(263 days)
No
The summary describes a reprocessed pulse oximeter sensor, a standard medical device for measuring oxygen saturation and pulse rate. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The focus is on the accuracy of the sensor's measurements.
No
The device is a sensor used for monitoring physiological parameters (oxygen saturation and pulse rate), not for providing therapy.
Yes
The device is a non-invasive arterial oxygen saturation and pulse rate monitor, which are diagnostic indicators of health status.
No
The device description clearly states that the device is a "Reprocessed Nellcor OxiMax SpO2 Sensor," which is a physical sensor designed for continuous non-invasive monitoring. It is a hardware component that attaches to a patient.
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.
- Device Function: The description clearly states that this device is a non-invasive sensor used for continuous noninvasive arterial oxygen saturation and pulse rate monitoring. It works by being placed on the patient's finger, toe, or similar digit. It does not involve taking any samples from the body for testing.
Therefore, based on the provided information, the Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors are not IVDs. They are considered in vivo devices as they are used directly on the patient's body.
N/A
Intended Use / Indications for Use
The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors models MAXAL, MAXP, and MAXI are indicated for single patient use when continuous noninvasive 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.
Product codes (comma separated list FDA assigned to the subject device)
NLF
Device Description
The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors, models MAXA, MAXAL, MAXP, and MAXI are 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 Reprocessed Nellcor OxiMax SpO2 Sensors, models MAXA, MAXAL, MAXP, and MAXI are intended for prescription use with adult, pediatric and infant 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, Pediatric, Infant
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D) for use in 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
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)
Clinical Tests:
Study type: Oxygen saturation (SpO2) accuracy comparison.
Sample size: 10 healthy adults volunteer subjects.
Key results: 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%.
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; 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 accuracy: 2% for 70% - 100% SpO2.
Pulse rate accuracy: 20 - 250 bpm ± 3 digits
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). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency's name in a lighter blue font.
Surgical Instrument Service and Savings Inc (dba Medline) % Stephanie Boyle Mays Regulatory Specialist, Quality Assurance and Regulatory Affairs Surgical Instrument Service and Savings Inc (dba Medline ReNewal) 1500 NE Hemlock Ave. Redmond, Oregon 97756
Re: K181738
Trade/Device Name: Medline ReNewal Reprocessed Nellcor OxiMax Spoz Sensors, models MAXA, MAXAL, MAXP, and MAXI Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: NLF Dated: February 18, 2019 Received: February 19, 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 D. Courtney -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181738
Device Name
Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors Models MAXAL, MAXP and MAXI
Indications for Use (Describe)
The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors models MAXAL, MAXP, and MAXI are indicated for single patient use when continuous noninvasive 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.
| 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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3
Image /page/3/Picture/1 description: The image shows two logos side by side. The first logo is for Medline, and it features a blue square with a white star-like symbol and the word "MEDLINE" in white letters. 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 letters below.
K181738 510(k) Summary
This 510(k) summary 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
Regulatory Affairs Specialist, Quality Assurance/Regulatory Affairs
P: 541-516-4205 • F: 541-923-3375 • E:smays@medline.com | |
| Date Prepared | February 18, 2019 | |
| Device Name
and
Classification | 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 |
| Predicate
Device | 510(k) number: | K052186 |
| | Proprietary/Trade Name: | Nellcor OxiMax Pulse Oximeter Sensors, models
MAX-A, MAX-AL, MAX-N, MAX-P, MAX-I and MAX-FAST |
| | Common or usual name | Oxygen sensor |
| | Regulatory Name/Reference: | Oximeter; 21 CFR § 870.2700 |
| | Regulatory Class: | Class II |
| | Product Code: | DQA |
| | Panel: | Cardiovascular/anesthesiology |
| | Manufacturer: | Nellcor Puritan Bennett, Inc.
