Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI or ML.

Therapeutic

No.
The device's intended use is to allow airflow for speaking, which is a functional rather than therapeutic purpose. Its description focuses on facilitating speech.

Diagnostic

No
The device description and intended use clearly state its purpose is to facilitate speech by allowing airflow over vocal cords, not to diagnose any condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it consists of a "plastic housing with a captured ball," indicating it is a physical hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "allow airflow over the vocal cords for speaking function." This is a direct therapeutic and functional purpose related to breathing and speech, not the diagnosis of a disease or condition using in vitro methods.
Device Description: The description details a mechanical valve that facilitates airflow. It does not involve the analysis of biological samples (blood, urine, tissue, etc.) which is characteristic of IVDs.
Lack of IVD Indicators: There is no mention of analyzing samples, detecting biomarkers, or any other activity typically associated with in vitro diagnostics.

IVDs are devices used to examine specimens taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

To allow airflow over the vocal cords for speaking function. To be used with a standard 15 mm connection on tracheostomy tubes.

Product codes

JOH

Device Description

The Shikani speaking valve consists of a plastic housing with a captured ball that acts as a check valve. Once attached to the tracheostomy tube connector the speaking valve allows the patient to inhale through the tracheostomy tube and exhale across the vocal cords which facilitates speech or phonation.

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

Home, Hospital, Sub-acute Institutions

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

Performance testing which was used in the original submission K982128 was:

Resistance to flow comparison to predicates demonstrated that the values were equivalent
Weight comparison to predicates demonstrated that the values were equivalent.
Biocompatibility according to ISO 10993 was performed and the materials passed.
The proposed device meeting and passed all the performance testing as outlined above and thus demonstrated substantial equivalence.

Key Metrics

Not Found

Predicate Device(s)

K982128

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

K100995

Premarket Notification 510(k) Section 5 - 510(k) Summary

Shikani Medical

| | 510(k) Summary
Page 1 of 3
7-Apr-10 | |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Shikani Medical LLC
689 Pyle Road
Forest Hill, MD 21050 | Tel - 410-638-1066
Fax - 410-638-1413 | JUN 2 5 2010 |
| Official Contact: | Fred DeBaugh - Partner | |
| Proprietary or Trade Name: | Shikani speaking valve | |
| Common/Usual Name: | Speaking valve | |
| Classification Name: | Tube tracheostomy and tube cuff
JOH - 21 CFR 868.5800 | |
| Predicate Devices: | Pilling Weck (Teleflex) - Shikani-French speaking valve
K982128 | |
| | | |
| 510(k) Summary
Page 2 of 3
7-Apr-10 | | |
| Features | Predicate
K982128
Shikani-French | Proposed
Shikani speaking valve
(Shikani-French 15) |
| Intended use | To allow airflow over the vocal cords for
speaking function | To allow airflow over the vocal cords for speaking function |
| Comment | The intended use is identical as the devices are the same | |
| Indications for use | To allow airflow over the vocal cords for
speaking function. To be used only as an
attachment to CL Jackson improved trachea
tubes | To allow airflow over the vocal cords for speaking function. To be used with
a standard 15 mm connection on tracheostomy tubes |
| Comment | The indications for use are identical with exception that K982128 was for the model which was only to be attached to the CL
Jackson tracheostomy tube. Teleflex later introduced another model for use with standard tracheostomy tubes with 15 mm
connections. This model was considered a line extension and not requiring a modification to the existing 510(k). | |
| | As the proposed Shikani speaking valve is the same as the Shikani-French 15 speaking valve, the indications for use are
identical. | |
| Environment of Use | Hospital, Sub-acute Institutions, Home | Hospital, Sub-acute Institutions, Home |
| Comment | Identical | Identical |
| Patient Population | Tracheostomy patients | Tracheostomy patients |
| Comment | K982128 did not specify patient population, | but we intend for the patient population to be the same. |
| Contraindications | Not for use in-line with a ventilator | Not for use with an inflated tracheostomy tube cuff

Not for use with an unconscious patient

Not for use with patients without the ability to exhale air around the
tracheostomy tube and cuff and through the upper airway. |
| Comment | | Teleflex did not include contraindications in K982128, but a review of other speaking valves suggests that the proposed
contraindications would be appropriate to add to our labeling.

Device Description

The Shikani speaking valve consists of a plastic housing with a captured ball that acts as a check valve. Once attached to the tracheostomy tube connector the speaking valve allows the patient to inhale through the tracheostomy tube and exhale across the vocal cords which facilitates speech or phonation.

Indications for Use

To allow airflow over the vocal cords for speaking function. To be used with a standard 15 mm connection on tracheostomy tubes.

Environment of Use

Home, Hospital, Sub-acute Institutions

Performance Testing

Performance testing which was used in the original submission K982128 was:

Resistance to flow comparison to predicates demonstrated that the values were . equivalent
Weight comparison to predicates demonstrated that the values were equivalent .
Biocompatibility according to ISO 10993 was performed and the materials passed .

The proposed device meeting and passed all the performance testing as outlined above and thus demonstrated substantial equivalence.

