(30 days)
Not Found
No
The document describes a reprocessed pulse oximeter sensor and its performance testing, with no mention of AI or ML technologies.
No
The device is described as a sensor for monitoring oxygen saturation and pulse rate, which falls under diagnostic or monitoring functions, not therapeutic.
Yes
The device is described as being indicated for "continuous non-invasive arterial oxygen saturation and pulse rate monitoring," which involves measuring physiological parameters to provide information for diagnosis or treatment.
No
The device description explicitly states it is a "SpO2 Sensor" and describes physical characteristics and performance testing related to hardware components (biocompatibility, electrical, tissue heating, adhesive peel, cleaning). It is a physical sensor, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body.
- Device Function: The description clearly states that this device is a "continuous non-invasive arterial oxygen saturation and pulse rate monitoring" sensor. It measures these parameters directly from the patient's body (specifically, a finger, toe, or similar digit) using light absorption. This is a non-invasive measurement performed on the living body.
Therefore, based on the provided information, the Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor Model MAXNAR is a non-invasive monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor Model MAXNAR is indicated for single patient use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring is required for adult patients as indicated in the sensor directions for use. This device is for prescription use only.
Product codes
NLF
Device Description
The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR is designed for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in conjunction with a Nellcor Pulse Oximeter. The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR, is intended for prescription use with adult patients in hospitals, hospital-type facilities, and intra-hospital transport. The proposed device is not provided sterile
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
• Finger = MAXA, MAXL, MAXP
• Toe or digit of similar size = MAXI
Indicated Patient Age Range
Adult
Intended User / Care Setting
hospitals, hospital-type facilities, and intra-hospital transport.
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)
The purpose of the clinical trial in predicate submission K181738 (which included proposed device Model MAXNAR) was to perform an oxygen saturation (SpO2) accuracy comparison. The study was conducted in accordance with CFR for Non-significant Risk Investigational Studies, following ISO 14155:2011 Clinical Investigation of medical devices for human subjects – Good clinical practice as appropriate and the pulse oximeter guidelines of ISO 80601-2-61:2011 Procedure for invasive laboratory testing on healthy volunteers applicable sections and Pulse Oximeters - Premarket Notifications Submissions [510(k)] Guidance for Industry and Food and Drug Administration Staff (March 4, 2013). After Institutional Review Board Approval, 10 healthy adults volunteer subjects (ages 25 to 36 yr.; weight 105 - 220 lb.; height 60 – 72 in.; BMI of 20.0 – 33.4) were included in the study which was conducted from May 9 to May.
SpO2 accuracy of the proposed devices. The proposed devices achieved an accuracy of 2% for 70% - 100% SpO2. The study concluded that the SpO2 accuracy performance of the proposed devices passed the Arms specification of 3% under steady state and non-motion conditions for the range of 70% to 100%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 accuracy: 2% for 70% - 100% SpO2.
SpO2 accuracy: 70% - 100% ± 2 digits in adults (MAXA, MAXAL, MAXP, MAXI)
Pulse rate accuracy (bpm): 20 - 250 ± 3 digits (MAXA, MAXAL, MAXP, MAXI)
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 shows 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" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Surgical Instrument and Savings Inc (dba Medline ReNewal) % Stephanie Mays Sr. Regulatory Affairs Specialist, Quality Assurance and Regulatory Affairs Surgical Instrument Service and Savings Inc (dba Medline ReNewal) 1500 NE Hemlock Ave Redmond, Oregon 97756
Re: K201699
Trade/Device Name: Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor (model: MAXNAR) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: NLF Dated: June 19, 2020 Received: June 22, 2020
Dear Stephanie Mays:
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.
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
1
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 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/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,
Todd Courtney Assistant Director DHT1C: Division of ENT, 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
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Indications for Use
510(k) Number (if known) K201699
Device Name
Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor Model MAXNAR
Indications for Use (Describe)
The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor Model MAXNAR is indicated for single patient use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring is required for adult patients as indicated in the sensor directions for use. This device is for prescription use only.
| 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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| OEM Device
| Modela | Device Name | OEM |
|---|---|---|
| MAXNAR | Nellcor OxiMax Pulse Oximeter | |
| Sensor | ||
| (Adult SpO2 Sensor > 40 kg; woven | ||
| bandage) | Nellcor Puritan | |
| Bennett | ||
| a OEM = original equipment manufacturer. |
K201699 Reprocessed Nellcor OxiMax SpO2 Sensor included in Submission:
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Image /page/4/Picture/1 description: The image shows two logos side by side. The logo on the left is for Medline, and it features a blue star-like symbol with the word "MEDLINE" in white letters. The logo on the right is for ReNewal, and it features the word "ReNewal" in green and blue letters, with the words "Full Circle Reprocessing" in smaller letters below.
