The Dillard Airway Dilatation System includes a balloon catheter whose working length is 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.

AI/ML Overview

The provided text describes the Dillard Airway Dilatation System (K153484) and its claim of substantial equivalence to a predicate device. However, it does not contain information related to an AI/ML-driven device or study results with acceptance criteria.

The document is a 510(k) premarket notification for a medical device (dilatation catheter) and focuses on demonstrating substantial equivalence to a legally marketed predicate device through physical descriptions, indications for use, comparison of characteristics, and traditional performance testing.

Therefore, I cannot fulfill your request for the following reasons derived from the text:

No AI/ML Device: The device described, the Dillard Airway Dilatation System, is a physical medical instrument (a balloon catheter) used for dilating airway strictures. It is not an AI/ML software or system.
No Acceptance Criteria for AI/ML Performance: Since it's a physical device, the "acceptance criteria" and "reported device performance" are related to mechanical and biocompatibility tests (e.g., dimensional specifications, joint separation strength, balloon burst pressure, inflation/deflation times, cycle fatigue, biocompatibility), not AI/ML metrics like sensitivity, specificity, or AUC.
No Human Reader Study: As it's not an AI/ML device, there are no mentions of sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, or MRMC studies.
No Standalone Algorithm Performance: The concept of "standalone performance" for an algorithm is not applicable to a physical medical device.
No Ground Truth for Training Set: There is no training set mentioned, as it's not a machine learning model.

The document solely focuses on demonstrating substantial equivalence of a physical medical device to a predicate device through conventional engineering and biological testing.

Summary

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Public Health Service

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

July 27, 2016

Intuit Medical Products, LLC Mr. Jack Griffis VP, Research & Development 6018 Eagles Rest Trail Sugar Hill, GA 30518

Re: K153484

Trade/Device Name: Dillard Airway Dilatation System Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: KTI Dated: June 22, 2016 Received: June 29, 2016

Dear Mr. 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. 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.

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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,

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153484

Device Name Airway Dilatation System

Indications for Use (Describe) The Dillard Airway Dilatation System is intended to dilate strictures of the airway trees.

Type of Use (Select one or both, as applicable)
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X 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 profile view of a person's head and neck, with the internal structures of the nasal passages, mouth, and throat visible. These structures are highlighted in shades of blue and purple. To the right of the head is a blue rectangle containing the text "IMP" in large, bold letters, followed by "Intuit Medical Products, LLC" in smaller text below.

510(k) Summary

510(k) Number: K153484

July 25th, 2016 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 Airway Dilatation Catheter
	Common Name:	Airway Dilatation System
D.	Classification:	Bronchoscope (flexible or rigid) and accessoriesKTI, 21 CFR 874.4680

E. Predicate Device: Acclarent Airway Dilation Catheter (Inspira®), K090660
Class II

F. Physical Description:

NOTE: the proposed device is identical to that previously cleared under K143738, with the exception of additional balloon sizes and indication for use in airway dilatation.

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G. Indications for Use: The Dillard Airway Dilatation System is intended to dilate strictures of the airway tree.
H. Comparison of Characteristics / Performance Testing / Substantial Equivalence: The Dillard Airway Dilatation System is substantially equivalent to the predicate device in intended use, indications for use, fundamental scientific technology, and important performance specifications. Refer to the Table below for a summary:

Parameter	DAS Air Balloon Catheter(Proposed)	Acclarent Inspira® AIR Balloon Catheter(Predicate, K090660)
Indications for Use	Intended to dilate strictures of the airway tree.
Principle of Operation	Operates on the principle of hydraulic pressurization applied through an inflatableballoon attached to the distal end
Guidewire Style	OTW	OTW and Integrated
Guidewire Compatibility	OTW: 0.035"	Integrated: UnknownOTW: 0.035"
Catheter Lengths	25cm and 140cm	30cm
Balloon Lengths	20 and 40mm	24 and 40mm
Balloon Diameters	5.0 thru 12.0mm	5.0 thru 16.0mm
Nominal InflationPressure	6 ATM for all catheters	6 ATM
MAX RecommendedInflation Pressure	12 ATM for balloon diameters 5.0thru 10.0mm10 ATM for balloon diameters11.0 and 12.0mm	16 ATM for balloon diameters 5.0 thru 7.0mm12 ATM for balloon diameters 8.0 thru 11mm10 ATM for balloon diameters 12.0 thru 14.0mm8 ATM for balloon diameter 16.0mm
Single Use?	Yes
Sterilization Method	100% Ethylene Oxide gas
Packaging	Tyvek-Mylar Pouch, Protective Tube, Stylet
Balloon Material	Nylon	Nylon blend
Catheter Materials	Nylon, Pebax/Plexar/HDPE Tri-Extrusion, Platinum-IridiumMarker Bands	Polymer Extrusions (unknown), Platinum-IridiumMarker Bands

In addition, the device was subjected to the following performance tests to support the assertion of substantial equivalence:

Dimensional specifications (including compliance)
l Joint separation strength
' Compatibility with (standard) accessories
l Balloon burst pressure

Image /page/4/Picture/9 description: The image shows a medical illustration of the human head and neck, with the nasal passages, sinuses, and throat highlighted in blue and purple. To the right of the illustration is the text "IMP Intuit Medical Products, LLC" in a blue box. The illustration is a side view of the head and neck, showing the internal structures of the respiratory system.

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Inflation and deflation times
Balloon cycle fatigue
Balloon deflation challenge testing
Biocompatibility Testing in Compliance with the ISO 10993-1 and the FDA Bluebook Memorandum (G-95-1) as follows (and where applicable):
- O Cytotoxicity
- Sensitization (Guinea Pig Maximization) o
- Mucosal (oral) Irritation O

No new questions of safety or effectiveness were identified during device testing; therefore, the Dillard Airway Dilatation System is considered substantially equivalent to the predicate device.

Jack Griffis Vice President, Research & Development

Image /page/5/Picture/11 description: The image shows a logo for Intuit Medical Products, LLC. The logo features a side profile of a person's head and neck, with the inside of the head colored in shades of blue and purple to represent the respiratory system. To the right of the head is a light blue rectangle with the letters "IMP" in large, bold, white font. Below "IMP" are the words "Intuit Medical Products, LLC" in a smaller, white font.

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.