(115 days)
The 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 and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.
The LNCS Oximetry Sensors are fully compatible disposable sensors for use with Masimo SET and Masimo SET compatible pulse oximeter monitors. The LNCS Oximetry Sensors are also compatible with Nellcor and Nellcor compatible pulse oximeter monitors.
There is no change in the sensor design or performance. The only change is that the sensors are to be subjected to ethylene oxide (EO) sterilization and are to be supplied as sterile sensors by Masimo.
N/A
510(k) SUMMARY
Page 1
APR - 2 2009
Submitted by: Masimo Corporation
40 Parker
Irvine, CA 92618
949-297-7000
FAX 949-297-7001
Company Contact: Marguerite Thomlinson, Manager of Regulatory Affairs
Date Summary Prepared: December 5, 2008
Trade Name: LNCS Oximetry Sensors
Common Name: Oximeter Sensor
Classification Name and Product Code: Oximeter (74DQA) (870.2700)
Cable, Transducer and Electrode (74DSA) (870.2900)
Substantially Equivalent Devices: Masimo LNCS Oximetry Sensors, 510(k) No. K041815
Masimo LNCS Oximetry Sensors, 510(k) No. K051212
Masimo LNCS Oximetry Sensors, 510(k) No. K060143
Device Description
The LNCS Oximetry Sensors are fully compatible disposable sensors for use with Masimo SET and Masimo SET compatible pulse oximeter monitors. The LNCS Oximetry Sensors are also compatible with Nellcor and Nellcor compatible pulse oximeter monitors.
There is no change in the sensor design or performance. The only change is that the sensors are to be subjected to ethylene oxide (EO) sterilization and are to be supplied as sterile sensors by Masimo.
Predicate Device
The predicate devices used in this filing are the LNCS Oximetry Sensors (K041815, K051212, and K060143).
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Masimo Sterilized LNCS Sensors
510(k) File
Page 11 of 394
Page 2
510(k) SUMMARY
Intended Use/ Indications for Use
The 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.
Technology Comparison
The LNCS Oximetry Sensors in this filing are substantially equivalent in design, principles of operation, materials, and performance to predicate LNCS Oximetry Sensors (K041815, K051212, and K060143) and operate on identical principles of non-invasive optical assessment of tissue oxygenation using emitters and detectors.
The LNCS Oximetry Sensors in this filing are designed, configured, and manufactured for full compatibility with Masimo SET and Masimo SET compatible pulse oximeter monitors, and Nellcor and Nellcor compatible pulse oximeter monitors. The accuracy of the LNCS Oximetry Sensors is equivalent to those of the predicate devices.
Performance Testing
Performance data include results from in-house and laboratory validation testing on the sensors after they have been subjected to EO sterilization.
Conclusion
The results of the performance data demonstrate that the LNCS Oximetery Sensors are as safe and effective as the legally marketed predicate devices.
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Masimo Sterilized LNCS Sensors
510(k) File
Page 12 of 394
Page 3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
Ms. Marguerite Thomlinson
Manager, Regulatory Affairs
Masimo Corporation
40 Parker
Irvine, California 92618
APR - 2 2009
Re: K083622
Trade/Device Name: LNCS Sensors
Regulation Number: 21 CFR 870.2700
Regulation Name: Oximeter
Regulatory Class: II
Product Code: DQA
Dated: March 5, 2009
Received: March 10, 2009
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - 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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ginette Y. Michaud, M.D.
Acting 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): K083622
Device Name: LNCS Sensors
Indications For Use:
The 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 ☒ AND/OR Over-The-Counter Use ☐
(Per 21 CFR 801.109 Subpart D) (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 of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K083622
Masimo Sterilized LNCS Sensors
510(k) File
Page 10 of 394
§ 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).