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 manufacturer, Portex, Inc., submitted a 510(k) premarket notification (K031057) for their PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula. The submission includes a summary of nonclinical and clinical tests that support the device's substantial equivalence to predicate devices and its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety: No trauma associated with tube insertion.	The clinical user evaluation found "no trauma or difficulty associated with insertion of the tube featuring the modified bevel and using the angled obturator."
Effectiveness (Occlusion): Reduction in the incidence of tracheostomy tube occlusion.	The clinical user evaluation concluded that "the reduction in the incidence of occlusion of the tracheostomy tube with the proposed device was statistically highly significant." It was also concluded that the proposed device is "at least equivalent to the current device in these respects."
Equivalence (Insertion Technique): No difficulty associated with tube insertion using the modified bevel and angled obturator.	The clinical user evaluation found "no trauma or difficulty associated with insertion of the tube featuring the modified bevel and using the angled obturator." This supported the conclusion that the proposed device is equivalent to the predicate device(s).
Substantial Equivalence (General): Device is substantially equivalent to predicate devices with respect to intended use, materials, and design characteristics.	A side-by-side comparison of the proposed device to three legally marketed devices (predicates) was conducted. This comparison "concluded that the proposed device is substantially equivalent to the predicate devices cited."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The clinical user evaluation involved 28 subjects in the control group and 26 subjects in the two study groups. This totals 54 subjects for the clinical test set.
Data Provenance: The study was a prospective clinical user evaluation conducted at St. John's Mercy Medical Center. The country of origin is not explicitly stated but can be inferred as the United States (given the submission to the FDA and the U.S. location of the manufacturer and study site).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). It refers to a "clinical user evaluation," which implies participation from medical professionals. The study was conducted at "St. John's Mercy Medical Center," suggesting that the evaluation was carried out by healthcare professionals at that institution who are experienced in performing tracheostomies and managing tracheostomy patients.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical user evaluation. It presents the findings as conclusions from the evaluation without detailing the consensus or disagreement resolution process.

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, an MRMC comparative effectiveness study was not conducted, nor is this device an AI-assisted device. The study was a clinical user evaluation comparing a new medical device to existing (predicate) devices, focusing on clinical outcomes directly related to the device itself, not AI interpretation or human reader performance with or without AI.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical medical device (tracheostomy kit), not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used in this study would be based on clinical observation and assessment of patient outcomes. This would include:

Clinical Assessment: Direct observation by healthcare professionals during tube insertion for "trauma or difficulty."
Patient Outcomes/Monitoring: Data collected on the "incidence of occlusion of the tracheostomy tube" over time for the study subjects.
Expert Clinical Judgement: The expertise of the clinicians performing the procedures and evaluating the patients would form the basis of the "ground truth" for success or failure regarding safety and effectiveness.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of this device. As a physical medical device, there isn't a "training set" in the sense of data used to train a machine learning model. Instead, the design and development of the device would have involved internal testing and refinement (e.g., engineering tests, bench testing, animal studies, or earlier human factors analysis) which are not detailed as a "training set" in this summary.

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set" in the context of an algorithm or machine learning for this device, the concept of establishing ground truth for a training set does not apply. The development process for the physical device would have involved standard medical device design control procedures, where design inputs are translated into design outputs, and verification/validation activities ensure the device meets its requirements. Any "ground truth" during development would stem from engineering specifications, material testing standards, and preclinical (e.g., animal, bench) study results.

Summary

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K031057

JUL 1 8 2003

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Portex, Inc.

Bourna: Drive Kerse NH-13431-1772-05-A let o63 357 3812 www.puttershall.com

K: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

510(K) SUMMARY:

PREPARATION DATE OF SUMMARY

April 2, 2003

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 DEVICES

Predicate 1: Our current PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula, K980466[K960429]. This is the main predicate device, cited for materials/biocompatibility and for most design characteristics.

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Predicate 2: Our DIC (Disposable Inner Cannula) Tracheostomy Tube, K934465[K903730]. This predicate device is cited, in conjunction with Predicate 1 above, for the tube/inner cannula shape and distal tip geometry.

Predicate 3: The Rusch 'PercuQuick® Dilatator Set', K011210. This predicate device is cited for the obturator angled tip.

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, K980466[K960429]. The device is being modified to increase the bevel and change to the anterior position, slightly modify the shape of the tube and inner cannula [increased arc of curvature, reduced length of straight portion resulting in an overall decrease in nominal length], provide an angled obturator/introducer, and add marking on the dilator stop on the guiding catheter. The Instructions for Use Physician's Clinical Guide are also revised to reflect these changes.

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SUMMARY OF NONCLINICAL AND CLINICAL TESTS

A side-by-side comparison of the proposed device to three legally marketed devices has been conducted, covering intended use, materials and design characteristics. A clinical user evaluation has been conducted at St. John's Mercy Medical Center with 28 subjects in the control group and 26 subjects in the two study groups.

CONCLUSION OF NONCLINICAL AND CLINICAL TESTS

The side-by-side comparison concluded that the proposed device is substantially equivalent to the predicate devices cited.

The clinical user evaluation concluded that the reduction in the incidence of occlusion of the tracheostomy tube with the proposed device was statistically highly significant. It was concluded that the proposed device is at least equivalent to the current device in these respects.

The evaluation also found that there was no trauma or difficulty associated with insertion of the tube featuring the modified bevel and using the angled obturator. This provided useful support of the conclusion that the proposed device is equivalent to the predicate device(s) in these respects.

CONCLUSION

The proposed device is safe and effective and is substantially equivalent to the predicate devices.

Portex, Inc.
Timothy Dalton

Timothy J. Paleott Director, Regulatory Affairs

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2003

Mr. Timothy J. Talcott Portex, Incorporated 10 Bowman Drive Keene, New Hampshire 03431

Re: K031057

Trade/Device Name: PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula Regulation Number: 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: April 2, 2003 Received: April 3, 2003

Dear Mr. Talcott:

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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

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.

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Page 2 - Mr. Timothy J. Talcott

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 (21 CFR Part 807); listing (21 CFR Part 807), labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 the labeling regulation, please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Kein Muly

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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B: INTENDED USE OF DEVICE

Page 1_of_1

510(k) Number (if known): KO3105 F

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)

Prescription Use

Over-The-Counter Use

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

510(k) Number: K031057

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.