Special 510(k) Notification
Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, Model MAXNAR
K201699 Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR § 807.92.
| Submitter/Owner | Surgical Instrument Service and Savings (dba Medline ReNewal)
1500 NE Hemlock Ave., Redmond, OR 97756 | | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--|
| Prepared by/Contact Name | Stephanie Boyle Mays
Senior Regulatory Affairs Specialist, Quality Assurance/Regulatory Affairs
P: 541-516-4205 • F: 541-923-3375 • E:smays@medline.com | | |
| Date Prepared | June 19, 2020 | | |
| Device Name and Classification | Proprietary/Trade Name: | Medline ReNewal Reprocessed Nellcor OxiMax SpO2
Sensor, model MAXNAR | |
| | Common or usual name | Oximeter, reprocessed | |
| | Regulatory Name/Reference: | Oximeter; 21 CFR § 870.2700 | |
| | Regulatory Class: | Class II | |
| | Product Code: | NLF | |
| | 510(k) number: | K181738 (March 22, 2019) | |
| Predicate Device | Proprietary/Trade Name: | Medline ReNewal Reprocessed Nellcor OxiMax SpO2
Sensors, models MAXA, MAXAL, MAXP, and MAXI | |
| | Common or usual name | Oximeter, reprocessed | |
| | Regulatory Name/Reference: | Oximeter; 21 CFR § 870.2700 | |
| | Regulatory Class: | Class II | |
| | Product Code: | NLF | |
| | Panel: | Cardiovascular/anesthesiology | |
| | Manufacturer: | Surgical Instrument Service and Savings
(dba Medline ReNewal)
1500 NE Hemlock Ave., Redmond, OR 97756 | |
| Statement of Indications for Use | The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor Model
MAXNAR is indicated for single patient use when continuous non-invasive
arterial oxygen saturation and pulse rate monitoring is required for adult
patients as indicated in the sensor directions for use. This device is for
prescription use only. | | |
| Device Description | The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, model
MAXNAR is designed for the continuous non-invasive monitoring of
functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in
conjunction with a Nellcor Pulse Oximeter. The Medline ReNewal
Reprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR, is intended
for prescription use with adult patients in hospitals, hospital-type facilities,
and intra-hospital transport. The proposed device is not provided sterile | | |
5
Image /page/5/Picture/1 description: The image shows two logos side by side. The first logo is for Medline, and it features a blue star-like symbol with the word "MEDLINE" in blue letters next to it. The second logo is for ReNewal, and it features the word "ReNewal" in green and blue letters, with the words "Full Circle Reprocessing" in smaller blue letters below it.
Medline ReRenewal Reprocessed Nellcor OxiMax SpO2 Sensor, Model MAXNAR
| Statement of
Intended Use | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor is indicated
for the continuous non-invasive monitoring of functional oxygen saturation
of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with
adult patients in hospitals, hospital-type facilities and intra-hospital
transport. The device is for prescription use only. |
|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
(including
features,
materials and
principles of
operation) | The technological characteristics and the fundamental scientific technology
of the subject device are similar to the predicate devices. The proposed
device is a reprocessed Nellcor OxiMax SpO2 Sensor as are the devices
within the scope of predicate K181738. The proposed device uses use an
adhesive bandage, light source (LEDs), photodetector (Faraday
cage/photodiode), cable, and connector in the same manner as the
predicate devices. The predicate devices were used to support intended
use, technological characteristics, and performance specifications. (Also
see comparison of technological features in the Summary Table) |
| Performance
Testing
Nonclinical
Tests | The functional characteristics of the predicate and proposed devices were
examined in K181738 and were evaluated in accordance with Pulse
Oximeters - Premarket Notifications Submissions [510(k)] Guidance for
Industry and Food and Drug Administration Staff (March 4, 2013). Testing
included:
• Biocompatibility: cytotoxicity, sensitization, irritation; acute systemic
toxicity
• Disinfection
• Shelf Life
• Electrical
• Performance testing:
• tissue heating
• pulse rate accuracy
• active element assessment
• adhesive peel and
• environment (extreme heat and operating conditions)
• Cleaning:
• visual inspection;
• cleaning efficacy (residual protein and residual hemoglobin). |
| Performance
Testing
Clinical Tests | The purpose of the clinical trial in predicate submission K181738 (which
included proposed device Model MAXNAR) was to perform an oxygen
saturation (SpO2) accuracy comparison. The study was conducted in
accordance with CFR for Non-significant Risk Investigational Studies,
following ISO 14155:2011 Clinical Investigation of medical devices for
human subjects – Good clinical practice as appropriate and the pulse
oximeter guidelines of ISO 80601-2-61:2011 Procedure for invasive
laboratory testing on healthy volunteers applicable sections and Pulse
Oximeters - Premarket Notifications Submissions [510(k)] Guidance for
Industry and Food and Drug Administration Staff (March 4, 2013). After
Institutional Review Board Approval, 10 healthy adults volunteer subjects
(ages 25 to 36 yr.; weight 105 - 220 lb.; height 60 – 72 in.; BMI of 20.0 –
33.4) were included in the study which was conducted from May 9 to May |
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Image /page/6/Picture/1 description: The image contains two logos. The first logo is for Medline, and it features the word "MEDLINE" in a stylized font next to a blue star. The second logo is for ReNewal Full Circle Reprocessing, with the word "ReNewal" in green and the words "Full Circle Reprocessing" in blue below it.
