(106 days)
The LNCS/M-LNCS Sensors are indicated for the continuous nonitoring 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 hospitals, hospital-type facilities, mobile, and home environments.
The LNCS/M-LNCS Oximetry Sensors are fully compatible for use with instruments which include or compatible with the following technologies:
- · Masimo SET technology
- · Masimo Rainbow SET technology
- Nellcor technology
- · Philips FAST-SpO2 technology
The main difference is that the sensors in this filing have a lower profile in comparison to the predicates, for optimal fit and comfort for patients. The design is optimized or improved by the removal of excess inner wrap materials and an alternate molding compound in LED assemblies.
Here's an analysis of the acceptance criteria and supporting study for the Masimo LNCS/M-LNCS Oximetry Sensors based on the provided document:
This document is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full de novo clinical trial for device acceptance. Therefore, the "study that proves the device meets the acceptance criteria" is primarily by demonstrating equivalence to the previously cleared predicate device's performance through non-clinical testing.
The acceptance criteria are essentially the specifications of the predicate device, which the new device aims to meet or exceed. The "reported device performance" refers to the new device (LNCS/M-LNCS Oximetry Sensors) meeting these specifications.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are the specifications of the predicate device (K051212) which the new device aims to match or improve upon. The "reported device performance" indicates that the new device meets these criteria.
| Category | Specific Criterion (Predicate Device Specification) | Reported Device Performance (New LNCS/M-LNCS Oximetry Sensors) |
|---|---|---|
| Masimo Technology | ||
| SpO2, no motion | 70-100%, ± 2% (Adult/Pediatric/Infant) | Same (70-100%, ± 2%) |
| 70-100%, ± 3% (Neonatal) | Same (70-100%, ± 3%) | |
| SpO2, motion | 70-100%, ± 3% | Same (70-100%, ± 3%) |
| SpO2, low perfusion | 70-100%, ± 2% (Adult/Pediatric/Infant) | Same (70-100%, ± 2%) |
| 70-100%, ± 3% (Neonatal) | Same (70-100%, ± 3%) | |
| Pulse rate, no motion | 25-240 bpm, ± 3 bpm | Improved: 25-300 bpm, ± 3 bpm |
| Pulse rate, motion | 25-240 bpm, ± 5 bpm | Improved: 25-300 bpm, ± 5 bpm |
| Pulse rate, low perfusion | 25-240 bpm, ± 3 bpm | Improved: 25-300 bpm, ± 3 bpm |
| Nellcor/Philips Fast Technology | ||
| SpO2, no motion | 70-100%, ± 2% (Adult/Pediatric/Infant) | Same (70-100%, ± 2%) |
| 70-100%, ± 3% (Neonatal) | Same (70-100%, ± 3%) | |
| Pulse rate, no motion | 25-240 bpm, ± 3 bpm | Same (25-240 bpm, ± 3 bpm) |
Note: The primary "acceptance" here for the 510(k) is demonstrating that the modified device performs at least as well as the predicate device, with some improvements noted.
2. Sample Size Used for the Test Set and Data Provenance
The document states "The following non-clinical testing was conducted to verify that the LNCS/M-LNCS Oximetry Sensors met all design specifications: biocompatibility testing, performance testing including bench accuracy testing and visual and validated functional testing."
- Sample Size for Test Set: The document does not specify a sample size for the "bench accuracy testing" or "visual and validated functional testing." These would typically involve laboratory measurements on a various number of sensors or test setups, but the exact count isn't provided.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective/prospective. As this is a non-clinical, bench testing submission, the data would originate from internal Masimo Corporation testing facilities (likely Irvine, CA, USA, based on their address).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this 510(k) submission. The "ground truth" for sensor accuracy in this context would be established through:
- Reference instrumentation: For SpO2, this typically involves a co-oximeter measuring arterial blood gas samples. For pulse rate, a reference ECG machine or other highly accurate heart rate monitor.
- Standardized test methods: Following established protocols for evaluating oximetry sensors (e.g., ISO standards, AAMI standards).
There are no human experts "adjudicating" the ground truth for sensor performance; it's based on objective measurements against a reference standard.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
None. Adjudication by human experts is not relevant for objective performance measurements like sensor accuracy.
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 oximetry sensor, not an AI-assisted diagnostic tool requiring human interpretation. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The "performance testing including bench accuracy testing and visual and validated functional testing" (Test Summary, page 2) represents the standalone performance evaluation of the device. The sensor itself is a standalone measurement device; its reported accuracy ranges (e.g., ± 2% SpO2) are its standalone performance characteristics.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth for oximetry sensor performance (SpO2 and pulse rate) is typically established through:
- Co-oximetry (blood gas analysis): For oxygen saturation (SpO2), actual arterial blood samples are taken and analyzed by a laboratory co-oximeter, which is considered the gold standard for arterial oxygen saturation.
- Reference ECG/physiologic monitoring: For pulse rate, a highly accurate physiological monitor (e.g., ECG) provides the reference pulse rate.
This is objective, quantitative data, not based on expert consensus, pathology, or outcomes data in this context.
8. The sample size for the training set
Not applicable. The Masimo LNCS/M-LNCS Oximetry Sensors are hardware devices, not AI/ML algorithms that require a "training set." Their performance is based on physical design, materials, and signal processing, validated through engineering and clinical testing, not machine learning model training.
9. How the ground truth for the training set was established
Not applicable. As stated above, there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the logo for Masimo. The logo consists of a stylized letter 'V' inside of a circle, followed by the text 'Masimo' in a bold, sans-serif font. To the right of the word 'Masimo' are a few vertical lines.
MASIMO CORPORATION
Forty Parker
Irvine, CA 92618
| Submitted by: | Masimo Corporation40 Parker, Irvine, CA 92618Phone: 949-297-7000, Fax: 949-297-7592 | OCT 2 1 2010 |
|---|---|---|
| Company Contact: | Anil Bhalani, Director of Regulatory Affairs | |
| Date Summary Prepared: | September 17, 2010 | |
| Trade Name | LNCS/M-LNCS Oximetry Sensors | |
| Common Name | Oximeter Sensor | |
| Regulation Number: | 21 CFR 870.2700 | |
| Regulation Name/Product Code: | Oximeter/ DQA | |
| Substantially Equivalent Devices: | LNCS Oximetry Sensors, 510(k) No. K051212 |
Device Description:
The LNCS/M-LNCS Oximetry Sensors are fully compatible for use with instruments which include or compatible with the following technologies:
- · Masimo SET technology
- · Masimo Rainbow SET technology
- Nellcor technology
- · Philips FAST-SpO2 technology
Intended Use/ Indications for Use
The LNCS/M-LNCS Sensors are indicated for the continuous nonitoring 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 hospitals, hospital-type facilities, mobile, and home environments.
Comparison to Predicate Device
The sensors in this filing are the same indications for use, intended use, performance and principle of operations, as the respective predicate sensors (K051212).
The main difference is that the sensors in this filing have a lower profile in comparison to the predicates, for optimal fit and comfort for patients. The design is optimized or improved by the removal of excess inner wrap materials and an alternate molding compound in LED assemblies. The sensor model names in Inist was motenally and the corresponding predicate segsor model names are the same. See Table 1 below for the sensor model names and comparison descriptions.
Additionally, the upper pulse rate accuracy range for Masimo technology has been revised from 240 bpm to 300 bpm. See Table 2 below for the sensor specifications.
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Masimo Cordoration .
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Image /page/1/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a stylized letter "M" with a checkmark-like shape incorporated into it, followed by the word "MASIMO" in bold, sans-serif font. To the right of the logo, the text "MASIMO CORPORATION" is printed above the address "irvino, CA 92618".
510(k) SUMMARY
Table 1: Sensor Models for LNCS and M-LNCS Oximetry Sensors
| Pending MasimoLNCS and M-LNCS Oximetry Sensors | Predicate MasimoLNCS/M-LNCS Oximetry SensorsIn K051212 | Comparison Description(pending vs. predicate) |
|---|---|---|
| LNCS Inf-L: Infant Adhesive Sensor | LNCS Inf-L | |
| LNCS/M-LNCS Inf : Infant Adhesive Sensor | LNCS/M-LNCS Inf | |
| LNCS/M-LNCS Inf-3: Infant AdhesiveSensor | LNCS/M-LNCS Inf-3 | |
| LNCS Neo-L: Neonatal Adhesive Sensor | LNCS Neo-L | Lower profile design for |
| LNCS/M-LNCS Neo: Neonatal/AdultAdhesive Sensor | LNCS/M-LNCS Neo | optimized fit and patientcomfort. |
| LNCS/M-LNCS Neo-3: Neonatal/AdultAdhesive Sensor | LNCS/M-LNCS Neo-3 | |
| LNCS NeoPt-L: Neonatal Adhesive Sensor | LNCS NeoPt-L | Same indications for use,intended use, patient |
| LNCS/M-LNCS NeoPt: Neonatal AdhesiveSensor | LNCS/M-LNCS NeoPt | populations, patient weightmeasurement sites, |
