MICROENDOSCOPE

K063078 · Acclarent, Inc. · EOB · Oct 24, 2006 · Ear, Nose, Throat

Device Facts

• Record ID: K063078
• Device Name: MICROENDOSCOPE
• Applicant: Acclarent, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Oct 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2

Intended Use

The MicroEndoscope is intended to provide an endoscopic means to view a body cavity for ear, nose or throat procedures.

Device Story

MicroEndoscope is a semi-rigid fiberscope designed for visualization of ear, nose, and throat cavities. Device utilizes illumination and image fibers to transmit visual data from distal to proximal end. It includes a camera coupler for connection to standard endoscopic cameras. Operated by clinicians in clinical settings; device is non-sterile and requires sterilization prior to use. Output is a visual image displayed via external camera system, assisting physicians in diagnostic or procedural visualization of anatomical structures.

Clinical Evidence

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

Technological Characteristics

Semi-rigid fiberscope; contains illumination and image fibers for optical transmission. Includes camera coupler for standard endoscopic camera interface. Non-sterile; requires sterilization prior to use. Class II device under 21 CFR 874.4760.

Indications for Use

Indicated for patients undergoing ear, nose, or throat procedures requiring endoscopic visualization of body cavities. Prescription use only.

Regulatory Classification

Identification

A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

Predicate Devices

• Pollux Endoscopy Sinuscope (K002214)
• Acueity ViaDuct MicroEndoscope and Accessories (K011189)
• EBI VueCath Spinal Endoscopic System (K010179)

Submission Summary (Full Text)

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## APPENDIX A: 510(k) SUMMARY

| Sponsor/Submitter: | Acclarent, Inc.<br>1525-B O'Brien Drive<br>Menlo Park, California 94025 |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Debbie Cogan<br>Quality Engineer<br>Phone: [phone]<br>Fax: [phone] |
| Date of Submission: | October 6, 2006<br>OCT 24 2006 |
| Device Trade Name: | To be determined |
| Common Name: | MicroEndoscope |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 874.4760 |
| Classification Name: | Nasopharyngoscope (flexible or rigid) and accessories |
| Product Code: | EOB |
| Predicate Device: | Pollux Endoscopy Sinuscope (K002214)<br>Acueity ViaDuct MicroEndoscope and Accessories (K011189)<br>EBI VueCath Spinal Endoscopic System (K010179) |
| Device Description: | The MicroEndoscope is a semi-rigid fiberscope that allows for<br>visualization of the ear, nose, and throat. The device is labeled non-<br>sterile and must be sterilized prior to use. The MicroEndoscope is<br>accompanied by a camera coupler, which allows the<br>MicroEndoscope to connect to a standard endoscopic camera. |
| Indications for Use: | The MicroEndoscope is intended to provide an endoscopic means to<br>view a body cavity for ear, nose or throat procedures. |
| Technological<br>Characteristics | The MicroEndoscope contains illumination and image fibers that<br>transmit an image from the distal to the proximal end of the device. |
| Performance Data | The MicroEndoscope met all performance testing acceptance<br>criteria. |
| Summary of<br>Substantial<br>Equivalence: | The MicroEndoscope is substantially equivalent to the predicate<br>devices as confirmed through relevant performance tests. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Acclarent, Inc. c/o Debbie Cogan Clinical and Regulatory Manager 1525-B O'Brien Drive Menlo Park, CA 94025

OCT 2 4 2006

Re: K063078

Trade/Device Name: MicroEndoscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: October 6, 2006 Received: October 10, 2006

Dear Ms. Cogan:

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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## Page 2 – Debbie Cogan

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,

M.B. Egelman Simund

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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Traditional 510(k): MicroEndoscope

.... . .

## APPENDIX B: INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K063078

Trade Name:

To be determined

Common Name:

MicroEndoscope

Indications For Use:

The MicroEndoscope is intended to provide an endoscopic means to view a body cavity for ear, nose or throat procedures.

Prescription Use (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)

Karin Bohm

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

510(k) Number K063078

X Prescription Use (Per 21 CFR 801.109)