(134 days)
Not Found
No
The description focuses on video visualization and mechanical flexibility, with no mention of AI/ML for image analysis or other functions.
No
The device aids in a medical procedure (ETT placement) but does not directly treat a disease or condition; it provides visualization and guidance.
No
The device is described as an aid in the placement of an Endotracheal Tube (ETT) by providing visual confirmation and guiding the ETT. It does not perform detection, diagnosis, or treatment of a disease or condition.
No
The device description explicitly states it is a "handheld, portable stylet with a built in camera" and mentions electrical safety and biocompatibility testing, indicating it is a physical hardware device with integrated software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- IntubaidFlex Function: The IntubaidFlex is a medical device used during a medical procedure (intubation) to aid in the placement of an endotracheal tube. It provides visual guidance within the body (in vivo) using a camera. It does not analyze samples taken from the body.
The description clearly states its purpose is to provide "visual confirmation of where the tip of the device is in the human anatomy" and "video-assisted visualization of the laryngeal inlet." This is an in-vivo visualization tool, not an in-vitro diagnostic test.
N/A
Intended Use / 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.
Product codes
BTR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
video-assisted visualization
Anatomical Site
laryngeal inlet, human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5730 Tracheal tube.
(a)
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.(b)
Classification. Class II (performance standards).
0
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: (415) 561-2550 | |
| Correspondence Contact Information: | Pavan Sethi, Ph.D. |
| Vice President, Regulatory, Quality & Scientific | |
| Affairs | |
| Tel: (408) 513-7529 | |
| Pavan@ezcmedical.com | |
| 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
1
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.
2
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.
3
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 (800) 638-2041 or (240) 276-3150 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
4
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