APA Oxy Blade

K191602 · Venner Medical (Singapore) Pte, Ltd. · CCW · Aug 2, 2019 · Anesthesiology

Device Facts

• Record ID: K191602
• Device Name: APA Oxy Blade
• Applicant: Venner Medical (Singapore) Pte, Ltd.
• Product Code: CCW · Anesthesiology
• Decision Date: Aug 2, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5540
• Device Class: Class 1
• Attributes: Therapeutic

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.

Device Story

The APA Oxy Blade is a single-use, disposable MacIntosh-style laryngoscope blade designed for use with the Venner Medical APA Video Laryngoscope. It features an integrated oxygen tube adaptor and tubing to deliver supplemental oxygen to the patient during intubation. The device is operated by healthcare professionals trained in intubation within clinical environments. By lifting or displacing the epiglottis, the blade exposes the laryngeal inlet to facilitate endotracheal tube placement while simultaneously providing oxygenation. This dual-functionality aids in airway management, particularly in difficult airway scenarios, by maintaining patient oxygen levels during the intubation process.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included packaging integrity (visual inspection, seal strength, dye penetration), biocompatibility (ISO 10993-5, -10, -11), and performance testing (dimensional, anti-fog, flow rate >15 L/min, and mechanical integrity/air-leak testing).

Technological Characteristics

Curved MacIntosh-style rigid laryngoscope blade. Materials: Polycarbonate (blade), Polyvinylchloride (tubing). Dimensions: MAC 3 (12.2 x 3.8 x 3.5 cm), MAC 4 (15.3 x 3.8 x 3.6 cm). Non-sterile, single-use. Integrates oxygen tube adaptor and tubing for supplemental oxygen delivery. Complies with ISO 10993 for biocompatibility.

Indications for Use

Indicated for adult patients undergoing endotracheal intubation who may require supplemental oxygen during the procedure, including those with routine or difficult airways.

Regulatory Classification

Identification

A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

Predicate Devices

• Venner Medical APA MAC Blade
• Vyaire Medical Airlife Oxygen Supply Tubing

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

| <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|----------------------------------------------|
| <span></span> | 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: [phone] E-mail: [e-mail]

#### 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<br>(This Application) | APA MAC Blade<br>(510(k) Exempt) | Airlife Oxygen Supply<br>Tubing (510(k) Exempt) |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Classification<br>Regulation | 21 CFR 868.5540 | 21 CFR 868.5540 | 21 CFR 868.5860 |
| Product Code | CCW - Rigid<br>Laryngoscope | CCW - Rigid<br>Laryngoscope | BYX - Tubing Pressure<br>and Accessories |
| Class | I | I | I |
| Indication for Use | ... to assist direct and<br>indirect laryngoscopy... | ... to assist direct and<br>indirect laryngoscopy... | --- |
| | ... to facilitate and aid in<br>tracheal intubation... | ...to facilitate endotracheal<br>intubation... | |
| | ... to provide supplemental<br>oxygen | | |
| Purpose | To facilitate and aid in<br>placement of an<br>endotracheal tube for<br>intubation | To facilitate and aid in<br>placement of an<br>endotracheal tube for<br>intubation | To provide supplemental<br>oxygen |
| | To view the larynx | To view the larynx | |
| | To provide supplemental<br>oxygen | | |
| Function | Lifts or displaces epiglottis<br>out of the visual pathway to<br>expose the laryngeal inlet to<br>facilitate endotracheal tube<br>placement | Lifts or displaces epiglottis<br>out of the visual pathway to<br>expose the laryngeal inlet<br>to facilitate endotracheal<br>tube placement | Provides supplemental<br>oxygen |

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| Characteristic | APA Oxy Blade<br>(This Application) | APA MAC Blade<br>(510(k) Exempt) | Airlife Oxygen Supply<br>Tubing (510(k) Exempt) |
|------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------|-------------------------------------------------|
| | Provides supplemental<br>oxygen | | |
| Target Population | Adult patients undergoing<br>endotracheal intubation who<br>may require supplemental<br>oxygen | Adult patients undergoing<br>endotracheal intubation | Patients requiring<br>supplemental oxygen |
| Target User | Health care professionals<br>trained in intubation | Health care professionals<br>trained in intubation | Health care professionals |
| Prescription Device | Yes | Yes | Yes |
| Intended for Use in<br>Clinical<br>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<br>Characteristic | APA Oxy Blade<br>(This Application) | APA MAC Blade<br>(510(k) Exempt) |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Design | Curve laryngoscope blade – MacIntosh<br>Adaptor of holder on blade to secure<br>tubing | Curve laryngoscope blade - MacIntosh |
| Use | Attached to laryngoscope to assist in<br>endotracheal intubation when<br>continuous oxygen delivery deemed<br>appropriate by health care professional | Attached to laryngoscope to assist in<br>endotracheal intubation |
| Recommended<br>Laryngoscope | Yes - Venner Medical APA Video<br>Laryngoscope | Yes - Venner Medical APA Video<br>Laryngoscope |
| Components for<br>Oxygen Delivery | Yes – Tubing for oxygen delivery | No |
| Size | MAC 3 Blade: 12.2 x 3.8 x 3.5 cm<br>MAC 4 Blade: 15.3 x 3.8 x 3.6 cm | MAC 3 Blade: 12.2 x 3.8 x 3.5 cm<br>MAC 4 Blade: 15.3 x 3.8 x 3.6 cm |
| Material<br>Composition | Blade: Polycarbonate<br>Tubing: Polyvinylchloride | Blade: Polycarbonate |

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| Technological<br>Characteristic | APA Oxy Blade<br>(This Application) | APA MAC Blade<br>(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<br>Characteristic | APA Oxy Blade<br>(This Application) | Vyaire Medical Airlife Oxygen<br>Supply Tubing<br>(510(k) Exempt) |
|---------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Design | Tubing with coupling to attach to<br>oxygen supply | Tubing with coupling to attach to<br>oxygen supply |
| Use | Delivers supplemental oxygen to<br>patient<br>Connects to oxygen supply | Delivers supplemental oxygen to<br>patient<br>Connects to oxygen supply |
| Size | Length: 4 meters | Length: 7-50 meters |
| Material<br>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

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