SHIKANI-FRENCH SPEAKING VALVE

K982128 · Pilling Weck Surgical · JOH · Oct 23, 1998 · Anesthesiology

Device Facts

• Record ID: K982128
• Device Name: SHIKANI-FRENCH SPEAKING VALVE
• Applicant: Pilling Weck Surgical
• Product Code: JOH · Anesthesiology
• Decision Date: Oct 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 CLJackson improved function. trachea tubes, manufactured by Pilling Weck Surgical.

Device Story

Shikani-French Speaking Valve is a phonation accessory for tracheostomized patients. Device consists of plastic outer body and captured inner ball check valve. Attaches to C.L. Jackson Improved Stainless Steel Trachea Tube. Operation: allows patient to inhale through tracheostomy tube; during exhalation, ball valve closes, redirecting air across vocal cords to facilitate speech. Used in clinical or home settings by patients with tracheostomies. Benefits include restoration of speech capability.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Plastic outer body with captured inner ball check valve. Designed as an attachment for C.L. Jackson Improved Stainless Steel Trachea Tubes. Mechanical check valve principle. No electronic components or software.

Indications for Use

Indicated for tracheostomized patients requiring redirection of exhaled air over vocal cords to facilitate speech. Used exclusively as an attachment to Pilling Weck Surgical C.L. Jackson Improved Stainless Steel Trachea Tubes.

Regulatory Classification

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.

Predicate Devices

• Passy Muir (K944451)
• Willy Rüsch (K964056)
• A&M speaking valves

Submission Summary (Full Text)

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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

1. Submitter Name, Address, and Date of Submission.

Elizabeth Lazaro Pilling Weck Surgical 420 Delaware Drive Fort Washington, PA 19034 Telephone Number [phone] Fax Number [phone]

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 [phone], Fax: [phone]

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)