EZC MEDICAL, LLC INTUBAIDFLEX

K090777 · Ezc Medical, LLC · BTR · Aug 4, 2009 · Anesthesiology

Device Facts

• Record ID: K090777
• Device Name: EZC MEDICAL, LLC INTUBAIDFLEX
• Applicant: Ezc Medical, LLC
• Product Code: BTR · Anesthesiology
• Decision Date: Aug 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2

Intended Use

The IntubaidFlex™ is intended for use as an aid in the placement of an Endotracheal Tube (ETT) directly or through an Intubating Laryngeal Mask Airway (LMA) during non difficult and difficult intubation procedures. The IntubaidFlex achieves its purpose by providing the user with a visual confirmation of where the tip of the device is in the human anatomy. The flexible tip of the IntubaidFlex allows the user to guide the ETT in the desired direction.

Device Story

IntubaidFlex is a disposable, sterile, handheld, portable stylet with an integrated camera and light source. It functions as an accessory to an Endotracheal Tube (ETT) or Intubating Laryngeal Mask Airway (LMA). The device provides real-time video visualization of the laryngeal inlet to assist clinicians during intubation. The stylet features an articulating flexible tip, allowing the user to steer the ETT into the desired position. The device connects via an integrated cable to a TV monitor, handheld monitor, or PC (via USB) for live video display. By providing visual confirmation of the device tip location within the anatomy, it aids in successful intubation. It is intended for use by healthcare professionals in clinical settings.

Clinical Evidence

Bench testing only. Compliance with ISO 10993 (biocompatibility), IEC 60601-1 and IEC 60601-1-2 (electrical safety/EMC), and ISO 8600-3 and ISO 8600-5 (endoscope performance). Mechanical testing included tensile strength (5.0 lb load), 36-inch drop test, and fatigue testing of the plunger mechanism.

Technological Characteristics

Disposable, sterile, handheld stylet with embedded video camera and light source. Features an articulating flexible tip. Connectivity via integrated cable to external monitors or PC (USB). Compliant with ISO 10993, IEC 60601-1, IEC 60601-1-2, ISO 8600-3, and ISO 8600-5.

Indications for Use

Indicated for use as an aid in endotracheal tube (ETT) placement, either directly or via intubating laryngeal mask airway (LMA), during both non-difficult and difficult intubation procedures in patients requiring airway management.

Regulatory Classification

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.

Predicate Devices

• ETView Tracheoscopic Ventilation Tube (TVTTM) (K082420)

Submission Summary (Full Text)

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# Section V-510(k) Summary

## AUG 0 4 2009

#### 5.1. Device Information

| Category | Comments |
|-------------------------------------|--------------------------------------------------|
| Sponsor: | Company: EZC Medical, LLC |
| | Address: The Presidio |
| | 16A Funston Avenue |
| | San Francisco, Ca, 94129, USA |
| | Tel: [phone] |
| | |
| Correspondence Contact Information: | Pavan Sethi, Ph.D. |
| | Vice President, Regulatory, Quality & Scientific |
| | Affairs |
| | Tel: [phone] |
| | [e-mail] |
| | |
| | |
| Device Common Name: | Stylet / Videoscope |
| Device Classification and Code: | Class II, BTR |
| Device Classification Name: | Tracheal Tube (Accessory) |
| Device Proprietary Name: | IntubaidFlexTM |

#### Predicate Device Information 5.2.

| Predicate Device: | ETView Tracheoscopic Ventilation Tube (TVTTM) |
|-------------------------------------------|-----------------------------------------------|
| Predicate Device Manufacturer: | ETView Ltd |
| Predicate Device Common Name | Tracheal Tube |
| Predicate Device Classification and Code: | Class II, BTR |
| Predicate Device Classification: | 21CFR868.5730 |

#### 5.3. Date Summary Prepared

Date Submitted: March 20, 2009

#### Description of Device: 5.4.

The IntubaidFlex" is a simple, disposable, single-patient use, sterile, handheld, portable stylet with a built in camera, that fits within an Endotracheal tube (ETT) directly or through an Intubating Laryngeal Mask Airway(LMA) and provides for video-assisted visualization of the laryngeal inlet. The IntubaidFlex" can plug into any TV monitor, hand held monitor or PC (via USB) for live video visualization.

#### 5.5. Intended Use

The IntubaidFlex™ is intended for use as an aid in the placement of an Endotracheal Tube (ETT) directly or through an Intubating Laryngeal Mask Airway (LMA) during non difficult and difficult intubation procedures. The IntubaidFlex achieves its purpose by providing the user with a visual confirmation of where the

V-1

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tip of the device is in the human anatomy. The flexible tip of the IntubaidFlex allows the user to guide the ETT in the desired direction.

#### 5.6. Comparison to Predicate Device:

The EZC Medical's IntubaidFlex™ is substantially equivalent to ETView Tracheoscopic Ventilation Tube (TVTTM) in intended use and operation (K082420).

Both the devices are endoscopic, and transmit images through a video camera to a video monitor and use a light source for illumination. Both the devices are disposable, single-patient use, sterile, have an embedded video camera, an embedded light source, and an integrated cable which connects to the video monitor.

The devices are different in design. The IntubaidFlex™ is an accessory to the ETT, where as TVT" is an Endotracheal Tube by itself. The IntubaidFlex " has an articulation capability, which TVT" does not have.

However, these differences do not impact the intended use or optical performance of the IntubaidFlex. The testing described below demonstrates that the differences in the devices do not raise any unresolved issues of safety or efficacy.

EZC Medical concludes that the devices are substantially equivalent.

#### 5.7. Summary of Supporting Data:

Biocompatibility data demonstrates that the device is in compliance with ISO 10993.

Electrical Safety and Electromagnetic Compatibility data demonstrates that the device is in compliance with IEC 60601-1 and IEC 60601-1-2.

Bench testing has demonstrated that the device is in compliance with ISO 8600-3 and ISO 8600-5. In addition the bench testing included the Tensile Strength test, Drop test and Fatigue test. The Tensile Strength Test demonstrated that joints can withstand a 5.0 lb tensile load, the Drop Test demonstrated that the device can withstand a 36 inch fall and the Fatigue test demonstrated that the plunger can withstand multiple actuations without affecting the image functionality of the device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized symbol featuring three curved lines, which may represent people or services.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

# AUG 0 4 2009

Ms. Pavan Sethi Vice President Regulatory, Quality & Scientific Affairs EZC Medical, L.L.C. 16 A Funston Avenue San Francisco, California 94129

Re: K090777

Trade/Device Name: EZC Medical, LLC, IntubaidFlexTM Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: July 27, 2009 Received: July 29, 2009

Dear Ms. Sethi:

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. 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.

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.

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## Page 2- Ms. Sethi

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

signature

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Section IV-Indications for Use Statement

510(k) Number: K090777

EZC Medical, LLC, IntubaidFlex™ Device Name:

Indications for Use:

The IntubaidFlex" is intended for use as an aid in the placement of an Endotracheal Tube (ETT) directly or through an Intubating Laryngeal Mask Airway (LMA) during non difficult and difficult intubation procedures. The IntubaidFlex achieves its purpose by providing the user with a visual confirmation of where the tip of the device is in the human anatomy. The flexible tip of the IntubaidFlex allows the user to guide the ETT in the desired direction.

Prescription Use X (Per 21 CFR §801 subpart D)

Over-The-Counter Use (Per 21 CFR §801 subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

L. Schutte

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K090777

Section IV-Indications for Use Statement

Company Confidential

Page IV-1