The SolidAIRity III Endotracheal Suction Tube is indicated for airway management of patients requiring oral intubation and for evacuation and drainage of subglottic secretions that accumulate above the cuff.

The SolidAIRity III Endotracheal Tube Stabilizer is indicated for airway management of patients by securing a SolidAIRity III Endotracheal Tube during oral intubation.

Device Description

The SolidAIRity III Airway Stabilization System consists of:

Two (2) types of Oral Endotracheal Tubes (the SolidAIRity III Standard Oral Endotracheal Tube or the SolidAIRity III Suction Oral Endotracheal Tube), and
The SolidAIRity III Endotracheal Tube Stabilizer

Each type (standard and suction) of the SolidARity III Oral Endotracheal Tubes will be available in the following five (5) adult sizes:

6.0mm ID
6.5mm ID
7.0mm ID
7.5mm ID
8.0mm ID

A clinician inserts the endotracheal tube into a patient's trachea, via the mouth, in accordance with standard clinical technique to maintain an open airway. The stabilizer remains outside the patient's mouth and, by means of a locking device and straps, secures the endotracheal tube in place.

AI/ML Overview

The provided text is a 510(k) summary for the SolidAIRity III Airway Stabilization System. It describes the device, its indications for use, and a comparison to predicate devices. The summary of testing outlines various tests conducted to demonstrate the device's safety and effectiveness.

Here’s an breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria alongside performance data in a detailed quantitative manner for most tests. Instead, it generally states that "The results of all testing met acceptance criteria." and "The results of the testing satisfy the requirements of the study protocols and comply with ISO 10993-1." However, for Biocompatibility, it lists the tests and states "Pass" for each. For the "Resistance to Movement Against Force testing," an acceptance criterion is implied by the statement "to resist tube movement against multidirectional external forces of up to 20 pounds."

Here's a condensed table based on the information available:

Test Category	Specific Test	Acceptance Criteria (Implied/Stated)	Reported Device Performance
Biocompatibility	Cytotoxicity	Comply with ISO 10993-5	Pass
	Sensitization	Comply with ISO 10993-10	Pass
	Irritation	Comply with ISO 10993-10	Pass
	Acute Systemic Toxicity	Comply with ISO 10993-11	Pass
	Material-Mediated Pyrogenicity	Comply with ISO 10993-11	Pass
	Subacute / Subchronic Toxicity	Comply with ISO 10993-11	Pass
	Genotoxicity	Comply with ISO 10993-3	Pass
	Implantation	Comply with ISO 10993-6	Pass
Sterilization	Sterilization Process Validation	Comply with ISO 11135-1 and ISO 10993-7	Met acceptance criteria
Packaging	Package Integrity Validation	Comply with ISO 11607-1 (non-aged and 2-year accelerated aging)	Met acceptance criteria
Performance Bench	Endotracheal Tube Conformance Test	(Predefined acceptance criteria based on ISO 5361)	Met predefined acceptance criteria
	Cuff Inflation Tube Leak Test	(Predefined acceptance criteria based on ISO 5361)	Met predefined acceptance criteria
	Cuff Resting Diameter Test	(Predefined acceptance criteria based on ISO 5361)	Met predefined acceptance criteria
	Cuffed Tube Collapse Test	(Predefined acceptance criteria based on ISO 5361)	Met predefined acceptance criteria
	Cuff Herniation Test	(Predefined acceptance criteria based on ISO 5361)	Met predefined acceptance criteria
	Tracheal Seal Test	(Predefined acceptance criteria based on ISO 5361)	Met predefined acceptance criteria
	Kink Resistance Test	(Predefined acceptance criteria based on ISO 5361)	Met predefined acceptance criteria
	Radiopaque Marker Compliance Test	(Predefined acceptance criteria based on ISO 5361)	Met predefined acceptance criteria
	KAD Collar/Inflation Tube Pull Test	Ensure proper performance strength against external forces	Met predefined acceptance criteria
	Suction Tube Performance Test	Performance substantially equivalent to predicate (based on ISO 8836)	Met predefined acceptance criteria
	Resistance to Movement Against Force	Resist tube movement against multidirectional external forces up to 20 pounds	Validated (met acceptance criteria)
Human Factors	Usability Validation	Users can perform all phases of advanced airway management as safely and effectively as predicate	Demonstrated (met acceptance criteria)

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

The document does not specify the sample sizes used for the test sets in any of the described tests (biocompatibility, sterilization, packaging, performance bench, or human factors).

