(128 days)
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, or any related concepts in the provided text.
Yes
The device is described as allowing airflow over the vocal cords for speaking, which facilitates speech. This directly addresses and improves a physiological function, making it a therapeutic device.
No
The device is a speaking valve that allows airflow to facilitate speech, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it consists of a "plastic outer body and a captured inner ball," indicating it is a physical, hardware device.
Based on the provided information, 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.
- Device Function: The Shikani-French Speaking Valve is a mechanical device that attaches to a tracheostomy tube to facilitate speech by directing airflow. It does not perform any tests on biological samples.
- Intended Use: The intended use is to "allow airflow over the vocal cords for speaking," which is a physical function, not a diagnostic test.
Therefore, this device falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Shikani-French speaking valve is intended to redirect exhaled air over the vocal cords to allow speech in tracheostomized patient.
To allow airflow over the vocal cords for speaking. To be used only as an attachment to C.L. Jackson improved trachea tubes, manufactured by Pilling Weck Surgical.
Product codes
JOH
Device Description
The Shikani-French Speaking Valve consists of a plastic outer body and a captured inner ball that forms the check valve. The assembly attaches to the C.L. Jackson Improved Stainless Steel Trachea Tube. Once in place, the valve allows the patient to inhale through the tracheostomy tube and exhale across the vocal chords which facilitates speak.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vocal cords
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Passy Muir (K944451), Willy Rüsch (K964056), and A&M speaking valves.
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.
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Image /page/0/Picture/0 description: The image shows the logo for Pilling Weck. The logo consists of a stylized "W" shape with a small diamond above it, followed by the words "Pilling Weck" in a bold, serif typeface. The logo is black and white.
OCT 2 3 1998
1982128
510 (k) Summary
- Submitter Name, Address, and Date of Submission.
Elizabeth Lazaro Pilling Weck Surgical 420 Delaware Drive Fort Washington, PA 19034 Telephone Number (800) 523-6507 Fax Number (800) 332-2308
Contact: Same as above
- Name of the Device, Common, Proprietary (if Known), and 2. Classification.
Classification Name: Tracheostomy Tube and tube cuff
Common Name: Phonation (speaking) Valve
Proprietary Name: Shikani-French Speaking Valve
3. Identification of the legally marketed device to which the submitter claims equivalence.
The Shikani-French Speaking Valve is substantially equivalent to the Passy Muir, Willy Rüsch and A&M speaking valves.
Description of the Device. 4 .
The Shikani-French Speaking Valve consists of a plastic outer body and a captured inner ball that forms the check valve. The assembly attaches to the C.L. Jackson Improved Stainless Steel Trachea Tube. Once in place, the valve allows the patient to inhale through the tracheostomy tube and exhale across the vocal chords which facilitates speak.
A Telefiex Company
420 Delaware Drive, P.O. Box 7514 Fort Washington, Pennsylvania 19034 (215) 643-2600, Fax: (215) 646-0340
1
Intended Use of the Device. 5.
The Shikani-French speaking valve is intended to redirect exhaled air over the vocal cords to allow speech in tracheostomized patient.
Summary of Technological Characteristics. 6.
The technological characteristics are the same as, or equivalent to, predicate devices by Passy Muir (K944451), Willy Rüsch (K964056), and A&M speaking valves.
2
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, arranged in a cascading manner. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
OCT 23 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Betty Lazaro Requlatory Affairs Associate Pilling Weck Surgical Surgical Division 420 Delaware Drive Fort Washington, PA 19034
K982128 Re: Shikani French Speaking Valve Requlatory Class: II (Two) Product Code: JOH Dated: October 14, 1998 Received: October 15, 1998
Dear Ms. Lazaro:
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 against 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance 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 regulatory 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 - Ms. Betty Lazaro
This letter will allow you to begin marketing your device as described in your 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 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" (21CFR 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. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K982128 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:___Shikani-French Speaking Valve
Indications for Use:
To allow airflow over the vocal cords for speaking To be used only as an attachment to CLJackson improved function. trachea tubes, manufactured by Pilling Weck Surgical.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number
Prescription Use _
OR
Over-The-Counter Use _
(Per 21 CFR
801.1
09)