4280 Hacienda Dr., Pleasanton, CA 94588 |
| Reference
Device | 510(k) number: | K041867 |
| | Proprietary/Trade Name: | Hygia Health Services Reprocessed OxiMax Sensors
Model # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N |
| | Regulatory Name/Reference: | Oximeter; 21 CFR § 870.2700 |
| | Common or usual name | Oximeter, reprocessed |
| | Regulatory Class: | II |
| | Product Code: | NLF |
| | Panel: | Cardiovascular/anesthesiology |
| | Manufacturer: | Hygia Health Services, Inc. |
| Statement of
Indications for
Use | The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors models
MAXA, MAXAL, MAXP, and MAXI are indicated for single patient use when
continuous noninvasive 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. | |
| Device
Description | The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors,
models MAXA, MAXAL, MAXP, and MAXI are 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 Reprocessed Nellcor OxiMax SpO2 Sensors, models MAXA,
MAXAL, MAXP, and MAXI are intended for prescription use with adult,
pediatric and infant patients in hospitals, hospital-type facilities, and intra-
hospital transport. The proposed device is not provided sterile. | |
| Statement of
Intended Use | 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. | |
| Technology
(including
features,
materials and
principles of
operation) | The technological characteristics and the fundamental scientific technology
of the subject devices are identical to the predicate and reference devices.
The proposed devices are a reprocessed version of the predicate K052186
device. 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 and reference
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 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; 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 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 | MAXA, MAXAL, MAXP, and MAXI | |
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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 the company name in bold, sans-serif font, accompanied by a stylized star-like graphic. The logo on the right is for ReNewal, with the words "Full Circle Reprocessing" underneath. The ReNewal logo has the "Re" in green and the "Newal" in blue.
5
Image /page/5/Picture/1 description: The image contains two logos. The first logo is for Medline, and it features the word "MEDLINE" in a sans-serif font, with a blue star-like symbol above it. The second logo is for Renewal, and it features the word "Renewal" in a combination of green and blue, with the words "Full Circle Reprocessing" underneath it in a smaller font.
Summary continued on next page.
[This area of page was left blank intentionally]
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Image /page/6/Picture/1 description: The image shows two logos side by side. The logo on the left is for Medline, and it features a blue square 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" underneath in smaller blue letters.
| Summary Table: Predicate, Reference and Revocessed Covidien Nellor OxiMax pulse oximeter sensor comparison. | ||||||
|---|---|---|---|---|---|---|
| -- | -- | -- | -------------------------------------------------------------------------------------------------------------- | -- | -- | -- |
| Predicate | Reference | Proposed | Comparison | |
|---|---|---|---|---|
| Device | ||||
| Characteristics | Covidien Nellcor | |||
| OxiMax Pulse Oximeter | ||||
| Sensors | Hygia Health Services | |||
| Reprocessed OxiMax Sensors | Medline ReNewal | |||
| Reprocessed Nellcor OxiMax | ||||
| Sp02 Sensors | Same devices; | |||
| original and | ||||
| reprocessed | ||||
| 510(k) Number | K052186 | K041867 | K181738 | 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 | MAXA, MAXAL, MAXN, MAXP, | |||
| MAXI and MAXFAST | MAXA, MAXAL, MAXN | MAXA, MAXAL, MAXP, and | ||
| MAXI | As stated | |||
| Indications for use | The Nellcor OxiMax Pulse | |||
| Oximetry Sensors, models | ||||
| MAX-A, MAX-AL, MAX-N, MAX- | ||||
| P, MAX-I and MAX-FAST are | ||||
| indicated for single patient use | ||||
| when continuous noninvasive | ||||
| arterial oxygen saturation and | ||||
| pulse rate monitoring are | ||||
| required for patients in the sizes | ||||
| indicated in the respective | ||||
| sensor directions for use. | The sensor is indicated for use | |||
| as a non-invasive method to | ||||
| provide continuous SpO2 | ||||
| monitoring and pulse rate. | The Medline ReNewal | |||
| Reprocessed Nellcor OxiMax | ||||
| SpO2 Sensors models MAXA, | ||||
| MAXAL, MAXP, and MAXI are | ||||
| indicated for single patient use | ||||
| when continuous noninvasive | ||||
| 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 predicate and | |||
