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 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.

AI/ML Overview

Here's an analysis of the provided FDA 510(k) summary regarding the ReddyPort Elbow, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary for a medical device that interfaces with respiratory therapy equipment. It is not an AI/ML medical device. Therefore, many of the requested elements for AI/ML device studies (like sample size of test/training sets, expert ground truth, MRMC studies, etc.) are not applicable to this type of traditional medical device submission. This document focuses on the physical and functional equivalence to predicate devices through bench testing and biocompatibility testing, not on algorithmic performance.

I will address the applicable sections of your request based on the provided text.

Device Name: ReddyPort Elbow
Regulation Name: Continuous Ventilator (specifically an accessory/interface)
Regulatory Class: Class II
Product Code: MNS
Applicant: SMD Manufacturing LLC

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't present a formal table of "acceptance criteria" against "reported performance" in the way one might see for an AI/ML device (e.g., sensitivity, specificity thresholds). Instead, for this type of mechanical device, the acceptance criteria are generally implied by meeting the requirements of recognized standards (ISO 17510, ISO 5356-1) and demonstrating performance (e.g., leak rates, resistance to flow). The device is deemed acceptable if it meets these standards and is substantially equivalent to predicate devices.

However, based on the "Substantial Equivalence Comparison Table" (pages 4-5) and "Performance Testing" section (page 6), here's an attempt to structure the information in a table format, focusing on quantitative metrics where available:

Characteristic/Test	Acceptance Criteria (Implied/Standard)	Reported Device Performance (ReddyPort Elbow - Subject Device)	Substantial Equivalence Remarks
Indications for Use	Consistent with predicate devices for CPAP/bi-level therapy interface during other procedures (e.g., oral care, suctioning, bronchoscopy).	Provides interface for CPAP/bi-level therapy during oral care, suctioning, bronchoscopy.	Similar
Patient Population	Patients > 40 lbs / 18.2 kg (similar to predicates).	Patients (> 40 lbs / 18.2 kg).	Similar
Environment of Use	Hospital/Institutional Environment Only.	Hospital/Institutional Environment Only.	Same
Sterility	Provided Non-Sterile (Clean).	Provided Non-Sterile (Clean).	Same
Patient Usage Type	Single patient use in hospital/institutional environment.	Single patient use in hospital/institutional environment.	Same
Design	Permanent replacement elbow with duckbill and anti-asphyxia valve, clip-style connection (similar to predicate/reference).	Permanent replacement elbow with duckbill and anti-asphyxia valve, clip-style connection.	Similar
Valve Type	Duckbill Valve for access (similar to predicate).	Duckbill Valve.	Similar
Body Material	Biocompatible material (e.g., Polycarbonate or Polypropylene).	Polypropylene.	Similar (to Philips Respironics)
Access Valve Material	Silicone Elastomer.	Silicone Elastomer.	Similar
Anti-Asphyxia Valve Material	Silicone Elastomer.	Silicone Elastomer.	Same
Elbow Deadspace	Comparable to traditional NIV elbows (implied by "streamlined, low dead-space design").	37.59 mL (Predicate: 50.9 mL). Subject device has lower dead space.	Similar (and improved)
Leak Rates (4 cmH2O)	Comparable to predicate (e.g., 8.46 L/min for predicate).	0.6 L/min. (Predicate: 8.46 L/min). Subject device has significantly lower leak rates.	Similar (and improved)
Leak Rates (10 cmH2O)	Comparable to predicate (e.g., 7.26 L/min for predicate).	0.65 L/min. (Predicate: 7.26 L/min).	Similar (and improved)
Leak Rates (17 cmH2O)	Comparable to predicate (e.g., 7.65 L/min for predicate).	0.89 L/min. (Predicate: 7.65 L/min).	Similar (and improved)
Leak Rates (24 cmH2O)	Comparable to predicate (e.g., 7.56 L/min for predicate).	1.11 L/min. (Predicate: 7.56 L/min).	Similar (and improved)
Leak Rates (30 cmH2O)	Comparable to predicate (e.g., 7.35 L/min for predicate).	1.34 L/min. (Predicate: 7.35 L/min).	Similar (and improved)
Resistance to Flow (50 L/min)	Low resistance (e.g., 0.223 cmH2O for predicate).	0.23 cmH2O. (Predicate: 0.223 cmH2O).	Similar
Resistance to Flow (100 L/min)	Low resistance (e.g., 0.217 cmH2O for predicate).	0.13 cmH2O. (Predicate: 0.217 cmH2O). Subject device has lower resistance.	Similar (and improved)
Resistance Under Single Fault (Inspiratory)	Acceptable (e.g., 0.6 cmH2O for predicate).	1.23 cmH2O. (Predicate: 0.6 cmH2O). This shows higher resistance compared to the predicate, but is still considered acceptable under ISO standards.	Similar
Resistance Under Single Fault (Expiratory)	Acceptable (e.g., 0.5 cmH2O for predicate).	0.43 cmH2O. (Predicate: 0.5 cmH2O).	Similar
Safety Valve	Includes anti-asphyxia valve (similar to predicate).	Includes anti-asphyxia valve.	Same
Duration of Replacement	In place for entirety of NIV therapy (similar to predicate).	In place for entirety of NIV therapy.	Similar
Intentional Vent Holes	No vent holes (similar to predicate).	No vent holes.	Same
Pressure Range	4 to 30 cmH2O (similar to predicate).	4 to 30 cmH2O.	Same
Patient Circuit Connection	22mm Connection.	22mm Connection.	Same

Conclusion from section "Performance Testing": "The ReddyPort Elbow met all applicable requirements and acceptance criteria."

