(106 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on physical design changes and compatibility with existing technologies, not advanced algorithms.
No
The device is indicated for monitoring vital signs (SpO2 and pulse rate), not for providing treatment or therapy.
Yes
The device is indicated for "continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," which are physiological parameters used to assess a patient's health status and aid in diagnosis.
No
The device description explicitly states it is an "Oximetry Sensor" and details physical components like "LED assemblies" and "inner wrap materials," indicating it is a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use describes the continuous monitoring of physiological parameters (oxygen saturation and pulse rate) directly from the patient's body. This is a physiological monitoring function, not an in vitro test performed on samples taken from the body.
- Device Description: The device is described as an oximetry sensor, which is a non-invasive device that attaches to the patient's skin to measure light absorption. This is consistent with physiological monitoring.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the LNCS/M-LNCS Sensors are considered a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The LNCS/M-LNCS Sensors are indicated for the continuous 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 hospitals, hospital-type facilities, mobile, and home environments.
Product codes
DQA
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
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 LNCS/M-LNCS Oximetry Sensors met all design specifications: biocompatibility testing, performance testing including bench accuracy testing and visual and validated functional testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2, no motion: Accuracy Range 70-100%, Accuracy: Adult/Pediatric/Infant +/- 2%, Accuracy: Neonatal +/- 3%
SpO2, motion: Accuracy Range 70-100%, Accuracy: Adult/Pediatric/Infant +/- 3%, Accuracy: Neonatal +/- 3%
SpO2, low perfusion: Accuracy Range 70-100%, Accuracy: Adult/Pediatric/Infant +/- 2%, Accuracy: Neonatal +/- 3%
Pulse rate, no motion: Accuracy Range 25-300 bpm, Accuracy: Adult/Pediatric/Infant +/- 3 bpm, Accuracy: Neonatal +/- 3 bpm
Pulse rate, motion: Accuracy Range 25-300 bpm, Accuracy: Adult/Pediatric/Infant + 5 bpm, Accuracy: Neonatal + 5 bpm
Pulse rate, low perfusion: Accuracy Range 25-300 bpm, Accuracy: Adult/Pediatric/Infant + 3 bpm, Accuracy: Neonatal + 3 bpm
Nellcor/Philips Fast Technology:
SpO2, no motion: Accuracy Range 70-100%, Accuracy: Adult/Pediatric/Infant + 2%, Accuracy: Neonatal + 3%
Pulse rate, no motion: Accuracy Range 25-240 bpm, Accuracy: Adult/Pediatric/Infant + 3 bpm, Accuracy: Neonatal + 3 bpm
Predicate Device(s)
LNCS Oximetry Sensors, 510(k) No. K051212
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 Corporation
40 Parker, Irvine, CA 92618
Phone: 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.
Page 1 of 3
Masimo Cordoration .
4
1
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 Masimo
LNCS and M-LNCS Oximetry Sensors | Predicate Masimo
LNCS/M-LNCS Oximetry Sensors
In 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 Adhesive
Sensor | LNCS/M-LNCS Inf-3 | |
| LNCS Neo-L: Neonatal Adhesive Sensor | LNCS Neo-L | Lower profile design for |
| LNCS/M-LNCS Neo: Neonatal/Adult
Adhesive Sensor | LNCS/M-LNCS Neo | optimized fit and patient
comfort. |
| LNCS/M-LNCS Neo-3: Neonatal/Adult
Adhesive 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 Adhesive
Sensor | LNCS/M-LNCS NeoPt | populations, patient weight
measurement sites, |
| LNCS/M-LNCS NeoPt-3: Neonatal Adhesive
Sensor | LNCS/M-LNCS NeoPt-3 | performance, and
biocompatible materials. |
| LNCS/M-LNCS NeoPt-500: Neonatal
Adhesive 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 Newborn
Infant/Pediatrics | |
| | Accessories used with Masimo LNCS/M-LNCS Sensors | |
| LNCS/M-LNCS Inf Series: Replacement
Tapes for LNCS/M-LNCS Inf Series Sensors | LNCS/M-LNCS Inf Series
Replacement Tapes | |
| LNCS/M-LNCS Neo Series: Replacement
Tapes for LNCS/M-LNCS Neo Series
Sensors | LNCS/M-LNCS Neo Series
Replacement Tapes | |
| LNCS/M-LNCS NeoPt and Newborn Series:
Replacement Wraps for LNCS/M-LNCS
NeoPt and Newborn Neonatal Series
Sensors | LNCS/M-LNCS NeoPt and Newborn
Neonatal 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-LNC
Series 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 |
Page 2 of 3
2
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.
Page 3 of 3
3
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.
4
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
5
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