(263 days)
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.
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.
This document describes the validation of Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors (models MAXA, MAXAL, MAXP, and MAXI), which are reprocessed pulse oximetry sensors. The study aims to demonstrate that the reprocessed devices are substantially equivalent to the original, legally marketed predicate device (Nellcor OxiMax Pulse Oximeter Sensors, K052186) and a reference device (Hygia Health Services Reprocessed OxiMax Sensors, K041867).
Due to the nature of this medical device (a reprocessed pulse oximetry sensor that measures physiological parameters, not an AI/ML powered device), many of the requested criteria related to AI/ML software validation (e.g., sample size for test set/training set, number of experts for ground truth, adjudication method, MRMC studies) are not applicable (N/A) in this context. The study focuses on demonstrating physical and performance equivalence through non-clinical and clinical testing, rather than evaluating the accuracy of a machine learning algorithm against a human expert's interpretation of images or other complex data.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on achieving performance comparable to the predicate device, particularly in terms of SpO2 and pulse rate accuracy, and satisfying relevant standards and guidance documents.
| Acceptance Criteria Category | Specific Criteria (Target) | Reported Device Performance (Achieved) |
|---|---|---|
| SpO2 Accuracy | SpO2 accuracy of 70% - 100% ± 2 digits (as per predicate device, under steady state and non-motion conditions) | 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%." (Note: The predicate device listed 2 digits, while the study concludes it passed 3% Arms, which is generally acceptable for pulse oximeters within the 70-100% range, often assessed using Arms and bias. The 2% claimed for 70-100% SpO2 seems to match the predicate's ±2 digits.) |
| Pulse Rate Accuracy | 20 - 250 bpm ± 3 digits (as per predicate device) | 20 - 250 bpm ± 3 digits (explicitly stated in the comparison table as "Medline ReNewal is same as predicate") |
| Biocompatibility | No cytotoxicity, sensitization, irritation; acceptable acute systemic toxicity. | Tested and deemed acceptable: "Biocompatibility: cytotoxicity, sensitization, irritation; acute systemic toxicity" |
| Disinfection | Effective disinfection. | Tested and deemed acceptable. |
| Shelf Life | Appropriate shelf life validation. | Tested and deemed acceptable. |
| Electrical Safety | Compliance with electrical safety standards. | Tested and deemed acceptable. |
| Performance Testing | Acceptable tissue heating, pulse rate accuracy, active element assessment, adhesive peel, and environmental (extreme heat and operating conditions) performance. | Tested and deemed acceptable: "tissue heating," "pulse rate accuracy," "active element assessment," "adhesive peel," and "environment (extreme heat and operating conditions)." |
| Cleaning Efficacy | Effective cleaning with minimal residual protein and hemoglobin. | Tested and deemed acceptable: "Cleaning: visual inspection; cleaning efficacy (residual protein and residual hemoglobin)." |
| Intended Use Equivalence | Medline ReNewal will not make claims for neonatal use or for motion or low perfusion performance. Otherwise, same as predicate. | Conformed to this restriction. "Medline ReNewal will only reprocess pulse oximeter sensors. Medline ReNewal will not make claims for neonatal use or for motion or low perfusion performance; otherwise same as written." The patient population for the proposed device is "Adult, Pediatric, Infant," excluding neonates compared to the predicate/reference which included neonates. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Test Set: 10 healthy adult volunteer subjects.
- Data Provenance: The clinical study was conducted from May 9 to May 10, 2018. While the specific country of origin is not explicitly stated, the FDA 510(k) submission format suggests it's likely a study conducted in the U.S. or in accordance with U.S. regulatory standards (CFR for Non-significant Risk Investigational Studies, ISO 14155:2011, and ISO 80601-2-61:2011 are referenced). It was a prospective clinical study specifically designed to evaluate the reprocessed device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- N/A. For this type of device (pulse oximetry sensor), "ground truth" for SpO2 accuracy is not typically established by human expert consensus or radiologists' interpretations. Instead, it's established by a recognized clinical methodology, such as arterial blood gas (ABG) analysis (co-oximetry), which provides a direct and objective measurement of arterial oxygen saturation (SaO2) and is considered the gold standard for validating SpO2 accuracy. The study mentions it followed "ISO 80601-2-61:2011 Procedure for invasive laboratory testing on healthy volunteers," which describes how to perform such comparisons using co-oximetry. There are no "experts" in the sense of image readers or diagnosticians determining a "ground truth" for each measurement.
