The Rusch TracFlex Plus Pediatric Tracheostomy Tube Set is a sterile, single patient use tracheotomy tube, available in sizes 3-6mm in 1 mm increments, with accessories which may be included in a set or sold separately. The device is used to provide an artificial airway. The device is introduced into a tracheotomy incision in the patient's neck that provides access to the trachea. The TracFlex Plus Pediatric tracheostomy tube is made from Polyvinyl chloride (PVC) resin that is formulated without DEHP ("Non-DEHP" = < 0.1% DEHP w/w), and is stainless steel spiral armored. It is available cuffed and uncuffed. Accessories included in the set are a disposable inner cannula, obturator, shower cap, cough cap and sealing cap. The tracheostomy tube is secured using the flange that is connected to the neck strap.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Rusch TracFlex Plus Pediatric Tracheostomy Tube Set." This submission aims to demonstrate substantial equivalence to existing predicate devices, rather than establishing de novo acceptance criteria for a new type of device. Therefore, the document primarily focuses on comparison to established standards and the predicate device's performance, rather than defining novel performance targets for the AI.

However, based on the non-clinical comparative performance testing conducted to demonstrate substantial equivalence, we can infer some "acceptance criteria" through the lens of meeting established ISO standards or demonstrating comparable performance to the predicate device.

Here's an analysis structured around your request:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are primarily met by adhering to relevant ISO standards and demonstrating performance comparable to the predicate devices. The study performed is a non-clinical comparative performance testing to establish substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance:

Test	Standard (if applicable)	Acceptance Criteria (Implied by standard/comparison)	Reported Device Performance (Implied from "meets intended use")
Connector bonding strength	ISO 5366-3	The connector must remain securely attached under specified axial separation force.	Device met the requirements of ISO 5366-3 for connector bonding strength.
Flange (neck-plate) bonding strength	ISO 5366-3	The neck-plate must remain securely attached under specified axial separation force.	Device met the requirements of ISO 5366-3 for flange bonding strength.
Cuff resting diameter	ISO 5366-3	The cuff resting diameter must be within specified limits when inflated to a reference pressure.	Device met the requirements of ISO 5366-3 for cuff resting diameter.
Tube collapse	ISO 5366	The airway lumen must remain patent with the cuff inflated (steel ball pass through).	The tube maintained patency as per ISO 5366.
Cuff herniation	ISO 5366	The cuff must not herniate excessively beyond the bevel, which could occlude the orifice.	The device demonstrated acceptable cuff herniation as per ISO 5366.
Cuff Burst Evaluation	N/A	The cuff must not burst or rupture when inflated inside the trachea.	The cuff demonstrated adequate burst strength.
Cuff Bond Strength	N/A	The cuff must remain securely bonded to the tube.	The cuff demonstrated satisfactory bond strength.
Side arm bonding strength	N/A	The inflation line connection to the tracheostomy tube must have sufficient retention force.	The side arm demonstrated adequate bonding strength.
Ink adhesion test	N/A	Printing must remain legible after aging, sterilization, and wiping with solvent.	The ink adhesion was satisfactory, maintaining legibility.
Biocompatibility (Materials)	ISO 10993-1	All patient-contacting materials must be biocompatible.	Materials complied with ISO 10993-1 (cytotoxicity, sensitization, etc.).

Note: The document explicitly states "Performance test results demonstrate that the proposed device meets its intended use." This implies that all tested parameters met the specified criteria or acceptable ranges defined by the standards or internal protocols.

Detailed Study Information:

Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (number of devices/components) used for each non-clinical test. It only lists the tests performed.
- Data Provenance: The data is generated from non-clinical laboratory testing of the new "Rusch TracFlex Plus Pediatric Tracheostomy Tube Set." The country of origin for the testing is not explicitly stated but implied to be under the purview of Teleflex Medical, Inc. (USA-based applicant). The testing is prospective in the sense that the new device was tested in a controlled laboratory environment.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This section is not applicable as this is a non-clinical device performance study, not an AI or diagnostic device study that requires human "ground truth" establishment by experts. The "ground truth" for these tests is defined by the objective pass/fail criteria of the ISO standards or internal test protocols.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is a non-clinical study. Adjudication methods like 2+1 or 3+1 are used in clinical trials or diagnostic studies to resolve discrepancies among human readers/annotators in establishing ground truth, which is not relevant here.
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:
- Not applicable. This document describes a traditional medical device (tracheostomy tube) and its non-clinical testing. It does not involve AI or human readers, therefore no MRMC study was conducted.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this non-clinical performance study, the "ground truth" is defined by:
  - Standardized Test Methods and Specifications: Primarily adherence to ISO 5366 and ISO 10993-1. These standards set objective, measurable criteria for device performance and safety.
  - Engineering Specifications: Internal design and manufacturing specifications for parameters not covered by ISO standards (e.g., Cuff Burst, Cuff/Side Arm Bond Strength, Ink Adhesion).
The sample size for the training set:
- Not applicable. This refers to a physical medical device, not an AI model requiring a training set.
How the ground truth for the training set was established:
- Not applicable. As above, there is no AI model or training set involved.

Summary

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K133173

Name, Address, Phone and Fax Number of Applicant

MAY 2 3 2014

Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-4908 919-433-4996 Fax:

Contact Person

Lori Pfohl Regulatory Affairs Specialist

Device Name

Trade Name: Rusch TracFlex Plus Pediatric Tracheostomy Tube Set

Common Name: Tracheostomy Tube

Classification Name: Tube Tracheostomy and tube cuff (Class II per 21 CFR 868.5800, Product Code JOH)

Predicate Devices

K023918 - Rusch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless K122235 - Rusch TracFlex Plus Tracheostomy Tube Set (Reference)

Device Description and Changes to Predicate

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The Rusch TracFlex Plus Pediatric Tracheostomy Tube Set is used in airway management of tracheostomized patients

Patient Population: Pediatric Patients

Environment of use: Home, Hospital and Sub-acute Institutions

Contraindications

Insurmountable intubation obstruction

For patients during radiation therapy and magnetic resonance imaging

Substantial Equivalence Comparison to Predicates

Features	Proposed TracFlex PlusPediatric	Predicate Crystal ClearK023918	Predicate (for reference)TracFlex PlusK122235
Device	Rusch TracFlex PlusPediatric TracheostomySet	Rusch Crystal ClearTracheostomy Sets, Cuffedand Cuffless	Rusch TracFlex PlusTracheostomy Tube Set
Indications for use	The Rusch TracFlex PlusPediatric TracheostomyTube Set is used in airwaymanagement oftracheostomized patients	The Rusch Crystal ClearTracheostomy Sets, Cuffedand Cuffless are intendedfor airway management oftracheostomized patients.	The Rusch TracFlex Plustracheostomy tube set isused in airwaymanagement oftracheostomized patients
Environment of Use	Home, Hospital and Sub-acute Institutions	Same	Same
Patient Population	Pediatric	Pediatric and adult	Adult
FDA Product Code	JOH 868.5800	Same	Same
Contraindications	Insurmountable intubationobstructionFor patients duringradiation therapy andmagnetic resonanceimaging	None	Same
Sizes	3-6	3.5 - 10.5 mm	7 to 11 mm
Fenestrated	No	Yes and No	No
Cuff (if present)	Low Pressure	Same	Same
Available in sets	Yes	Yes	Yes
Low pressure cuff	Spring return luer	same	Same

The proposed device is substantially equivalent to the predicate device:

Teleflex Medical

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inflation system	operated valve
Radiopaque	Yes	Yes
Stainless steel spiralreinforced tube	Yes	Yes
Method ofSterilization	Ethylene Oxide	Same
Packaging Material	Thermoformed tray withTyvek Lid	Same
Inner cannula	Disposable	same
Materials in patientcontact	PVC and Silicone	same
15 mm connectorcompliant to ISO5356-1	Yes	Same
Manufactured withDEHP (Non-DEHP)	No	Yes

Indications for Use The indications for use are identical for the proposed device when . compared to the predicate - K023918. Each device is indicated for use in airway management of tracheostomized patients.
. Technology and construction - The design, fabrication, shape, size, etc. are equivalent to the predicate - K023918. This design includes the disposable inner cannula, obturator, shower cap, cough cap and sealing cap. They are available in sizes from 3.0 to 6.0mm OD.
Environment of use The environments of use are identical to predicate K023918 .
. Patient Population -The patient population is identical to the predicate - K023918
Materials -All patient contacting materials are in compliance with ISO 10993-1. Testing ● included cytotoxicity, sensitization, intracutaneous activity, genotoxicity and implantation testing.

