BCI WW1030 PULSE OXIMETER

K083557 · Smiths Medical Pm, Inc. · DQA · May 1, 2009 · Cardiovascular

Device Facts

• Record ID: K083557
• Device Name: BCI WW1030 PULSE OXIMETER
• Applicant: Smiths Medical Pm, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: May 1, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The BC1® Model WW1030 pulse oximeter is intended to be used for continuous monitoring of a patient's functional oxygen saturation (%SpO2), pulse rate, pulse signal strength, and pulse amplitude index readings. It is equipped with audible and visual alarms. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, emergency medical technicians, sleep technicians, clinicians and home use. The intended patient population ranges from neonatal to adult. It can be used on patients with low perfusion or during patient motion. The WW 1030 may be used in the hospital or clinical environment, during emergency land transport, and the home.

Device Story

Handheld pulse oximeter for continuous monitoring of SpO2, pulse rate, perfusion index, and signal strength; utilizes Digital Micro Power OEM oximeter board (31402B2) to process sensor inputs; displays data via blue LED; features audible/visual alarms; operated by clinicians or home users; compatible with various BCI and Nellcor sensors; supports accessories including docking station, thermal printer, and USB connectivity; provides real-time physiological data to assist clinical decision-making; benefits patients through continuous monitoring in diverse environments including transport and home.

Clinical Evidence

Clinical evidence consists of three desaturation studies (Desat 37, 38, 39) using the Digital Micro Power OEM oximeter board (31402B2). Studies 37 and 38 evaluated SpO2 accuracy across the 70-100% SaO2 range compared to a reference CO-oximeter. Study 39 evaluated SpO2 accuracy under controlled motion conditions across the 70-100% SaO2 range. Results confirmed performance within acceptable limits.

Technological Characteristics

Handheld pulse oximeter; utilizes Digital Micro Power OEM oximeter board (31402B2); LED display; 5-button keypad; battery-powered (disposable or rechargeable pack); compatible with BCI and Nellcor sensors; includes audible/visual alarms; connectivity via USB and nurse call cables; tested for EMC, electrical, and mechanical durability.

Indications for Use

Indicated for continuous monitoring of functional oxygen saturation (%SpO2), pulse rate, pulse signal strength, and perfusion index in patients ranging from neonates to adults. Suitable for use in hospital, clinical, home, and emergency land transport settings. Includes patients with low perfusion or during motion.

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

• Masimo SET Radical pulse oximeter (K040214)
• BCI® Autocorr model 3304 pulse oximeter (K070732)
• BCI® MiniCorr model 3402 pulse oximeter (K991410)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

| Manufacturer: | Smiths Medical |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | N7 W22025 Johnson Drive<br>Waukesha, WI 53186 |
| | MAY - 1 2009 |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Contact Person: | Donald Alexander<br>Director Regulatory Affairs |
| Date Prepared: | December 1, 2008 |
| Proprietary Name: | BCI® model WW1030 Handheld Pulse Oximeter |
| Common/Classification Name: | Pulse Oximeter |
| Product Code: | DQA |
| Regulation Number: | 870.2700 (Class II) |
| Predicate Devices: | Masimo SET Radical pulse oximeter (K040214)<br>BCI® Autocorr model 3304 pulse oximeter (K070732)<br>BCI® MiniCorr model 3402 pulse oximeter (K991410) |

#### Device Description:

The aim of this submission is to obtain market clearance for the BCI model WW1030 pulse oximeter.

The BCI model WW1030 is a handheld pulse oximeter intended for continuous monitoring. The WW1030 monitors and displays patient functional oxygen saturation %SpO2, pulse rate, perfusion index, and pulse signal strength information. It is equipped with audible and visual patient alarms. The user interface includes a blue LED display, speaker, a 5-button keypad control, and an ON/OFF button.

The WW1030 comes with disposable batteries, a reusable pulse oximetry sensor with extension cable and relevant manuals. Optional accessories include other oximetry sensors, docking station, thermal printer (attaches to dock), rechargeable battery pack, universal mains AC charger, patient isolated USB cable, nurse call cables, universal mounting bracket and protective glove. The WW1030 is compatible with BCI oximetry sensors, Nellcor DS100A oximetry sensor and extension cables.

#### Indications for Use

The BC10 model WW1030 handheld pulse oximeter is intended to be used for continuous monitoring of a patient's functional oxygen saturation (%SpO2), pulse rate, pulse signal strength, and perfusion index readings. It is equipped with audible and visual alarms. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, emergency medical technicians, sleep technicians, clinicians and home users. The intended patient population ranges from neonatal to adult. It can be used on patients with

## FDA CDRH DMC

DEC 2 2008

Received

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low perfusion or during patient motion. The WW1030 may be used in the hospital or clinical environment, during emergency land transport and in the home.

#### 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 | Accuracy Testing (Section 9)<br>Benchtop Performance Testing (Section 9)<br>Software Documentation and Testing<br>(Section 8) |
| Electrical or Mechanical Failure | Electrical, Mechanical, and Environmental<br>Testing (Section 9) |
| Electromagnetic Interference | Electromagnetic Compatibility Testing<br>(Section 9) |
| Adverse Tissue Reactivity | Biocompatibility Information (Section 10) |
| Cross-contamination or Infection | Cleaning and Disinfection Testing (Section<br>9) |
| Improper Use | Labeling (Section 7) |

An in-depth risk management analysis, including mitigation measures, was performed on the BCI WW1030 system. The results are provided under Section 5.

#### Performance Testing

The BCI WW1030 pulse oximeter passed all performance bench top testing including EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity. Test reports, including test protocols, pass/fail criteria, results and conclusions, are provided under Section 9.

#### Clinical Testing

The Digital Micro Power OEM oximeter board (31402B2) is a satellite board capable of monitoring a patient's SpO2 level, pulse rate and plethysmogram waveform. The Digital Micro Power OEM oximeter board is the pulse oximetry board in the BCI WW1030 pulse oximeter. This board has undergone three separate desaturation clinical studies: Desat 37. Desat 38, and Desat 39. The intent of the Desat Studies 37 and 38 was to determine the SpO2 accuracy of the pulse oximeter module using various sensors over the range 70-100% SaO2 as determined by the reference CO-oximeter. The intent of Desat Study 39 was to obtain clinical data to determine the SpO2 accuracy over the range 70-100% SaO2 as determined by a reference CO-oximeter under controlled motion conditions.

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### Conclusion

Supporting information per this premarket submission confirms that the BCI® WW1030 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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY - 1 2009

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

Re: K083557

Trade/Device Name: BCI® Model WW1030 Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: December 1, 2008 Received: December 2, 2008

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 (QS) regulation (21 CFR Parl 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 Rinnes

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: K083557

Device Name: BCI Model® WW1030 Handheld Pulse Oximeter

Indications for Use: The BC1® Model WW1030 pulse oximeter is intended to be used for continuous monitoring of a patient's functional oxygen saturation (%SpO2), pulse rate, pulse signal strength, and pulse amplitude index readings. It is equipped with audible and visual alarms. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, emergency medical technicians, sleep technicians, clinicians and home use. The intended patient population ranges from neonatal to adult. It can be used on patients with low perfusion or during patient motion. The WW 1030 may be used in the hospital or clinical environment, during emergency land transport, and the home.

L. Schutte

(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dentai Devices

K08355 510(k) Number:

Prescription Use XXX (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)