ReddyPort NIV Access Elbow

K171827 · Smd Manufacturing, LLC · MNS · Jan 19, 2018 · Anesthesiology

Device Facts

• Record ID: K171827
• Device Name: ReddyPort NIV Access Elbow
• Applicant: Smd Manufacturing, LLC
• Product Code: MNS · Anesthesiology
• Decision Date: Jan 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The ReddyPort NIV Access Elbow is intended to provide an interface for application of CPAP or bi-level therapy. The elbow is for single patient use in the hospital/institutional environment. The elbow is to be used on patients 7 years or older (>40lbs/18.2kg) for whom CPAP or bi-level therapy has been prescribed.

Device Story

ReddyPort NIV Access Elbow serves as an interface component for CPAP or bi-level ventilation therapy; facilitates access to the patient's mouth for oral care or suctioning without removing the mask or interrupting therapy. Used in hospital/institutional environments by clinicians. Device connects between the ventilator circuit and the patient mask. Benefits include maintenance of therapy pressure during oral care procedures, reducing risk of patient desaturation or therapy interruption.

Clinical Evidence

Bench testing only.

Technological Characteristics

Elbow-shaped interface component for ventilator circuits; single-patient use; designed for integration with standard CPAP/bi-level masks and tubing.

Indications for Use

Indicated for patients 7 years or older (>40lbs/18.2kg) requiring CPAP or bi-level therapy in hospital/institutional settings.

Regulatory Classification

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.

January 19, 2018

SMD Manufacturing, LLC Rian Wendling Director of Regulatory Affairs 2500 South State Street, Suite D224 Salt Lake City, Utah 84115

Re: K171827

Trade/Device Name: ReddyPort NIV Access Elbow Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: MNS Dated: December 20, 2017 Received: December 27, 2017

Dear Rian Wendling:

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. 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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/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,

Tara A. Ryan -S 2018.01.19 19:15:33 -05'00'

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) K171827

Device Name ReddyPort NIV Access Elbow

## Indications for Use (Describe)

The ReddyPort NIV Access Elbow is intended to provide an interface for application of CPAP or bi-level therapy. The elbow is for single patient use in the hospital/institutional environment. The elbow is to be used on patients 7 years or older (>40lbs/18.2kg) for whom CPAP or bi-level therapy has been prescribed.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------|-----------------------------------------------|
| <span style="font-size:10px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |

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