Regarding data provenance:

For Biocompatibility, the testing was performed, but the location or specific origin of the samples/data is not mentioned beyond compliance with FDA Guidance and ISO standards.
For Human Factors, the study was "conducted in simulated use scenarios employing accepted models of evaluation" and "in simulated environments consistent with those environments in which representative users typically perform airway management." It doesn't state the country of origin of the data explicitly but implies a controlled, simulated environment rather than real-world patient data.
The document implies that all tests were conducted by the manufacturer, Securisyn Medical, LLC, or their appointed testing facilities to support the 510(k) submission.
The studies were prospective in nature, as they were conducted specifically to support the 510(k) submission and evaluate the performance of the device against predefined criteria. No retrospective data analysis is mentioned.

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

The document does not provide this information.

For the Human Factors Validation Study, it mentions "representative users," but does not specify the number or qualifications of experts involved in establishing ground truth or evaluating performance.
For bench testing, ground truth is typically established by engineering specifications and industry standards (e.g., ISO 5361, ISO 8836), not by human experts interpreting data for a "ground truth" purpose in the way described for AI/diagnostic studies.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. This level of detail is typically associated with clinical studies or studies involving subjective assessments that require consensus, which are not explicitly detailed here. The tests described are primarily objective and involve predefined criteria for pass/fail.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No, an MRMC comparative effectiveness study was not done.
The device described is a physical medical device (airway stabilization system), not an AI/software device that assists human readers in interpreting diagnostic images or data. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.

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

No, a standalone (algorithm-only) performance test was not done in the context of AI.
Again, the device is a physical medical device. Performance testing was conducted on the physical device itself (bench testing) and in simulated human use scenarios (human factors study), which inherently involves a "human-in-the-loop" interaction with the device.

7. The Type of Ground Truth Used

For the various tests, the "ground truth" was established by engineering specifications, industry standards (e.g., ISO 5361, ISO 8836, ISO 10993, ISO 11135-1, ISO 11607-1, ASTM 1980), and predefined acceptance criteria. For the human factors study, the "ground truth" was established based on the ability of users to perform tasks "safely and as effectively as the predicate" in simulated use scenarios. There is no mention of pathology, expert consensus in a diagnostic sense, or outcomes data being used as ground truth for these tests.

8. The Sample Size for the Training Set

Not applicable.
This term typically refers to the data used to train an AI algorithm. As this is a physical medical device and not an AI/machine learning device, there is no "training set" in this context.

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

Not applicable.
As there is no training set for an AI algorithm, the establishment of ground truth for such a set is not relevant to this submission.

Summary

{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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 9, 2019

Securisyn Medical, LLC Arthur Kanowitz Founder. Chairman. Chief Medical Officer 9150 Commerce Center Circle, Suite 135 Highlands Ranch, Colorado 80129

Re: K190630

Trade/Device Name: SolidAIRity III Airway Stabilization System Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR, CBH Dated: September 9, 2019 Received: September 10, 2019

Dear Arthur Kanowitz:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

{1}------------------------------------------------

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 (OS) 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,

for 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 Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K190630

Device Name

SolidAIRity III Airway Stabilization System

Indications for Use (Describe)

The SolidAIRity III Endotracheal Standard Tube is indicated for airway management of patients requiring oral intubation.

The SolidAIRity III Endotracheal Tube Stabilizer is indicated for airway management of patients by securing a SolidAIRity III Endotracheal Tube during oral intubation.

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)

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}------------------------------------------------

Section 7: 510(k) Summary

Introduction:

This document contains the 510(k) Summary for the SolidAIRity® III Airway Stabilization System. The content of this summary is based on the requirements set forth in 21 CFR 807.92.

Applicant/Manufacturer Name and Address:

Securisyn Medical, LLC 9150 Commerce Center Circle, Suite 135 Highlands Ranch, CO USA 80129

510(k) Contact Person:

Arthur Kanowitz, MD FACEP Founder, Chairman, Chief Medical Officer Securisyn Medical, LLC

Email: akanowitz@securisyn.com Tel: (720) 641-3540

Date Prepared:

March 8, 2019

Device Trade Name:

SolidAIRity® III Airway Stabilization System

Classification and Classification Name:

Name: Tube, Tracheal (W/Wo Connector)

Product Code: BTR

Regulation Number: 21 CFR 868.5730

Class: II

Panel: Anesthesiology

Predicate Devices:

BEVER Endotracheal Tube and BEVER Eva Endotracheal Tube (K111401, Primary Predicate) Laerdal Thomas ET Tube Holder (K843790, Secondary Predicate)

