BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR

K020739 · Bci, Inc. · DQA · Jun 3, 2002 · Cardiovascular

Device Facts

• Record ID: K020739
• Device Name: BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR
• Applicant: Bci, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Jun 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Reusable finger sensor; inputs light signals via LEDs and photo detector; transforms light absorption data into SpO2, pulse rate, and plethysmographic waveforms; used with BCI pulse oximeter monitors; intended for spot checks in clinical settings; provides real-time physiological data to clinicians to assist in patient monitoring; benefits include non-invasive assessment of oxygenation status in pediatric patients.

Clinical Evidence

Clinical testing performed on adults during desaturation conditions to validate SpO2 accuracy. Additional testing on pediatric subjects (non-desaturated) confirmed functionality across the indicated weight range (10-100 lbs).

Technological Characteristics

Reusable finger sensor; components include cable with molded connector, shell with LEDs, and shell with photo detector. Complies with EN 60601-1:1990 for electrical, mechanical, and thermal safety.

Indications for Use

Indicated for pediatric patients weighing 10 to 100 lbs (5-45 kg) for non-invasive spot check measurement of SpO2, pulse rate, and plethysmographic pulse waves. Not intended for prolonged 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 3044 Reusable Pulse Oximetry Sensor (K893877)
• BCI 3025 Reusable Infant Pulse Oximetry Sensor (K901861)
• BCI 3043 Reusable Universal "Y" Pulse Oximetry Sensor (K893877)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for BCI. The logo consists of a circle on the left side, which is filled with vertical lines. To the right of the circle are the letters BCI in bold, sans-serif font. There is a small registered trademark symbol in the upper right corner of the I.

JUN 0 3 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:<br>Address: | BCI, Inc.<br>N7 W22025 Johnson Road<br>Waukesha, WI 53186 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | [phone] |
| 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<br>(K893877)<br>BCI 3025 Reusable Infant Pulse Oximetry<br>Sensor (K901861)<br>BCI 3043 Reusable Universal "Y" Pulse Oximetry<br>Sensor (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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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure, composed of three overlapping profiles facing to the right.

#### 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 [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,

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