| proposed devices | ||||
| have the same | ||||
| indications. The | ||||
| predicate and | ||||
| reference devices | ||||
| share the same | ||||
| predicate, | ||||
| K012891. | ||||
| Intended use | The OxiMax Pulse Oximeter | |||
| System 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 neonatal, | ||||
| pediatric, and adult patients | None listed | 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 | Medline Renewal | |||
| will only reprocess | ||||
| pulse oximeter | ||||
| sensors. Medline | ||||
| ReNewal will not | ||||
| make claims for | ||||
| neonatal use or for | ||||
| motion or low | ||||
| Device | ||||
| Characteristics | Predicate | Reference | Proposed | Comparison |
| Covidien Nellcor | ||||
| OxiMax Pulse Oximeter | ||||
| Sensors | Hygia Health Services | |||
| Reprocessed OxiMax Sensors | Medline ReNewal | |||
| Reprocessed Nellcor OxiMax | ||||
| SpO2 Sensors | ||||
| Intended use | ||||
| concluded | during both no motion and | |||
| motion conditions and for | ||||
| patients who are either well or | ||||
| poorly perfused, in hospitals, | ||||
| hospital-type facilities, intra- | ||||
| hospital transport, and home | ||||
| environments. These devices | ||||
| are for prescription only. | patients in hospitals, hospital- | |||
| type facilities, and intra-hospital | ||||
| transport. These devices are for | ||||
| prescription use only. | perfusion | |||
| performance; | ||||
| otherwise same as | ||||
| written | ||||
| Comparison of | ||||
| technological | ||||
| features | The OxiMax 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 | The predicate device and the | |||
| Hygia reprocessed device | ||||
| contain dual wavelength LED | ||||
| and photodiode. The LED and | ||||
| photodiode are encased in a pad | ||||
| which attached 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 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 | 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. Medline | ||||
| ReNewal, however, | ||||
| will only reprocess | ||||
| the proposed | ||||
| devices and not | ||||
| any other monitors, | ||||
| components or | ||||
| accessories of the |
7
Image /page/7/Picture/0 description: The image shows two logos side by side. The logo on the left is for Medline, and it features a blue square 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 blue letters below.
Summary Table: Predicate, Reference and Medline ReNewal Reprocessed OxiMax comparison (continued).
8
Image /page/8/Picture/0 description: The image shows two logos side by side. The logo on the left is for Medline, and it features a blue square 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 blue letters below.
Summary Table: Predicate, Reference and Medline ReNewal Reprocessed OxiMax comparison (continued).
| Device
| Characteristics | Predicate | Reference | Proposed | Comparison |
|---|---|---|---|---|
| Covidien Nellcor | ||||
| OxiMax Pulse Oximeter | ||||
| Sensors | Hygia Health Services | |||
| Reprocessed OxiMax Sensors | Medline ReNewal | |||
| Reprocessed Nellcor OxiMax | ||||
| SpO2 Sensors | ||||
| Technological | ||||
| features concluded | sensor and processes the | |||
| information by use of an | ||||
| algorithm to provide real time | ||||
| values of SpO2, pulse rate and | ||||
| pulse amplitude. | 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. | system | |||
| Intended patient | ||||
| population | Adult, Pediatric, Infant, Neonate | Adult, Pediatric, Infant, Neonate | Adult, Pediatric, Infant | Same as shared |
| models | ||||
| Patient weight | ||||
| range | • >30 kg = adult (MAXA, | |||
| MAXAL) | ||||
| • 10 - 50 kg = pediatric (MAXP) | ||||
| • 3 - 20 kg = infants (MAXI) | ||||
| • 40 kg adults | ||||
| (MAXN) | ||||
| • unknown = MAXFAST | • >30 kg = adult (MAXA, | |||
| MAXAL) | ||||
| • 40 kg adults | ||||
| (MAXN) | • >30 kg = adult (MAXA, | |||
| MAXAL) | ||||
| • 10 - 50 kg = pediatric (MAXP) | ||||
| • 3 - 20 kg = infants (MAXI) | Same as shared | |||
| models | ||||
| Application site | • Finger = MAXA, MAXL, | |||
| MAXP, MAXN (adult) | ||||
| • Toe or digit of similar size = | ||||
| MAXI | ||||
| • Foot = MAXN (neonate) | ||||
| • Forehead = MAXFAST | • Finger = MAXA, MAXL, | |||
| MAXN (adult) | ||||
| • Foot = MAXN (neonate) | • Finger = MAXA, MAXL, MAXP | |||
| • Toe or digit of similar size = | ||||
| MAXI | Same as shared | |||
| models | ||||
| Single use | Yes | Yes | Yes | Same |
9
Image /page/9/Picture/0 description: The image contains two logos. The first logo is for Medline, and it features a blue square with a white star-like symbol and the word "MEDLINE" in white letters. 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 black letters below.
