(134 days)
The M-LNCS Sensors are indicated for the continuous non-invasive 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 conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.
The Reprocessed M-LNCS Sensors are indicated for the continuous non-invasive 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 M-LNCS and Reprocessed M-LNCS Oximetry Sensors are fully compatible disposable sensors for use with instruments which include or compatible with the following technologies:
- · Masimo SET technology
- · Masimo Rainbow SET technology
- · Nellcor technology
The M-LNCS series has been validated with Masimo SET Oximetry Technology and on Nellcor's N-200 Pulse Oximeter. The saturation accuracy of the Neonate and Preterm sensors were validated on adult volunteers and 1% was added to account for properties of fetal hemoglobin.
Here's an analysis of the provided text regarding the acceptance criteria and study data for the Masimo M-LNCS Oximetry Sensors:
Important Note: The provided document is a 510(k) summary, which often summarizes the results of studies rather than detailing the full study methodology. As such, some specific details like exact sample sizes for each test, data provenance in terms of country of origin for all tests, specific ground truth establishment for all parameters, and multi-reader multi-case study details are not fully elaborated in this summary.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are presented as the accuracy specifications for SpO2 and pulse rate under different conditions (no motion, motion, low perfusion) and for different patient populations (adult/pediatric/infant, neonatal). The study's reported performance is implied by the statement that the sensors "met all design specifications" and "are as safe and effective as the legally marketed predicate devices." Therefore, the reported performance aligns with the specified accuracy ranges.
| Parameter | Accuracy Range | Acceptance Criteria (Adult/Pediatric/Infant) | Reported Device Performance (Adult/Pediatric/Infant) | Acceptance Criteria (Neonatal) | Reported Device Performance (Neonatal) |
|---|---|---|---|---|---|
| Masimo Technology | |||||
| SpO2, no motion | 70-100% | ± 2% | Meets ± 2% | ± 3% | Meets ± 3% |
| SpO2, motion | 70-100% | ± 3% | Meets ± 3% | ± 3% | Meets ± 3% |
| SpO2, low perfusion | 70-100% | ± 2% | Meets ± 2% | ± 3% | Meets ± 3% |
| Pulse rate, no motion | 25-240 bpm | ± 3 bpm | Meets ± 3 bpm | ± 3 bpm | Meets ± 3 bpm |
| Pulse rate, motion | 25-240 bpm | ± 5 bpm | Meets ± 5 bpm | ± 5 bpm | Meets ± 5 bpm |
| Pulse rate, low perfusion | 25-240 bpm | ± 3 bpm | Meets ± 3 bpm | ± 3 bpm | Meets ± 3 bpm |
| Nellcor Technology | |||||
| SpO2, no motion | 70-100% | ± 2% | Meets ± 2% | ± 3% | Meets ± 3% |
| Pulse rate, no motion | 25-240 bpm | ± 3 bpm | Meets ± 3 bpm | ± 3 bpm | Meets ± 3 bpm |
2. Sample Size Used for the Test Set and Data Provenance
The document states that the saturation accuracy of the Neonate and Preterm sensors were validated on adult volunteers. However, it does not specify the sample size for this validation or for other tests. The provenance is implied to be human subject testing for some aspects (adult volunteers) but no geographical location is specified. The studies are non-clinical, implying they were prospective tests conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of "experts" to establish ground truth in the context of radiologists or similar medical specialists. For oximetry, ground truth is typically established by reference devices or methods (e.g., co-oximetry for SpO2, ECG for pulse rate).
4. Adjudication Method for the Test Set
Not applicable. Adjudication is typically used for subjective diagnoses or interpretations by multiple readers. For oximetry accuracy, the comparison is to a definitive reference standard, not expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or subjective interpretation tasks where the performance of human readers, with and without AI assistance, is evaluated. Oximetry sensor evaluation focuses on the accuracy of the device itself against physiological parameters.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the testing described appears to be standalone performance of the device. The "performance testing including bench accuracy testing" and the validation on "adult volunteers" for saturation accuracy are tests of the device's ability to measure physiological parameters independently.
7. The Type of Ground Truth Used
For saturation accuracy, the ground truth for neonatal/preterm sensors was established by validation on adult volunteers, where a "1% was added to account for properties of fetal hemoglobin." This implies that the ground truth for SpO2 was likely established using a reference co-oximeter on the adult volunteers. For pulse rate, the ground truth would typically be from an ECG or similar gold standard. The other tests, such as "bench accuracy testing," would use simulated physiological signals or phantoms.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. Oximetry sensors traditionally rely on algorithms based on physiological principles and empirical data, not typically large-scale machine learning training sets in the modern sense. The validation studies mentioned would be more akin to "test sets" for verifying the device's performance against established criteria.
