(314 days)
The Venner PneuX™ TT (Tracheostomy Tube) is intended to be inserted into the patient's tracheostomy stoma during extended periods (not more than 30 days) of intensive or critical care to facilitate ventilation and for the evacuation or drainage of secretions from the subglottic space.
The Venner Pneux TT (Tracheostomy Tube) is a disposable, sterile, single-patient, single-use device. It is a flexible, low volume and low pressure cuffed tracheostomy tube, which is reinforced with a Nitinol wire. The Venner PneuX TT may be used with the Venner PneuX TSM™ to monitor, maintain and regulate cuff pressure. The Venner PneuX TSM was cleared for marketing via 510(k) application K110631.
The Venner PneuX TT is available in three sizes (inner diameters: 7.0, 8.0 and 9.0 mm) and is MRI Conditional. Depth markings indicate the distance to the distal tip of the tube and a printed black line provides a means to orient the tube.
The device provides access to subglottic space by having three additional lumens running along the airway lumen. The three lumens are integrated into the tube wall ending just above the proximal end of the cuff for ease of suction. Connected to the suction tube and subglottic connector, it allows intermittent suctioning of secretions from the subglottic space, and irrigation.
A winged tube holder allows for securement with openings on each end for a head/neck strap to pass through. A fixation block secures the position of the tube to preventunintended movement during use. A standard connector (15 mm) for universal attachment to a ventilator is present, as well as an inflation line to connect the cuff for inflation and deflation. A pilot balloon connects the cuff to provide an indication of the pressure within the cuff and the pilot valve opens to allow free flow of air to the cuff for inflation when a Luer lock syringe is engaged. When the syringe is removed, the valve closes to prevent leakage of air and ensures the cuff is inflated.
The obturator fits in the airway tube of the TT and guides its placement. Its tip is designed to aid passage through the surgical opening of a tracheostomy stoma. The obturator also has a hole which allows a guidewire to pass through, if clinically required.
The Venner PneuX™ TT (Tracheostomy Tube) is a medical device. The provided text outlines the performance data to establish its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Venner PneuX™ TT are primarily based on established ISO standards for medical devices and specific performance tests, as well as biocompatibility assessments. The reported device performance indicates that the device passed all conducted tests.
| Acceptance Criteria Category | Specific Criteria / Test Performed | Reported Device Performance |
|---|---|---|
| Sterilization, Shelf Life, & Packaging | - Sterility Assurance Level (SAL) of 10⁻⁶ via Ethylene Oxide (EO) sterilization (conformance to ISO 11135:2014 using half-cycle approach).- Ethylene oxide residue levels meeting Tolerable Contact Limit (TCL) for prolonged exposure devices (patient contact > 24 hours up to 30 days) according to ISO 10993-7.- Packaging integrity supporting proposed shelf life through accelerated and real-time aging studies. | Passed (device is provided sterile, met SAL, EO residue levels met TCL, aging studies supported shelf life including packaging integrity). |
| Biocompatibility | - MEM Elution Assay (Cytotoxicity) per ISO 10993-5:2009 & ISO 10993-12:2012.- Intracutaneous Reactivity per ISO 10993-10:2010 & ISO 10993-12:2012.- Guinea Pig Maximum Sensitization per ISO 10993-10:2010 & ISO 10993-12:2012.- Acute Systemic Toxicity per ISO 10993-11:2006 & ISO 10993-12:2012.- Subacute/subchronic Toxicity (14-day) per ISO 10993-11:2006 & ISO 10993-12:2012.- Genotoxicity – Ames and Mouse Lymphoma Assay per ISO 10993-3:2014 & ISO 10993-12:2012.- Implantation (4-week) per ISO 10993-6:2007.- Material-Mediated Pyrogenicity per ISO 10993-11:2006 & ISO 10993-12:2012. | Passed for all listed tests. |
| Performance Testing (Mechanical & Functional) | - Conformance to ISO 5366:2016 (Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors) for dimensions, curvature, cuff diameter, and connectors.- Conformance to ISO 5361:2016 (Anaesthetic and respiratory equipment - Tracheal tubes and connectors).- Mechanical and functional requirements, including: cuff leakage, cuff herniation, tube collapse, radiopacity, kink resistance, 15mm connector leakage and seal pressure leakage (tested on terminally sterilized unaged and aged samples).- Cuff inflation, leakage and function.- Lumen function.- Pull tests for all joints and connections.- Bite block resistance.- Meeting the same acceptance criteria as the predicate device (K100950). | Passed (met all standards and requirements, both unaged and aged, and met predicate device's acceptance criteria). |
| MRI Compatibility | - Magnetically induced displacement force per FDA guidance.- Magnetically induced torque per FDA guidance.- Heating by radiofrequency fields per FDA guidance.- Image artifact per FDA guidance.(Evaluated per FDA guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" issued December 11, 2014). | Passed (demonstrated MR compatible under specified conditions in labeling). |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the specific sample sizes for each individual test. However, it indicates that "Terminally sterilized unaged and aged samples were tested" for mechanical and functional assessments. The various biocompatibility tests would have their own sample size requirements as per the specified ISO standards, but these details are not provided in this summary.
