(43 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard pulse oximetry technology and clinical performance metrics, with no mention of AI/ML algorithms for data processing or interpretation.
No.
The device is a sensor used for monitoring physiological parameters (SpO2 and pulse rate), not for directly treating a medical condition.
Yes
The device is intended for the continuous monitoring of oxygen saturation and pulse rate, which are physiological parameters used to assess a patient's health status, especially in patients with congenital cyanotic cardiac lesions. This monitoring provides information essential for diagnosis and management.
No
The device description explicitly states it is a "disposable sensor" and describes its function using optical emitters and detectors, indicating it is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The LNOP Blue oximetry sensors are described as non-invasive optical sensors that measure functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate directly from the patient's body. This is a non-invasive physiological measurement, not a test performed on a sample taken from the body.
- Intended Use: The intended use is for continuous monitoring of physiological parameters (SpO2 and pulse rate) in patients, not for analyzing biological samples.
Therefore, the LNOP Blue oximetry sensor falls under the category of a physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LNOP Blue oximetry sensors are intended for the continuous nomitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
Product codes (comma separated list FDA assigned to the subject device)
74DQA
Device Description
The LNOP Blue Oximetry Sensors are fully compatible disposable sensors for use with Masimo SET compatible pulse oximeter monitors. The LNOP Blue sensor is substantially equivalent to Masimo's LNOP Inf-L sensor except it is designed for use on patients with congenital cyanotic cardiac lesions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
non-invasive optical assessment of tissue oxygenation
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric, infant, and neonatal
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)
Clinical studies were performed using the LNOP Blue Disposable oximetry sensors with Masimo SET Radical Pulse Oximeters on pediatric, infant, and neonatal patients with congenital cyanotic cardiac lesions and measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter. Clinical testing of the LNOP Disposable sensors resulted in an accuracy of less than 4% SpO2 ARMs in the range of 60%-80% SaO2 and less than 3% SpO2 ARMS in the range of 80%-100% for pediatrics, infants and neonates on patients with congenital cyanotic lesions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
accuracy of less than 4% SpO2 ARMs in the range of 60%-80% SaO2 and less than 3% SpO2 ARMS in the range of 80%-100%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUL 1 5 2005
e
Image /page/0/Picture/3 description: The image shows the logo for Masimo, a medical technology company. Below the logo is the address "40 Parker Irvine, CA 92618". The image also includes the phone number 949-297-7000 and fax number 949-297-7001.
| 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: | May 23, 2005 |
| Trade Name | LNOP Blue Oximetry Sensors |
| Common Name | Oximeter Sensor |
| Classification Name and Product Code: | Oximeter (74DQA) (870.2700) |
| Substantially Equivalent Devices: | Masimo SET® Rad 57 Pulse CO-Oximeter
510(k) Number - K042536. |
Device Description
The LNOP Blue Oximetry Sensors are fully compatible disposable sensors for use with Masimo SET compatible pulse oximeter monitors. The LNOP Blue sensor is substantially equivalent to Masimo's LNOP Inf-L sensor except it is designed for use on patients with congenital cyanotic cardiac lesions.
Intended Use
The LNOP Blue oximetry sensors are intended for the continuous nomitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
1
510(k) SUMMARY
Technology Comparison
The LNOP Blue 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 LNOP Blue oximetry sensors are designed, configured, and manufactured for full compatibility with Masimo SET and Masimo SET compatible pulse oximetry sensors are constructed of similar materials and components as used in the predicate devices.
Performance Testing
Biocompatibility
All the patient contacting materials used in the LNOP Blue sensors are the same materials that are used in Masimo's LNOP Inf-L sensors. Test results demonstrated that the materials were non-toxic, non-irritating, and non sensitizing.
Clinical Testing
Clinical studies were performed using the LNOP Blue Disposable oximetry sensors with Masimo SET Radical Pulse Oximeters on pediatric, infant, and neonatal patients with congenital cyanotic cardiac lesions and measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter. Clinical testing of the LNOP Disposable sensors resulted in an accuracy of less than 4% SpO2 ARMs in the range of 60%-80% SaO2 and less than 3% SpO2 ARMS in the range of 80%-100% for pediatrics, infants and neonates on patients with congenital cyanotic lesions.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or a caduceus-like design, representing health and well-being.
Public Health Service
JUL 1 5 2005
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: K051439
Trade/Device Name: LNOP Blue Oximetry Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximetry Sensor Regulatory Class: II Product Code: DQA Dated: May 31, 2005 Received: June 02, 2005
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 (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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sujite J. Michie, M.D.
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
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Indications for Use
510(k) Number (if known):
LNOP Blue Device Name:
Indications For Use:
The LNOP Blue Sensors are indicated for the continuous nonitoring of fifictional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with pediatric, infant, and neonatal patients with congenital cyanotic cardiac lesions in 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 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ain Sshom
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devic
510(k) Number:_