9. How the Ground Truth for the Training Set Was Established
As no explicit training set for an AI algorithm is mentioned, the method for establishing ground truth for a training set is not applicable based on the provided text. The device's underlying technology (Masimo SET, Masimo Rainbow SET, Nellcor technology) already incorporates established algorithms for signal processing and SpO2/pulse rate calculation.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows a handwritten string of characters, "KW10723". The characters are written in black ink on a white background. The handwriting is somewhat stylized, with the numbers being more rounded than the letters.
510(k) SUMMARY
JUL 28 2011
| Submitted by: | Masimo Corporation40 Parker, Irvine, CA 92618Phone: 949-297-7000Fax: 949-297-7592 |
|---|---|
| Company Contact: | Anil Bhalani, Director of Regulatory Affairs |
| Date Summary Prepared: | May 11, 2011 |
| Trade Name | M-LNCS and Reprocessed M-LNCS Oximetry Sensors |
| Requlation Number: | 21 CFR 870.2700 |
| Regulation Class: | Class II |
| Regulation Name: | Oximeter |
| Common Name: | Oximeter Sensor |
| Product Code: | NLF, DQA, DSA |
| Substantially Equivalent Devices: | Masimo LNCS/M-LNCS Oximetry Sensors, 510(k) No. K101896LNCS Oximetry Sensors-Sterile, 510(k) No. K083622Reprocessed LNCS Oximetry Sensors, 510(k) No. K083719 |
Device Description
The M-LNCS and Reprocessed M-LNCS Oximetry Sensors are fully compatible disposable sensors for use with instruments which include or compatible with the following technologies:
- · Masimo SET technology
- · Masimo Rainbow SET technology
- · Nellcor technology
The M-LNCS series has been validated with Masimo SET Oximetry Technology and on Nellcor's N-200 Pulse Oximeter. The saturation accuracy of the Neonate and Preterm sensors were validated on adult volunteers and 1% was added to account for properties of fetal hemoglobin.
Intended Use/ Indications for Use
The M-LNCS Sensors are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpQ2 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 hospital-type facilities, mobile, and home environments.
The Reprocessed M-LNCS Sensors are indicated for the continuous non-invasive monitoring of functional oxvgen 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 hospital-type facilities, mobile, and home environments.
Comparison to Predicate Devices
The predicate devices used in this filing are:
K110723-M-LNCS Sensors June 2011, Page 5 of 35
{1}------------------------------------------------
510(k) SUMMARY
- LNCS Oximetry Sensors-Sterile, 510(k) No. K083622 .
- Reprocessed LNCS Oximetry Sensors, 510(k) No. K083719 .
The sensors in this filing are substantially equivalent to the predicate sensors in the indication for use/intended use. In addition, they have the same performance and principle of operations, and are subjected to the same processes for sterile (ethylene oxide sterilization) and reprocessing as the respective predicate sensors in the cleared K083719 filings. The main difference is that the sensors in this filing have a different interfacing connector in comparison to the predicates.
