BCI WW1021 PC APPLICATION

K090205 · Smiths Medical Pm, Inc. · DQA · Apr 28, 2009 · Cardiovascular

Device Facts

• Record ID: K090205
• Device Name: BCI WW1021 PC APPLICATION
• Applicant: Smiths Medical Pm, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Apr 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Software as a Medical Device, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K090205 · Apr 28, 2009	BCI WW1021 PC APPLICATION	Smiths Medical Pm, Inc.	Retrospective clinical data from prior BCI 1621 Software investigation	The sponsor re-analyzed existing clinical data to validate the desaturation detection algorithm of the new BCI WW1021 software by comparing it against clinician scoring of desaturation events.	Retrospective analysis; Algorithm validation; Desaturation detection

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Re-analysis of BCI 1621 Software clinical data; Descriptive, cross-sectional retrospective re-analysis	Adult subjects, including those with or suspected of having obstructive sleep apnea and those not suspected of having sleep apnea.; Sample Size: 4 subjects (one subject studied twice)	Clinician scoring of desaturation events	Clinical accuracy and functionality of desaturation detection algorithm (false negative and false positive rates)

Indications for Use

The WW1021 is intended for use with any oximeter/device which supports the BCI® Communication Protocol 1030 (BCICP 1030), if the device is connected to the PC through the USB port. It can be used to view the data being recorded in real time; download the recorded data to the PC from the device; analyze and print the recorded data and can be used in sleep screening. It can show only visual alarms and cannot annunciate audio alarms. It is not intended to be used as a central station monitoring system or as a patient monitoring system. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, sleep technicians and other qualified health care providers. The WW1021 may be used in the hospital or clinical environment.

Device Story

BCI® WW1021 PC Application Software connects to compatible oximeters via USB; enables real-time data viewing, data download, analysis, and printing; supports sleep screening. Operated by physicians, respiratory therapists, nurses, sleep technicians in hospital/clinical environments. Software processes oximetry data to detect desaturation events; displays visual alarms only (no audio). Healthcare providers use output for clinical assessment of sleep-related desaturation. Benefits include streamlined data management and analysis for sleep screening workflows.

Clinical Evidence

Descriptive, cross-sectional study of 4 adult subjects (including those with/without sleep apnea). Compared software-detected desaturation events against clinician scoring. Results: 7.49% false negative rate and 0.17% false positive rate. Both metrics met the pre-defined pass criteria of ≤10%.

Technological Characteristics

PC-based software application; connects to oximeters via standard USB cable using BCI® Communication Protocol 1030 (BCICP 1030). Features include real-time data visualization, data download, and event analysis. Software-only device; no hardware components. Operates on standard PC hardware.

Indications for Use

Indicated for use with BCI® Communication Protocol 1030-compatible oximeters/devices in hospital or clinical settings. Intended for adult patients, including those with or suspected of having sleep apnea, for real-time data viewing, data download, analysis, and sleep screening. Not for use as a central station or patient monitoring system.

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® WW1621 Oximetry Data Management Oximetry Software

Submission Summary (Full Text)

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K090203

APR 9 8 2009

## 510(k) Summary of Safety and Effectiveness

| Manufacturer: | Smiths Medical |
|-----------------------------|-----------------------------------------------------------|
| Address: | N7 W22025 Johnson Drive |
| | Waukesha, WI 53186 |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Contact Person: | Donald Alexander<br>Director Regulatory Affairs |
| Date Prepared: | January 23, 2009 |
| Proprietary Name: | BCI® WW1021 PC Application Software |
| Common/Classification Name: | Oximetry PC Software |
| Product Code: | DQA |
| Regulation Number: | 870.2700 (Class II) |
| Predicate Devices: | BCI® WW1621 Oximetry Data Management Oximetry<br>Software |

#### Device Description:

The aim of this submission is to obtain market clearance for the BCI® WW1021 PC Application Oximetry Software.

