(117 days)
No
The summary describes a standard pulse oximeter that measures and displays physiological parameters. There is no mention of AI, ML, or any advanced algorithms beyond standard signal processing for SpO2 and pulse rate calculation. The performance studies focus on clinical desaturation trials and comparison testing with existing technology, not on the evaluation of AI/ML model performance.
No.
This device is for monitoring and displaying physiological parameters, such as oxygen saturation and pulse rate, not for providing therapy or treatment.
Yes
Explanation: The device monitors and displays patient physiological parameters such as oxygen saturation and pulse rate, which are used to assess a patient's condition. While it doesn't offer alarms, the provision of these measurements to medical professionals and home users for spot-checking and assessment aligns with the function of a diagnostic tool.
No
The device description explicitly mentions hardware components such as a red LED display, an ON/OFF button, disposable AA batteries, and a reusable pulse oximetry sensor. It also lists optional hardware accessories.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). This device, a pulse oximeter, measures physiological parameters on the human body (oxygen saturation and pulse rate) using a non-invasive sensor placed on the finger or other body part.
- The description focuses on measuring vital signs directly from the patient. There is no mention of collecting or analyzing biological samples.
Therefore, the BCI® model WW1000 handheld pulse oximeter falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
DQA, DPZ
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
infant to adult
Intended User / Care Setting
It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, emergency medical technicians, sleep technicians, clinicians, and home users. The WW1000 may be used in the hospital or clinical environment, during emergency land transport, and in the home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Benchtop 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. 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. Complete desaturation test reports for Desat 24, 27 and 40 and applicable project file memos can be found in Section 11.
Key Metrics
Not Found
Predicate Device(s)
Masimo SET Radical pulse oximeter (K040214), BCI® Autocorr model 3304 pulse oximeter (K070732), BCI® MiniCorr model 3402 pulse oximeter (K991410)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 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
Indications for Use
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.
1
1
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 Environmental |
| Testing (Section 9) | |
| Electromagnetic Interference | Electromagnetic Compatibility Testing |
| (Section 9) | |
| Adverse Tissue Reactivity | Biocompatibility Information (Section 10) |
| Cross-contamination or Infection | Cleaning and Disinfection Testing (Section |
-
|
| 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.
2
2
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.
3
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.
4
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
5
Indications for Use
510(k) Number (if known):
Device Name: BCI® Model WW1000 Pulse Oximeter
Indications for Use: .. .
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.
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