(46 days)
Venner Medical APA MAC Blade, Vyaire Medical Airlife Oxygen Supply Tubing
Not Found
No
The summary describes a standard laryngoscope blade with an added oxygen delivery feature. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on physical and functional characteristics, not algorithmic performance.
No
The device is a laryngoscope blade intended to assist in direct and indirect laryngoscopy and facilitate tracheal intubation. While it provides supplemental oxygen during the procedure, its primary function is diagnostic/interventional (aiding intubation) rather than directly treating a condition or disease. The oxygen delivery is an auxiliary function to support the intubation process, not a standalone therapy.
No
The device is a laryngoscope blade designed to assist in tracheal intubation, which is a therapeutic procedure—it does not diagnose a condition.
No
The device description clearly states it is a physical laryngoscope blade with added hardware components (oxygen tube adaptor and tubing). The performance studies also focus on physical characteristics and mechanical testing, not software validation.
Based on the provided information, the APA Oxy Blade™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to assist in direct and indirect laryngoscopy and facilitate tracheal intubation. This is a procedure performed directly on the patient's airway.
- Device Description: The device is a laryngoscope blade with added oxygen delivery capabilities. It is used to visualize the airway and aid in placing a tube.
- Anatomical Site: The device interacts with the upper airway (trachea/airway) and larynx, which are internal anatomical structures.
- 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.) outside of the body to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on samples taken from the body, not to directly interact with or manipulate structures within the body for procedural purposes. The APA Oxy Blade™ is a surgical/procedural tool used during intubation.
N/A
Intended Use / Indications for Use
The APA Oxy Blade™ is a multi-functional, single-use, disposable larynoscope blade intended to assist in direct and indirect laryngoscopy and to facilitate and aid in tracheal intubation in routine and difficult airways in adult patients. The APA Oxy Blade™ incorporates an oxygen tube adaptor and tubing to provide supplemental oxygen to the patient while undergoing endotracheal intubation.
Product codes
CCW
Device Description
The APA Oxy Blade is a laryngoscope blade intended to be used with the Venner Medical APA™ Video Laryngoscope. The APA Oxy Blade is a standard MacIntosh laryngoscope blade with the addition of an oxygen tube adaptor/holder and tubing to provide supplemental oxygen to the patient when using the Venner APA Video Laryngoscope. The Venner APA Video Laryngoscope, like other rigid laryngoscopes, provides a clear view of the upper airway (trachea/airway) and aids in the placement of an endotracheal tube for intubation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper airway (trachea/airway), Larynx
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Health care professionals trained in intubation / 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.
- Packaging Integrity: Assessed by visual inspections, pouch seal strength, and dye penetration testing. Devices were assessed by visual inspection and functional tests; all devices and pouches passed the tests, deemed suitable for use.
- Biocompatibility: Evaluation performed 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". Studies (ISO MEM Elution Assay, ISO Intracutaneous Reactivity, ISO Guinea Pig Maximum Sensitization, ISO Acute Systemic Toxicity) were successfully completed, showing materials were non-toxic, nonirritating, and non-sensitizing.
- Performance Testing: Characterized the APA Oxy Blade through dimensional, mechanical, and functional testing.
- Dimensional Specifications: Met for both MAC 3 and MAC 4 sizes.
- Functional Testing: Anti-fog testing showed no fogging observed. Flow rate testing met acceptance criterion of > 15 L/min.
- Mechanical Testing: Evaluated mechanical integrity of connections through diffuser and tube pull test, tube coupling and tube pull test, simulation tensile test (blade to adaptor to diffuser). Air-leak testing also performed. All devices successfully met acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Venner Medical APA MAC Blade, Vyaire Medical Airlife Oxygen Supply Tubing
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5540 Rigid laryngoscope.
