The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is indicated for use in providing percutaneous temporary tracheal access for airway management.

Device Description

The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is designed to permit percutaneous insertion of a specifically designed tracheostomy tube. This single cannula Percutaneous Tracheostomy Tube has a radiopaque blue line and is constructed of biocompatible polyvinylchloride material and incorporates a tapered and beveled distal tube tip to facilitate insertion through the percutaneously dilated stoma site. The tracheostomy tube has a neck flange, an integral 15 mm connector, and a cuff which deflates to a low profile on the tube for a smooth transition during insertion. The cuff inflation line has a self sealing luer valve. The tracheostomy tube is supplied with a disposable inner cannula of the appropriate size. The Percutaneous Tracheostomy Kit comes with the necessary components for percutaneous tracheostomy tube insertion into a stoma created by serial dilation.

AI/ML Overview

The provided text describes a 510(k) summary for the PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and proving performance through a detailed clinical study with performance metrics.

Based on the provided information, I can answer some of your questions and explain why others cannot be answered from this text:

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

This information is not available in the provided text. The document is a 510(k) summary, which aims to demonstrate "substantial equivalence" to a predicate device rather than setting or meeting specific performance acceptance criteria with detailed metrics like sensitivity, specificity, or inter-reader agreement. The "Conclusion" section states: "The testing performed and comparison to the predicate devices demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate devices." This implies that the device meets the safety and effectiveness standards derived from the predicate, but it doesn't quantify specific performance metrics or acceptance criteria as you would find in a clinical trial report.

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

This information is not available in the provided text. The document refers to "testing performed and comparison to the predicate devices" but does not detail any specific human subject test sets, their sample sizes, or data provenance. It's highly probable that the testing referred to was primarily bench testing and material compatibility assessments, rather than a clinical study requiring human subject data provenance.

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)

This information is not available in the provided text. Since there's no mention of a clinical test set with human data requiring ground truth establishment by experts, this detail is not relevant to the content provided.

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

This information is not available in the provided text. Again, without a clinical test set for human readers, adjudication methods are not discussed.

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

This information is not available in the provided text. The device described is a medical instrument (tracheostomy kit) and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable or expected for this type of device.

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

This information is not available and not applicable to the device described. This question typically relates to the performance of artificial intelligence algorithms. The PER-FIT™ Percutaneous Dilational Tracheostomy Kit is a physical medical device.

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

This information is not available in the provided text. As explained above, the submission claims substantial equivalence through testing and comparison to predicates, which likely involved engineering and material testing rather than clinical ground truth establishment in the traditional sense for diagnostic tools.

8. The sample size for the training set

This information is not available in the provided text. This question is typically relevant for machine learning algorithms, which is not what this device is.

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

This information is not available in the provided text and is not applicable to this device.

Summary

{0}------------------------------------------------

K980466

Image /page/0/Picture/1 description: The image shows the logo for Smiths Industries Medical Systems. The logo consists of the text "SMITHS INDUSTRIES" in bold, sans-serif font, with the words "Medical Systems" in a smaller, italicized font below. To the left of the text is a stylized graphic element, possibly representing the letters "SI".

SIMS Portex Inc.

10 Bowman Drive PO Box 0724 Keene NH 03431 USA Telephone: 603-352-3812 Fax: 603-352-3703 FEB 2 4 1998

K: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

510(K) SUMMARY:

PREPARATION DATE OF SUMMARY

February 4, 1998

TRADE NAME

PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula

COMMON NAME

Tracheostomy Tube with Disposable Inner Cannula

PRODUCT CLASS/CLASSIFICATION

Class II, 73 JOH, 21 CFR 868.5800.

PREDICATE DEVICE

Our current PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Our Current i EX-FFF - - Forstansous - e e cannula, K960429 and Cook Critical Care's Ciaglia Percutaneous Tracheostomy Introducer Set.

{1}------------------------------------------------

DESCRIPTION

INDICATIONS FOR USE

TECHNICAL CHARACTERISTICS

The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula has the same technical characteristics as is currently marketed with our existing PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula, K960429 and Cook Critical Care's Ciaglia Percutaneous Tracheostomy Introducer Set. The "Dilator Stop" of the proposed modification is the same as the "Safety Ridge" of Cook Critical Care's guiding catheter.

CONCLUSION

The testing performed and comparison to the predicate devices demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate devices.

Very truly yours,

SIMS Portex Inc.
Timothy J. Talaska

Timothy Talcott Manager, Regulatory Affairs

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 1998

Mr. Timothy J. Talcott Manager, Regulatory Affairs SIMS Portex, Inc. 10 Bowman Drive P.O. Box 0724 Keene, NH 03431

Re: K980466 PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula Regulatory Class: II (twō) Product Code: 73 JOH Dated: February 4, 1998 Received: February 6, 1998

Dear Mr. Talcott:

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 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, Druq, 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 requlations 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 requlation 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 requlations.

{3}------------------------------------------------

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" (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/dsmamain.html".

Sincerely yours,

Thomas L. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

B: INTENDED USE OF DEVICE

Page 1 of 1

510(k) Number (if known): Unknown

Device Name: PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
	M. Pazaral (Reviewer)

Prescription Use	X
OR	Over-The-Counter Use

(Division Sign Off)
Division of	Vascular Respiratory,
and	Dental Devices
510(k) Number	K980466

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.