(265 days)
Not Applicable
No
The device description and performance studies focus on the physical characteristics and biological safety of the endotracheal tube, with no mention of AI or ML capabilities.
No
The device is used for airway management, acting as a conduit for ventilation, which is a supportive function rather than directly treating a disease or condition.
No
An endotracheal tube is used for airway management and ventilation, not for diagnosing medical conditions.
No
The device description clearly states it is a physical device (endotracheal tube) made of materials like plastic and stainless steel, and includes components like a cuff, inflation line, and connector. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "airway management" and "ventilation" by inserting the tube into the trachea. This is a direct intervention on the patient's airway, not a test performed on a sample taken from the body.
- Device Description: The description details a physical device for establishing an airway, including components like a cuff, inflation line, and connector. It does not describe a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on in vitro testing.
In summary, this device is a medical device used for airway management and ventilation, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Reinforced Tube: Rusch Reinforced Endotracheal Tubes are designed for nasal intubation and are indicated for airway management. The correct designation (oral, nasal or oral/nasal) is printed on the tube and unit package. Reinforced Endotracheal Tubes may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. The Reinforced Endotrached to be used on all patients requiring ventilation, pediatric and adult.
Safety Clear and Safety Clear Pediatric Tubes: Rusch Endotracheal Tubes, Cuffed and Uncuffed, with or without Murphy Eye are for oral or nasal intubation. They are indicated for airway management. The Rusch Endotracheal Tubes are intended to be used on all patients requiring ventilation, pediatric and adult.
Product codes
BTR
Device Description
An endotracheal tube is a device that is inserted into the trachea via the nose or the mouth to establish a patent airway to allow ventilation. The proposed Teleflex Medical Rusch Endotracheal Tubes are sterile, single use devices that are made non made with DEHP. The tracheal tubes contain a compatible cuff, inflation line, pilot balloon and one-way valve. A radiopaque line is incorporated into the full length of the Safety Clear tracheal tube, while the Reinforced tube contains an embedded stainless-steel spiral that allows for X-ray visualization. Each tracheal tube is supplied with an appropriately sized 15mm connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Trachea
Indicated Patient Age Range
pediatric and adult.
Intended User / Care Setting
Locations where ET intubation may be performed
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 to the side arm, inflation tube and connector), Tube curvature, cuff restrained burst, Bevel angle Cuff inflation, Kink resistance, Cuff herniation, Cuff diameter, Tube collapse and Tracheal seal testing, as well as testing required by ISO 10993-1 Fifth Edition 2018-08 - Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process.
The testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device.
Biological testing was performed according to ISO 10993: - Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
- Implantation
- Subacute Systemic Toxicity
- Genotoxicity
- Chemical Characterization-Exhaustive and Simulated Use. Toxicological Risk Assessment Related to Extractable and Leachables
- Particulates and VOC. Toxicological Risks Related to Inhalation of VOCs and Particulates
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
February 11, 2025
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Teleflex Incorporated Bouse Angela Senior Manager Regulatory Affairs-Product Management 3015 Carrington Mills Blvd Suite 600 Morrisville, North Carolina 27560
Re: K241451
Trade/Device Name: Rusch Endotracheal Tubes (Reinforced): Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR Dated: May 22, 2024 Received: January 3, 2025
Dear Bouse Angela:
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.
1
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" (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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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. See
2
the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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
Indications for Use
510(k) Number (if known) K241451
Device Name
Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)
Indications for Use (Describe)
Reinforced Tube: Rusch Reinforced Endotracheal Tubes are designed for nasal intubation and are indicated for airway management. The correct designation (oral, nasal or oral/nasal) is printed on the tube and unit package. Reinforced Endotracheal Tubes may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. The Reinforced Endotrached to be used on all patients requiring ventilation, pediatric and adult.
