Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors

K191018 · Surgical Instrument Service and Savings, Inc. · NLF · Jul 3, 2019 · Cardiovascular

Device Facts

• Record ID: K191018
• Device Name: Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors
• Applicant: Surgical Instrument Service and Savings, Inc.
• Product Code: NLF · Cardiovascular
• Decision Date: Jul 3, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Medline ReNewal Reprocessed Masimo LNCS Adult and Pediatric SpO2 Adhesive Sensors are indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult and pediatric patients during no motion conditions, and for patients who are well perfused in hospitals and hospital-type facilities.

Device Story

Reprocessed SpO2 adhesive sensors; input: light signals interacting with tissue via pulsatile blood flow; output: SpO2 and pulse rate values; used in hospitals/hospital-type facilities; operated by clinicians; device consists of adhesive bandage, dual-wavelength LEDs, photodetector, cable, and connector; connects to Masimo SET oximetry instruments; provides real-time monitoring; aids clinical decision-making regarding patient oxygenation status; benefits patient through continuous, non-invasive monitoring.

Clinical Evidence

Clinical trial conducted on 10 healthy adult volunteers (ages 25-36) to compare SpO2 accuracy. Study followed ISO 80601-2-61:2011 and ISO 14155:2011. Results showed 2% accuracy for 70%-100% SpO2 range, meeting the Arms specification of 3% under steady-state, no-motion conditions.

Technological Characteristics

Transmissive sensor; dual-wavelength LEDs (red/infrared) and photodiode; adhesive bandage housing; cable with pin connector. Operates via light signal interaction with tissue. No changes in performance specifications or method of operation compared to predicate. Biocompatibility (cytotoxicity, sensitization, irritation) and cleaning efficacy (residual protein/hemoglobin) validated.

Indications for Use

Indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in adult and pediatric patients (>10 kg) who are well perfused, in hospital and hospital-type settings, during no-motion conditions.

Regulatory Classification

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.

Predicate Devices

• Masimo LNCS/M-LNCS Oximetry Sensors (K101896)

