RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER

K073041 · Acclarent, Inc. · KAM · Mar 11, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073041
• Device Name: RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER
• Applicant: Acclarent, Inc.
• Product Code: KAM · General, Plastic Surgery
• Decision Date: Mar 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4800
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended Use

Relieva Sinus 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. Relieva Acella Sinus 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

Relieva and Relieva Acella Sinus Balloon Catheters are manual surgical instruments used to dilate blocked sinus ostia and paranasal spaces. The device consists of a catheter with an integrated balloon; the balloon is inflated using a high-pressure inflation device. Used by physicians in clinical settings to perform diagnostic and therapeutic procedures. The device provides mechanical dilation of the sinus ostia, which can improve sinus drainage and ventilation, potentially benefiting patients with chronic sinusitis or other obstructive sinus conditions.

Clinical Evidence

Bench testing only. The devices met all performance acceptance criteria.

Technological Characteristics

Manual surgical instruments; balloon-based dilation mechanism; high-pressure inflation device required for operation; non-powered; sterile.

Indications for Use

Indicated for dilation of sinus ostia and paranasal sinus spaces in adults; for children aged 17 and under, indicated for dilation of sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.

Regulatory Classification

Identification

A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.

Predicate Devices

• Relieva Sinus Balloon Catheter (K043527)
• Relieva Acella Sinus Balloon Catheter (K061903)

Submission Summary (Full Text)

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

Acclarent

K073041

Traditional 510(k)

2008

| Sponsor/Submitter: | Acclarent, Inc.<br>1525-B O'Brien Drive<br>Menlo Park, California 94025 | MAR 1 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|
| Contact Person: | Keri Yen<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] | |
| Date of Submission: | October 26, 2007 | |
| Device Trade Name: | Relieva™ Sinus Balloon Catheter<br>Relieva Acella™ Sinus Balloon Catheter | |
| Common Name: | Sinus Balloon Catheter<br>Sinus Balloon Catheter—Integrated Wire | |
| Device Classification: | Class I | |
| Regulation Number: | 21 CFR 874.4420 | |
| Classification Name: | ENT Manual Surgical Instrument | |
| Product Code: | LRC | |
| Predicate Devices: | Relieva Sinus Balloon Catheter (K043527)<br>Relieva Acella Sinus Balloon Catheter (K061903) | |
| Device Description: | The Relieva Sinus Balloon Catheter is a catheter designed to<br>dilate the sinus ostia and paranasal spaces in adults and<br>maxillary sinus spaces in children.<br><br>The Relieva Acella Sinus Balloon Catheter is a catheter<br>designed to access and to dilate the sinus ostia and paranasal<br>spaces in adults and maxillary sinus spaces in children. | |
| Indications for Use: | Relieva Sinus Balloon Catheter is an instrument intended to<br>dilate sinus ostia and spaces within the paranasal sinus cavities<br>for diagnostic and therapeutic procedures. For children aged<br>17 and under, the balloon catheter system is intended to dilate<br>sinus ostia and spaces associated with the maxillary sinus for<br>diagnostic and therapeutic procedures.<br><br>Relieva Acella Sinus Balloon Catheter is an instrument<br>intended to dilate sinus ostia and spaces within the paranasal<br>sinus cavities for diagnostic and therapeutic procedures. For<br>children aged 17 and under, the balloon catheter system is<br>intended to dilate sinus ostia and spaces associated with the<br>maxillary sinus for diagnostic and therapeutic procedures. | |
| Technological<br>Characteristics: | The Relieva Sinus Balloon Catheter and the Relieva Acella<br>Sinus Balloon Catheter utilize a balloon to dilate blocked nasal<br>passageways. The balloon is inflated with a high pressure<br>inflation device. | |
| Performance Data: | The Relieva Sinus Balloon Catheter met all performance<br>acceptance criteria. | |
| | The Relieva Acella Sinus Balloon Catheter met all<br>performance criteria. | |
| Summary of Substantial<br>Equivalence: | The clarifying statement added to the indications for use does<br>not impact the intended use, performance, fundamental<br>scientific technology, or safety and effectiveness of the subject<br>device and therefore the subject device is substantially<br>equivalent to the predicate devices. | |
| | The Relieva Sinus Balloon Catheter and the Relieva Acella<br>Sinus Balloon Catheter are substantially equivalent to the<br>predicate devices. | |

## APPENDIX A: 510(k) SUMMARY

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

K073041

Image /page/1/Picture/1 description: The image shows the word "Acclarent" in a bold, sans-serif font. A curved line appears above the right side of the word, starting above the 'e' and extending to the right. The text is black against a white background.

## Relieva™ Sinus Balloon Catheter
Relieva Acella™ Sinus Balloon Catheter

Traditional 510(k)

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines extending from the bottom of the profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 1 2008

Acclarent, Inc c/o Keri Yen 1525-B O'Brien Drive Menlo Park, CA 94025

Re: K073041

Trade/Device Name: Relieva™ Sinus Balloon Catheter Relieve™ Acella Sinus Balloon Catheter Regulation Number: 21 CFR 874.4800 Regulation Name: ENT Manual Surgical Instrument Regulatory Class: Class I Product Code: KAM Dated: February 18, 2008 Received: February 19, 2008

Dear Ms. Yen:

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, Trug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA), 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 af 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.

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

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Maling B. Epple, M.D.

Malvina B. Eydelman, M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

K073041

Image /page/4/Picture/1 description: The image shows the word "Acclarent" in a bold, sans-serif font. There is a curved line above the word, starting from the "A" and ending near the "t". The text is black against a white background.

Traditional 510(k)

Relieva™ Sinus Balloon Catheter Relieva Acella™ Sinus Balloon Catheter

## APPENDIX B: INDICATIONS FOR USE STATEMENT

K073041 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number (if known): Relieva™ Sinus Balloon Catheter Trade Name: Relieva™ Acella Sinus Balloon Catheter Sinus Balloon Catheter Common Name: Sinus Balloon Catheter-Integrated Wire Relieva Sinus Balloon Catheter is an instrument intended to dilate sinus Indications For Use: 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. Relieva Acella Sinus 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 Over-The-Counter Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

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

(Posted November 13, 2003)
Khen & Baken

(Division Sian-Off Division of Ophthalmic Ea Nose and Throat Devise

510(k) Number K073041