LMA Fastrach ETT SU

K242495 · Teleflex Medical · BTR · Apr 29, 2025 · Anesthesiology

Device Facts

Record IDK242495
Device NameLMA Fastrach ETT SU
ApplicantTeleflex Medical
Product CodeBTR · Anesthesiology
Decision DateApr 29, 2025
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 868.5730
Device ClassClass 2
AttributesTherapeutic

Intended Use

The LMA® Fastrach™ ETT Single Use is indicated for tracheal intubation through the LMA® Fastrach™. The Stabiliser Rod is indicated for use during removal of the LMA® Fastrach™ and LMA® Fastrach™ Single Use after intubation to keep the LMA® Fastrach™ ETT Single Use in place.

Device Story

LMA Fastrach ETT SU is a straight, cuffed, wire-reinforced endotracheal tube designed for use with the LMA Fastrach airway. Features include a Murphy Eye, 15mm connector, pilot balloon with luer check valve, and a soft, molded tip for atraumatic vocal cord passage. Depth markers assist with positioning; radiopaque materials enhance X-ray visibility. Used by clinicians for airway management during intubation. The Stabiliser Rod accessory facilitates tube retention during LMA removal. Device is sterile, single-use, and MR Conditional. Benefits include facilitated oxygenation and ventilation in patients requiring intubation via the LMA Fastrach system.

Clinical Evidence

Bench testing only. Evaluations included visual inspection, dimensional testing, bonding strength, kink resistance, cuff herniation, resistance to collapse, and tracheal seal testing. Biocompatibility testing conducted per ISO 10993-1 and ISO 18562-1. All tests passed.

Technological Characteristics

Straight, cuffed, wire-reinforced tube; non-DEHP PVC main tube, stainless steel reinforcement, PVC cuff/tip/inflation line. 15mm polyamide connector. Radiopaque. Sterilized via Ethylene Oxide (10-6 SAL). MR Conditional. Sizes 6.0mm–8.0mm. Single-use.

Indications for Use

Indicated for patients requiring tracheal intubation through the LMA® Fastrach™ to facilitate oxygenation and ventilation. Contraindicated for patients undergoing procedures involving laser beams or electrosurgical active electrodes in the immediate device area.

