(77 days)
No
The summary describes a reprocessed pulse oximetry sensor and its performance testing, with no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is for monitoring SpO2 and pulse rate, not for providing therapy or treating a condition.
Yes
The device is indicated for "continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," which provides physiological data used to assess a patient's condition, hence fitting the definition of a diagnostic device.
No
The device description explicitly states it is a "Reprocessed Masimo LNCS Adult and Pediatric SpO2 Adhesive Sensors" and details performance testing including biocompatibility, disinfection, shelf life, packaging, electrical, and tissue heating, all of which are related to physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The Medline ReNewal Reprocessed Masimo LNCS Adult and Pediatric SpO2 Adhesive Sensors are used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. This is done by placing the sensor on the patient's finger, not by analyzing a sample taken from the body.
- Intended Use: The intended use clearly states "continuous noninvasive monitoring."
- Device Description: The description reinforces the non-invasive nature of the device, used in conjunction with instruments containing oximetry.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Medline ReNewal Reprocessed Masimo LNCS Adult and Pediatric SpO2 Adhesive Sensors are indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult and pediatric patients during no motion conditions, and for patients who are well perfused in hospitals and hospital-type facilities.
Product codes (comma separated list FDA assigned to the subject device)
DQA, NLF
Device Description
Medline ReNewal Reprocessed Masimo LNCS Adult and Pediatric SpO2 Adhesive Sensors, models LNCS Adtx, LNCS Pdtx, LNCS Adtx-3, and LNCS Pdtx-3 are designed for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in conjunction with instruments containing Masimo SET oximetry or licensed to use LNCS sensors. The Medline ReNewal Reprocessed Masimo LNCS sensor models LNCS Adtx, LNCS Pdtx, LNCS Adtx-3, and LNCS Pdtx-3 are intended for prescription use with adult and pediatric 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
• >30 kg = middle or ring finger of non-dominant hand (adult) Adtx, Adtx-3)
• 10 - 50 kg = middle or ring finger of non-dominant hand (pediatric) Pdtx, Pdtx-3
Indicated Patient Age Range
Adult and Pediatric
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
The purpose of the clinical trial 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 10, 2018 to evaluate the SpO2 accuracy of the proposed devices.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing Nonclinical Tests: The functional characteristics of the subject device have been evaluated in accordance with Pulse Oximeters – Premarket Notifications Submissions [510(k)] Guidance for Industry and Food and Drug Administration Staff (March 4, 2013) and have been determined to be substantially equivalent to the predicate device based on the following tests:
• Biocompatibility: cytotoxicity, sensitization, irritation
• Disinfection
• Shelf Life
• Packaging
• 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 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 10, 2018 to evaluate the 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.
Pulse rate accuracy: 25 - 240 bpm ± 3 digits for adults/pediatrics.
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.
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 3, 2019
Surgical Instrument Service and Savings Inc Stephanie Boyle Mays Senior Regulatory Specialist, Quality Assurance and Regulatory Affairs (dba Medline ReNewal) 1500 NE Hemlock Ave. Redmond, Oregon 97756
Re: K191018
Trade/Device Name: Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors (models LNCS Adtx, LNCS Pdtx, LNCS Adtx-3, and LNCS Pdtx-3) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: May 7, 2019 Received: May 8, 2019
Dear Stephanie Boyle 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.
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 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191018
Device Name
Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors
Indications for Use (Describe)
The Medline ReNewal Reprocessed Masimo LNCS Adult and Pediatric SpO2 Adhesive Sensors are indicated for single patient use for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult and pediatric patients during no motion conditions, and for patients who are well 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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| OEM Device
| Modela | Device Name | OEM |
|---|---|---|
| LNCS Adtx | ||
| (part number 1859) | Masimo LNCS Adhesive Sensor | |
| (Masimo Adult SpO2 Sensor, |
30 kg, 18 inches) | Masimo Corporation |
| LNCS Adtx-3
(part number 2317) | Masimo LNCS Adhesive Sensor
(Masimo Adult SpO2 Sensor,
30 kg, 3 feet) | Masimo Corporation |
| LNCS Pdtx
(part number 1860) | Masimo LNCS Adhesive Sensor
(Masimo Pediatric SpO2 Sensor,
10 - 50 kg, 18 inches) | Masimo Corporation |
| LNCS Pdtx-3
(part number 2318) | Masimo LNCS Adhesive Sensor
(Masimo Pediatric SpO2 Sensor,
10 - 50 kg, 3 feet) | Masimo Corporation |
| a OEM = original equipment manufacturer. | | |
K191018 Reprocessed Masimo LNCS Adhesive Sensors included in Submission:
4
Image /page/4/Picture/0 description: The image contains the Medline and Renewal logos. The Medline logo is a blue square with a white star and the word "MEDLINE" in white letters. The Renewal logo is in green and blue and says "Renewal" in large letters and "Full Circle Reprocessing" in smaller letters below. There is a trademark symbol next to the word Renewal.