4. Adjudication Method for the Test Set
- N/A. As the ground truth is established by objective, invasive laboratory testing (e.g., co-oximetry), there is no need for human adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is relevant for evaluating diagnostic imaging systems where human readers interpret cases with and without AI assistance. This study pertains to a reprocessed medical sensor for physiological measurement, not an imaging or AI diagnostic device. Therefore, no MRMC study was performed, and no effect size regarding human reader improvement with AI assistance is applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance
- Yes, in essence. The clinical study evaluates the reprocessed sensor's performance (SpO2 accuracy) on subjects by comparing its readings to a recognized gold standard (invasive laboratory testing). While the device outputs a reading for a human to interpret, its fundamental performance (accuracy of the SpO2 measurement) is assessed as a standalone measurement, irrespective of specific human interpretation biases. There isn't an "algorithm" in the AI/ML sense, but the device's sensing and processing of physiological signals are evaluated directly.
7. Type of Ground Truth Used
- Clinical Gold Standard / Objective Measurement: The ground truth for SpO2 accuracy was established through invasive laboratory testing, specifically by comparing the device's SpO2 readings to reference SaO2 values obtained from arterial blood samples (co-oximetry), as per the procedures outlined in ISO 80601-2-61:2011. This method is considered the gold standard for pulse oximeter accuracy validation.
8. Sample Size for the Training Set
- N/A. This device is a reprocessed sensor, not a machine learning or AI-powered system that requires a "training set." Its performance is based on its physical and functional characteristics after reprocessing, which are validated against established standards and the predicate device, not by training an algorithm on a dataset.
9. How the Ground Truth for the Training Set Was Established
- N/A. As there is no training set for an AI/ML algorithm, this question is not applicable.
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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.
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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
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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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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 MaysRegulatory Affairs Specialist, Quality Assurance/Regulatory AffairsP: 541-516-4205 • F: 541-923-3375 • E:smays@medline.com | |
| Date Prepared | February 18, 2019 | |
| Device NameandClassification | Proprietary/Trade Name: | Medline ReNewal Reprocessed Nellcor OxiMax SpO2Sensors, 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 | |
| PredicateDevice | 510(k) number: | K052186 |
| Proprietary/Trade Name: | Nellcor OxiMax Pulse Oximeter Sensors, modelsMAX-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 | |
| ReferenceDevice | 510(k) number: | K041867 |
| Proprietary/Trade Name: | Hygia Health Services Reprocessed OxiMax SensorsModel # 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 ofIndications forUse | The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors modelsMAXA, MAXAL, MAXP, and MAXI are indicated for single patient use whencontinuous noninvasive arterial oxygen saturation and pulse rate monitoringare required for patients in the sizes indicated in the respective sensordirections for use. These devices are for prescription use only. | |
| DeviceDescription | The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors,models MAXA, MAXAL, MAXP, and MAXI are designed for the continuousnon-invasive monitoring of functional oxygen saturation of arterialhemoglobin (SpO2) and pulse rate in conjunction with a Nellcor PulseOximeter. 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 ofIntended Use | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors areindicated for the continuous non-invasive monitoring of functional oxygensaturation of arterial hemoglobin (SpO₂) and pulse rate. They are intendedfor use with infant, pediatric and adult patients in hospitals, hospital-typefacilities, and intra-hospital transport. These devices are for prescription useonly. | |
| Technology(includingfeatures,materials andprinciples ofoperation) | The technological characteristics and the fundamental scientific technologyof the subject devices are identical to the predicate and reference devices.The proposed devices are a reprocessed version of the predicate K052186device. These devices use an adhesive bandage, light source (LEDs),photodetector (Faraday cage/photodiode), cable, and connector in thesame manner as the predicate devices. The predicate and referencedevices were used to support intended use, technological characteristics,and performance specifications. (Also see comparison of technologicalfeatures in the Summary Table) | |
| PerformanceTesting -NonclinicalTests | The functional characteristics of the subject device have been evaluated inaccordance 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 equivalentto the predicate device based on the following tests:· Biocompatibility: cytotoxicity, sensitization, irritation; acute systemictoxicity· 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). | |
| PerformanceTesting -Clinical Tests | The purpose of the clinical trial was to perform an oxygen saturation (SpO2)accuracy comparison. The study was conducted in accordance with CFRfor Non-significant Risk Investigational Studies, following ISO 14155:2011Clinical Investigation of medical devices for human subjects - Good clinicalpractice as appropriate and the pulse oximeter guidelines of ISO 80601-2-61:2011 Procedure for invasive laboratory testing on healthy volunteersapplicable sections and Pulse Oximeters – Premarket NotificationsSubmissions [510(k)] Guidance for Industry and Food and DrugAdministration Staff (March 4, 2013 ). After Institutional Review BoardApproval, 10 healthy adults volunteer subjects (ages 25 to 36 yr.; weight105 – 220 lb.; height 60 – 72 in.; BMI of 20.0 – 33.4) were included in thestudy which was conducted from May 9 to May 10, 2018 to evaluate theSpO2 accuracy of the proposed devices. The proposed devices achievedan accuracy of 2% for 70% - 100% SpO2. The study concluded that theSpO2 accuracy performance of the proposed devices passed the Armsspecification of 3% under steady state and non-motion conditions for therange 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.
