(210 days)
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.
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.
The Yeescope Laryngoscope is a single use, disposable laryngoscope blade and handle intended to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment up to a 3.0 Tesla static magnetic field.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from ASTM F2052-02) | Reported Device Performance |
|---|---|
| Deflection of < 45 degrees when tested in a 3.0 Tesla MR environment. | 23° deflection for Macintosh 4 laryngoscope 25° deflection for Macintosh 3 laryngoscope |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document specifies "Mac 4" and "Mac 3" without detailing the exact number of units tested for each size. However, it implies at least one of each size was tested to obtain the reported deflection values.
- Data Provenance: The testing was performed according to ASTM F2052-02, a standard test method. The country of origin of the data is not explicitly stated, but the manufacturer is based in Australia. It is a prospective test, as the document describes the testing performed on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to this submission. The ground truth for this device is based on objective, quantifiable physical properties (magnetic deflection) as measured by a standardized test method (ASTM F2052-02), not on expert subjective opinion or interpretation.
4. Adjudication Method for the Test Set:
Not applicable. The test involves direct physical measurement of magnetic deflection, which does not require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This device is a physical medical instrument, not an AI or imaging diagnostic tool that would involve human readers interpreting output.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):
Not applicable. This device is not an algorithm or AI system. Its performance criteria are based on its physical properties in an MR environment.
7. Type of Ground Truth Used:
The ground truth used is a standardized physical test method (ASTM F2052-02) that objectively measures the magnetic field displacement force on medical devices. The pass criteria for this test (deflection < 45 degrees) serves as the defined ground truth for magnetic compatibility in an MR environment.
8. Sample Size for the Training Set:
Not applicable. There is no training set for this device as it is not an AI/ML product.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, formed by three stylized human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and movement.
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.
{1}------------------------------------------------
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
{2}------------------------------------------------
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
| 510(k) Summary | |
|---|---|
| Page 1 of 3 | |
| 11-Apr-2014 | |
| Yeescope Pty. Ltd. | |
| 10 Binney Road | |
| KINGS PARK NSW 2148 | |
| AUSTRALIA | |
| Official Contact: | Kevin Yee - Managing DirectorTel: +61 2 9892 3400Fax: +61 2 9892 3116 |
| 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.
{4}------------------------------------------------
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 isused to facilitate and aid in trachealintubation in a Magnetic Resonance(MR) environment, not to exceed a3.0 Tesla static magnetic field. | The Yeescope laryngoscope is asingle use, disposable laryngoscopeblade and handle that is intended tofacilitate and aid in trachealintubation in a MagneticResonance (MR) environment, notto exceed a 3.0 Tesla staticmagnetic field. |
| Environment of Use | MR environmentsNot to exceed 3.0 Tesla | SameNot to exceed 3.0 Tesla |
| Patient Population | Patients to be intubated | Patients to be intubated |
| Configurations | HandlesBatteryBlades | HandleBatteryBlade (2 sizes)These are supplied assembled |
| PerformanceTesting | ASTM F2052-02Standard Test Method ofMagnetically InducedDisplacement Force of Medicaldevices in the Magnetic ResonanceEnvironmentPass criteria is deflection of < 45degrees | ASTM F2052-02Standard Test Method ofMagnetically InducedDisplacement Force of Medicaldevices in the Magnetic ResonanceEnvironmentPass criteria is deflection of < 45degreesResults degree deflection 23° forMac 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.
{5}------------------------------------------------
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.
§ 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