The Rusch TracFlex Plus Tracheostomy Tube Set is a sterile, single patient use tracheotomy tube, available in sizes 7-11mm 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, in order to provide access to the patient's airway. The device is introduced into a tracheotomy incision in the patient's neck that provides access to the trachea. The TracFlex Plus 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 a medical device, the Rusch TracFlex Plus Tracheostomy Tube Set. This type of submission relies on demonstrating "substantial equivalence" to a legally marketed predicate device rather than conducting a full clinical study to prove efficacy and safety from scratch.

Therefore, the "study that proves the device meets the acceptance criteria" is primarily a non-clinical comparative performance testing study, designed to show that the new device performs equivalently to the predicate device. This is not a human clinical trial with outcomes data or a statistical analysis of diagnostic accuracy.

Here's an analysis based on your request, highlighting the differences in a 510(k) submission:

Acceptance Criteria and Reported Device Performance

The acceptance criteria in this context are established by engineering and performance standards (like ISO standards) and internal requirements to ensure the device performs comparably to the predicate and safely. The "reported device performance" indicates that the new device met these criteria.

Test	Acceptance Criteria	Reported Device Performance
Connector bonding strength	Comply with ISO 5366-1 Section 6.1: The attachment of the connector to the tracheostomy tube must withstand an axial separation force.	Met (implied by "pass/fail criteria has been met")
Flange (neck-plate) bonding strength	Comply with ISO 5366-1 Section 6.2: The attachment of the neck-plate to the tracheostomy tube must withstand an axial separation force.	Met (implied by "pass/fail criteria has been met")
Cuff resting diameter	Comply with ISO 5366-1 Section 6.4.3: Cuff diameter measured under specified inflation pressure to remove creases without excessive stretching.	Met (implied by "pass/fail criteria has been met")
Tube collapse	Comply with ISO 5361 section 4.5 (for cuff tests): Patency of the ET tube airway lumen tested by passing a steel ball through it with the cuff inflated within a transparent tube.	Met (implied by "pass/fail criteria has been met")
Cuff herniation	Comply with ISO 5361 section 4.5 (for cuff tests): Tendency of the cuff to herniate beyond a perpendicular plane at the bevel edge tested under axial force with the cuff inflated within a transparent tube, ensuring no excessive protrusion that could occlude the orifice.	Met (implied by "pass/fail criteria has been met")
Cuff Burst Evaluation	Ensure the cuff does not burst or rupture when inflated inside the trachea (no specific standard cited, likely internal specification).	Met (implied by "pass/fail criteria has been met")
Cuff Bond Strength	Evaluate the strength needed to separate the cuff from the tube (no specific standard cited, likely internal specification).	Met (implied by "pass/fail criteria has been met")
Side arm bonding strength	Evaluate the retention force of the inflation line connection to the Tracheostomy tube (no specific standard cited, likely internal specification).	Met (implied by "pass/fail criteria has been met")
Ink adhesion (Tracheostomy tube)	Ensure printing remains legible after aging, sterilization, and wiping with a solvent (no specific standard cited, likely internal specification).	Met (implied by "pass/fail criteria has been met")
DEHP testing	Comply with ISO 10993-17 and 10993-18: Determine the content of DEHP in the total device, demonstrating < 0.1% DEHP w/w ("Non-DEHP").	Met (implied by "pass/fail criteria has been met")
Dimensional evaluation (Inner cannula)	Verify the inner cannula component meets engineering drawing specifications (no specific standard cited, likely internal specification).	Met (implied by "pass/fail criteria has been met")
Dimensional evaluation (Silicone stopper ring)	Verify the silicone stopper ring component meets engineering drawing specifications (no specific standard cited, likely internal specification).	Met (implied by "pass/fail criteria has been met")
Inner Cannula tensile strength after silicone coating	Determine the tensile strength of the inner cannula after the coating process (no specific standard cited, likely internal specification).	Met (implied by "pass/fail criteria has been met")
Ink Adhesion Test (Inner cannula)	Ensure the ink adheres to the inner cannula surface (no specific standard cited, likely internal specification).	Met (implied by "pass/fail criteria has been met")
Assembly Bonding Strength	Determine the bond strength between the stopper and the inner cannula (no specific standard cited, likely internal specification).	Met (implied by "pass/fail criteria has been met")
Kinking Test	Ensure the patency of the inner cannula during use (no specific standard cited, likely internal specification).	Met (implied by "pass/fail criteria has been met")
Biocompatibility	Comply with ISO 10993-1: Demonstrate biocompatibility of materials used. Testing included cytotoxicity, sensitization, intracutaneous activity, genotoxicity, and implantation testing.	Met (implied by "pass/fail criteria has been met") and "All patient contacting materials are in compliance with ISO 10993-1."

