The DSS Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.

Device Description

The DSS Balloon Catheter is a flexible catheter that is intended to dilate the sinus ostia. The device is compatible with commonly used accessories including standard guide wires, guide cannulas and inflation devices. Catheter working length is from 25cm up to 140cm and is available in both over-the-wire (large diameter balloons) and rail configurations (small diameter configurations).

The distal end of the catheter includes a balloon that expands to known diameters and lengths at specific pressures. The balloon has radiopaque markers to assist with radiographic positioning. 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 from either a rapid exchange style distal port just proximal to the balloon (small diameter configurations) or through the central lumen back to the proximal hub (large diameter configurations) and through the distal tip. The DSS Balloon Catheter is supplied sterile and intended for single use.

AI/ML Overview

This FDA 510(k) summary for the Dillard Sinuplasty System (DSS) Balloon Catheter does not contain the detailed acceptance criteria and study information typically found in a clinical study report for device performance. This document primarily focuses on establishing substantial equivalence to predicate devices based on:

Indications for Use: The DSS Balloon Catheter is intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, it's specifically for dilating sinus ostia and spaces associated with the maxillary sinus.
Fundamental scientific technology.
Important performance specifications.
Non-clinical performance testing: This includes dimensional verification, balloon rated burst pressure, balloon fatigue, balloon inflation and deflation, catheter joint bond strengths, and biocompatibility testing.

The document states that "No new questions of safety or effectiveness were identified during device testing," which implies that the device met internal design specifications and safety requirements as demonstrated by these tests. However, it does not provide:

A table of acceptance criteria and reported device performance with specific numerical values. The listed performance tests are categories, not specific criteria or results.
Clinical study details: This includes sample size, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, or details on ground truth establishment for either training or test sets. This device appears to have been approved based on substantial equivalence and non-clinical bench testing, not a clinical trial demonstrating specific performance metrics against clinical outcomes or expert consensus.

Therefore, for the specific questions asked, based solely on the provided text:

A table of acceptance criteria and the reported device performance: Not provided in the document. The document lists performance tests conducted (e.g., Balloon Rated Burst Pressure (RBP), Balloon Fatigue) but does not state the specific acceptance criteria (e.g., "RBP must be > X psi") or the actual reported performance values.
Sample sized used for the test set and the data provenance: Not applicable as no clinical test set for performance against human or clinical outcome ground truth is described. The tests mentioned are non-clinical, bench-top tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no expert ground truth for a clinical test set is described.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a manual surgical instrument, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used: For the non-clinical tests, the "ground truth" would be established engineering specifications and physical properties of the materials and device. For example, for "Dimensional Verification," the ground truth is the engineering drawing specification.
The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary, this document is a 510(k) summary, which establishes substantial equivalence, often through bench testing and comparisons to predicate devices, rather than comprehensive clinical performance studies involving human subjects and specific acceptance criteria for diagnostic accuracy or clinical outcomes.

Summary

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

August 27, 2015

Intuit Medical Products, LLC Mr. Jack Griffis Vice President, R&D 6018 Eagles Rest Trail Sugar Hill, Georgia 30518

Re: K143738

Trade/Device Name: Dillard Sinuplasty Balloon Catheter Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, and Throat Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: July 28, 2015 Received: July 29, 2015

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.

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

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the quality systems (OS) 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 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: _______________________________________________________________________________________________________________________________________________________________

Device Name: DSS Balloon Catheter

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary

510(k) Number:

December 28th, 2014 Date Prepared:

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 Sinuplasty System (DSS) Common Name: Sinus Balloon Catheter
D. Classification: Ear, Nose, and Throat Manual Surgical Instrument LRC, 21 CFR 874.4420

E. Predicate Device(s):

Acclarent Relieva® and Relieva Acella Sinuplasty Balloon Catheter, K073041 Acclarent Relieva® Solo Sinuplasty Balloon Catheter, K111254

F. Physical Description:

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G. Indications for Use:

H. Comparison of Characteristics / Performance Testing / Substantial Equivalence:

The DSS Balloon Catheter is substantially equivalent to the predicate devices in intended use, indications for use, fundamental scientific technology, and important performance specifications. The device was subjected to the following performance tests to support the assertion of substantial equivalence:

Dimensional Verification
Balloon Rated Burst Pressure (RBP) ●
Balloon Fatigue
Balloon Inflation and Deflation
Catheter Joint Bond Strengths
. Biocompatibility Testing in Compliance with the ISO 10993-1 and the FDA Bluebook Memorandum (G-95) as follows:
- Cytotoxicity o
- Sensitization (Guinea Pig Maximization) о
- Irritation and (Acute) Systemic Toxicity O
- o Material-mediated Pyrogenicity

No new questions of safety or effectiveness were identified during device testing; therefore, the DSS Balloon Catheter is considered substantially equivalent to the predicate devices.

Jack Griffis Vice President, Research & Development

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Regulation Number and Section

§ 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.