(326 days)
Not Found
No
The device description and performance studies focus on traditional signal processing and light absorption principles, with no mention of AI or ML algorithms.
No
The device is described as a sensor used for continuous noninvasive arterial oxygen saturation and pulse rate monitoring. It measures and calculates oxygen saturation (SpO2) and pulse rate, providing diagnostic information rather than directly treating or preventing a disease.
Yes.
The device measures oxygen saturation of arterial blood (SpO2) and pulse rate, which are physiological parameters used to assess a patient's health status. The "Intended Use / Indications for Use" section explicitly states "continuous noninvasive arterial oxygen saturation and pulse rate monitoring," which are diagnostic functions.
No
The device description explicitly details hardware components (LED, sensor, wiring system, taping system) and their physical interaction with the patient's body to measure physiological parameters. The submission focuses on the reprocessing method of these physical sensors, not on software functionality.
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 pulse oximeter sensor measures oxygen saturation and pulse rate noninvasively by placing the sensor on the patient's finger or foot. It does not require a sample to be taken from the body.
- Mechanism of Action: The device works by emitting and detecting light through the patient's tissue, analyzing the absorption characteristics of oxygenated and deoxygenated hemoglobin within the blood vessels. This is an external measurement, not an analysis of a biological sample.
Therefore, while it provides diagnostic information about the patient's physiological state, it does so through an in vivo (within the living body) measurement rather than an in vitro (in glass/outside the body) analysis of a sample.
N/A
Intended Use / Indications for Use
Reprocessed Masimo Pulse Oximeter sensor is indicated for use in continuous noninvasive arterial oxygen saturation and pulse rate monitoring.
Product codes (comma separated list FDA assigned to the subject device)
NLF
Device Description
In a clinical setting, a pulse oximeter sensor measures the oxygen saturation of arterial blood (SpO2). A pulse oximeter sensor is composed of a light emitting diode (LED) and a sensor that are placed on opposite sides of a patient's finger or foot. The LED contains a red light and an infrared light that are differentially absorbed by oxygenated hemoglobin. Based on the relative absorption of the two wavelengths that is determined by the sensor, the POX determines the relative amount of oxygenated and deoxygenated hemoglobin, which is calculated as SpO2. In order to make the SpO2 calculation independent of skin color, finger size, etc., the pulse oximeter sensor uses only the time varying light absorption component generated by the patient's pulse. The sensor also uses the period of pulsation to measure patient pulse rate. The pulse oximeter can estimate the amount of oxygen in the blood without having to draw a blood sample.
The primary components of an oxygen transducer, or Pulse Oximeter (POX) Sensor, are light-emitting diodes (red and infrared LED) and a photo sensor. These components (with their wiring system) are embedded within a taping system designed for wrapping the POX Sensor around a patient's finger, foot, or hand so that the LED and photo sensor are directly opposite to each other. As the lights are emitted and received across a vascular bed, the rates of absorption at the two wavelengths vary depending upon the ratios of oxygenated hemoglobin within the blood.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's finger, foot, or hand
Indicated Patient Age Range
Adult, Pediatric, Infant
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)
Non-Clinical and/or Clinical Tests Summary & Conclusions:
To support the substantial equivalence of product performance after by vaporized hydrogen peroxide to that of the predicate devices, non-clinical bench simulation testing was conducted using a stand-in device allows for SpO2 sensor verification by passing the light source of the pulse oximeter sensor (LED) thru one side of the stand-in with the signal transmission measured by the photocell (photo-detector) of the pulse oximeter sensor on the opposing side of the stand-in.
A functional pulse oximeter sensor when connected to a pulse oximeter console will have the ability to monitor SpO2 and Pulse Rate. Bench and laboratory testing was conducted to determine whether a pulse oximeter sensor is functional and is assessed by performing continuity and sensitivity testing. This included the following tests:
- Continuity testing to verify there are no open circuits and the current along the path of a circuit is continuous
- Sensitivity testing to detect the signal transmission between the photodiode and the LED (light emitting diode)
Performance testing , incorporated by reference K081238, also included the following which are not altered by the use of vaporized hydrogen peroxide.
Clinical Testing:
Stryker Sustainability Solutions performed the clinical validation testing of the SpO2 performance under no motion on healthy, adult volunteers in the range of 70% to 100%. The ARMS for SpO2 under no motion was found to be 1.48% and 1.72% for woven and non-woven tape over the range of 70-100%.
