BCI AUTOCON 3304 DIGITAL PULSE OXIMETER

K070732 · Smiths Medical Pm, Inc. · DQA · Jul 9, 2007 · Cardiovascular

Device Facts

• Record ID: K070732
• Device Name: BCI AUTOCON 3304 DIGITAL PULSE OXIMETER
• Applicant: Smiths Medical Pm, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Jul 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The 3304 provides fast, reliable SpO2, pulse rate and pulse strength measurements. It may be used in the hospital or clinical environment, during emergency air or land transport and in the home. The oximeter will operate accurately over an ambient temperature range of 32 to 104°F (0 to 40°C). The oximeter works with all BCI oximetry probes providing SpO2 and pulse rate on all patients from neonate to adult. The oximeter permits continuous patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.

Device Story

BCI Autocorr 3304 is a tabletop digital pulse oximeter; provides SpO2, pulse rate, and pulse strength measurements. Device interfaces with BCI oximetry probes; processes optical signals to derive saturation data; displays results via LED. Used in hospitals, clinics, home, and transport settings by clinicians or patients. This submission adds performance specifications for motion conditions; device hardware and software remain unchanged from predicate. Output includes real-time patient data and audible/visible alarms for out-of-limit conditions; assists clinicians in patient status assessment and monitoring.

Clinical Evidence

Clinical investigation conducted on 10 healthy adult volunteers (ages 21-36) to validate SpO2 accuracy during controlled motion (tapping/rubbing, max 5 Hz). Study compared device SpO2 readings to CO-oximeter SaO2 reference values across 70-100% range. Results showed ARMS of 2.95% during motion, meeting the <3% pass criterion. Control (non-motion) performance was consistent with original 1996 validation data.

Technological Characteristics

Tabletop pulse oximeter; LED display; SpO2 probe interface; printer/PC port; optional analog output/digital alarm adapter. Operates on optical plethysmography principle. Compatible with BCI disposable sensors (1300, 1301, 1302, 1303). No changes to hardware or software from predicate.

Indications for Use

Indicated for continuous monitoring of SpO2, pulse rate, and pulse strength in patients ranging from neonate to adult. Suitable for use in hospital, clinical, and home environments, as well as during emergency air or land transport.

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® Autocorr™ 3304 Digital Pulse Oximeter (K962156)

Submission Summary (Full Text)

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# Summary of Safety and Effectiveness

JUL - 9 2007

| Manufacturer: | Smiths Medical PM, Inc. |
|-----------------------------|------------------------------------------------------|
| Address: | N7 W22025 Johnson Drive<br>Waukesha, WI 53186 |
| Telephone: | [phone] |
| Contact: | VP Regulatory Affairs |
| Prepared: | February 28, 2007 |
| Proprietary Name: | BCI® Autocorr™ 3304 Digital Pulse Oximeter |
| Common/Classification Name: | Pulse Oximeter |
| Predicate Devices: | BCI® Autocorr™ 3304 Digital Pulse Oximeter (K962156) |

## Device Description:

The subject device is the same as the legally marketed predicate device BCl 3304 Autocorr M Digital Pulse Oximeter (K962156) with one minor change to the labeling that does not raise new questions of safety and efficacy. This pulse oximeter was originally cleared with the current algorithms. However, it was not clinically validated under motion conditions and no motion claims were made. The aim of this premarket submission is to obtain clearance for an additional motion claim.

The 3304 Autocorrille pulse oximeter is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top oximeter with a wall mount charger. The system features an SpO2 probe interface, display of patient data via an LED display (SpO2, Pulse Rate, Pulse Strength), system status LEDs (Probe, Lo Batt, Silence, Alarm, Artifiact, Search), and the function keypad area consisting of eight keys (O/I, ID/Clear, Up and Down Arrows, Alarm Select, Alarm Silence. Alarm Volume, Pulse Volume). The oximeter has a printer/pc port that is used for data communication, an optional analog output and an optional digital alarm adapter for a remote location.

This Special 510(k) covers the labeling modification of BCI® Autocorr™ 3304 Digital Pulse Oximeter that was cleared under 510(k) K962156. The modification involves revising the 3304 labeling to add pulse oximetry performance specifications with motion. Results from clinical evaluation are provided to support the labeling change. No significant device modifications have been made to the 3304. The labeling change does not affect the intended use or alter the fundamental scientific technology of the device.

### Intended Use:

The intended use is identical to that originally submitted for BCT® Autocorr™ 3304 pulse oximeter. As stated per K962156, the intended use is as follows:

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The 3304 provides fast, reliable SpO2, pulse rate and pulse strength measurements. It may be used in the hospital or clinical environment, during emergency air or land transport and in the home. The oximeter will operate accurately over an ambient temperature range of 32 to 104°F (0 to 40°C). The oximeter works with all BCI oximetry probes providing SpO2 and pulse rate on all patients from neonate to adult. The oximeter permits continuous patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.

## Summary of Technological Characteristics of the Device Compared to the Legally Marketed Predicate Device:

No significant design modifications have been made to the BCI® Autocorr™ 3304 Pulse Oximeter.

No significant changes have been made to the software or hardware of the 3304 pulse oximeter.

#### Performance Testing:

Previous performance testing including EMC, electrical, mechanical durability, clinical desaturation studies, safety (operator and patient), and temperature/humidity was submitted in K962156. Additional clinical testing, submitted in Section 7 of this submission, was performed to support the labeling change.