| LNCS/M-LNCS NeoPt-3: Neonatal AdhesiveSensor | LNCS/M-LNCS NeoPt-3 | performance, andbiocompatible materials. |
| LNCS/M-LNCS NeoPt-500: NeonatalAdhesive Sensor | LNCS/M-LNCS NeoPt-500 | |
| LNCS/M-LNCS Newborn Neonatal:Neonatal Adhesive Sensor | LNCS/M-LNCS Newborn Neonatal | |
| LNCS/M-LNCS Newborn Infant/Pediatrics:Infant/Pediatric Adhesive Sensor | LNCS/M-LNCS NewbornInfant/Pediatrics | |
| Accessories used with Masimo LNCS/M-LNCS Sensors | ||
| LNCS/M-LNCS Inf Series: ReplacementTapes for LNCS/M-LNCS Inf Series Sensors | LNCS/M-LNCS Inf SeriesReplacement Tapes | |
| LNCS/M-LNCS Neo Series: ReplacementTapes for LNCS/M-LNCS Neo SeriesSensors | LNCS/M-LNCS Neo SeriesReplacement Tapes | |
| LNCS/M-LNCS NeoPt and Newborn Series:Replacement Wraps for LNCS/M-LNCSNeoPt and Newborn Neonatal SeriesSensors | LNCS/M-LNCS NeoPt and NewbornNeonatal Series Replacement Wraps | Same as predicate. |
| Red LNC Series: Patient Cables | Red LNC Series Patient Cables | |
| LNC/M-LNC Series: Patient Cables | LNC/M-LNC Series Patient Cables | |
| LNCS/M-LNCS and LNC/M-LNC Series:Adapter Cables | LNCS/M-LNCS and LNC/M-LNCSeries Adapter Cables |
Table 2: Sensor Specifications for LNCS/M-LNCS Oximetry Sensors
| Accuracy Range | Accuracy:Adult/ Pediatric/Infant | Accuracy:Neonatal | Predicate Device:Accuracy Range/Specification | |
|---|---|---|---|---|
| Masimo Technology | ||||
| SpO2, no motion | 70-100% | $\pm$ 2% | $\pm$ 3% | Same |
| SpO2, motion | 70-100% | $\pm$ 3% | $\pm$ 3% | Same |
| SpO2, low perfusion | 70-100% | $\pm$ 2% | $\pm$ 3% | Same |
| Pulse rate, no motion | 25-300 bpm | $\pm$ 3 bpm | $\pm$ 3 bpm | 25-240 bpm/ $\pm$ 3 bpm |
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Image /page/2/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a stylized letter 'M' followed by the word 'Masimo' in bold font. To the right of the logo, the text 'MASIMO CORPORATION' is displayed above the address 'Forty Parker, Irvine, CA 92618'.
510(k) SUMMARY
| Accuracy Range | Accuracy:Adult/ Pediatric/Infant | Accuracy:Neonatal | Predicate Device:Accuracy Range/Specification | |
|---|---|---|---|---|
| Masimo Technology | ||||
| Pulse rate, motion | 25-300 bpm | $+ 5 bpm$ | $+ 5 bpm$ | 25-240 bpm/ $+ 5 bpm$ |
| Pulse rate, low perfusion | 25-300 bpm | $+ 3 bpm$ | $+ 3 bpm$ | 25-240 bpm/ $+ 3 bpm$ |
| Nellcor/Philips Fast | ||||
| Technology | ||||
| SpO2, no motion | 70-100% | $+ 2%$ | $+ 3%$ | Same |
| Pulse rate, no motion | 25-240 bpm | $+ 3 bpm$ | $+ 3 bpm$ | Same |
Test Summary
The following non-clinical testing was conducted to verify that the LNCS/M-LNCS Oximetry Sensors met all design specifications: blocompatibility testing, performance testing including bench accuracy testing and visual and validated functional testing.
Conclusion
The results demonstrated that the LNCS/M-LNCS Oximetry Sensors are as safe and effective as the legally marketed predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Anil Bhalani Director of Regulatory Affairs Masimo Corporation 40 Parker Irvine, California 92618
OCT 2 1 2010
Re: K101896
Trade/Device Name: Masimo LNCS/M-LNCS Oximetry Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: September 17, 2010 Received: September 22, 2010
Dear Mr. Bhalani:
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.
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Page 2- Mr. Bhalani
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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jus L. Hito
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
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Indications for Use
510(k) Number (if known):
OCT 2 1 2010
Masimo LNCS/M-LNCS Oximetry Sensors Device Name:
Indications For Use:
The LNCS/M-LNCS Sensors are indicated for the continuous nonitoring 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.
Prescription Use 2 (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)
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, Dental Devices Division of Ancolnomian Devices
infection control
510(k) Number: L. Lull
510(k) Special, LNCS/M-LNCS Sensors Masimo, 7/6/2010 Page 15 of 254
§ 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).