The results of the non-clinical and clinical testing demonstrate that all requirements and performance specifications were satisfied and support the subject device is substantially equivalent to its predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ARMS for SpO2 under no motion was found to be 1.48% and 1.72% for woven and non-woven tape over the range of 70-100%.
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
March 8, 2022
Stryker Sustainability Solutions Moira Barton-Varty Senior Principal Regulatory Affairs 1810 West Drake Drive Tempe, Arizona 85283
Re: K211140
Trade/Device Name: Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2329 Adult O2 Transducer) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: NLF Dated: February 10, 2022 Received: February 11, 2022
Dear Moira Barton-Varty:
(NOTE: Reprocessed SUD device types require a separate attachment of the list of all models cleared in the submission. A corrected SE letter will be required if the attachment is omitted.)
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
1
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd Courtney Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Enclosure
3
Indications for Use
510(k) Number (if known) K211140
Device Name Reprocessed Masimo Pulse Oximeter
Indications for Use (Describe)
Reprocessed Masimo Pulse Oximeter sensor is indicated for use in continuous noninvasive arterial oxygen saturation and pulse rate monitoring.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/1 description: The image shows the Stryker logo with the words "Sustainability Solutions" underneath. The Stryker logo is in bold, black font. Above the logo, the text "Page 1 of 3" is visible. The words "Sustainability Solutions" are also in bold, black font but are smaller than the Stryker logo.
510(k) Summary
Contact Details
| Applicant Name: | Stryker Sustainability Solutions |
|---|---|
| Applicant Address: | 1810 West Drake Drive Tempe AZ 85283 United States of America |
| Applicant Contact | |
| Telephone: | 6024100204 |
| Applicant Contact: | Mrs. Moira Barton-Varty |
| Applicant Contact Email: | moira.barton@stryker.com |
Device Name
Device Trade Name:
Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer) Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer) Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer) Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer) Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer) Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer) Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer) Reprocessed Masimo Pulse Oximeter (2328 Infant O2 Transducer) Reprocessed Masimo Pulse Oximeter (2329 Adult O2 Transducer)
Common Name: Oximeter Classification Name: Oximeter, Reprocessed Regulation Number: 870.2700 Product Code: NLF
Legally Marketed Predicate Devices
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K081238 | Reprocessed Masimo Pulse Oximeter Sensors | NLF |
| K060143 | LNCS and SPO2.COM Sensors | DQA |
Device Description Summary
In a clinical setting, a pulse oximeter sensor measures the oxygen saturation of arterial blood (SpO2). A pulse oximeter sensor is composed of a light emitting diode (LED) and a sensor that are placed on opposite sides of a patient's finger or foot. The LED contains a red light and an infrared light that are differentially absorbed by oxygenated hemoglobin. Based on the relative absorption of the two wavelengths that is determined by the sensor, the POX determines the relative amount of oxygenated and deoxygenated hemoglobin, which is calculated as SpO2. In order to make the SpO2 calculation independent of skin color, finger size, etc., the pulse oximeter sensor uses only the time varying light absorption component generated by the patient's pulse. The sensor also uses the period of pulsation to measure patient pulse rate. The pulse oximeter can estimate the amount of oxygen in the blood without having to draw a blood sample.
The primary components of an oxygen transducer, or Pulse Oximeter (POX) Sensor, are light-emitting diodes (red and infrared LED) and a photo sensor. These components (with their wiring system) are embedded within a taping system designed for wrapping the POX Sensor around a patient's finger, foot, or hand so that the LED and photo sensor are directly opposite to each other. As the lights are emitted and received across a vascular bed, the rates of absorption at the two wavelengths vary depending upon the ratios of oxygenated hemoglobin within the blood.
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Image /page/5/Picture/1 description: The image shows the Stryker logo with the words "Sustainability Solutions" written below it. The Stryker logo is in bold, black letters. Above the logo, the text "Page 2 of 3" is visible. The text is smaller than the Stryker logo and is located in the upper right corner of the image.
The proposed devices of this submission do not differ from the predicate device. The only difference is that the proposed devices will be exposed to vaporized hydrogen peroxide instead of ethylene oxide.
Intended Use/Indications for Use
Reprocessed Masimo Pulse Oximeter sensor is indicated for use in continuous noninvasive arterial oxygen saturation and pulse rate monitoring.
Indications for Use Comparison
The indications for use are the same as the predicate device.