The data provenance is from in-vitro (laboratory) and potentially in-vivo (animal for some biocompatibility tests like sensitization, toxicity, implantation) studies conducted by the manufacturer or contracted labs to demonstrate compliance with recognized standards. There is no mention of human clinical trial data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable in the context of this device and testing. The "ground truth" for these tests (sterilization, biocompatibility, mechanical performance, MRI compatibility) is established by adherence to pre-defined international standards and scientific methodology, rather than expert consensus on diagnostic images or clinical outcomes. The "experts" involved would be the qualified personnel performing and interpreting the laboratory tests and analyses according to those standards (e.g., microbiologists for sterility, toxicologists for biocompatibility, engineers for mechanical testing).
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, particularly for diagnostic devices where subjective interpretation of results (e.g., imaging) is involved and a consensus among multiple readers is needed to establish ground truth. For the physical and chemical testing performed for this device, results are objective (e.g., pass/fail for a cytotoxicity assay, numerical values within a specified range for dimensions, etc.) and do not require expert adjudication as described.
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
There was no MRMC comparative effectiveness study done. This device is a tracheostomy tube, a physical medical device, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
There was no standalone (algorithm only) performance study done. This device is a physical medical device, not an algorithm or software.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of this device is based on:
- International Standards: Adherence to established ISO standards (e.g., ISO 11135, ISO 10993, ISO 5366, ISO 5361) that define acceptable parameters and test methods for tracheostomy tubes, sterilization, and biocompatibility.
- Predicate Device Equivalence: The new device met the same acceptance criteria as the legally marketed predicate device (K100950), implying that the predicate's established safety and effectiveness forms a basis for comparison.
- FDA Guidance: Compliance with specific FDA guidance documents, particularly for MRI compatibility.
- Pre-defined Specifications: The device successfully passed tests against its own performance specifications (e.g., regarding cuff inflation, leakage, lumen function, pull tests, bite block resistance).
8. The Sample Size for the Training Set
This information is not applicable. Since this is a physical medical device and not an AI/machine learning model, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As there is no training set, there is no "ground truth for the training set."
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Venner Medical (Singapore) PTE Ltd % Christine Brauer Regulatory Affairs Consultant Brauer Device Consultants, LLC 7 Trail House Court Rockville, Maryland 20850
Re: K192511
Trade/Device Name: Venner PneuX™ TT (Tracheostomy Tube) Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube And Tube Cuff Regulatory Class: Class II Product Code: BTO Dated: June 18, 2020 Received: June 19, 2020
Dear Christine Brauer:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 medical devices and radiation-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,
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
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Indications for Use
510(k) Number (if known) K192511
Device Name Venner PneuX™M TT
Indications for Use (Describe)
The Venner Pneux™ TT (Tracheostomy Tube) is intended to be inserted into the patient's tracheostomy stoma during extended periods (not more than 30 days) of intensive or critical care to facilitate ventilation and for the evacuation or drainage of secretions from the subglottic space.
