Who is the manufacturer of ReddyPort Elbow?

Smd Manufacturing, LLC filed the 510(k) submission for ReddyPort Elbow (K231064).

What is the FDA product code for ReddyPort Elbow?

MNS. It is classified under 21 CFR 868.5895 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for ReddyPort Elbow?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ReddyPort Elbow?

ReddyPort NIV Access Elbow (K171827).

Who can help prepare an FDA 510(k) submission like ReddyPort Elbow?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ReddyPort Elbow

K231064 · Smd Manufacturing, LLC · MNS · Jul 13, 2023 · Anesthesiology

Device Facts

Record ID	K231064
Device Name	ReddyPort Elbow
Applicant	Smd Manufacturing, LLC
Product Code	MNS · Anesthesiology
Decision Date	Jul 13, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5895
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Indications for Use

The ReddyPort Elbow is intended to provide an interface for application of CPAP or bi-level therapy to the patient including while the patient is simultaneously undergoing another care procedure (e.g. oral care, suctioning, bronchoscopy) by hospital/institutional clinicians. The elbow is for single patient use in the hospital/institutional environment. The elbow is to be used on patients (> 40 lbs/ 18.2 kg) for whom CPAP or bi-level therapy has been prescribed. The elbow can be used with Philips Respironics AF541 masks and AF531 masks with the clip-style connection.

Device Story

ReddyPort Elbow is a non-invasive ventilation (NIV) interface component; replaces standard mask elbows on Philips Respironics AF541/AF531 masks. Device features a duckbill valve for clinical access (oral care, suctioning, bronchoscopy) and an anti-asphyxia valve for safety. Used in hospital/institutional settings by clinicians; maintains positive pressure during procedures. Input is pressurized air from ventilator circuit; output is delivered therapy to patient airway. Benefits include enabling respiratory care procedures without removing the mask or interrupting ventilation. Device is single-patient use.

Clinical Evidence

No clinical data. Bench testing only, including ISO 17510:2015 (sleep apnea breathing therapy masks), ISO 5356-1:2015 (conical connectors), mask/tubing connection force, dead space, and resistance to flow. Biocompatibility testing performed per ISO 10993 and ISO 18562 series for long-term (>30 days) indirect tissue contact.

Technological Characteristics

Polypropylene body; silicone elastomer valves (duckbill and anti-asphyxia). 22mm patient circuit connection. Streamlined, low dead-space (37.59 mL) design. Non-sterile (clean). Compatible with clip-style mask interfaces. Pressure range 4-30 cmH2O.

Indications for Use

Indicated for patients (> 40 lbs/ 18.2 kg) requiring CPAP or bi-level therapy in a hospital/institutional setting, including during concurrent procedures like oral care, suctioning, or bronchoscopy. Compatible with Philips Respironics AF541 and AF531 masks with clip-style connections.

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.

Predicate Devices

ReddyPort NIV Access Elbow (K171827)

Reference Devices

AF541 EE Full Face Mask (K150639)
BRONCHOSCOPY ELBOW (K132168)

