BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM

K013862 · Bci, Inc. · DQA · Feb 21, 2002 · Cardiovascular

Device Facts

• Record ID: K013862
• Device Name: BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM
• Applicant: Bci, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Feb 21, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The BCI 1621 Oximetry Data Management Program analyzes data recorded using the BCI 3403 pulse oximeter and provides a printed oximetry data analysis report and graphical SpO2 trend. This information is designed for health care professionals in environments such as hospitals, skilled nursing facilities, physician offices, and home care. It can aid in the analysis of pulse oximetry data from sleep screening, oxygen therapy validation, and/or related studies. Data from the BCI 3403 pulse oximeter are downloaded for analysis using a unique cable.

Device Story

Software accessory for BCI 3403 pulse oximeter; downloads stored oximetry data via unique cable. Performs desaturation analysis; constructs histograms and SpO2 trend graphs. Used by healthcare professionals in hospitals, clinics, and home care to support clinical decision-making for sleep screening and oxygen therapy validation. Provides printed reports for review. Benefits include automated data visualization and analysis of patient oxygenation trends.

Clinical Evidence

Bench testing and clinical validation performed. Included clinical testing of desaturation identification algorithm and software validation using simulators. Results confirmed device performance met specifications.

Technological Characteristics

Software-based data management program. Performs desaturation analysis, histogram construction, and SpO2 graphing. Connectivity via unique cable for data download from BCI 3403 pulse oximeter. Developed per FDA software guidance (May 1998).

Indications for Use

Indicated for health care professionals to analyze pulse oximetry data from sleep screening, oxygen therapy validation, and related studies in clinical and home care settings.

Regulatory Classification

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.

Predicate Devices

• BCI® 3403 Sleep Screening Pulse Oximeter (K011156)
• Nellcor Score™ Software (K961450)

Submission Summary (Full Text)

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K013862

Image /page/0/Picture/1 description: The image shows a logo with the letters 'BCI' in bold, sans-serif font. To the left of the letters, there is a circular graphic composed of vertical lines, resembling a stylized sun or a data visualization. A small circle is present to the upper right of the letters, possibly serving as a design element or a trademark symbol. The overall design is simple and modern, with a focus on clean lines and geometric shapes.

## FFB 2 1 2002

BCI, Inc. N7 W22025 Johnson Road Waukesha, WI 53186-1856 USA Tel: [phone] Fax: [phone] www.smiths-bci.com

# Summary of Safety and Effectiveness

| Submitter: | BCI, Inc. |
|-----------------------------|--------------------------------------------------------------------------------------------|
| Address: | N7 W22025 Johnson Road<br>Waukesha, WI 53186 |
| Telephone: | [phone] |
| Contact: | VP Regulatory Affairs |
| Prepared: | November 15, 2001 |
| Proprietary Name: | BCI® 1621 Oximetry Data Management Program |
| Common/Classification Name: | Pulse Oximeter Display Software |
| Predicate Devices: | BCI® 3403 Sleep Screening Pulse Oximeter<br>(K011156)<br>Nellcor Score™ Software (K961450) |

### New Device Description:

The BCI® 1621 Oximetry Data Management Program is a software program used as a pulse oximetry accessory.

#### Intended Use:

The BCI® 1621 Oximetry Data Management Program provides a printed oximetry data analysis report and graphical SpO2 trend. It is designed for health care professionals in environments such as hospitals, skilled nursing facilities, physician offices, and home care. It can aid in the analysis of pulse oximetry data from sleep screening, oxygen therapy validation, and/or related studies. A unique cable is used to download data from the BCI 3403 pulse oximeter or compatible device.

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Image /page/1/Picture/0 description: The image shows a logo with a circular design on the left and the letters 'BCI' on the right. The circular design is composed of vertical lines, creating a textured effect. The letters 'BCI' are in a bold, sans-serif font, with a small circle or dot above and to the right of the 'I'. The logo appears to be in black and white.

### Performance Data:

The design of this device utilizes currently available technology found in legally marketed devices. The software performs the same analysis as the BCI 3403 pulse oximeter (K011156). In addition, it performs desaturation analysis, constructs histograms, and SpO2 graphs similar to the Nellcor Score™ software (K961450).

Software development and testing was conducted in accordance with the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, FDA, May 29, 1998. Testing of device performance included clinical testing of the desaturation identification algorithm and overall software validation using simulators. The results demonstrated that the BCI® 1621 Oximetry Data Management Program performed within its specifications.

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, suggesting movement or flight. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 2 1 2002

Mr. Donald J. Alexander BCI, Inc. N7 W22025 Johnson Road Waukesha, WI 53186-1856

Re: K013862

BCI 1621 Oximetry Data Management Program Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II (two) Product Code: 74 DQA Dated: February 8, 2002 Received: February 11, 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 J. Alexander

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast of advised that I Dri brisualite over device complies with other requirements of the Act that I DA has made a acterimalistions administered by other Federal agencies. You must or any I cacal statutes and regarments, including, but not limited to: registration and listing (21 Comply with an the 11et 81equirements)01); good manufacturing practice requirements as set CI'N in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality byticles (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) I mis letter will anow you to organization of substantial equivalence of your device to a legally premarket notification: "The Dr. I massification 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 If you desire specific ad rise for in vitro diagnostic devices), please contact the Office of additionally 21 OF N F art 6646. Additionally, for questions on the promotion and advertising of Compination at (301) 597-1 the Office of Compliance at [phone]. 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 Other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Da V. Tellh

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):___

613862

Device Name: BCI 1621 Oximetry Data Management Program

Indications For Use:

Intended Use:

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oximeter and provides a printed oximery data and your and graphical Sport of en oximeter and provides a printed oximely data. Data from the BCI 3403 pulse oximeter are downloaded for analysis using a unique cable.

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Concurrence of CDRH, Office of Device Evaluation (ODE)


| Division of Cardiovascular & Respiratory Devices | |
|--------------------------------------------------|---------|
| 510(k) Number | K013862 |

| Prescription Use (Per 21 CFR 801.109) | <div style="text-align:center;">OR</div> | Over-The-Counter Use |
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