(570 days)
No
The device description and intended use focus on a mechanical balloon catheter for anatomical displacement. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as an instrument intended to provide increased intranasal space for procedures and/or address nasal obstruction by displacing tissue, which falls under diagnostic or surgical facilitation rather than directly treating a disease or condition in a therapeutic manner.
No
The device is an instrument designed to facilitate access for procedures and temporarily address nasal obstruction by displacing tissue. It is not described as gathering or interpreting data for diagnosis.
No
The device description clearly details a physical catheter with a balloon, lumens, a hub, and radiopaque markers, indicating it is a hardware device, not software only.
Based on the provided information, the Dillard Nasal Balloon (DNB) Catheter is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The DNB Catheter is a device that is inserted into the nasal cavity to physically manipulate tissue (displacing the inferior turbinate and lower nasal septum) and create space. It does not analyze or test any biological samples.
- The intended use describes a physical intervention. The purpose is to facilitate access for procedures and address nasal obstruction by displacing tissue, not to diagnose a condition based on analyzing a sample.
- The device description details a physical instrument. It describes a catheter with a balloon for inflation, lumens for guidewire use, and radiopaque markers for positioning. This is consistent with a surgical or procedural device, not a diagnostic one.
Therefore, the Dillard Nasal Balloon (DNB) Catheter is a medical device used for a procedural purpose, not an IVD.
N/A
Intended Use / Indications for Use
The Dillard Nasal Balloon (DNB) Catheter is an instrument intended to provide increased intransal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum.
The Dillard Nasal Balloon (DNB) Catheter is intended for use in ages 17 years or older.
Product codes
QGK
Device Description
The Dillard Nasal Balloon (DNB) Catheter has a total length of either 25cm or 100cm and is available in balloon diameters from 5mm to 12mm and balloon lengths of 20mm and 40mm. The balloon component of the catheter has radiopaque markers to assist with radiographic positioning (as applicable). The proximal end of the device is a common catheter design consisting of a plastic hub and strain relief. The hub is used to inflate the balloon and the luer connector integrated into the hub is compatible with standard inflation devices. A second lumen within the catheter, intended for guidewire use, extends through the central lumen back to the proximal hub and through the distal tip. All catheters and accessories are supplied sterile and intended for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intranasal space, nasal obstruction by displacing the inferior turbinate and lower nasal septum.
Indicated Patient Age Range
17 years or older.
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)
The device was subjected to the following performance tests to support the assertion of substantial equivalence:
- Dimensional specifications
- Joint separation strength
- Compatibility with (standard) accessories
- Balloon burst pressure
- Inflation and deflation times
- Balloon cycle fatigue in simulated use (simulated nasal septum and surrounding support structures)
- Simulated use in cadavers
- Biocompatibility Testing in compliance with the ISO 10993
- Sterilization Validation in compliance with the ISO 11135
- Packaging Integrity and Transportation Validation in compliance with the ISO 11607 and ISTA Part 2A
- Shelf life testing to 3 years real-time equivalent in compliance with the ASTM F1980
NOTE: no clinical testing was required to establish safety and efficacy
Conclusion from Clinical and Non-Clinical Testing:
No new questions of safety or effectiveness were identified for the Dillard Nasal Balloon Catheter compared to the predicate. Performance testing demonstrated the DNB performs as intended and is as safe and as effective as the predicate device. Therefore, the DNB is considered substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4420 Ear, nose, and throat manual surgical instrument.
(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
January 3, 2020
Intuit Medical Products, LLC Jack Griffis Vice President, R&D 6018 Eagles Rest Trail Sugar Hill, Georgia 30518
Re: K181546
Trade/Device Name: Dillard Nasal Balloon Catheter Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, And Throat Manual Surgical Instrument Regulatory Class: Class I, reserved Product Code: QGK Dated: October 7, 2019 Received: October 8, 2019
Dear Jack Griffis:
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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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 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,
for Michael J. Ryan Director DHT1C: Division of ENT, 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
Enclosure
2
Indications for Use
510(k) Number (if known) K181546
Device Name Dillard Nasal Balloon (DNB) Catheter
Indications for Use (Describe)
The Dillard Nasal Balloon (DNB) Catheter is an instrument intended to provide increased intransal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum.
The Dillard Nasal Balloon (DNB) Catheter is intended for use in ages 17 years or older.
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) |
|---|---|
| ------------------------------------------------------------- | ------------------------------------------------------------ |
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Image /page/3/Picture/1 description: The image shows a logo for Intuit Medical Products, LLC. On the left side of the logo is a blue illustration of a human head and neck in profile, showing the nasal passages and throat. To the right of the illustration is a light blue rectangle containing the letters "IMP" in large, white font, with the words "Intuit Medical Products, LLC" written in a smaller, white font below the letters.
510(k) Summary
510(k) Number: K181546
December 31st, 2019 Date Revised:
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
- A. Submitter: Intuit Medical Products (IMP), LLC 6018 Eagles Rest Trail Sugar Hill, Georgia 30518
- B. Company Contact: Jack Griffis Vice President, Research & Development (404) 583-6889 (direct) jgriffis@intuitmedicalproducts.com
- C. Device Information: Trade Name: Dillard Nasal Balloon Catheter (DNB) Common Name: Balloon, Nasal Airway
- D. Classification: Ear, nose, and throat manual surgical instruments QGK, 21 CFR 874.4420 Class I
- E. Predicate Devices: Acclarant RELIEVA TRACT™ Balloon Dilation System, K183090
Additional Reference Devices (for technological comparison ONLY): ECONOM™ speculum for ENT applications, K925754 Dillard Sinuplasty Balloon Catheter (DSB), K143738 Dillard Airway Dilatation System (DAS), K153484
- F. Physical Description:
The Dillard Nasal Balloon (DNB) Catheter has a total length of either 25cm or 100cm and is available in balloon diameters from 5mm to 12mm and balloon lengths of 20mm and 40mm. The balloon component of the catheter has radiopaque markers to assist with radiographic positioning (as applicable). The proximal end of the device is a common catheter design consisting of a plastic hub and strain relief. The hub is used to inflate the balloon and the luer connector integrated into the hub is compatible with standard inflation devices. A second lumen within the catheter, intended for guidewire use, extends through the central lumen back to the proximal hub and through the distal tip. All catheters and accessories are supplied sterile and intended for single use.
