(618 days)
Not Found
No
The summary describes a physical medical device (tracheostomy tube) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as providing an effective airway for breathing and/or ventilation for a tracheostomy patient, which directly addresses a medical condition or ailment, qualifying it as therapeutic.
No
Explanation: The device is a tracheostomy tube designed to provide an airway for breathing and ventilation. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition. Its purpose is therapeutic/supportive.
No
The device description clearly describes a physical medical device (tracheostomy tubes) made of materials like soft inner and outer cannulas and a soft flange. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide an airway for breathing and/or ventilation in a tracheostomy patient. This is a direct intervention on the patient's body for a physiological function.
- Device Description: The description details a physical tube designed to be inserted into the trachea.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device does not interact with specimens in this way.
The device described is a medical device used for respiratory support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Disposable Cannula Tracheostomy Tubes are designed to provide an adult tracheostomy patient with an effective airway for breathing and/or ventilation.
Product codes
73 JOH
Device Description
The PneumoCare Disposable Cannula Tracheostomy Tube is constructed of a soft inner and outer cannula and incorporates a soft flange which is attached to the outer cannula. The tracheostomy tubes are available in both the fenestrated and standard configuration. Both configurations are available in 6.0. 7.0. 8.0 and 9.0mm sizes, where the size of the tube is determined by the inner diameter of the inner cannula. The tracheostomy tubes incorporate a swivel connection and a rotating angled elbow. The features allow for increased chin movement and patient comfort.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway (tracheostomy)
Indicated Patient Age Range
adult
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)
Not Found
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
SECTION 13: SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
SUBMITTER INFORMATION 13.1
| a. | Company Name: | PneumoCare, Inc. |
|---|---|---|
| b. | Company Address: | P.O. Box 7811 |
| Laguna Niguel, CA 92607-7811 | ||
| c. | Company Phone: | (714) 643-2306 |
| d. | Contact Person: | Joseph Bales |
| President | ||
| e. | Date Summary Prepared: | January 10, 1997 |
13.2. DEVICE IDENTIFICATION
| a. | Trade/Proprietary Name: | Disposable Cannula Tracheostomy Tube
Disposable Cannula Fenestrated Tracheostomy Tub- |
|----|-------------------------|------------------------------------------------------------------------------------------|
| b. | Classification Name: | Tracheostomy Tube and Tube Cuff |
13.3 IDENTIFICATION OF PREDICATE DEVICE
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Mallinckrodt | Disposable Cannula | ||
| Trach Tubes | K811447 | June 26, 1981 | |
| Concord Portex | D.I.C. Tracheostomy | ||
| Tubes | K903730 | September 25,1990 |
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13.4 DEVICE DESCRIPTION
The PneumoCare Disposable Cannula Tracheostomy Tube is constructed of a soft inner and outer cannula and incorporates a soft flange which is attached to the outer cannula. The tracheostomy tubes are available in both the fenestrated and standard configuration. Both configurations are available in 6.0. 7.0. 8.0 and 9.0mm sizes, where the size of the tube is determined by the inner diameter of the inner cannula. The tracheostomy tubes incorporate a swivel connection and a rotating angled elbow. The features allow for increased chin movement and patient comfort.
SUBSTANTIAL EQUIVALENCE 13.2
The PneumoCare Disposable Tracheostomy Tube is substantially equivalent to other tracheostomy tubes currently in commercial distribution by Mallinckrodt and Concord Portex in terms of the intended use of achieving a safe and effective airway for breathing or ventilation in adult tracheostomy patients.
The fundamental technical characteristics are similar to those of the predicate devices and are listed on the comparison chart provided in this 510(k) submission.
13.6 INTENDED USE
The PneumoCare Disposable Cannula Tracheostomy Tubes are designed to provide adult tracheostomy patients with an effective airway for breathing or ventilation.
2
TECHNOLOGICAL CHARACTERISTICS 13.7
A comparison of the technological characteristics of the predicate and legally marketed devices is provided in this submission.
510(K) CHECKLIST 13.8
..
This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, composed of three curved lines that suggest the profile of a human face. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 1998
Mr. Joseph H. Bales PneumoCare Inc. P.O. Box 7811 Laquna Niguel, CA 92607-7811
K970811 Re: Disposable Cannula Tracheostomy Tubes Regulatory Class: II (two) Product Code: 73 JOH Dated: November 4, 1998 Received: November 9, 1998
Dear Mr. Bales:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Joseph H. Bales
This letter will allow you to beqin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE (Separate Page) SECTION 7:
| 510(k) Number: | To Be Assigned By FDA |
|---|---|
| Device Name: | PneumoCare Disposable Cannula Tracheostomy Tube |
| Indications For Use: | The Disposable Cannula Tracheostomy Tubes are designed |
| to provide an adult tracheostomy patient with an effective | |
| airway for breathing and/or ventilation. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark Kraine
(Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Devices K970611 510(k) Number_
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)