(150 days)
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.
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.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria for the SpO2 accuracy tests. However, it implicitly suggests that the device passed these tests. For pulse oximeters, the FDA typically requires accuracy within a certain range (e.g., ±2-3% SpO2) compared to a co-oximeter. Given that the device received 510(k) clearance, it implies that the device met the established accuracy requirements, even if the specific numerical criteria for passing are not detailed in this summary.
| Acceptance Criteria (Implied for Pulse Oximeters) | Reported Device Performance |
|---|---|
| SpO2 Accuracy (e.g., within ±X% compared to reference co-oximeter) | Passed desaturation clinical studies (Desat 37, 38, 39) to determine SpO2 accuracy over the range 70-100% SaO2. |
| Performance in low perfusion conditions | Can be used on patients with low perfusion (stated in Indications for Use). Accuracy implicitly met in studies. |
| Performance during patient motion | Can be used during patient motion (stated in Indications for Use). Desat Study 39 specifically obtained clinical data to determine SpO2 accuracy under controlled motion conditions. |
| Mechanical Durability, Electrical Safety, EMC, etc. | Passed all performance bench top testing including EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity. |
| Biocompatibility | Biocompatibility Information (Section 10) indicates this risk was addressed. |
| Sterilization/Cleaning | Cleaning and Disinfection Testing (Section 9) indicates this risk was addressed. |
2. Sample Size Used for the Test Set and Data Provenance
The exact sample sizes for the "Desat 37, Desat 38, and Desat 39" studies are not explicitly stated in the provided text.
The data provenance is clinical testing, presumably conducted in a controlled environment as indicated by "desaturation clinical studies." The country of origin is not specified but it relates to FDA submission, so likely US or through an international standard applicable to FDA. The studies appear to be prospective as they were designed specifically to determine the SpO2 accuracy of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The text states that the SpO2 accuracy was determined "as determined by the reference CO-oximeter." This implies that the ground truth for oxygen saturation levels was established by a co-oximeter, which is a laboratory device, not by human experts. Therefore, the concept of "number of experts" and "qualifications of those experts" for establishing ground truth in this context is not applicable as scientific instrumentation provided the reference.
4. Adjudication Method for the Test Set
Since the ground truth was established by a reference co-oximeter, there was no human adjudication method required for the primary physiological parameter (SpO2). The co-oximeter directly provided the reference values for comparison.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done based on the provided text. This type of study is more common for diagnostic imaging AI algorithms where human interpretation is a primary component. The device in question is a pulse oximeter, and its performance is evaluated against a gold standard (co-oximeter), not against human readers. Therefore, there's no mention of how much human readers improve with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, the performance studies described are essentially standalone (algorithm only) performance assessments. The device (specifically, its internal Digital Micro Power OEM oximeter board) was directly evaluated against a reference co-oximeter to determine its SpO2 accuracy. The accuracy determined was of the device itself, providing objective measurements, not an assessment of human-in-the-loop performance.
7. The Type of Ground Truth Used
The type of ground truth used for SpO2 accuracy was established by a reference CO-oximeter. This is akin to a "laboratory gold standard" or "scientific instrumentation gold standard" rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
The provided text does not mention a training set or its sample size. This is common for devices that are not "AI" in the modern sense of machine learning algorithms requiring explicit training data. The BCI model WW1030 pulse oximeter relies on established physiological principles and signal processing, and while its internal algorithms are likely sophisticated, they are not described as being "trained" in the typical machine learning paradigm. The studies aim to validate the device's accuracy after its design and development are complete.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, the establishment of ground truth for a training set is not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows a handwritten string of alphanumeric characters. The string appears to be "K08 3357". The characters are written in a simple, slightly slanted style, with some variation in line thickness.
510(k) Summary of Safety and Effectiveness
| Manufacturer: | Smiths Medical |
|---|---|
| Address: | N7 W22025 Johnson DriveWaukesha, WI 53186 |
| MAY - 1 2009 | |
| Telephone Number: | (262) 542-3100 |
| Fax Number: | (262) 542-3325 |
| Contact Person: | Donald AlexanderDirector 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)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 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
{1}------------------------------------------------
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)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 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.
{2}------------------------------------------------
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.
{3}------------------------------------------------
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
{4}------------------------------------------------
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 (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 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
{5}------------------------------------------------
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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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).