Safety Clear and Safety Clear Pediatric Tubes: Rusch Endotracheal Tubes, Cuffed and Uncuffed, with or without Murphy Eye are for oral or nasal intubation. They are indicated for airway management. The Rusch Endotracheal Tubes are intended to be used on all patients requiring ventilation, pediatric and adult.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 USA Phone: 919-332-8189
B. Contact Person
Angela Bouse Principal Regulatory Affairs Specialist
C. Date Prepared
February 6, 2025
D. Device Name
Subject Device 1
| Trade Name: | Rusch Endotracheal Tubes (Reinforced |
|---|---|
| Common Name: | Tracheal Tube |
| Product Code: | BTR |
| Regulation Number: | 21 CFR 868.5730 |
| Classification Name: | Tube, Tracheal (W/Wo Connector) |
| Classification: | II |
| Classification Panel: | Anesthesia |
Subject Device 2
| Trade Name: | Rusch Endotracheal Tube (Safety Clear) |
|---|---|
| Common Name: | Tracheal Tube |
| Product Code: | BTR |
| Regulation Number: | 21 CFR 868.5730 |
| Classification Name: | Tube, Tracheal (W/Wo Connector) |
| Classification: | II |
| Classification Panel: | Anesthesia |
Subject Device 3
| Trade Name: | Rusch Endotracheal Tubes (Safety Clear Pediatric |
|---|---|
| Common Name: | Tracheal Tube |
| Product Code: | BTR |
| Regulation Number: | 21 CFR 868.5730 |
| Classification Name: | Tube, Tracheal (W/Wo Connector) |
| Classification: | II |
| Classification Panel: | Anesthesia |
5
E. Predicate Device
K990619 Rusch Reinforced Endotracheal (or Tracheal) Tube K961837 Rusch Oral/Nasal Tracheal Tube/Safety Clear Plus Tracheal Tube K993786 Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube
F. Device Description
An endotracheal tube is a device that is inserted into the trachea via the nose or the mouth to establish a patent airway to allow ventilation. The proposed Teleflex Medical Rusch Endotracheal Tubes are sterile, single use devices that are made non made with DEHP. The tracheal tubes contain a compatible cuff, inflation line, pilot balloon and one-way valve. A radiopaque line is incorporated into the full length of the Safety Clear tracheal tube, while the Reinforced tube contains an embedded stainless-steel spiral that allows for X-ray visualization. Each tracheal tube is supplied with an appropriately sized 15mm connector.
G. Indications for Use
See Substantial Equivalence Table Below
H. Contraindications
None
I. Substantial Equivalence
The subject devices are substantially equivalent to the predicate device with respect to intended use, technology, and construction. 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.
| Features | Teleflex Medical
Rusch Reinforced
Endotracheal Tube
(Subject Device 1) | Rusch/Teleflex Medical
Reinforced Endotracheal
Tube
(Predicate K990619) | Comments |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|----------|
| Classification Name | Tube, Tracheal (w/wo connector) | Same | Same |
| Product Code | BTR | Same | Same |
| Regulation Number | 868.5730 | Same | Same |
| Indications for Use | Rusch Reinforced
Endotracheal Tubes are
designed for oral or nasal
intubation and are indicated
for airway management.
The correct designation
(oral, nasal or oral/nasal) is
printed on the tube and unit | Same | Same |
| Substantial Equivalence Comparative Table: Reinforced Endotracheal Tube (Subject | ||||
|---|---|---|---|---|
| Device 1) |
6
| | package. Reinforced
Endotracheal Tubes may be
used to reduce the potential
for kinking whenever an
unusual positioning of the
head or neck is required
following intubation. The
Reinforced Endotracheal
Tubes are intended to be
used on all patients
requiring ventilation,
pediatric and adult. | | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Environment of
Use | Locations where ET
intubation may be
performed | Not stated | Same |
| Patient Population | Pediatric and Adult | Not stated | Same |
| Contraindications | None | Same | Same |
| Single Use | Yes | Same | Yes |
| Size Range | 3.5 mm – 10.0 mm | 2.5 mm – 11.0 mm | Within cleared
range |
| Cuffed | Yes | Same | Same |
| Radiopaque | Yes | Same | Same |
| Connection to
ventilation source | 15 mm connector | Same | Same |
| Method of
Sterilization | Ethylene Oxide 10-6 SAL | Same | Same |
| Biocompatibility | Materials have been tested
per ISO 10993-1 | Same | Same |
| Made without
DEHP | Yes | No | While slightly
different, the
prosed device is
made without
the known
hazardous
substance |
| Sterile | Yes | Same | Same |
| Eye | Murphy | Same | Same |
| Graduations | Multiple cm markings | Same | Same |
| Shaft (main tube) | PVC | Same | Same |
| Features | Teleflex Medical
Rusch Safety Clear
Endotracheal Tube
(Subject Device 2) | Rusch/Teleflex Medical
Oral/Nasal Tracheal
Tube/Safety Clear Plus
Tracheal Tube
(Predicate K961837) | Comments |
| Classification
Name | Tube, Tracheal (w/wo
connector) | Same | Same |
| Product Code | BTR | Same | Same |
| Regulation
Number | 868.5730 | Same | Same |
| Indications for Use | Rusch Endotracheal Tubes,
Cuffed and Uncuffed, with
or without Murphy Eye are
for oral or nasal intubation.
