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.

AI/ML Overview

The provided text describes a 510(k) summary for the Clarus Model 30000-V Video Endoscope. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive new clinical studies with defined acceptance criteria and statistical analysis of performance against ground truth. Therefore, much of the requested information, particularly regarding detailed performance metrics, ground truth establishment, expert involvement, and MRMC studies, is not present in this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for substantial equivalence, formal acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity) against a specific ground truth are not provided. The acceptance criteria for this submission are based on demonstrating equivalence to predicate devices and meeting physical and biocompatibility requirements.

Acceptance Criteria Category	Reported Device Performance (as per submission)
Substantial Equivalence to Predicate Devices	The Clarus Model 30000-V is stated to be substantially equivalent to other FDA Cleared video endoscopes on the market for the stated Indications for Use. Similarities in materials, size, configuration, packaging, and disinfection methods are cited.
Biocompatibility	"All materials that may come into contact with human tissue during normal use are biocompatible and are suitable for this application."
Physical Testing	"Physical testing of the endoscope included: dimensional inspection, visual examination for workmanship, bond strength testing, optical clarity, light transmittance, and distal tip temperature study." (Specific pass/fail criteria or quantitative results not provided in the summary.)
Indications for Use Equivalence	The clinical Indications for Use are equivalent to those of other FDA Cleared predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable/Not explicitly stated. The submission primarily relies on demonstrating substantial equivalence to predicate devices and meeting physical and biocompatibility testing. There is no mention of a clinical test set with a specific sample size used to evaluate performance against ground truth in a clinical setting.
Data Provenance: Not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable. No clinical test set requiring ground truth establishment by experts is described in this 510(k) summary.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No clinical test set requiring expert adjudication is described in this 510(k) summary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. The document does not describe any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated, nor does it quantify any effect size. This type of study is more common for AI-driven diagnostic or screening tools.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Standalone Study: No. The device is a video endoscope, a tool used by a human practitioner for visualization. Its performance is intrinsically linked to human-in-the-loop operation, and the concept of an "algorithm only" standalone performance is not relevant to this device type as described.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable for clinical performance evaluation. The "ground truth" implicitly used for this 510(k) is the established safety and effectiveness of the identified predicate devices, as well as the successful completion of standard physical and biocompatibility testing.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is a traditional medical device (video endoscope), not an AI/ML-driven device that requires a training set for model development.

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set Establishment: Not applicable. As stated above, this is not an AI/ML device requiring a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (in the context of a 510(k) submission) is the demonstration of substantial equivalence to legally marketed predicate devices and the successful completion of physical and biocompatibility testing.

The key elements of this "study" are:

Comparison to Predicate Devices: The Clarus Model 30000-V Video Endoscope was compared to Vision-Sciences ENT-5000 and ENT-5100 Video ENTS (K072073), Karl Storz Video Bronchoscope System (K071530), Clarus 2127 Murphy Pen (K962255), and ETVIEW Tracheoscopic Ventilation Tube System (TVT), K052233. The submission asserts equivalence in materials, sizes, configurations, packaging, disinfection methods, and especially in the "Indications for Use: visualization of airway anatomy to aid in the placing and confirming placement of artificial airways."
Physical Testing: Included dimensional inspection, visual examination for workmanship, bond strength testing, optical clarity, light transmittance, and distal tip temperature study. While specific results are not detailed in this summary, the completion of these tests suggests they met internal specifications.
Biocompatibility Testing: Confirmed that all materials in contact with human tissue are biocompatible and suitable for the application.

The conclusion drawn from these comparisons and tests is that "this product do not raise any new safety or effectiveness issues," thereby satisfying the requirements for 510(k) clearance by demonstrating substantial equivalence.

Summary

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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 (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

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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 (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

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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)

Regulation Number and Section

§ 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).