Device Description:

The SolidAIRity III Airway Stabilization System consists of:

o Two (2) types of Oral Endotracheal Tubes (the SolidAIRity III Standard Oral Endotracheal Tube or the SolidAIRity III Suction Oral Endotracheal Tube), and
The SolidAIRity III Endotracheal Tube Stabilizer ●

Page 7-1 of 7

{4}------------------------------------------------

Each type (standard and suction) of the SolidARity III Oral Endotracheal Tubes will be available in the following five (5) adult sizes:

6.0mm ID
6.5mm ID
7.0mm ID
7.5mm ID ●
8.0mm ID ●

Standard Oral Endotracheal Tube Description

The SolidAIRity III Standard Oral Endotracheal Tube is a sterile, single-use airway device designed to be used as part of the SolidAIRity III Airway Stabilization System. This oral endotracheal tube features a retention structure (KAD collar) that interfaces with the SolidAlRity III Stabilizer to secure the endotracheal tube. As a fully integrated stabilization system, the system is designed to resist movement of the tube against applied extubation forces of up to 20 pounds.

The tube design includes a pair of depth localizer bands that promote proper placement of the tracheal tube in relation to the patient's vocal cords, as well as a depth indicator line on the KAD collar that allows for monitoring of tube depth relative to the Stabilizer tower and allows for easy and accurate depth repositioning of the ETT. The tube design also includes identification lettering ("ETT") on the inflation line to assist in preventing Luer fitting misconnections.

Suction Oral Endotracheal Tube Description

The SolidAlRity III Suction Oral Endotracheal Tube is identical to the SolidAIRity III Standard Oral Endotracheal Tube with an additional lumen for the suction functionality. The dorsal suction lumen allows suctioning of contaminated mucous or subglottic secretions that accumulate above the cuff. The tube design also includes identification lettering on both the inflation line ("ETT") and the suction line ("Suction") to assist in preventing Luer fitting misconnections.

Stabilizer

The SolidAIRity III Endotracheal Tube Stabilizer is a non-sterile, single-use endotracheal tube stabilization device designed to be used externally and only with the SolidAIRity III Standard or Suction Oral Endotracheal Tubes. This device uses a fixation mechanism to hold the SolidAlRity III Oral Endotracheal Tube firmly in place without crimping, pinching or squeezing the tube. Use of the SolidAIRity III Endotracheal Tube Stabilizer may withstand up to 20 pounds of external force.

{5}------------------------------------------------

Indications for Use Statement:

The SolidAIRity III Endotracheal Standard Tube is indicated for airway management of patients requiring oral intubation.

The SolidAIRity III Endotracheal Tube Stabilizer is indicated for airway management of patients by securing a SolidAIRity III Endotracheal Tube during oral intubation.

Technological Characteristics Comparison

The table below provides a comparison of the technological characteristics between the SolidAIRity III Airway Stabilization System and its identified predicate devices.

