(192 days)
No
The device description and performance studies focus on the mechanical and functional aspects of the endotracheal tube and its compatibility with existing systems, with no mention of AI or ML.
Yes
The device is used for tracheal intubation and the evacuation or drainage of secretions, which are therapeutic interventions.
No
Explanation: The Venner PneuX ETT (Endotracheal Tube) is intended for tracheal intubation and secretion evacuation, and while it interacts with devices that monitor cuff pressure, its primary function is not to diagnose a condition or disease.
No
The device description clearly outlines a physical, disposable medical device (endotracheal tube) with various hardware components (tube, cuff, lumens, connectors, etc.). There is no mention of software being the primary or sole component of this device.
Based on the provided information, the Venner PneuX™ ETT (Endotracheal Tube) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "patients undergoing tracheal intubation during routine anesthesia or over extended periods... and for the evacuation or drainage of secretion from the subglottic space." This describes a device used in vivo (within the living body) for a medical procedure and patient care.
- Device Description: The description details a physical tube inserted into the trachea, connected to other medical equipment like a ventilator or anesthesia equipment. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: 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.
IVD devices are used to perform tests on samples taken from the body, while the Venner PneuX ETT is a device used directly on the patient for airway management.
N/A
Intended Use / Indications for Use
The Venner Pneux ™ ETT (Endotracheal Tube) is intended to be used for patients undergoing tracheal intubation during routine anesthesia or over extended periods (not more than 30 days) and for the evacuation or drainage of secretion from the subglottic space.
Product codes
BTR
Device Description
The Venner Pneux ETT (Endotracheal Tube) is a disposable, sterile, single-patient, single-use device. It is a straight, flexible cuffed (low volume, low pressure) Nitinol wire-reinforced tracheal tube with a Murphy Eye. When a patient is intubated with a Venner PneuX ETT and inflated by standard techniques, it can be attached to the Venner PneuX TSM™M via the Venner PneuX™ Extension Tube, to monitor, maintain and regulate cuff pressure. The Venner Pneux TSM, a cuff pressure controller, was cleared for marketing via 510(k) application K110631 and the Venner PneuX Extension Tube is a class I, 510(k) exempt device.
The Venner PneuX ETT is available in four sizes (inner diameters: 6.0, 7.0, 8.0 and 9.0 mm) and is MRI compatible. Depth markings indicate 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. An integrated bite block with fixation block provides a protective covering and secures the position of the tube to preventunintended movement duringuse. A standard connector (15mm)for universal attachment to a ventilator or anesthesia equipment 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Trachea
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Health care professionals trained in intubation. Intended for Use in 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 to establish substantial equivalence. Studies included:
- Sterilization, Shelf Life and Packaging Integrity:
- Sterilization using ethylene oxide (EO) to a sterility assurance level (SAL) of 10-6, conforming to ISO 11135:2014.
- Ethylene oxide residue levels meet tolerable contact limit (TCL) for prolonged exposure (up to 30 days) according to ISO 10993-7.
- Accelerated and real-time aging studies support the proposed shelf life and packaging integrity.
- Biocompatibility:
- Evaluation according to 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 performed: MEM Elution Assay (Cytotoxicity), Intracutaneous Reactivity, Guinea Pig Maximum Sensitization, Acute Systemic Toxicity, Subacute/subchronic Toxicity (14-day), Genotoxicity – Ames, Implantation (4-week), Material-Mediated Pyrogenicity. All tests passed.
- Performance Testing:
- Characterization for mechanical and functional testing, MRI compatibility testing, and compliance to ISO 5361:2016.
- ISO 5361:2016 Compliance: Evaluated for dimensions (bevel angle, curvature, cuff diameter, connectors, murphy eye size/placement) and mechanical/functional requirements (cuff leakage, cuff herniation, tube collapse, radiopacity, kink resistance, 15mm connector leakage, seal pressure leakage). Both unaged and aged samples 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. All tests passed meeting specifications.
- Comparison to predicate device for functional and mechanical tests showed that the subject device met the same acceptance criteria, demonstrating substantial equivalence.
- MRI Compatibility:
- Evaluated in accordance with FDA guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff" (December 11, 2014).
- Tests performed: magnetically induced displacement force, magnetically induced torque, heating by radiofrequency fields, and image artifact.
- Testing demonstrated the device is MR compatible 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
§ 868.5730 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).
