(89 days)
The BCI® 3178 Pediatric Pulse Oximetry Sensor is a reusable finger sensor that can be used to non-invasively measure oxygen saturation (SpO2), pulse rate and wethysmographic pulse waves. It's performance was validated with the BCI® 3304 pulse oximeter. The BCT® 3178 Pediatric Pulse Oximetry Sensor will provide reliable spot check measurements on patients weighing from 10 to 100 lbs (5 -45 kg). The sensor is not intended for prolonged use.
The BCI® 3178 pediatric pulse oximetry sensor is similar to other existing finger sensors, legally marketed by BCI, Inc. and others. This new finger sensor is designed to work with all BCI pulse oximeters on pediatric patients from 10 to 100 lbs. The sensor is made up of three major parts, the cable with the molded connector, the top part of the shell containing the LEDs and the bottom part of the shell containing the photo detector.
This document describes the regulatory submission for the BCI® 3178 Pediatric Pulse Oximetry Sensor. It focuses on demonstrating its substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report with specific performance metrics as might be found in a more comprehensive clinical study report.
However, based on the provided text, we can extract information regarding overall performance and the studies conducted.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for SpO2 accuracy for this specific device. Instead, it relies on demonstrating that the new device performs "within its specifications" and "as well as the legally marketed predicate device(s)."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safe operation (electrical, mechanical, thermal) as per standards (EN 60601-1: 1990, Reviewer's Guidance for Respiratory Devices, 1993) | "The results demonstrate that the BCI® 3178 pediatric pulse oximetry sensor is in compliance with the guidelines and standards referenced in the reviewer's guides and that it performs within its specifications and functional requirements." |
| Accurate SpO2 measurement during desaturation conditions (for adults) | "Tests on adults showed the sensor to be accurate during desaturation conditions." |
| Functionality over the indicated size range (pediatric patients 10-100 lbs) | "Additional tests on pediatric subjects (not desaturated) demonstrated the functionality of the sensor over the indicated size range. The results demonstrated that the BCI® 3178 pediatric pulse oximetry sensor performed within its specifications." |
| No functional difference compared to predicate devices | "The testing described above indicate that there is no functional difference between the operation of the BCI® 3178 pediatric pulse oximetry sensor and the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Adults: The sample size for adults tested under desaturation conditions is not specified ("Tests on adults showed...").
- Pediatric Subjects: The sample size for pediatric subjects (not desaturated) is not specified ("Additional tests on pediatric subjects...").
- Data Provenance: The document does not specify the country of origin. It implicitly describes prospective testing as part of the device's validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For pulse oximetry, the "ground truth" for SpO2 accuracy is typically established using arterial blood gas (ABG) analysis with a co-oximeter, not usually expert consensus in the same way it would be for interpreting images or clinical findings. The text only states that testing was done under "desaturation conditions," implying a controlled study where reference measurements (like ABG) would be taken.
4. Adjudication Method for the Test Set
This information is not applicable to pulse oximetry accuracy testing, as the "ground truth" (e.g., co-oximetry via ABG) is an objective measurement, not subject to interpretation that would require expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic imaging or interpretation tasks where multiple readers evaluate cases. Pulse oximetry involves direct measurement, not interpretation of cases by multiple readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, a standalone performance study was done. The described testing of the BCI® 3178 Pediatric Pulse Oximetry Sensor for SpO2 accuracy and functionality is by its nature a standalone performance evaluation of the device itself. The sensor produces an output (SpO2, pulse rate) based on its algorithm and hardware, independent of human interpretation or assistance beyond initial placement and monitor reading.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth. However, for pulse oximetry accuracy testing, especially during desaturation studies, the gold standard for ground truth is typically arterial blood gas (ABG) analysis using a co-oximeter. The statement "Tests on adults showed the sensor to be accurate during desaturation conditions" strongly implies the use of such a reference method.
8. Sample Size for the Training Set
- This information is not applicable or not provided in the context of this traditional medical device submission. Pulse oximeters, like the BCI® 3178, typically rely on established optical and physiological principles, not on machine learning algorithms trained on large datasets in the way an AI diagnostic algorithm would be. Therefore, there wouldn't be a "training set" in the sense of AI/ML development. The design is based on known physics and engineering, refined through testing.
9. How the Ground Truth for the Training Set Was Established
- As a training set is not applicable (see point 8), this question is also not applicable.
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JUN 0 3 2002
BCI. Inc.
