(84 days)
OtoTemp LighTouch LTXP-1, 3301T OxiTemp with the 3340 series adult temperature probes
Not Found
No
The summary does not mention AI, ML, or any related concepts like neural networks, deep learning, or training/inference processes typically associated with AI/ML. The description focuses on standard physiological measurements and temperature compensation techniques.
No
The device measures SpO2, pulse rate, and temperature, which are diagnostic measurements for patient monitoring and do not provide therapeutic intervention.
Yes
The device provides measurements of SpO2, pulse rate, and temperature, which are physiological parameters used to assess a patient's health status. These measurements contribute to a broader clinical picture rather than providing a singular diagnosis.
No
The device description explicitly states "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". This indicates the device includes physical hardware components (the Oxitemp unit and temperature probes) and is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The OxiTemp measures SpO2 (blood oxygen saturation), pulse rate, and temperature. These measurements are taken directly from the patient's body (via a probe on the finger or ear) and do not involve analyzing samples taken from the body.
The device is a patient monitoring device that provides physiological measurements, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
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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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear canal
Indicated Patient Age Range
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.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
OtoTemp LighTouch LTXP-1, 3301T OxiTemp with the 3340 series adult temperature probes
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/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.
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:
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.
Intended Use
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.
BCI International W238 N1650 Rockwood Drive Waukesha, WI 53188-1199 USA Phone: 414/542-3100 Fax: 414/542-0718
1
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
2
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