Related Devices

K171827 — ReddyPort NIV Access Elbow · Smd Manufacturing, LLC · Jan 19, 2018
K030822 — 7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS · Hans Rudolph, Inc. · Jun 3, 2003
K132168 — BRONCHOSCOPY ELBOW · Respironics, Inc. · Nov 20, 2013
K121747 — FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS · Intersurgical Incorporated · Mar 14, 2013
K103395 — PERFORMAX TOTAL FACE MASK · Respironics, Inc. · Mar 24, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 13, 2023 SMD Manufacturing LLC % Tianna Benson RAOA Manager Lean RAQA, LLC 131 E Loch Lomond Dr. Oro Valley, Arizona 85737 Re: K231064 Trade/Device Name: ReddyPort Elbow Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: MNS Dated: April 13, 2023 Received: April 14, 2023 Dear Tianna Benson: 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. 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 {1}------------------------------------------------ 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 mediation-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, # Ethan L. Nyberg -S Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K231064 Device Name ReddyPort Elbow ## Indications for Use (Describe) The ReddyPort Elbow is intended to provide an interface for application of CPAP or bi-level therapy to the patient including while the patient is simultaneously undergoing another care procedure (e.g. oral care, suctioning, bronchoscopy) by hospital/institutional clinicians. The elbow is for single patient use in the hospital/institutional environment. The elbow is to be used on patients (> 40 lbs/ 18.2 kg) for whom CPAP or bi-level therapy has been prescribed. The elbow can be used with Philips Respironics AF541 masks and AF531 masks with the clip-style connection. Type of Use (Select one or both, as applicable) | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |-------------------------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary K231064 ## Applicant/Submitter | Company Name | : SMD MANUFACTURING LLC | |----------------|-------------------------| | Street Address | : 918 S 500 W, Ste A | | City | : Salt Lake City | | State | : UT | | Zip Code | : 84101 | ## Contact Person | Full Name | : Jared Spendlove | |-----------|---------------------| | Phone | : (801) 458-1959 | ## Correspondent Information | Full Name | : Laura Nygard | |-----------|----------------| | Phone | : 734-807-1282 | ## Date of Preparation Date of Preparation : 07/06/2023 ## Device Information #### Device Information Table | Trade Name | ReddyPort Elbow | |----------------------|---------------------------------------------| | Common or Usual Name | Ventilator, Continuous, Non-Life-Supporting | | Classification Name | 21 CFR 868.5895 Continuous ventilator. | | Regulatory Class | 2 | | Product Code | MNS | Predicate Device(s) {4}------------------------------------------------ #### Predicate Device(s) Table | Predicate Type | 510(k) Number | Name Of Device | Name Of Manufacturer | Purpose of Reference Device | |------------------|---------------|-------------------------------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Primary Device | K171827 | ReddyPort NIV Access Elbow | SMD Manufacturing, LLC | N/A - Primary Predicate Device | | Reference Device | K150639 | AF541 EE Full Face Mask | RESPIRONICS, INC. | The ReddyPort Elbow interfaces with this mask, replacing the AF541 EE elbow, in order to allow patients under CPAP or bi-level therapy to also undergo another care procedure. | | Reference Device | K132168 | BRONCHOSCOPY ELBOW | RESPIRONICS, INC. | Demonstrate substantial equivalence for the ReddyPort Elbow's use during bronchoscopy indication. | #### Device Description The ReddyPort Elbow is an NIV elbow that replaces the elements AF541 style masks and AF531 masks with a clip-style comection and provides oral access for clinicians to the patient's airway during CPAP and bi-level therapy. The ReddyPort Elbow is compatible with both Over the Nose (OTN) cushion ((S, M, L, XL sizes) and an Under the Nose (UTN) cushion (A, B, C sizes) configurations of the AF541 EE Mask and AF531 mask with clip-style connection. ReddyPort permanently replaces the conventional elbow on the mask and maintains positive pressure. This elbow allows for respiratory care procedures (e.g. oral care, suctioning, bronchoscopy) to be performed on a patient while the patient is receiving non-invasive ventilation. The elbow contains a duckbill valve that allows the patient's airway and that seals with similar leak rates to conventional NIV elbows. In addition, the elbow includes an anti-asphysia valve to ensure safety of the patient. #### Intended Use/Indications for Use The ReddyPort Elbow is intended to provide an