Comparison to Predicate Device:

The proposed TracFlex Plus Pediatric tracheostomy tubes are substantially equivalent to the predicate devices with respect to indications for use, technology and construction. The differences between the predicate and the proposed devices are minor and any risks have been mitigated through testing. The proposed device is designed with different materials than the main predicate, but essentially identical materials to the reference predicate. The proposed device is Non-DEHP.

Non-clinical Comparative Performance Testing

Teleflex Medical

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A brief summary of tests relied upon to demonstrate substantial equivalence to the predicate can be found in the table below:

Test	Reference toStandard (ifapplicable)	Principle of Test
Connectorbonding strength	ISO 5366-3	The security of the attachment of the connector to thetracheostomy tube is tested by applying an axial separationforce to the connector
Flange (neck-plate) bondingstrength	ISO 5366-3	The security of the attachment of the neck-plate to thetracheostomy tube is tested by applying an axial separationforce to the neck-plate (flange)
Cuff restingdiameter	ISO 5366-3	The resting diameter of the cuff is measured when the cuffis inflated to a reference pressure which is intended toremove creases but minimize stretching of its walls
Tube collapse	ISO 5366	The patency of the tracheostomy tube airway lumen istested by passing a steel ball through the tracheostomytube lumen with the cuff inflated within a transparent tube
Cuff herniation	ISO 5366	The tendency of the cuff to herniate beyond the planeperpendicular to the long axis of the tube at the nearestedge of the bevel is tested by applying an axial force withthe cuff inflated within a transparent tube. A cuff whichprotrudes excessively at its patient end may partially orcompletely occlude the orifice at the patient end
Cuff BurstEvaluation	N/A	The cuff restrained burst test is designed to ensure the cuffwill not burst or rupture when inflated inside the trachea
Cuff BondStrength	N/A	To evaluate the strength needed to separate the cuff fromthe tube
Side armbonding strength	N/A	To evaluate the retention force of the inflation lineconnection to the Tracheostomy tube
Ink adhesion test	N/A	To ensure the printing remains legible after the aging andsterilization processes and being wiped with a solvent

Substantial Equivalence Conclusion

The Rusch TracFlex Plus Pediatric has the same indications for use, patient population and technology of construction as the predicate device. Performance test results demonstrate that the proposed device meets its intended use. It is for these reasons that the devices can be found substantially equivalent.

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

May 23, 2014

Teleflex Medical, Incorporated Lori Pfohl Senior Regulatory Affairs Specialist 2917 Week Drive Research Triangle Park, NC 27709

Re: K133173

Trade/Device Name: Rusch TracFlex Plus Pediatric Tracheostomy Tube Set Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy tube and tube cuff. Regulatory Class: Class II Product Code: JOH Dated: April 24, 2014 Received: April 25, 2014

Dear Ms. Pfohl:

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.

: .

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Page 2 - Lori Pfohl

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/default.hum 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours.

Teiashri P

Erin 1. Keith. M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K133173

Device Name Rusch TracFlex Plus Pediatric Tracheostomy Tube Set

Indications for Use (Describe)

The Rusch TracFlex Plus Pediatric Tracheostomy Tube Set is used in airway management of tracheostomized patients.

Patient Population: Pediatric Patients per below:

Pediatric Subgroup	Approximate Age Range
Neonate/Newborn	Birth to 28 days
Infant	29 days to < 2 years
Child	2 years to <12 years
Adolescent	12 years to <18 years
Transitional Adolescent A	18 years to <21 years

Environment of use: Home, Hospital and Sub-acute Institutions

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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.