(149 days)
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.
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.
The provided text describes a 510(k) submission for Philips Reusable SpO2 Sensors. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in a dedicated table format. However, it indicates that "clinical evaluations for accuracy" were conducted and "Test results showed substantial equivalence." The basis for calibrating the saturation values is described: "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."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Clinically accurate SpO2 measurement within relevant physiological range (70%-100% SaO2). | * Clinical evaluations for accuracy were conducted. * Test results showed "substantial equivalence" to predicate devices. * Calibration curves are based on controlled hypoxia studies (100%-70% SaO2). |
| Performance of the modified connector and sensor wavelength coding. | Hardware verification testing and cable interface verification testing were conducted with substantial equivalence reported. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "controlled hypoxia studies with healthy non-smoking adult volunteers."
- Sample Size: Not explicitly stated, but implies a cohort of "healthy non-smoking adult volunteers."
- Data Provenance: The study involved human volunteers, making it a prospective clinical study. The location of the study is not specified, but the applicant (Philips Medizin Systeme Boeblingen GmbH) is based in Germany, and typically such studies would be conducted in the country of origin or a relevant regulatory jurisdiction.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
The establishment of ground truth ("calibration curves") for SpO2 measurements in hypoxia studies typically involves:
- Ground Truth Method: Direct arterial blood gas analysis, which is considered the gold standard for arterial oxygen saturation (SaO2).
- Number of Experts/Qualifications: The document does not specify the number or qualifications of medical professionals (e.g., intensivists, pulmonologists, clinical researchers) involved in conducting the hypoxia studies or performing arterial blood gas measurements. However, such studies are inherently under the supervision of qualified medical personnel.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe an adjudication method as it pertains to expert consensus on interpretation. For SpO2 measurement, the ground truth (direct SaO2 from blood gas) is a quantitative measurement, not subject to subjective adjudication by multiple readers in the same way an image interpretation might be.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was done. This device is a sensor (hardware) that provides a direct physiological measurement (SpO2), not an AI-driven interpretation system that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a form of standalone performance was assessed. The device itself, as an oximeter sensor and an internal algorithm, calculates the SpO2 value. The "clinical evaluations for accuracy" and "calibration curves" against directly measured SaO2 from blood gases represent a standalone performance assessment of the device's ability to accurately measure SpO2. This is the device operating without human judgment to interpret the output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for establishing the calibration curves was physiologically derived actual arterial oxygen saturation (SaO2), typically measured via co-oximetry from arterial blood samples. This is obtained during "controlled hypoxia studies."
8. The sample size for the training set
The document refers to "controlled hypoxia studies with healthy non-smoking adult volunteers" for establishing calibration curves. The sample size for these calibration studies is not explicitly stated.
9. How the ground truth for the training set was established
The ground truth for the calibration curves (which serve as the basis for the device's "training" or fundamental operational logic) was established through controlled hypoxia studies. In these studies, healthy volunteers' arterial oxygen saturation (SaO2) was varied and simultaneously measured using a gold standard method (e.g., co-oximetry via arterial blood gas analysis) while the device's raw signal ratio was recorded. This allowed for the correlation of the device's internal ratio to a true SaO2 value, creating the "validated calibration table."
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510(k) Summary (As required by 21 C.F.R. §807.92)
| Submitted by: | Egon PfeilPhilips Medizin Systeme Boeblingen GmbHCardiac and Monitoring SystemsHewlett-Packard Str.271034 BoeblingenGermany | |
|---|---|---|
| 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: | Oximeter21 C.F.R §870.2700 |
| Predicate Devices | Philips M1191A, M1192A, M1193A, M1901B (Nellcor/TycoOxisensor IITM N-25), M1903B (Nellcor/Tyco Oxisensor IITM D-20)and M1904B (Nellcor/Tyco Oxisensor IITM D-25) disposable SpO2sensors 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
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| signals are forwarded to a measurement device that amplifies theacquired signal and an algorithm that calculates the ratio and convertsvia 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 ofoxygen saturation.M1191T is indicated for adult patients, M1192T is indicated forpediatric patients, and M1193T is indicated for neonatal patients. |
| Technologicalcharacteristics | The Philips Reusable SpO2 Sensors have the same technologicalcharacteristics as the legally marketed predicate devices. |
| Testing | Verification and validation testing activities were conducted toestablish the performance and reliability characteristics of the modifieddevice.Testing involved environmental and clinical evaluations for accuracy.Hardware verification testing and cable interface verification testingwere also conducted. Test results showed substantial equivalence. |
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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.
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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
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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
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
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§ 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).