interface for application of CPAP or bi-level therapy to the patient is simultaneously undergoing another care procedure (e.g. oral care, suctioning, bronchoscopy) by hospital/institutional clinicians. The elbow is for single patient use in the hospital'institutional environment. The elbow is to be used on patients (> 40 lbs/ 18.2 kg) for whom CPAP or bi-level therapy has been prescribed. The elbow can be used with Philips Respironics AF541 masks with the clip-style connection. #### Comparison of Technological Characteristics with Predicate #### Substantial Equivalence Comparison Table | Characteristics | Subject Device | Predicate Device | Reference Device | Reference Device | Substantial Equivalence Remarks | |------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------| | Device | ReddyPort Elbow | ReddyPort NIV Access Elbow | AF541 Leak 1 EE Elbow | BRONCHOSCOPY ELBOW | N/A | | Manufacturer | SMD Manufacturing, LLC | SMD Manufacturing, LLC. | Respironics, Inc | RESPIRONICS, INC. | N/A | | Model | RP-541-L1 | RP531 | Unknown | Unknown | N/A | | 510(k) Number | K231064 | K171827 | K150639 | K132168 | N/A | | Characteristics | Subject Device | Predicate Device | Reference Device | Reference Device | Substantial Equivalence Remarks | | Indications for Use | The ReddyPort Elbow is intended to provide an interface for application of CPAP or bi-level therapy to the patient including while the patient is simultaneously undergoing another care procedure (e.g. oral care, suctioning, bronchoscopy) by hospital/institutional clinicians. The elbow is for single patient use in the hospital/institutional environment. The elbow is to be used on patients (> 40 lbs/ 18.2 kg) for whom CPAP or bi-level therapy has been prescribed. The elbow can be used with Philips Respironics AF541 masks and AF531 masks with the clip- style connection. | 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. | This Mask is intended to provide an interface for application of CPAP or bilevel therapy to patients. The mask is for single use in the hospital/institutional environment only.The mask is to be used on patients (>40lbs/20kg) for whom CPAP or bilevel therapy has been prescribed. | The Bronchoscopy Elbow can be used with Respironics Masks that incorporate the mating elbow hub design. Use of this elbow with these masks allows CPAP and bi-level therapy to be delivered to the patient during a bronchoscopy procedure. The elbow is for single use in the hospital/institutional environment only | Similar | | PatientPopulation | Patients (>40lbs/18.2kg) | Patients 7 years or older (>40lbs/18.2kg) | Patients (>40lbs/20kg) | Pediatrics and adults (age >7 years and >40 lbs) | Similar | | Environment of Use | Hospital/Institutional Environment Only | Hospital/Institutional Environment Only | Hospital/InstitutionalEnvironment only | Hospital/Institutional Environment Only | Same | | Product Code | MNS | MNS | BZD | BZD | Same as predicate | | Provided Sterile or Non-Sterile | Provided Non- Sterile (Clean) | Provided Non- Sterile (Clean) | Provided Non-Sterile (Clean) | Provided Non- Sterile (Clean) | Same | | Patient Usage Type | Single patient use in the hospital/institutional environment | Single patient use in the hospital/institutional environment | Single patient use in the hospital/institutional environment | Single patient use in the hospital/institutional environment | Same | | Design | Permanent replacement elbow with duckbill and anti-asphyxia valve.The RP-541- L1 style has a clip style connection to the mask. | Permanent replacement elbow with duckbill and anti-asphyxia valve.The connection style is a press fit design. | EE Leak 1 Elbow with anti- asphyxia valve. | The Bronchoscopy Elbow is a Leak 1 elbow that attaches to an AF541 mask.It contains an S-slit valve through which a bronchoscopy scope may be inserted to perform a bronchoscopy procedure while a patient is on non- invasive ventilation. The elbow does not contain an anti- asphyxia valve or exhalation ports and is only intended to be used during a bronchoscopy procedure and should be replaced with an EE Elbow after the procedure if the patient is to remain on non- invasive ventilation. | Similar | | Valve Type/Size | Duckbill Valve | Duckbill Valve | No access valve is incorporated | Valve for | Similar | | Characteristics | Subject Device | Predicate Device | Reference Device | Reference Device | Substantial Equivalence Remarks | | Body Material | Polypropylene | Polycarbonate | Polypropylene | Unknown | Similar | | Access Valve Material | Silicone Elastomer | Silicone Elastomer | Does not have an Access Valve feature | Silicone Elastomer | Similar | | Anti-Asphyxia Valve Material | Silicone Elastomer | Silicone Elastomer | Silicone Elastomer | N/A | Same | | Pick Off Port | N/A | Included | N/A | Included | N/A | | Shape and Size | ReddyPort has a streamlined, low dead-space design with a large duckbill valve. | Has a larger overall profile with higher dead-space. | Traditional NIV elbow streamlined, low dead space design | Sizes small and large | Similar | | Safety Valve | Includes anti- asphyxia valve | Includes anti- asphyxia valve | Includes anti-asphyxia valve | The bronchoscopy elbow does not have built in exhalation or entrainment valve. | Same | | Duration of Replacement | In place for entirety of NIV therapy | In place for entirety of NIV therapy | In place for entirety of NIV therapy | For temporary use during a bronchoscopy procedure | Similar | | Intentional vent holes | No vent holes | No vent holes | No vent holes | No vent holes | Same | | Pressure Range | 4 to 30 cmH2O | 4 to 30 cmH20 | 4 to 30 cmH2O | 4 to 30 cmH2O | Same | | Patient Circuit Connection | 22mm Connection | 22mm connection | 22mm Connection | 22mm Connection | Same | | Elbow Deadspace | 37.59 mL | 50.9mL | Unknown* | Unknown* | Similar | | Leak Rates | 4 cmH2O: 0.6 L/min 10 cmH2O: 0.65 L/min 17 cmH2O: 0.89 L/min 24 cmH2O: 1.11 L/min 30 cmH2O: 1.34 L/min | 4 cmH2O: 8.46 L/min 10 cmH2O: 7.26 L/min 17 cmH2O: 7.65 L/min 24 cmH2O: 7.56 L/min 30 cmH2O: 7.35 L/min | Unknown * | Unknown* | Similar | | Resistance to Flow During Regular Condition | Added resistance to flow during: 50 L/min flow: 0.23 cmH2O 100L/min flow: 0.13 cmH2O | Added resistance to flow during: 50 L/min flow: 0.223 cmH2O 100 L/min flow: 0.217 cmH2O | Unknown* | Unknown* | Similar | | Resistance Under Single Fault | Added Inspiratory Resistance: 1.23 cmH2O Added Expiratory Resistance 0.43 cmH2O | Added Inspiratory Resistance: 0.6 cmH20 Added Expiratory Resistance 0.5 cmH2O | Unknown* | Unknown* | Similar | {5}------------------------------------------------ {6}------------------------------------------------ *Data not publicly available. #### Performance Testing The following bench testing was completed for the proposed device: - ISO 17510:2015 Medical devices -- Sleep apnoea breathing therapy Masks and application accessories ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical conne - - Mask and Tubing Connection Force - Dead Space The ReddyPort Elbow met all applicable requirements and acceptance criteria. {7}------------------------------------------------ #### Biocompatibility Testing The biocompatibility impact of the changes was evaluated in accordance to ISO 18562-1:2017, and FDA Guidance for Industry and Food and Drug Administration Staff "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" Document issued on September 4, 2020. The battery of testing included: - ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity and reproductive toxicity - · ISO 10993-5:2009 Biological evaluation of medical devices Part 5:Tests for in vitro cytotoxicity - · ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization - · ISO 10993-11:2017 Biological evaluation of medical devices Part 11:Tests for systemic toxicity - · ISO 10993-17:2002 Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances - · ISO 10993-18:2020 Biological evaluation of medical devices Part 18: Chemical device materials within a risk management process - · ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management process - · ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 2: Tests for emissions of particulate matter - · ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 2: Tests for emissions of particulate matter - ISO 18562-4:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 4: Tests for leachables in condensate The device is categorized as an External Communicating Device with Indirect Tissue contact for long-term duration contact (> 30 days). All biological testing conducted demonstrated passince criteria) and were conducted on test articles that are representative of the final, finished device in its final, finished form. #### Clinical Testing No clinical testing was conducted as part of this 510(k) submission. #### Conclusion The conclusions drawn from the nonelinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.

ReddyPort Elbow

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Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

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Reference Devices

Related Devices

Submission Summary (Full Text)

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ReddyPort Elbow

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

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Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

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