(148 days)
Not Found
No
The document describes standard pulse oximetry sensors and their sterilization method. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is used for continuous monitoring of oxygen saturation and pulse rate, which are diagnostic and monitoring functions, not therapeutic interventions.
Yes
The device is intended for the 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. This falls under the definition of a diagnostic device as it provides information used for diagnosis or patient monitoring.
No
The device description explicitly states that the devices are "disposable sensors" and describes physical changes (sterilization method), indicating they are hardware components, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality.
- Device Function: The description clearly states that these are oximetry sensors intended for the continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. This is a non-invasive measurement taken directly from the patient's body (likely a finger, toe, or earlobe), not from a specimen in vitro.
- Input Modality: The input modality is described as "Non-invasive optical assessment of tissue oxygenation using emitters and detectors," which further confirms it's a direct measurement on the patient.
The device is a medical device used for patient monitoring, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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 conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The SPO2.COM 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, pediatic, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
Product codes
DQA
Device Description
The LNCS Oximery Sensors are fully compatible disposable sensors for use with Masimo SET compatible pulse oximeter monitors and also with Nellcor compatible pulse oximeter monitors. There is no change in design to the sensors. The only change is to add that the sensors can be sterilized by Ethylene Oxide.
The SPO2.COM Oximetry Sensors are fully compatible disposable sensors for use with Nellcor compatible pulse oximeter monitors. There is no change in design to the sensors. The only change is to add that the sensors can be sterilized by Ethylene Oxide.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Performance data include results from Ethylene Oxide Sterilization Testing and in-house laboratory testing.
The performance data demonstrate that the LNCS and SPO2.COM sensors are substantially equivalent to the LNCS and SPO2.COM sensors before and after Ethylene Oxide Sterilization.
Key Metrics
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Predicate Device(s)
SPO2.COM A, P, I, N, RS-I Pulse Oximeter Sensors 510(k) Number - K033298, LNCS Oximetry Sensors - K041815, LNCS Oximetry Sensors - 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
510(k) SUMMARY
Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters, specifically 'K060143'. The characters are written in a handwritten style, with varying stroke thicknesses. The overall impression is that of a label or identifier.
Image /page/0/Picture/2 description: The image shows the logo for Masimo, a medical technology company. Below the logo is the company's address, which is 40 Parker, Irvine, CA 92618. The image also includes the company's phone number, which is 949-297-7000, and fax number, which is 949-297-7001.
JUN 16 2006
| Submitted by: | Masimo Corporation
40 Parker
Irvine, CA 92618
949-297-7000
FAX 949-297-7001 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | James J. Cronin, Vice President, Regulatory Affairs/Quality Assurance |
| Date Summary Prepared: | January 17, 2006 |
| Trade Name | LNCS and SPO2.com Oximetry Sensors |
| Common Name | Oximeter Sensor |
| Classification Name and Product Code: | Oximeter (74DQA) (870.2700) |
| Substantially Equivalent Devices: | SPO2.COM A, P, I, N, RS-I Pulse Oximeter Sensors 510(k) Number - K033298
LNCS Oximetry Sensors - K041815
LNCS Oximetry Sensors - K051212 |
Device Description
The LNCS Oximery Sensors are fully compatible disposable sensors for use with Masimo SET compatible pulse oximeter monitors and also with Nellcor compatible pulse oximeter monitors. There is no change in design to the sensors. The only change is to add that the sensors can be sterilized by Ethylene Oxide.
The SPO2.COM Oximetry Sensors are fully compatible disposable sensors for use with Nellcor compatible pulse oximeter monitors. There is no change in design to the sensors. The only change is to add that the sensors can be sterilized by Ethylene Oxide.
Intended Use
The LNCS oximetry sensors are intended for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
The SPO2.COM oximetry sensors are intended for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
1
510(k) SUMMARY
Technology Comparison
The LNCS and SPO2.COM oximetry sensors are equivalent in intended use, design, principles of operation, materials, and performance to predicate sensors and operate on identical principles of non-invasive optical assessment of tissue oxygenation using emitters and detectors.
The LNCS oximetry sensors are designed, and manufactured for full compatibility with Masimo SET and Masimo SET compatible pulse oximeters and Nellcor compatible pulse oximeter monitors. The LNCS oximetry sensors are constructed of exact materials and components as used in the predicate devices.
The SPO2.COM oximetry sensors are designed, configured, and manufactured for full compatibility with Nellcor compatible pulse oximeter monitors. The SPO2.COM oximetry sensors are constructed of exact materials and components as used in the predicate devices.
The accuracy of the LNCS and SPO2.COM oximetry sensors is equivalent to those of the predicate devices.
Performance Testing
Performance data include results from Ethylene Oxide Sterilization Testing and in-house laboratory testing.
The performance data demonstrate that the LNCS and SPO2.COM sensors are substantially equivalent to the LNCS and SPO2.COM sensors before and after Ethylene Oxide Sterilization.
Conclusion
The results of the performance data demonstrate that the LNCS and SPO2.COM oximetry sensors are as safe and effective than the legally marketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes forming its wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
Public Health Service
JUN 16 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James J. Cronin Vice President, Regulatory Affairs/Quality Assurance Masimo Corporation 40 Parker Irvine, California 92618
Re: K060143
Trade/Device Name: LNCS and SPO2.COM Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: June 9, 2006 Received: June 12, 2006
Dear Mr. Cronin:
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.
3
Page 2 - Mr. Cronin
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 (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.
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Chiu Lin, Ph.D.
. . . . . . .
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):
LNCS and SPO2.COM Sensors Device Name:
Indications For Use:
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 conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The SPO2.COM 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, pediatic, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C) 011
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sign-Off)
ton of Anesthesiology, General Hospital,
Cion Control Dental Dovinn
AA6
Number: K066/73