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: Not applicable. For this type of device, "test set" refers to physical samples of the device undergoing bench testing, not a dataset of patient cases. The number of physical units tested is not specified but is assumed to be sufficient for engineering and regulatory standards (e.g., multiple units to ensure consistency and robustness, per standard requirements like ISO).
Data Provenance: Not applicable. This is not clinical data. The data comes from bench testing performed by the manufacturer, likely in a controlled laboratory setting (e.g., specific to the manufacturing facility or a third-party testing lab). The document does not specify a country of origin for the testing, but it is for a US regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. "Ground truth" in the context of an AI/ML device refers to a definitive 'correct answer' for a diagnostic task, often established by expert consensus or pathology results. For this mechanical device, the "truth" is established by physical measurement against engineering standards and specifications. Engineers and technicians, not medical experts as defined in the prompt, perform these tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among multiple human readers in diagnostic tasks, which is characteristic of AI/ML performance studies. This device's evaluation is based on objective physical measurements via bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for evaluating the impact of AI on human diagnostic performance. This device is a mechanical accessory, not a diagnostic AI.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

No. There is no algorithm or AI component in this device. The performance data presented (leak rates, resistance, dead space) is indeed "standalone" in the sense that it's the raw physical performance of the device without human interaction being assessed as part of the primary outcome, but this is standard bench testing, not AI standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is defined by:

Engineering Specifications and Design Requirements: What the device is designed to do.
Recognized International Standards: Such as ISO 17510 (Medical devices -- Sleep apnoea breathing therapy Masks and application accessories) and ISO 5356-1 (Anaesthetic and respiratory equipment Conical connections). These standards specify acceptable ranges for performance characteristics like leak rates and resistance.
Performance of Legally Marketed Predicate Devices: Especially the primary predicate (ReddyPort NIV Access Elbow, K171827) and reference devices (AF541 EE Full Face Mask, K150639; BRONCHOSCOPY ELBOW, K132168). The subject device must perform as well as or better than these predicates to prove substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is a manufactured physical device, not an AI/ML model that requires training data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for a mechanical device.

Summary of Acceptance and Proof for ReddyPort Elbow:

The ReddyPort Elbow's acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices. This is proven through:

Bench Testing: As detailed in the table above, the device's physical performance characteristics (dead space, leak rates, resistance to flow) are measured and shown to be comparable to, and in some cases better than, the predicate devices, while meeting the requirements of relevant ISO standards. The document explicitly states: "The ReddyPort Elbow met all applicable requirements and acceptance criteria."
Biocompatibility Testing: The materials used in the device meet the requirements of ISO 10993 series and ISO 18562 series, indicating the device is biologically safe for its intended use and contact duration.
No Clinical Testing: The FDA determined that no clinical testing was required, implying that the bench testing and comparison to predicates provided sufficient evidence of safety and effectiveness for a 510(k) clearance.

In essence, the "study" proving the device meets acceptance criteria consists of these comprehensive engineering, performance, and biocompatibility tests conducted according to recognized standards, demonstrating the device's functional and safety equivalence to previously cleared devices.

Summary

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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 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

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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

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Indications for Use

510(k) Number (if known) K231064

Device Name ReddyPort Elbow

Indications for Use (Describe)

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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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

: 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)

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Predicate Device(s) Table

Predicate Type	510(k) Number	Name Of Device	Name Of Manufacturer	Purpose of ReferenceDevice
Primary Device	K171827	ReddyPort NIV AccessElbow	SMD Manufacturing, LLC	N/A - Primary PredicateDevice
Reference Device	K150639	AF541 EE Full Face Mask	RESPIRONICS, INC.	The ReddyPort Elbowinterfaces with thismask, replacing theAF541 EE elbow, inorder to allow patientsunder CPAP or bi-leveltherapy to also undergoanother care procedure.
Reference Device	K132168	BRONCHOSCOPYELBOW	RESPIRONICS, INC.	Demonstrate substantialequivalence for theReddyPort Elbow's useduring bronchoscopyindication.

