(285 days)
No
The device description focuses on the physical and optical components of the endoscope and does not mention any software features related to image analysis or decision support, nor are there any mentions of AI, DNN, or ML.
No
The device is used for visualization and placement of artificial airways, which are diagnostic and procedural assistance functions, not therapeutic treatments.
No
The device is used for visualization and placement confirmation of artificial airways, which are procedural uses rather than diagnostic. While it visualizes anatomy, the 'Indications for Use' do not state it is for diagnosing a condition or disease.
No
The device description explicitly details hardware components such as a tubular device with a malleable shaft, a camera, electrical connectors, a battery, a video screen, and illumination light. Physical testing of these hardware components is also described.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "VISUALIZATION OF AIRWAY ANATOFILY AND INDICATED PLACING AND CONFIRMING PLACEMENT of AID IN THE To ARTIFICIAL AIRWAYS". This describes a device used for direct visualization and procedural assistance within the body.
- Device Description: The description details a tubular endoscope with a camera and light for viewing internal anatomy. This is consistent with an endoscopic device used for direct observation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. This device does not mention analyzing any biological specimens.
Therefore, this device is a medical device used for visualization and procedural guidance in vivo (within the body), not an IVD.
N/A
Intended Use / 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.
FOR VISUALIZATION OF AIRWAY ANATOFILY AND INDICATED PLACING AND CONFIRMING PLACEMENT of AID IN THE To ARTIFICIAL AIRWAYS
Product codes
BTR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Physical testing of the endoscope included: dimensional inspection, visual examination for workmanship, bond strength testing, optical clarity, light transmittance, and distal tip temperature study.
Key Metrics
Not Found
Predicate Device(s)
Vision-Sciences ENT-5000 and ENT-5100 Video ENTS (K072073), Karl Storz Video Bronchoscope System (K071530)
Reference Device(s)
Clarus 2127 Murphy Pen (K962255), ETVIEW Tracheoscopic Ventilation Tube System (TVT), K052233
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5730 Tracheal tube.
(a)
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.(b)
Classification. Class II (performance standards).
0
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 (763) 525-8401 FAX (763) 525-8656 Email: tbarthel@clarus-medical.com 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.
1
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.
2
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.
3
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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
4
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)