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.

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.

AI/ML Overview

Please note: The provided text is a 510(k) summary for a medical device (Shikani-French Speaking Valve) seeking market clearance based on substantial equivalence to predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study would for a novel device or AI algorithm.

The document focuses on establishing equivalence rather than presenting an independent performance study with detailed acceptance criteria and results.

Therefore, many of the requested categories for AI/algorithm-based studies (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.

Here's the information that can be extracted or deduced from the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or report specific performance metrics for the Shikani-French Speaking Valve. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices.

Acceptance Criteria Category	Reported Device Performance / Equivalence Claim
Intended Use	"To redirect exhaled air over the vocal cords to allow speech in tracheostomized patient." This matches the intended use of predicate devices.
Technological Characteristics	"The technological characteristics are the same as, or equivalent to, predicate devices by Passy Muir (K944451), Willy Rüsch (K964056), and A&M speaking valves." This is the primary "performance" claim – that its design and function are sufficiently similar to devices already on the market.
Safety and Effectiveness	Implied to be equivalent to predicate devices, as a 510(k) clearance signifies a finding of substantial equivalence in this regard.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable / Not provided. The document describes a device, not a data-driven model or algorithm that would have a "test set." The basis for equivalence is the design and function of the device compared to predicate devices, not data analysis on a specific patient population.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable / Not provided. Ground truth for a test set is not relevant for this type of device submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable / Not provided. Adjudication is not relevant in this context.

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

No. This is a hardware medical device (a speaking valve), not an AI algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable / No. This is a hardware device; there is no "algorithm only" performance to evaluate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable / No explicit ground truth. The "truth" in this context is the established safety and effectiveness of the predicate devices and the new device's demonstrable similarity to them in design, materials, and intended use. Performance is implicitly validated by comparison to these established devices.

8. The sample size for the training set

Not applicable / Not provided. This is not an AI/machine learning device that would have a training set.

9. How the ground truth for the training set was established

Not applicable / Not provided.

Summary

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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 .

A Telefiex Company

420 Delaware Drive, P.O. Box 7514 Fort Washington, Pennsylvania 19034 (215) 643-2600, Fax: (215) 646-0340

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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.

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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)

Regulation Number and Section

§ 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.