NASOPHARYNGOSCOPE, BRONCHOSCOPE

K070580 · Xion GmbH · EOB · Jun 13, 2007 · Ear, Nose, Throat

Device Facts

• Record ID: K070580
• Device Name: NASOPHARYNGOSCOPE, BRONCHOSCOPE
• Applicant: Xion GmbH
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Jun 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Nasopharyngoscopes are intended to examine or treat the nasal cavity and nasal pharynx. They are used between the upper respiratory tracts of the nasal passage and the vocal chords. They allow the recognition of anomalies in the tissue of the accessible organs. The EF-N 14 and EF-N 14S models with their working channel allow the insertion of an instrument to carry out a biopsy.

Device Story

Flexible nasopharyngoscope used for visualization and treatment of nasal cavity and pharynx; includes insertion tube with bendable distal tip, handle, eyepiece, and focus ring. Models EF-N 14 and EF-N 14S feature a working channel for biopsy instrument insertion. Operated by physicians in clinical settings to identify tissue anomalies. Device transmits optical images via fiber-optics to the eyepiece. Provides diagnostic visualization and enables interventional access to upper respiratory tracts.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Flexible fiber-optic endoscope. Materials: medical grade silicone (body cover), stainless steel (connectors/valves), medical grade plastics (eyepiece/focus ring), anodized/parylene-coated aluminum (control lever). Features: 2.8-4.1 mm sheath diameter, 320 mm working length, 130° up/down bending angle, 80° field of view. Connectivity: compatible with standard light guide cables (ACMI, Richard Wolf, Storz). Sterilization: not specified.

Indications for Use

Indicated for examination or treatment of the nasal cavity and nasal pharynx, including the upper respiratory tracts from the nasal passage to the vocal chords, in patients requiring visualization or biopsy (EF-N 14/14S models) of tissue anomalies.

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

• Flexible nasopharyngo-laryngoscope and flexible bronchoscope (K992526)

Submission Summary (Full Text)

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K070580

Image /page/0/Picture/1 description: The image shows the logo for XION medical. The logo consists of the word "XION" in a sans-serif font, with the "i" dotted with a solid black circle. Below the "ION" portion of the logo is the word "medical" in a smaller font size.

## 510(k) - Summary 6

| Submitter: | XION GmbH<br>Pankstr. 8-10<br>13127 Berlin<br>Germany<br>Phone [phone]<br>Fax [phone] | JUN 1 3 2007 |
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| Contact: | Alexander Kliem<br>Email [e-mail] | |
| Date: | 05/11/2007 | |
| Name of Device: | Nasopharyngoscope EF-N, EF-NS, EF-N Slim, EF-N 14, EF-N 14 S | |
| Common Name: | Naso-pharyngo-laryngo-fiberscope | |
| Classification Name of Device: | Nasopharyngoscope a) product code: EOB<br>b) regulation number: 874.4760 | |
| Legally Marketed Device to which Equivalence is Claimed: | Flexible nasopharyngo-laryngoscope and flexible bronchoscope<br>Richard Wolf Medical Instruments Corp.<br>(Premarket notification K992526) | |
| Description: | Flexible nasopharyngoscopes with or without a working channel are built of the insertion tube with its bendable distal tip, the handle, the eyepiece and the focus ring. The handle incorporates the control lever to bend the distal tip and the connectors for the leakage tester and the fibre-optic light- guide cable. | |
| Indications for Use: | Nasopharyngoscopes are intended to examine or treat the nasal cavity and nasal pharynx. They are used between the upper respiratory tracts of the nasal passage and the vocal chords. They allow the recognition of anomalies in the tissue of the accessible organs. The EF-N 14 and EF-N 14S models with their working channel allow the insertion of an instrument to carry out a biopsy. | |

