(116 days)
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No
The document explicitly states that no significant device modifications have been made and the labeling change does not alter the fundamental scientific technology of the device. There is no mention of AI or ML in the description of the device or the performance studies. The term "Autocorr" in the predicate device name likely refers to autocorrelation, a signal processing technique, not necessarily AI/ML.
No.
This device is a pulse oximeter, which is a diagnostic device used for monitoring vital signs (SpO2, pulse rate, pulse strength). It does not provide any therapeutic function.
Yes
A pulse oximeter that measures SpO2, pulse rate, and pulse strength is used to provide information about a patient's physiological state, which can be used to diagnose conditions related to oxygenation and heart function.
No
The device description clearly outlines hardware components including a table top oximeter, wall mount charger, SpO2 probe interface, LED display, system status LEDs, and a function keypad. This is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as providing "fast, reliable SpO2, pulse rate and pulse strength measurements." These are physiological measurements taken directly from the patient's body, not measurements performed on samples of human origin in vitro (outside the body).
- Device Description: The description details a pulse oximeter with a probe interface, display of patient data, and various system status indicators. This aligns with a device that interacts directly with the patient to obtain measurements.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Laboratory testing
- Diagnosing conditions based on analysis of samples
The device is a pulse oximeter, which is a medical device used for non-invasive monitoring of oxygen saturation and pulse rate in a living patient. This falls under the category of patient monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The 3304 provides fast, reliable SpO2, pulse rate and pulse strength measurements. It may be used in the hospital or clinical environment, during emergency air or land transport and in the home. The oximeter will operate accurately over an ambient temperature range of 32 to 104°F (0 to 40°C). The oximeter works with all BCI oximetry probes providing SpO2 and pulse rate on all patients from neonate to adult. The oximeter permits continuous patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The subject device is the same as the legally marketed predicate device BCl 3304 Autocorr M Digital Pulse Oximeter (K962156) with one minor change to the labeling that does not raise new questions of safety and efficacy. This pulse oximeter was originally cleared with the current algorithms. However, it was not clinically validated under motion conditions and no motion claims were made. The aim of this premarket submission is to obtain clearance for an additional motion claim.
The 3304 Autocorrille pulse oximeter is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top oximeter with a wall mount charger. The system features an SpO2 probe interface, display of patient data via an LED display (SpO2, Pulse Rate, Pulse Strength), system status LEDs (Probe, Lo Batt, Silence, Alarm, Artifiact, Search), and the function keypad area consisting of eight keys (O/I, ID/Clear, Up and Down Arrows, Alarm Select, Alarm Silence. Alarm Volume, Pulse Volume). The oximeter has a printer/pc port that is used for data communication, an optional analog output and an optional digital alarm adapter for a remote location.
This Special 510(k) covers the labeling modification of BCI® Autocorr™ 3304 Digital Pulse Oximeter that was cleared under 510(k) K962156. The modification involves revising the 3304 labeling to add pulse oximetry performance specifications with motion. Results from clinical evaluation are provided to support the labeling change. No significant device modifications have been made to the 3304. The labeling change does not affect the intended use or alter the fundamental scientific technology of the device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
neonate to adult
Intended User / Care Setting
hospital or clinical environment, during emergency air or land transport and in the home.
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
The intent of the clinical investigation was to determine the oxygen saturation accuracy specifications for the model 3304 during controlled motion. Ten paid, adult, volunteer subjects participated in this trial. They varied in age from 21 to 36 years. There were three Black or African American and seven White subjects enrolled. They were three females and seven males. Nine subjects described themselves ethnically as non-Hispanic or non-Latino and one subject described himself as Hispanic or Latino.
This study was a descriptive, cross-sectional investigation of healthy, human subjects comparing Model 3304 pulse oximeter determined oxygen saturation (SpO2) values during motion (test condition) to CO-oximeter determined functional oxygen saturation (SaO-) values (reference condition). Additional Model 3304 pulse oximeters which were not subjected to motion were used as a control and to determine stable plateaus in the oxygen saturation readings. The study was conducted at oxygen concentrations that targeted an even distribution over the SaO2 range of 70 to 100%-SaO2. The motion protocol used in this study consisted of tapping and rubbing motions of randomly varied frequency and amplitude. The maximum frequency was 300 cycles/minute (5 Hz). The maximum height was generally approximately 2.5 cm. The data were electronically gathered by the Smiths Medical PM, Inc. proprietary CRAWDADS program and analyzed by the CRAWDADS EXCEL template. Manual recording of the data was also made.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Investigation
Sample Size: 10 paid, adult, volunteer subjects
Key Results: The Smiths Medical PM, Inc. Model 3304 Pulse Oximeter operated within the pass criterion of less than 3%-SpO2 evenly distributed over the range 70 to 100%-SaO2 during motion of controlled amplitude and frequency. There were no adverse events or adverse device effects in this study.
ARMS for Motion Condition: 2.95%
Performance Specification: 3.00%
Standard Deviation for Motion Condition: 2.84%
Average Difference for Motion Condition: -0.82%
Comparison with Original Control Condition:
Average Difference (Motion Desaturation Trial Control Condition): 0.05%
Standard Deviation (Motion Desaturation Trial Control Condition): 1.69%
ARMS (Motion Desaturation Trial Control Condition): 1.69%
Average Difference (Accuracy Desaturation Trial Original): 0.83%
Standard Deviation (Accuracy Desaturation Trial Original): 1.70%
ARMS (Accuracy Desaturation Trial Original): 1.89%
These results show that the 3304 pulse oximeter in the control condition (non-motion) in this trial performed with an accuracy comparable to the 3304 pulse oximeter in the original desaturation trial performed for accuracy testing on 7-8 May 2006. In both cases, the sensors were not in motion during the study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Acceptance Criteria: The acceptance pass criteria for this study was less than 3%-SpO2.
Motion: 70-100% ± 3% SpO2 Accuracy
No Motion: 70-100% ± 2% SpO2 Accuracy (identical to original K962156)
50-69% ± 3% SpO2 Accuracy
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.
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.
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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 contains a sequence of alphanumeric characters. The characters are 'K07073Z'. The characters are written in a bold, sans-serif font. The image is in black and white.
Summary of Safety and Effectiveness
JUL - 9 2007
| Manufacturer: | Smiths Medical PM, Inc. |
|---|---|
| Address: | N7 W22025 Johnson Drive |
| Waukesha, WI 53186 | |
| Telephone: | (262) 542-3100 |
| Contact: | VP Regulatory Affairs |
| Prepared: | February 28, 2007 |
| Proprietary Name: | BCI® Autocorr™ 3304 Digital Pulse Oximeter |
| Common/Classification Name: | Pulse Oximeter |
| Predicate Devices: | BCI® Autocorr™ 3304 Digital Pulse Oximeter (K962156) |
Device Description:
The subject device is the same as the legally marketed predicate device BCl 3304 Autocorr M Digital Pulse Oximeter (K962156) with one minor change to the labeling that does not raise new questions of safety and efficacy. This pulse oximeter was originally cleared with the current algorithms. However, it was not clinically validated under motion conditions and no motion claims were made. The aim of this premarket submission is to obtain clearance for an additional motion claim.
The 3304 Autocorrille pulse oximeter is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top oximeter with a wall mount charger. The system features an SpO2 probe interface, display of patient data via an LED display (SpO2, Pulse Rate, Pulse Strength), system status LEDs (Probe, Lo Batt, Silence, Alarm, Artifiact, Search), and the function keypad area consisting of eight keys (O/I, ID/Clear, Up and Down Arrows, Alarm Select, Alarm Silence. Alarm Volume, Pulse Volume). The oximeter has a printer/pc port that is used for data communication, an optional analog output and an optional digital alarm adapter for a remote location.
This Special 510(k) covers the labeling modification of BCI® Autocorr™ 3304 Digital Pulse Oximeter that was cleared under 510(k) K962156. The modification involves revising the 3304 labeling to add pulse oximetry performance specifications with motion. Results from clinical evaluation are provided to support the labeling change. No significant device modifications have been made to the 3304. The labeling change does not affect the intended use or alter the fundamental scientific technology of the device.