Reference Devices

• Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors (K181738)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 Device<br>Modela | Device Name | OEM |
|------------------------------------------|-----------------------------------------------------------------------------------------|--------------------|
| LNCS Adtx<br>(part number 1859) | Masimo LNCS Adhesive Sensor<br>(Masimo Adult SpO2 Sensor,<br>>30 kg, 18 inches) | Masimo Corporation |
| LNCS Adtx-3<br>(part number 2317) | Masimo LNCS Adhesive Sensor<br>(Masimo Adult SpO2 Sensor,<br>>30 kg, 3 feet) | Masimo Corporation |
| LNCS Pdtx<br>(part number 1860) | Masimo LNCS Adhesive Sensor<br>(Masimo Pediatric SpO2 Sensor,<br>10 - 50 kg, 18 inches) | Masimo Corporation |
| LNCS Pdtx-3<br>(part number 2318) | Masimo LNCS Adhesive Sensor<br>(Masimo Pediatric SpO2 Sensor,<br>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/<br>Owner | Surgical Instrument Service and Savings (dba Medline ReNewal)<br>1500 NE Hemlock Ave., Redmond, OR 97756 | |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Prepared<br>by/Contact<br>Name | Stephanie Boyle Mays<br>Senior Regulatory Affairs Specialist, Quality Assurance/Regulatory Affairs<br>P: 541-516-4205 • F: 541-923-3375 • E: [e-mail] | |
| Date Prepared | April 12, 2019 | |
| Device Name<br>and<br>Classification | Proprietary/Trade Name: | Medline ReNewal Reprocessed Masimo LNCS Adult<br>and Pediatric SpO2 Adhesive Sensors |
| | Common or usual name | Oximeter, reprocessed |
| | Regulatory Name/Reference: | Oximeter; 21 CFR § 870.2700 |
| | Regulatory Class: | Class II |
| | Product Code: | NLF |
| | Panel: | Anesthesiology |
| Predicate<br>Device | 510(k) number: | K101896 |
| | Proprietary/Trade Name: | K101896 Masimo LNCS/M-LNCS Oximetry Sensors |
| | Common or usual name | Oxygen sensor |
| | Regulatory Name/Reference: | Oximeter; 21 CFR § 870.2700 |
| | Regulatory Class: | Class II |
| | Product Code: | DQA |
| | Panel: | Anesthesiology |
| | Manufacturer: | Masimo Corporation<br>40 Parker, Irvine, CA 92618 |
| Reference<br>Device | 510(k) number: | K181738 |
| | Proprietary/Trade Name: | Medline ReNewal Reprocessed Nellcor OxiMax SpO2<br>Sensors |
| | Common or usual name | Oximeter, reprocessed |
| | Regulatory Name/Reference: | Oximeter; 21 CFR § 870.2700 |
| | Regulatory Class: | Class II |
| | Product Code: | NLF |
| | Panel: | Anesthesiology |
| | Manufacturer: | Medline ReNewal<br>1500 NE Hemlock Ave., Redmond, OR 97756 |
| Device<br>Description | Medline ReNewal Reprocessed Masimo LNCS Adult and Pediatric SpO2<br>Adhesive Sensors, models LNCS Adtx, LNCS Pdtx, LNCS Adtx-3, and<br>LNCS Pdtx-3 are designed for the continuous non-invasive monitoring of<br>functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in<br>conjunction with instruments containing Masimo SET oximetry or licensed<br>to use LNCS sensors. The Medline ReNewal Reprocessed Masimo LNCS<br>sensor models LNCS Adtx, LNCS Pdtx, LNCS Adtx-3, and LNCS Pdtx-3<br>are intended for prescription use with adult and pediatric patients in<br>hospitals, hospital-type facilities, and intra-hospital transport.<br>The proposed device is not provided sterile. | |
| Statement of<br>Intended<br>Use/Indications<br>for Use | The Medline ReNewal Reprocessed Masimo LNCS Adult and Pediatric SpO2<br>Adhesive Sensors are indicated for single patient use for continuous<br>noninvasive monitoring of functional oxygen saturation of arterial<br>hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use<br>with adult and pediatric patients during no motion conditions, and for<br>patients who are well perfused in hospitals and hospital-type facilities. | |
| Technological<br>Characteristics | The technological characteristics and the fundamental scientific technology<br>of the subject devices are identical to the predicate devices. The proposed<br>devices are a reprocessed version of the predicate K101896 devices.<br>These devices use an adhesive bandage, light source (LEDs),<br>photodetector (Faraday cage/photodiode), cable, and connector in the<br>same manner as the predicate devices. The predicate devices were used to<br>support intended use, technological characteristics, and performance<br>specifications. (Also see comparison of technological features in the<br>Summary Table.)<br>Comparison of Technological Features | |
| Performance<br>Testing<br>Nonclinical<br>Tests | The functional characteristics of the subject device have been evaluated in<br>accordance with Pulse Oximeters – Premarket Notifications Submissions<br>[510(k)] Guidance for Industry and Food and Drug Administration Staff<br>(March 4, 2013 ) and have been determined to be substantially equivalent<br>to the predicate device based on the following tests:<br>• Biocompatibility: cytotoxicity, sensitization, irritation<br>• Disinfection<br>• Shelf Life<br>• Packaging<br>• Electrical<br>• Performance testing:<br>• tissue heating<br>• pulse rate accuracy<br>• active element assessment<br>• adhesive peel and<br>• environment (extreme heat and operating conditions)<br>• Cleaning:<br>• visual inspection;<br>• cleaning efficacy (residual protein and residual hemoglobin). | |
| Performance<br>Testing<br>Clinical Tests | The purpose of the clinical trial was to perform an oxygen saturation (SpO2)<br>accuracy comparison. The study was conducted in accordance with CFR<br>for Non-significant Risk Investigational Studies, following ISO 14155:2011<br>Clinical Investigation of medical devices for human subjects - Good clinical<br>practice as appropriate and the pulse oximeter guidelines of ISO 80601-2-<br>61:2011 Procedure for invasive laboratory testing on healthy volunteers<br>applicable sections and Pulse Oximeters – Premarket Notifications<br>Submissions [510(k)] Guidance for Industry and Food and Drug<br>Administration Staff (March 4, 2013 ). After Institutional Review Board<br>Approval, 10 healthy adults volunteer subjects (ages 25 to 36 yr.; weight<br>105 – 220 lb.; height 60 – 72 in.; BMI of 20.0 – 33.4) were included in the<br>study which was conducted from May 9 to May 10, 2018 to evaluate the<br>SpO2 accuracy of the proposed devices. The proposed devices achieved<br>an accuracy of 2% for 70% - 100% SpO2. The study concluded that the<br>SpO2 accuracy performance of the proposed devices passed the Arms<br>specification of 3% under steady state and non-motion conditions for the<br>range of 70% to 100%. | |
| Device Models | LNCS Adtx, LNCS Pdtx, LNCS Adtx-3, and LNCS Pdtx-3 | |

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Image /page/5/Picture/0 description: The image shows the Medline Renewal Full Circle Reprocessing logo. The Medline logo is on the left side of the image and is a blue square with a white cross inside. The Renewal logo is on the right side of the image and is green and blue. The words "Full Circle Reprocessing" are below the Renewal logo.

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Image /page/6/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left side of the image and is a blue square with a white cross inside. The Renewal logo is on the right side of the image and is green and blue. The words "Full Circle Reprocessing" are below the Renewal logo.