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, 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: K192120
Trade/Device Name: Venner PneuX™ ETT Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR Dated: January 7, 2020 Received: January 8, 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 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,
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) K192120
Device Name Venner PneuXTM ETT
Indications for Use (Describe)
The Venner Pneux ™ ETT (Endotracheal Tube) is intended to be used for patients undergoing tracheal intubation during routine anesthesia or over extended periods (not more than 30 days) and for the evacuation or drainage of secretion 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) |
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3
510(k) SUMMARY K192120
1 GENERAL INFORMATION
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 | Tradename | Product Size |
|---|---|---|
| 901160 | Venner PneuX™ ETT (Endotracheal Tube) | 6.0 mm |
| 901170 | Venner PneuX™ ETT (Endotracheal Tube) | 7.0 mm |
| 901180 | Venner PneuX™ ETT (Endotracheal Tube) | 8.0 mm |
| 901190 | Venner PneuX™ ETT (Endotracheal Tube) | 9.0 mm |
1.4 510(k) Number and Date of Preparation
Submission Number: K192120 Date of Preparation: 05 January 2020
2 NAME OF THE DEVICE AND CLASSIFICATION INFORMATION
Trade/Proprietary Name 2.1
Venner PneuX™ ETT (Endotracheal Tube)
4
2.2 Common/Usual Name
Endotracheal Tube - Low Volume, Low Pressure, Cuff
| General Information | |
|---|---|
| Trade Name: | Venner PneuX™ ETT (Endotracheal Tube) |
| Classification Regulation: | 21 CFR 868.5730 Tracheal Tube |
| Product Code: | BTR - Tube, tracheal (w/wo connector) |
| Class: | II |
| Panel: | Anesthesiology |
Classification Information 2.3
3 PREDICATE DEVICE
The predicate device is as follows:
- Venner PneuX ETT (Endotracheal Tube) cleared via K093135 on May 24, 2010
DEVICE DESCRIPTION 4
The Venner Pneux ETT (Endotracheal Tube) is a disposable, sterile, single-patient, single-use device. It is a straight, flexible cuffed (low volume, low pressure) Nitinol wire-reinforced tracheal tube with a Murphy Eye. When a patient is intubated with a Venner PneuX ETT and inflated by standard techniques, it can be attached to the Venner PneuX TSM™M via the Venner PneuX™ Extension Tube, to monitor, maintain and regulate cuff pressure. The Venner Pneux TSM, a cuff pressure controller, was cleared for marketing via 510(k) application K110631 and the Venner PneuX Extension Tube is a class I, 510(k) exempt device.
The Venner PneuX ETT is available in four sizes (inner diameters: 6.0, 7.0, 8.0 and 9.0 mm) and is MRI compatible. Depth markings indicate 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. An integrated bite block with fixation block provides a protective covering and secures the position of the tube to preventunintended movement duringuse. A standard connector (15mm)for universal attachment to a ventilator or anesthesia equipment is present, as well as an inflation line to connect the cuff for inflation and deflation. A pilot balloon
5
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.
5 INDICATIONS FOR USE
Below is the indication for use for the Venner PneuX ETT.
The Venner PneuX™ ETT (Endotracheal Tube) is intended to be used for patients undergoing tracheal intubation during routine anesthesia or over extended periods (not more than 30 days) and for the evacuation or drainage of secretion from the subglottic space.
COMPARISON OF THE INDICATION FOR USE AND INTENDED USE 6 BETWEEN THE VENNER PNEUX ETT AND THE PREDICATE DEVICE
The Venner PneuX ETT 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 ETT
(This Application) | Venner PneuX ETT
(K093135) |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Regulation | 21 CFR 868.5730 | 21 CFR 868.5730 |
| Product Code | BTR - Tube, tracheal (w/wo
connector) | BTR - Tube, tracheal (w/wo
connector) |
| Class | II | II |
| Indication for Use | ... is intended to be used for
patients undergoing tracheal
intubation during routine
anesthesia or over extended
periods (not more than 30
days) and for the evacuation
or drainage of secretion from
the subglottic space. | ...intended to be used for
patients undergoing tracheal
tube intubation during
extended periods (not more
than 30 days) and for
evacuation or drainage of
secretion from the subglottic
space. It is also compatible
with tracheal intubation
during routine anesthesia. |
| Purpose | To intubate patients during
routine anesthesia
To intubate patients for
extended durations but not
more than 30 days | To intubate patients during
routine anesthesia
To intubate patients for
extended durations but not
more than 30 days |
Table 1. Summary of Intended Use of the Venner PneuX ETT and the Predicate Device
6
| Characteristic | Venner PneuX ETT
(This Application) | Venner PneuX ETT
(K093135) |
|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Function | To maintain the airway so that
gases can flow between a
patient's lungs and a
ventilator or anesthesia
equipment
To provide positive pressure
ventilation
To support breathing in
critically ill patients
To protect the lungs from
aspiration | To maintain the airway so
that gases can flow between a
patient's lungs and a
ventilator or anesthesia
