(115 days)
Not Found
No
The summary describes a standard pulse oximeter with basic signal processing for SpO2 and pulse rate. There is no mention of AI, ML, or advanced algorithms beyond typical signal processing for motion artifact reduction.
No.
A pulse oximeter monitors and displays physiological parameters, it does not provide treatment or therapy.
Yes
Explanation: The device "monitors and displays a patient's functional oxygen saturation (%SpO2), pulse rate, pulse signal strength, and pulse amplitude index readings." These readings provide information about a patient's physiological state, which can be used by healthcare professionals to assess health, and therefore diagnose or monitor conditions.
No
The device description explicitly states it includes hardware components such as a blue LED display, 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 IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The BCI® model WW1020 pulse oximeter measures physiological parameters directly from the patient's body (functional oxygen saturation, pulse rate, etc.) using a sensor placed on the skin. It does not analyze samples taken from the body.
Therefore, the device's function falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The BCI® model WW1020 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 neonatal to adult. It can be used on patients with low perfusion or during patient motion. The WW1020 may be used in the hospital or clinical environment, during emergency land transport, and in the home.
Product codes (comma separated list FDA assigned to the subject device)
DQA, DPZ
Device Description
The aim of this submission is to obtain market clearance for the BCI model WW1020 pulse oximeter.
The BC10 model WW1020 pulse oximeter is intended for spot-check applications. The WW1020 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 blue LED display and an ON/OFF button.
The WW1020 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 glove. The WW1020 is compatible with BCT® oximetry sensors, Nellcor DS100A oximetry sensor, and extension cables.
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
neonatal 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 WW1020 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing
The BCI WW1020 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 WW1020 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Masimo SET Radical pulse oximeter (K040214), BCI® Autocorr model 3304 pulse oximeter (K070732), BCI® MiniCorr model 3402 pulse oximeter (K991410)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
APR 0 9 2009
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 March 27, 2009
BCI® model WW1020 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)
08 3705
Device Description:
The aim of this submission is to obtain market clearance for the BCI model WW1020 pulse oximeter.
The BC10 model WW1020 pulse oximeter is intended for spot-check applications. The WW1020 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 blue LED display and an ON/OFF button.
The WW1020 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
glove. The WW1020 is compatible with BCT® oximetry sensors, Nellcor DS100A oximetry sensor, and extension cables. ·
Indications for Use
The BCI® model WW1020 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 neonatal to adult. It can be used on patients with low perfusion
1
1
or during patient motion. The WW1020 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 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 WW1020 system. The results are provided under Section 5.
Performance Testing
The BCI WW1020 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 WW1020 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.
2
Conclusion
Supporting information per this premarket submission confirms that the BCI® WW1020 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is enclosed within a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 9 2009
Mr. Donald Alexander Director Regulatory Affairs Smiths Medical PM, Incorporated N7 W22025 Johnson Drive Waukesha, Wisconsin 53186-1856
Re: K083705
Trade/Device Name: BCI® Model WW1020 Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, DPZ Dated: March 27, 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.
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.
4
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 (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.
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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.
Anthony V. Araton for
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):_K083705
Device Name: BCI® Model WW1020 Pulse Oximeter
Indications for Use:
The BCI® model WW1020 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 neonatal to adult. It can be used on patients with low perfusion or during patient motion. The WW1020 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
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K083705 510(k) Number: -