Summary continued on next page.

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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.

| Device<br>Characteristics | Predicate<br>Masimo LNCS Sensors | Reference<br>Medline ReNewal<br>Reprocessed<br>Nellcor OxiMax SpO2<br>Sensors | Proposed<br>Medline ReNewal<br>Reprocessed Masimo LNCS<br>Adult and Pediatric SpO2<br>Adhesive Sensors | Comparison |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K101896 | K181738 | TBD | N/A |
| Common Name | Oximeter | Oximeter | Oximeter | Same |
| Regulation No. | 870.2700 | 870.2700 | 870.2700 | Same |
| Product Code | DQA | NLF | NLF | As stated |
| Models | LNCS/M-LNCS | Nellcor MAXA, MAXA,<br>MAXAL, MAXP, and MAXI | LNCS Adtx, LNCS Pdtx, LNCS<br>Adtx-3, and LNCS Pdtx-3 | As stated |
| Intended Use/<br>Indications for<br>Usea | The LNCS/M-LNCS Sensors are<br>indicated for the continuous<br>noninvasive monitoring of<br>functional oxygen saturation of<br>arterial hemoglobin (SpO2) and<br>pulse rate (measured by an<br>SpO2 sensor) for use with adult,<br>pediatric and infant patients<br>during no motion and motion<br>conditions, and for patients who<br>are well or poorly perfused in<br>hospitals, hospital-type facilities,<br>mobile and home environments. | Medline ReNewal<br>Reprocessed Nellcor OxiMax<br>SpO2 Sensors are indicated<br>for the continuous non-<br>invasive monitoring of<br>functional oxygen saturation of<br>arterial hemoglobin (SpO2) and<br>pulse rate. They are intended<br>for use with infant, pediatric<br>and adult patients in hospitals,<br>hospital-type facilities, and<br>intra-hospital transport. These<br>devices are for prescription<br>use only. | The Medline ReNewal<br>Reprocessed Masimo LNCS<br>Adult and Pediatric SpO2<br>Adhesive Sensors are<br>indicated for single patient use<br>for continuous noninvasive<br>monitoring of functional oxygen<br>saturation of arterial<br>hemoglobin (SpO2) and pulse<br>rate (measured by an SpO2<br>sensor) for use with adult and<br>pediatric patients during no<br>motion conditions, and for<br>patients who are well perfused<br>in hospitals and hospital-type<br>facilities | Medline ReNewal will<br>not make claims for<br>infant or neonatal use,<br>for motion or low<br>perfusion performance;<br>or for use in home<br>environment otherwise<br>same 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 | |
| Device<br>Characteristics | Masimo LNCS Sensors | Medline ReNewal<br>Reprocessed<br>Nellcor OxiMax SpO2<br>Sensors | Medline ReNewal<br>Reprocessed Masimo LNCS<br>Adult and Pediatric SpO2<br>Adhesive Sensors | Comparison |
| Technological<br>characteristics | The Masimo Pulse Oximeter<br>System measures functional<br>oxygen saturation non-invasively<br>via a light signal interacting with<br>tissue, by utilizing the time-<br>varying changes in tissue optical<br>properties that occur with<br>pulsatile blood flow. Red and<br>infrared light-emitting diodes<br>(LEDS) are utilized as light<br>sources. A photodiode acting as<br>a photo detector senses the<br>signal strengths of the two<br>wavelengths of light, which vary<br>with the amount of light<br>transmitted through the tissue.<br>The pulse oximeter receives this<br>electrical information from the<br>sensor and processes the<br>information by use of an<br>algorithm to provide real time<br>values of SpO2, pulse rate and<br>pulse amplitude | The predicate device and the<br>Medline ReNewal reprocessed<br>device contain dual<br>wavelength LED and<br>photodiode. The LED and<br>photodiode are encased in a<br>pad which attach to the patient<br>using adhesive material. The<br>sensors are connected to a<br>cable and they terminate in a<br>pin connector.<br>Biocompatibility and<br>performance/functional testing<br>demonstrate that the devices<br>are equivalent and are safe<br>and effective for their intended<br>use. | The principle of operation of<br>the reprocessed devices is<br>identical to that of the<br>predicates. There are no<br>changes in performance<br>specifications or method of<br>operation. These devices use<br>an adhesive bandage, light<br>source (LEDs), photodetector<br>(Faraday cage/photodiode),<br>cable, and connector in the<br>same manner as the predicate<br>devices. | As stated<br>Medline ReNewal will<br>not make claims for<br>motion or low perfusion<br>performance; otherwise<br>same as written |
| Summary: | | | Predicate, reference and Medline ReNewal Reprocessed Masimo LNCS sensor comparison table (continued). | |
| Device<br>Characteristics | Predicate | Reference | Proposed | |
| | Masimo LNCS Sensors…