equipment
To provide positive pressure
ventilation
To support breathing in
critically ill patients
To protect the lungs from
aspiration |
| Target Population | Adult patients undergoing
endotracheal intubation
Adult patients who are
severely ill and experiencing
breathing difficulties | Adult patients undergoing
endotracheal intubation
Adult patients who are
severely ill and experiencing
breathing difficulties |
| Target User | Health care professionals
trained in intubation | Health care professionals
trained in intubation |
| 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 TSMTM
(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 ETT
(This Application) | Venner PneuX ETT
(K093135) |
| Design | | |
| Straight | Yes - Multi-lumen, straight
tube | Yes - Multi-lumen straight
tube |
| Sizes - Inner Diameter
(mm) | 6, 7, 8 and 9 | 6, 7, 8, and 9 |
| Cuff | Low volume
Low pressure | Low volume
Low pressure |
| Tip Design | Boat Tip | Boat Tip |
| Murphy Eye | Yes | Yes |
| Reinforced | Yes - Nitinol Wire | Yes - Stainless Steel Wire |
| Ports | Yes - Three subglottic ports
for removal secretions and
irrigation | Yes - Three subglottic ports
for removal secretions and
irrigation |
| Internal Tube Coating | Yes - Inhibit adhesion of
biological material | Yes - Inhibit adhesion of
biological material |
| Depth Markings | Yes | Yes |
| Integrated Bite Block | Yes - Integrated with Fixation
Block | Yes |
| Standard Connector (15
mm) | Yes | Yes |
| Compatible with Venner
PneuX TSM | Yes | Yes |
| MRI Compatible | 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, straight tube | Silicone | Silicone |
| Wire for Reinforcement | Nitinol
(MRI compatible) | Stainless Steel |
| 15 mm Connector | Polycarbonate (DEHP-free) | Polycarbonate |
| Subglottic Line | Silicone | Silicone |
| Subglottic Connector | Silicone | Silicone |
| Technological
Characteristic | Venner PneuX ETT
(This Application) | Venner PneuX ETT
(K093135) |
| Female Luer | Polypropylene | N/A |
| Reservoir | Silicone | Silicone |
| Inflation Line | Silicone | Silicone |
| Pilot Balloon | Silicone | Silicone |
| Pilot Valve (Check Valve) | Polypropylene
(MRI compatible) | Polypropylene |
| Lock Nut | Polypropylene | Polyoxymethylene copolymer |
| Winged Tube holder | Silicone | Silicone |
| Integrated Bite Block with
Fixation Block | Polycarbonate (DEHP-free) | Polycarbonate |
| Cuff | Silicone | Silicone |
| Boat Tip with Murphy
Eye | Silicone | Silicone |
COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE 7 PREDICATE DEVICE
The Venner PneuX ETT and the predicate share many of the same technological characteristics although there are some differences (see Table 2). Both systems are multilumen, straight endotracheal tubes 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 ETT, the wire is made from Nitinol, allowing the device to be MRI compatible whereas a stainless-steel wire is used in the predicate device. Other material changes have been made to the Venner PneuX ETT compared to the predicate to support MRI compatibility (pilot valve), to use phthalate (DEHP) free material (15 mm connector and integrated bite block with fixation block), and for commercial reasons such as supplier
7
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.
Table 2. Summary of Technological Characteristics Comparing the Venner PneuX ETT and the Predicate Device
8
8 PERFORMANCE DATA
This 510(k) notification provided performance data to establish the substantial equivalence of the Venner PneuX ETT.
Sterilization, Shelf Life and Packaging Integrity: The Venner PneuX ETT is provided sterile for single patient use. The device is sterilized using ethylene oxide (EO) to a sterility assurance level (SAL) of 106. 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 Venner PneuX ETT 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 ETT.
Table 3. Summary of the Biocompatibility Tests and Results
| Test Performed | Test Method | Test Results |
|---|---|---|
| MEM Elution Assay (Cytotoxicity) | ISO 10993-5:2009 | |
| ISO 10993-12:2012 | Pass |
9
| Test Performed | Test Method | Test Results |
|---|---|---|
| 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 | 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: Performance testing was performed to characterize the Venner PneuX ETT, including mechanical and functional testing, MRI compatibility testing and compliance to the standard ISO 5361: 2016 Anaesthetic and respiratory equipment -Tracheal tubes and connectors.
The Venner Pneux ETT has been tested in accordance with the standard ISO 5361: 2016 for dimensions, including bevel angle, curvature, cuff diameter, connectors and murphy eye size/placement. The Venner PneuX ETT met the standard.
The Venner PneuX ETT was evaluated in accordance with the standard ISO 5361:2016 for the following 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 ETT 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 ETT 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
10
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).
CONCLUSIONS 9
Based on the comparison, biocompatibility testing, and performance testing, it has demonstrated that the subject device is substantially equivalent to the predicate device, and does not raise different questions of safety and effectiveness