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 i·Logic 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 i·Logic 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 provided text does not contain detailed acceptance criteria or a specific study proving the device meets those criteria. Instead, it describes a 510(k) summary for the "superDimension® Marker Delivery Kit," which is an accessory to an existing system. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo performance study with specific acceptance criteria.

A table of acceptance criteria and the reported device performance:
The document does not provide a table of acceptance criteria or specific device performance metrics in the way one might expect for a new device undergoing extensive clinical trials. The focus is on demonstrating that the new accessory (Marker Delivery Kit) does not alter the fundamental safety and effectiveness of the existing superDimension i-Logic inReach System. The "Performance Test Summary-New Device" section states that the device and its instructions for use were subjected to the superDimension design control process, and "Risk Management was performed to analyze the potential hazards associated with the changes. Appropriate design verification and validations were performed to assure the superDimension i-Logic inReach System continues to be safe and effective for its intended use." However, no quantitative criteria or reported performance values are given.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
No specific test set or clinical study data are mentioned for the Marker Delivery Kit. The document explicitly states: "Clinical tests were not required to validate the changes to the superDimension System." This implies that the assessment of safety and effectiveness was primarily based on non-clinical engineering and risk management activities, and comparison to the predicate device.
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):
Since no clinical test set or study is described, there is no mention of experts establishing a ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
As no clinical test set is described, there is no mention of an adjudication method.
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:
No MRMC study was mentioned. The device described is a medical instrument (marker delivery kit) and guiding system, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the device is a physical marker delivery kit used with a bronchoscope guidance system, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
No ground truth determination is discussed in the context of device performance, as the submission relies on substantial equivalence and non-clinical testing.
The sample size for the training set:
No training set is mentioned as clinical data were not required for this submission.
How the ground truth for the training set was established:
Not applicable, as no training set is discussed.

Summary

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

K110093

FEB 1 1 2011

510(k) SUMMARY superDimension® Marker Delivery Kit

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
Submitter Information
Name	superDimension, Ltd.
Address	8 Hamenofim St.P.O. Box 2045Herzliya 46120Israel
Phone number	+972-(0)9-971-3700
Fax number	+972-(0)9-971-3701
EstablishmentRegistration Number	3004659744
Name of contactperson	Jonathan KovachVice President, Quality and Regulatory Affairs763-210-4000
Date prepared	01/10/2011
Name of device
Trade or proprietaryname	superDimension i·Logic inReach SystemsuperDimension inReach SystemsuperDimension/Bronchus
Common or usualname	Bronchoscope
Classification name	Computed tomography x-ray system
Classification panel	Radiology
Regulation	21 CFR Part 892.1750
Product Code(s)	JAK
Legally marketed device(s)to which equivalence isclaimed	superDimension i·Logic inReach System, K071473/K092365/K102604
Reason for 510(k)submission	Introduction of accessory Marker Delivery Kit for the placement of markersinto soft lung tissue using the superDimension i·Logic inReach System.
Device description	The superDimension i·Logic inReach System is a device that guides abronchoscope and endoscopic tools to a target in or adjacent to thebronchial tree on a path identified by CT scan. The superDimension i·LogicinReach System also allows visualization of the target and the interior of thebronchial tree; placement of catheters in the bronchial tree; and placementof radiosurgical and dye markers into soft lung tissue to guide radiosurgeryand thoracic surgery.
Intended use of the device	Enable the diagnosis and treatment of lung cancer.

........

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

dications for use
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.
Summary of the technological characteristics of the device compared to the predicate device
Characteristic	Comparison to New Device
Indications for Use	Same
Anatomical Sites	Same
Basic Principle	Same
Localization Methodology	Same
Visualization Principle andMethod of Visualization of Pathand Organs	Same
Display Methods	Same
Interventional Instrument	Same. Accessory Marker Delivery Kit is being added.
Method of tracking location	Same
Computer function and type	Same
Energy Released into Body(Negligible)	Same
Compatibility with other devices	Same. Accessory Marker Delivery Kit is being added.
.ocompatibility	Same. Accessory Marker Delivery Kit is being added.
Medical electrical equipmentsafety compliance	Same
Registration Modes andNavigation Guidance	Same
Software	Same
Sterile Accessories	Same. Accessory Marker Delivery Kit is being added.
Marker Placement	Same. Accessory Marker Delivery Kit is being added.

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

SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Performance Test Summary-New Device

The superDimension Marker Delivery Kit 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 i-Logic inReach System continues to be safe and effective for its intended use.

PERFORMANCE DATA

and the comments of the comments of the first of the states of the states of the states of the states of the states of the states of the states of the states of the states of

Comparative Performance Information Summary

Not Required to validate the changes to the superDimension System.

SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

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

CLINICAL CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATACH A CENTER న్నారు. స్వ

The superDimension i Logic inReach System with the accessory Marker Delivery Kit is safe and effective for its intended use.

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

Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three birds in flight, arranged in a stacked formation.

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

superDimension, Ltd. % Mr Jonathan Kovach Vice President, Quality and Regulatory Affairs superDimension, Inc. 161 Cheshire Lane, Suite 100 MINNEAPOLIS MN 55441

FEB 1 1 2011

Re: K110093

Trade/Device Name: superDimension® Marker Delivery Kit Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: January 10, 2011 Received: January 12, 2011

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary S Postel

Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

K 110093 510(k) Number (if known):

Device Name: superDimension® Marker Delivery Kit

Indications for Use:

Prescription Use (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 In Vitro Diagnostic Devices (OIVD)

Mury S. Pastit
(Division Sign Off)

Page 1 of

(Division Sign-Off Division of Radiological De Vitro Diagnostic Device Evaluation and

510K Klioo93

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.