The proposed Teleflex Medical Rusch Safety Silk Pediatric Tracheal Tube Series tracheal tubes are sterile, single use devices that are made from Polyvinyl chloride (PVC) resin that is formulated without DEHP ("Non-DEHP" = < 0.1% DEHP w/w). The tracheal tubes contain a compatible cuff, inflation line, pilot balloon and one-way valve. A radiopague line is incorporated into the full length of the tracheal tube. Each tracheal tube is supplied with an appropriately sized 15mm connector.

The oral version of the device (Super Safety Silk) will be sold in both Murphy eye and Magill styles.

The nasal version of the device (Nasal Safety Silk) will be offered in the Murphy eye style only.

AI/ML Overview

The document provided describes a 510(k) premarket notification for the Teleflex Medical Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube. It does not contain information about a study proving the device meets acceptance criteria in the context of AI/ML performance, but rather outlines performance testing for a medical device.

Therefore, many of the requested categories related to AI/ML studies are not applicable. However, I can extract the acceptance criteria and a summary of the performance studies mentioned for the medical device itself.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Cuff Bonding Leak Evaluation	No leak around the welding area	Not explicitly stated "met," but implied by "Performance test results demonstrate that the proposed device meets its intended use."
Tube Curvature Test	Must meet the product requirement of 140mm ± 20mm	Not explicitly stated "met," but implied by "Performance test results demonstrate that the proposed device meets its intended use."
Tube Collapse	The steel ball (OD = 75% of the stated ID) must pass through the lumen freely.	Not explicitly stated "met," but implied by "Performance test results demonstrate that the proposed device meets its intended use."
Cuff Resting Diameter	The cuff resting diameter shall be within ± 15% of specification for each individual size	Not explicitly stated "met," but implied by "Performance test results demonstrate that the proposed device meets its intended use."
Cuff Herniation	No abnormality or defect on the cuff (any part of the inflated cuff reaches beyond the nearest edge of the bevel will be considered as defect). No abnormality on the configuration of the cuff during deflating the cuff over a period of not less than 10s (any abnormality will be considered as defect).	Not explicitly stated "met," but implied by "Performance test results demonstrate that the proposed device meets its intended use."
Tube Compression Evaluation	Must be within the range of current data	Not explicitly stated "met," but implied by "Performance test results demonstrate that the proposed device meets its intended use."
Cuff Unrestrained Burst Evaluation	Must be within the range of current data	Not explicitly stated "met," but implied by "Performance test results demonstrate that the proposed device meets its intended use."
Cuff Restrained Burst Evaluation	Must be within the range of current data	Not explicitly stated "met," but implied by "Performance test results demonstrate that the proposed device meets its intended use."
Cuff Sealing Pressure Evaluation	Must be within the range of current data	Not explicitly stated "met," but implied by "Performance test results demonstrate that the proposed device meets its intended use."
Biocompatibility	Materials have been tested per ISO 10993	"All patient contacting materials are in compliance with ISO 10993-1. Testing included Cytotoxicity, sensitization, intracutaneous activity, implantation and genotoxicity testing, and Extractables/Leachables Testing."

Study Proving Device Meets Acceptance Criteria:

The document states, "Performance test results demonstrate that the proposed device meets its intended use." This is a general statement rather than a detailed report of specific study outcomes for each acceptance criterion. The tests conducted were primarily engineering and material characterization tests to ensure the physical and functional aspects of the tracheal tube met specifications, often by comparing them to existing "current data" or "specifications." The overall conclusion drawn is that the device is substantially equivalent to its predicates.

The following information is not present in the provided document, as it pertains to a different type of medical device assessment (AI/ML performance studies) than what is described for this tracheal tube:

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a physical medical device, not an AI/ML system.
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): Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as there is no "ground truth" in the AI/ML sense for a physical tracheal tube's performance tests. The "ground truth" for these tests would be the established engineering specifications and material properties.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger, bolder font, while "U.S. FOOD & DRUG" is in a slightly smaller font, and "ADMINISTRATION" is in an even smaller font below.

