(314 days)
No
The summary describes a mechanical tracheostomy tube and its accessories, with no mention of AI or ML technology.
Yes
The device is described as facilitating ventilation and the evacuation/drainage of secretions, which are therapeutic actions aimed at treating or alleviating a condition.
No
The device description indicates that the Venner PneuX™ TT is a tracheostomy tube intended to facilitate ventilation and the evacuation of secretions from the subglottic space. These are therapeutic functions, not diagnostic ones. While it may be used with a monitoring device (Venner PneuX TSM™), the tracheostomy tube itself does not diagnose medical conditions.
No
The device description clearly details a physical, disposable tracheostomy tube with various hardware components (tube, cuff, lumens, connectors, obturator, etc.) and mentions mechanical and functional testing.
Based on the provided information, the Venner PneuX™ TT (Tracheostomy Tube) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for insertion into a patient's tracheostomy stoma to facilitate ventilation and manage secretions. This is a direct interaction with the patient's body for therapeutic and supportive purposes.
- Device Description: The description details a physical tube with lumens, a cuff, connectors, and an obturator. These are all components designed for mechanical and physiological interaction with the airway.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. Its function is entirely focused on supporting respiration and managing secretions within the airway.
IVD devices are specifically designed to perform tests on samples taken from the body, not to be inserted into the body for direct physiological support or treatment.
N/A
Intended Use / Indications for Use
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.
Product codes
BTO
Device Description
The Venner Pneus 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's tracheostomy stoma, trachea, subglottic space
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Health care professionals trained in airway management, Clinical Environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data was provided for Sterilization, Shelf Life and Packaging Integrity, Biocompatibility, and Performance Testing.
Sterilization, Shelf Life and Packaging Integrity:
The device is sterilized using ethylene oxide (EO) to a sterility assurance level (SAL) of 10^-6, in conformance to ISO 11135:2014. Ethylene oxide residue levels were evaluated according to ISO 10993-7 for prolonged exposure devices (patient contact for more than 24 hours and up to 30 days). Accelerated and real-time aging studies support the proposed shelf life, including packaging integrity.
Biocompatibility:
Evaluation was performed in accordance with 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".
Tests included:
- MEM Elution Assay (Cytotoxicity) - ISO 10993-5:2009, ISO 10993-12:2012: Pass
- Intracutaneous Reactivity - ISO 10993-10:2010, ISO 10993-12:2012: Pass
- Guinea Pig Maximum Sensitization - ISO 10993-10:2010, ISO 10993-12:2012: Pass
- Acute Systemic Toxicity - ISO 10993-11:2006, ISO 10993-12:2012: Pass
- Subacute/subchronic Toxicity (14-day) - ISO 10993-11:2006, ISO 10993-12:2012: Pass
- Genotoxicity – Ames and Mouse Lymphoma Assay - ISO 10993-3:2014, ISO 10993-12:2012: Pass
- Implantation (4-week) - ISO 10993-6:2007: Pass
- Material-Mediated Pyrogenicity - ISO 10993-11:2006, ISO 10993-12:2012: Pass
Performance Testing:
Characterization included mechanical and functional testing, MRI compatibility testing, and compliance to standards ISO 5366:2016 and ISO 5361:2016.
- The device met ISO standards for dimensions, curvature, cuff diameter, and connectors.
- Evaluated for mechanical and functional requirements, and met the standard. This included 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, and both met the standard, supporting a 1-year shelf life.
- Additional mechanical tests: cuff inflation, leakage and function, lumen function, pull tests for all joints and connections, and bite block resistance. The device successfully passed each test.
- Compared to the predicate device for functional and mechanical tests and met the same acceptance criteria, demonstrating substantial equivalence.
- MRI compatibility: Evaluation according to FDA guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff" (Dec 11, 2014). Tests performed: magnetically induced displacement force, magnetically induced torque, heating by radiofrequency fields, and image artifact. Testing demonstrated MR compatibility under conditions identified in the device labeling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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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3
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)
4
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
5
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 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 | ...intended to be inserted into the | |
| patient's trachea via a | ||
| tracheostomy stoma during | ||
| extended periods (not more than | ||
| 30 days) of intensive or critical | ||
| care to facilitate ventilation and | ||
| for evacuation or drainage of | ||
| secretion from the subglottic space |
Table 1. Summary of Intended Use of the Venner PneuX TT and the Predicate Device
6
| Characteristic | Venner PneuX TT | Venner PneuX TT |
|---|---|---|
| (This Application) | (K100950) | |
| Purpose | To establish and maintain an | |
| airway in patients who require | ||
| ventilation due to illness or | ||
| trauma or because the airway | ||
| is blocked | To establish and maintain an | |
| airway in patients who require | ||
| ventilation due to illness or | ||
| trauma or because the airway | ||
| is blocked | ||
| Function | Provides a physical conduit | |
| for gases to flow between a | ||
| patient's lungs and a | ||
| ventilator | Provides a physical conduit | |
| for gases to flow between a | ||
| patient's lungs and a ventilator | ||
| Connects to a ventilator | Connects to a ventilator | |
| Provides a means to remove | ||
| secretions | Provides a means to remove | |
| secretions | ||
| Target Population | Adult patients requiring a | |
| tracheostomy | Adult patients requiring a | |
| tracheostomy | ||
| Target User | Health care professionals | |
| trained in airway management | Health care professionals | |
| trained in airway management | ||
| Prescription Device | Yes | Yes |
| Intended for Use in | ||
| Clinical Environment | Yes | Yes |
| Body Contact | Surface-contacting mucosal | |
| tissue - Positioned in the | ||
| trachea | Surface-contacting mucosal | |
| tissue - Positioned in the | ||
| trachea | ||
| Compatible for Use with | ||
| the Venner PneuX TSM™ | ||
| (K110631) | Yes, connects to the Venner | |
| PneuX TSM via the Venner | ||
| PneuX Extension Tube | Yes, connects to the Venner | |
| PneuX TSM via the Venner | ||
| PneuX Extension Tube | ||
| Technological | ||
| Characteristic | 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 volume | |
| Low pressure | Low volume | |
| Low pressure | ||
| Reinforced | Yes - Nitinol Wire | Yes - Stainless Steel Wire |
| Ports | Yes - Three subglottic ports | |
| for removal secretions | Yes - Three subglottic ports | |
| for removal secretions | ||
| Internal Tube Coating | Yes - Inhibit adhesion of | |
| biological material | Yes - Inhibit adhesion of | |
| biological material | ||
| Depth Markings | Yes | Yes |
| Fixation Block | Yes | Yes |
| Standard Connector (15 | ||
| mm) | Yes | Yes |
| Compatible with Venner | ||
| PneuX TSM | Yes | Yes |
| MRI Conditional | Yes | No |
| Sterile and | ||
| Sterility 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 |
| Technological | ||
| Characteristic | 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
7
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
8
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 10993-5:2009 | |
| ISO 10993-12:2012 | Pass | |
| Intracutaneous Reactivity | ISO 10993-10:2010 | |
| ISO 10993-12:2012 | Pass |
Table 3. Summary of the Biocompatibility Tests and Results
9
| 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 Lymphoma | ||
| Assay | 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
10
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