(210 days)
No
The description focuses on the physical design and materials of the laryngoscope for use in an MR environment, with no mention of AI or ML capabilities.
No
The device, a laryngoscope, is intended to facilitate tracheal intubation, which is a diagnostic or procedural aid, not a treatment itself. Therefore, it does not directly treat or prevent a disease or condition.
No
The device is a laryngoscope intended to aid in tracheal intubation, which is a therapeutic or procedural action, not a diagnostic one.
No
The device description explicitly states it is a disposable laryngoscope blade and handle, which are physical hardware components. The modification mentioned is a change in the battery, also a hardware component.
Based on the provided information, the Yeescope laryngoscope is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "facilitate and aid in tracheal intubation." This is a procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device is a laryngoscope blade and handle, used for visualizing the larynx during intubation. This is a medical device used for a procedural purpose.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Yeescope laryngoscope's function is purely procedural.
N/A
Intended Use / 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.
Product codes
CCW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Patients who are to be intubated as determined by the clinician.
Intended User / Care Setting
MR environments up to 3.0 Tesla strength.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing:
- ASTM F2052-02 Standard Test Method of Magnetically Induced Displacement Force of Medical devices in the Magnetic Resonance Environment.
- Pass criteria is deflection of
§ 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
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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 (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
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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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| 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 Director |
| Tel: +61 2 9892 3400 | |
| Fax: +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.
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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 | |
| used to facilitate and aid in tracheal | ||
| intubation in a Magnetic Resonance | ||
| (MR) environment, not to exceed a | ||
| 3.0 Tesla static magnetic field. | 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. | ||
| Environment of Use | MR environments | |
| Not to exceed 3.0 Tesla | Same | |
| Not to exceed 3.0 Tesla | ||
| Patient Population | Patients to be intubated | Patients to be intubated |
| Configurations | Handles | |
| Battery | ||
| Blades | Handle | |
| Battery | ||
| Blade (2 sizes) | ||
| These are supplied assembled | ||
| Performance | ||
| Testing | ASTM F2052-02 | |
| Standard Test Method of | ||
| Magnetically Induced | ||
| Displacement Force of Medical | ||
| devices in the Magnetic Resonance | ||
| Environment | ||
| Pass criteria is deflection of |