The BCI® model WW1000 handheld pulse oximeter is intended for spot-checking applications (non-continuous use). It monitors and displays a patient's functional oxygen saturation (%SpO2), pulse rate, pulse signal strength, and pulse amplitude index readings. 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 infant to adult. It can be used on patients with low perfusion. The WW1000 may be used in the hospital or clinical environment, during emergency land transport, and in the home.

Device Description

The BCI® model WW1000 handheld pulse oximeter is intended for spot-check applications. The WW1000 monitors and displays patient functional oxygen saturation (%SpO2), pulse rate, pulse amplitude index, and pulse signal strength information. It does not have audible or visual patient alarms. The user interface includes a red LED display and an ON/OFF button. The WW1000 comes with disposable AA batteries, the 3044S reusable pulse oximetry sensor 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, universal mounting bracket and protective

AI/ML Overview

The provided text describes the BCI® model WW1000 Pulse Oximeter, its intended use, and the performance testing conducted to support its substantial equivalence. However, it does not explicitly state specific, quantifiable acceptance criteria in the form of a table for device performance (e.g., accuracy +/- X% with Y% confidence). Instead, it refers to general performance expectations and the results of clinical desaturation studies.

Thus, I will synthesize the information provided to construct a response that best addresses your request, highlighting what is available and what is not.

Here's an analysis of the acceptance criteria and study information for the BCI® model WW1000 Pulse Oximeter, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state a table of quantifiable acceptance criteria with specific thresholds for accuracy, precision, or other performance metrics. Instead, it broadly states that "Results of the three individual clinical desaturation trials indicate that the WW1000 pulse oximeter performs as intended and is safe and effective for use." and that "The Micro-power OEM board produced the same readings (within ±1 digit) in all three host devices" during comparison testing.

Without explicit acceptance criteria, it's impossible to create a direct comparison table. However, the document does imply that the device performance was deemed acceptable based on the clinical desaturation studies (Desat 24, 27, and 40) and comparison testing, which confirmed the expected functionality and consistency across different host devices.

Implied Acceptance Criterion (based on comparison testing):

Deviation between Micro-power OEM board and host devices: <= ±1 digit for SpO2 and Pulse Rate readings.

Reported Device Performance:

The Micro-power OEM board, which provides the complete SpO2 and Pulse Rate measurement for the WW1000, produced readings within ±1 digit across the Evaluation Kit (3375), OxiLink-I, and WW1000 host devices.
The clinical desaturation trials (Desat 24, 27, and 40) for the 31392B1 oximeter board (the core measurement component) indicated that the WW1000 pulse oximeter performs as intended and is safe and effective for use.

2. Sample Size for the Test Set and Data Provenance

Sample Size (Clinical Desaturation Studies): The document mentions "three individual clinical desaturation trials" (Desat 24, Desat 27, and Desat 40) for the 31392B1 oximeter board. However, the specific number of subjects/cases used in each of these trials (i.e., the sample size for the test set) is not provided in this summary. Complete desaturation test reports in Section 11 are referenced as containing this detail, but are not included here.
Data Provenance: The studies are clinical desaturation studies, implying a prospective and controlled environment where patient oxygen levels are intentionally varied. The country of origin is not specified but given the manufacturer (Smiths Medical, USA) and the FDA submission, it's likely the studies were conducted in the USA or a region with comparable regulatory standards. The studies were conducted in July 2002 (Desat 24), September 2003 (Desat 27), and 2007/2008 (Desat 40).

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used to establish the ground truth for the clinical desaturation studies, nor does it explicitly state their qualifications.
For pulse oximetry, the "ground truth" for oxygen saturation is typically established by arterial blood gas (ABG) analysis (co-oximetry) performed by trained clinical laboratory personnel. While experts (e.g., medical staff overseeing the study) are involved in patient management and data collection, the ground truth itself is an objective measurement from a reference device (co-oximeter).

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. This detail is usually relevant for studies involving subjective interpretations (e.g., image analysis by multiple readers). For objective measurements like pulse oximetry compared to co-oximetry, the ground truth is typically a direct measurement, not an expert consensus requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The device is a pulse oximeter, not an AI-assisted diagnostic tool that would typically involve multiple human readers interpreting results. The studies focused on the accuracy of the device's measurements against a gold standard.

6. Standalone Performance Study

Yes, a standalone performance study was done. The clinical desaturation studies (Desat 24, 27, and 40) evaluated the accuracy of the 31392B1 oximeter board (which forms the core of the WW1000) by comparing its SpO2 readings directly against a "ground truth" (presumably arterial blood co-oximetry). The comparison testing among the Evaluation Kit, OxiLink-I, and WW1000 host devices also assessed the standalone measurement consistency of the OEM board across different integrations.

