The BCI® 3420 Digit™ Pulse Oximeter is a handheld, finger-mounted pulse oximeter that combines the monitor and sensor into one assembly that measures SpO2, pulse rate, and pulse strength. It may be used as a spot check device in the home, hospital or clinical environments, including patient ground transport in clinical and EMS (Emergency Medical Services) settings. The BCI 3420 Digit™ Pulse Oximeter will provide reliable measurements on patients ranging from pediatric to adults.

Device Description

The BCI® 3420 Digit™ Pulse Oximeter consists of an pulse oximeter monitor and sensor contained on a single assembly. The device includes an LED display and power on key, and is powered by two "AAA" batteries.

AI/ML Overview

The provided documentation for the BCI® 3420 Digit™ Pulse Oximeter describes safety and performance testing to demonstrate substantial equivalence to predicate devices, but it does not detail specific acceptance criteria as numerical thresholds or perform a statistical study against such criteria. The document focuses on compliance with general medical device standards and functional equivalence rather than a precise quantitative evaluation against predefined acceptance metrics.

Therefore, many of the requested elements for a detailed acceptance criteria and study description cannot be extracted directly from this document.

Here's an attempt to answer based on the available information, with clear indications where information is not provided:

Acceptance Criteria and Device Performance Study for BCI® 3420 Digit™ Pulse Oximeter

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Parameter Tested	Acceptance Criteria	Reported Device Performance
Safety Testing	Compliance with Reviewer's Guidance for Respiratory Devices, 1993, EN 60601-1: 1990, and EN 60601-1-2: 1993.	Demonstrated compliance with referenced guidelines and standards.
Environmental Testing	Compliance with Reviewer's Guidance for Respiratory Devices, 1993, EN 60601-1: 1990, and EN 60601-1-2: 1993 for EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity.	Demonstrated compliance with referenced guidelines and standards.
SpO2 Performance	Within device specifications.	Performed within its specifications.
Software Validation	Not specified	Performed within its specifications.
Functional Equivalence to Predicate	"No functional difference" from predicate devices.	"No functional difference" found between the operation of the BCI® 3420 Digit™ pulse oximeter and the predicate devices.

2. Sample size used for the test set and the data provenance

Sample Size (Clinical Testing for SpO2): Not specified. The document mentions "clinical testing of the SpO2 parameter" but does not provide details on the number of subjects or data points.
Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or the country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified. The document does not describe the establishment of a "ground truth" using experts in the context of a performance study with a test set. The focus is on compliance with standards and functional equivalence to predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified. This level of detail about adjudication methods is not present in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This document describes a pulse oximeter, which is a medical device for direct measurement, not an AI-assisted diagnostic tool involving human readers. Therefore, an MRMC study or AI-related effectiveness is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device is a standalone pulse oximeter that directly measures physiological parameters. Its performance is inherently "standalone" in this context, meaning it operates without a human-in-the-loop for interpreting the core measurement output beyond standard clinical use. The "clinical testing of the SpO2 parameter" would evaluate this standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For SpO2 measurement, the "ground truth" (or reference standard) in clinical testing typically involves simultaneous measurements against a well-calibrated co-oximeter or arterial blood gas analysis. The document states "clinical testing of the SpO2 parameter" was performed, implying such a reference standard would have been used, but the specific method is not detailed.
For safety and environmental testing, the "ground truth" is compliance with the specified international and national standards (e.g., EN 60601-1).

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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KO13/7!

Image /page/0/Picture/1 description: The image shows the logo for BCI, which is a company that specializes in battery charging and testing equipment. The logo consists of a circle with vertical lines on the left, followed by the letters BCI in bold, sans-serif font. The circle is meant to represent a battery, and the letters BCI stand for Battery Charging and Testing International.

JAN 0 3 2002

BCI, Inc. N7 W22025 Johnson Road Waukesha, WI 53186-1856 USA Tel: 262-542-3100 Fax: 262-542-3325 w.smiths-bci.com

Summary of Safety and Effectiveness

Submitter:	BCI, Inc.
Address:	N7 W22025 Johnson RoadWaukesha, WI 53186
Telephone:	(262) 542-3100
Contact:	VP Regulatory Affairs
Prepared:	September 21, 2001
Proprietary Name:	BCI® 3420 Digit™ Pulse Oximeter
Common/Classification Name:	Pulse Oximeter
Predicate Devices:	BCI 3301® Hand-Held Pulse Oximeter (K943404)BCI® 3401 Handheld Pulse Oximeter (K980714)Nonin® Onyx , Model 9500 (K942248, K001085)

New Device Description:

Intended Use:

The BCI® 3420 Digit™ Pulse Oximeter is a handheld, finger-mounted pulse oximeter that combines the monitor and sensor into one assembly that measures SpO2, pulse rate, and pulse strength. It may be used as a spot check device in the home, hospital or clinical environments, including patient ground transport in clinical and EMS (Emergency Medical Services) settings. The BCI® 3420 Digit™ Pulse Oximeter will provide reliable measurements on patients ranging from pediatric to adults.

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Image /page/1/Picture/0 description: The image shows the logo for BCI, which is a company that specializes in business continuity. The logo is black and white and features a circle made of vertical lines on the left, followed by the letters BCI in bold font. There is a registered trademark symbol to the right of the I.

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 BCI 3301 Handheld Pulse Oximeter is the combination of the pulse oximeter monitor and sensor, similar to the Nonin® Onyx®. Testing was done to ensure that the BCI® 3420 Digit™ 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 compatability (EMC), electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing have been completed. The results demonstrate that the BC1® 3420 Digit™ 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 SpO2 parameter and overall software validation. The results demonstrated that the BCI® 3420 Digit™ pulse oximeter performed within its specifications.

The testing described above indicate that there is no functional difference between the operation of the BCI® 3420 Digit™ pulse oximeter 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).

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 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 3 2002

Donald J. Alexander Vice President of Regulatory Affairs BCI, Inc. N7 W22025 Johnson Road Waukesha, WI 53186-1856

Re: K013171

3420 Digit™ Pulse Oximeter Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: Class II (two) Product Code: DQA Dated: November 20, 2001 Received: November 21, 2001

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 J. 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 vours.

Dea G. Tell

Bram D. Zuckerman, M.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): `K013171

Device Name: BCI® 3420 Digit™ 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)

Prescription Use
(Per 21 CFR 801.109)

Over-The Counter Use

Division of Cardiovascular & Respiratory Devices
510(k) Number K013171

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).