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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.
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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 | |
|---|---|---|---|---|
| DeviceCharacteristics | Covidien NellcorOxiMax Pulse OximeterSensors | Hygia Health ServicesReprocessed OxiMax Sensors | Medline ReNewalReprocessed Nellcor OxiMaxSp02 Sensors | Same devices;original andreprocessed |
| 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, andMAXI | As stated |
| Indications for use | The Nellcor OxiMax PulseOximetry Sensors, modelsMAX-A, MAX-AL, MAX-N, MAX-P, MAX-I and MAX-FAST areindicated for single patient usewhen continuous noninvasivearterial oxygen saturation andpulse rate monitoring arerequired for patients in the sizesindicated in the respectivesensor directions for use. | The sensor is indicated for useas a non-invasive method toprovide continuous SpO2monitoring and pulse rate. | The Medline ReNewalReprocessed Nellcor OxiMaxSpO2 Sensors models MAXA,MAXAL, MAXP, and MAXI areindicated for single patient usewhen continuous noninvasivearterial oxygen saturation andpulse rate monitoring arerequired for patients in the sizesindicated in the respectivesensor directions for use. Thesedevices are for prescription useonly. | The predicate andproposed deviceshave the sameindications. Thepredicate andreference devicesshare the samepredicate,K012891. |
| Intended use | The OxiMax Pulse OximeterSystem is indicated for thecontinuous non-invasivemonitoring of functional oxygensaturation of arterial hemoglobin(SpO2) and pulse rate. It isintended for use with neonatal,pediatric, and adult patients | None listed | The reprocessed NellcorOxiMax SpO2 Sensors areindicated for the continuousnon-invasive monitoring offunctional oxygen saturation ofarterial hemoglobin (SpO2) andpulse rate. They are intended foruse with pediatric and adult | Medline Renewalwill only reprocesspulse oximetersensors. MedlineReNewal will notmake claims forneonatal use or formotion or low |
| DeviceCharacteristics | Predicate | Reference | Proposed | Comparison |
| Covidien NellcorOxiMax Pulse OximeterSensors | Hygia Health ServicesReprocessed OxiMax Sensors | Medline ReNewalReprocessed Nellcor OxiMaxSpO2 Sensors | ||
| Intended useconcluded | during both no motion andmotion conditions and forpatients who are either well orpoorly perfused, in hospitals,hospital-type facilities, intra-hospital transport, and homeenvironments. These devicesare for prescription only. | patients in hospitals, hospital-type facilities, and intra-hospitaltransport. These devices are forprescription use only. | perfusionperformance;otherwise same aswritten | |
| Comparison oftechnologicalfeatures | The OxiMax Pulse OximeterSystem measures functionaloxygen saturation non-invasivelyvia a light signal interacting withtissue, by utilizing the time-varying changes in tissue opticalproperties that occur withpulsatile blood flow. Red andinfrared light-emitting diodes(LEDS) are utilized as lightsources. A photodiode acting asa photo detector senses thesignal strengths of the twowavelengths of light, which varywith the amount of lighttransmitted through the tissue.The pulse oximeter receives thiselectrical information from the | The predicate device and theHygia reprocessed devicecontain dual wavelength LEDand photodiode. The LED andphotodiode are encased in a padwhich attached to the patientusing adhesive material. Thesensors are connected to acable and they terminate in a pinconnector.Biocompatibility andperformance/functional testingdemonstrate that the devices areequivalent and are safe andeffective for their intended use. | The reprocessed Nellcor OxiMaxSpO2 Sensors measurefunctional oxygen saturationnon-invasively via a light signalinteracting with tissue, byutilizing the time-varyingchanges in tissue opticalproperties that occur withpulsatile blood flow. Red andinfrared light-emitting diodes(LEDS) are utilized as lightsources. A photodiode acting asa photo detector senses thesignal strengths of the twowavelengths of light, which varywith the amount of lighttransmitted through the tissue.The pulse oximeter receives this | The principle ofoperation of thereprocesseddevices is identicalto that of thepredicates. Thereare no changes inperformancespecifications ormethod ofoperation. MedlineReNewal, however,will only reprocessthe proposeddevices and notany other monitors,components oraccessories of the |
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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).
