(30 days)
Not Found
No
The summary describes a navigation system based on CT scans and algorithms for guidance, but there is no mention of AI, ML, or related concepts like training/test sets for such technologies.
No.
The device is used to display images and guide endoscopic tools and markers. It does not exert a therapeutic effect itself, but rather aids in procedures that may be therapeutic.
No
The "Intended Use / Indications for Use" section explicitly states, "It does not make a diagnosis."
No
The device description explicitly states it "guides a bronchoscope and endoscopic tools" and allows "placement of catheters" and "placement of radiosurgical and dye markers," implying interaction with and control of physical hardware components beyond just software processing or display.
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 that the device "guides a bronchoscope and endoscopic tools to a target in or adjacent to the bronchial tree on a path identified by CT scan." It also allows for visualization and marker placement.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. Its function is based on image guidance using a CT scan and assisting with physical procedures within the body.
- Intended Use: The intended use is to "aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue." This is a procedural guidance and assistance tool, not a diagnostic test performed on a sample.
Therefore, the superDimension inReach System, as described, falls under the category of a medical device used for image-guided procedures and 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan
Anatomical Site
tracheobronchial tree, pulmonary tract, 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 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 tests were not required to validate the changes to the superDimension inReach System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
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:
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.
Intended 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 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.
2
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:
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 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
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