| Performance
Testing
Clinical Tests
(concluded) | SpO2 accuracy of the proposed devices. The proposed devices achieved
an accuracy of 2% for 70% - 100% SpO2. The study concluded that the
SpO2 accuracy performance of the proposed devices passed the Arms
specification of 3% under steady state and non-motion conditions for the
range of 70% to 100%. | | |
|--------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Device Model | MAXNAR | | |
| Summary Table: Predicate (unmodified) and Proposed (modified) Medline ReNewal
Reprocessed Nellcor OxiMax SpO2 sensor comparison. | | | |
| | Predicate | Proposed | |
| Device
Characteristics | Medline ReNewal
Reprocessed
Nellcor OxiMax
SpO2 Sensors | Medline ReNewal
Reprocessed
Nellcor OxiMax
SpO2 Sensor, MAXNAR | Comparison |
| 510(k) Number | K181738 | TBD | N/A |
| Common Name | Oximeter | Oximeter | Same |
| Regulation No. | 870.2700 | 870.2700 | Same |
| Product Code | NLF | NLF | As stated |
| Models | MAXA, MAXAL, MAXP,
and MAXI | MAXNAR | As stated |
| Indications for Use | The Medline ReNewal
Reprocessed Nellcor
OxiMax SpO2 Sensors
models MAXA, MAXP
and MAXI are indicated
for single patient use
when continuous non-
invasive arterial oxygen
saturation and pulse rate
monitoring are required
for patients in the sizes
indicated in the
respective sensor
directions for use. These
devices are for
prescription use only. | The Medline ReNewal
Reprocessed Nellcor
OxiMax SpO2 Sensor
model MAXNAR is
indicated for single
patient use when
continuous non-invasive
arterial oxygen saturation
and pulse rate monitoring
is required for adult
patients as indicated in
the sensor directions for
use. This device is for
prescription use only. | Same |
| Intended Use | The reprocessed Nellcor
OxiMax SpO2 Sensors
are indicated for the
continuous non-invasive
monitoring of functional
oxygen saturation of
arterial hemoglobin
(SpO2) and pulse rate.
They are intended for use
with pediatric and adult
patients in hospitals, | The reprocessed Nellcor
OxiMax SpO2 Sensor is
indicated for the
continuous non-invasive
monitoring of functional
oxygen saturation of
arterial hemoglobin
(SpO2) and pulse rate. It
is intended for use with
adult patients in
hospitals, hospital-type | Same |
| | Predicate | Proposed | |
| Device
Characteristics | Medline ReNewal
Reprocessed
Nellcor OxiMax
SpO2 Sensors | Medline ReNewal
Reprocessed
Nellcor OxiMax
SpO2 Sensor, MAXNAR | Comparison |
| Intended Use
(concluded) | hospital-type facilities,
and intra-hospital
transport. These devices
are for prescription use
only. | facilities, and intra-hospital transport.
This device is for prescription
use only. | Same |
| Comparison of
technological
features | The reprocessed Nellcor
OxiMax SpO2 Sensors
measure functional
oxygen saturation non-
invasively via a light
signal interacting with
tissue, by utilizing the
time-varying changes in
tissue optical properties
that occur with pulsatile
blood flow. Red and
infrared light-emitting
diodes (LEDS) are
utilized as light sources.
A photodiode acting as a
photo detector senses
the signal strengths of
the two wavelengths of
light, which vary with the
amount of light
transmitted through the
tissue. The pulse
oximeter receives this
electrical information
from the sensor and
processes the
information by use of an
algorithm to provide real
time values of SpO2,
pulse rate and pulse
amplitude. | The reprocessed Nellcor
OxiMax SpO2 Sensor
measures functional
oxygen saturation non-
invasively, via a light
signal interacting with
tissue, by utilizing the
time-varying changes in
tissue optical properties
that occur with pulsatile
blood flow. Red and
infrared light-emitting
diodes (LEDS) are
utilized as light sources.
