(294 days)
No
The device description and performance studies focus on the physical properties and function of a mechanical introducer/dilator, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is an introducer/dilator designed to ease the passage of a nasal endotracheal tube, not to directly treat a medical condition.
No
The device is an introducer/dilator for endotracheal tubes, which means it facilitates a medical procedure (tube insertion) rather than identifying a disease or condition.
No
The device description clearly states it is constructed primarily of polyvinylchloride and is a physical tube with a tapered body and closed end, indicating it is a hardware device.
Based on the provided information, the Rhinoguard device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Rhinoguard's Function: The Rhinoguard is a physical tool used to facilitate the insertion of a nasal endotracheal tube into the airway. It is a mechanical device that interacts directly with the patient's anatomy.
- Intended Use: The intended use clearly states it's for "allowing the passage of a nasal endotracheal tube from the nares to the oropharynx." This is a procedural aid, not a diagnostic test performed on a sample.
- Device Description: The description details its physical construction and how it's used to guide a tube. There is no mention of analyzing biological samples.
Therefore, the Rhinoguard falls under the category of a medical device used for a procedural purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Rhinoguard is a nasal endotracheal tube introducer/dilator designed to allow the passage of a nasal endotracheal tube from the nares to the oropharynx.
The device can be used with cuffed and non-cuffed nasal endotracheal tubes.
Product codes
BTR
Device Description
The Rhinoguard is a nasal endotracheal tube introducer/dilator designed to ease the passage of a nasal endotracheal tube from the nares to the oropharynx. The Rhinoguard device is constructed primarily of polyvinylchloride and consists of a tube with a hollow proximal end, a tapered cylindrical body and a closed, rounded distal end. The device has markings to indicate the approximate mating location for corresponding sizes of nasal endotracheal tubes. The device is provided in a small and large size. The small Rhinoguard is intended to mate with 3.0 to 4.5 mm nasal endotracheal tubes and the large Rhinoguard is intended to mate with 5.0 to 8.0 mm nasal endotracheal tubes. The device can be used with cuffed and non-cuffed nasal endotracheal tubes. Prior to using the device, the desired size of the nasal endotracheal tube must be selected and then matched to corresponding Rhinoguard size (large or small). The device is then cut just above the indices (marks) corresponding to the selected endotracheal tube size and connected with the endotracheal tube. Once mated, the distal end of the device is introduced into the naris of choice and gently pushed forward into the oropharynx. Lastly, the distal end of Rhinoguard is grasped and removed from the mouth with the aid of a laryngoscope and McGill forceps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nares, oropharynx
Indicated Patient Age Range
Adult and pediatric
Intended User / Care Setting
Not Found
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)
Nonclinical testing was conducted for supporting substantial equivalence between the Rhinoguard and predicate device. The nonclinical tests addressed device performance characteristics such as flexibility, penetration force, biocompatibility, sterilization, packaging and shelf life. In conclusion, the proposed device performed equivalent to or better than the predicate device. All performance testing met acceptance criteria defined in protocols.
Bench Testing:
- Kink Testing: The purpose of this test was to confirm that the Rhinoguard meets the pre-determined flexibility requirements and that device performance is equivalent to the predicate device.
- Disconnection Testing: The purpose of this test was to confirm that the Rhinoguard meets the pre-determined flexibility requirements and that the device performance is equivalent to the predicate device.
- Perforation Testing: The purpose of this test was to confirm that the Rhinoguard is less of a penetrator than the predicate device.
- Biocompatibility Testing: The purpose of this test was to confirm that the Rhinoguard meets pre-determined biocompatibility requirements.
- Sterility Testing: The purpose of this test was to confirm that the Rhinoguard can be sterilized to a Sterility Assurance Level (SAL) of 1.0 X 10-6.
- Shelf Life Testing (Packaging): The purpose of this test was to confirm that the device packaging functionality and performance is acceptable after the desired shelf life of the product.
- Shelf Life Testing (Device): The purpose of this test was to confirm that the device functionality and performance is acceptable after the desired shelf life of the product.
