(134 days)
The Reprocessed LNCS Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Reprocessed LNCS Oximetry Sensors are fully compatible disposable sensors for use with Masimo SET and Masimo SET compatible pulse oximeter monitors. The Reprocessed LNCS Oximetry Sensors , are also compatible with Nellcor compatible pulse oximeter monitors.
The provided 510(k) summary describes the acceptance criteria and testing for Reprocessed LNCS Oximetry Sensors.
The central focus of the submission is to demonstrate substantial equivalence to existing predicate devices (Reprocessed LNCS Oximetry Sensors, 510(k) No. K083719), emphasizing that the new devices have the "same specifications."
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are the claimed accuracy ranges for SpO2 and pulse rate under various conditions, which are stated to be "the same specifications as the predicate devices." The device performance is implicitly stated to meet these criteria, as the conclusion is that the devices are "equivalent" and "met all design specifications."
| Measurement | Acceptance Criteria (Accuracy Range) | Reported Device Performance (within range) |
|---|---|---|
| SpO2, no motion (Masimo technology) | 70-100%, ± 2% (infant), ± 3% (neonatal) | Met |
| SpO2, motion (Masimo technology) | 70-100%, ± 3% | Met |
| SpO2, low perfusion (Masimo technology) | 70-100%, ± 2% (infant), ± 3% (neonatal) | Met |
| Pulse rate, no motion (Masimo technology) | 25-240 bpm, ± 3 bpm | Met |
| Pulse rate, motion (Masimo technology) | 25-240 bpm, ± 5 bpm | Met |
| Pulse rate, low perfusion (Masimo technology) | 25-240 bpm, ± 3 bpm | Met |
| SpO2, no motion (Nellcor technology) | 70-100%, ± 2% (infant), ± 3% (neonatal) | Met |
| Pulse rate, no motion (Nellcor technology) | 25-240 bpm, ± 3 bpm | Met |
2. Sample size used for the test set and the data provenance
The document indicates "performance testing including bench accuracy testing." However, the specific sample sizes for these tests are not provided. The data provenance (e.g., country of origin, retrospective/prospective) is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the summary. The tests described are non-clinical (bench accuracy, biocompatibility, etc.), which typically do not involve human experts to establish ground truth in the same way clinical trials for diagnostic algorithms would. For oximetry devices, ground truth for SpO2 is usually established by a co-oximeter in controlled desaturation studies, which are not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The testing described is non-clinical performance and bench testing, not a clinical study involving human reviewer adjudication of cases.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an oximeter sensor, not an AI-powered diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, "bench accuracy testing" falls under standalone testing, demonstrating the device's inherent performance. The results "demonstrated that the Reprocessed LNCS Oximetry Sensors are equivalent to the predicate devices" and "met all design specifications."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For "bench accuracy testing" of oximeter sensors, the ground truth for SpO2 measurements would typically be established using a co-oximeter in a controlled calibration or desaturation study setting. For pulse rate, a calibrated physiological simulator or ECG would typically be used. This specific detail is not explicitly stated but is the standard for such devices.
8. The sample size for the training set
Not applicable. This device is a reprocessed sensor, and the testing described is verification against specifications and predicate device equivalence, not the training of an algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no algorithm training set discussed for this device.
{0}------------------------------------------------
510(k) SUMMARY
MAY 1 4 2010 :
| Submitted by: | Masimo Corporation40 Parker, Irvine, CA 92618Phone: 949-297-7000; Fax: 949-297-7592 |
|---|---|
| Company Contact: | Marguerite Thomlinson, Manager of Regulatory Affairs |
| Date Summary Prepared: | May 6, 2010 |
| Trade Name | Reprocessed LNCS Oximetry Sensors |
| Common Name | Oximeter Sensor |
| Regulation Number: | 21 CFR 870.2700 |
| Regulation Name/ Product Code: | Oximeter/ NLF, DQA |
| Substantially Equivalent Devices: | Reprocessed LNCS Oximetry Sensors, 510(k) No. K083719 |
Device Description
The Reprocessed LNCS Oximetry Sensors are fully compatible disposable sensors for use with Masimo SET and Masimo SET compatible pulse oximeter monitors. The Reprocessed LNCS Oximetry Sensors , are also compatible with Nellcor compatible pulse oximeter monitors.
Intended Use/ Indications for Use
The Reprocessed LNCS Sensors are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpQ2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
Comparison to Predicate Device
The sensors in this filing are the same in design, performance, and principle of operations, as the respective predicate sensors (K083719). The main difference is that the predicate devices have replaceable tapes and the pending sensors do not have replaceable tapes.
The predicate sensors and the corresponding Reprocessed LNCS Oximetry Sensors in this filing are:
| Predicate Reprocessed LNCSSensors in K083719 | Reprocessed LNCS Oximetry Sensors |
|---|---|
| Infant single-use sensor:Reprocessed LNCS InfReprocessed LNCS Inf-3 | Infant single-use sensor:Reprocessed LNCS Inf-LReprocessed LNCS Inf-L-3 |
| Neonatal single-use sensor:Reprocessed LNCS NeoReprocessed LNCS Neo-3 | Neonatal single-use sensor:Reprocessed LNCS Neo-LReprocessed LNCS Neo-L-3 |
| Neonatal single-use sensor:Reprocessed LNCS NeoPtReprocessed LNCS NeoPt-3 | Neonatal single-use sensor:Reprocessed LNCS NeoPt-LReprocessed LNCS NeoPt-L-3 |
{1}------------------------------------------------
510(k) SUMMARY
| Measurement | AccuracyRange | Accuracy:Reprocessed LNCSinfant sensors | Accuracy:Reprocessed LNCSneonatal sensors |
|---|---|---|---|
| SpO2, no motion(Masimo technology) | 70-100% | $\pm$ 2% | $\pm$ 3% |
| SpO2, motion(Masimo technology) | 70-100% | $\pm$ 3% | $\pm$ 3% |
| SpO2, low perfusion(Masimo technology) | 70-100% | $\pm$ 2% | $\pm$ 3% |
| Pulse rate, no motion(Masimo technology) | 25-240 bpm | $\pm$ 3 bpm | $\pm$ 3 bpm |
| Pulse rate, motion(Masimo technology) | 25-240 bpm | $\pm$ 5 bpm | $\pm$ 5 bpm |
| Pulse rate, low perfusion(Masimo technology) | 25-240 bpm | $\pm$ 3 bpm | $\pm$ 3 bpm |
| SpO2, no motion(Nellcor technology) | 70-100% | $\pm$ 2% | $\pm$ 3% |
| Pulse rate, no motion(Nellcor technology) | 25-240 bpm | $\pm$ 3 bpm | $\pm$ 3 bpm |
The sensors in this filing have the same specifications as the predicate devices, which are as following:
Test Summary
The following non-clinical testing was conducted to verify that the Reprocessed LNCS Sensors met all design specifications: biocompatibility testing including cytotoxicity, sensitization, and skin irritation testing; performance testing including bench accuracy testing including process validation of the sterilization procedures, and visual and validated functional testing of all products; and environmental testing including device packaging validation.
Conclusion
The results demonstrated that the Reprocessed LNCS Oximetry Sensors are equivalent to the predicate devices.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Public Health Service
MAY 1 4 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Marguerite Thomlinson Manager of Regulatory Affairs Masimo Corporation 40 and 50 Parker Irvine, California 92618
Re: K094046
Trade/Device Name: Masimo LNCS Oximetry Sensors, Masimo Reprocessed LNCS Oximetry Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Il Product Code: DQA Dated: April 12, 2010 Received: April 14, 2010
Dear Ms. Thomlinson:
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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
{3}------------------------------------------------
Page 2- Ms. Thomlinson
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours:
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
| 510(k) Number (if known): | |
|---|---|
| --------------------------- | -- |
Masimo Reprocessed LNCS Oximetry Sensors Device Name:
Indications For Use:
The Reprocessed LNCS Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
Prescription Use (Per 21 CFR 801.109 Subpart D)
AND/OR
Over-The-Counter Use (Per 21 CFR 801,109 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schuller
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devic
510(k) Number: K094046
§ 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).