A photodiode acting as a
photo detector senses
the signal strengths of
the two wavelengths of
light, which vary with the
amount of light
transmitted through the
tissue. The pulse
oximeter receives this
electrical information
from the sensor and
processes the
information by use of an
algorithm to provide real
time values of SpO2,
pulse rate and pulse
amplitude. | Same |
| Intended patient
population | Adult (MAXA, MAXAL),
Pediatric (MAXP), Infant
(MAXI) | Adult | Same as Predicate
MAXA, MAXAL |
| Device
Characteristics | Predicate
Medline ReNewal
Reprocessed
Nellcor OxiMax
SpO2 Sensors | Proposed
Medline ReNewal
Reprocessed
Nellcor OxiMax
SpO2 Sensor, MAXNAR | Comparison |
| Patient Weight
Range | • > 30 kg = adult (MAXA,
MAXAL)
• 10 - 50 kg = pediatric
(MAXP)
• 3 - 20 kg = infants (MAXI) | • > 40 kg = adult | Same
Within weight
range of Predicate
MAXA, MAXAL |
| Application site | • Finger = MAXA, MAXL,
MAXP
• Toe or digit of similar
size = MAXI | • Finger | Same as predicate
MAXA, MAXAL,
MAXP |
| Single Use | Yes | Yes | Same |
| Use Environment | Hospitals, hospital-type
facilities, and
intra-hospital transport | Hospitals, hospital-type
facilities, and
intra-hospital transport | Same |
| Measurement
Parameter | Oxygen saturation, pulse
rate | Oxygen saturation, pulse
rate | Same |
| Monitor system
compatibility | Nellcor OxiMax and
Nellcor compatible pulse
oximeters | Nellcor OxiMax and
Nellcor compatible pulse
oximeters | Same |
| Specified SpO2
measurement
range | 70% - 100% (MAXA,
MAXAL, MAXP, MAXI) | 70% - 100% | Same |
| SpO2 accuracy | 70% - 100% ± 2 digits in
adults (MAXA, MAXAL,
MAXP, MAXI) | 70% - 100% ± 2 digits in
adults | Same |
| Pulse rate
measurement
range (bpm) | 20 - 250 bpm (MAXA,
MAXAL, MAXP, MAXI) | 20 - 250 bpm | Same |
| Pulse rate accuracy
(bpm) | 20 - 250 ± 3 digits
(MAXA, MAXAL, MAXP,
MAXI) | 20 - 250 ± 3 digits | Same |
| Temperature
Operational/
Storage | Operational = 5°C - 40°C
Storage = 20°C - 60°C | Operational = 5°C - 40°C
Storage = 20°C - 60°C | Same |
| Relative humidity | 15% - 95% non-
condensing | 15% - 95% non-
condensing | Same |
| Device
Characteristics | Predicate | Proposed | |
| | Medline ReNewal
Reprocessed
Nellcor OxiMax
SpO2 Sensors | Medline ReNewal
Reprocessed
Nellcor OxiMax
SpO2 Sensor, MAXNAR | Comparison |
| Optical design | Transmissive sensor | Transmissive sensor | Same |
| Housing design | Adhesive bandage | Adhesive bandage | Same |
| Conclusion | The subject device has the same intended use as the proposed predicate
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 Medline ReNewal
Reprocessed Nellcor O2 Sensor, Model MAXNAR is substantially
equivalent to the predicate device. | | |
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Image /page/7/Picture/1 description: The image contains two logos. The first logo is for Medline, and it features the word "MEDLINE" in a stylized font next to a blue star-like symbol. The second logo is for ReNewal, and it features the word "ReNewal" in green and blue, with the words "Full Circle Reprocessing" underneath.
Summary Table (continued)
8
Image /page/8/Picture/1 description: The image contains two logos. The first logo is for Medline, and it features the word "MEDLINE" in a stylized font next to a star-like symbol. The second logo is for ReNewal Full Circle Reprocessing, with "ReNewal" in green and blue and "Full Circle Reprocessing" underneath in a smaller font.
Summary Table (continued)
9
Image /page/9/Picture/1 description: The image shows two logos side by side. The logo on the left is for Medline, and it features a blue background with a white star-like symbol and the word "MEDLINE" in white letters. The logo on the right is for ReNewal, and it features the word "ReNewal" in green and blue letters, with the words "Full Circle Reprocessing" in smaller letters below.
Summary Table (concluded)
10
Image /page/10/Picture/1 description: The image shows two logos side by side. The logo on the left is for Medline, and it features the word "MEDLINE" in blue with a stylized star above it. The logo on the right is for ReNewal Full Circle Reprocessing, with "ReNewal" in green and blue and "Full Circle Reprocessing" in a smaller font below it.
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