(30 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on image guidance based on CT scans, not AI/ML processing.
No
Explanation: The device is indicated for displaying images to guide endoscopic tools and enabling marker placement, but it explicitly states "It does not make a diagnosis and is not an endoscopic tool." This functionality is for guidance and assistance, not direct treatment or diagnosis.
No
The "Intended Use / Indications for Use" section explicitly states, "It does not make a diagnosis." The device's purpose is to aid in guiding endoscopic tools and placing markers, not to diagnose conditions.
No
The device description explicitly states it is a "System" that guides a bronchoscope and endoscopic tools, implying hardware components beyond just software. The performance studies also mention testing of a "Marker Delivery Kit," further indicating hardware is part of the system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device's purpose is to guide endoscopic tools or catheters within the pulmonary tract and to enable marker placement in soft lung tissue. It uses CT scan images for navigation and visualization.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. Its function is entirely focused on image-guided navigation and tool placement within the body.
- Explicitly Not a Diagnostic Tool: The "Intended Use" section explicitly states, "It does not make a diagnosis and is not an endoscopic tool." While it aids the physician, it doesn't perform a diagnostic test itself.
Therefore, the superDimension i·Logic inReach System falls under the category of a medical device used for image-guided procedures and interventions, not an in vitro diagnostic device.
N/A
Intended Use / Indications 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.
Product codes
JAK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan
Anatomical Site
tracheobronchial tree, pulmonary tract, bronchial tree, soft lung tissue
Indicated Patient Age Range
Not for pediatric use.
Intended User / Care Setting
physician
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Clinical tests were not required to validate the changes to the superDimension System. The superDimension i Logic inReach System with the accessory Marker Delivery Kit is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
superDimension i·Logic inReach System, K071473/K092365/K102604
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 2045 | |
| Herzliya 46120 | |
| Israel | |
| Phone number | +972-(0)9-971-3700 |
| Fax number | +972-(0)9-971-3701 |
| Establishment | |
| Registration Number | 3004659744 |
| Name of contact | |
| person | Jonathan Kovach |
| Vice President, Quality and Regulatory Affairs | |
| 763-210-4000 | |
| Date prepared | 01/10/2011 |
| Name of device | |
| Trade or proprietary | |
| name | superDimension i·Logic inReach System |
| superDimension inReach System | |
| superDimension/Bronchus | |
| Common or usual | |
| name | 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 is | |
| claimed | superDimension i·Logic inReach System, K071473/K092365/K102604 |
| Reason for 510(k) | |
| submission | Introduction of accessory Marker Delivery Kit for the placement of markers |
| into soft lung tissue using the superDimension i·Logic inReach System. | |
| 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. | |
| 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 and | |
| Method of Visualization of Path | |
| and 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 equipment | |
| safety compliance | Same |
| Registration Modes and | |
| Navigation 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:
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.
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