#### Additional Clinical Testing:

The intent of the clinical investigation was to determine the oxygen saturation accuracy specifications for the model 3304 during controlled motion. Ten paid, adult, volunteer subjects participated in this trial. They varied in age from 21 to 36 years. There were three Black or African American and seven White subjects enrolled. They were three females and seven males. Nine subjects described themselves ethnically as non-Hispanic or non-Latino and one subject described himself as Hispanic or Latino.

This study was a descriptive, cross-sectional investigation of healthy, human subjects comparing Model 3304 pulse oximeter determined oxygen saturation (SpO2) values during motion (test condition) to CO-oximeter determined functional oxygen saturation (SaO-) values (reference condition). Additional Model 3304 pulse oximeters which were not subjected to motion were used as a control and to determine stable plateaus in the oxygen saturation readings. The study was conducted at oxygen concentrations that targeted an even distribution over the SaO2 range of 70 to 100%-SaO2. The motion protocol used in this study consisted of tapping and rubbing motions of randomly varied frequency and amplitude. The maximum frequency was 300 cvcles/minute (5 Hz). The maximum height was generally approximately 2.5 cm. The data were electronically gathered by the Smiths Medical PM, Inc. proprietary CRAWDADS program and

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analyzed by the CRAWDADS EXCEL template. Manual recording of the data was also made.

Acceptance Criteria: The acceptance pass criteria for this study was less than 3%-SpO2.

Results:

| | Motion Desaturation Trial Motion<br>Condition (%SpO2) | Performance Specification<br>(%SpO2) |
|--------------------|-------------------------------------------------------|--------------------------------------|
| ARMS | 2.95 | 3.00 |
| Standard Deviation | 2.84 | - |
| Average Difference | -0.82 | - |

The Smiths Medical PM, Inc. Model 3304 Pulse Oximeter operated within the pass criterion of less than 3%-SpO2 evenly distributed over the range 70 to 100%-SaO2 during motion of controlled amplitude and frequency. There were no adverse events or adverse device effects in this study.

The table below compares the summarized results for the SMPM 3304 Pulse Oximeter in the control condition (non-motion) of this study to the results in the original SMPM 3304 Pulse Oximeter desaturation trial performed for accuracy testing on 7-8 May 1996.

| | Motion Desaturation Trial<br>Control Condition (non-motion)<br>(%-SpO2) | Accuracy Desaturation Trial<br>Original (non-motion)<br>(%-SpO2) |
|--------------------|-------------------------------------------------------------------------|------------------------------------------------------------------|
| Average Difference | 0.05 | 0.83 |
| Standard Deviation | 1.69 | 1.70 |
| ARMS | 1.69 | 1.89 |

These results show that the 3304 pulse oximeter in the control condition (non-motion) in this trial performed with an accuracy comparable to the 3304 pulse oximeter in the original desaturation trial performed for accuracy testing on 7-8 May 2006. In both cases, the sensors were not in motion during the study.

## Summary of Labeling Change:

The labeling modification consists of detailing SpO2 accuracy specifications within the device specifications according to motion and no motion conditions. Please note that the accuracy of SpO2 measurements detected by the 3304 pulse oximeter has not changed. The labeling modification is detailed as follows:

This value is an estimate of the ARMS using the formula ARMS (est.) = ( Average Difference

SpO2 Accuracy: Motion: 70-100% ± 3% 50-69% not defined

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No Motion: 70-100% ± 2% (identical to original K962156) 50-69% ± 3% <50% not defined

These motion accuracy specifications are applicable with the following sensors: 1300 (adult), 1301 (pediatric), 1302 (neonate), 1303 (infant) disposable sensors. This labeling modification, along with a list of applicable sensors, will be made to the device specifications located in the functional specifications, operational manual and draft promotional literature.

# Conclusion:

The results of the clinical test support the labeling change and do not raise new questions of safety or effectiveness when compared to the legally marketed predicate device.

Supporting information per this premarket submission confirms that the BCI® Autocorr™ 3304 Digital Pulse Oximeter is substantially equivalent to its predicate (K962156).

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 Heyraud

Donald Alexander VP Regulatory Affairs Smiths Medical PM, Inc.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 9 2007

Mr. Donald Alexander Vice President Regulatory Affairs Smith Medial PM, Incorporated N7 W22025 Johnson Drive Waukesha, Wisconsin 53186-1856

Re: K070732

Trade/Device Name: BCI® Autocorr™ 3304 Digital Pulse Oximeter Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: June 20, 2007 Received: June 22, 2007

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. 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 (OS) 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Senate Y. Mahieu MD.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: BCI® Autocorr™ 3304 Digital Pulse Oximeter

Indications for Use:

The 3304 provides fast, reliable SpO2, pulse rate and pulse strength measurements. It may be used in the hospital or clinical environment, during emergency air or land transport and in the home. The oximeter will operate accurately over an ambient temperature range of 32 to 104°F (0 to 40°C). The oximeter works with all BCI oximetry probes providing SpO2 and pulse rate on all patients from neonate to adult. The oximeter permits patient monitoring with adjustable alarms limits as well as visible and audible alarm signals.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __ (21 CFR 801 Subpart C)

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

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

te Michail Sus

(Division Sign-Off) Division of Anesthesiology, General Hospital Intection Control, Dental Devices

510(k) Number: Ko 70732