Specification	SolidAIRity III AirwayStabilizer System(Endotracheal Tube andStabilizer)	BEVER Endotracheal Tubeand BEVER EvaEndotracheal Tube(Primary Predicate)	Laerdal Thomas ET TubeHolder (SecondaryPredicate)
510(k) Number	TBD	K111401	K843790
RegulationNumber	21 CFR 868.5730	21 CFR 868.5730	21 CFR 868.5770
Product Code	BTR	BTR	CBH
Classification	II	II	I
Indications for Use	The SolidAIRity IIIEndotracheal Standard Tubeis indicated for airwaymanagement of patientsrequiring oral intubation.The SolidAIRity IIIEndotracheal Suction Tube isindicated for airwaymanagement of patientsrequiring oral intubation andfor evacuation and drainageof subglottic secretions thataccumulate above the cuff.The SolidAIRity IIIEndotracheal Tube Stabilizeris indicated for airwaymanagement of patients bysecuring a SolidAIRity IIIEndotracheal Tube duringoral intubation.	The BEVERTM Endotrachealtube is indicated for airwaymanagement by oral or nasalintubation of the tracheaduring mechanical ventilationand anesthesia. The BEVEREVATM Endotracheal tube isindicated for airwaymanagement by oralintubation of the trachea andfor evacuation or drainage ofthe contaminated mucous andsubglottic secretion thataccumulate above the cuff bycontinuous or intermittentsuctioning.	Thomas Select TubeHolder is designed tosecure advanced airwaydevices e.g. EndotrachealTubes (ETs), LaryngealMask Airways (LMAs) andother wider SupraglotticAirway devices (SGAs),after insertion into thetrachea or esophagus toreduce the risk ofaccidental extubation.
Intubation Route	Oral only	Oral or nasal	N/A
Patient Population	Adult	Pediatric and Adult	Pediatric and Adult
Intended Users	Physicians, respiratorytherapists and paramedics	Physicians, respiratorytherapists and paramedics	Physicians, respiratorytherapists and paramedics
Use Environment	Hospital, Point of Use	Hospital, Point of Use	Hospital, Point of Use
Usage	Single Use	Single Use	Single Use
Sterilization	ETT: Ethylene oxideStabilizer: Non-sterile	Ethylene oxide	Non-sterile
ETT OuterDiameter SizeRange (mm)	6.0 - 8.0mm in 0.5mmincrements	BEVER: 4.0 - 10.0mm in0.5mm incrementsBEVER Eva: 6.0 – 9.0mm in0.5mm increments	N/A
SuctionMechanism	Yes	Yes	N/A
SuctionEvacuation PortLocation	Directly Proximal to Cuff	Directly Proximal to Cuff	N/A
Tube Design	Per ISO 5361	Per ISO 5361	N/A
Tube Material	Medical Grade PVC	Medical Grade PVC	N/A
Magill Curve	Per ISO 5361	Per ISO 5361	N/A
Murphy Eye	Per ISO 5361	Per ISO 5361	N/A
Radiopaque Stripe	Full length Barium SulfiteRadiopaque Line	Full length Barium SulfiteRadiopaque Line	N/A
Cuff Design	Barrel Shape; High Volume/ Low Pressure	Barrel Shape: High Volume/ Low Pressure	N/A
Cuff Inflation	Inflation tube with pilotballoon and self-sealing valve	Inflation tube with pilotballoon and self-sealing valve	N/A
Proximal (machineend) connection	SolidAIRity III 15mmconnector with twist lockfeature	Standard 15mm connector	N/A
Line Protection	Inflation Line / Suction LineProtection Hub	None	N/A
Depth Markers	Yes, numerical (cm):6.0 ID = 17-22cm;6.5 ID = 18- 23cm;7.0 ID = 19-24cm;7.5 ID = 20-25cm;8.0 ID = 21-26cm	Yes, numerical (cm): 18-28cm for all ID sizes	N/A
Location of DepthMarkers	Printed on single side of tube	Printed on single side of tube	N/A
Depth PositioningLocalizer Bands	Yes	No	N/A
ETT SecurementMechanism forStabilizer	Ribbed KAD Collar tointerface with SolidAIRity IIIStabilizer	Compatible with commonETT stabilizers	Tube Clamp
Stabilizer/ETTSize Compatibility	6.0 – 8.0mm	N/A	4.3mm - 21.0mm
StabilizerOpenings for OralCare	Yes	N/A	Yes
Stabilizer HeadStrap	Yes	N/A	Yes
VentilationCompatibility	Yes – stabilizer can beapplied, adjusted or removedwithout disconnecting ETTfrom ventilation	N/A	Yes - stabilizer can beapplied, adjusted orremoved withoutdisconnecting ETT fromventilation
Stabilizer FoamMaterial	Polyethylene foam	N/A	Polyethylene foam
Stabilizer StrapMaterial	Polyethylene foam	N/A	Polyurethane foam,Polyester flannel, andPolyamide
DeviceBiocompatibility	Yes; ISO 10993	Yes; ISO 10993	Yes; ISO 10993

{6}------------------------------------------------

{7}------------------------------------------------

The Indications for Use of the SolidAIRity III Endotracheal Tubes and the primary predicate device are essentially the same. Both devices are indicated for airway management of patients requiring oral intubation. Although the primary predicate device is additionally indicated for nasal intubation, the indications of the subject device do not introduce new or different questions of safety and effectiveness since the scope of the subject device's indications have been previously cleared by the Agency as part of a larger scope in the primary predicate device. The indications for use of the SolidAIRity III Endotracheal Tube Stabilizer and the secondary predicate device are essentially the same. Both devices are indicated for airway management of patients by securing an endotracheal tube. Although the secondary predicate device is additionally indicated for use with other endotracheal tubes, laryngeal mask airways, and other supraglottic airway devices, the subject device is only indicated for use with SolidAIRity III Endotracheal Tubes. These differences do not affect the intended use of the device for airway management of patients requiring oral intubation. The indications for use do not result in the subject device being used for a different patient population, by different users, or in different use environments. Therefore, the SolidAIRity III Airway Stabilization System can be determined to be substantially equivalent to the predicate devices in terms of indications for use.

