(72 days)
Not Found
No
The device description details a standard pulse oximetry measurement method based on light absorption and a fixed algorithm using a calibration table. There is no mention of adaptive learning, pattern recognition beyond the basic ratio calculation, or any other characteristics typically associated with AI/ML.
No
The device is used for monitoring arterial oxygen saturation and pulse rate, which are diagnostic/monitoring functions, not therapeutic.
Yes
The device is designed to measure arterial oxygen saturation and pulse rate, which are physiological parameters used to assess a patient's health status. This measurement provides information that can aid in diagnosis (e.g., identifying hypoxemia).
No
The device description explicitly mentions hardware components such as red and infrared light sources, a photodiode, and a measurement device. It also details 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Philips reusable SpO2 sensors measure arterial oxygen saturation and pulse rate non-invasively by emitting light through human tissue (like a finger) and receiving the non-absorbed light. This is a measurement taken on the body, not from a sample taken from the body.
Therefore, this device falls under the category of a non-invasive medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Philips reusable SpO2 sensors are for multi-patient use, when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are required.
M1191B, M1191BL and M1191BNL sensors are indicated for use with adult patients.
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 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 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. Design verification and validation test results confirmed that the device is substantially equivalent with the identified predicate devices.
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.
Philips Medical System Adult SpO2 sensor, model # M1191A Cleared for marketing via FD&C Act §510(k)# K882609, K990972, K000822 and K030973.
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
PHILIPS Medical Systems
NOV - 3 2006
510(k) Summary (As required by 21 C.F.R. §807.92)
| Submitted by: | Philips Medical Systems, Inc.
Ultrasound and Monitoring Division / Patient Monitoring Supplies
3000 Minuteman Road
Andover, MA 01810 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Mr. Rich McCleary
Senior Manager of Quality and Regulatory Affairs
Tel: (978) 659-4914 |
| Date of Summary: | August 18, 2006 |
| Device Name | Philips Reusable SpO2 Sensor,
Models M1191B, M1191BL and M1191BNL |
| Common Name | SpO2 pulse oximeter sensor |
| Classification Name | Classification Name: Oximeter
Regulation Number: 21 C.F.R §870.2700 |
| Predicate Device | Philips Medical System Adult SpO2 sensor, model # M1191A
Cleared for marketing via FD&C Act §510(k)# K882609, K990972,
K000822 and K030973. |
| Modifications | The modification involves changes to the exterior cuff materials to
improve quality, enhance value and accommodate patients with large
fingers. |
.
1
| 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. |
| Intended Use | Philips reusable SpO2 sensors are for multi-patient use, when
continuous non-invasive arterial oxygen saturation and pulse rate
monitoring are required. |
| | M1191B, M1191BL and M1191BNL sensors are indicated for use
with adult 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. Design verification and validation test results
confirmed that the device is substantially equivalent with the identified
predicate devices. |
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 2006
Mr. Rich McCleary Senior Manager, Quality & Regulatory Affairs Phillips Medical Systems 3000 Minuteman Road Andover, Massachusetts 01810-1099
Re: K062455
Trade/Device Name: Philips Reusable Sp02 Sensors Models, M1191B, M1191BL and M1191BNL Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: October 2, 2006 Received: October 4, 2006
Dear Mr. McCleary:
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 (sec 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. McCleary
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely vours,
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
510(k) Number (if known): K062455
| Device Name: | Philips Reusable SpO2 Sensors
Models M1191B, M1191BL and M1191BNL |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use: | Philips reusable SpO2 sensors are for multi-patient use,
when continuous non-invasive arterial oxygen saturation and
pulse rate monitoring are required. |
Prescription Use
(Part 21 CFR 801 Subpart D)
✓
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
lumm Solum
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
KOL:2465 510(k) Number
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