(a)
Identification. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9
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August 2, 2019
Venner Medical (Singapore) Pte Ltd % Christine Brauer Regulatory Affairs Consultant Brauer Device Consultants, LLC 7 Trail House Court Rockville, Maryland 20850
Re: K191602
Trade/Device Name: APA Oxy Blade Regulation Number: 21 CFR 868.5540 Regulation Name: Rigid Laryngoscope Regulatory Class: Class I Product Code: CCW Dated: June 14, 2019 Received: June 17, 2019
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191602
Device Name APA Oxy Blade™
Indications for Use (Describe)
The APA Oxy Blade™ is a multi-functional, single-use, disposable larynoscope blade intended to assist in direct and indirect laryngoscopy and to facilitate and aid in tracheal intubation in routine and difficult airways in adult patients. The APA Oxy Blade™ incorporates an oxygen tube adaptor and tubing to provide supplemental oxygen to the patient while undergoing endotracheal 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) |
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510(k) SUMMARY
GENERAL INFORMATION 1
1.1 Submitter and Owner of the 510(k)
Venner Medical (Singapore) Pte Ltd 35 Joo Koon Circle Singapore 629110 Establishment Registration: 3007740622
1.2 Official Correspondent
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
Devices Subject of this 510(k) 1.3
| Venner Product Code | Tradename | Product Description |
|---|---|---|
| 700330 | APA Oxy Blade™ | APA™ O2 MAC 3 Blade |
| 700340 | APA Oxy Blade™ | APA™ O2 MAC 4 Blade |
510(k) Number and Date of Preparation 1.4
| Submission Number: | K191602 |
|---|---|
| Date of Preparation: | 14 June 2019 |
NAME OF THE DEVICE AND CLASSIFICATION INFORMATION ର
Trade/Proprietary Name 2.1
APA Oxy Blade™ (APA™ O2 MAC 3 and APA™ O2 MAC 4)
Common/Usual Name 2.2
MacIntosh Laryngoscope Blade
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2.3 Classification Information
| Classification Information | |
|---|---|
| Classification Regulation: | 21 CFR 868.5540 - Rigid Laryngoscope |
| Product Code: | CCW - Rigid Laryngoscope |
| Class: | I |
| Panel: | Anesthesiology |
3 PREDICATE DEVICE
The predicate devices are as follows:
- . Primary Predicate- Venner Medical APA MAC Blade, a class I, 510(k) exempt device
- Secondary Predicate- Vyaire Medical Airlife Oxygen Supply Tubing, a class I, 510(k) exempt device
Two predicate devices were selected in accordance with Section IV.C.1 of the guidance document entitled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] - Guidance for Industry and Food and Drug Administration Staff" dated July 28, 2014.
DEVICE DESCRIPTION ব
The APA Oxy Blade is a laryngoscope blade intended to be used with the Venner Medical APA™ Video Laryngoscope. The APA Oxy Blade is a standard MacIntosh laryngoscope blade with the addition of an oxygen tube adaptor/holder and tubing to provide supplemental oxygen to the patient when using the Venner APA Video Laryngoscope. The Venner APA Video Laryngoscope, like other rigid laryngoscopes, provides a clear view of the upper airway (trachea/airway) and aids in the placement of an endotracheal tube for intubation.
INDICATIONS FOR USE ഗ
Below is the indication for use for the APA Oxy Blade.
The APA Oxy Blade™ is a multi-functional, single-use, disposable laryngoscope blade intended to assist in direct and indirect laryngoscopy and to facilitate and aid in tracheal intubation in routine and difficult airways in adult patients. The APA Oxy Blade™ incorporates an oxygen tube adaptor and tubing to provide supplemental oxygen to the patient while undergoing endotracheal intubation.
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COMPARISON OF THE INDICATION FOR USE AND INTENDED USE 6 BETWEEN THE APA OXY BLADE AND THE PREDICATE DEVICES
The APA Oxy Blade and the predicate APA MAC Blade share the same intended use, including the same purpose, function, conditions of use, users, target patient populations, and patient contact although there are slight variations in the indication for use statements (see table). The APA Oxy Blade and the Vyaire Medical Airlife Oxygen Supply Tubing device also share the same intended use, including the same purpose, function, conditions of use, users, target patient populations and patient contact. An indication for use statement was not available for the Vyaire Medical Airlife Oxygen Supply Tubing, likely reflecting the fact that the intended use and use of this simple, class I. 510(k) exempt device is commonly known and exempt from the requirements for adequate directions for use (21 CFR 801.116). Notwithstanding this, it clear that the APA Oxy Blade and the Vyaire Medical Airlife Oxygen Supply Tubing share the same intended use of oxygen delivery to patients.