Device Description

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	SubstantialEquivalenceRemarks
Device	ReddyPort Elbow	ReddyPort NIVAccess Elbow	AF541 Leak 1 EE Elbow	BRONCHOSCOPYELBOW	N/A
Manufacturer	SMDManufacturing, LLC	SMDManufacturing,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	SubstantialEquivalenceRemarks
Indications forUse	The ReddyPortElbow is intended toprovide an interfacefor application ofCPAP or bi-leveltherapy to the patientincluding while thepatient issimultaneouslyundergoing anothercare procedure (e.g.oral care, suctioning,bronchoscopy) byhospital/institutionalclinicians. Theelbow is for singlepatient use in thehospital/institutionalenvironment. Theelbow is to be usedon patients (> 40 lbs/18.2 kg) for whomCPAP or bi-leveltherapy has beenprescribed. Theelbow can be usedwith PhilipsRespironics AF541masks and AF531masks with the clip-style connection.	The ReddyPort NIVAccess Elbow isintended to providean interface forapplication of CPAPor bi-leveltherapy. The elbow isfor single patient usein thehospital/institutionalenvironment.Theelbow is to be usedon patients 7 yearsor older(>40lbs/18.2kg) forwhom CPAP or bi-level therapy hasbeen prescribed.	This Mask is intended to providean interface for application ofCPAP or bilevel therapy topatients. The mask is for singleuse in the hospital/institutionalenvironment only.The mask is tobe used on patients (>40lbs/20kg)for whom CPAP or bileveltherapy has been prescribed.	The BronchoscopyElbow can be usedwith RespironicsMasks thatincorporate themating elbow hubdesign. Use of thiselbow with thesemasks allows CPAPand bi-level therapyto be delivered to thepatient during abronchoscopyprocedure. Theelbow is for singleuse in thehospital/institutionalenvironment only	Similar
PatientPopulation	Patients(>40lbs/18.2kg)	Patients 7 years orolder(>40lbs/18.2kg)	Patients (>40lbs/20kg)	Pediatrics and adults(age >7 years and>40 lbs)	Similar
Environment ofUse	Hospital/InstitutionalEnvironment Only	Hospital/InstitutionalEnvironment Only	Hospital/InstitutionalEnvironmentonly	Hospital/InstitutionalEnvironment Only	Same
Product Code	MNS	MNS	BZD	BZD	Same as predicate
Provided Sterileor Non-Sterile	Provided Non-Sterile (Clean)	Provided Non-Sterile (Clean)	Provided Non-Sterile (Clean)	Provided Non-Sterile (Clean)	Same
Patient UsageType	Single patient use inthehospital/institutionalenvironment	Single patient use inthehospital/institutionalenvironment	Single patient use in thehospital/institutionalenvironment	Single patient use inthehospital/institutionalenvironment	Same
Design	Permanentreplacement elbowwith duckbill andanti-asphyxiavalve.The RP-541-L1 style has a clipstyle connection tothe mask.	Permanentreplacement elbowwith duckbill andanti-asphyxiavalve.Theconnection style is apress fit design.	EE Leak 1 Elbow with anti-asphyxia valve.	The BronchoscopyElbow is a Leak 1elbow that attachesto an AF541 mask.Itcontains an S-slitvalve through whicha bronchoscopyscope may beinserted to perform abronchoscopyprocedure while apatient is on non-invasive ventilation.The elbow does notcontain an anti-asphyxia valve orexhalation ports andis only intended tobe used during abronchoscopyprocedure andshould be replacedwith an EE Elbowafter the procedure ifthe patient is toremain 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	SubstantialEquivalenceRemarks
Body Material	Polypropylene	Polycarbonate	Polypropylene	Unknown	Similar
Access ValveMaterial	Silicone Elastomer	Silicone Elastomer	Does not have an Access Valvefeature	Silicone Elastomer	Similar
Anti-AsphyxiaValve 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 astreamlined, lowdead-space designwith a large duckbillvalve.	Has a larger overallprofile with higherdead-space.	Traditional NIV elbowstreamlined, low dead spacedesign	Sizes small and large	Similar
Safety Valve	Includes anti-asphyxia valve	Includes anti-asphyxia valve	Includes anti-asphyxia valve	The bronchoscopyelbow does not havebuilt in exhalation orentrainment valve.	Same
Duration ofReplacement	In place for entiretyof NIV therapy	In place for entiretyof NIV therapy	In place for entirety of NIVtherapy	For temporary useduring abronchoscopyprocedure	Similar
Intentional ventholes	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 CircuitConnection	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/min10 cmH2O: 0.65L/min17 cmH2O: 0.89L/min24 cmH2O: 1.11L/min30 cmH2O: 1.34L/min	4 cmH2O: 8.46L/min10 cmH2O: 7.26L/min17 cmH2O: 7.65L/min24 cmH2O: 7.56L/min30 cmH2O: 7.35L/min	Unknown *	Unknown*	Similar
Resistance toFlow DuringRegularCondition	Added resistance toflow during:50 L/min flow: 0.23cmH2O100L/min flow: 0.13cmH2O	Added resistance toflow during:50 L/min flow:0.223 cmH2O100 L/min flow:0.217 cmH2O	Unknown*	Unknown*	Similar
Resistance UnderSingle Fault	Added InspiratoryResistance: 1.23cmH2OAdded ExpiratoryResistance 0.43cmH2O	Added InspiratoryResistance: 0.6cmH20Added ExpiratoryResistance 0.5cmH2O	Unknown*	Unknown*	Similar

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*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.

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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.

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
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.(b)
Classification. Class II (performance standards).