Study Details (as applicable to a 510(k) non-clinical comparison)

Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (e.g., number of tubes, cuffs, or inner cannulas) used for each individual non-clinical performance test.
- Data Provenance: The tests are described as "Non-clinical Comparative Performance Testing," implying they were conducted in a laboratory setting by the manufacturer (Teleflex Medical) as part of their regulatory submission process. No country of origin for data generation is explicitly stated, but the applicant is from the USA. These tests are inherently prospective in nature, as they are performed specifically to support the premarket notification.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission. "Ground truth" established by human experts is typically relevant for studies involving diagnostic accuracy of an AI algorithm based on interpretation of medical images or clinical data.
- For this device, the "truth" for non-clinical tests is determined by physical measurements, material properties, and mechanical performance against established engineering specifications and international standards (like ISO). The "experts" involved would be engineers, material scientists, and quality assurance personnel conducting and interpreting the tests.
Adjudication method for the test set:
- This is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert opinions, especially in studies where subjective interpretation or consensus is required to establish a ground truth (e.g., grading lesions in a medical image). Non-clinical performance tests involve objective measurements and pass/fail criteria against predefined standards.
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 done. This type of study is specific to evaluating the impact of AI on human diagnosticians or interpreters, typically in imaging or clinical decision support. The Rusch TracFlex Plus is a physical medical device (tracheostomy tube), not an AI diagnostic tool.
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 product, not a software algorithm.
The type of ground truth used:
- For the non-clinical performance tests, the "ground truth" is defined by international standards (e.g., ISO 5366-1, ISO 5361, ISO 10993-1, ISO 10993-17, ISO 10993-18) and internal engineering specifications/drawings. These standards and specifications define the expected physical, mechanical, and biological properties of the device for safe and effective use.
The sample size for the training set:
- This is not applicable. "Training set" refers to data used to train a machine learning algorithm. This device is not an AI/ML product.
How the ground truth for the training set was established:
- This is not applicable for the same reason as above.

Summary

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Name, Address, Phone and Fax Number of Applicant

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

Contact Person

SEP 06 2013

Lori Pfohl Regulatory Affairs Specialist

Device Name

Trade Name: Rusch TracFlex Plus 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 Device

Rusch Ultra TracheoFlex Teleflex Medical, Inc - K964056

Device Description and Changes to Predicate

Indications for Use

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

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This device is intended for use on adult patients o
Intended Environment of Use –
This device is intended for use in hospital and hospital-type facilities, surgery o centers and home care environments.
The product is single patient, multi-use

Contraindications

Use of the Rusch TracFlex Plus is contraindicated in patients having abnormal upper airway or pathology and for patients during radiation therapy and magnetic resonance imaging

Substantial Equivalence Comparison to Predicates

The proposed device is substantially equivalent to the predicate device:

Features	Proposed (TracFlex Plus)	Predicate (Ultra Tracheoflex) K964056
Device	Rusch TracFlex Plus Tracheostomy Tube Set	Rusch Ultra Tracheoflex Tracheostomy Kits K964056
Indications for use	The Rusch TracFlex Plus tracheostomy tube set is used in airway management of tracheostomized patients	Tracheostomy tube kits intended for airway management in a tracheostomized patient
FDA Product Code	JOH 868.5800	Same
Environment of Use	Home, Hospital, Sub-acute Institutions	Same
Patient Population	Adult	Same
Contraindications	Use of the TrachFlex Plus Tracheostomy Set is contraindicated in patients having abnormal upper airway anatomy or pathologyFor patients during radiation therapy and magnetic resonance imaging	Use of the Rusch Ultra Tracheoflex Tracheostomy Set is contraindicated in patients having abnormal upper airway anatomy or pathology
Sizes	7 to 11 mm	6-11 mm
Fenestrated	No	Yes and No
Cuff (if present)	Low Pressure	Same
Available in sets	Yes	Yes
Pilot balloon (cuffed version)	Pressure indicating	same
Flange	Adjustable	Fixed
Low pressure cuff inflation system	Spring return luer operated valve	same
Radiopaque	Yes	Yes
Stainless steel spiral reinforced tube	Yes	Yes
Method of Sterilization	Ethylene Oxide	Same
Packaging Material	Thermoformed tray with Tyvek Lid	Same

