(149 days)
Not Found
No
The device description details a standard pulse oximetry mechanism based on light absorption and does not mention any AI/ML components or algorithms. The testing described is also standard for pulse oximeters and does not involve AI/ML specific evaluations.
No.
The device is a pulse oximeter sensor, which is a diagnostic device used for monitoring rather than treating a condition.
Yes
Explanation: The device is indicated for "continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," which are diagnostic measurements used to assess a patient's physiological state.
No
The device description explicitly details hardware components (LEDs, photo sensor, wiring system, taping system) and the reprocessing of physical devices. It is a hardware device with potential embedded software, not a software-only medical device.
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 involve taking a sample from the body.
- Mechanism of Action: The device works by emitting and receiving light through the skin and tissue to analyze the absorption characteristics of hemoglobin, which is a physical measurement, not a chemical or biological analysis of a sample.
Therefore, the Reprocessed RD SET pulse oximeter sensor 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
The Reprocessed RD SET pulse oximeter sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, and infant patients during non-motions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.
Product codes
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 and deoxygenated 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 lightemitting 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 and deoxygenated hemoglobin within the blood.
As part of the reprocessing manufacturing process, we collect used devices from hospitals, replace required components, clean the devices and test the functional performance of the devices to ensure they meet or exceed requlatory requirements and the expectations of our customers.
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.
Specifically for the 4000: Middle or ring finger.
Specifically for the 4001: Middle or ring finger.
Specifically for the 4002: (3 - 10 kg): Great toe, toe next to great toe, or thumb; (10 - 20 kg): Middle or ring finger.
Specifically for the 4003: (>40 kg): Middle or ring finger.
Indicated Patient Age Range
Adult, pediatric, and infant patients.
Intended User / Care Setting
Hospitals and hospital-type facilities.
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
Non-clinical bench testing was conducted using a stand-in device. The stand-in device allows for SpO2 sensor verification by passing the light source of the pulse oximeter sensor (LED) through 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 SpQ2 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
- Sensitivity testing
- Clinical laboratory testing
- Non-clinical bench testing (SpO2, Pulse Rate, Monitor Compatibility)
Stryker Sustainability Solutions performed the clinical validation testing of the SpO2 performance under no motion conditions on healthy, adult volunteers in the range of 70% to 100%.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-clinical bench testing, clinical validation testing.
Sample Size: Healthy, adult volunteers for clinical validation. Specific number not provided.
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found
Key Results: The A rms (average root means squared) for SpO2 under no motion conditions was found to be 2.04% and 2.11% for non-woven and woven tape, respectively, over the range of 70-100%. These A rms results are less than 3.0% and are in conformance with Clause 201.12.1.101.1 of ISO 80601-2-61:2011 and Table 3 of "Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff."
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 devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Saturation Accuracy, No Motion: 2.2%
- Saturation Accuracy, Low Perfusion: 2.5%
- Pulse Rate Accuracy, No Motion: ±3 bpm (30-200 bpm)
- Pulse Rate Accuracy, Low Perfusion: ±3 bpm (30-200 bpm)
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).
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December 4, 2022
Stryker Sustainability Solutions Michael Wong Regulatory Affairs Specialist 1810 W Drake Drive Tempe, Arizona 85283
Re: K222019
Trade/Device Name: Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: NLF Dated: November 4, 2022 Received: November 4, 2022
Dear Michael Wong:
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 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.
1
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 (QS) 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 mediation-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/cdrh-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.
James J. Lee -S
James J. Lee, Ph.D. 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
Enclosure
2
Indications for Use
510(k) Number (if known) K222019
Device Name
Reprocessed RD SET Adt Pulse Oximeter Sensor (4000): Reprocessed RD SET Pat Pulse Oximeter Sensor (4001): Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)
Indications for Use (Describe)
The Reprocessed RD SET pulse oximeter sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, and infant patients during non-motions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
Submitter:
Stryker Sustainability Solutions 1810 W. Drake Drive Tempe, AZ 85283
Contact:
Michael Wong Regulatory Affairs Specialist (480) 213-1342 Michael.wong@stryker.com
Device Name:
Device Trade Name:
Reprocessed RD SET® Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET® Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET® Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET® Adt Pulse Oximeter Sensor (4003)
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 |
|---|---|---|
| K211140 | 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 | NLF |
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| | Transducer), Reprocessed Masimo Pulse Oximeter (2328
Infant O2 Transducer),
Reprocessed Masimo Pulse Oximeter (2329 Adult O2
Transducer) | |
|---------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| K180046 | Masimo Rad-97 and Accessories | 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 and deoxygenated 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 lightemitting 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 and deoxygenated hemoglobin within the blood.
As part of the reprocessing manufacturing process, we collect used devices from hospitals, replace required components, clean the devices and test the functional performance of the devices to ensure they meet or exceed requlatory requirements and the expectations of our customers.
Indications for Use:
The Reprocessed RD SET® pulse oximeter sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, and infant patients during nonmotion conditions, and for patients who are well or poorly perfused in hospitals and hospitaltype facilities.
