YEESCOPE LARYNGOSCOPES

K140951 · Yeescope Pty. , Ltd. · CCW · Nov 10, 2014 · Anesthesiology

Device Facts

• Record ID: K140951
• Device Name: YEESCOPE LARYNGOSCOPES
• Applicant: Yeescope Pty. , Ltd.
• Product Code: CCW · Anesthesiology
• Decision Date: Nov 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5540
• Device Class: Class 1

Intended Use

The Yeescope laryngoscope is a single use, disposable laryngoscope blade and handle that is intended to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

Device Story

Yeescope Laryngoscope is a single-use, disposable device consisting of a blade and handle; designed for tracheal intubation in MR environments (up to 3.0 Tesla). Device utilizes a specialized battery with low magnetic properties to ensure MR compatibility. Operated by clinicians in clinical settings; provides visualization of the airway to facilitate intubation. Output is visual access to the airway; assists in clinical decision-making during emergency or elective airway management. Benefits include safe intubation within MR suites without interference from magnetic fields.

Clinical Evidence

Bench testing only. Performance testing conducted per ASTM F2052-02 to evaluate magnetically induced displacement force in a 3.0 Tesla environment. Results showed deflection of 23° for Mac 4 and 25° for Mac 3, meeting the pass criteria of < 45 degrees.

Technological Characteristics

Single-use, disposable laryngoscope (Macintosh style, sizes 3 and 4). Constructed of plastic materials. MR-conditional design utilizing a low-magnetic battery. Tested for magnetically induced displacement force per ASTM F2052-02.

Indications for Use

Indicated for patients requiring tracheal intubation in Magnetic Resonance (MR) environments up to 3.0 Tesla.

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

• Truphatek Tru-MR™ (K062523)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 10,2014

Yeescope Pty. LTD c/o Paul Dryden, Consultant Yeescope Pty. LTD 10 Binney Rd Kings Park, New South Whales 2148

Re: K140951

Trade/Device Name: Yeescope Laryngoscope Regulation Number: 21 CFR 868.5540 Regulation Name: Rigid Laryngoscope Regulatory Class: I Product Code: CCW Dated: September 24, 2014 Received: September 25, 2014

Dear Mr. Dryden:

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. 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.

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, mA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K140951

Device Name Yeescope Laryngoscope

Indications for Use (Describe)

The Yeescope laryngoscope is a single use, disposable laryngoscope blade and handle that is intended to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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| <b>510(k) Summary</b> | |
|----------------------------|-------------------------------------------------------------------------------|
| Page 1 of 3 | |
| 11-Apr-2014 | |
| Yeescope Pty. Ltd. | |
| 10 Binney Road | |
| KINGS PARK NSW 2148 | |
| AUSTRALIA | |
| Official Contact: | Kevin Yee - Managing Director<br>Tel: [phone]<br>Fax: [phone] |
| Proprietary or Trade Name: | Yeescope Laryngoscope |
| Common/Usual Name: | Rigid Laryngoscope |
| Classification Name: | Rigid Laryngoscope |
| | Product code – CCW |
| | 21 CFR 868.5540 |
| | Class 1 |
| Predicate Devices: | Truphatek Tru-MR™ - K062523 |

# Device Description:

Yeescope laryngoscope blades and handles are single use, fully disposable laryngoscopes identical to our standard units except we have exchanged the battery to one that is less magnetic and thus would meet the requirements for MR conditional environments.

Yeescope laryngoscope are offered in one (1) style and two (2) sizes; Macintosh style (curved) and in Sizes 3 and 4.

#### Indications for Use:

The Yeescope laryngoscope is a single use, disposable laryngoscope blade and handle that is intended to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

## Patient Population:

Patients who are to be intubated as determined by the clinician.

#### Environment of Use:

Adding Magnetic Resonance (MR) environments up to 3.0 Tesla strength.

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## 510(k) Summary Page 2 of 3 11-Apr-2014

#### Comparison to Predicates

| Features | Truphatek | Proposed Device |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Tru-MRTM K062523 | Yeescope MR |
| Indications for use | The Tru-MR TM laryngoscope set is<br>used to facilitate and aid in tracheal<br>intubation in a Magnetic Resonance<br>(MR) environment, not to exceed a<br>3.0 Tesla static magnetic field. | The Yeescope laryngoscope is a<br>single use, disposable laryngoscope<br>blade and handle that is intended to<br>facilitate and aid in tracheal<br>intubation in a Magnetic<br>Resonance (MR) environment, not<br>to exceed a 3.0 Tesla static<br>magnetic field. |
| Environment of Use | MR environments<br>Not to exceed 3.0 Tesla | Same<br>Not to exceed 3.0 Tesla |
| Patient Population | Patients to be intubated | Patients to be intubated |
| Configurations | Handles<br>Battery<br>Blades | Handle<br>Battery<br>Blade (2 sizes)<br>These are supplied assembled |
| Performance<br>Testing | ASTM F2052-02<br>Standard Test Method of<br>Magnetically Induced<br>Displacement Force of Medical<br>devices in the Magnetic Resonance<br>Environment<br>Pass criteria is deflection of < 45<br>degrees | ASTM F2052-02<br>Standard Test Method of<br>Magnetically Induced<br>Displacement Force of Medical<br>devices in the Magnetic Resonance<br>Environment<br>Pass criteria is deflection of < 45<br>degrees<br><br>Results degree deflection 23° for<br>Mac 4 and 25° for Mac 3 |

## Substantial Equivalence Discussion

The Yeescope laryngoscopes are viewed as substantially equivalent to the predicate device because:

## Indications –

- Identical to predicate K062523 ●
- . Intended to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

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#### 510(k) Summary Page 3 of 3

# 11-Apr-2014

#### Technology -

- . Similar - handle, battery, blade design to predicate - K062523
- The Yeescope is an all plastic single use disposable while the predicate is metal and . reusable
- . Both devices are Class 1 exempt

## Materials –

- The materials are part of a Class I exempt device. ●
# Environment of Use -

- Identical to predicate K062523 ●
- Adding Magnetic Resonance (MR) environments up to 3.0 Tesla strength. .

# Patient Population -

- Identical to predicates K062523 ●
- Patients who are to be intubated

## Performance Testing

- · Identical to predicate K062523
- Testing has been performed according to ASTM F2052-02 for deflection in a 3.0 Tesla ● environment

## Substantial Equivalence Conclusion -

The proposed device has been found to be substantially equivalent to the predicate. Differences between the proposed device and the predicate do not raise new questions of safety or efficacy.