Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors

K181738 · Surgical Instrument Service and Savings Inc (Dba Medline · DQA · Mar 22, 2019 · Cardiovascular

Device Facts

• Record ID: K181738
• Device Name: Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors
• Applicant: Surgical Instrument Service and Savings Inc (Dba Medline
• Product Code: DQA · Cardiovascular
• Decision Date: Mar 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate. They are intended for use with infant, pediatric and adult patients in hospitals, hospital-type facilities, and intra-hospital transport. These devices are for prescription use only.

Device Story

Reprocessed Nellcor OxiMax SpO2 sensors; transmissive sensors using red and infrared LEDs and photodiode detectors. Device attaches to patient via adhesive bandage; connects to Nellcor pulse oximeter via cable/pin connector. Operates by sensing light signal interaction with tissue; pulse oximeter processes electrical signals to calculate SpO2 and pulse rate. Used in hospitals and intra-hospital transport; operated by clinicians. Output provides real-time SpO2, pulse rate, and pulse amplitude values to assist clinical decision-making regarding patient oxygenation status. Benefits include non-invasive, continuous monitoring of patient vital signs.

Clinical Evidence

Clinical trial conducted on 10 healthy adult volunteers (ages 25-36) to evaluate SpO2 accuracy. Study followed ISO 80601-2-61:2011 and ISO 14155:2011. Results demonstrated 2% accuracy for 70%-100% SpO2 range, meeting the Arms specification of 3% under steady-state, non-motion conditions.

Technological Characteristics

Transmissive pulse oximeter sensor; dual-wavelength (red/infrared) LEDs and photodiode detector. Form factor: adhesive bandage with cable and pin connector. Non-sterile. Connectivity: wired to Nellcor-compatible pulse oximeter. Principle: photoplethysmography (time-varying tissue optical properties).

Indications for Use

Indicated for single patient use for continuous noninvasive arterial oxygen saturation and pulse rate monitoring in infant, pediatric, and adult patients in hospitals, hospital-type facilities, and intra-hospital transport. Prescription use only.

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

• Nellcor OxiMax Pulse Oximeter Sensors, models MAX-A, MAX-AL, MAX-N, MAX-P, MAX-I and MAX-FAST (K052186)