Technological Comparison
The design of the reprocessed device is the same as the predicate device. There are no changes to the claims, clinical applications, patient population, or performance specifications for use does not change from the predicate device (K081238). The same standard mechanical design and equivalent materials are utilized. There are no changes to the claims, clinical applications, patient population, or performance specifications.
The subject device, LNCS Pulse Oximeter Sensors and the predicate device, have the following key similarities:
- intended use;
- principle of operation;
- form factor and components;
- measurement application sites;
- performance specifications;
- environmental and mechanical specifications- Both devices have the same indicated populations;
Principle of Operation
The principle of operation of pulse oximetry is based upon the fundamental principle that hemoglobin bound to oxygen (oxyhemoglobin) and hemoglobin unbound to oxygen (deoxyhemoglobin) vary in the absorption of different wavelengths of the light and the absorptions can be used to estimate SpO2 and pulse rate. The mechanism by which this process occurs is the use of red and infrared wavelengths of light delivered by an emitter and the signal from the light absorption of oxygenated blood and deoxygenated blood to determine functional oxygen saturation of hemoglobin (SpO2).
Mechanism of Action for Achieving the Intended Effect
The Reprocessed Pulse Oximeter Sensor provides the intended effect equivalent to the previously cleared pulse oximeter sensor in that it utilizes an optical sensor that is applied to the patient's finger or toe through which light is transmitted to the photodetector that detects the signal transmissionis processed by the Pulse Oximeter to provide SpO2 and pulse rate.The principles of operation are still based upon the use of red and infrared wavelengths of light provided by an emitter and the detection of the signal from the light absorption of oxygenated blood and deoxygenated blood to provide functional oxygen saturation of hemoglobin (SpO2).
A functional pulse oximeter sensor when connected to a pulse oximeter console will have the ability to monitor SpO2 and Pulse Rate. Bench and laboratory testing was conducted to determine whether a pulse oximeter sensor is functional and is assessed by performing continuity and sensitivity testing. This included the following tests:
- Continuity testing to verify there are no open circuits and the current along the path of a circuit is continuous
- Sensitivity testing to detect the signal transmission between the photodiode and the LED (light emitting diode)
Non-Clinical and/or Clinical Tests Summary & Conclusions
To support the substantial equivalence of product performance after by vaporized hydrogen peroxide to that of the predicate devices, non-clinical bench simulation testing was conducted using a stand-in device allows for SpO2 sensor verification by passing the light source of the pulse oximeter sensor (LED) thru one side of
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Image /page/6/Picture/1 description: The image shows the Stryker logo with the words "Sustainability Solutions" underneath. The Stryker logo is in black and is a stylized version of the company name. The words "Sustainability Solutions" are in black and are in a smaller font than the Stryker logo. The words "Page 3 of 3" are in the upper right corner of the image.
the stand-in with the signal transmission measured by the photocell (photo-detector) of the pulse oximeter sensor on the opposing side of the stand-in.
A functional pulse oximeter sensor when connected to a pulse oximeter console will have the ability to monitor SpO2 and Pulse Rate. Benchand laboratory testing was conducted to determine whether a pulse oximeter sensor is functional and is assessed by performing continuity and sensitivity testing. This included the following tests:
- Continuity testing to verify there are no open circuits and the current along the path of a circuit is continuous
- Sensitivity testing to detect the signal transmission between the photodiode and the LED (light emitting diode)
Performance testing , incorporated by reference K081238, also included the following which are not altered by the use of vaporized hydrogen peroxide.
All reprocessed pulse oximeter sensors materials that are normally in contact with the patient are replaced with medical grade adhesive tape during reprocessing by Stryker Sustainability Solutions. The reprocessed pulse oximeter sensors meet biocompatibility requirements of ANSI/AAMI/ISO 10993-1: 2009: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process for surface contacting devices with prolonged exposure (> 24 hours, but less than 30 days) with skin.
Clinical Testing
Stryker Sustainability Solutions performed the clinical validation testing of the SpO2 performance under no motion on healthy, adult volunteers in the range of 70% to 100%. The ARMS for SpO2 under no motion was found to be 1.48% and 1.72% for woven and non-woven tape over the range of 70-100%.
The results of the non-clinical and clinical testing demonstrate that all requirements and performance specifications were satisfied and support the subject device is substantially equivalent to its predicate.
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Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer) Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer) Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer) Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer) Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer) Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer) Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer) Reprocessed Masimo Pulse Oximeter (2328 Infant O2 Transducer) Reprocessed Masimo Pulse Oximeter (2329 Adult O2 Transducer)