| 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
K192511
GENERAL INFORMATION 1
Submitter and Owner of the 510(k) 1.1
Venner Medical (Singapore) Pte Ltd 35 Joo Koon Circle Singapore 629110 Establishment Registration: 3007740622
Official Correspondent 1.2
Christine L. Brauer, PhD Regulatory Affairs Consultant Brauer Device Consultants, LLC 7 Trail House Court Rockville, MD 20850
Telephone: (301) 545-1990 E-mail: chris.brauer@comcast.net
1.3 Devices Subject of this 510(k)
| Venner Product Code | Trade Name | Product Size |
|---|---|---|
| 902170 | Venner PneuX™ TT (Tracheostomy Tube) | 7.0 mm |
| 902180 | Venner PneuX™ TT (Tracheostomy Tube) | 8.0 mm |
| 902190 | Venner PneuX™ TT (Tracheostomy Tube) | 9.0 mm |
510(k) Number and Date of Preparation 1.4
Submission Number: K192511 Date of Preparation: 17 June 2020
2 NAME OF THE DEVICE AND CLASSIFICATION INFORMATION
2.1 Trade/Proprietary Name
Venner PneuX™ TT (Tracheostomy Tube)
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2.2 Common/Usual Name
Tracheostomy Tube – Low Volume, Low Pressure, Cuff
Classification Information 2.3
| Classification Information | |
|---|---|
| Trade Name: | Venner PneuX™ TT (Tracheostomy Tube) |
| Classification Regulation: | 21 CFR 868.5800 - Tracheostomy Tube and Tube Cuff |
| Product Code: | BTO - Tube, tracheostomy (w/wo connector) |
| Class: | II |
| Panel: | Anesthesiology |
ತಿ PREDICATE DEVICE
The predicate device is as follows:
- . Venner PneuX TT (Tracheostomy Tube) cleared via K100950 on July 13, 2010
DEVICE DESCRIPTION ব
The Venner Pneux TT (Tracheostomy Tube) is a disposable, sterile, single-patient, single-use device. It is a flexible, low volume and low pressure cuffed tracheostomy tube, which is reinforced with a Nitinol wire. The Venner PneuX TT may be used with the Venner PneuX TSM™ to monitor, maintain and regulate cuff pressure. The Venner PneuX TSM was cleared for marketing via 510(k) application K110631.
The Venner PneuX TT is available in three sizes (inner diameters: 7.0, 8.0 and 9.0 mm) and is MRI Conditional. Depth markings indicate the distance to the distal tip of the tube and a printed black line provides a means to orient the tube.
The device provides access to subglottic space by having three additional lumens running along the airway lumen. The three lumens are integrated into the tube wall ending just above the proximal end of the cuff for ease of suction. Connected to the suction tube and subglottic connector, it allows intermittent suctioning of secretions from the subglottic space, and irrigation.
A winged tube holder allows for securement with openings on each end for a head/neck strap to pass through. A fixation block secures the position of the tube to preventunintended movement during use. A standard connector (15 mm) for universal attachment to a ventilator is present, as well as an inflation line to connect the cuff for inflation and deflation. A pilot balloon connects the cuff to provide an indication of the pressure within the cuff and the pilot
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valve opens to allow free flow of air to the cuff for inflation when a Luer lock syringe is engaged. When the syringe is removed, the valve closes to prevent leakage of air and ensures the cuff is inflated.
The obturator fits in the airway tube of the TT and guides its placement. Its tip is designed to aid passage through the surgical opening of a tracheostomy stoma. The obturator also has a hole which allows a guidewire to pass through, if clinically required.
5 INDICATIONS FOR USE
Below is the indication for use for the Venner PneuX TT.
The Venner PneuX™ TT (Tracheostomy Tube) is intended to be inserted into the patient's tracheostomy stoma during extended periods (not more than 30 days) of intensive or critical care to facilitate ventilation and for the evacuation or drainage of secretions from the subglottic space.
COMPARISON OF THE INDICATION FOR USE AND INTENDED USE 6 BETWEEN THE VENNER PNEUX TT AND THE PREDICATE DEVICE
The Venner PneuX TT and the predicate device share intended use, including the same purpose, function, conditions of use, users, target patient populations, and patient contact (see Table 1).