Indications for Use Comparison:
The indications for use for the subject device are the same as those of the predicate devices, with the exceptions that the neonatal indication has been removed from the 4003 model and
Stryker Sustainability Solutions Reprocessed RD SET® Pulse Oximeter Sensor Traditional 510(k)
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motion and mobile/home environment indications have been removed from the 4000, 4001, 4002, and 4003 models.
Technological Comparison:
The design of the reprocessed device is the same as the predicate device. The indications for use does not change from the predicate devices (K211140 and K180046), with the exception that the neonatal indication has been removed from the 4003 model and the motion and mobile/home environment indications have been removed from the 4000, 4001, 4002, and 4003 models. The same standard mechanical design and sizes and equivalent materials are utilized. There are no changes to the claims, clinical applications, or performance specifications.
The subject device and the predicate devices have the same technological characteristics, i.e., they have the same:
- intended use;
- principle of operation;
- form factor; -
- measurement application sites;
- performance specifications; -
- environmental and mechanical specifications -
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 detection of the signal from the light absorption of oxygenated blood and deoxygenated blood to determine the functional oxygen saturation of hemoglobin (SpO2).
Mechanism of Action for Achieving the Intended Effect
The Reprocessed RD SET® 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 transmission. The signal transmission is processed by the Pulse Oximeter to provide SpO2 and pulse rate.
Non-Clinical and/or Clinical Tests Summary:
To support the substantial equivalence of product performance after being reprocessed and decontaminated by vaporized hydrogen peroxide to that of the predicate devices, non-clinical bench testing was conducted using a stand-in device. The stand-in device allows for SpO2 sensor verification by passing the light source of the pulse oximeter sensor (LED) through one
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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 SpQ2 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 -
- -Sensitivity testing
- Clinical laboratory testing
- -Non-clinical bench testing (SpO2, Pulse Rate, Monitor Compatibility)
Stryker Sustainability Solutions performed the clinical validation testing of the SpO2 performance under no motion conditions on healthy, adult volunteers in the range of 70% to 100%. The Ams (average root means squared) for SpO2 under no motion conditions was found to be 2.04% and 2.11% for non-woven and woven tape, respectively, over the range of 70-100%. These Arms results are less than 3.0% and are in conformance with Clause 201.12.1.101.1 of ISO 80601-2-61:2011 and Table 3 of "Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff."
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 devices.
Comparison Table:
Please see Pages 5-7 for a table comparing the subject device with the primary (K211140) and secondary (K180046) predicate devices.
Conclusion:
The subject device has the same intended use as the proposed predicates and the differences in technological features do not raise different questions of safety and effectiveness. Based on a comparison of the intended use/indications for use, technological characteristics, and performance data to the predicate devices, the subject device is equivalent to the predicate devices. The results from bench and laboratory testing demonstrate that the Reprocessed RD SET® Pulse Oximeter Sensor is as safe and effective as the identified legally marketed predicate devices as described herein.
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| Description | Subject Device | K180046
Secondary Predicate | K211140
Primary Predicate | Comparison | | | |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Patient Population | 4000 | Adult | 4000 Adult | 1859, 2317,
1862, 2320,
2329 Adult | Stryker Sustainability Solutions will not make
claims for neonatal use. | | |
| | 4001 | Pediatric | 4001 Pediatric | | | | |
| | 4002 | Infant | 4002 Infant | 1860 Pediatric | | | |
| | 4003 | Adult | 4003 Adult/Neonatal | 1861, 2319,
2328 Infant | | | |
| Patient Weight Range | • Adult: >30 kg (4000)
• Adult: >40 kg (4003)
• Pediatric: 10 - 50 kg (4001)
• Infant: 3 - 20 kg (4002) | • Adult: >30 kg (4000)
• Adult: >40 kg (4003)
• Pediatric: 10-50 kg (4001)
• Infant: 3 - 20 kg (4002)
• Neonate: 30 kg (Adtx, Adtx-3)
• Pediatric: 10 - 50 kg (Pdtx, Pdtx-3)
• Infant: 3-20 kg (Inf, Inf-L, Inf-3) | Stryker Sustainability Solutions will not make
claims for neonatal use. | | | |
| Intended Application Site | 4000 | Middle or ring finger | 4000 Middle or ring finger of non-
dominant hand | 1859, 2317 Finger | As stated | | |
| | 4001 | Middle or ring finger | 4001 Middle or ring finger of non-
