condition.
Yes
The device measures SpO2, pulse rate, and temperature, which are physiological parameters used to assess a patient's health status and aid in the identification of medical conditions.
No
The device description and performance studies clearly indicate this is a physical device (pulse oximeter and thermometer) with hardware components, not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use describes measuring physiological parameters directly from the patient (SpO2, pulse rate, and temperature). IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, or disease.
- Device Description: The description confirms it's a pulse oximeter and tympanic thermometer, both devices that interact directly with the patient.
- Anatomical Site: The anatomical site is the ear canal, which is a direct measurement from the patient.
- Lack of Specimen Handling: There is no mention of collecting or analyzing any biological specimens.
Therefore, the 3301T OxiTemp is a patient-contacting medical device for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 3301T OxiTemp provides fast, reliable SpO2, pulse rate and temperature measurements. It can be used in the houpital or clinical environment, and during emergency air or land transport. The counter 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 tachnique 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 OniTemp 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 oximusery probes providing SpO2 and pulse rate on all nationts from necessare 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.
Product codes
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Device Description
The Oxitemp, 3301T SA, pulse coximeter 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Ear canal
Indicated Patient Age Range
Oximeter: necessare to adult
3301T IR ear thermometer: patients over two years of age
3301T SA tympanic temperature measurements: patients over three years of age
Intended User / Care Setting
Hospital or clinical environment, and during emergency air or land transport.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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 1309F. The device was put into an oven for almost eight hours. Approximately 4.5 hours were spent at 130°F.
The second test showed that the 3301T SA would correctly operate and track the temperature of a target up to 130°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°F in ambient temperatures up to 130°F.
The fourth test showed that the 3301T SA would read a patient (target) temperature of approximately 98.6ºF in an ambient temperature of 32ºF.
The fifth test showed that the 330}T SA would measure a target temperature over the specified range of 65°F to 110°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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 1309F. The device was put into an oven for almost eight hours. Approximately 4.5 hours were spent at 130°F.
The second test showed that the 3301T SA would correctly operate and track the temperature of a target up to 130°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°F in ambient temperatures up to 130°F.
The fourth test showed that the 3301T SA would read a patient (target) temperature of approximately 98.6ºF in an ambient temperature of 32ºF.
The fifth test showed that the 330}T SA would measure a target temperature over the specified range of 65°F to 110°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 1.0ºF (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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The device performed within the 1.0ºF (two standard deviation, 95.45% population) specification for both comparisons.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
BCI 3301T OxiTemp and Exergen Ototemp
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows a logo for ODCI International. The logo is black and white and features the letters "ODCI" in a bold, sans-serif font. The word "INTERNATIONAL" is written in a smaller font below the letters "ODCI". The logo is simple and modern.
MAY 1 5 1996
Summary of Safety and Effectiveness
Submitter: Address:
Telephone: Contact:
Prepared:
Proprietary Name: Common/Classification Name: Predicate Devices:
BCI International, Inc. W238 N1650 Rockwood Drive Waukesha, WI 53188 (414) 542-3100 VP Regulatory Affairs
December 15, 1995
OxiTemp. 3301T SA Oximeter with Ear Thermometer BCI 3301T OxiTemp and Exergen Ototemp
New Device Description:
The Oxitemp, 3301T SA, pulse coximeter 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 houpital or clinical environment, and during emergency air or land transport. The counter 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 tachnique 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 OniTemp 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 oximusery probes providing SpO2 and pulse rate on all nationts from necessare 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.
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 1309F. The device was put into an oven for almost eight hours. Approximately 4.5 hours were spent at 130°F.
The second test showed that the 3301T SA would correctly operate and track the temperature of a target up to 130°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°F in ambient temperatures up to 130°F.
The fourth test showed that the 3301T SA would read a patient (target) temperature of approximately 98.6ºF in an ambient temperature of 32ºF.
The fifth test showed that the 330}T SA would measure a target temperature over the specified range of 65°F to 110°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 1.0ºF (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.
Donald Alexand
Donald Alexander VP Regulatory Affairs