(92 days)
The Vitaid ET Tubes are designed for oral / nasal intubation and are indicated for airway management. The Vitaid ET tubes have an ultra thin inflatable cuff.
The Vitaid endotracheal tubes are available in sizes 3.0 mm in increments of 0.5 mm. They are available cuffed, uncuffed and with Murphy eye. Some are pre-formed, they are made with a ultra thin urethane cuff, referred to as the MicroCuff.
The provided document is a 510(k) summary for a medical device (Vitaid ET Tubes), which focuses on establishing substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria and results in the manner typically seen for novel AI/software devices. This document does not describe a study involving an algorithm's performance, human readers, or ground truth establishment.
Therefore, the requested information elements related to algorithmic performance studies (e.g., test set sample size, number of experts, adjudication, MRMC studies, standalone performance, training set) cannot be extracted from this document.
The document states that there are "no significant differences" between the proposed device and the identified predicates. The substantial equivalence is based on attributes like indications for use, environments of use, patient population, contraindications, technology, material (with a noted difference in cuff material), sizes, and sterility.
Here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present specific acceptance criteria in terms of quantitative performance metrics for the device, nor does it report performance against such criteria. Instead, it relies on the concept of substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if the device is found to be substantially equivalent to devices already on the market.
| Attribute/Criterion | Vitaid ET Tubes Description/Performance | Predicate Devices Description | Commentary on Equivalence |
|---|---|---|---|
| Indications for Use | Designed for oral/nasal intubation, indicated for airway management. Has an ultra-thin inflatable cuff. | Same | Substantially Equivalent |
| Environments of Use | Institutional (Hospital, Sub-acute), Pre-hospital (emergency services) | Same | Substantially Equivalent |
| Patient Population | Patients requiring intubation | Same | Substantially Equivalent |
| Contraindications | Use in procedures involving laser beams or electrosurgical active electrodes in the immediate area due to combustion risk. | Same | Substantially Equivalent |
| Technology | Endotracheal Tube | Endotracheal Tube | Substantially Equivalent |
| Material | Tube - PVC, Cuff - Polyurethane | Tube - PVC, Cuff - PVC | Difference noted (cuff material), but deemed not significant for equivalence. |
| Sizes | 3.0 mm to 10.0 mm | Yes | Substantially Equivalent |
| Configuration | Cuffed and uncuffed, pre-formed with and without Murphy eye | Yes | Substantially Equivalent |
| Sterility | Supplied Sterile | Yes | Substantially Equivalent |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a submission for a physical medical device (endotracheal tube) based on substantial equivalence to existing predicate devices, not a study involving a test set of data for an algorithm or software. No data provenance is mentioned as it's not a data-driven study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No "ground truth" was established in the context of an algorithmic performance study. The evaluation is based on comparison of physical device attributes and intended use.
4. Adjudication Method for the Test Set
Not applicable. There was no test set or human adjudication process as part of an algorithmic performance study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/software device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/software device.
7. The type of ground truth used
Not applicable. The concept of "ground truth" as typically applied in AI/software performance studies is not relevant here. The "truth" for this submission is based on engineering specifications, material properties, and intended use comparison to legally marketed predicate devices.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is not an algorithm or AI.
9. How the ground truth for the training set was established
Not applicable.
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Premarket Notification 510(k) Section 3 - Certifications and Summaries - Revised 20-June-05 Vitaid ET Tubes
Summary of Safety and Effectiveness 3.1
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 20-June-05
| 300 International Dr.Suite 100Williamsville, NY 14221 | Tel: | (716) 626-3428 |
|---|---|---|
| Fax: | (800) 655-5304 | |
| Official Contact: | Will Stewart, President | |
| Proprietary or Trade Name: | Vitaid ET tubes | |
| Common/Usual Name: | Endotracheal tubes | |
| Classification Name: | Tracheal Tubes with and without connectors | |
| Predicate Devices: | Unomedical -- Standard ET Tubes K951696Unomedical -- Pediatric ET Tubes K951967Sheridan -- K822982 -- Sheridan CFMallinckrodt -- K852025 -- Brandt Hi-contour |
Device Description:
The Vitaid endotracheal tubes are available in sizes 3.0 mm in increments of 0.5 mm. They are available cuffed, uncuffed and with Murphy eye. Some are pre-formed, they are made with a ultra thin urethane cuff, referred to as the MicroCuff.
Indications:
Vitaid Ltd.
| Indications for Use -- | The Vitaid ET Tubes are designed for oral I nasalintubation and are indicated for airway management. The VitaidET tubes have an ultra thin inflatable cuff. |
|---|---|
| Patient Population -- | Patients requiring intubation |
| Environment of Use -- | Institutional -- Hospitals. Sub-acutePre-hospital - emergency services |
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Non-Confidential Summary of Safety and Effectiveness
Page 2 of 2
20-June-05
Comparison to Predicate Devices:
| Vitaid ET Tubes | Predicates | |
|---|---|---|
| Attributes | ||
| Indications for use | The Vitaid ET Tubes are designed for oral /nasal intubation and are indicated for airwaymanagement. | Unomedical - K951696 -Standard ET TubesUnomedical - K951967 -Pediatric ET TubesSheridan - K822982 -Sheridan CFMallinckrodt - K852025 -Brandt Hi-contour |
| Environments of use | Institutional - Hospital, Sub-acutePre-hospital - emergency services | Same |
| Patient Population | Patients requiring intubation | Same |
| Contraindications | Use of endotracheal tubes in procedures whichinvolve the use of laser beams orelectrosurgical active electrodes in theimmediate area of the device is contraindicated.Contact of the endotracheal tub with a laserbeam or electrosurgical active electrodeespecially in the presence of oxygen-enrichedmixtures could result in rapid combustion ofthe endotracheal tube with harmful thermaleffects and with emission of corrosive andtoxic products including hydrochloric acid(HCl). | Same |
| Technology | ||
| Material | Tube - PVCCuff - Polyurethane | Tube - PVCCuff -- PVC |
| Sizes - 3.0 mm to10.0 mm | Yes | Yes |
| Cuffed and uncuffed.pre-formed with andwithout Murphy eye | Yes | Yes |
| Supplied Sterile | Yes | Yes |
Differences Between Other Legally Marketed Predicate Devices
There are no significant differences between the proposed device. Vitaid ET Tubes, and the identified predicates.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
JUN 3 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Viataid, Ltd. C/o Mr. Paul E. Dryden ProMedic Incorporated Regulatory Consultant for Vitaid Ltd. 6329 W. Waterview Court McCordsville, Indiana 46055-9501
Re: K050803
Trade/Device Name: Vitaid ET Tubes Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal tube Regulatory Class: II Product Code: BTR Dated: June 22, 2005 Received: June 23, 2005
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2- Mr. Paul E. Dryden
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page I of I
Indications for Use - Revised 3.3
(To be assigned) 510(k) Number: K050803 Vitaid ET Tubes Device Name: The Vitaid ET Tubes are designed for oral / nasal Indications for Use: intubation and are indicated for airway management. The Vitaid ET tubes have an ultra thin inflatable cuff.
Prescription Use XX (Per CFR 801.109)
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Over-the-counter use __
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cuxnduen
(Division Sign-Off)
Division of Anesthesiology, General Hospital. Infection Control, Deni 510(k) Number:
Page 3.3
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§ 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).