(77 days)
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 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.
The provided text describes a 510(k) summary for the Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors. This document is a premarket notification to the FDA, demonstrating that the reprocessed device is substantially equivalent to legally marketed predicate devices.
The study described is a clinical trial conducted to evaluate the SpO2 accuracy of the reprocessed sensors, specifically focusing on the acceptance criteria for SpO2 accuracy.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Measured) | Reported Device Performance |
|---|---|
| SpO2 Accuracy: 70% - 100% SpO2 (ARMS specification) | 2% for 70% - 100% SpO2 |
| ARMS (Accuracy Root Mean Square) specification | 3% (passed) |
2. Sample size used for the test set and the data provenance
- Sample Size: 10 healthy adult volunteer subjects.
- Data Provenance: The study was conducted from May 9 to May 10, 2018. The location of the study (e.g., country of origin) is not explicitly stated but is implied to be within the jurisdiction of the U.S. FDA, given it's part of a 510(k) submission. The study involved prospective data collection as it was a clinical trial performed specifically to evaluate the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts (e.g., medical professionals, technicians) used to establish the ground truth for SpO2 measurements. The ground truth for SpO2 accuracy in pulse oximetry studies typically relies on co-oximetry measurements from arterial blood samples. While the study followed ISO standards that dictate such procedures, the explicit mention of experts establishing ground truth is absent.
4. Adjudication method for the test set
The document does not describe an adjudication method. For a study evaluating SpO2 accuracy against a reference method (like co-oximetry), adjudication in the sense of multiple expert reviews of a single interpretation is not typically applicable. The comparison is between the device's measurement and the objective reference measurement.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study solely focused on the accuracy of the device itself (standalone performance) in measuring SpO2 in comparison to a reference method, not on how human readers (if this were an AI diagnostic tool) might improve with AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone study was done. The clinical trial specifically evaluated the SpO2 accuracy of the proposed devices (the reprocessed sensors) themselves. The performance assessed was the sensor's ability to accurately measure SpO2, which is an inherent function of the device's technology.
7. The type of ground truth used
The ground truth used for SpO2 accuracy in this type of study is typically invasive laboratory testing on healthy volunteers where arterial blood samples are taken and analyzed by a co-oximeter. This is implied by the reference to "ISO 80601-2-61:2011 Procedure for invasive laboratory testing on healthy volunteers applicable sections" in the "Performance Testing Clinical Tests" section. This forms an objective, physiological ground truth.
8. The sample size for the training set
The document describes a clinical trial for performance evaluation, not the training of an AI algorithm. Therefore, there is no mention of a training set sample size. The device is a reprocessed medical sensor, not an AI model that requires a training dataset.
9. How the ground truth for the training set was established
As the device is a reprocessed sensor and not an AI algorithm, there is no training set or associated ground truth establishment for a training phase. The clinical study tested the device's performance directly against established physiological measurements.
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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.
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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/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
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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 DeviceModela | 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:
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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 | |
|---|---|---|
| Preparedby/ContactName | Stephanie Boyle MaysSenior Regulatory Affairs Specialist, Quality Assurance/Regulatory AffairsP: 541-516-4205 • F: 541-923-3375 • E: smays@medline.com | |
| Date Prepared | April 12, 2019 | |
| Device NameandClassification | Proprietary/Trade Name: | Medline ReNewal Reprocessed Masimo LNCS Adultand 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 | |
| PredicateDevice | 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 Corporation40 Parker, Irvine, CA 92618 | |
| ReferenceDevice | 510(k) number: | K181738 |
| Proprietary/Trade Name: | Medline ReNewal Reprocessed Nellcor OxiMax SpO2Sensors | |
| 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 ReNewal1500 NE Hemlock Ave., Redmond, OR 97756 | |
| DeviceDescription | Medline ReNewal Reprocessed Masimo LNCS Adult and Pediatric SpO2Adhesive Sensors, models LNCS Adtx, LNCS Pdtx, LNCS Adtx-3, andLNCS Pdtx-3 are designed for the continuous non-invasive monitoring offunctional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate inconjunction with instruments containing Masimo SET oximetry or licensedto use LNCS sensors. The Medline ReNewal Reprocessed Masimo LNCSsensor models LNCS Adtx, LNCS Pdtx, LNCS Adtx-3, and LNCS Pdtx-3are intended for prescription use with adult and pediatric patients inhospitals, hospital-type facilities, and intra-hospital transport.The proposed device is not provided sterile. | |
| Statement ofIntendedUse/Indicationsfor Use | The Medline ReNewal Reprocessed Masimo LNCS Adult and Pediatric SpO2Adhesive Sensors are indicated for single patient use for continuousnoninvasive monitoring of functional oxygen saturation of arterialhemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for usewith adult and pediatric patients during no motion conditions, and forpatients who are well perfused in hospitals and hospital-type facilities. | |
| TechnologicalCharacteristics | The technological characteristics and the fundamental scientific technologyof the subject devices are identical to the predicate devices. The proposeddevices 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 thesame manner as the predicate devices. The predicate devices were used tosupport intended use, technological characteristics, and performancespecifications. (Also see comparison of technological features in theSummary Table.)Comparison of Technological Features | |
| PerformanceTestingNonclinicalTests | 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• 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). | |
| PerformanceTestingClinical 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 | 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.