- Design (Usability) Validation Testing: The purpose of this test was to confirm that the Rhinoguard meets the intended use, user needs, and usability requirements when tested under a simulated use environment.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 20, 2015
Davis Medical, LLC % Ms. Michelle Lott Owner (President) Lean RAQA Systems 12602 N. Summer Wind Drive Marana, AZ 85658
Re: K141747
Trade/Device Name: Rhinoguard Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR Dated: March 19, 2015 Received: March 20, 2015
Dear Ms. Lott,
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.
1
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 devicerelated 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" (21 CFR 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
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
Enclosure
2
Indications for Use
510(k) Number (if known) K141747
Device Name Rhinoguard
Indications for Use (Describe)
The Rhinoguard is a nasal endotracheal tube introducer/dilator designed to allow the passage of a nasal endotracheal tube from the nares to the oropharynx.
The device can be used with cuffed and non-cuffed nasal endotracheal tubes.
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."
3
SECTION 5 510(K) SUMMARY
4
510(k) Summary
As required by 21 CFR 807.92, this "510(k) Summary" provides a basis for the substantial equivalence determination of the device listed below.
| General Information | |
|---|---|
| Date Prepared: | June 27th, 2014 |
| 510(k) Submitter: | Davis Medical LLC |
| 6112 Peters Creek Road | |
| Roanoke, VA 24019 | |
| Contact: John Davis, CEO | |
| (540) 492-0453 | |
| info@betternasalintubation.com | |
| 510(k) Correspondent: | Lean RAQA Systems |
| Attn: Michelle Lott | |
| 12602 N Summer Wind Drive | |
| Marana, AZ 85658 | |
| Contact: Michelle Lott, RAC | |
| (520) 275-9838 | |
| leanraqasystems@gmail.com |
Device Information
| Trade Name: | Rhinoguard |
|---|---|
| Common Name: | Endotracheal Tube Introducer |
| Classification Name: | Tubes, Tracheal (W/Wo Connector) |
| [21 CFR 868.5730, Product Code BTR] | |
| Classification Panel: | Anesthesiology |
| Class: | Class II |
Predicate Device Information
| Trade Name: | Rusch Preformed AGT Nasal Endotracheal Tubes (cuffed & uncuffed) |
|---|---|
| Common Name: | Endotracheal Tube Introducer |
| Classification Name: | Tubes, Tracheal (W/Wo Connector) |
| [21 CFR 868.5730, Product Code BTR] | |
| Classification Panel: | Anesthesiology |
| Class: | Class II |
| 510(k) Number: | K931164 & K931165 |
Device Description
The Rhinoguard is a nasal endotracheal tube introducer/dilator designed to ease the passage of a nasal endotracheal tube from the nares to the oropharynx. The Rhinoguard device is constructed primarily of polyvinylchloride and consists of a tube with a hollow proximal end, a tapered cylindrical body and a closed, rounded distal end. The device has markings to indicate the approximate mating location for corresponding sizes of nasal endotracheal tubes. The device is provided in a small and large size. The small Rhinoguard is intended to mate with 3.0 to 4.5 mm nasal endotracheal tubes and the large
5
Rhinoguard is intended to mate with 5.0 to 8.0 mm nasal endotracheal tubes. The device can be used with cuffed and non-cuffed nasal endotracheal tubes. Prior to using the device, the desired size of the nasal endotracheal tube must be selected and then matched to corresponding Rhinoguard size (large or small). The device is then cut just above the indices (marks) corresponding to the selected endotracheal tube size and connected with the endotracheal tube. Once mated, the distal end of the device is introduced into the naris of choice and gently pushed forward into the oropharynx. Lastly, the distal end of Rhinoguard is grasped and removed from the mouth with the aid of a laryngoscope and McGill forceps.
Intended Use/Indications for Use
The Rhinoguard is a nasal endotracheal tube introducer/dilator designed to allow the passage of a nasal endotracheal tube from the nares to the oropharynx. The device can be used with cuffed nasal endotracheal tubes.
Technological Characteristics
The device comparison table below provides a general summary of the technological characteristics of the Rhinoguard device compared to the predicate device. The Rhinoguard was classified as a class II device because it is an accessory to class II nasal endotracheal tubes. For this reason, nasal endotracheal tubes were selected as the predicate to the Rhinoguard. Provided that the Rhinoguard is an accessory to nasal endotracheal tubes and to assist with the characterization of certain design features and performance characteristics of the Rhinoguard device, two other class I reference devices (Sun-med Endotracheal Tube Introducer and Pilling Bougie/Dilator) were also selected. The Rhinoguard device is similar in operation to the legally marketed class I reference devices. These similarities between the proposed and reference devices are identified to support safety and efficacy of the introducing and dilating features of the Rhinoguard.
