Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

Device Description

The superDimension inReach System is a device that guides a bronchoscope and endoscopic tools to a target in or adjacent to the bronchial tree on a path identified by CT scan. The superDimension inReach System also allows visualization of the target and the interior of the bronchial tree; placement of catheters in the bronchial tree; and placement of radiosurgical and dye markers into soft lung tissue to guide radiosurgery and thoracic surgery.

AI/ML Overview

The submission indicates that the superDimension inReach System, with its updated software functionalities (autoIR and dynamic registration algorithms, new views, and continuous pathway guidance), continues to be safe and effective for its intended use. However, it explicitly states that clinical tests were not required to validate these changes. Therefore, the document does not contain information about acceptance criteria, performance metrics, or study details.

Since no clinical study was conducted for this specific submission to demonstrate the device meets acceptance criteria, I cannot provide the requested information in the table format or answer the questions related to clinical study design, sample size, ground truth establishment, or multi-reader multi-case studies.

The provided document {0}-{4} details a 510(k) submission (K092365) for the superDimension inReach™ System, focusing on software functionality additions.

Here's a breakdown of what is and is not present in the document regarding acceptance criteria and performance studies:

What the document states about performance:

Performance Data: "The changes to the algorithms and Instructions for Use were subjected to the superDimension design control process. Risk Management was performed to analyze the potential hazards associated with the changes. Appropriate design verification and validations were performed to assure the superDimension inReach System continues to be safe and effective for its intended use."
Clinical Data: "Clinical tests were not required to validate the changes to the superDimension inReach System."
Conclusion: "The superDimension inReach System is safe and effective for its intended use."

Based on this, the requested information cannot be fully provided because the submission explicitly states that clinical tests were not required to validate the changes. Therefore, there is no clinical study described in the document that proves the device meets specific acceptance criteria based on human performance or outcome metrics.

Nevertheless, I will

provide a table of acceptance criteria and the reported device performance.
indicate what type of performance data and studies were provided.
indicate what type of performance data and studies were not provided.

Acceptance Criteria and Device Performance

Acceptance Criteria (Not Explicitly Stated for Clinical Performance)	Reported Device Performance (as per document)
Safety and Effectiveness for Intended Use	Claim: The superDimension inReach System is "safe and effective for its intended use."
Algorithm Functionality (autoIR, DR)	Changes subjected to design control process; appropriate design verification and validations performed.
New Views (LG tip indicator, local view, virtual bronchoscopy, MIP)	Changes subjected to design control process; appropriate design verification and validations performed.
Continuous Pathway Guidance	Changes subjected to design control process; appropriate design verification and validations performed.

Detailed breakdown of requested information:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The document does not explicitly list specific numerical acceptance criteria for clinical performance because clinical tests were not required. The overall implicit acceptance criterion is that the modified device remains "safe and effective for its intended use," as determined through design control, risk management, and design verification/validation processes.
- Reported Device Performance: The document states that the changes were subjected to design control, risk management, and appropriate design verification and validations to assure continued safety and effectiveness. No specific performance metrics (e.g., accuracy, sensitivity, specificity, or navigation precision values) are provided in this summary.
Sample size used for the test set and the data provenance:
- Not Applicable. The document explicitly states, "Clinical tests were not required to validate the changes to the superDimension inReach System." Therefore, there is no test set, corresponding sample size, or data provenance from a clinical study described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not Applicable. As no clinical test set was required or performed, there were no experts used to establish ground truth for such a set described in this document.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. The document does not describe any MRMC or comparative effectiveness study. The device provides "guidance" tools but is not an AI for diagnosis or interpretation that would typically require such a study to measure reader improvement.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- The submission mentions "implementation of algorithms for CT-to-Body Automatic Initial Registration (autoIR) and dynamic registration (DR)". While "design verification and validations" were performed on these algorithms, the document does not specify if standalone, algorithm-only performance studies (e.g., measuring registration accuracy or robustness purely on data without human interaction) were conducted, nor does it provide results from such studies if they were performed as part of the broader "design verification and validations."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable for clinical performance. For the non-clinical "design verification and validations" mentioned, the type of ground truth would typically relate to engineering standards, phantom studies, or simulated data for assessing algorithm accuracy (e.g., comparing algorithm-reported position to a known true position in a controlled setup), but this is not detailed in the summary.
The sample size for the training set:
- Not Applicable / Not provided. The document describes "algorithms" (autoIR and DR) but does not provide information about how these algorithms were developed or if they involved machine learning with a distinct training set. If they are rule-based or conventional algorithmic approaches, a "training set" in the machine learning sense might not be applicable.
How the ground truth for the training set was established:
- Not Applicable / Not provided. No information on algorithm development or training set ground truth is included.

Summary

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K092365
Page 1 of 2

510(k) Summary

superDimension, Ltd. Special 510(k) superDimension inReach System Addition of Software Functionality

Date Prepared:

07/31/2009

510(k) Applicant:

superDimension, Ltd. 8 Hamenofim St., P.O. Box 2045 Herzliya 46120 Israel Ph: +972-(0)9-971-3700 Fax: +972-(0)9-971-3701

510(k) Application Correspondent:

Jonathan Kovach Vice President, Quality and Regulatory Affairs superDimension, Inc. 161 Cheshire Lane, Suite 100 Minneapolis, MN 55441 Phone: 763-210-4015 Cell : 763-360-4984 763-210-4098 Fax : Email : jkovach(@superdimension.com

Name of Device :

superDimension inReach™ System Trade Name : Bronchoscope Common Name: Classification Name: Computed tomography x-ray system 21 CFR Part 892.1750 Product code JAK

Equivalent Legally-Marketed Device:

superDimension inReach System, K081379

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K092365
Page 2 of 2

Description:

Intended Use:

Summary of Characteristics Compared to Predicate Device:

Changes are being made to the software through implementation of algorithms for CT-to-Body Automatic Initial Registration (autoIR) and dynamic registration (DR) for electromagnetic navigation bronchoscopy. These new algorithms provide alternative methods for registration and navigation. Additional views are being added including a real-time Locatable Guide (LG) tip location indicator on the 3D Map, a local view showing the CT volume cut through the LG tip location, a real-time virtual bronchoscopy view synchronized with the LG position, and a Maximum Intensive Projection (MIP) view synchronized with the LG position. The software will also provide guidance on a continuous pathway (line-based guidance) when navigating inside the 3D Map.

Minor changes are being made to the Personal and Laptop Computer. No changes are being made to the disposable products. The Instructions for Use are being changed to address the changes to the software.

Performance Data:

The changes to the algorithms and Instructions for Use were subjected to the superDimension design control process. Risk Management was performed to analyze the potential hazards associated with the changes. Appropriate design verification and validations were performed to assure the superDimension inReach System continues to be safe and effective for its intended use.

Clinical Data:

Clinical tests were not required to validate the changes to the superDimension inReach System.

Conclusion:

The superDimension inReach System is safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

SEP - 4 2009

superDimension, Ltd. HealthCare Corporation % Mr. Jonathan Kovach Vice President. Quality and Regulatory Affairs superDimension, Incorporated 161 Cheshire lane, Suite 100 MINNEAPOLIS MN 55441

Re: K092365

Trade/Device Name: superDimension® inReach™ System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: July 31, 2009 Received: August 5, 2009

Dear Mr. Kovach:

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. 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

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

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 vours. '

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

192245 510(k) Number (if known):

Device Name: superDimension® inReach™ System

Indications for Use:

Not for pediatric use.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hito Reum

(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devic

Page of

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.