| Characteristic | Venner PneuX TT | Venner PneuX TT |
|---|---|---|
| (This Application) | (K100950) | |
| Classification Regulation | 21 CFR 868.5800 | 21 CFR 868.5800 |
| Product Code | BTO - Tube, tracheostomy(w/wo connector) | BTO - Tube, tracheostomy(w/wo connector) |
| Class | II | II |
| Indication for Use | ...is intended to be insertedinto the patient'stracheostomy stoma duringextended periods (not morethan 30 days) of intensive orcritical care to facilitateventilation and for theevacuation or drainage ofsecretions from the subglotticspace | ...intended to be inserted into thepatient's trachea via atracheostomy stoma duringextended periods (not more than30 days) of intensive or criticalcare to facilitate ventilation andfor evacuation or drainage ofsecretion from the subglottic space |
Table 1. Summary of Intended Use of the Venner PneuX TT and the Predicate Device
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| Characteristic | Venner PneuX TT | Venner PneuX TT |
|---|---|---|
| (This Application) | (K100950) | |
| Purpose | To establish and maintain anairway in patients who requireventilation due to illness ortrauma or because the airwayis blocked | To establish and maintain anairway in patients who requireventilation due to illness ortrauma or because the airwayis blocked |
| Function | Provides a physical conduitfor gases to flow between apatient's lungs and aventilator | Provides a physical conduitfor gases to flow between apatient's lungs and a ventilator |
| Connects to a ventilator | Connects to a ventilator | |
| Provides a means to removesecretions | Provides a means to removesecretions | |
| Target Population | Adult patients requiring atracheostomy | Adult patients requiring atracheostomy |
| Target User | Health care professionalstrained in airway management | Health care professionalstrained in airway management |
| Prescription Device | Yes | Yes |
| Intended for Use inClinical Environment | Yes | Yes |
| Body Contact | Surface-contacting mucosaltissue - Positioned in thetrachea | Surface-contacting mucosaltissue - Positioned in thetrachea |
| Compatible for Use withthe Venner PneuX TSM™(K110631) | Yes, connects to the VennerPneuX TSM via the VennerPneuX Extension Tube | Yes, connects to the VennerPneuX TSM via the VennerPneuX Extension Tube |
| TechnologicalCharacteristic | Venner PneuX TT(This Application) | Venner PneuX TT(K100950) |
| Design | ||
| Tube | Multi-lumen, flexible tube | Multi-lumen, flexible tube |
| Sizes - Inner Diameter(mm) | 7, 8 and 9 | 7, 8, and 9 |
| Cuff | Low volumeLow pressure | Low volumeLow pressure |
| Reinforced | Yes - Nitinol Wire | Yes - Stainless Steel Wire |
| Ports | Yes - Three subglottic portsfor removal secretions | Yes - Three subglottic portsfor removal secretions |
| Internal Tube Coating | Yes - Inhibit adhesion ofbiological material | Yes - Inhibit adhesion ofbiological material |
| Depth Markings | Yes | Yes |
| Fixation Block | Yes | Yes |
| Standard Connector (15mm) | Yes | Yes |
| Compatible with VennerPneuX TSM | Yes | Yes |
| MRI Conditional | Yes | No |
| Sterile andSterility Assurance Level | Yes - 10-6 | Yes - 10-6 |
| Single-Use | Yes | Yes |
| Tissue Contact | Surface contacting – Trachea | Surface contacting – Trachea |
| Duration of Use | Up to 30 days | Up to 30 days |
| Materials | ||
| Multi-lumen, tube | Silicone | Silicone |
| Wire for Reinforcement | Nitinol(MRI Conditional) | Stainless Steel |
| 15 mm Connector | Polycarbonate (DEHP-free) | Polycarbonate |
| Subglottic Line | Silicone | Silicone |
| Subglottic Connector | Silicone | Silicone |
| Female Luer | Polypropylene | N/A |
| Reservoir | Silicone | Silicone |
| Inflation Line | Silicone | Silicone |
| TechnologicalCharacteristic | Venner PneuX TT(This Application) | Venner PneuX TT(K100950) |
| Pilot Balloon | Silicone | Silicone |
| Pilot Valve (Check Valve) | Polypropylene(MRI Conditional) | Polypropylene |
| Lock Nut | Polypropylene | Polyoxymethylene copolymer |
| Winged Tube holder | Silicone | Silicone |
| Fixation Block | Polycarbonate (DEHP-free) | Polycarbonate |
| Cuff | Silicone | Silicone |
| Obturator Rod | Stainless Steel ANSI 304V | Stainless Steel ANSI 304V |
| Obturator Handle | Polypropylene Blue | Polypropylene Blue |
| Obturator Tip | Polypropylene Natural(DEHP-free) | Polyvinylchloride |
COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE 7 PREDICATE DEVICE
The Venner PneuX TT and the predicate share many of the same technological characteristics although there are some differences (see Table 2). Both systems are multilumen, with low volume, low pressure cuffs, and compatible for use with the Venner PneuX TSM.
Both are wire-reinforced tubes although different materials are used for the wire. In the modified Venner PneuX TT, the wire is made from Nitinol, allowing the device to be MRI conditional whereas a stainless-steel wire is used in the predicate device. Other material changes have been made to the Venner PneuX TT compared to the predicate to support MRI
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compatibility (pilot valve), to use phthalate (DEHP) free material (15 mm connector, fixation block and obturator tip), and for commercial reasons such as supplier preferences. In addition, a new component, a female luer made of polypropylene, has been added to the end of the subglottic line and the design of the winged tube holder has been modified as well for ergonomic reasons.
