(81 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a tracheostomy tube, with no mention of AI or ML capabilities.
Yes
The device is intended to provide an artificial airway and maintain airway patency, which directly addresses a physiological dysfunction (lack of a patent airway) and is used to restore normal function.
No
The device is a tracheostomy tube designed to establish and maintain an artificial airway, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical, sterile, single-use tracheostomy tube made of polyvinyl chloride with a balloon cuff and inner cannulae, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide an artificial airway to establish airway patency and to provide maintenance of the airway." This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The description details a physical device (tracheostomy tube) used to manage the airway. It does not describe any components or processes related to testing samples from the human body to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The VersaTube is a medical device used for airway management, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The VersaTube™ Tapered Tracheostomy Tube is intended to provide an artificial airway to establish airway patency and to provide maintenance of the airway.
Product codes
BTO
Device Description
The VersaTube is a sterile, single use cuffed tracheostomy tube with a disposable inner cannula, and will be manufactured as a 7, 8, or 9 mm ID device (with the inner cannula being either 6, 7, or 8 mm ID). The angle of curvature of the VersaTube is 96° (7, 8 mm ID) or 97 ° (9 mm ID) and ranges from 78 to 98 mm. The neck-plate, 15 mm airway connector, and inner cannula are color coded to marry together the tracheostomy tube with the correctly sized inner cannula. The device is not intended to be used for more than 29 days.
The VersaTube consists of a polyvinyl chloride outer cannula which is tapered at the distal end for smooth insertion. The device also incorporates a low pressure, high volume balloon cuff at the distal end of the device for the purpose of sealing the airway for proper ventilation. Included with the VersaTube are two inner cannulae. Each inner cannula is designed for a close fit to the corresponding size VersaTube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
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)
To demonstrate reliable design and performance of the VersaTube, the following verification testing was performed:
- Strength of neck-plate and 15 mm connector attachment to cannula.
- Cuff performance.
- Insertion force.
- Inner cannula extraction force.
- Sterilization testing.
- Biocompatibility testing.
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
§ 868.5800 Tracheostomy tube and tube cuff.
(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.
0
K100283
6
Cook Incorporated VersaTube™ Tapered Tracheostomy Tube with Disposable Inner Cannula 29 January 2010
-
- 510(k) Summary
APR 2 8 2010
- 510(k) Summary
Cook Incorporated VersaTube™ Tapered Tracheostomy Tube with Disposable Inner Cannula 510(k) Summary 21 CFR 807.92
1. Submitter Information:
Applicant:
Cook Incorporated
(800) 468-1379
(812) 332-0281
Address:
750 Daniels Way P.O. Box 489 Bloomington, IN 47402
Phone Number: Fax Number:
Contact: Contact Address:
Susanne Galin, RAC Cook Incorporated 750 Daniels Way Bloomington, IN 47404
Contact Phone Number: 812-339-2235 x2296 812-332-0281 Contact Fax Number:
2. Device Information:
Trade name:
Common name: Classification:
Regulation:
Product Code:
VersaTube™ Tapered Tracheostomy Tube with Disposable Inner Cannula Tube Tracheostomy and Tube Cuff Class II
21 CFR § 868.5800 Tracheostomy tube and tube cuff
BTO
1
Cook Incorporated
VersaTube™ Tapered Tracheostomy Tube with Disposable Inner Cannula 29 January 2010
3. Predicate Devices:
Cook Incorporated's VersaTube™ Tapered Tracheostomy Tube with Disposable Cannula (hereafter referred to as the VersaTube) is substantially equivalent to the Portex® Blue Line Ultra® Tracheostomy Tube originally manufactured by Portex Ltd. under 510(k) clearance K030381.
4. Device Description:
The VersaTube is a sterile, single use cuffed tracheostomy tube with a disposable inner cannula, and will be manufactured as a 7, 8, or 9 mm ID device (with the inner cannula being either 6, 7, or 8 mm ID). The angle of curvature of the VersaTube is 96° (7, 8 mm ID) or 97 ° (9 mm ID) and ranges from 78 to 98 mm. The neck-plate, 15 mm airway connector, and inner cannula are color coded to marry together the tracheostomy tube with the correctly sized inner cannula. The device is not intended to be used for more than 29 days.
5. Intended Use:
The VersaTube Tapered Tracheostomy Tube is intended to provide an artificial airway to establish airway patency and to provide maintenance of the airway.
6. Technological Characteristics:
The VersaTube consists of a polyviny1 chloride outer cannula which is tapered at the distal end for smooth insertion. The device also incorporates a low pressure, high volume balloon cuff at the distal end of the device for the purpose of sealing the airway for proper ventilation. Included with the VersaTube are two inner cannulae. Each inner cannula is designed for a close fit to the corresponding size VersaTube.
The technological characteristics of the VersaTube and the predicate device, the Portex Blue Line Ultra Tracheostomy Tube, are substantially equivalent in that both devices have the same main trachestomy tube materials, components, basic design, and function. No new technological aspects are being introduced with the proposed device.
2
To demonstrate reliable design and performance of the VersaTube, the following verification testing was performed:
- Strength of neck-plate and 15 mm connector attachment to cannula, .
- Cuff performance, .
- Insertion force, .
.
- Inner cannula extraction force, .
- Sterilization testing, .
- . Biocompatibility testing.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem of an eagle, with its wings spread and head turned to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Susanne Galin Regulatory Affairs Specialist Cook, Incorporated 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47402
APR 2 3 2010
Re: K100283
Trade/Device Name: VersaTube™ Tapered Tracheostomy Tube with Disposable Inner Cannula Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: BTO Dated: January 29, 2010 Received: February 1, 2010
Dear Ms. Galin:
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.
4
Page 2 - Ms. Galin
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/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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Wh for
Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Cook Incorporated VersaTube™ Tapered Tracheostomy Tube with Disposable Inner Cannula 29 January 2010
- Indications for Use Statement
510(k) Number (if known):
Device Name: VersaTube™ Tapered Tracheostomy Tube with Disposable Inner Cannula
Indications for Use:
The VersaTube™ Tapered Tracheostomy Tube is intended to provide an artificial airway to establish airway patency and to provide maintenance of the airway.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schultheis
· Division Sign-Off) )ivision of Anesthesiology, General Hospital nection Control, Dental Devices
10(k) Number: K 10 02.83