K191018 510(k) Summary
This 510(k) summary of 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 | April 12, 2019 | |
| Device Name
and
Classification | Proprietary/Trade Name: | Medline ReNewal Reprocessed Masimo LNCS Adult
and Pediatric SpO2 Adhesive Sensors |
| | Common or usual name | Oximeter, reprocessed |
| | Regulatory Name/Reference: | Oximeter; 21 CFR § 870.2700 |
| | Regulatory Class: | Class II |
| | Product Code: | NLF |
| | Panel: | Anesthesiology |
| Predicate
Device | 510(k) number: | K101896 |
| | Proprietary/Trade Name: | K101896 Masimo LNCS/M-LNCS Oximetry Sensors |
| | Common or usual name | Oxygen sensor |
| | Regulatory Name/Reference: | Oximeter; 21 CFR § 870.2700 |
| | Regulatory Class: | Class II |
| | Product Code: | DQA |
| | Panel: | Anesthesiology |
| | Manufacturer: | Masimo Corporation
40 Parker, Irvine, CA 92618 |
| Reference
Device | 510(k) number: | K181738 |
| | Proprietary/Trade Name: | Medline ReNewal Reprocessed Nellcor OxiMax SpO2
Sensors |
| | Common or usual name | Oximeter, reprocessed |
| | Regulatory Name/Reference: | Oximeter; 21 CFR § 870.2700 |
| | Regulatory Class: | Class II |
| | Product Code: | NLF |
| | Panel: | Anesthesiology |
| | Manufacturer: | Medline ReNewal
1500 NE Hemlock Ave., Redmond, OR 97756 |
| Device
Description | Medline ReNewal Reprocessed Masimo LNCS Adult and Pediatric SpO2
Adhesive Sensors, models LNCS Adtx, LNCS Pdtx, LNCS Adtx-3, and
LNCS Pdtx-3 are designed for the continuous non-invasive monitoring of
functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in
conjunction with instruments containing Masimo SET oximetry or licensed
to use LNCS sensors. The Medline ReNewal Reprocessed Masimo LNCS
sensor models LNCS Adtx, LNCS Pdtx, LNCS Adtx-3, and LNCS Pdtx-3
are intended for prescription use with adult and pediatric patients in
hospitals, hospital-type facilities, and intra-hospital transport.
The proposed device is not provided sterile. | |
| Statement of
Intended
Use/Indications
for Use | The Medline ReNewal Reprocessed Masimo LNCS Adult and Pediatric SpO2
Adhesive Sensors are indicated for single patient use for continuous
noninvasive monitoring of functional oxygen saturation of arterial
hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use
with adult and pediatric patients during no motion conditions, and for
patients who are well perfused in hospitals and hospital-type facilities. | |
| Technological
Characteristics | The technological characteristics and the fundamental scientific technology
of the subject devices are identical to the predicate devices. The proposed
devices are a reprocessed version of the predicate K101896 devices.
These devices 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.)
Comparison of Technological Features | |
| Performance
Testing
Nonclinical
Tests | The functional characteristics of the subject device have been evaluated in
accordance with Pulse Oximeters – Premarket Notifications Submissions
[510(k)] Guidance for Industry and Food and Drug Administration Staff
(March 4, 2013 ) and have been determined to be substantially equivalent
to the predicate device based on the following tests:
• Biocompatibility: cytotoxicity, sensitization, irritation
• Disinfection
• Shelf Life
• Packaging
• 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 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 10, 2018 to evaluate the
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 Models | LNCS Adtx, LNCS Pdtx, LNCS Adtx-3, and LNCS Pdtx-3 | |
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Image /page/5/Picture/0 description: The image shows the Medline Renewal Full Circle Reprocessing logo. The Medline logo is on the left side of the image and is a blue square with a white cross inside. The Renewal logo is on the right side of the image and is green and blue. The words "Full Circle Reprocessing" are below the Renewal logo.