NOTE: the proposed device is identical to those previously cleared under K143738 and K153484 with the exception of the indication for use.
4
- G. Indications for Use:
The Dillard Nasal Balloon Catheter is an instrument intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum.
The Dillard Nasal Balloon Catheter is intended for use in ages 17 years or older.
- H. Comparison of Characteristics / Performance Testing / Substantial Equivalence: The DNB Catheter is substantially equivalent to the predicate devices in intended use, indications for use or fundamental scientific technology and important performance specifications. Refer to the Table below for a summary:
| Characteristic | Proposed Device
(Dillard Nasal Balloon Catheter,
K181546) | Predicate Device
(Acclarent TRACT™ Balloon
Catheter, K183090) | Reference Device
(Single use speculum for
ENT applications, K925754) |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | "…an instrument intended to
provide increased intranasal
space to facilitate access for
endonasal and transnasal
procedures and/or temporarily
address nasal obstruction by
displacing the inferior turbinate
and lower nasal septum" | "…an instrument intended to
provide increased intranasal
space to facilitate access for
endonasal and transnasal
procedures and/or temporarily
address nasal obstruction by
displacing the inferior turbinate
and lower nasal septum" | Speculum (ENT) – Procode
EPY: ...a device intended to
be inserted into a body
cavity to aid observation. It
is either nonilluminated or
illuminated and may have
various accessories |
| Classification Name | Ear, nose, and throat manual surgical instrument | | Speculum, ENT |
| Product Code | QGK | | EPY |
| Classification Section | 21 CFR 874.4420 | | 21 CFR 878.1800 |
| Principle of Operation | Operates on the principle of hydraulic pressurization applied
through an inflatable balloon attached to the distal end to
mechanically dilate internal passages | | Operates on the principle of
mechanical leverage
applied through a rigid
body and a fulcrum for
leverage to expand internal
passages |
| Materials | Various medical grade polymers and metal alloys - refer to Table A,
page 38 of the submission | | Various medical grade
polymers and metal alloys |
| Single Patient Use | Yes | Yes | Yes |
| Direct Patient Contact | Yes | Yes | Yes |
| Balloon Diameter and
Length | 5mm X 20mm & 40mm
6mm X 20mm & 40mm
7mm X 20mm & 40mm
8mm X 20mm & 40mm
9mm X 20mm & 40mm
10mm X 20mm & 40mm
11mm X 20mm & 40mm
12mm X 20mm & 40mm | 5mm x 24mm
7mm x 24mm
8.5mm x 24mm
10mm x 40mm
12mm x 40mm
14mm x 40mm
16mm x 40mm | N/A |
Image /page/4/Picture/6 description: The image shows a diagram of the human head and neck with the nasal passages and throat highlighted in blue and purple. To the right of the diagram is a blue square with the text "IMP Intuit Medical Products, LLC" in white. The text is stacked, with "IMP" on the top line, "Intuit Medical" on the second line, and "Products, LLC" on the third line.
5
| Characteristic | Proposed Device
(Dillard Nasal Balloon Catheter,
K181546) | Predicate Device
(Acclarent TRACT™ Balloon
Catheter, K183090) | Reference Device
(Single use speculum for
ENT applications, K925754) |
|-------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------|----------------------------------------------------------------------------|
| Maximum Inflation
Pressure | 10 – 12ATM | 8 – 16ATM | N/A |
| Flexible Shaft | Yes | Yes | No - rigid body |
| Catheter Length | 25CM and 100CM | 45CM | N/A |
| Sterilization Method | 100% Ethylene Oxide gas | | |
| Packaging | Pouch, Protective Tube, Stylet | | Pouch |
In addition, the device was subjected to the following performance tests to support the assertion of substantial equivalence:
- Dimensional specifications
- Joint separation strength
- 트 Compatibility with (standard) accessories
- l Balloon burst pressure
- I Inflation and deflation times
- . Balloon cycle fatigue in simulated use (simulated nasal septum and surrounding support structures)
- . Simulated use in cadavers
- . Biocompatibility Testing in compliance with the ISO 10993
- Sterilization Validation in compliance with the ISO 11135
- . Packaging Integrity and Transportation Validation in compliance with the ISO 11607 and ISTA Part 2A
- Shelf life testing to 3 years real-time equivalent in compliance with the ASTM F1980
- NOTE: no clinical testing was required to establish safety and efficacy
l. Conclusion from Clinical and Non-Clinical Testing:
No new questions of safety or effectiveness were identified for the Dillard Nasal Balloon Catheter compared to the predicate. Performance testing demonstrated the DNB performs as intended and is as safe and as effective as the predicate device. Therefore, the DNB is considered substantially equivalent to the predicate device.
Jack Griffis Vice President, Research & Development
Image /page/5/Picture/19 description: The image shows a diagram of the human respiratory system next to a logo for Intuit Medical Products, LLC. The diagram shows the nasal cavity, pharynx, larynx, and trachea. The logo is a blue rectangle with the letters "IMP" in large, white font. Below the letters, the words "Intuit Medical Products, LLC" are written in a smaller, white font.