(149 days)
Not Found
No
The description details a standard pulse oximetry device using light absorption and a calibration table, with no mention of AI or ML algorithms.
No.
The device is intended for "acquiring non-invasively the arterial oxygen saturation to support the measurement of oxygen saturation," which is a diagnostic function rather than a therapeutic one. It provides data for measurement but does not directly treat or alleviate a medical condition.
Yes
The device is intended for "acquiring non-invasively the arterial oxygen saturation to support the measurement of oxygen saturation," which provides information about a patient's physiological state. Monitoring oxygen saturation is a key diagnostic parameter in healthcare.
No
The device description explicitly mentions hardware components (red and infrared light source, photodiode) and the summary of performance studies includes hardware verification testing.
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 used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Philips Reusable SpO2 Sensors acquire non-invasively the arterial oxygen saturation by measuring light absorption through human tissue (like a finger). This is a direct measurement on the living body, not an analysis of a specimen taken from the body.
- Intended Use: The intended use is to support the measurement of oxygen saturation, which is a physiological parameter measured directly on the patient.
Therefore, while it's a medical device used for diagnostic purposes (providing information for diagnosis), it does not meet the definition of an In Vitro Diagnostic because it does not analyze specimens taken from the body.
N/A
Intended Use / Indications for Use
The Philips Reusable SpO2 Sensors are intended for acquiring non-invasively the arterial oxygen saturation to support the measurement of oxygen saturation.
M1191T is indicated for adult patients, M1192T is indicated for pediatric patients, and M1193T is indicated for neonatal patients.
Product codes
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 non-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 non-absorbed 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
Not Found
Indicated Patient Age Range
Adult, pediatric, and neonatal 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation testing activities were conducted to establish the performance and reliability characteristics of the modified device.
Testing involved environmental and clinical evaluations for accuracy. Hardware verification testing and cable interface verification testing were also conducted. Test results showed substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
Ka32979
. "
FEB 2 0 2004
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 | |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Date of Summary: | September 19, 2003 | |
| Device Name | The Philips Reusable SpO2 Sensors M1191T, M1192T, and M1193T. | |
| Common Name | SpO2 Sensor | |
| Classification Name | Classification Name:
Regulation Number: | Oximeter
21 C.F.R §870.2700 |
| Predicate Devices | Philips M1191A, M1192A, M1193A, M1901B (Nellcor/Tyco
Oxisensor IITM N-25), M1903B (Nellcor/Tyco Oxisensor IITM D-20)and M1904B (Nellcor/Tyco Oxisensor IITM D-25) disposable SpO2
sensors cleared pursuant to K882609, 1/19/89; K990972, 4/19/99, and K000822, 4/6/00. | |
| Modifications | The modification involves a change to the connector from the proprietary Philips version to a Nellcor compatible connector with corresponding change in sensor wave length coding from the Philips Rtype to the Nellcor Rcal. | |
| 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 non-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 | |
The devices contain a red and infrared light source and a photodiode receiving the non-absorbed red and infrared light. The received
1
| | 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 Reusable SpO2 Sensors are intended for acquiring non-
invasively the arterial oxygen saturation to support the measurement of
oxygen saturation.
M1191T is indicated for adult patients, M1192T is indicated for
pediatric patients, and M1193T is indicated for neonatal patients. |
| Technological
characteristics | The Philips Reusable SpO2 Sensors have the same technological
characteristics as the legally marketed predicate devices. |
| Testing | Verification and validation testing activities were conducted to
establish the performance and reliability characteristics of the modified
device.
Testing involved environmental and clinical evaluations for accuracy.
Hardware verification testing and cable interface verification testing
were also conducted. Test results showed substantial equivalence. |
:
,
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2004
Mr. Egon Pfeil Regulatory Affairs Engineer Philips Medizin Ayateme Böeblingen GmbH Cardiac and Monitoring Systems, Incorporated Hewlett-Packard Str.2 71034 Böeblingen GERMANY
Rc: K032979/S2
Trade/Device Name: The Philips Reusable SpO2 Sensors M1191T, M1192T and M1193 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: January 27, 2004 Received: January 30, 2004
Dear Mr. Pfeil:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reveal above and have cetermined 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 menside commerce proces that have been reclassified in accordance with the provisions of Amendments, or to activetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvial applicions 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 cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 WA), it may be can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device earrer publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Pfeil
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be auvisor mat i Dri o losuanse on that your device complies with other requirements Incan that I DA has made a deceminary unations administered by other Federal agencies. of the Act of ally I ederal batales and squirements, including, but not limited to: registration r od linest comply with a 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CF RT art 807), labality systems (QS) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) requirences as set form in the quading tontrol 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) I mis letter whilanow you to our finding of substantial equivalence of your device to a premaired predicated. - 11 - 11 - 11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at not Compliance at (301) 594-4646. 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 may overnir 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,
Chuls
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 Statement
510(k) Number (if known)
Device Name: The Philips Reusable SpO2 Sensors M1191T, M1192T, and M1193T
Indications for Use: The Philips Reusable SpO2 Sensors are intended for acquiring nonindications for Use. The I milips Reasurement of support the measurement of oxygen saturation.
M1191T is indicated for adult patients, M1192T is indicated for pediatric patients, and M1193T is indicated for neonatal patients.
VAn h
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division Control, Dental Devices
510(k) Number: K032979
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_V
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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
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