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Image /page/6/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left side of the image and is a blue square with a white cross inside. The Renewal logo is on the right side of the image and is green and blue. The words "Full Circle Reprocessing" are below the Renewal logo.
Summary continued on next page.
[This area of page was left blank intentionally]
7
Image /page/7/Picture/0 description: The image contains the Medline and Renewal logos. The Medline logo is on the left and consists of a blue square with a white cross and the word "MEDLINE" in white letters. The Renewal logo is on the right and consists of the word "Renewal" in green letters, with the words "Full Circle Reprocessing" in smaller blue letters below it. There is a trademark symbol next to the word Renewal.
| Device
Characteristics | Predicate
Masimo LNCS Sensors | Reference
Medline ReNewal
Reprocessed
Nellcor OxiMax SpO2
Sensors | Proposed
Medline ReNewal
Reprocessed Masimo LNCS
Adult and Pediatric SpO2
Adhesive Sensors | Comparison |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K101896 | K181738 | TBD | N/A |
| Common Name | Oximeter | Oximeter | Oximeter | Same |
| Regulation No. | 870.2700 | 870.2700 | 870.2700 | Same |
| Product Code | DQA | NLF | NLF | As stated |
| Models | LNCS/M-LNCS | Nellcor MAXA, MAXA,
MAXAL, MAXP, and MAXI | LNCS Adtx, LNCS Pdtx, LNCS
Adtx-3, and LNCS Pdtx-3 | As stated |
| Intended Use/
Indications for
Usea | The LNCS/M-LNCS 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 and motion
conditions, and for patients who
are well or poorly perfused in
hospitals, hospital-type facilities,
mobile and home environments. | Medline ReNewal
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 infant, pediatric
and adult patients in hospitals,
hospital-type facilities, and
intra-hospital transport. These
devices are for prescription
use only. | The Medline ReNewal
Reprocessed Masimo LNCS
Adult and Pediatric SpO2
Adhesive Sensors are
indicated for single patient use
for continuous noninvasive
monitoring of functional oxygen
saturation of arterial
hemoglobin (SpO2) and pulse
rate (measured by an SpO2
sensor) for use with adult and
pediatric patients during no
motion conditions, and for
patients who are well perfused
in hospitals and hospital-type
facilities | Medline ReNewal will
not make claims for
infant or neonatal use,
for motion or low
perfusion performance;
or for use in home
environment otherwise
same as stated |
Predicate, reference and Medline ReNewal Reprocessed Masimo LNCS sensor comparison tables. Summary:
Continued
8
Image /page/8/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left side of the image and is a blue square with the word "MEDLINE" in white letters and a white cross symbol. To the right of the Medline logo is the word "Renewal" in green letters, with the words "Full Circle Reprocessing" in blue letters below it. The Renewal logo has a trademark symbol in the upper right corner.
| Summary: | Predicate, reference and Medline ReNewal Reprocessed Masimo LNCS sensor comparison table (continued). | |||
|---|---|---|---|---|
| Predicate | Reference | Proposed | ||
| Device | ||||
| Characteristics | Masimo LNCS Sensors | Medline ReNewal | ||
| Reprocessed | ||||
| Nellcor OxiMax SpO2 | ||||
| Sensors | Medline ReNewal | |||
| Reprocessed Masimo LNCS | ||||
| Adult and Pediatric SpO2 | ||||
| Adhesive Sensors | Comparison | |||
| Technological | ||||
| characteristics | The Masimo Pulse Oximeter | |||
| System 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 | The predicate device and the | |||
| Medline ReNewal reprocessed | ||||
| device contain dual | ||||
| wavelength LED and | ||||
| photodiode. The LED and | ||||
| photodiode are encased in a | ||||
| pad which attach to the patient | ||||
| using adhesive material. The | ||||
| sensors are connected to a | ||||
| cable and they terminate in a | ||||
| pin connector. | ||||
| Biocompatibility and | ||||
| performance/functional testing | ||||
| demonstrate that the devices | ||||
| are equivalent and are safe | ||||
