CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V

K082038 · Clarus Medical, LLC · BTR · Apr 28, 2009 · Anesthesiology

Device Facts

• Record ID: K082038
• Device Name: CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V
• Applicant: Clarus Medical, LLC
• Product Code: BTR · Anesthesiology
• Decision Date: Apr 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2

Indications for Use

The Clarus Model 30000-V Video Endoscope is indicated for visualization of airway anatomy to aid in the placing and confirming placement of artificial airways.

Device Story

Model 30000-V is a tubular, malleable video endoscope used for airway visualization. It features a small-diameter camera at the distal tip and integrated illumination. The device connects to a battery-powered video screen. It is intended for use by clinicians to assist in the placement and confirmation of artificial airways. The shaft is removable, soakable, and capable of high-level disinfection. The device provides real-time visual feedback to the operator, facilitating accurate tube placement and reducing risks associated with blind intubation.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included dimensional inspection, visual examination, bond strength testing, optical clarity, light transmittance, and distal tip temperature study. All materials in contact with human tissue were confirmed to be biocompatible.

Technological Characteristics

Tubular, malleable shaft endoscope with distal tip camera and illumination. Components include removable, soakable shaft and battery-powered video display. Biocompatible materials. High-level disinfection compatible. No software algorithm or connectivity specified.

Indications for Use

Indicated for visualization of airway anatomy to aid in the placement and confirmation of artificial airways in patients requiring airway management.

Regulatory Classification

Identification

A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

Predicate Devices

• Vision-Sciences ENT-5000 and ENT-5100 Video ENTS (K072073)
• Karl Storz Video Bronchoscope System (K071530)
• Clarus 2127 Murphy Pen (K962255)
• ETVIEW Tracheoscopic Ventilation Tube System (TVT) (K052233)

Submission Summary (Full Text)

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K082038

## 510(k) Summary

## Model 30000-V, Video Endoscope

APR 2 8 2009

General Information Class II 21 CFR 868.5730 Classifications Product Code BTR Clarus Model 30000-V, Video Endoscope Trade Name Clarus Medical, LLC Submitter 1000 Boone Avenue North, Suite 300 Minneapolis, Minnesota 55427 Thomas Barthel Official Contact President [phone] FAX [phone] Email: [e-mail] Predicate Devices

Predicate Devices

Vision-Sciences ENT-5000 and ENT-5100 Video ENTS (K072073) Karl Storz Video Bronchoscope System (K071530) Clarus 2127 Murphy Pen (K962255) ETVIEW Tracheoscopic Ventilation Tube System (TVT), K052233

Date Prepared

June 26, 2008

## Device Description

The Model 30000-V endoscope is a tubular device with a malleable shaft. The optical element of the endoscope consists of a small diameter camera bonded into the distal tip of the endoscope shaft. The removable shaft of the endoscope is attached to the battery and video screen by means of various electrical connectors. Illumination light is provided at the tip of the endoscope for direct viewing. The removable shaft of the endoscope is soakable and can be high-level disinfected. A waterproof cap is provided to protect the connector during the cleaning/disinfection process.

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### Indications for Use

The Clarus Model 30000-V Video Endoscope is indicated for visualization of airway anatomy to aid in the placing and confirming placement of artificial airways.

#### Testing

All materials that may come into contact with human tissue during normal use are biocompatible and are suitable for this application.

Physical testing of the endoscope included: dimensional inspection, visual examination for workmanship, bond strength testing, optical clarity, light transmittance, and distal tip temperature study.

#### Summary of Substantial Equivalence

The Clarus Model 30000-V, Video Endoscope is substantially equivalent to other FDA Cleared video endoscopes on the market Indicated for Use for the visualization of airway anatomy and to aid in placing and confirming placement of artificial airways. The sizes and configurations of the endoscope available along with the packaging and disinfection methods are also equivalent. See devices listed in Table 2

The clinical Indications for Use of the Model 30000-V Video Endoscope are equivalent to those of other FDA Cleared devices listed in Table 2.

Therefore, due to the similarity of materials to other predicate devices, the test results and the equivalent Indications for Use to other predicate devices, Clarus believes this product do not raise any new safety or effectiveness issues.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design. The eagle is a symbol of strength and freedom, and the logo represents the department's mission to protect the health of all Americans.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 2 8 2009

Mr. Thomas Barthel President Clarus Medical, LLC 1000 Boone Avenue North Suite 300 Minneapolis, Minnesota 55427

Re: K082038

Trade/Device Name: Clarus 30000-V Video Airway Endoscope Regulation Number: 21 CFR 868.5730 Regulation Name: Regulatory Class: II Product Code: BTR Dated: April 16, 2009 Received: April 24, 2009

Dear Mr. Barthel:

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 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.

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Page 2- Mr. Barthel

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 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Susan Ruane

Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology. General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

510(k) Number (if known): KOBZO38

Device Name: CLARUS_30000-V_VIDED AIRWAy ENDOSCOPE

Indications For Use:

FOR VISUALIZATION OF AIRWAY ANATOFILY AND INDICATED PLACING AND CONFIRMING PLACEMENT of AID IN THE To ARTIFICIAL AIRWAYS

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ OR (Per 21 CFR 801.109

· 510(k) Number:

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Over-The-Counter Use_

(Optional Format 1-2-96)