Table 1. Summary of Intended Use of the APA Oxy Blade™ and the Predicate Device, the APA MAC Blades
| Characteristic | APA Oxy Blade
(This Application) | APA MAC Blade
(510(k) Exempt) | Airlife Oxygen Supply
Tubing (510(k) Exempt) |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Classification
Regulation | 21 CFR 868.5540 | 21 CFR 868.5540 | 21 CFR 868.5860 |
| Product Code | CCW - Rigid
Laryngoscope | CCW - Rigid
Laryngoscope | BYX - Tubing Pressure
and Accessories |
| Class | I | I | I |
| Indication for Use | ... to assist direct and
indirect laryngoscopy... | ... to assist direct and
indirect laryngoscopy... | --- |
| | ... to facilitate and aid in
tracheal intubation... | ...to facilitate endotracheal
intubation... | |
| | ... to provide supplemental
oxygen | | |
| Purpose | To facilitate and aid in
placement of an
endotracheal tube for
intubation | To facilitate and aid in
placement of an
endotracheal tube for
intubation | To provide supplemental
oxygen |
| | To view the larynx | To view the larynx | |
| | To provide supplemental
oxygen | | |
| Function | Lifts or displaces epiglottis
out of the visual pathway to
expose the laryngeal inlet to
facilitate endotracheal tube
placement | Lifts or displaces epiglottis
out of the visual pathway to
expose the laryngeal inlet
to facilitate endotracheal
tube placement | Provides supplemental
oxygen |
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| Characteristic | APA Oxy Blade
(This Application) | APA MAC Blade
(510(k) Exempt) | Airlife Oxygen Supply
Tubing (510(k) Exempt) |
|------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------|-------------------------------------------------|
| | Provides supplemental
oxygen | | |
| Target Population | Adult patients undergoing
endotracheal intubation who
may require supplemental
oxygen | Adult patients undergoing
endotracheal intubation | Patients requiring
supplemental oxygen |
| Target User | Health care professionals
trained in intubation | Health care professionals
trained in intubation | Health care professionals |
| Prescription Device | Yes | Yes | Yes |
| Intended for Use in
Clinical
Environment | Yes | Yes | Yes |
| Body Contact | Surface contacting | Surface contacting | Surface contacting |
COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE 7 PREDICATE DEVICE
The APA Oxy Blade and the predicate device, the APA MAC Blade, share many of the same technological characteristics (see Table 2). Both systems are curved rigid laryngoscope blades, referred to as the MacIntosh design. Both are used to assist in endotracheal intubation by lifting or displacing the epiglottis, and to allow for visualization of the larynx. Both share the same dimensions and materials. Both are provided non-sterile for single-patient use and have the same tissue contact.
Table 2. Summary of Technological Characteristics Comparing the APA Oxy Blade™ to the APA™ MAC Blade
| Technological
Characteristic | APA Oxy Blade
(This Application) | APA MAC Blade
(510(k) Exempt) |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Design | Curve laryngoscope blade – MacIntosh
Adaptor of holder on blade to secure
tubing | Curve laryngoscope blade - MacIntosh |
| Use | Attached to laryngoscope to assist in
endotracheal intubation when
continuous oxygen delivery deemed
appropriate by health care professional | Attached to laryngoscope to assist in
endotracheal intubation |
| Recommended
Laryngoscope | Yes - Venner Medical APA Video
Laryngoscope | Yes - Venner Medical APA Video
Laryngoscope |
| Components for
Oxygen Delivery | Yes – Tubing for oxygen delivery | No |
| Size | MAC 3 Blade: 12.2 x 3.8 x 3.5 cm
MAC 4 Blade: 15.3 x 3.8 x 3.6 cm | MAC 3 Blade: 12.2 x 3.8 x 3.5 cm
MAC 4 Blade: 15.3 x 3.8 x 3.6 cm |
| Material
Composition | Blade: Polycarbonate
Tubing: Polyvinylchloride | Blade: Polycarbonate |
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| Technological
Characteristic | APA Oxy Blade
(This Application) | APA MAC Blade
(510(k) Exempt) |
|---------------------------------|-------------------------------------|----------------------------------|
| Sterile | No | No |
| Single Use | Yes | Yes |
The primary difference between the two MacIntosh blades is the addition of the tubing for oxygen delivery in the APA Oxy Blade. Therefore, the APA Oxy Blade has been compared to the Vyaire Medical Airlife Supply Tubing with respect to technological characteristics and shown to be substantially equivalent (see table).
