The BCI 3180 pulse oximeter is indicated for continuous patient monitoring of patient SpO2, pulse rate, and pulse strength measurements. It is intended for the hospital or clinical environment and during emergency land transport. It is intended for use in critical environments, including ventilatory applications, patient transport, and anesthesia. It is not intended for use in the home. The pulse oximeter is intended for use with all BCI pulse oximetry sensors, providing SpO2 and pulse rate measurements on all patients from neonate to adult.

Device Description

The BCI 3180 pulse oximeter is a new monitor with the same parameters as existing devices legally marketed by BCI, Inc. This device is designed to provide full featured monitoring capabilities in a tabletop design. The system features an SpO2 sensor interface, display of patient and waveform data via an LCD display, power status LED, and the function keypad area consisting of six keys (on/off, waveform / trend, alarm audio pause/off, menu / enter, up arrow & down arrow). The monitor has an infrared serial port that is used for data communications to a printer and can download trend data to a printer of personal computer through connection to the SpQ2 sensor interface (sensor must be removed from the device).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BCI 3180 Pulse Oximeter, based on the provided documents:

Acceptance Criteria and Device Performance Study for BCI 3180 Pulse Oximeter

The BCI 3180 Pulse Oximeter is presented as a redesign of the BCI 3100 Pulse Oximeter, aiming to meet current product standards with an updated design while maintaining similar functionality. The primary claim for proving met acceptance criteria is that there is "no functional difference" between the BCI 3180 and its predicate device (BCI 3100 Pulse Oximeter), and that it performs within its specifications.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria in a dedicated table format. Instead, it refers to compliance with guidelines and standards, and performance "within specifications." Based on the provided text, the inferred acceptance criteria relate to safety, accuracy, and compliance with general medical device standards.

Acceptance Criteria Category	Specific Criteria (Inferred from text)	Reported Device Performance
Safety	Compliance with EN 60601-1: 1990	Demonstrated compliance
	Compliance with Reviewer's Guidance for Respiratory Devices, 1993	Demonstrated compliance
Environmental	Compliance with EN 60601-1-2: 1993 (EMC)	Demonstrated compliance
	Electrical Safety	Passed Testing
	Mechanical Durability	Passed Testing
	Temperature/Humidity Tolerance	Passed Testing
Performance/Accuracy	SpO2 parameter accuracy	Performed within specifications
	Overall software validation	Performed within specifications
	Functional equivalence to predicate device (BCI 3100)	No functional difference reported

2. Sample Size and Data Provenance for Test Set

Sample Size: The document does not specify a numerical sample size for "clinical testing of the SpO2 parameter." It simply states that testing was done.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It mentions "clinical testing," which implies prospective data collection, but no further details are provided.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide any information regarding experts used to establish ground truth, their number, or qualifications. This suggests the validation relied on instrumental measurements and comparison to a predicate device rather than human expert interpretation of results.

4. Adjudication Method for Test Set

The document does not specify any adjudication method. Given the type of device (pulse oximeter) and the nature of "clinical testing of the SpO2 parameter," it's highly likely that ground truth was established through validated reference instrumentation rather than expert adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

There is no indication that a Multi Reader Multi Case (MRMC) comparative effectiveness study was done. The device measures physiological parameters (SpO2, pulse rate, pulse strength) and doesn't involve human interpretation of images or complex data where AI assistance for human readers would be applicable.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was performed in the sense that the device's output (SpO2, pulse rate) was directly tested against its specifications. The document states: "Testing of device performance included clinical testing of the SpO2 parameter and overall software validation. The results demonstrated that the BCI 3180 pulse oximeter performed within its specifications." This refers to the algorithm's (or device's) direct measurement capability.

7. Type of Ground Truth Used

The type of ground truth used was likely instrumental reference measurements for SpO2 and pulse rate. The document mentions "clinical testing of the SpO2 parameter," which typically involves comparing the device's readings against a gold-standard measurement method (e.g., arterial blood gas analysis for SpO2, or a reference ECG for pulse rate) in a clinical setting.

8. Sample Size for Training Set

The document does not mention a training set or its sample size. This is expected as the BCI 3180 is a physical medical device (pulse oximeter) that performs direct physiological measurements, not a machine learning or AI-driven diagnostic tool that would require a distinct training set in the conventional sense. Its "training" is in its engineering design and calibration.

9. How Ground Truth for Training Set Was Established

Since there is no mention of a "training set" in the context of machine learning, there is no information on how ground truth for a training set was established. The device's fundamental parameters and algorithms would have been developed based on established physiological principles and engineering best practices for pulse oximetry, validated through the performance testing described.

Summary

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APR 3 0 2002

K020350

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:

Telephone:

Contact:

Prepared:

BCI. Inc. N7 W22025 Johnson Road Waukesha, WI 53186

(262) 542-3100

VP Requlatory Affairs

January 30, 2002

BCI 3180 Pulse Oximeter

Common/Classification Name:

Predicate Devices:

Proprietary Name:

Pulse Oximeter

BCI 3100 Pulse Oximeter (K893877) BCI 3304 Pulse Oximeter (K962156) BCI 3401 Pulse Oximeter (K980714)

New Device Description:

smiths Smiths Medical - a part of Smiths Group pla

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Image /page/1/Picture/0 description: The image shows the logo for BCI. The logo consists of a circle on the left side that is filled with vertical lines. To the right of the circle are the letters BCI in bold, sans-serif font.

Intended Use:

The BCI 3180 pulse oximeter is indicated for continuous patient monitoring of patient SpO2, pulse rate, and pulse strength measurements. It is intended for the hospital or clinical environment and during emergency land transport. It is intended for use in critical environments, including ventilatory applications, patient transport, and anesthesia. It is not intended for use in the home. The pulse oximeter is intended for use with all BC1 pulse oximetry sensors, providing SpO2 and pulse rate measurements on all patients from neonate to adult.

Performance Data:

The design of this device utilizes currently available technology found in legally marketed devices. The BCI 3180 Pulse Oximeter is a redesign of the BCI 3100 Pulse Oximeter. The new design uses currently available parts, meet the most recent product standards, and has a more up-to-date case and display. Testing was done to ensure that the BC1 3180 Pulse Oximeter would perform safely and accurately within the environment(s) for which it is to be marketed.

Safety and environmental testing was conducted in accordance with the Reviewer's Guidance for Respiratory Devices, 1993, EN 60601-1: 1990, and EN 60601-1-2: 1993. Electromagnetic compatibility (EMC), electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing have been completed. The results demonstrate that the BCI 3180 pulse oximeter is in compliance with the guidelines 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 SpO» parameter and overall software validation. The results demonstrated that the BCI 3180 pulse oximeter performed within its specifications.

The testing described above indicates that there is no functional difference between the operation of the BCl 3180 pulse oximeter and the predicate device. 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).

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.

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Respectfully,

Donald Aliyant

Donald Alexander VP Regulatory Affairs

BCI is a trademark of BCI, Inc. The symbol ® indicates it is registered in the U.S. Patent and Trademark Office and certain other countries,

smiths Smiths Medical - a part of Smiths Group ple

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 2002

Mr. Donald Alexander BCI, Inc. N7 W22025 Johnson Road Waukesha. WI 53186

Re: K020350

BCI 3180 Pulse Oximeter Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II (two) Product Code: 74 DQA Dated: January 30, 2002 Received: February 4, 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) 594-4646. 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,

Martin

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): Ko20350

Device Name: BCI 3180 Pulse Oximeter

Indications For Use:

Intended Use:

( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use

Division of Cardiovascular & Respiratory Devices
510(k) Number K020350

Regulation Number and Section

§ 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).