Summary Table: Predicate, Reference and Medline ReNewal Reprocessed OxiMax comparison (continued).
| Device
| Characteristics | Predicate | Reference | Proposed | Comparison |
|---|---|---|---|---|
| Covidien Nellcor | ||||
| OxiMax Pulse Oximeter | ||||
| Sensors | Hygia Health Services | |||
| Reprocessed OxiMax Sensors | Medline ReNewal | |||
| Reprocessed Nellcor OxiMax | ||||
| Sp02 Sensors | ||||
| Use environment | Hospitals, hospital-type facilities, | |||
| intra-hospital transport, and | ||||
| home environments | Hospitals, hospital-type facilities, | |||
| intra-hospital transport, and | ||||
| home environments | Hospital-type facilities, and intra- | |||
| hospital transport | Same | |||
| Measurement | ||||
| parameter | Oxygen saturation, pulse rate | 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 | Nellcor OxiMax and Nellcor | |||
| compatible pulse oximeters | Same | |||
| Specified SpO2 | ||||
| measurement range | 70% - 100% (MAXA, MAXAL, | |||
| MAXP, MAXI, MAXN) | 0 - 100% (MAXA, MAXAL, | |||
| MAXP, MAXI, MAXN) | 70% - 100% (MAXA, MAXAL, | |||
| MAXP, MAXI) | Medline ReNewal is | |||
| same as predicate | ||||
| SpO2 accuracy | 70% - 100% ± 2 digits in adults | |||
| (MAXA, MAXAL, MAXP, MAXI, | ||||
| MAXN) | ||||
| 70% - 100% ± 3 digits in | ||||
| neonates (MAXN) | 70% - 100% ± 3 digits (MAXA, | |||
| MAXAL, MAXP) | ||||
| 70% - 100% ± 3 digits in adults | ||||
| (MAXI, MAXN) | ||||
| 70% - 100% ± 4 digits in | ||||
| neonates (MAXI, MAXN) | 70% - 100% ± 2 digits in adults | |||
| (MAXA, MAXAL, MAXP, MAXI) | Medline ReNewal is | |||
| same as predicate | ||||
| Pulse rate | ||||
| measurement range | 20 - 250 bpm (MAXA, MAXAL, | |||
| MAXP, MAXI, MAXN) | 30 - 240 bpm (MAXA, MAXAL, | |||
| MAXP, MAXI, MAXN) | 20 - 250 bpm (MAXA, MAXAL, | |||
| MAXP, MAXI) | Medline ReNewal is | |||
| same as predicate |
continued
10
Image /page/10/Picture/0 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 blue letters below.
Summary Table: Predicate, Reference and Medline ReNewal Reprocessed OxiMax comparison (concluded).
| Device
| Characteristics | Predicate | Reference | Proposed | Comparison |
|---|---|---|---|---|
| Covidien Nellcor | ||||
| OxiMax Pulse Oximeter | ||||
| Sensors | Hygia Health Services | |||
| Reprocessed OxiMax Sensors | Medline ReNewal | |||
| Reprocessed Nellcor OxiMax | ||||
| SpO2 Sensors | ||||
| Pulse rate accuracy | ||||
| (beats per minute) | 20 - 250 ± 3 digits (MAXA, | |||
| MAXAL, MAXP, MAXI, MAXN) | 30 to 240 ± 3 digits (MAXA, | |||
| MAXAL, MAXP, MAXI, MAXN) | 20 - 250 bpm ± 3 digits (MAXA, | |||
| MAXAL, MAXP, MAXI) | Medline ReNewal is | |||
| same as predicate | ||||
| Temperature | ||||
| Operational/Storage | ||||
| (°C) | Operational = 5°C - 40°C | |||
| Storage = -20°C - 60°C | Operational = -2°C - 42°C | |||
| Storage: -38°C - 49°C | Operational = 5°C - 40°C | |||
| Storage = -20°C - 60°C | Medline ReNewal is | |||
| same as predicate | ||||
| Relative Humidity | 15% to 95% non-condensing | 15% to 95% non-condensing | 15% to 95% non-condensing | Same |
| Optical Design | Transmissive sensor | Transmissive sensor | Transmissive sensor | Same |
| Housing design | Adhesive bandage | Adhesive bandage | Adhesive bandage | Same |
| a Intended Use/Indications for Use are the same section in the summary of K052186. |
11
Image /page/11/Picture/1 description: The image contains two logos. The first logo is for Medline, and it features the word "MEDLINE" in white text with a blue background and a white star-like symbol above the text. The second logo is for Renewal, and it features the word "Renewal" in green and blue text, with the words "Full Circle Reprocessing" in smaller blue text below.