RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A

K071845 · Acclarent, Inc. · KAM · Sep 28, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K071845
• Device Name: RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A
• Applicant: Acclarent, Inc.
• Product Code: KAM · General, Plastic Surgery
• Decision Date: Sep 28, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4800
• Device Class: Class 1

Intended Use

The Relieva Luma™ Sinus Illumination System is intended to provide a means to access the sinus space for diagnostic and therapeutic procedures in conjunction with other nasal and sinus products. It is also intended to illuminate within and transilluminate across nasal and sinus structures.

Device Story

Relieva Luma™ Sinus Illumination System is a flexible guidewire device designed for sinus access. It transmits light from its distal tip to provide internal illumination and transillumination of nasal and sinus structures. The device connects to a standard external light source via an included light cable and adapter. Used by clinicians during nasal and sinus procedures, the device assists in navigating and visualizing sinus anatomy. By providing light, it helps the physician confirm the position of the guidewire within the sinus space, facilitating diagnostic or therapeutic interventions. This visual feedback aids in accurate placement, potentially improving procedural outcomes and patient safety during sinus surgery.

Clinical Evidence

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

Technological Characteristics

Flexible sinus guidewire with distal tip light transmission. Connects to standard external light sources via proprietary light cable and adapter. Class I manual surgical instrument.

Indications for Use

Indicated for patients requiring access to the sinus space for diagnostic or therapeutic procedures in conjunction with other nasal and sinus products, and for illumination within or transillumination across nasal and sinus structures.

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 Guidewire (K043445)

Submission Summary (Full Text)

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K071845

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SEP 2 8 7007

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## APPENDIX A: 510(k) SUMMARY

| | APPENDIX A: 510(k) SUMMARY |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor/Submitter: | Acclarent, Inc.<br>1525-B O'Brien Drive<br>Menlo Park, California 94025 |
| Contact Person: | Keri Yen<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |
| Date of Submission: | July 3, 2007 |
| Device Trade Name: | Relieva Luma™ Sinus Illumination System |
| Common Name: | Sinus Guidewire |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 878.4800 |
| Classification Name: | Manual surgical instrument for general use |
| Product Code: | KAM |
| Predicate Device: | Relieva™ Sinus Guidewire (K043445) |
| Device Description: | The Relieva Luma™ Sinus Illumination System is a flexible device<br>that transmits light at the distal tip. The system also contains two<br>accessories: a light cable and an adapter. |
| Indications for Use: | The Relieva Luma™ Sinus Illumination System is intended to provide<br>means to access the sinus space for diagnostic and therapeutic<br>procedures in conjunction with other nasal and sinus products. It is<br>also intended to illuminate within and transilluminate across nasal and<br>sinus structures. |
| Technological<br>Characteristics | The Relieva Luma™ Sinus Illumination System is a device that<br>allows for access to the desired sinus space. Light from the distal tip<br>of the device can be seen via transillumination. The device is<br>connected to any standard light source via a light cable and an<br>adapter. |
| Performance Data | The Relieva Luma™ Sinus Illumination System met all performance<br>testing acceptance criteria. |
| Summary of<br>Substantial<br>Equivalence: | The Relieva Luma™ Sinus Illumination System is substantially<br>equivalent to the predicate device as confirmed through relevant<br>performance tests. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 2007

Acclarent, Inc. c/o Keri Yen Regulatory Affairs Specialist 1525-B O'Brien Drive Menlo Park, CA 90425

Re: K071845

Trade/Device Name: Relieva Luma™ Sinus Illumination System Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: Class I Product Code: KAM Dated: August 30, 2007 Received: August 31, 2007

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, 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 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 yours.

M.B. Eylerus, MD

Malvina B. 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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KO7184S

## APPENDIX B: INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K071845

Relieva Luma™ Sinus Illumination System Trade Name: Sinus Guidewire Common Name: The Relieva Luma™ Sinus Illumination System is intended to provide a Indications For Use: means to access the sinus space for diagnostic and therapeutic procedures in conjunction with other nasal and sinus products. It is also intended to illuminate within and transilluminate across nasal and sinus structures.

Prescription Use X (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)

Page of

(Posted November 13, 2003)

Division Sign-Division of Ophthalmic Ea Nose and Throat D

**510(k) Number**