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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.
| DeviceCharacteristics | PredicateMasimo LNCS Sensors | ReferenceMedline ReNewalReprocessedNellcor OxiMax SpO2Sensors | ProposedMedline ReNewalReprocessed Masimo LNCSAdult and Pediatric SpO2Adhesive 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, LNCSAdtx-3, and LNCS Pdtx-3 | As stated |
| Intended Use/Indications forUsea | The LNCS/M-LNCS Sensors areindicated for the continuousnoninvasive monitoring offunctional oxygen saturation ofarterial hemoglobin (SpO2) andpulse rate (measured by anSpO2 sensor) for use with adult,pediatric and infant patientsduring no motion and motionconditions, and for patients whoare well or poorly perfused inhospitals, hospital-type facilities,mobile and home environments. | Medline ReNewalReprocessed Nellcor OxiMaxSpO2 Sensors are indicatedfor the continuous non-invasive monitoring offunctional oxygen saturation ofarterial hemoglobin (SpO2) andpulse rate. They are intendedfor use with infant, pediatricand adult patients in hospitals,hospital-type facilities, andintra-hospital transport. Thesedevices are for prescriptionuse only. | The Medline ReNewalReprocessed Masimo LNCSAdult and Pediatric SpO2Adhesive Sensors areindicated for single patient usefor continuous noninvasivemonitoring of functional oxygensaturation of arterialhemoglobin (SpO2) and pulserate (measured by an SpO2sensor) for use with adult andpediatric patients during nomotion conditions, and forpatients who are well perfusedin hospitals and hospital-typefacilities | Medline ReNewal willnot make claims forinfant or neonatal use,for motion or lowperfusion performance;or for use in homeenvironment otherwisesame as stated |
Predicate, reference and Medline ReNewal Reprocessed Masimo LNCS sensor comparison tables. Summary:
Continued
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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 | ||
| DeviceCharacteristics | Masimo LNCS Sensors | Medline ReNewalReprocessedNellcor OxiMax SpO2Sensors | Medline ReNewalReprocessed Masimo LNCSAdult and Pediatric SpO2Adhesive Sensors | Comparison |
| Technologicalcharacteristics | The Masimo 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 thesensor and processes theinformation by use of analgorithm to provide real timevalues of SpO2, pulse rate andpulse amplitude | The predicate device and theMedline ReNewal reprocesseddevice contain dualwavelength LED andphotodiode. The LED andphotodiode are encased in apad which attach to the patientusing adhesive material. Thesensors are connected to acable and they terminate in apin connector.Biocompatibility andperformance/functional testingdemonstrate that the devicesare equivalent and are safeand effective for their intendeduse. | The principle of operation ofthe reprocessed devices isidentical to that of thepredicates. There are nochanges in performancespecifications or method ofoperation. These devices usean adhesive bandage, lightsource (LEDs), photodetector(Faraday cage/photodiode),cable, and connector in thesame manner as the predicatedevices. | As statedMedline ReNewal willnot make claims formotion or low perfusionperformance; otherwisesame as written |
| Summary: | Predicate, reference and Medline ReNewal Reprocessed Masimo LNCS sensor comparison table (continued). | |||
| DeviceCharacteristics | Predicate | Reference | Proposed | |
| Masimo LNCS Sensors | Medline ReNewalReprocessedNellcor OxiMax SpO2Sensors | Medline ReNewalReprocessed Masimo LNCSAdult and Pediatric SpO2Adhesive Sensors | Comparison | |
| Intended PatientPopulation | Adult, Pediatric, Infant, Neonataland Preterm | Adult, Pediatric, Infant | Adult, Pediatric | As stated |
| Patient WeightRange | • >30 kg = adult (Adtx, Adtx-3)• 10 - 50 kg = pediatric (Pdtx,Pdtx-3)• 3 - 20 kg = infants (Inf, Inf-L,Inf-3)• < 3 kg = infants - > 40 kg =adults (Neo, Neo-L, Neo-3)• <1 kg = preterm (NeoPt,NeoPt-L, NeoPt-3, NeoPt-500) | • >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 sharedmodels |