7. Type of Ground Truth Used

For the clinical desaturation studies, the ground truth for oxygen saturation (%SpO2) is inherently established by arterial blood gas analysis (co-oximetry), which is considered the gold standard for measuring arterial oxygen saturation. This is standard practice for pulse oximeter accuracy testing.

8. Sample Size for the Training Set

The document describes the device as a pulse oximeter, which traditionally relies on established physiological algorithms and optical principles rather than machine learning or AI models that require "training sets" in the conventional sense. Therefore, no "training set" sample size is applicable or mentioned in this context. The "hardware and software enhancements" mentioned for Desat 40 were likely algorithm refinements based on engineering principles and prior testing, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

As concluded in point 8, the concept of a "training set" for an AI algorithm is not applicable here. The device's underlying algorithms are based on established physiological models and signal processing, not a machine learning training process that requires a labeled dataset to learn patterns.

Summary

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K05-3787

510(k) Summary of Safety and Effectiveness

Manufacturer: Address:

Telephone Number:

Fax Number:

Contact Person:

Date Prepared:

Proprietary Name:

Common/Classification Name: Product Code:

Regulation Number: Predicate Devices:

Smiths Medical N7 W22025 Johnson Drive Waukesha, WI 53186

(262) 542-3100

(262) 542-3325

Donald Alexander Director Regulatory Affairs December 1, 2008

BCI® model WW1000 Pulse Oximeter

Pulse Oximeter DQA

870.2700 (Class II) Masimo SET Radical pulse oximeter (K040214) BCI® Autocorr model 3304 pulse oximeter (K070732) BCI® MiniCorr model 3402 pulse oximeter (K991410)

Device Description:

The aim of this submission is to obtain market clearance for the BCI model WW1000 pulse oximeter.

The WW1000 comes with disposable AA batteries, the 3044S reusable pulse oximetry sensor 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, universal mounting bracket and protective

Indications for Use

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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 11)Benchtop Performance Testing (Section 9)Software Documentation and Testing(Section 8)
Electrical or Mechanical Failure	Electrical, Mechanical, and EnvironmentalTesting (Section 9)
Electromagnetic Interference	Electromagnetic Compatibility Testing(Section 9)
Adverse Tissue Reactivity	Biocompatibility Information (Section 10)
Cross-contamination or Infection	Cleaning and Disinfection Testing (Section9)
Improper Use	Labeling (Section 7)

An in-depth risk management analysis, including mitigation measures, was performed on the BCI WW1000 system. The results are provided under Section 5.

Performance Testing

The BCI WW1000 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 WW1000 pulse oximeter utilizes an existing oximeter daughter-board (Micro-power OEM board 31392B1) that provides the complete measurement of SpO2 and Pulse Rate (PR) and digitally transmits the calculated values to a host device. The 31392B2 oximeter daughter-board underwent three clinical desaturation studies; two trials (Desat 24 and Desat 27) used the Micro-power OEM Board Evaluation kit (3375) with additional optoisolation of the communication signals, and one (Desat 40) used the OxiLink-I host device which provides signal isolation.

Comparison testing among the Evaluation Kit (3375). OxiLink-I and WW1000 host devices was performed to demonstrate that all three systems produce the same readings under identical simulator settings. Results indicate that the Micro-power OEM board produced the same readings (within ±1 digit) in all three host devices.

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The 31392B1 oximeter board underwent clinical desaturation study Desat 24 in July 2002 and Desat 27 in September 2003. In 2007/2008, hardware and software enhancements were made to the 31392B1 board to extend its operation over a wider range of perfusion index values and improve lower perfusion performance. Desat 40 was performed with the intent of verifying that these enhancements did not adversely affect SpO2 accuracy.

Results of the three individual clinical desaturation trials indicate that the WW1000 pulse oximeter performs as intended and is safe and effective for use. Please find complete desaturation test reports for Desat 24, 27 and 40 and applicable project file memos in Section 11.

Conclusion

Supporting information per this premarket submission confirms that the BC1® WW1000 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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 5 2009

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

Re: K083787

Trade/Device Name: BCI® Model WW1000 Pulse Oximeter Regulation Number: 21 CFR 880.2700 Regulatory Class: II Product Code: DQA, DPZ Dated: March 26, 2009 Received: March 30, 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.

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); 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 Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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Page 2- Mr. Alexander

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Runne
S. Susan Runne, DDS, MA

-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: BCI® Model WW1000 Pulse Oximeter

Indications for Use: .. .

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

Susan Rums
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: KCS

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
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.(b)
Classification. Class II (performance standards).