Regulatory Classification

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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION April 29, 2025 Teleflex Medical Irma Govea Regulatory Affairs Specialist 3015 Carrington Mills Blvd Morrisville, North Carolina 27560 Re: K242495 Trade/Device Name: LMA Fastrach ETT SU Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR Dated: April 2, 2025 Received: April 2, 2025 Dear Irma Govea: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K242495 - Irma Govea Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. {2} K242495 - Irma Govea Page 3 See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Bradley Q. Quinn -S Bradley Quinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K242495 Device Name LMA Fastrach ETT SU Indications for Use (Describe) The LMA® Fastrach™ ETT Single Use is indicated for tracheal intubation through the LMA® Fastrach™. The Stabiliser Rod is indicated for use during removal of the LMA® Fastrach™ and LMA® Fastrach™ Single Use after intubation to keep the LMA® Fastrach™ ETT Single Use in place. 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) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4} 510(k) Submission LMA Fastrach ETT SU # 510(k) Summary A. Name, Address, Phone and Fax Number of Applicant Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 USA Phone: 1 919-361-3973 B. Contact Person Irma Govea Regulatory Affairs Specialist C. Date Prepared March 31, 2025 D. Device Name Subject Device 1 Trade Name: LMA Fastrach™ ETT SU Common Name: Endotracheal Tube Product Code: BTR Regulation Number: 21 CFR 868.5730 Classification Name: Tube, Tracheal (W/Wo Connector) Classification: II Classification Panel: Anesthesiology E. Predicate Device K051993 LMA Fastrach ETT SU F. Device Description The LMA® Fastrach™ ETT Single Use has been developed specifically for use with the LMA® Fastrach™. It is a straight, cuffed, wire-reinforced tube with a Murphy Eye and a standard 15mm connector. The LMA® Fastrach™ ETT Single Use has a pilot balloon with a luer check valve and a unique, soft, moulded tip for atraumatic passage through the vocal cords. As a reference during intubation, the LMA® Fastrach™ ETT Single Use has depth markers to indicate the distance to the distal tip of the LMA™ airway. The LMA® Fastrach™ ETT Single Use is radiopaque along its full length and its tip is made out of a radio opaque material to enhance its visibility in x-rays. Accessory device: The Stabiliser Rod Single Use is an accessory and it is indicated for use during removal of the reusable LMA® Fastrach™ and LMA® Fastrach™ Single Use after intubation to keep the Endotracheal Tube (ETT) in place. G. Indications for Use See Substantial Equivalence Table Below 510(k) Summary - Page 1 of 4 {5} 510(k) Submission LMA Fastrach ETT SU # H. Contraindications The LMA® Fastrach™ ETT Single Use should not be placed in patients eligible for procedures which involve the use of a laser beam or electrosurgical active electrode in the immediate area of the device. There are no known contraindications associated with the Stabiliser Rod accessory device. # I. Substantial Equivalence The subject device is substantially equivalent to the predicate device with respect to intended use, technology, and design. The differences between the predicate and the subject devices are minor and any risks have been mitigated through testing. The table below summarizes the differences between the subject and predicate device. Table 1. Substantial Equivalence Comparative Table LMA Fastrach ETT SU | Features | Teleflex Medical LMA Fastrach ETT SU | Teleflex Medical LMA Fastrach ETT SU (Predicate K051993) | Comments | | --- | --- | --- | --- | | Classification Name | Tube, Tracheal (w/wo connector) | Same | Same | | Product Code | BTR | Same | Same | | Regulation Number | 868.5730 | Same | Same | | Indications for Use | The LMA® Fastrach™ ETT Single Use is indicated for tracheal intubation through the LMA® Fastrach™. The Stabiliser Rod is indicated for use during removal of the LMA® Fastrach™ and LMA® Fastrach™ Single Use after intubation to keep the LMA® Fastrach™ ETT Single Use in place. | The LMA Fastrach™ ETT SU is indicated for airway management by oral intubation on the trachea. Reinforced ETT may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. | Indication is not changing; a rewording was made for better readability | | Patient Population | LMA® Fastrach™ ETT Single Use is intended for patients who require intubation through the Fastrach LMA to facilitate oxygenation and ventilation. Clinical judgement should be used in the selection of the appropriate device size for an individual patient. | Not stated | Although predicate device does not clearly state the patient population in the IFU, it remains the same for both products | | Contraindications | The LMA® Fastrach™ ETT Single Use should not be placed | LMA Fastrach ETT is contraindicated in procedures | Contraindications are not | 510(k) Summary - Page 2 of 4 {6} 510(k) Submission LMA Fastrach ETT SU | | in patients eligible for procedures which involve the use of a laser beam or electrosurgical active electrode in the immediate area of the device. There are no known contraindications associated with the LMA ® Fastrach™ Stabiliser Rod accessory device. | which involve the use of a laser beam or electrosurgical active electrode in the immediate area of the device. | changing; a rewording was made for better readability A statement has been added for the stabilizer rod, even though there are no known contraindications | | --- | --- | --- | --- | | Single Use | Yes | Same | Yes | | Size Range | 6.0 mm – 8.0 mm | Same | Same | | Cuffed | Yes | Same | Same | | Radiopaque | Yes | Same | Same | | Connection to ventilation source | 15 mm connector Polyamide | 15 mm connector Polypropylene (PP) | Materials have been tested per ISO 10993-1 | | Method of Sterilization | Ethylene Oxide 10-6SAL | Same | Same | | Biocompatibility | Materials have been tested per ISO 10993-1 | Materials biocompatible | Materials have been tested per ISO 10993-1 | | Components & Materials | Main tube – Non-DEHP Polyvinylchloride (PVC) reinforced with Stainless Steel Cuff – PVC Boat tip – PVC Inflation line – PVC Ink – Black Ink + Reducer Stabilizer rod - PVC | Main tube – Polyvinylchloride (PVC) reinforced with Stainless Steel Cuff -PVC Boat tip – PVC Inflation line – PVC Ink – Black Ink Stabilizer rod - PVC | Materials were changed to non-DEHP | | Sterile | Yes | Same | Same | | Eye | Murphy | Same | Same | | Graduations | Multiple cm markings | Same | Same | | MR Safety | MR Conditional | Not declared | Testing has been conducted | | Shelf-life | 1 year | 2 years | Testing has been conducted | 510(k) Summary - Page 3 of 4 {7} 510(k) Submission LMA Fastrach ETT SU | Packaging | Preformed pouch | Blister tray | Packaging performance testing was conducted | | --- | --- | --- | --- | | | Packaging film – PET/EP 12/60 Tyvex – Uncoated Tyvex Paper 1073B | Packaging film – Perfecseal 30652-EE (8 mil) nylon film Tyvex – PerfecSeal 2FS Tyvex heat seal coated with SBP 2000 | | J. Comparison to the Predicate The table above illustrates the similarities and differences between the subject and predicate device. The basic technological and operating principles are the same for both devices. Both the subject and predicate devices are for airway management. Both the subject and predicate devices are disposable, sterile, single patient use devices. The subject devices are substantially equivalent to the predicate device. There are no significant differences that would affect safety and efficacy. K. Performance Data The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include: - Testing performed included visual inspection, dimensional testing, bonding strength (main tube with boat tip, side arm, 15mm connector and cuff bonding), kink resistance, cuff herniation, resistance to collapse, tracheal seal testing. The testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. The LMA Fastrach ETT SU passed all evaluations and tests. The device is biocompatible and meets the requires pertaining to biocompatibility per 10993-1, ISO 18562-1, the US FDA Guidance on Application of 10993-1. L. Conclusion The subject device has the same intended use and technological characteristics and construction as the predicate. Test results demonstrate that the subject device meets it's intended use. It is for these reasons that the subject device can be found substantially equivalent to the predicate devices. 510(k) Summary - Page 4 of 4
Innolitics
510(k) Summary
Decision Summary
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