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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).
| DeviceCharacteristics | Predicate | Reference | Proposed | Comparison |
|---|---|---|---|---|
| Covidien NellcorOxiMax Pulse OximeterSensors | Hygia Health ServicesReprocessed OxiMax Sensors | Medline ReNewalReprocessed Nellcor OxiMaxSpO2 Sensors | ||
| Technologicalfeatures concluded | sensor and processes theinformation by use of analgorithm to provide real timevalues of SpO2, pulse rate andpulse amplitude. | electrical information from thesensor and processes theinformation by use of analgorithm to provide real timevalues of SpO2, pulse rate andpulse amplitude. | system | |
| Intended patientpopulation | Adult, Pediatric, Infant, Neonate | Adult, Pediatric, Infant, Neonate | Adult, Pediatric, Infant | Same as sharedmodels |
| Patient weightrange | • >30 kg = adult (MAXA,MAXAL)• 10 - 50 kg = pediatric (MAXP)• 3 - 20 kg = infants (MAXI)• < 3 kg infants - > 40 kg adults(MAXN)• unknown = MAXFAST | • >30 kg = adult (MAXA,MAXAL)• < 3 kg infants - > 40 kg adults(MAXN) | • >30 kg = adult (MAXA,MAXAL)• 10 - 50 kg = pediatric (MAXP)• 3 - 20 kg = infants (MAXI) | Same as sharedmodels |
| 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 sharedmodels |
| Single use | Yes | Yes | Yes | Same |
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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).
| DeviceCharacteristics | Predicate | Reference | Proposed | Comparison |
|---|---|---|---|---|
| Covidien NellcorOxiMax Pulse OximeterSensors | Hygia Health ServicesReprocessed OxiMax Sensors | Medline ReNewalReprocessed Nellcor OxiMaxSp02 Sensors | ||
| Use environment | Hospitals, hospital-type facilities,intra-hospital transport, andhome environments | Hospitals, hospital-type facilities,intra-hospital transport, andhome environments | Hospital-type facilities, and intra-hospital transport | Same |
| Measurementparameter | Oxygen saturation, pulse rate | Oxygen saturation, pulse rate | Oxygen saturation, pulse rate | Same |
| Monitor systemcompatibility | Nellcor OxiMax and Nellcorcompatible pulse oximeters | Nellcor OxiMax and Nellcorcompatible pulse oximeters | Nellcor OxiMax and Nellcorcompatible pulse oximeters | Same |
| Specified SpO2measurement range | 70% - 100% (MAXA, MAXAL,MAXP, MAXI, MAXN) | 0 - 100% (MAXA, MAXAL,MAXP, MAXI, MAXN) | 70% - 100% (MAXA, MAXAL,MAXP, MAXI) | Medline ReNewal issame as predicate |
| SpO2 accuracy | 70% - 100% ± 2 digits in adults(MAXA, MAXAL, MAXP, MAXI,MAXN)70% - 100% ± 3 digits inneonates (MAXN) | 70% - 100% ± 3 digits (MAXA,MAXAL, MAXP)70% - 100% ± 3 digits in adults(MAXI, MAXN)70% - 100% ± 4 digits inneonates (MAXI, MAXN) | 70% - 100% ± 2 digits in adults(MAXA, MAXAL, MAXP, MAXI) | Medline ReNewal issame as predicate |
| Pulse ratemeasurement 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 issame as predicate |
continued
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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).
| DeviceCharacteristics | Predicate | Reference | Proposed | Comparison |
|---|---|---|---|---|
| Covidien NellcorOxiMax Pulse OximeterSensors | Hygia Health ServicesReprocessed OxiMax Sensors | Medline ReNewalReprocessed Nellcor OxiMaxSpO2 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 issame as predicate |
| TemperatureOperational/Storage(°C) | Operational = 5°C - 40°CStorage = -20°C - 60°C | Operational = -2°C - 42°CStorage: -38°C - 49°C | Operational = 5°C - 40°CStorage = -20°C - 60°C | Medline ReNewal issame 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. |
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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.
Based on a comparison of the intended use/indications for use, technological characteristics, and performance data to the predicate Conclusion devices, the Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors are substantially equivalent to the predicate device.
§ 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).