October 28, 2021

Teleflex Medical, Inc. Lori Pfohl Senior Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, North Carolina 27709

Re: K150603

Trade/Device Name: Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal tube Regulatory Class: Class II Product Code: BTR

Dear Lori Pfohl:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on November 27, 2015. Specifically, FDA is updating this SE letter due to the clearance date not appearing on the original letter.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Todd Courtney, Office of Ophthalmic, Anesthesia, Respiratory, ENT and Devices, 301-796-6371, todd.courtney@fda.hhs.gov.

Sincerely,

Todd D. Courtney -S

Todd Courtney Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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

Teleflex Medical, Inc. Lori Pfohl Senior Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, NC 27709

Re: K150603

Trade/Device Name: Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal tube Regulatory Class: Class II Product Code: BTR Dated: November 5, 2015 Received: November 6, 2015

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.

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

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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/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 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.

Sincerely yours,

Image /page/2/Picture/8 description: The image shows the FDA logo on the left side. On the right side, the text "Richard C. Chapman - S 2015.11.27 13:42:38 -05'00'" is displayed. The text appears to be a timestamp or signature related to the FDA logo.

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

for

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube

Indications for Use (Describe)

Rusch tracheal tubes are indicated for airway management by oral or nasal intubation of the trachea.

Intended Population: Pediatric

Intended Environment of Use: Locations where ET intubation may be performed

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube

Name, Address, Phone and Fax Number of Applicant

Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-491-8960 919-433-4996 Fax:

Contact Person

Lori Pfohl Senior Regulatory Affairs Specialist

Date Prepared

3/9/2015

Device Name

Trade Name: Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube

Common Name: Tracheal Tube

Classification Name: Tube, Tracheal (Class II per 21 CFR 868.5730, Product Code BTR)

Predicate Devices

Teleflex Medical's Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/Murphy - K993786

Teleflex Medical's Rusch Oral/Nasal Tracheal Tube Cuffed. Magill/Murphy - K961837

Device Description

The oral version of the device (Super Safety Silk) will be sold in both Murphy eye and Magill styles.

The nasal version of the device (Nasal Safety Silk) will be offered in the Murphy eye style only.

Teleflex Medical

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Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube

Indications for Use

Rusch tracheal tubes are indicated for airway management by oral or nasal intubation of the . trachea.
Intended Population
Pediatric patients ●
Intended Environment of Use
Locations where ET intubation may be performed. .
Contraindications

None

Substantial Equivalence

The proposed device is substantially equivalent to the predicate devices:

Features	Teleflex MedicalSafety Silk SeriesOral / NasalTracheal Tube(Proposed)	Teleflex MedicalOral / Nasal TrachealTube(Safety Clear Plus)(K993786)	TeleflexMedicalOral / NasalTracheal Tube(K961837)	Teleflex MedicalSafety Silk SeriesOral / Nasal TrachealTube(132415)
ClassificationName	Tube, Tracheal(w/wo connector)	Same	Same	Same
Product Code	73 BTR	Same	Same	Same
RegulationNumber	868.5730	Same	Same	Same
Indications forUse	Rusch tracheal tubesare indicatedfor airwaymanagement by oralor nasal intubationof the trachea	Rusch Oral / NasalTrachea Tube,Cuffed,Magill/Murphy is adevice inserted into apatient's trachea viathe nose or mouthand used to maintainan open airway.	Oral or nasalintubation andairwaymanagement	Same
Environment ofUse	Locations where ETintubation may beperformed	Not stated	Not stated	Same
PatientPopulation	Pediatric	Not stated	Not stated	Adult
Contraindications	None	Same	Same	Same
Single Use	Yes	Same	Same	Yes

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Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube
-------------------------------------------------------------