N7 W22025 Johnson Road Waukesha, Wi 53186-1856 USA Tel: 262-542-3100 Fax: 262-542-3325 www.smiths-bci com
Summary of Safety and Effectiveness
| Submitter:Address: | BCI, Inc.N7 W22025 Johnson RoadWaukesha, WI 53186 |
|---|---|
| Telephone: | (262) 542-3100 |
| Contact: | VP Regulatory Affairs |
| Prepared: | March 1, 2002 |
| Proprietary Name: | BCI 3178 Pediatric Pulse Oximetry Sensor |
| Common/Classification Name: | Pulse Oximeter Sensor |
| Predicate Devices: | BCI 3044 Reusable Pulse Oximetry Sensor(K893877)BCI 3025 Reusable Infant Pulse OximetrySensor (K901861)BCI 3043 Reusable Universal "Y" Pulse OximetrySensor (K893877) |
New Device Description:
The BCI® 3178 pediatric pulse oximetry sensor is similar to other existing finger sensors, legally marketed by BCI, Inc. and others. This new finger sensor is designed to work with all BCI pulse oximeters on pediatric patients from 10 to 100 lbs. The sensor is made up of three major parts, the cable with the molded connector, the top part of the shell containing the LEDs and the bottom part of the shell containing the photo detector.
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Intended Use:
The BCI® 3178 Pediatric Pulse Oximetry Sensor is a reusable finger sensor that can be used with BCI® pulse oximeter monitors to non-invasively measure oxygen saturation (SpO2), pulse rate and plethysmographic pulse waves. It is for use with BCI® pulse oximeter monitors or monitors that are licensed to use BCI® pulse oximetry sensors. The BC1® 3178 Pediatric Pulse Oximetry Sensor will provide reliable spot check measurements on patients weighing from 10 to 100 Ibs (5 - 45 kg). The sensor is not intended for prolonged use.
Performance Data:
The design of this device utilizes currently available technology found in legally marketed devices. The major difference between the new device and the predicate BC1 3044 pulse oximeter sensor is the smaller size of the new device and . Testing was done to ensure that the BC1® 3178 pediatric pulse oximetry sensor would perform safely and accurately within the environment(s) for which it is to be marketed.
Safety testing was conducted in accordance with the Reviewer's Guidance for Respiratory Devices, 1993, and EN 60601-1: 1990. Electrical, mechanical durability, and thermal safety tests have been completed. The results demonstrate that the BC1® 3178 pediatric pulse oximetry sensor is in compliance with the quidelines and standards referenced in the reviewer's guides and that it performs within its specifications and functional requirements.
Testing of device performance included clinical testing of the SpO2 parameter. Tests on adults showed the sensor to be accurate during desaturation conditions. Additional tests on pediatric subjects (not desaturated) demonstrated the functionality of the sensor over the indicated size range. The results demonstrated that the BCI® 3178 pediatric pulse oximetry sensor performed within its specifications.
The testing described above indicate that there is no functional difference between the operation of the BCI® 3178 pediatric pulse oximetry sensor and the predicate devices. Based on these results, it is our determination that the device is safe, effective, and performs as well as the legally marketed predicate device(s).
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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 Alexander
Donald Alexander VP Regulatory Affairs BCI, Inc.
BCI and Digit are a BCI trademarks. The symbol ® indicates it is registered in the U.S. Patent and Trademark Office and certain other countries. Nonin and Onyx are Nonin trademarks.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 0 3 2002
Mr. Donald Alexander BCI, Inc. N7 W22025 Johnson Road Waukesha, WI 53186
Re: K020739
BCI® 3178 Pediatric Pulse Oximetry Sensor Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II (two) Product Code: 74 DQA Dated: March 1, 2002 Received: March 6, 2002
Dear Mr. Alexander:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Donald Alexander
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Da Till
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
510(k) Number (if Known): KO20739
Device Name: BCI® 3178 Pediatric Pulse Oximetry Sensor
Indications For Use:
Intended Use:
The BCI® 3178 Pediatric Pulse Oximetry Sensor is a reusable finger sensor that can be used to non-invasively measure oxygen saturation (SpO2), pulse rate and wethysmographic pulse waves. It's performance was validated with the BCI® 3304 pulse oximeter. The BCT® 3178 Pediatric Pulse Oximetry Sensor will provide reliable spot check measurements on patients weighing from 10 to 100 lbs (5 -45 kg). The sensor is not intended for prolonged use.
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K020759
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The_Counter Use
§ 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).