Intended Use:
The intended use is identical to that originally submitted for BCT® Autocorr™ 3304 pulse oximeter. As stated per K962156, the intended use is as follows:
1
The 3304 provides fast, reliable SpO2, pulse rate and pulse strength measurements. It may be used in the hospital or clinical environment, during emergency air or land transport and in the home. The oximeter will operate accurately over an ambient temperature range of 32 to 104°F (0 to 40°C). The oximeter works with all BCI oximetry probes providing SpO2 and pulse rate on all patients from neonate to adult. The oximeter permits continuous patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.
Summary of Technological Characteristics of the Device Compared to the Legally Marketed Predicate Device:
No significant design modifications have been made to the BCI® Autocorr™ 3304 Pulse Oximeter.
No significant changes have been made to the software or hardware of the 3304 pulse oximeter.
Performance Testing:
Previous performance testing including EMC, electrical, mechanical durability, clinical desaturation studies, safety (operator and patient), and temperature/humidity was submitted in K962156. Additional clinical testing, submitted in Section 7 of this submission, was performed to support the labeling change.
Additional Clinical Testing:
The intent of the clinical investigation was to determine the oxygen saturation accuracy specifications for the model 3304 during controlled motion. Ten paid, adult, volunteer subjects participated in this trial. They varied in age from 21 to 36 years. There were three Black or African American and seven White subjects enrolled. They were three females and seven males. Nine subjects described themselves ethnically as non-Hispanic or non-Latino and one subject described himself as Hispanic or Latino.
This study was a descriptive, cross-sectional investigation of healthy, human subjects comparing Model 3304 pulse oximeter determined oxygen saturation (SpO2) values during motion (test condition) to CO-oximeter determined functional oxygen saturation (SaO-) values (reference condition). Additional Model 3304 pulse oximeters which were not subjected to motion were used as a control and to determine stable plateaus in the oxygen saturation readings. The study was conducted at oxygen concentrations that targeted an even distribution over the SaO2 range of 70 to 100%-SaO2. The motion protocol used in this study consisted of tapping and rubbing motions of randomly varied frequency and amplitude. The maximum frequency was 300 cvcles/minute (5 Hz). The maximum height was generally approximately 2.5 cm. The data were electronically gathered by the Smiths Medical PM, Inc. proprietary CRAWDADS program and
2
analyzed by the CRAWDADS EXCEL template. Manual recording of the data was also made.
Acceptance Criteria: The acceptance pass criteria for this study was less than 3%-SpO2.
Results:
| | Motion Desaturation Trial Motion
Condition (%SpO2) | Performance Specification
(%SpO2) |
|--------------------|-------------------------------------------------------|--------------------------------------|
| ARMS | 2.95 | 3.00 |
| Standard Deviation | 2.84 | - |
| Average Difference | -0.82 | - |
The Smiths Medical PM, Inc. Model 3304 Pulse Oximeter operated within the pass criterion of less than 3%-SpO2 evenly distributed over the range 70 to 100%-SaO2 during motion of controlled amplitude and frequency. There were no adverse events or adverse device effects in this study.
The table below compares the summarized results for the SMPM 3304 Pulse Oximeter in the control condition (non-motion) of this study to the results in the original SMPM 3304 Pulse Oximeter desaturation trial performed for accuracy testing on 7-8 May 1996.
| | Motion Desaturation Trial
Control Condition (non-motion)
(%-SpO2) | Accuracy Desaturation Trial
Original (non-motion)
(%-SpO2) |
|--------------------|-------------------------------------------------------------------------|------------------------------------------------------------------|
| Average Difference | 0.05 | 0.83 |
| Standard Deviation | 1.69 | 1.70 |
| ARMS | 1.69 | 1.89 |
These results show that the 3304 pulse oximeter in the control condition (non-motion) in this trial performed with an accuracy comparable to the 3304 pulse oximeter in the original desaturation trial performed for accuracy testing on 7-8 May 2006. In both cases, the sensors were not in motion during the study.
Summary of Labeling Change:
The labeling modification consists of detailing SpO2 accuracy specifications within the device specifications according to motion and no motion conditions. Please note that the accuracy of SpO2 measurements detected by the 3304 pulse oximeter has not changed. The labeling modification is detailed as follows:
This value is an estimate of the ARMS using the formula ARMS (est.) = ( Average Difference
SpO2 Accuracy: Motion: 70-100% ± 3% 50-69% not defined
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No Motion: 70-100% ± 2% (identical to original K962156) 50-69% ± 3%