Predicate Devices
Table 1 - Oximetry Sensors, Sterile
| M-LNCS Oximetry Sensors(Single-Use and Sterile) | Predicate LNCS Oximetry Sensors(Single-Use and Sterile) in K083622 |
|---|---|
| M-LNCS Adtx-3: Adult Adhesive Sensor | LNCS Adtx-3 |
| M-LNCS Pdtx-3: Pediatric Adhesive Sensor | LNCS Pdtx-3 |
| M-LNCS Inf-3: Infant Adhesive Sensor | LNCS Inf-3 |
| M-LNCS Neo-3: Neonatal Adhesive Sensor | LNCS Neo-3 |
| M-LNCS NeoPt-3: Neonatal Adhesive Sensor | LNCS NeoPt-3 |
| M-LNCS NeoPt-500: Neonatal Adhesive Sensor | LNCS NeoPt-500 |
Table 2 - Oximetry Sensors, Reprocessed
| Reprocessed M-LNCS (Single-Use) Sensors | Predicate Reprocessed LNCS(Single-Use) Sensors in K083719 |
|---|---|
| Reprocessed M-LNCS Adtx: Adult Adhesive Sensor | Reprocessed LNCS Adtx |
| Reprocessed M-LNCS Adtx-3: Adult Adhesive Sensor | Reprocessed LNCS Adtx-3 |
| Reprocessed M-LNCS Pdtx: Pediatric Adhesive Sensor | Reprocessed LNCS Pdtx |
| Reprocessed M-LNCS Pdtx-3: Pediatric Adhesive Sensor | Reprocessed LNCS Pdtx-3 |
| Reprocessed M-LNCS Inf: Infant Adhesive Sensor | Reprocessed LNCS Inf |
| Reprocessed M-LNCS Inf-3: Infant Adhesive Sensor | Reprocessed LNCS Inf-3 |
| Reprocessed M-LNCS Neo: Neonatal Adhesive Sensor | Reprocessed LNCS Neo |
| Reprocessed M-LNCS Neo-3: Neonatal Adhesive Sensor | Reprocessed LNCS Neo-3 |
| Reprocessed M-LNCS NeoPt: Neonatal Adhesive Sensor | Reprocessed LNCS NeoPt |
| Reprocessed M-LNCS NeoPt-3: Neonatal Adhesive Sensor | Reprocessed LNCS NeoPt-3 |
| Reprocessed M-LNCS NeoPt-500: Neonatal Adhesive Sensor | Reprocessed LNCS NeoPt-500 |
Table 3 - Sensor Specifications for Sterile and Reprocessed M-LNCS Sensors
| Accuracy Range | Accuracy:Adult/ Pediatric/ Infant | Accuracy:Neonatal | |
|---|---|---|---|
| Masimo Technology | |||
| SpO2, no motion | 70-100% | $\pm$ 2% | $\pm$ 3% |
| SpO2, motion | 70-100% | $\pm$ 3% | $\pm$ 3% |
| SpO2, low perfusion | 70-100% | $\pm$ 2% | $\pm$ 3% |
| Pulse rate, no motion | 25-240 bpm | $\pm$ 3 bpm | $\pm$ 3 bpm |
| Pulse rate, motion | 25-240 bpm | $\pm$ 5 bpm | $\pm$ 5 bpm |
| Pulse rate, low perfusion | 25-240 bpm | $\pm$ 3 bpm | $\pm$ 3 bpm |
| Nellcor Technology | |||
| SpO2, no motion | 70-100% | $\pm$ 2% | $\pm$ 3% |
| Pulse rate, no motion | 25-240 bpm | $\pm$ 3 bpm | $\pm$ 3 bpm |
K110723-M-LNCS Sensors June 2011, Page 6 of 35
{2}------------------------------------------------
510(k) SUMMARY
Test Summary
The following non-clinical testing was conducted and verifies that the sterile and reprocessed M-LNCS Oximetry Sensors met all design specifications: biocompatibility testing, in-house and laboratory validation testing on the sensors after they have been subjected to ethylene oxide sterilization (EO) or the sensors have been reprocessed and subjected to EO sterilization, performance testing including bench accuracy testing and visual and validated functional testing.
Conclusion
The results of the performance data demonstrate that the sterile M-LNCS and Reprocessed M-LNCS Oximetry Sensors are as safe and effective as the legally marketed predicate devices.
Page 3 of 3
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Shelly Harris Manager of Regulatory Affairs Masimo Corporation 40 Parker Irvine, California 92618
JUL 2 8 2011
Re: K110723
Trade/Device Name: Masimo M-LNCS Oximetry Sensors Masimo Reprocessed M-LNCS Oximetry Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF, DQA, DSA Dated: June 14, 2011 Received: June 28, 2011
Dear Ms. Harris:
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.
{4}------------------------------------------------
Page 2 – Ms. Harris
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 (OS) 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/Safetv/Reporta Problem /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/ResourcesforYou/Industry/default.htm.
Sincerely yours
Susan Ruane
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
{5}------------------------------------------------
Indications for Use
| 510(k) Number (if known): | K110723 |
|---|---|
| --------------------------- | --------- |
Masimo M-LNCS Oximetry Sensors Device Name: Masimo Reprocessed M-LNCS Oximetry Sensors
Indications For Use:
The M-LNCS Sensors are indicated for the continuous non-invasive 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 conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.
The Reprocessed M-LNCS Sensors are indicated for the continuous non-invasive 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)
L Shutte
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sion 040
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K110723
510(k) Special, 03/11/2011 Masimo M-LNCS Sterile & Reprocessed Sensors Page 2-1
§ 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).