BCI 3180 PULSE OXIMETER

K020350 · Bci, Inc. · DQA · Apr 30, 2002 · Cardiovascular

Device Facts

• Record ID: K020350
• Device Name: BCI 3180 PULSE OXIMETER
• Applicant: Bci, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Apr 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for 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.

Device Story

BCI 3180 pulse oximeter; tabletop monitor for continuous SpO2, pulse rate, and pulse strength measurement. Inputs: SpO2 sensor signals. Processing: signal analysis for physiological parameters; trend data storage. Outputs: LCD display of patient data/waveforms; power status LED; infrared serial port for printer/PC data download. Used in hospitals, clinics, and emergency land transport; operated by clinicians. Benefits: provides real-time physiological monitoring in critical environments like anesthesia and transport. Healthcare providers use output for patient status assessment and clinical decision-making.

Clinical Evidence

Clinical testing of SpO2 parameter and overall software validation performed. Bench testing included electromagnetic compatibility (EMC), electrical safety, mechanical durability, and environmental (temperature/humidity) testing per EN 60601-1 and EN 60601-1-2. Results demonstrated device performance within specifications and compliance with applicable standards.

Technological Characteristics

Tabletop pulse oximeter; SpO2 sensor interface; LCD display; infrared serial port for data communication. Powered device. Software-based parameter calculation. Complies with EN 60601-1 (safety) and EN 60601-1-2 (EMC).

Indications for Use

Indicated for continuous monitoring of SpO2, pulse rate, and pulse strength in neonate to adult patients. Intended for hospital, clinical, and emergency land transport settings, including critical care, anesthesia, and ventilatory applications. Not for home use.

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

Submission Summary (Full Text)

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Image /page/0/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 a bold, sans-serif font. There is a registered trademark symbol in the upper right corner of the logo.

APR 3 0 2002

K020350

#### 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: Address:

Telephone:

Contact:

Prepared:

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

[phone]

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:

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).

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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Image /page/2/Picture/0 description: The image shows the logo for BCI. The logo consists of a circle with vertical lines and two horizontal lines going through the middle. To the right of the circle are the letters BCI in bold black font.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact 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 Division of Small Manufacturers, International 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,

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:

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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use (Per 21 CFR 801.109)

OR

Over-The Counter Use

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