| and effective for their intended | ||||
| use. | The principle of operation of | |||
| the reprocessed devices is | ||||
| identical to that of the | ||||
| predicates. There are no | ||||
| changes in performance | ||||
| specifications or method of | ||||
| operation. These devices use | ||||
| an adhesive bandage, light | ||||
| source (LEDs), photodetector | ||||
| (Faraday cage/photodiode), | ||||
| cable, and connector in the | ||||
| same manner as the predicate | ||||
| devices. | As stated | |||
| Medline ReNewal will | ||||
| not make claims for | ||||
| motion or low perfusion | ||||
| performance; otherwise | ||||
| same as written | ||||
| Summary: | Predicate, reference and Medline ReNewal Reprocessed Masimo LNCS sensor comparison table (continued). | |||
| Device | ||||
| Characteristics | Predicate | Reference | Proposed | |
| Masimo LNCS Sensors | Medline ReNewal | |||
| Reprocessed | ||||
| Nellcor OxiMax SpO2 | ||||
| Sensors | Medline ReNewal | |||
| Reprocessed Masimo LNCS | ||||
| Adult and Pediatric SpO2 | ||||
| Adhesive Sensors | Comparison | |||
| Intended Patient | ||||
| Population | Adult, Pediatric, Infant, Neonatal | |||
| and Preterm | Adult, Pediatric, Infant | Adult, Pediatric | As stated | |
| Patient Weight | ||||
| Range | • >30 kg = adult (Adtx, Adtx-3) | |||
| • 10 - 50 kg = pediatric (Pdtx, | ||||
| Pdtx-3) | ||||
| • 3 - 20 kg = infants (Inf, Inf-L, | ||||
| Inf-3) | ||||
| • 40 kg = | ||||
| adults (Neo, Neo-L, Neo-3) | ||||
| • 30 kg = adult (MAXA, | ||||
| MAXAL) | ||||
| • 10 - 50 kg = pediatric | ||||
| (MAXP) | ||||
| • 3 - 20 kg = infants (MAXI) | • >30 kg = adult (Adtx, Adtx-3) | |||
| • 10 - 50 kg = pediatric (Pdtx, | ||||
| Pdtx-3) | Same as shared | |||
| models | ||||
| Preferred | ||||
| Application Site | • >30 kg = middle or ring finger | |||
| of non-dominant hand (adult - | ||||
| Adtx, Adtx-3) | ||||
| • 10 - 50 kg = middle or ring | ||||
| finger of non-dominant hand | ||||
| (pediatric - Pdtx, Pdtx-3) | ||||
| • 3 - 20 kg = great toe (infants - | ||||
| Inf, Inf-L, Inf-3) | ||||
| • 40 kg | ||||
| = middle or ring finger or non- | ||||
| dominant hand (adult - Neo, | ||||
| Neo-L, Neo-3) | ||||
| • 30 kg = middle or ring | ||||
| finger of non-dominant hand | ||||
| (adult) Adtx, Adtx-3) | ||||
| • 10 - 50 kg = middle or ring | ||||
| finger of non-dominant hand | ||||
| (pediatric) Pdtx, Pdtx-3 | Same as shared | |||
| models | ||||
| Summary: | Predicate, reference and Medline ReNewal Reprocessed Masimo LNCS sensor comparison table. (continued). | |||
| Device | ||||
| Characteristics | Predicate | Reference | Proposed | Comparison |
| Masimo LNCS Sensors | Medline ReNewal | |||
| Reprocessed | ||||
| Nellcor OxiMax SpO2 | ||||
| Sensors | Medline ReNewal | |||
| Reprocessed Masimo LNCS | ||||
| Adult and Pediatric SpO2 | ||||
| Adhesive Sensors | ||||
| Single Use | Yes | Yes | Yes | Same |
| Use Environment | Hospitals, hospital-type | |||
| facilities, mobile and home | ||||
| environments | Hospitals, hospital-type | |||
| facilities, and intra-hospital | ||||
| transport | Hospitals and hospital-type | |||
| facilities | As stated | |||
| Measurement | ||||
| Parameter | Oxygen saturation, pulse rate | Oxygen saturation, pulse rate | Oxygen saturation, pulse rate | Same |
| Monitor system | ||||
| compatibility | Instruments containing | |||
| Masimo SET oximetry or | ||||
| licensed to use LNCS sensors | ||||
| and also with Nellcor and | ||||
| Nellcor compatible pulse | ||||
| oximeters | Nellcor OxiMax and Nellcor | |||
| compatible pulse oximeters | Instruments containing | |||
| Masimo SET oximetry or | ||||
| licensed to use LNCS sensors | As stated | |||
| Specified Sp02 | ||||
| measurement range | 70% - 100% for | |||
| adults/pediatrics/ infants/ | ||||
| neonates | 70% - 100% for adults, | |||
| pediatrics, infants | 70% - 100% for | |||
| adults/pediatrics | Medline ReNewal is | |||
| same as predicate | ||||
| SpO2 accuracy | 70% - 100% ± 2 digits for | |||
| adults/pediatrics/ infants and | ||||
| ±3 for neonates | 70% - 100% ± 3 digits for | |||