1

Premarket Notification 510(

Shikani Medica

2

Premarket Notification 5100
Section 5 – 510(k) Summary

Differences between Other Legally Marketed Predicate Device

There are no differences between the proposed device and the predicate device as they are the same device

3

Premarket Notification 510(k)

Section 9 – Declarations of Conformity and Summary Reports

Form Approved: OMB No 0910-0120; Expiration Date: 5/31/10

Department of Health and Human Services
Food and Drug Administration

STANDARDS DATA REPORT FOR 510(k)s
(To be filled in by applicant)

This report and the Summary Report Table are to be completed by the applicant when submitting a 510(k) that refer-
ences a national or international standard. A separate report is required for each standard referenced in the 510(k).

TYPE OF 510(K) SUBMISSION

☑ Traditional	☐ Special	☐ Abbreviated
-----------------------------------------------------------	-------------------------------------------------------	-----------------------------------------------------------

STANDARD TITLE	ISO 5356-1:2004. Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets.
----------------	---------------------------------------------------------------------------------------------------------

Please answer the following questions

Is this standard recognized by FDA?	☑ Yes ☐ No
FDA Recognition number	# 1-62
Was a third party laboratory responsible for testing conformity of the device to this standard identified in the 510(k)?	☐ Yes ☑ No
Is a summary report describing the extent of conformance of the standard used included in the 510(k)?
If no, complete a summary report table.	☑ Yes ☐ No
Does the test data for this device demonstrate conformity to the requirements of this standard as it pertains to this device?	☑ Yes ☐ No
Does this standard include acceptance criteria?
If no, include the results of testing in the 510(k).	☑ Yes ☐ No
Does this standard include more than one option or selection of tests?
If yes, report options selected in the summary report table.	☐ Yes ☑ No
Were there any deviations or adaptations made in the use of the standard?
If yes, were deviations in accordance with the FDA supplemental information sheet (SIS)?	☐ Yes ☑ No
Were deviations or adaptations made beyond what is specified in the FDA SIS?
If yes, report these deviations or adaptations in the summary report table.	☐ Yes ☑ No
Were there any exclusions from the standard?
If yes, report these exclusions in the summary report table.	☐ Yes ☑ No
Is there an FDA guidance that is associated with this standard?
If yes, was the guidance document followed in preparation of this 510(k)?	☐ Yes ☑ No
Title of guidance:

1 The formatting convention for the title is: [SDC] [numeric identifier
of standard] [date of publication]

2 Authority [21 U.S.C. 360d], www.fda.gov/cdrh/standards/stdsprog.html

3 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/
search.cfm

4 The summary report should include: any adaptations used to adapt
to the device under review (for example, alternative test methods);
choices made when options or a selection of method or attribute,
deviations from the standard; requirements not applicable to the
device; and the name and address of the test laboratory or

certification body involved in conformance assessment to this
standard. The summary report includes information on all standards
utilized during the development of the device.

5 The supplemental information sheet (SIS) is additional information
which is necessary before FDA recognizes the standard. Found at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/
search.cfm

6 The online search for CDRH Guidance Documents can be found at:
www.fda.gov/cdrh/guidance.html

FORM FDA 3654 (9/07) Page 1

4

Premarket Notification 510(k) Section 9 – Declarations of Conformity and Summary Reports

EXTENT OF STANDARD CONFORMANCE
SUMMARY REPORT TABLE

STANDARD TITLE
----------------	--

CONFORMANCE WITH STANDARD SECTIONS*
SECTION NUMBER	SECTION TITLE	CONFORMANCE?
	TYPE OF DEVIATION OR OPTION SELECTED*	✓ Yes ☐ No ☐ N/A
Conformance was not tested as the device is unchanged, but this standard is referenced.
DESCRIPTION
JUSTIFICATION

SECTION NUMBER	SECTION TITLE	CONFORMANCE?
	TYPE OF DEVIATION OR OPTION SELECTED*	☐ Yes ☐ No ☐ N/A
DESCRIPTION
JUSTIFICATION

SECTION NUMBER	SECTION TITLE	CONFORMANCE?
	TYPE OF DEVIATION OR OPTION SELECTED*	☐ Yes ☐ No ☐ N/A
DESCRIPTION
JUSTIFICATION

For completeness list all sections of the standard and indicate whether conformance is met. If a section is not applicable (N/A)
an explanation is needed under "justification." Some standards include options, so similar to deviations, the option chosen needs
to be described and adequately justified as appropriate for the subject device. Explanation of all deviations or description of
options selected when following a standard is required under "type of deviation or option selected," "description" and "justifica-
tion" on the report. More than one page may be necessary.
Types of deviations can include an exclusion of a section in the standard, a deviation brought out by the FDA supplemental
information sheet (SIS), a deviation to adapt the standard to the device, or any adaptation of a section.

Paperwork Reduction Act Statement

Public reporting burden for this collection of information is estimated to average 1 hour per response, including the
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to:

Center for Devices and Radiological Health
1350 Piccard Drive
Rockville, MD 20850

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number.

FORM FDA 3654 (9/07)
Page 2

FORM FDA 3654 (9/07)

.

Page 2

5

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 2 5 2010

Shikani Medical, LLC C/O Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134

Re: K100995

Trade/Device Name: Shikani Speaking Valve Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: April 7, 2010 Received: April 9, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

6

Page 2- Mr. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Cintan On

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

7

Indications for Use Statement

Page 1 of 1

510(k) Number:

KI00995 (To be assigned)

Shikani speaking valve Device Name:

Indications for Use:

To allow airflow over the vocal cords for speaking function. To be used with a standard 15 mm connection on tracheostomy tubes.

Prescription Use XX or (Part 21 CFR 801 Subpart D)

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schuttman

(Division Sign-Üff) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K100993 510(k) Number: