K Number

Device Name

DSS Sinusplasty Balloon Catheter

Manufacturer

Intuit Medical Products, LLC

Date Cleared

2015-08-27

(240 days)

Product Code

LRC

Regulation Number

874.4420

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K073041, K111254

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical device (balloon catheter) and its physical properties and performance tests. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "therapeutic procedures."

Diagnostic

The device is primarily intended to dilate sinus ostia and spaces, which is a therapeutic action. While it can be used for "diagnostic and therapeutic procedures," its function is not to diagnose conditions but to facilitate procedures, which may include diagnostic steps. The device itself does not perform any diagnostic measurements or analyses.

SaMD (Software as a Medical Device)

The device description clearly outlines a physical catheter with a balloon, lumens, a hub, and radiopaque markers. The performance studies also focus on physical properties like burst pressure, fatigue, and bond strengths, indicating a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures." This describes a physical intervention within the body, not a test performed on samples taken from the body.
Device Description: The description details a physical catheter with a balloon for dilation, designed for insertion into the sinuses. This is a medical device used for a procedure, not for analyzing biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting specific substances, or providing information about a patient's health status based on laboratory testing.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device performs a mechanical action (dilation) within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

LRC

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

sinus ostia and spaces within the paranasal sinus cavities, maxillary sinus

Indicated Patient Age Range

For children aged 17 and under, and inferred for adults.

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 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
- Sensitization (Guinea Pig Maximization)
- Irritation and (Acute) Systemic Toxicity
- 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K073041, K111254

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing right, with three lines above them that could be interpreted as wings or feathers.

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

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

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)

Page 1 of 1

Image /page/3/Picture/0 description: The image shows the logo for Intuit Medical Products LLC. The logo features the company name in bold, black font, with the words "Intuit Medical Products" on the top line and "LLC" on the bottom right. A light blue line underlines the company name. To the left of the company name is a circular design with gray and light blue concentric circles.

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:

G. Indications for Use:

H. Comparison of Characteristics / Performance Testing / 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

Image /page/4/Picture/18 description: The image is a logo for Intuit Medical Products LLC. The logo features a blue and gray circular design on the left side, with the text "Intuit Medical Products" in bold, black letters to the right of the circle. A blue line underlines the text, and the letters "LLC" are in smaller, black font in the bottom right corner of the logo.