(134 days)
Not Found
No
The summary describes a reprocessed pulse oximetry sensor and its performance characteristics, with no mention of AI or ML technology.
No.
The device is indicated for monitoring purposes (diagnosis), not for treating a disease or condition.
Yes
The device is indicated for "continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," which are measurements obtained to assess a patient's physiological state and aid in diagnosis.
No
The device description explicitly states it is a "disposable sensor" and the performance testing includes "biocompatibility testing" and "process validation of the sterilization procedures," which are indicative of a physical hardware device, not software.
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. The intended use and device description clearly state that this device is a sensor for continuous noninvasive monitoring of physiological parameters (SpO2 and pulse rate) on the patient. It does not involve collecting and analyzing samples like blood, urine, or tissue.
- The testing described is focused on device performance and biocompatibility on the patient. The performance studies and key metrics relate to the accuracy of the sensor's measurements when applied to a patient, not the analysis of biological samples.
Therefore, the Reprocessed LNCS Sensors are a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NLF, DQA
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.
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
adult, pediatric, infant, and neonatal patients
Intended User / Care Setting
hospitals, hospital-type facilities, mobile, and home environments.
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)
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.
The results demonstrated that the Reprocessed LNCS Oximetry Sensors are equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2, no motion (Masimo technology): Accuracy 70-100%, +/- 2% (infant), +/- 3% (neonatal)
SpO2, motion (Masimo technology): Accuracy 70-100%, +/- 3% (infant), +/- 3% (neonatal)
SpO2, low perfusion (Masimo technology): Accuracy 70-100%, +/- 2% (infant), +/- 3% (neonatal)
Pulse rate, no motion (Masimo technology): 25-240 bpm, +/- 3 bpm (infant), +/- 3 bpm (neonatal)
Pulse rate, motion (Masimo technology): 25-240 bpm, +/- 5 bpm (infant), +/- 5 bpm (neonatal)
Pulse rate, low perfusion (Masimo technology): 25-240 bpm, +/- 3 bpm (infant), +/- 3 bpm (neonatal)
SpO2, no motion (Nellcor technology): 70-100%, +/- 2% (infant), +/- 3% (neonatal)
Pulse rate, no motion (Nellcor technology): 25-240 bpm, +/- 3 bpm (infant), +/- 3 bpm (neonatal)
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.
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
510(k) SUMMARY
MAY 1 4 2010 :
| Submitted by: | Masimo Corporation
40 Parker, Irvine, CA 92618
Phone: 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 LNCS
| Sensors in K083719 | Reprocessed LNCS Oximetry Sensors |
|---|---|
| Infant single-use sensor: | |
| Reprocessed LNCS Inf | |
| Reprocessed LNCS Inf-3 | Infant single-use sensor: |
| Reprocessed LNCS Inf-L | |
| Reprocessed LNCS Inf-L-3 | |
| Neonatal single-use sensor: | |
| Reprocessed LNCS Neo | |
| Reprocessed LNCS Neo-3 | Neonatal single-use sensor: |
| Reprocessed LNCS Neo-L | |
| Reprocessed LNCS Neo-L-3 | |
| Neonatal single-use sensor: | |
| Reprocessed LNCS NeoPt | |
| Reprocessed LNCS NeoPt-3 | Neonatal single-use sensor: |
| Reprocessed LNCS NeoPt-L | |
| Reprocessed LNCS NeoPt-L-3 |
1
510(k) SUMMARY
| Measurement | Accuracy
Range | Accuracy:
Reprocessed LNCS
infant sensors | Accuracy:
Reprocessed LNCS
neonatal 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