Reference Devices

• Hygia Health Services Reprocessed OxiMax Sensors (K041867)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)<br>1500 NE Hemlock Ave., Redmond, OR 97756 | |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Prepared by/Contact Name | Stephanie Boyle Mays<br>Regulatory Affairs Specialist, Quality Assurance/Regulatory Affairs<br>P: 541-516-4205 • F: 541-923-3375 • E:[e-mail] | |
| Date Prepared | February 18, 2019 | |
| Device Name<br>and<br>Classification | Proprietary/Trade Name: | Medline ReNewal Reprocessed Nellcor OxiMax SpO2<br>Sensors, models MAXA, MAXAL, MAXP, and MAXI |
| | Common or usual name | Oximeter, reprocessed |
| | Regulatory Name/Reference: | Oximeter; 21 CFR § 870.2700 |
| | Regulatory Class: | Class II |
| | Product Code: | NLF |
| | Panel: | Cardiovascular/anesthesiology |
| Predicate<br>Device | 510(k) number: | K052186 |
| | Proprietary/Trade Name: | Nellcor OxiMax Pulse Oximeter Sensors, models<br>MAX-A, MAX-AL, MAX-N, MAX-P, MAX-I and MAX-FAST |
| | Common or usual name | Oxygen sensor |
| | Regulatory Name/Reference: | Oximeter; 21 CFR § 870.2700 |
| | Regulatory Class: | Class II |
| | Product Code: | DQA |
| | Panel: | Cardiovascular/anesthesiology |
| | Manufacturer: | Nellcor Puritan Bennett, Inc.<br>4280 Hacienda Dr., Pleasanton, CA 94588 |
| Reference<br>Device | 510(k) number: | K041867 |
| | Proprietary/Trade Name: | Hygia Health Services Reprocessed OxiMax Sensors<br>Model # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N |
| | Regulatory Name/Reference: | Oximeter; 21 CFR § 870.2700 |
| | Common or usual name | Oximeter, reprocessed |
| | Regulatory Class: | II |
| | Product Code: | NLF |
| | Panel: | Cardiovascular/anesthesiology |
| | Manufacturer: | Hygia Health Services, Inc. |
| Statement of<br>Indications for<br>Use | The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors models<br>MAXA, MAXAL, MAXP, and MAXI are indicated for single patient use when<br>continuous noninvasive arterial oxygen saturation and pulse rate monitoring<br>are required for patients in the sizes indicated in the respective sensor<br>directions for use. These devices are for prescription use only. | |
| Device<br>Description | The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors,<br>models MAXA, MAXAL, MAXP, and MAXI are designed for the continuous<br>non-invasive monitoring of functional oxygen saturation of arterial<br>hemoglobin (SpO2) and pulse rate in conjunction with a Nellcor Pulse<br>Oximeter. The Reprocessed Nellcor OxiMax SpO2 Sensors, models MAXA,<br>MAXAL, MAXP, and MAXI are intended for prescription use with adult,<br>pediatric and infant patients in hospitals, hospital-type facilities, and intra-<br>hospital transport. The proposed device is not provided sterile. | |
| Statement of<br>Intended Use | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors are<br>indicated for the continuous non-invasive monitoring of functional oxygen<br>saturation of arterial hemoglobin (SpO₂) and pulse rate. They are intended<br>for use with infant, pediatric and adult patients in hospitals, hospital-type<br>facilities, and intra-hospital transport. These devices are for prescription use<br>only. | |
| Technology<br>(including<br>features,<br>materials and<br>principles of<br>operation) | The technological characteristics and the fundamental scientific technology<br>of the subject devices are identical to the predicate and reference devices.<br>The proposed devices are a reprocessed version of the predicate K052186<br>device. 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 and reference<br>devices were used to support intended use, technological characteristics,<br>and performance specifications. (Also see comparison of technological<br>features in the Summary Table) | |
| 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; acute systemic<br>toxicity<br>· Disinfection<br>• Shelf Life<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 | 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 |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Characteristics | Covidien Nellcor<br>OxiMax Pulse Oximeter<br>Sensors | Hygia Health Services<br>Reprocessed OxiMax Sensors | Medline ReNewal<br>Reprocessed Nellcor OxiMax<br>Sp02 Sensors | Same devices;<br>original and<br>reprocessed |
| 510(k) Number | K052186 | K041867 | K181738 | N/A |
| Common Name | Oximeter | Oximeter | Oximeter | Same |
| Regulation No. | 870.2700 | 870.2700 | 870.2700 | Same |
| Product Code | DQA | NLF | NLF | As stated |
| Models | MAXA, MAXAL, MAXN, MAXP,<br>MAXI and MAXFAST | MAXA, MAXAL, MAXN | MAXA, MAXAL, MAXP, and<br>MAXI | As stated |
| Indications for use | The Nellcor OxiMax Pulse<br>Oximetry Sensors, models<br>MAX-A, MAX-AL, MAX-N, MAX-<br>P, MAX-I and MAX-FAST are<br>indicated for single patient use<br>when continuous noninvasive<br>arterial oxygen saturation and<br>pulse rate monitoring are<br>required for patients in the sizes<br>indicated in the respective<br>sensor directions for use. | The sensor is indicated for use<br>as a non-invasive method to<br>provide continuous SpO2<br>monitoring and pulse rate. | The Medline ReNewal<br>Reprocessed Nellcor OxiMax<br>SpO2 Sensors models MAXA,<br>MAXAL, MAXP, and MAXI are<br>indicated for single patient use<br>when continuous noninvasive<br>arterial oxygen saturation and<br>pulse rate monitoring are<br>required for patients in the sizes<br>indicated in the respective<br>sensor directions for use. These<br>devices are for prescription use<br>only. | The predicate and<br>proposed devices<br>have the same<br>indications. The<br>predicate and<br>reference devices<br>share the same<br>predicate,<br>K012891. |
| Intended use | The OxiMax Pulse Oximeter<br>System is indicated for the<br>continuous non-invasive<br>monitoring of functional oxygen<br>saturation of arterial hemoglobin<br>(SpO2) and pulse rate. It is<br>intended for use with neonatal,<br>pediatric, and adult patients | None listed | The reprocessed Nellcor<br>OxiMax SpO2 Sensors are<br>indicated for the continuous<br>non-invasive monitoring of<br>functional oxygen saturation of<br>arterial hemoglobin (SpO2) and<br>pulse rate. They are intended for<br>use with pediatric and adult | Medline Renewal<br>will only reprocess<br>pulse oximeter<br>sensors. Medline<br>ReNewal will not<br>make claims for<br>neonatal use or for<br>motion or low |
| Device<br>Characteristics | Predicate | Reference | Proposed | Comparison |
| | Covidien Nellcor<br>OxiMax Pulse Oximeter<br>Sensors | Hygia Health Services<br>Reprocessed OxiMax Sensors | Medline ReNewal<br>Reprocessed Nellcor OxiMax<br>SpO2 Sensors | |
| Intended use<br>concluded | during both no motion and<br>motion conditions and for<br>patients who are either well or<br>poorly perfused, in hospitals,<br>hospital-type facilities, intra-<br>hospital transport, and home<br>environments. These devices<br>are for prescription only.…