The design of the SolidAIRity III Airway Stabilization System and the primary predicate device are substantially equivalent in that both designs are in accordance with ISO 5361. Both the SolidAIRity III Suction Oral Endotracheal Tubes and the BEVER Eva Endotracheal Tube (primary predicate device) are designed with an additional suction lumen for use during advanced airway management. The suction lumen allows for evacuation or drainage by suctioning of contaminated mucous or subglottic secretions that accumulate above the cuff. On both devices the suction port is located directly proximal to the cuff. The material from which both the subject device and the primary predicate tubes are manufactured are also identical. Additionally, both devices are disposable and intended for single-use. The SolidAIRity III Airway Stabilization System is designed with features such as the inflation line / suction line protection hub, KAD collar, and Stabilizer. Although the primary predicate device does not offer these additional means of risk mitigation, the performance testing demonstrates that these features do not affect safety and effectiveness of the subject device. Many of the technological characteristics between the SolidAIRity III Airway Stabilization System and the predicate devices are essentially identical. Any differences are either minor or have been supported by risk mitigation and performance test data.

{8}------------------------------------------------

Securisyn Medical, LLC SolidAIRity® III Airway Stabilization System

Summary of Testing

Biocompatibility testing was performed in accordance to FDA Guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"". The results of the testing satisfy the requirements of the study protocols and comply with ISO 10993-1. The battery of testing included the following tests:

Test	Standard	Result
Cytotoxicity	ISO 10993-5	Pass
Sensitization	ISO 10993-10	Pass
Irritation	ISO 10993-10	Pass
Acute Systemic Toxicity	ISO 10993-11	Pass
Material-Mediated Pyrogenicity	ISO 10993-11	Pass
Subacute / Subchronic Toxicity	ISO 10993-11	Pass
Genotoxicity	ISO 10993-3	Pass
Implantation	ISO 10993-6	Pass

The device is sterilized by ethylene oxide. The sterilization process is validated to comply with ISO 11135-1 and ISO 10993-7. A formal package validation has been conducted in accordance with ISO 11607-1 on non-aged and aged product following 2-vear accelerated aging in accordance with ASTM 1980 to demonstrate that the device and packaging integrity remain in compliance with the specifications throughout transport, storage, and shelf-life. The results of all testing met acceptance criteria.

A Human Factors Validation Study was conducted in accordance with FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices". Usability of the SolidAIRity III Airway Stabilization System was evaluated in simulated use scenarios employing accepted models of evaluation. The scenario-based simulated use human factors validation was performed in simulated environments consistent with those environments in which representative users typically perform airway management. The Human Factors Validation data demonstrate that users can perform all phases of advanced airway management (pre-intubation preparation, intubation, stabilization, routine care, and extubation) as safely and as effectively as the predicate with the SolidAIRity III Airway Stabilization System for the intended users, uses, and use environments.

Performance bench testing was conducted on the SolidAIRity III Airway Stabilization System. The following tests were performed in accordance with ISO 5361:

Endotracheal Tube Conformance Test
Cuff Inflation Tube Leak Test
Cuff Resting Diameter Test ●
Cuffed Tube Collapse Test ●
. Cuff Herniation Test

{9}------------------------------------------------

Securisyn Medical, LLC SolidAIRity® III Airway Stabilization System

Tracheal Seal Test ●
Kink Resistance Test
Radiopaque Marker Compliance Test .

Additional performance bench testing was conducted on the KAD collar and inflation tube to ensure proper performance strength of assembly with respect to external forces. A comparative inflation tube pull test was performed on the SolidAIRity III Endotracheal Tube and Mallinckrodt Hi-Lo Evac Endotracheal Tube to further support substantial equivalence. Suction tube performance testing was conducted on the subject and predicate device in accordance with ISO 8836 to provide objective evidence that the performance of the SolidAIRity III Suction Endotracheal Tube is substantially equivalent to that of the predicate device. Resistance to Movement Against Force testing was conducted to validate the ability of the SolidAIRity III Airway Stabilization System to resist tube movement against multidirectional external forces of up to 20 pounds under simulated use. The results of all performance bench testing met the predefined acceptance criteria.

Clinical testing was not conducted as part of the submission.

Conclusion

The SolidAIRity III Airway Stabilization System is substantially equivalent to legally marketed predicate devices with respect to intended use/indications for use, target user, patient population, use environment and technological characteristics.

Regulation Number and Section

§ 868.5730 Tracheal tube.

(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).