RELIEVA SINUS BALLOON DILATION CATHETER

K043527 · Exploramed Nc1, Inc. · LRC · Apr 5, 2005 · Ear, Nose, Throat

Device Facts

• Record ID: K043527
• Device Name: RELIEVA SINUS BALLOON DILATION CATHETER
• Applicant: Exploramed Nc1, Inc.
• Product Code: LRC · Ear, Nose, Throat
• Decision Date: Apr 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4420
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Relieva Sinus Balloon Dilation Catheter is intended to provide a means to dilate ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.

Device Story

Relieva Sinus Balloon Dilation Catheter is a minimally invasive surgical instrument used to dilate sinus ostia and paranasal spaces. The device consists of a catheter with an inflatable balloon available in 3mm, 5mm, and 7mm sizes. Operation involves placing the catheter over a guidewire into the narrow sinus opening; the balloon is then inflated using a high-pressure inflation device. The inflation device provides internal pressure feedback to the clinician. After maintaining pressure for a few seconds, the balloon is deflated and removed. The device is intended for use by physicians in clinical or surgical settings to facilitate diagnostic or therapeutic procedures. By mechanically enlarging the sinus ostia, the device aims to improve sinus drainage and access, potentially benefiting patients with sinus-related conditions.

Clinical Evidence

Bench testing only. Testing included visual inspection, dimensional analysis, surface finish, catheter hub leak, shaft to hub separation, balloon inflation cycle fatigue, and balloon burst pressure to ensure conformance to product specifications.

Technological Characteristics

Manual surgical instrument; balloon dilation catheter. Available in 3mm, 5mm, and 7mm balloon diameters; 30cm working length. Materials are biocompatible and previously cleared. Operates via high-pressure inflation device (external). Non-powered, mechanical device.

Indications for Use

Indicated for dilation of sinus ostia and paranasal sinus spaces for diagnostic and therapeutic procedures in patients requiring minimally invasive sinus access.

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

• Circular Cutting Punch (Pre-Amendments)
• Antrum Curette (Pre-Amendments)
• Lacricath (K935233)

Submission Summary (Full Text)

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Kou35a7

#### 2005 APR 5

#### 510(k) Summary

| General Information | |
|----------------------|---------------------------------------------------------------------------------------------------------------------|
| Classification: | Class I |
| Classification Name: | Ear, Nose & Throat Manual Surgical Instrument |
| Regulation Code: | 21 CFR 874.4420 |
| Product Code: | LRC |
| Trade Name: | Relieva Sinus Balloon Dilation Catheter |
| Submitter: | ExploraMed NC1, Inc.<br>2570 West El Camino Real, Suite 310<br>Mountain View, CA 94040<br>Telephone: [phone] |
| Contact: | William M. Facteau<br>President & CEO |
| Date Revised: | 05 April 2005 |

#### Intended Use

The Relieva Sinus Balloon Dilation Catheter is intended to provide a means to dilate ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.

#### Device Description

The Relieva Sinus Balloon Dilation Catheter will be provided in the following balloon sizes:

- 3 mm Sinus Balloon Catheter .
- 5 mm Sinus Balloon Catheter .
- 7 mm Sinus Balloon Catheter .

The family of Relieva Sinus Balloon Dilation Catheters allows for the enlargement of sinus ostia and paranasal spaces with a minimally invasive method. The Relieva Sinus Balloon Dilation Catheters are placed in the narrow opening over a guidewire. Once positioned the balloons are inflated with a high pressure inflation device that provides feedback as to the internal pressure of the balloon. After a few seconds at the desired balloon inflation pressure, the balloon can be deflated and removed or repositioned.

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#### Materials

All materials used in the manufacture of the Relieva Sinus Balloon Catheter are suitable for their intended use and have been used in numerous previously cleared products.

#### Testing

Products were tested to ensure conformance to product specification. Testing included:

- Visual Inspection .
- Dimensional Analysis .
- Surface Finish .
- . Catheter Hub Leak
- Shaft to Hub Separation .
- Balloon Inflation Cycle Fatigue .
- Balloon Burst Pressure .

### Summary of Substantial Equivalence

The Relieva Sinus Balloon Catheter is substantially equivalent to marketed predicate devices with respect to intended use and technological characteristics.

### Comparison Chart of Relieva Sinus Balloon Catheter and Predicate Devices

| | Relieva Sinus<br>Balloon | Circular Cutting<br>Punch | Antrum Curette | Lacricath |
|--------------------------|--------------------------|---------------------------------|---------------------------------|--------------------|
| Manufacturer | ExploraMed NC1 | Karl Storz<br>Endoscopy America | Karl Storz<br>Endoscopy America | Atrion |
| 510(k) Number | K043527 | Pre-Amendments | Pre-Amendments | K935233 |
| CFR Section | 874.4420 | 874.4420 | 874.4420 | 886.4350 |
| Device<br>Classification | I | I | I | I |
| Product Code | LRC | LRC | LRC | HNW |
| Intended Use | Dilation of tissue | Dilation of tissue | Dilation of tissue | Dilation of tissue |
| Working Diameter | 3mm, 5mm, 7mm | 4.5mm | 5mm | 3mm, 5mm |
| Working Length | 30cm | 18cm | 19cm | 20cm |

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APR 5 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ExploraMed II, Inc. c/o William M. Facteau President & CEO 2570 W. El Camino Real Suite 310 Mountain View, CA 94040

Re: K043527

Trade/Device Name: Relieva Sinus Balloon Catheter Regulation Number: 21 CFR 874.4420 Regulation Name: ENT manual surgical instrument Regulatory Class: Class I Product Code: LRC Dated: March 24, 2005 Received: March 25, 2005

Dear Mr. Facteau:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

David M. Whipple

David M. Whipple Acting 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): | This application |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Relieva Sinus Balloon Dilation Catheter |
| Indications for Use: | The Relieva Sinus Balloon Dilation Catheter is<br>intended to provide a means to dilate the sinus<br>ostia and spaces within the paranasal sinus<br>cavities for diagnostic and therapeutic<br>procedures. |

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR 801.109) OR

Over-The-Counter Use . (Optional Format 1-2-96)

Kuna A. Baker
(Division Sign-Off)

Division of Ochthalmic Ear, ExploraMed NC1, Inc. Confidential Information Nose and Throat Devises

510(k) Number.

l

012

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