| adults/pediatrics/ infants | 70% - 100% ± 2 digits for | |||
| adults/pediatrics | Same | |||
| Pulse rate | ||||
| measurement range | 25 – 240 bpm for | |||
| adults/pediatrics/ infants/ | ||||
| neonates per Masimo monitor | ||||
| manual | 20 - 240 bpm for | |||
| adults/pediatrics/ infants | 25 - 240 bpm adults/pediatrics | Medline ReNewal is | ||
| same as predicate | ||||
| Pulse rate accuracy | 25 - 240 bpm ± 3 digits for | |||
| adults/ pediatrics/ infants/ | ||||
| neonatesb | 20 - 250 bpm ± 3 digits for | |||
| adults/ pediatrics/ infants | 25 - 240 bpm ± 3 digits for | |||
| adults/ pediatrics | Medline ReNewal is | |||
| same as predicate | ||||
| Summary: Predicate, reference and Medline ReNewal Reprocessed Masimo LNCS sensor comparison table. (concluded). | ||||
| Device | ||||
| Characteristics | Predicate | Reference | Proposed | |
| Masimo LNCS Sensors | Medline ReNewal | |||
| Reprocessed | ||||
| Nellcor OxiMax SpO2 | ||||
| Sensors | Medline ReNewal | |||
| Reprocessed Masimo LNCS | ||||
| Adult and Pediatric SpO2 | ||||
| Adhesive Sensors | Comparison | |||
| Temperature | ||||
| Operational/ | ||||
| Storage | Operational = 5°C - 40°C | |||
| Storage = -40°C - 70°C | Operational = 5°C - 40°C | |||
| Storage = -20°C - 60°C | Operational = 5°C - 40°C | |||
| Storage = -40°C - 70°C | Medline ReNewal is | |||
| same as predicate | ||||
| Humidity | 5% to 95% | 15% to 95% non-condensing | 5% to 95% | Medline ReNewal is |
| same as predicate | ||||
| Optical Design | Transmissive sensor | Transmissive sensor | Transmissive sensor | Same |
| Housing Design | Adhesive bandage | Adhesive bandage | Adhesive bandage | Same |
| a Indications for use/Intended use were the same category in K101896. The K101896 material was obtained from the FDA 510(k) database. | ||||
| b Pulse rate accuracy for the K101896 predicate is in accordance with the Masimo monitor manuals Rad-7 and Rad-8. |
9
Image /page/9/Picture/0 description: The image contains the logo for "ReNewal Full Circle Reprocessing". The word "ReNewal" is in a large, bold, green font, with the "R" slightly larger than the rest of the letters. Below "ReNewal" is the phrase "Full Circle Reprocessing" in a smaller, dark blue font. To the left of the text is a dark blue square containing the word "MEDLINE" in white letters, with a white cross-like symbol above it.
Predicate, reference and Medline ReNewal Reprocessed Masimo LNCS sensor comparison table (continued).
10
Image /page/10/Picture/0 description: The image contains the logos for Medline and Renewal. The Medline logo is on the left side of the image and consists of the word "MEDLINE" in white text on a blue square with a white cross symbol. To the right of the Medline logo is the Renewal logo, which consists of the word "Renewal" in green text and the words "Full Circle Reprocessing" in blue text below it.
Predicate, reference and Medline ReNewal Reprocessed Masimo LNCS sensor comparison table. (continued),
11
Image /page/11/Picture/0 description: The image contains the logo for "ReNewal Full Circle Reprocessing". The word "ReNewal" is in a large, bold, green font, with the "R" slightly larger than the rest of the letters. Below "ReNewal" is the phrase "Full Circle Reprocessing" in a smaller, dark blue font. To the left of the text is a dark blue square containing the word "MEDLINE" in white letters, with a white cross-like symbol above it.
12
Image /page/12/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and it is a blue square with a white cross inside. The word "MEDLINE" is written in white letters above the cross. To the right of the Medline logo is the word "Renewal" in green and blue letters. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in blue letters.
| Conclusion | Based on a comparison of the intended use/indications for use,
technological characteristics, and performance data to the predicate
devices, Medline ReNewal Reprocessed Masimo LNCS Sensors Adult and
Pediatric SpO2 Adhesive Sensors are substantially equivalent to the
predicate device. |
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