Device Comparison
As explained in detail below, the Rhinoguard is substantially equivalent to other legally marketed Rusch Preformed AGT Nasal Endotracheal Tubes (Cuffed & Uncuffed (K931164 & K931165), Sun-Med Endotracheal Tube Introducer, and Pilling Bougie/Dilator. Specifically, the Rhinoguard is substantially equivalent to the predicate devices identified. Rhinoguard has the same general intended use and similar indications, technological characteristics, and principles of operation as the previously cleared predicate device(s). A substantial equivalence device comparing the similarities and differences between the Rhinoguard and its predicate and reference device(s) is provided below. Minor differences in the technological characteristics do not raise new questions of safety or efficacy. Performance (bench) testing demonstrates that the Rhinoguard is as safe and effective as its predicate devices. Because the proposed device functions as an accessory to an endotracheal tube, the Rusch Preformed AGT Nasal Endotracheal Tube was selected as the predicate device and supporting devices with introducer/dilator functionalities were selected as reference devices.
6
| Device Comparison Table | ||||
|---|---|---|---|---|
| Rhinoguard | Rusch Preformed AGT Nasal | Sun-med Endotracheal | Pilling Bougie/ | |
| Dilator | ||||
| (Proposed device) | Endotracheal Tubes (cuffed | |||
| & uncuffed) | Tube Introducer | (Reference Device) | ||
| (Predicate Device) | (Reference Device) | |||
| Exempt | Exempt | |||
| K931164 & K931165 | ||||
| FDA Class | Class II | Class II | Class I | Class I |
| FDA Product Code | BTR | BTR | KCD | KCD |
| FDA Regulation | 868.5730 – Tracheal Tube | 868.5730 – Tracheal Tube | 874.4420 - Ear, nose, | |
| and throat manual | ||||
| surgical instrument | 874.4420 - Ear, nose, | |||
| and throat manual | ||||
| surgical instrument | ||||
| 510k # | N/A | K931164 & K931165 | N/A - Class I, 510(k) | |
| exempt | N/A - Class I, 510(k) | |||
| exempt | ||||
| Indications | Indicated to aid in nasal | |||
| intubation | Indicated for nasal | |||
| intubation and for airway | ||||
| management | Indicated to aid in oral | |||
| intubation | Indicated to aid in | |||
| oral intubation | ||||
| User Population | Adult and pediatric | Adult and pediatric | Adult and pediatric | Adult and pediatric |
| Operating | ||||
| principle | Device mates to tip of | |||
| nasal endotracheal tube | ||||
| and enters through the | ||||
| nostrils. Device is | ||||
| advanced to the | ||||
| oropharynx and then | ||||
| separated from the | ||||
| endotracheal tube. Device | ||||
| exits the mouth prior to | ||||
| entering trachea. | Device enters though the | |||
| nostrils and is advanced past | ||||
| the vocal cords and finally | ||||
| placed into the trachea. | Endotracheal tube is | |||
| inserted over the device. | ||||
| Device enters the | ||||
| trachea prior to the | ||||
| endotracheal tube and | ||||
| then the device is | ||||
| removed after placing | ||||
| the endotracheal tube | ||||
| into the trachea. | Device enters airway | |||
| and then is removed | ||||
| once airway is dilated. | ||||
| Enters trachea | No | Yes | Yes | Yes |
| Maintains an | ||||
| open airway | No | Yes | No | No |
| Materials | Polyvinyl Chloride | |||
| (thermoplastic) | Polyvinyl Chloride | |||
| (thermoplastic) | Low Density | |||
| Polyethylene | ||||
| (thermoplastic) | Silicone and tungsten | |||
| Sterile | Yes (Radiation) | Yes (ETO) | Yes (ETO) | Meant for |
| sterilization by end | ||||
| user | ||||
| Closed tip | Yes | No | Yes | Yes |
| Rounded tip | Yes | No | Yes | Yes |
| Straight or curved | Curved | Curved | Both available | |
| (for curved units, curve | ||||
| is just in tip of the | ||||
| device) | Straight | |||
| Sizes | Small and large sizes to | |||
| accommodate nasal | ||||
| endotracheal tube sizes | ||||
| 3.0 – 8.0 mm | 3.0 – 8.0 mm | Small and large sizes to | ||
| accommodate | ||||
| endotracheal tube sizes | ||||
| 4.0 – 11.0 mm | NA - dilates airway | |||
| rather than mates | ||||
| with tube | ||||
| Sizes available 20 FR |
