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.

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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the APA Oxy Blade, a rigid laryngoscope. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving the device meets specific acceptance criteria in the manner of a clinical trial or algorithm performance study.

Therefore, many of the requested elements (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, training set details) are not applicable as this submission is for a Class I medical device, which typically relies on comparisons to predicates and engineering/performance verification for regulatory clearance, not extensive clinical performance studies or AI algorithm validation.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance:

The document outlines performance data categories and successful outcomes, which effectively serve as the acceptance criteria and reported performance.

Acceptance Criterion (Category within performance testing)	Reported Device Performance (Result)
Packaging Integrity	Suitable and intact (visual inspection, pouch seal strength, dye penetration testing passed; devices and pouches passed all tests).
Biocompatibility (Cytotoxicity)	Pass (non-toxic per ISO 10993-5:2009, ISO 10993-12:2012)
Biocompatibility (Intracutaneous Reactivity)	Pass (non-irritating per ISO 10993-10:2010)
Biocompatibility (Guinea Pig Maximum Sensitization)	Pass (non-sensitizing per ISO 10993-10:2010, ISO 10993-12:2012)
Biocompatibility (Acute Systemic Toxicity)	Pass (non-toxic per ISO 10993-11:2017)
Dimensional Specifications	Met for both MAC 3 and MAC 4 sizes.
Functional Testing (Anti-fog)	All blades successfully passed with no fogging observed.
Functional Testing (Flow Rate)	All devices successfully passed and met the acceptance criterion of > 15 L/min.
Mechanical Testing (Diffuser and tube pull test)	All devices successfully met the acceptance criteria.
Mechanical Testing (Tube coupling and tube pull test)	All devices successfully met the acceptance criteria.
Mechanical Testing (Simulation tensile test (blade to adaptor to diffuser))	All devices successfully met the acceptance criteria.
Mechanical Testing (Air-leak testing)	All devices successfully met the acceptance criteria.

2. Sample sizes used for the test set and the data provenance:

Sample Size: The document does not explicitly state the numerical sample size for each test (e.g., "n=X blades were tested"). Instead, it uses phrases like "The results from testing were provided," "all devices and pouches passed the tests," "All blades successfully passed," and "All devices successfully met the acceptance criteria." This implies that a sufficient number of samples were tested to demonstrate conformity, as per standard engineering verification practices for medical devices of this class.
Data Provenance: The tests are described as "Performance testing was performed to characterize the APA Oxy Blade," indicating that these were prospective engineering and bench tests conducted specifically for this submission. The country of origin of the testing data is not specified, but the applicant, Venner Medical (Singapore) Pte Ltd, is based in Singapore.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This device is a physical medical instrument (laryngoscope blade) and its performance is evaluated through engineering and biocompatibility testing, not through expert-reviewed "ground truth" like in an AI/diagnostic study. The "ground truth" here is objective measurement against engineering specifications and biological safety standards.

4. Adjudication method for the test set:

Not Applicable. As per point 3, this is not an expert-driven diagnostic study requiring adjudication. The tests involve objective measurements (e.g., dimensions, flow rate, pull strength, visual inspection for fogging/leaks, lab results for biocompatibility).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This type of study is typically performed to evaluate the diagnostic performance of software or imaging devices, often involving human readers. The APA Oxy Blade is a physical instrument, and its clearance relies on substantial equivalence and bench testing, not MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This device does not involve an algorithm. The "standalone performance" is demonstrated through the various engineering and biocompatibility tests described (e.g., flow rate, anti-fogging, mechanical strength, material safety).

7. The type of ground truth used:

The "ground truth" for this device's performance is established by engineering specifications, standardized test methods (e.g., ISO standards for biocompatibility), and pre-defined acceptance criteria for physical and functional properties. For example, "acceptance criterion of > 15 L/min" for flow testing.

8. The sample size for the training set:

Not Applicable. This is not a machine learning or AI device that requires a "training set."

9. How the ground truth for the training set was established:

Not Applicable. As per point 8.

Summary

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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

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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)

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

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 SupplyTubing (510(k) Exempt)
ClassificationRegulation	21 CFR 868.5540	21 CFR 868.5540	21 CFR 868.5860
Product Code	CCW - RigidLaryngoscope	CCW - RigidLaryngoscope	BYX - Tubing Pressureand Accessories
Class	I	I	I
Indication for Use	... to assist direct andindirect laryngoscopy...	... to assist direct andindirect laryngoscopy...	---
	... to facilitate and aid intracheal intubation...	...to facilitate endotrachealintubation...
	... to provide supplementaloxygen
Purpose	To facilitate and aid inplacement of anendotracheal tube forintubation	To facilitate and aid inplacement of anendotracheal tube forintubation	To provide supplementaloxygen
	To view the larynx	To view the larynx
	To provide supplementaloxygen
Function	Lifts or displaces epiglottisout of the visual pathway toexpose the laryngeal inlet tofacilitate endotracheal tubeplacement	Lifts or displaces epiglottisout of the visual pathway toexpose the laryngeal inletto facilitate endotrachealtube placement	Provides supplementaloxygen

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Characteristic	APA Oxy Blade(This Application)	APA MAC Blade(510(k) Exempt)	Airlife Oxygen SupplyTubing (510(k) Exempt)
	Provides supplementaloxygen
Target Population	Adult patients undergoingendotracheal intubation whomay require supplementaloxygen	Adult patients undergoingendotracheal intubation	Patients requiringsupplemental oxygen
Target User	Health care professionalstrained in intubation	Health care professionalstrained in intubation	Health care professionals
Prescription Device	Yes	Yes	Yes
Intended for Use inClinicalEnvironment	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

TechnologicalCharacteristic	APA Oxy Blade(This Application)	APA MAC Blade(510(k) Exempt)
Design	Curve laryngoscope blade – MacIntoshAdaptor of holder on blade to securetubing	Curve laryngoscope blade - MacIntosh
Use	Attached to laryngoscope to assist inendotracheal intubation whencontinuous oxygen delivery deemedappropriate by health care professional	Attached to laryngoscope to assist inendotracheal intubation
RecommendedLaryngoscope	Yes - Venner Medical APA VideoLaryngoscope	Yes - Venner Medical APA VideoLaryngoscope
Components forOxygen Delivery	Yes – Tubing for oxygen delivery	No
Size	MAC 3 Blade: 12.2 x 3.8 x 3.5 cmMAC 4 Blade: 15.3 x 3.8 x 3.6 cm	MAC 3 Blade: 12.2 x 3.8 x 3.5 cmMAC 4 Blade: 15.3 x 3.8 x 3.6 cm
MaterialComposition	Blade: PolycarbonateTubing: Polyvinylchloride	Blade: Polycarbonate

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TechnologicalCharacteristic	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

TechnologicalCharacteristic	APA Oxy Blade(This Application)	Vyaire Medical Airlife OxygenSupply Tubing(510(k) Exempt)
Design	Tubing with coupling to attach tooxygen supply	Tubing with coupling to attach tooxygen supply
Use	Delivers supplemental oxygen topatientConnects to oxygen supply	Delivers supplemental oxygen topatientConnects to oxygen supply
Size	Length: 4 meters	Length: 7-50 meters
MaterialComposition	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

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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 10993-5:2009ISO 10993-12:2012	Pass
ISO Intracutaneous Reactivity	ISO 10993-10:2010	Pass
ISO Guinea Pig Maximum Sensitization	ISO 10993-10:2010ISO 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.

Regulation Number and Section

§ 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