MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER

K093594 · Acclarent, Inc. · KAM · Mar 3, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K093594
• Device Name: MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER
• Applicant: Acclarent, Inc.
• Product Code: KAM · General, Plastic Surgery
• Decision Date: Mar 3, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4800
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The MicroFlow Spacer (Frontal) is indicated for use as a postoperative spacer to maintain an opening to the frontal sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction. The MicroFlow Spacer (Ethmoid) is indicated for use as a postoperative spacer to maintain an opening to the ethmoid sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction.

Device Story

The Relieva Stratus MicroFlow Spacer is a manual surgical instrument designed for implantation into the frontal or ethmoid sinuses. It functions as a postoperative spacer to maintain sinus patency and prevent obstruction for up to 14 days. The device utilizes a self-retention mechanism to maintain its position within the sinus cavity. It is intended for use by physicians in a clinical setting and can be manually removed during a follow-up office visit. By maintaining the surgical opening, the device supports the healing process and prevents post-surgical closure of the sinus ostia.

Clinical Evidence

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

Technological Characteristics

Manual surgical instrument; self-retention mechanism for sinus implantation; frontal and ethmoid models; non-powered.

Indications for Use

Indicated for postoperative patients requiring maintenance of an opening to the frontal or ethmoid sinuses for up to 14 days following surgery to prevent obstruction.

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 Stratus MicroFlow Spacer (K083574)

Submission Summary (Full Text)

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Aclarent

## MAR - 3 2010

:

Krg3594

| | APPENDIX A: 510(k) SUMMARY |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor/Submitter: | Acclarent, Inc.<br>1525-B O'Brien Drive<br>Menlo Park, California 94025 |
| Contact Person: | Courtney Kalof<br>Regulatory Affairs Coordinator<br>Phone: [phone]<br>Fax: [phone] |
| Date of Submission: | November 16, 2009 |
| Device Trade Name: | Relieva Stratus MicroFlow Spacer |
| Common Name: | MicroFlow Spacer |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 878.4800 |
| Classification Name: | Manual surgical instrument for general use |
| Product Code: | KAM |
| Predicate Device: | Relieva Stratus MicroFlow Spacer (K083574) |
| Device Description: | The MicroFlow Spacer is a device that maintains an opening at the<br>target sinus for up to 14 days postoperatively. There are two models of<br>the MicroFlow Spacer: Ethmoid and Frontal. The modified device can<br>be manually removed during an office follow-up visit at any time. |
| Indications for Use: | The MicroFlow Spacer (Ethmoid) is indicated for use as a postoperative<br>spacer to maintain an opening to the ethmoid sinuses within the first 14<br>days following surgery. The MicroFlow Spacer also helps to prevent<br>obstruction.<br><br>The MicroFlow Spacer (Frontal) is indicated for use as a postoperative<br>spacer to maintain an opening to the frontal sinuses within the first 14<br>days following surgery. The MicroFlow Spacer also helps to prevent<br>obstruction. |
| Technological<br>Characteristics: | The MicroFlow Spacer is designed to be implanted into the frontal or<br>ethmoid sinuses and to maintain its position by a self-retention<br>mechanism. |

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Performance Data:

The MicroFlow Spacer met all performance acceptance criteria.

Summary of Substantial Equivalence:

. .

The MicroFlow Spacer is substantially equivalent to the predicate device as confirmed through relevant performance tests.

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MAR 3 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Acclarent, Inc. c/o Ms. Courtney Kalof Regulatory Affairs Coordinator 1525-B O'Brien Dr. Meno Park, CA 94025

Re: K093594

Trade/Device Name: Relieva Stratus MicroFlow Spacer Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: Class I Product Code: KAM Dated: January 26, 2010 Received: January 27, 2010

Dear Ms. Kalof:

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.

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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 device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Peter Schmidt

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

Enclosure

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K093594

Acclarént

## APPENDIX B: INDICATIONS FOR USE STATEMENT

| 510(k) Number (if known): | K093594 |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Relieva Stratus MicroFlow Spacer |
| Common Name: | MicroFlow Spacer |
| Indications For Use: | The MicroFlow Spacer (Frontal) is indicated for use as a postoperative spacer to maintain an opening to the frontal sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction.<br>The MicroFlow Spacer (Ethmoid) is indicated for use as a postoperative spacer to maintain an opening to the ethmoid sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction. |
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
| | AND/OR |
| Over-The-Counter Use<br>(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)

Daniel C. Cupp
(Division Sign-Off)

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Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

:10(k) Number KD93594