DSS Sinusplasty Balloon Catheter

K143738 · Intuit Medical Products, LLC · LRC · Aug 27, 2015 · Ear, Nose, Throat

Device Facts

• Record ID: K143738
• Device Name: DSS Sinusplasty Balloon Catheter
• Applicant: Intuit Medical Products, LLC
• Product Code: LRC · Ear, Nose, Throat
• Decision Date: Aug 27, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4420
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

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 Story

Flexible balloon catheter for dilation of sinus ostia; used in paranasal sinus cavities. Device features distal balloon with radiopaque markers for radiographic positioning; proximal hub with luer connector for inflation; dual-lumen design for guidewire compatibility (rapid exchange or over-the-wire). Operated by physicians in clinical settings. Device is compatible with standard guide wires, guide cannulas, and inflation devices. Inflation of balloon at specific pressures dilates sinus ostia to facilitate therapeutic access. Supplied sterile for single use.

Clinical Evidence

Bench testing only. Testing included dimensional verification, balloon rated burst pressure, balloon fatigue, inflation/deflation, catheter joint bond strengths, and biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, material-mediated pyrogenicity).

Technological Characteristics

Flexible catheter with distal balloon and proximal plastic hub. Available in over-the-wire and rail configurations. Lengths 25cm-140cm. Radiopaque markers for positioning. Biocompatibility per ISO 10993-1 and FDA G-95. Sterile, single-use. Mechanical dilation principle.

Indications for Use

Indicated for dilation of sinus ostia and paranasal sinus spaces for diagnostic/therapeutic procedures in adults and children (age 17 and under, maxillary sinus only).

Regulatory Classification

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.

Predicate Devices

• Acclarent Relieva and Relieva Acella Sinuplasty Balloon Catheter (K073041)
• Acclarent Relieva Solo Sinuplasty Balloon Catheter (K111254)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

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 [phone] (direct) [e-mail]
- 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:

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.

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### G. Indications for 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.

### 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

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.