Summary of Technological Characteristics Comparing the Venner PneuX TT and Table 2. the Predicate Device
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8 PERFORMANCE DATA
This 510(k) notification provided performance data to establish the substantial equivalence of the Venner PneuX TT.
Sterilization, Shelf Life and Packaging Integrity: The Venner PneuX TT is provided sterile for single patient use. The device is sterilized using ethylene oxide (EO) to a sterility assurance level (SAL) of 10°. The sterilization was performed in conformance to ISO 11135:2014 Sterilization of Health-Care Products - Ethylene Oxide - Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices, using the half-cycle approach. Ethylene oxide residue levels were evaluated to demonstrate that the device meets the tolerable contact limit (TCL) for prolonged exposure devices (patient contact for more than 24 hours and up to 30 days) for residues according to ISO 10993-7. Accelerated and real time aging studies support the proposed shelf life, including the packaging integrity.
Biocompatibility: Biocompatibility evaluation has been performed to show the device materials are safe, biocompatible and suitable for their intended use. Both ISO 10993 and FDA Guidance "Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process" have been taken into account to evaluate the biocompatibility of the device materials. The following biocompatibility studies were successfully completed with the Venner PneuX TT.
| Test Performed | Test Method | Test Results |
|---|---|---|
| MEM Elution Assay (Cytotoxicity) | ISO 10993-5:2009ISO 10993-12:2012 | Pass |
| Intracutaneous Reactivity | ISO 10993-10:2010ISO 10993-12:2012 | Pass |
Table 3. Summary of the Biocompatibility Tests and Results
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| Test Performed | Test Method | Test Results |
|---|---|---|
| Guinea Pig Maximum Sensitization | ISO 10993-10:2010 | Pass |
| ISO 10993-12:2012 | ||
| Acute Systemic Toxicity | ISO 10993-11:2006 | Pass |
| ISO 10993-12:2012 | ||
| Subacute/subchronic Toxicity (14-day) | ISO 10993-11:2006 | Pass |
| ISO 10993-12:2012 | ||
| Genotoxicity – Ames and Mouse LymphomaAssay | ISO 10993-3:2014 | Pass |
| ISO 10993-12:2012 | ||
| Implantation (4-week) | ISO 10993-6:2007 | Pass |
| Material-Mediated Pyrogenicity | ISO 10993-11:2006 | Pass |
| ISO 10993-12:2012 |
Performance Testing: Performance testing was performed to characterize the Venner PneuX TT, including mechanical and functional testing. MRI compatibility testing and compliance to the standards ISO 5366:2016 Anaesthetic and respiratory equipment -Tracheostomy tubes and connectors and ISO 5361: 2016 Anaesthetic and respiratory equipment - Tracheal tubes and connectors. The Venner PneuX TT has been tested in accordance with the ISO standards for dimensions, curvature, cuff diameter, and connectors. The Venner PneuX TT met the standard.
The Venner PneuX TT was evaluated in accordance with the standards for mechanical and functional requirements, and met the standard. This evaluation included an analysis of cuff leakage, cuff herniation, tube collapse, radiopacity, kink resistance, 15mm connector leakage and seal pressure leakage. Terminally sterilized unaged and aged samples were tested. The Venner PneuX TT both unaged and aged met the standard, supporting the 1-year shelf life. In addition, the following mechanical tests were performed: cuff inflation, leakage and function, lumen function, pull tests for all joints and connections, and bite block resistance. The device successfully passed each test, meeting its performance specifications.
The Venner PneuX TT was compared to the predicate device for the functional and mechanical tests and met the same acceptance criteria as the predicate device, demonstrating substantial equivalence.
For MRI compatibility, the device was evaluated for MRI compatibility in accordance with the FDA guidance document entitled "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff" issued on December 11, 2014. The following types of tests were performed: magnetically induced displacement force, magnetically induced torque, heating by radiofrequency fields and image artifact. The testing demonstrated that the device is MR compatible under the conditions identified in the device labeling (instructions for use).
9 CONCLUSIONS
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Based on the comparison, biocompatibility testing, and performance testing, it has demonstrated that the subject device is substantially equivalent to the proposed predicate. The subject device has the same intended use as the predicate device and the differences in technological features do not raise different questions of safety and effectiveness
§ 868.5800 Tracheostomy tube and tube cuff.
(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.