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| | SE Device | | Predicate Device |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| | XION Device | | Richard Wolf Device |
| Name | Nasopharyngoscope<br>(flexible or rigid) | | Flexible nasopharyngo-<br>laryngoscope and flexible<br>bronchoscope,<br>Richard Wolf Medical Instruments<br>Corp. |
| Identification | EF-N<br>EF-NS<br>EF-N Slim<br>EF-N14<br>EF-N14S | 130 400 034<br>130 400 134<br>130 400 028<br>130 414 040<br>130 414 140 | 7222, 7223, 7224, 7265, 7325,<br>7330 |
| Performance specification | Nasopharyngoscope | | Nasopharyngoscope |
| Sheath diameter | 2.8 - 4.1 mm | | 3.5 mm |
| Working length | 320 mm | | 300 mm |
| Bending angle<br>Up | 130° | | 130° |
| Down | 130° | | 130° |
| Bending radius | 8 mm | | |
| Optical system<br>Field of view | 80° | | 95° |
| Depth of field | 1 - 50 mm | | 3 - 50 mm |
| Weight | 230 - 320 g | | |
| Forceps channel diameter | 1.4 mm | | 1.1 mm |
| SE Device | | Predicate Device | |
| | XION Device | Richard Wolf Device | |
| Appearance, shape | | | |
| Control lever | Handling by turning, rotation axis<br>across to longitudinal axis of the<br>endoscope;<br>Milled of aluminium, anodized (for<br>mechanical resistance), parylene<br>coated (for chemical resistance) | Handling by turning, rotation axis<br>across to longitudinal axis of the<br>endoscope;<br>Milled of aluminium, black coated | |
| Light guide connector | Compatible to ACMI, Richard Wolf<br>and STORZ light guide cable;<br>Manufactured of stainless steel | Compatible to Richard Wolf light<br>guide cable;<br>Manufactured of stainless steel | |
| Leak tester connector | XION-standard;<br>Manufactured of stainless steel | Richard Wolf-standard;<br>Manufactured of stainless steel | |
| Biopsy channel entry | Compatible to FUJINON;<br>Manufactured of stainless steel | ISO594-2.2(Luer-Lock-innercone);<br>Manufactured of stainless steel | |
| Eyepiece | DIN 58105 (Medical endoscopes);<br>Manufactured of medical grade<br>plastics | DIN 58105 (Medical endoscopes);<br>Manufactured of medical grade<br>plastics | |
| Body cover | Manufactured of medical grade<br>silicone | Milled / drilled of aluminium, black<br>coated | |
| Suction valves<br>(bronchoscope only) | XION construction, cleanable by<br>removing;<br>Manufactured of stainless steel,<br>PTFE and medical grade silicone | Richard Wolf construction,<br>cleanable by removing;<br>Manufactured of stainless steel | |
| Focus ring | Handling by turning, rotation axis<br>parallel to longitudinal axis of the<br>endoscope;<br>Manufactured of medical grade<br>plastics | Handling by turning, rotation axis<br>parallel to longitudinal axis of the<br>endoscope:<br>Manufactured of medical grade<br>plastics | |
| Labelling | Image: XION Device Labelling | Image: Richard Wolf Device Labelling | |

## Technological Characteristics in Comparison to Predicate Device

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Image /page/3/Picture/0 description: The image shows the logo for XION medical. The logo consists of the word "XION" in a bold, sans-serif font, with a small dot above the "I". Below the word "XION" is the word "medical" in a smaller, italicized font. The logo is simple and modern, and the use of black and white gives it a professional look.

| Similarities to predicate<br>device: | The submitted devices are equivalent to the flexible endoscopes referred<br>to in K992526 flexible nasopharyngo-laryngoscope and flexible<br>bronchoscope. The fiberscopes in the submission use the same basic<br>design and device material as submitted in K992526.<br>Some flexible nasopharyngoscopes have a fixed light cable instead of a<br>removable one; some of them have a working channel. |
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| Differences to predicate<br>device: | There are only differences regarding diameters and lengths of the<br>insertion tube and the outer appearance and shaping of the shell parts<br>and control elements. |

The submitted devices pose the same type of questions about safety and effectiveness as the compared devices. The new technological characteristics have no influence on safety or effectiveness. The submitted devices are substantially equivalent to the 510(k) devices sold by Richard Wolf Medical Instruments Corp.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Xion GmbH c/o Alexander Kliem Quality Management Pankstraße 8-10 D-13127 Berlin Germany

JUN 1 3 2007

Re: K070580

Trade/Device Name: Nasophyngoscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: May 11, 2007 Received: May 14, 2007

Dear Mr. Kliem:

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 – Alexander Kliem

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 S. 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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Image /page/6/Picture/0 description: The image shows the logo for XION medical. The logo consists of the word "XION" in bold, sans-serif font, with a small circle above the "I". Below the word "XION" and slightly offset to the right is the word "medical" in a smaller, italicized font.

## 5 Indications for Use

Nasopharyngoscope

510(k) Number (if known):

Device Name:

Indications for Use:

Nasopharyngoscopes are intended to examine or treat the nasal cavity and nasal pharynx. They are used between the upper respiratory tracts of the nasal passage and the vocal chords.

They allow the recognition of anomalies in the tissue of the accessible organs. The EF-N 14 and EF-N 14S models with their working channel allow the insertion of an instrument to carry out a biopsy.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anabolut

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

**510(k) Number** K070580

Prescription Use (Per 21 CFR 801.109)

510 (k) Notification 061204 - 5 Indications for Use