dominant hand | 1860 Finger or toe | | | |
| | 4002 | (3 - 10 kg):
Great toe, toe next to great
toe, or thumb
(10 - 20 kg):
Middle or ring finger | 4002 (3 - 10 kg):
Great toe, toe next to great
toe, or thumb
(10 - 20 kg):
Middle or ring finger of non-
dominant hand | 1861, 2319,
2328 Thumb or great toe | | | |
| | 4003 | (>40 kg):
Middle or ring finger | 4003 (40 kg):
Middle or ring finger of non-
dominant hand | 1862, 2320,
2329 Adult finger or toe | | | |
| Indications for Use | The reprocessed RD SET Disposable Pulse
Oximeter Sensors are indicated for the
continuous noninvasive monitoring of
functional oxygen saturation of arterial
hemoglobin (SpO2) and pulse rate (measured
by an SpO2 sensor) for use with adult,
pediatric, and infant patients during no
motion conditions, and for patients who are
well or poorly perfused in hospitals and
hospital-type facilities. | | The RD SET® Series disposable sensors
are indicated for the continuous
noninvasive monitoring of functional
oxygen saturation of arterial
hemoglobin (SpO2) and pulse rate
(measured by an SpO2 sensor) for use
with adult, pediatric, infant, and
neonatal patients during both no
motion and motion conditions, and for
patients who are well or poorly
perfused in hospitals, hospital-type
facilities, mobile, and home
environments. | | INDICATIONS - When used with Masimo
SET Radical: Reprocessed Masimo Pulse
Oximeter sensor is indicated for use in
continuous noninvasive arterial oxygen
saturation and pulse rate monitoring. | | Stryker Sustainability Solutions will not make
claims for use in home or mobile
environments or for use during motion
conditions. |
| Contra-Indications | The reprocessed RD SET sensors are
contraindicated for patients who exhibit | | The RD SET sensors are
contraindicated for patients who | | Reprocessed Masimo Pulse Oximeter
sensor should not be used in patients who | | Same |
| | allergic reactions to foam rubber products
and/or adhesive tape. | exhibit allergic reactions to foam
rubber products and/or adhesive tape. | exhibit allergic reactions to foam rubber
products and/or adhesive tape. | | | | |
| Form Factor | • Adhesive Bandage | • Adhesive Bandage | • Adhesive Bandage | Same | | | |
| Single Use | Yes | Yes | Yes | Same | | | |
| Use Environment | Hospitals and hospital-type facilities | Hospitals, hospital-type facilities,
mobile, and home environments | Hospitals and hospital-type facilities | Stryker Sustainability Solutions will not make
claims for use in home and mobile
environments. | | | |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same | | | |
| Expiration Date | No | No | No | Same | | | |
| Uses | Single patient use | Single patient use | Single patient use | Same | | | |
| Number of Reprocessing
Cycles | 4 | N/A | 4 | As stated | | | |
| Laminate (replaced or saved) | The laminate that encloses the optical
components is replaced. | N/A | The laminate that encloses the optical
components is replaced. | Same | | | |
| Optical Design | Transmissive Sensor | Transmissive Sensor | Transmissive Sensor | Same | | | |
| | | Performance Specifications | | | | | |
| Saturation Accuracy, No
Motion | 2.2% | 1.5% | ±2% | As stated | | | |
| Saturation Accuracy, Motion | N/A | 1.5% | N/A | As stated | | | |
| Saturation Accuracy, Low
Perfusion | 2.5% | 2% | N/A | As stated | | | |
| Pulse Rate Accuracy, No
Motion | ±3 bpm (30-200 bpm) | ±3 bpm (25-240 bpm) | ±3 bpm | As stated | | | |
| Pulse Rate Accuracy, Motion | N/A | ±5 bpm (25-240 bpm)
N/A | | As stated | | | |
| Pulse Rate Accuracy, Low
Perfusion | ±3 bpm (30-200 bpm) | ±3 bpm (25-240 bpm) | N/A | As stated | | | |
| | | Safety Specifications (e.g., electrical, mechanical, environmental) | | | | | |
| Electrical | Universal 100-240 VAC to DC multi-voltage
power supply | Universal 100-240 VAC to DC multi-
voltage power supply | Universal 100-240 VAC to DC multi-voltage
power supply | Same | | | |
| Environmental | | | | | | | |
| Operating Temperature: | 5°C to 40°C, ambient humidity | 5°C to 40°C, ambient humidity | 41°F to 104°F (5°C to 40°C) | As stated | | | |
| Storage Temperature: | -20°C to +50°C, ambient humidity | -20°C to +40°C, ambient humidity | -40°F to +158°F (-40°C to +70°C) | As stated | | | |
| Operating Humidity: | 15% to 95%, non-condensing | 10% to 90%, non-condensing | 5% to 95%, non-condensing | As stated | | | |
| Features (e.g., alarms, display and indicators, modes) | | | | | | | |
| Alarms | N/A | Audible and visual alarms for high and
low saturation and pulse rate. | N/A | Stryker Sustainability Solutions does not
provide or reprocess the display. Therefore,
the alarms remain the same. | | | |
| Displays & Indicators | N/A | Data display: %SpO2, pulse rate, alarm
status, alarm silenced status, AC
power, Signal IQ/pleth bar, perfusion
index bar, battery status | N/A | Stryker Sustainability Solutions does not
provide or reprocess the display. Therefore,
the display characteristics remain the same. | | | |
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