Table 3. Summary of Technological Characteristics Comparing the APA Oxy Blade™ to the Vyaire Medical Airlife Oxygen Supply Tubing
| Technological
Characteristic | APA Oxy Blade
(This Application) | Vyaire Medical Airlife Oxygen
Supply Tubing
(510(k) Exempt) |
|---------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Design | Tubing with coupling to attach to
oxygen supply | Tubing with coupling to attach to
oxygen supply |
| Use | Delivers supplemental oxygen to
patient
Connects to oxygen supply | Delivers supplemental oxygen to
patient
Connects to oxygen supply |
| Size | Length: 4 meters | Length: 7-50 meters |
| Material
Composition | Polyvinylchloride | Polyvinylchloride |
| Sterile | No | No |
| Single Use | Yes | Yes |
PERFORMANCE DATA 8
This 510(k) notification provided performance data to establish the substantial equivalence of the APA Oxy Blade.
Packaging Integrity: The results from testing were provided to demonstrate the suitability and integrity of the packaging materials to protect the APA Oxy Blade. Packaging was assessed by visual inspections, pouch seal strength and the dye penetration testing. Devices were assessed by visual inspection and functional tests; all devices and pouches passed the tests. The packaging is suitable for its use.
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 APA Oxy Blade and/or
8
extracts thereof. In the completed studies, the materials were observed to be non-toxic, nonirritating and non-sensitizing according to the study protocols.
| Test Performed | Test Method | Test Results |
|---|---|---|
| ISO MEM Elution Assay (Cytotoxicity) | ISO 10993-5:2009 | |
| ISO 10993-12:2012 | Pass | |
| ISO Intracutaneous Reactivity | ISO 10993-10:2010 | Pass |
| ISO Guinea Pig Maximum Sensitization | ISO 10993-10:2010 | |
| ISO 10993-12:2012 | Pass | |
| ISO Acute Systemic Toxicity | ISO 10993-11:2017 | Pass |
Table 4. Summary of the Biocompatibility Tests and Results
Performance Testing: Performance testing was performed to characterize the APA Oxy Blade, including dimensional, mechanical and functional testing.
- Dimensional Specifications: The APA Oxy Blade met its dimensional specifications in both sizes.
- . Functional Testing: Functional testing included anti-fog testing and flow rate testing using standardized test methods and prospectively identified acceptance criteria. All blades successfully passed the anti-fog test with no fogging observed. All devices successfully passed the flow test and met the acceptance criterion of > 15 L/min.
- . Mechanical Testing: The mechanical integrity of the APA Oxy Blade was evaluated in three separate tests to confirm the mechanical integrity of the connections of the various components. The tests included: diffuser and tube pull test, tube coupling and tube pull test, and simulation tensile test (blade to adaptor to diffuser). In addition, air-leak testing was performed to evaluate the connection between the blade and the tubing. Standardized test methods and prospectively identified acceptance criteria were utilized. All devices successfully met the acceptance criteria for mechanical testing.
9 CONCLUSIONS.
Based on the comparison, biocompatibility testing, and performance testing, it has demonstrated that the subject device is substantially equivalent to the proposed predicates and does not raise different questions of safety and effectiveness.