RELIEVA SINUS BALLOON INFLATION DEVICE

K052198 · Acclarent, Inc. · LRC · Aug 31, 2005 · Ear, Nose, Throat

Device Facts

• Record ID: K052198
• Device Name: RELIEVA SINUS BALLOON INFLATION DEVICE
• Applicant: Acclarent, Inc.
• Product Code: LRC · Ear, Nose, Throat
• Decision Date: Aug 31, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4420
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Relieva Sinus Balloon Inflation Device is recommended for use to inflate the balloon, monitor the pressure within the balloon and deflate the balloon while performing balloon dilation procedures of the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.

Device Story

Disposable inflation device with integrated manometer; used to inflate, monitor pressure, and deflate dilation balloons during sinus ostia/paranasal sinus procedures. Operated by clinicians in surgical settings. Provides pressure control to ensure safe balloon dilation; facilitates therapeutic access to sinus cavities.

Clinical Evidence

Bench testing only. Testing included pressure accuracy, pressure decay, and pressure integrity to ensure conformance to product specifications.

Technological Characteristics

Disposable manual inflation device with integrated manometer. Measures pressures from vacuum to gauge capacity. Materials are biocompatible and previously cleared in other products. No software or electronic components.

Indications for Use

Indicated for use in patients undergoing balloon dilation procedures of the sinus ostia and paranasal sinus cavities for diagnostic and therapeutic purposes.

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

• Relieva Sinus Balloon Catheter (K043527)
• Circular Cutting Punch (Pre-Amendments)
• Antrum Curette (Pre-Amendments)

Submission Summary (Full Text)

{0}------------------------------------------------

# AUG 3 1 2005

### 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 Inflation Device |
| Submitter: | Acclarent, Inc.<br>1525-B O'Brien Drive<br>Menlo Park, CA 94025 |
| Contact: | Su-Mien Chong<br>VP, Clinical, Regulatory and Quality |
| Date Revised: | 25 August 2005 |

### Intended Use

The Relieva Sinus Balloon Inflation Device is recommended for use to inflate the balloon, monitor the pressure within the balloon and deflate the balloon while performing balloon dilation procedures of the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.

### Device Description

The Relieva Sinus Balloon Inflation Device is a disposable inflation device with a manometer that measures pressures ranging from vacuum to gauge capacity.

### Materials

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

{1}------------------------------------------------

### Testing

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

- Pressure Accuracy .
- Pressure Decay .
- Predicate Comparison .
- Pressure Integrity .

# Summary of Substantial Equivalence

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

### Comparison Chart of Relieva Sinus Balloon Inflation Device and Predicate Devices

| | Relieva Sinus<br>Inflation<br>Device | Relieva Sinus<br>Balloon<br>Catheter | Circular Cutting<br>Punch | Antrum Curette |
|--------------------------|-------------------------------------------------|--------------------------------------|------------------------------------|------------------------------------|
| Manufacturer | Acclarent | ExploraMed NC1 | Karl Storz<br>Endoscopy<br>America | Karl Storz<br>Endoscopy<br>America |
| 510(k) Number | K052198 | K043527 | Pre-Amendments | Pre-Amendments |
| CFR Section | 874.4420 | 874.4420 | 874.4420 | 874.4420 |
| Device<br>Classification | I | I | I | I |
| Product Code | LRC | LRC | LRC | LRC |
| Intended Use | Inflation &<br>deflation of<br>dilation balloon | Dilation of tissue | Dilation of tissue | Dilation of tissue |
| Working<br>Diameter | 8mm | 3mm, 5mm,<br>7mm | 4.5mm | 5mm |
| Working<br>Length | 20 cm | 30cm | 18cm | 19cm |

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings. The eagle is facing to the right.

Public Health Service

AUG 3 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Acclarent, Inc. c/o Su-Mien Chong VP Cinical, Regulatory and Quality 1525-B O'Brien Drive Menlo Park, CA 94025

Re: K052198

Trade/Device Name: Relieva Sinus Balloon Inflation Device Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, nose, and throat manual surgical instrument Regulatory Class: Class I Product Code: LRC Dated: August 11, 2005 Received: August 12, 2005

Dear Ms. Chong

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications felerenced above and nave determined in the are and and the summer of the marketed in interstate for use stated in the enclosure) to regard mannent date of the Medical Device Amendments, or to comments to May 20, 1978, the exactions with the provisions of the Federal Food. Drug, devices that have been recalismed in abece approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval app and Cosment Act (Act) market the device, subject to the general controls provisions of the Act. The 1 ou may, merciore, market the act include requirements for annual registration, listing of general controls provisions of the sice, 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 If your device is classified (see aborto) into Existing major regulations affecting your device can may be subject to suen additional connections, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous neements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1 Dri 3 issuated or a basevice complies with other requirements of the Act that TDA has made a determination an administered by other Federal agencies. You must of any Federal statutes and regulations and admited to: registration and listing (21 Comply with an the Her s requirements, and manufacturing practice requirements as set CFK Fart 807), adoling (21 CFR Part 820), good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

#### Page 2 - Su-Mien Chong

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maneting your antial equivalence of your device to a legally premitsel notification. The PDA miding of baction 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 If you desire specific advice for your ac 101 x 27-8910. Also, please note the regulation entitled, Colliact the Office of Complanoo at (301) SET 971 SET Part 807.97). You may obtain Misorananing by Telefone to premail.com in the Act from the Division of Small other general information on your response Assistance at its toll-free number [phone] or Mandracturers, International and Ocusal 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

{4}------------------------------------------------

## Indications for Use

K052198

510(k) Number (if known):

Device Name:

Indications for Use:

Relieva Sinus Balloon Inflation Device

The Relieva Sinus Balloon Inflation Device is recommended for use to inflate the balloon, monitor the pressure within the balloon and deflate the balloon while performing balloon dilation procedures of the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic 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)

Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K052498

Page 1 of 13