| Table 5.1 - Device Comparison Table | ||
|---|---|---|
| Testing Completed | Testing Description | Standards Referenced |
| Kink Testing | The purpose of this test was to confirm that the Rhinoguard meets the pre-determined flexibility requirements and that device performance is equivalent to the predicate device. | N/A |
| Disconnection Testing | The purpose of this test was to confirm that the Rhinoguard meets the pre-determined flexibility requirements and that the device performance is equivalent to the predicate device. | N/A |
| Perforation Testing | The purpose of this test was to confirm that the Rhinoguard is less of a penetrator than the predicate device. | N/A |
| Biocompatibility | ||
| Testing | ||
| (to include | ||
| cytotoxicity, systemic | ||
| toxicity, | ||
| intracutaneous, | ||
| maximaization | ||
| sensitization) | The purpose of this test was to confirm that the Rhinoguard meets pre-determined biocompatibility requirements. | ISO 10993-1:2009 |
| ISO 10993-5:2009 | ||
| ISO 10993-10:2010 | ||
| ISO 10993-11:2006 | ||
| Sterility Testing | ||
| (to include bioburden, | ||
| verification dose, | ||
| sterility, | ||
| bacteriostasis/ | ||
| fungistasis | The purpose of this test was to confirm that the Rhinoguard can be sterilized to a Sterility Assurance Level (SAL) of 1.0 X 10-6. | ISO 11137-1:2006 |
| ISO 11137-2:2012 | ||
| ISO 11737-1:2006 | ||
| ISO 11737-2:1995 | ||
| Shelf Life Testing | ||
| (Packaging - to | ||
| include label | ||
| retention, seal | ||
| strength, bubble leak | ||
| test, package drum | ||
| test, dye penetration) | The purpose of this test was to confirm that the device packaging functionality and performance is acceptable after the desired shelf life of the product. | ISO 11607-1:2006 |
| ISO 11607-2:2006 | ||
| D14169-09 | ||
| F2096-11 | ||
| Shelf Life Testing | ||
| (Device — to include | ||
| kink, disconnection, | ||
| and perforation) | The purpose of this test was to confirm that the device functionality and performance is acceptable after the desired shelf life of the product. | N/A |
| Design (Usability) | ||
| Validation Testing | The purpose of this test was to confirm that the Rhinoguard meets the intended use, user needs, and usability requirements when tested under a simulated use environment. | N/A |
7
Performance Characteristics
Nonclinical testing was conducted for supporting substantial equivalence between the Rhinoguard and predicate device. The nonclinical tests addressed device performance characteristics such as flexibility, penetration force, biocompatibility, sterilization, packaging and shelf life. In conclusion, the proposed device performed equivalent to or better than the predicate device.
All performance testing met acceptance criteria defined in protocols.
8
Substantial Equivalence – Comparison to Predicate Device
Among the information and summary tables included in this 510(k) submission to support substantial equivalence of the Rhinoguard device to the legally marketed predicate device are: 1.) device description, 2.) indications for use, 3.) device comparison tables, 4.) material information, 5.) nonclinical (bench) test results, and 6.) labeling. In particular, nonclinical test results demonstrate that there were no differences that are critical to the intended use of the proposed device or that affect the safety and effectiveness of the proposed device when used as labeled.
The proposed and predicate devices have intended use, in as far as that both are used during nasal intubations, and similar indications, technological characteristics and principles of operation. The proposed device differs from the predicate device in certain design features, which are required to support aiding in nasal intubation (as do the reference devices) rather than in airway management (as does the predicate). The minor differences in technological characteristics have been identified and do not present any new issues of safety or effectiveness. Thus, the Rhinoguard device is substantially equivalent to the Rusch Preformed AGT Nasal Endotracheal Tubes (K931164 & K931165).
(End of Section)