(27 days)
No
The device description and performance studies focus on traditional optical measurement and calculation methods for SpO2 and pulse rate, with no mention of AI or ML.
No
The device is a diagnostic tool designed for monitoring oxygen saturation and pulse rate, not for providing therapy or treatment.
Yes
Explanation: The device is intended for continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, which are measurements used to assess a patient's physiological state. Monitoring these parameters helps in diagnosing conditions related to oxygenation and heart rate.
No
The device description explicitly states that the device is a series of oximetry sensors that measure light absorption using LEDs, indicating 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. They are used to examine specimens outside of the body.
- Device Function: The description clearly states that the Masimo series of sensors are intended for continuous noninvasive monitoring of functional oxygen saturation and pulse rate. This is done by measuring light absorption through the skin (e.g., on a finger, ear, or other site).
- No Sample Collection: There is no mention of collecting any biological samples from the patient for analysis. The measurement is performed directly on the patient's body.
Therefore, because the device performs its measurement non-invasively on the patient's body rather than on a sample taken from the body, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The additional Masimo series of sensors are intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
The additional Masimo series of sensors are indicated for the following:
- Single use oximetry sensor intended for adults and pediatrics greater than 10 kg
- Reusable oximetry ear sensor intended for adults and pediatrics greater than 30 kg
- Reusable oximetry multisite sensor intended for adults, pediatrics, and neonates greater than 1 kg
The following additional Masimo Sensors are indicated for the continuous noninvasive function of arterial hemoglobin (SpO2) and pulse rate:
Single use oximetry sensor intended for adults and pediatrics greater than 10 kg Reusable oximetry ear sensor intended for adults and pediatrics greater than 30 kg Reusable oximetry multisite sensor intended for adults, pediatrics, and neonates greater than 1 kg
Product codes
74DQA, 74DSA, 74DPZ
Device Description
The Masimo series of oximetry sensors measure the light absorption of blood from two light emitting diodes (LED's). Oxygen saturated blood absorbs light differently than unsaturated blood. The amount of light absorbed by the blood is used to calculate the ratio of oxygenated hemoglobin in arterial blood. This filing includes the addition of 2 reusable sensors and a disposable sensor.
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, 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)
Performance testing was conducted on adult volunteers. The additional series of sensors were compared to arterial blood sampled r continet tooling was oneated or. Accuracy (Arms) for the NR7 was ± 2%, for the LNOP-Ear ± 3.5%, and for the LNOP-YI and your a nediatrics ± 2% and ± 3% for neonates over the range of 70% to 100% SaO2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy (Arms) for the NR7 was ± 2%, for the LNOP-Ear ± 3.5%, and for the LNOP-YI and your a nediatrics ± 2% and ± 3% for neonates over the range of 70% to 100% SaO2.
Predicate Device(s)
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
0061
OCT - 3 2001
510(k) SUMMARY
Image /page/0/Picture/3 description: The image shows the logo and contact information for Masimo. The logo features the company name in a bold, sans-serif font with a stylized "M". Below the logo is the address: 2852 Kelvin Avenue, Irvine, CA 92614. The telephone number is 949-250-9688, and the fax number is 949-250-9686.
| Submitted by: | Masimo Corporation 2852 Kelvin Ave Irvine, CA 92614-5826 (714) 250-9688 FAX (714) 250-9686 |
|---|---|
| Company Contact: | James J. Cronin, Vice President, Regulatory Affairs/Quality Assurance |
| Date Summary Prepared: | September 5, 2001 |
| Trade Names | LNOP-Ear Sensor, LNOP-YI Sensor, NR7 Sensor |
| Common Names | Pulse Oximetery Sensors SpO2 Ear Sensor |
| Classification Names | Oximeter (74DQA) (870.2700) Cable, Transducer and Electrode (74DSA) (870.2900) Oximeter, Ear (74DPZ) (870.2710) |
| Substantially Equivalent Devices | Masimo SET Radical Pulse Oximeter with SatShare™ and LNOP series of Sensors and Cables 510(k) Number - K000126 Nellcor DURA-Y Oxygen Transducer, Ear Clip - 510(k) Number - K944760 |
Description
The Masimo series of oximetry sensors measure the light absorption of blood from two light emitting diodes (LED's). Oxygen saturated blood absorbs light differently than unsaturated blood. The amount of light absorbed by the blood is used to calculate the ratio of oxygenated hemoglobin in arterial blood. This filing includes the addition of 2 reusable sensors and a disposable sensor.
Intended use
The additional Masimo series of sensors are intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
Indications For Use:
The additional Masimo series of sensors are indicated for the following:
- Single use oximetry sensor intended for adults and pediatrics greater than 10 kg
- Reusable oximetry ear sensor intended for adults and pediatrics greater than 30 kg
Reusable oximetry multisite sensor intended for adults, pediatrics, and neonates greater than 1 kg
1
510(k) SUMMARY
Comparison to Predicate Devices:
The additional Masimo series of sensors all use the same theory and principle of operation as the predicate devices.
Performance Data and Conclusions:
Performance testing was conducted on adult volunteers. The additional series of sensors were compared to arterial blood sampled r continet tooling was oneated or. Accuracy (Arms) for the NR7 was ± 2%, for the LNOP-Ear ± 3.5%, and for the LNOP-YI and your a nediatrics ± 2% and ± 3% for neonates over the range of 70% to 100% SaO2.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/2/Picture/12 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird.
OCT = 3 2001
Mr. James J. Cronin Masimo Corporation 2852 Kelvin Avenue Irvine, CA 92614-5826
Re: K012992
Masimo SET® Radical Pulse Oximeter with SatShare™ and the Masimo Series of Sensors (LNOP-Ear Sensor, LNOP-YI Sensor, NR7 Sensor) Regulation Number: 870.2700, 870.2710 Regulation Name: Oximeter, Ear Oximeter Regulatory Class: II (two) Product Code: 74 DQA, 74 DPZ Dated: September 5, 2001 Received: September 6, 2001
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.
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
3
Page 2 - Mr. James J. Cronin
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Oala Tullh
lillard Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
KO12992 510(k) Number (if known):
Masimo SET® Radical Pulse Oximeter with SatShare™ and the Masimo Series of Sensors and Cables Device Name:
Indications For Use:
The following additional Masimo Sensors are indicated for the continuous noninvasive function of arterial hemoglobin (SpO2) and pulse rate:
Single use oximetry sensor intended for adults and pediatrics greater than 10 kg Reusable oximetry ear sensor intended for adults and pediatrics greater than 30 kg Reusable oximetry multisite sensor intended for adults, pediatrics, and neonates greater than 1 kg
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dale Tell
Division of Cardiovascular & Respiratory Devices
510(k) Number K012992
Prescription Use (Per 21 CFR 801.109)
or
Over-The-Counter Use
0060
(Optional Format 1-2-96)