Features	Teleflex MedicalSafety Silk SeriesOral / NasalTracheal Tube(proposed)	Teleflex MedicalOral / Nasal TrachealTube(Safety Clear Plus)(K993786)	TeleflexMedicalOral / NasalTracheal Tube(K961837)	Teleflex MedicalSafety Silk SeriesOral / Nasal TrachealTube(Reference Predicate)
Size Range	3.0 mm – 4.5 mm	2.0 mm - 4.0 mm	4.5 mm - 11.0mm	5.0 mm – 10.0 mm
Cuffed	Yes	Same	Same	Same
Radiopaque	Yes	Same	Same	Same
Connection toventilation source	15 mm connector	Same	Same	Same
Method ofSterilization	Ethylene Oxide 10-6SAL	Same	Same	Same
Biocompatibility	Materials have beentested per ISO10993	Same	Same	Same
Made withoutDEHP	Yes	No	No	Yes
PackagingConfiguration	Ten (10) individualunits in a shelf box.Ten shelf boxes in ashipper	Not stated	Ten (10)individual unitsin a shelf box.	Same
Sterile	Yes	Same	Same	Same
Eye	Murphy and Magill	Same	Same	Same
Tip	Beveled	Same	Same	Same
Graduations	Multiple cmmarkings	Same	Same	Same
Shaft	PVC	Same	Same	Same
Cuff	PVC	Same	Same	Same
Pilot Balloon	PVC	Same	Same	Same
Inflation Valve	PVC	Same	Same	Same
Inflation Tube	PVC	Same	Same	Same
X-Ray Marker,Stripe	PVC with BariumSulfate	Same	Same	Same
Connector	Polyamide	Polypropylene	Polypropylene	Same

Comparison to Predicate Device:

The proposed Safety Silk series tracheal 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 essentially the similar materials as the predicate, and identical materials to the reference predicate

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Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube

Indications for Use -●

The indications for use are substantially equivalent for the proposed device when compared to the predicates. Each device is indicated for Oral or Nasal use in airway management.

● Technology and construction -

The design, fabrication, shape, size, etc. are substantially equivalent to the predicates. This design includes the disposable tracheal tube, cuff side arm assembly and 15mm connector.

● Environment of use -

While not specifically stated, the environments of use are equivalent to predicates

● Patient Population -

While not specifically stated, the patient population is equivalent to the predicate

. Materials -

All patient contacting materials are in compliance with ISO 10993-1. Testing included Cytotoxicity, sensitization, intracutaneous activity, implantation and genotoxicity testing, and Extractables/Leachables Testing.

Test	Reference toStandard (ifapplicable)	Principle of Test	Acceptance Criteria
Cuff Bonding LeakEvaluation	N/A	To perform a visual check at the weldingpoint of the cuff	No leak around the welding area
Tube CurvatureTest	ISO 5361	To measure the curvature of the tube	Must meet the product requirementof 140mm ± 20mm
Tube Collapse	ISO 5361	The patency of the ET tube airway lumenis tested by passing a steel ball throughthe tracheal tube lumen with the cuffinflated within a transparent tube	The steel ball (OD = 75% of thestated ID) must pass through thelumen freely.
Cuff RestingDiameter	ISO 5361	The resting diameter of the cuff ismeasured when the cuff is inflated to areference pressure which is intended toremove creases but minimize stretchingof its walls	The cuff resting diameter shall bewithin ± 15% of specification foreach individual size
Cuff Herniation	ISO 5361	The tendency of the cuff to herniatebeyond the plane perpendicular to thelong axis of the tube at the nearest edgeof the bevel is tested by applying an axialforce with the cuff inflated within atransparent tube. A cuff which protrudesexcessively at its patient end maypartially or completely occlude the orificeat the patient end	No abnormality or defect on the cuff(any part of the inflated cuff reachesbeyond the nearest edge of thebevel will be considered as defect).No abnormality on the configurationof the cuff during deflating the cuffover a period of not less than 10s(any abnormality will be consideredas defect).

Performance Testing

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Test	Reference toStandard (ifapplicable)	Principle of Test	Acceptance Criteria
TubeCompressionEvaluation	N/A	To measure the rigidity of the tube	Must be within the range of currentdata
Cuff UnrestrainedBurst Evaluation	N/A	To determine minimum cuff burstpressure under unrestrained conditions	Must be within the range of currentdata
Cuff RestrainedBurst Evaluation	N/A	To determine cuff burst volume underrestrained conditions to simulateconditions in the trachea	Must be within the range of currentdata
Cuff SealingPressureEvaluation	N/A	To determine the minimum cuff pressurerequired to seal the corrugated tube	Must be within the range of currentdata

Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube

The Rusch Safety Silk Pediatric Tracheal Tube Series has the same indications for use,

technological characteristics and construction as its predicates. Performance test results demonstrate that the proposed device meets its intended use. It is for these reasons that the proposed device can be found substantially equivalent.

Regulation Number and Section

§ 868.5730 Tracheal tube.

(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).