ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0

K032822 · Asap Endoscopic Products GmbH · EOB · Jan 8, 2004 · Ear, Nose, Throat

Device Facts

• Record ID: K032822
• Device Name: ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0
• Applicant: Asap Endoscopic Products GmbH
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Jan 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2

Intended Use

The asap ENT endoscope is intended to provide the physician with a means for direct viewing of the nasal cavity and nasal pharynx by providing illumination and visualization of these regions during various diagnostic and therapeutic procedures. The asap ENT endoscope is reusable.

Device Story

Rigid ENT endoscope; consists of eyepiece, body, light guide, and rod-lens system. Input: ambient light transmitted via fibers to illuminate nasal cavity/nasopharynx. Transformation: optical visualization via rod-lens system. Output: direct visual image for physician. Used in clinical settings by physicians for diagnostic and therapeutic procedures. Reusable device; requires user sterilization prior to each procedure.

Clinical Evidence

No clinical data. Substantial equivalence based on bench testing, material biocompatibility, and sterilization validation protocols.

Technological Characteristics

Rigid endoscope; surgical steel construction (DIN 17442); rod-lens optical system; fiber optic illumination. Complies with IEC 60601-2-18, DIN 58105, DIN 980. Non-sterile; reusable; requires user-performed sterilization.

Indications for Use

Indicated for physicians to perform direct visualization and illumination of the nasal cavity and nasal pharynx during diagnostic and therapeutic procedures.

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

• Sinuscope (K981751)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically "KO32822". The characters are written in a bold, sans-serif font. The letters and numbers are closely spaced together.

JAN - 8 2004

510(k) Summary

| Applicant: | asap endoscopic products GmbH<br>Tullastr. 87 a<br>79108 Freiburg / Germany |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of contact: | Dr. Martina Guenderoth<br>Regulatory Affairs Manager<br>C.R.C. Partnerschaftsgesellschaft<br>Katharinenstr. 5<br>23554 Luebeck, Germany |
| | Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Device name: | Sinuscope, Types:<br>10-0036-00, 10-0037-00, 10-0038-00, 10-0039-00,<br>10-0040-00, 10-0041-00, 10-0042-00, 10-0043-00,<br>10-0044-00, 10-0045-00, 10-0046-00, 10-0086-00,<br>10-0047-00 |
| Common name: | Sinuscope |
| Predicate device name: | Sinuscope (K 981751) |
| Classification name: | Nasopharyngoscope (flexible or rigid); 77-EOB |

### 510(k) Summary of safety and effectiveness

Code of Federal Regulations (CFR) number: 21 CFR 874.4760

#### General device description

The asap ENT endoscope is of the rigid type with a new generation of compact objectives and a newly developed rod-lens system.

The basic design of the asap ENT endoscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.

#### Indications for use

The asap ENT endoscope is intended to provide the physician with a means for direct viewing of the nasal cavity and nasal pharynx by providing illumination and visualization of these regions during various diagnostic and therapeutic procedures. The asap ENT endoscope is reusable.

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

#### Voluntary standard compliance

The asap ENT endoscope complies with

- applicable portions of voluntary standards IEC 60601-2-18
- DIN 58105, part 1 and 2
- DIN 17442 (medical steel), as well as applicable portions of
- DIN 980

## Substantially equivalence - Safety and effectiveness

The specifications and intended use of the asap ENT endoscope are the same to those of the claimed predicate devices. There are no significant differences between the asap ENT endoscope and the claimed predicates in design or conditions of intended use.

The asap ENT endoscope is constructed of materials of the same specifications as the predicate devices to ensure biocompatibility. The asap ENT endoscope conforms to applicable ISO standards.

The device will be sold non-sterile, to be sterilized prior to each procedure by the user. The ability to repeatedly adequately sterilize the devices has been confirmed by validation protocol.

#### Conclusion

In all respects, the asap ENT endoscope is substantially equivalent to one or more rigid endoscopes currently marketed in the USA.

It is constructed of materials of the same specifications as the predicate devices to ensure biocompatibility and it conforms to applicable ISO standards.

The ability to repeatedly adequately sterilize the asap ENT endoscope has been confirmed by validation protocol.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three curved lines that resemble a bird in flight. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 8 2004

Asap Endoscopic Products GmbH c/o Martina Guenderoth Regulatory Affairs Manager C.R.C. Partnerschaftsgellschaft Katharinenstr. 5 23554 Lubeck, Germany

Re: K032822 Trade/Device Name: Asap ENT Endoscope Regulatory Class: Class II Product Code: EOB Dated: August 21, 2003 Received: September 10, 2003

Dear Dr. Guenderoth:

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.

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

This letter will allow you to begin marketing your device as described in your Section 510(k) I this lotter will and work of substantial equivalence of your device 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/dsma/dsmamain.html

Sincerely yours,

A kalgi korenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

510(k) Number (if known):_K032822

Device Name:_asap ENT endoscopes_

Indications For Use:

The asap ENT endoscope is intended to provide the physician with a means for direct viewing of the nasal cavity and nasal pharynx by providing illumination and visualization of these regions during various diagnostic and therapeutic procedures.

The asap ENT endoscope is reusable.

Prescription Use V YES_ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ption Use ***_*****_**
21 CFR 801.109)

✓

Page 1 of

signature

510(k) Numbe