They are indicated for
airway management. The
Rusch Endotracheal Tubes
are intended to be used on
all patients requiring
ventilation, pediatric and
adult. | Same | Same |
| Environment of
Use | Locations where ET
intubation may be
performed | Not stated | Same |
| Patient Population | Pediatric and Adult | Not stated | Same |
| Contraindications | None | Same | Same |
| Single Use | Yes | Same | Yes |
| Size Range | 4.5 mm - 10.00 mm | 4.5 mm - 11.0 mm | Within cleared
range |
| Cuffed | Yes | Same | Same |
| Radiopaque | Yes | Same | Same |
| Connection to
ventilation source | 15 mm connector | Same | Same |
| Method of
Sterilization | Ethylene Oxide 10-6 SAL | Same | Same |
| Biocompatibility | Materials have been tested
per ISO 10993-1 | Same | Same |
| Made without
DEHP | Yes | No | While slightly
different, the |
| | | | prosed device is |
| | | | made without |
| | | | the known |
| | | | hazardous |
| | | | substance |
| Sterile | Yes | Same | Same |
| Eye | Murphy | Same | Same |
| Graduations | Multiple cm markings | Same | Same |
| Shaft (main tube) | PVC | Same | Same |
| Cuff | PVC | Same | Same |
7
Substantial Equivalence Comparative Table: Safety Clear Endotracheal Tube (Subject Device 2)
8
Substantial Equivalence Comparative Table: Safety Clear Pediatric Endotracheal Tube (Subject Device 3)
| Features | Teleflex Medical
Rusch Safety Clear
Endotracheal Tube
(Subject Device 2) | Rusch/Teleflex Medical
Oral/Nasal Tracheal
Tube/Safety Clear Plus
Tracheal Tube
(Predicate K961837) | Comments |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
Name | Tube, Tracheal (w/wo
connector) | Same | Same |
| Product Code | BTR | Same | Same |
| Regulation
Number | 868.5730 | Same | Same |
| Indications for Use | Rusch Endotracheal Tubes,
Cuffed and Uncuffed, with
or without Murphy Eye are
for oral or nasal intubation.
They are indicated for
airway management. The
Rusch Endotracheal Tubes
are intended to be used on
pediatric. | Rusch Oral/Nasal Tracheal
Tube, Cuffed.
Magill/Murphy is a device
inserted into a patient's
trachea via the nose or
mouth and used to
maintain an open airway. | Similar,
updated to align
with the
indication for
the rest of the
Rusch Safety
Clear
Endotracheal
Tube product
family. |
| Environment of
Use | Locations where ET
intubation may be
performed | Not stated | Same |
| Patient Population | Pediatric | Not stated | Same |
| Contraindications | None | Same | Same |
| Single Use | Yes | Same | Yes |
| Size Range | 2.5 mm - 4.0 mm | 2.0 mm - 4.0 mm | Within cleared
range |
| Cuffed | Yes | Same | Same |
9
| Radiopaque | Yes | Same | Same |
|---|---|---|---|
| Connection to | |||
| ventilation source | 15 mm connector | Same | Same |
| Method of | |||
| Sterilization | Ethylene Oxide 10-6 SAL | Same | Same |
| Biocompatibility | Materials have been tested | ||
| per ISO 10993-1 | Same | Same | |
| Made without | |||
| DEHP | Yes | No | While slightly |
| different, the | |||
| prosed device is | |||
| made without | |||
| the known | |||
| hazardous | |||
| substance | |||
| Sterile | Yes | Same | Same |
| Eye | Murphy | Same | Same |
| Graduations | Multiple cm markings | Same | Same |
| Shaft (main tube) | PVC | Same | Same |
| Cuff | PVC | Same | Same |
J. Comparison to the Predicate
The table above illustrates the similarities and differences between the subject and predicate devices. The basic technological and operating principles are the same for both devices. Although the indications for use wording is not identical, 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 to the side arm, inflation tube and connector), Tube curvature, cuff restrained burst, Bevel angle Cuff inflation, Kink resistance, Cuff herniation, Cuff diameter, Tube collapse and Tracheal seal testing, as well as testing required by ISO 10993-1 Fifth Edition 2018-08 - Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process.
The testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device.
Biological testing was performed according to ISO 10993:
- Cytotoxicity ●
510(k) Summary - Page 6 of 7
10
- Sensitization ●
- Irritation
- Acute Systemic Toxicity ●
- Material Mediated Pyrogenicity ●
- Implantation
- Subacute Systemic Toxicity
- Genotoxicity
- Chemical Characterization-Exhaustive and Simulated Use. Toxicological Risk ● Assessment Related to Extractable and Leachables
- Particulates and VOC. Toxicological Risks Related to Inhalation of VOCs and ● Particulates
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.