Teleflex Medical

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Features	Proposed (TracFlex Plus)	Predicate (Ultra Tracheoflex) K964056
Inner cannula	Disposable	same
Tube Components	15 mm connectorFlangeNeck PlateIntroducer / obturatorCuffed/UncuffedPilot balloon	Same
Accessories	yes	yes
15 mm connectorcompliant to ISO5356-1	yes	yes

Indications for Use The indications for use are identical for the proposed . device when compared to the predicate - K964056. Each device is indicated for use in airway management of tracheostomized patients.
Technology and construction The design, fabrication, shape, size, etc. are o equivalent to the predicate - K964056. This design includes the disposable inner cannula, obturator, shower cap, cough cap and sealing cap. They are available in sizes from 7.0 to 11.0 mm OD.
Environment of use The environments of use are identical to predicate -. K964056
Patient Population -The patient population is equivalent to the predicate -. K964056
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 essence of this change is to add a Non-DEHP PVC version of the previously cleared PVC tracheostomy tube. This change also changes the inner cannula material from polyurethane to polyethylene. The proposed device is substantially equivalent in intended use, design, performance and principles of operation to the identified predicate devices cleared under K964056. The differences between the Rusch TracFlex Plus and the predicate device are minor and raise no new issues of safety and efficacy.

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Non-clinical Comparative Performance Testing

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 5366-1Section 6.1Machine end	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 5366-1Section 6.2.Neck-plate	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 5366-1Section 6.4.3	The resting diameter of the cuff is measured when the cuff isinflated to a reference pressure which is intended to removecreases but minimize stretching of its walls
Tube collapse	ISO 5361 section4.5 for cuff tests	The patency of the ET tube airway lumen is tested by passinga steel ball through the tracheal tube lumen with the cuffinflated within a transparent tube
Cuff herniation	ISO 5361 section4.5 for cuff tests	The tendency of the cuff to herniate beyond the planeperpendicular to the long axis of the tube at the nearest edgeof the bevel is tested by applying an axial force with the cuffinflated within a transparent tube. A cuff which protrudesexcessively at its patient end may partially or completelyocclude 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 from thetube
Side arm bondingstrength	N/A	To evaluate the retention force of the inflation line connectionto the Tracheostomy tube
Ink adhesion	N/A	To ensure the printing remains legible after the aging andsterilization processes and being wiped with a solvent
DEHP testing	ISO 10993-17and 10993-18	Extractions are performed to determine the content of DEHPin the total device
Dimensionalevaluation (Innercannula)	N/A	To verify the inner cannula component meets the engineeringdrawing
Dimensionalevaluation(Silicone stopperring)	N/A	To verify the silicone stopper ring component meets theengineering drawing
Inner Cannulatensile strengthafter siliconecoating	N/A	To determine the tensile strength of the inner cannula afterthe coating process
Ink Adhesion Test	N/A	To ensure the ink adheres to the inner cannula surface
Assembly BondingStrength	N/A	To determine the bond strength between the stopper and theinner cannula
Kinking Test	N/A	To ensure the patency of the inner cannula during use
Biocompatibility	ISO 10993-1	To demonstrate biocompatibility of the materials used.Testing included cytotoxicity, sensitization, intracutaneous

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Substantial Equivalence Conclusion

The Rusch TracFlex Plus has the same indications for use, technological characteristics and construction as its predicate. Performance test results demonstrate that the proposed device is substantially equivalent and because pass/fail criteria has been met, the devices can be found substantially equivalent.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Gib09 Silver Spring, MI) 20993-0002

September 6, 2013

Teleflex Medical. Incorporated Ms. Lori Pfohl Regulatory Affairs Specialist 2917 Weck Drive RESEARCH TRIANGLE PARK NC 27709

Re: K122235

Trade/Device Name: Rusch Tracflex Plus Tracheostomy Tube Set Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff . Regulatory Class: II Product Code: JOH Dated: August 7, 2013 Reccived: August 8, 2013

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 10 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 gencral 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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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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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/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.

Image /page/6/Picture/7 description: The image contains a logo on the left side and some text on the right side. The text reads "Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID". The text is stacked vertically, with the name at the top, followed by the title, and then the organization name. The image is of low resolution and the text is slightly blurry.

Kwame Ulmer M.S. Acting Division 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 Statement

Page 1 of 1

510(k) Number:

4122235

Device Name:

Rusch TracFlex Plus Tracheostomy Tube Set

Indications for Use:

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

Prescription Use XX (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)

Tejashri S. Purohitsheth -S
Clinical Deputy Director,
DAGRID
2013.09.06 15:44:03-04'00'

(Division Sign-Off) tsion of Anesthestology, General Hospital ..ection Control, Dental Devices

510(k) Number: K122235

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.