| PreferredApplication Site | • >30 kg = middle or ring fingerof non-dominant hand (adult -Adtx, Adtx-3)• 10 - 50 kg = middle or ringfinger of non-dominant hand(pediatric - Pdtx, Pdtx-3)• 3 - 20 kg = great toe (infants -Inf, Inf-L, Inf-3)• < 3 kg = foot (infant) - > 40 kg= middle or ring finger or non-dominant hand (adult - Neo,Neo-L, Neo-3)• < 1 kg = foot (preterm - NeoPt.NeoPt-L, NeoPt-3, NeoPt-500) | • Finger = MAXA, MAXL,MAXP• Toe or digit of similar size =MAXI | • >30 kg = middle or ringfinger of non-dominant hand(adult) Adtx, Adtx-3)• 10 - 50 kg = middle or ringfinger of non-dominant hand(pediatric) Pdtx, Pdtx-3 | Same as sharedmodels |
| Summary: | Predicate, reference and Medline ReNewal Reprocessed Masimo LNCS sensor comparison table. (continued). | |||
| DeviceCharacteristics | Predicate | Reference | Proposed | Comparison |
| Masimo LNCS Sensors | Medline ReNewalReprocessedNellcor OxiMax SpO2Sensors | Medline ReNewalReprocessed Masimo LNCSAdult and Pediatric SpO2Adhesive Sensors | ||
| Single Use | Yes | Yes | Yes | Same |
| Use Environment | Hospitals, hospital-typefacilities, mobile and homeenvironments | Hospitals, hospital-typefacilities, and intra-hospitaltransport | Hospitals and hospital-typefacilities | As stated |
| MeasurementParameter | Oxygen saturation, pulse rate | Oxygen saturation, pulse rate | Oxygen saturation, pulse rate | Same |
| Monitor systemcompatibility | Instruments containingMasimo SET oximetry orlicensed to use LNCS sensorsand also with Nellcor andNellcor compatible pulseoximeters | Nellcor OxiMax and Nellcorcompatible pulse oximeters | Instruments containingMasimo SET oximetry orlicensed to use LNCS sensors | As stated |
| Specified Sp02measurement range | 70% - 100% foradults/pediatrics/ infants/neonates | 70% - 100% for adults,pediatrics, infants | 70% - 100% foradults/pediatrics | Medline ReNewal issame as predicate |
| SpO2 accuracy | 70% - 100% ± 2 digits foradults/pediatrics/ infants and±3 for neonates | 70% - 100% ± 3 digits foradults/pediatrics/ infants | 70% - 100% ± 2 digits foradults/pediatrics | Same |
| Pulse ratemeasurement range | 25 – 240 bpm foradults/pediatrics/ infants/neonates per Masimo monitormanual | 20 - 240 bpm foradults/pediatrics/ infants | 25 - 240 bpm adults/pediatrics | Medline ReNewal issame as predicate |
| Pulse rate accuracy | 25 - 240 bpm ± 3 digits foradults/ pediatrics/ infants/neonatesb | 20 - 250 bpm ± 3 digits foradults/ pediatrics/ infants | 25 - 240 bpm ± 3 digits foradults/ pediatrics | Medline ReNewal issame as predicate |
| Summary: Predicate, reference and Medline ReNewal Reprocessed Masimo LNCS sensor comparison table. (concluded). | ||||
| DeviceCharacteristics | Predicate | Reference | Proposed | |
| Masimo LNCS Sensors | Medline ReNewalReprocessedNellcor OxiMax SpO2Sensors | Medline ReNewalReprocessed Masimo LNCSAdult and Pediatric SpO2Adhesive Sensors | Comparison | |
| TemperatureOperational/Storage | Operational = 5°C - 40°CStorage = -40°C - 70°C | Operational = 5°C - 40°CStorage = -20°C - 60°C | Operational = 5°C - 40°CStorage = -40°C - 70°C | Medline ReNewal issame as predicate |
| Humidity | 5% to 95% | 15% to 95% non-condensing | 5% to 95% | Medline ReNewal issame 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. |
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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).
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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),
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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.
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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 predicatedevices, Medline ReNewal Reprocessed Masimo LNCS Sensors Adult andPediatric SpO2 Adhesive Sensors are substantially equivalent to thepredicate 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).