The BCI® WW1021 is intended for use with any device which supports the BCI® Communication Protocol (BCICP), if the device is connected to the PC through the USB port. It can be used to configure the device; view the data being recorded in real time; download the recorded data to the PC from the device; analyze and print the recorded data; view event logs and self diagnostic information from the device and can be used in sleep screening. It can show only visual alarms and cannot annunciate audio alarms. It is not intended to be used as a central station monitoring system or as a patient monitoring system. It cannot be used to configure or download data to the PC from devices that are wirelessly connected. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, emergency medical technicians, sleep technicians and other qualified health care providers. BCI® WW1021 may be used in the hospital or clinical environment. Communication between the device and BCI® WW1021 is possible using any standard USB cable.

#### Indications for Use

The WW1021 is intended for use with any oximeter/device which supports the BCI® Communication Protocol 1030 (BCICP 1030), if the device is connected to the PC through the USB port. It can be used to view the data being recorded in real time; download the recorded data to the PC from the device; analyze and print the recorded data and can be used in sleep screening. It can show only visual alarms and cannot annunciate audio alarms. It is not intended to be used as a central station monitoring

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system or as a patient monitoring system. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, sleep technicians and other qualified health care providers. The WW1021 may be used in the hospital or clinical environment.

#### Risk Mitigation Table

Below is a summary of risks common to pulse oximeters and how this submission addresses those risks.

| Identified Risk | Mitigation Measures |
|-------------------------------|----------------------------------------------------------------|
| Inadequate Device Performance | Software Validation (Volume 8)<br>Clinical Testing (Volume 10) |
| Improper Use | Proposed Labeling (Volume 7) |

An in-depth risk management analysis, including mitigation measures, was performed on the BCI WW1021 software. The results are provided under Volume 5.

#### Performance Testing

The BCI WW1021 PC Application Software passed software verification and validation testing. Test reports, including test protocols, pass/fail criteria, results and conclusions, are provided under Volume 8.

#### Clinical Testing

The intent of this study was to re-analyzed clinical data previously gathered for the investigation of the BCI® 1621 Software to determine the clinical accuracy and functionality of the BCI® WW1021 software's desaturation detection algorithm. There were four subjects enrolled. One subject (Subject A) was studied twice. Subjects included those not suspected of having obstructive sleep apnea, those with the diagnosis of sleep apnea or those suspected of having sleep apnea determined by self disclosure. This study was a descriptive, cross-sectional investigation of adult subjects including those not suspected of having obstructive sleep apnea, those with the diagnosis of sleep apnea or those suspected of having sleep apnea determined by self disclosure. This study involved the comparison to clinician scoring of desaturation events using the definition used by the BCI® WW1021 Software. The Clinical Investigation results were 7.49% false negative and 0.17% false positive events. This constitutes a pass condition for both the false negative (less than or equal to 10%) and false positive (less than or equal to 10%) criteria. A complete test protocol and results can be found under Volume 10.

#### Conclusion

Supporting information per this premarket submission confirms that the BCI® WW (030 Pulse Oximeter is substantially equivalent to its predicate devices.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### APR 2 8 2009

Mr. Donald Alexander Director Regulatory Affairs Smiths Medical PM. Incorporated N7 W22025 Johnson Drive Waukesha, Wisconsin 53186-1856

Re: K090205

Trade/Device Name: BCI WW1021 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA Dated: January 23, 2009 Received: January 28, 2009

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 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.

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

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Page 2- Mr. Alexander

and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Susan Cooper

Susan Runner, D.D.S., MA Acting 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: _BC1® WW1021 PC Application Software

Indications for Use:

WW1021 is intended for use with any oximeter/device which supports the BCI® Communication Protocol 1030 (BCICP 1030), if the device is connected to the PC through the USB port. It can be used to view the data being recorded in real time; download the recorded data to the PC from the device; and print the recorded data and can be used in sleep screening. It can show only visual alarms and cannot annunciate audio alarms. It is not intended to be used as a central station monitoring system or as a patient monitoring system. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, sleep technicians and other qualified health care providers. WW1021 may be used in the hospital or clinical environment.

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)

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Susan Rose

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

510(k) Number: KC90005