(79 days)
Not Found
No
The device description details a standard oximetry measurement based on light absorption and a calculation algorithm using a validated calibration table. There is no mention of AI or ML techniques for signal processing, interpretation, or calculation.
No.
The device is intended for non-invasive measurement of oxygen saturation and pulse rate, which are diagnostic measurements, not therapeutic interventions.
Yes
The device measures oxygen saturation (SpO2) and pulse rate, which are physiological parameters used to assess a patient's health status, thereby providing information for diagnosis.
No
The device description explicitly mentions hardware components (red and infrared light source, photodiode) and describes hardware verification testing.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
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 donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The Philips disposable SpO2 Sensors measure oxygen saturation and pulse rate non-invasively by emitting light through human tissue and receiving it with a photodiode. This is a measurement taken directly from the living body, not from a specimen in vitro (outside the body).
- Intended Use: The intended use is for non-invasive measurement of physiological parameters (SpO2 and pulse rate) in patients. This aligns with the definition of a non-invasive medical device, not an IVD.
Therefore, the description clearly indicates a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Philips Disposable SpO2 Sensors are intended for acquiring non-invasively the arterial oxygen saturation to support the measurement of oxygen saturation and pulse rate. M1132A is indicated for infant patients and M1133A is indicated for neonatal, infant, and adult patients.
The Philips disposable SpO2 Sensors are intended for non-invasive measurement of oxygen saturation (SpO2) and pulse rate.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The Philips SpO2 devices measure, non-invasively, the arterial oxygen saturation of blood. The measurement method is based on the red and infrared light absorption of hemoglobin and oxyhemoglobin. Light of a red and infrared light source is emitted through human tissue and received by a photodiode.
The measurement is based on the absorption of light, which is emitted through human tissue (for example through the index finger). The light comes from two sources (red LED and infrared LED) with different wavelengths and is received by a photodiode. Out of the different absorption behavior of the red and infrared light a so-called Ratio can be calculated. The saturation value is defined by the percentage ratio of the oxygenated hemoglobin [HbO2] to the total amount of hemoglobin [Hb].
SpO2 = {HbO2] / ( [Hb] + [HbO2] )
Out of calibration curves, which are based on controlled hypoxia studies with healthy nonsmoking adult volunteers over a specified saturation range (SaO2 from 100%-70%), the Ratio can be related to a SpO2 value.
The devices contain a red and infrared light source and a photodiode receiving the nonabsorbed red and infrared light. The received signals are forwarded to a measurement device that amplifies the acquired signal and an algorithm that calculates the ratio and converts via a validated calibration table the ratio to a saturation value.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human tissue (for example through the index finger)
Indicated Patient Age Range
M1132A is indicated for infant patients and M1133A is indicated for neonatal, infant, and adult patients.
Intended User / Care Setting
Not Found
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
Testing involved environmental, safety testing from hazard analysis, interference testing, and clinical evaluations for accuracy. Hardware verification testing was also conducted. Pass/Fail criteria were based on standards, where applicable, and on the specifications cleared for the predicate device. Test results showed substantial equivalence.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 (As required by 21 C.F.R. §807.92)
- Submitted by: Egon Pfeil Philips Medizin Systeme Boeblingen GmbH Cardiac and Monitoring Systems Hewlett-Packard Str.2 71034 Boeblingen Germany
- August 26, 2005 Date of Summary:
- Device Name Philips Disposable SpO2 Sensors M1132A and M1133A.
- Common Name SpO2 Sensor
- Classification Classification Name: Oximeter (DQA) Regulation Number: 21 C.F.R §870.2700 Name
- Predicate Devices Philips M1131A disposable Sp02 sensor, and M1901B (Nellcor/Tyco Oxisensor II™ N-25) and M1902B (Nellcor/Tyco Oxisensor II™ I-20) disposable SpO2 sensors cleared pursuant K042306, 10/15/04, K000822, 4/6/00, and K990972, 4/19/99.
- Device The Philips SpO2 devices measure, non-Description invasively, the arterial oxygen saturation of blood. The measurement method is based on the red and infrared light absorption of hemoglobin and oxyhemoglobin. Light of a red and infrared light source is emitted through human tissue and received by a photodiode.
The measurement is based on the absorption of light, which is emitted through human tissue (for example through the index finger). The light comes from two sources (red LED and infrared LED) with different wavelengths and is received by a photodiode. Out of the different absorption behavior of the red and infrared light a so-called Ratio can be calculated. The saturation value is defined by the percentage ratio of the oxygenated hemoglobin [HbO2] to the total amount of hemoglobin [Hb].
SpO2 = {HbO2] / ( [Hb] + [HbO2] )
Out of calibration curves, which are based on controlled hypoxia studies with healthy non
1
smoking adult volunteers over a specified saturation range (SaO₂ from 100%-70%), the Ratio can be related to a SpO2 value.
The devices contain a red and infrared light source and a photodiode receiving the nonabsorbed red and infrared light. The received signals are forwarded to a measurement device that amplifies the acquired signal and an algorithm that calculates the ratio and converts via a validated calibration table the ratio to a saturation value.
Intended Use The Philips Disposable SpO2 Sensors are intended for acquiring non-invasively the arterial oxygen saturation to support the measurement of oxygen saturation and pulse rate.
M1132A is indicated for infant patients and M1133A is indicated for neonatal, infant, and adult patients.
Technological The Philips Disposable SpO2 Sensors have the characteristics same technological characteristics as the leqally marketed predicate devices.
Testing Verification and validation testing activities were conducted to establish the performance and reliability characteristics of the new device.
Testing involved environmental, safety testing from hazard analysis, interference testing, and clinical evaluations for accuracy. Hardware verification testing was also conducted. Pass/Fail criteria were based on standards, where applicable, and on the specifications cleared for the predicate device. Test results showed substantial equivalence.
2
Image /page/2/Picture/2 description: The image is a black and white emblem for the U.S. Department of Health & Human Services. The emblem features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three curved lines that resemble a human figure in motion or a stylized representation of a wave or flow. The emblem is simple and conveys a sense of movement and progress.
NOV 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Medizin Systeme Böblingen GmbH Mr. Egon Pfeil Regulatory Affairs Engineer Cardiac and Monitoring Systems Hewlett-Packard Street 2 D-71034 Boeblingen GERMANY
Re: K052377
Trade/Device Name: The Philips Disposable SpO2 Sensors MII32A and MII33A Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 26, 2005 Received: August 30, 2005
Dear Mr. Pfeil:
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 - Mr. Pfeil
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,
Chiu Lin, Ph.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
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Indications for Use
510(k) Number (if known): The Philips Disposable SpO2 Sensors M1132A and M1133A Device Name:
Indications for Use: The Philips disposable SpO2 Sensors are intended for non-invasive measurement of oxygen saturation (SpO2) and pulse rate.
Indicated for adult/infant/neonatal (M1133A) and infant (M1132A) patients.
Over-The-Counter Use Prescription Use __ yes No AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K052377
Page of of
SIBK) Number: K052077-