(59 days)
No
The summary does not mention AI, ML, or related terms, nor does it describe any features or processes that are characteristic of AI/ML applications in medical imaging (e.g., automated detection, segmentation, or analysis beyond basic image display and guidance). The description focuses on image display and guidance based on CT scans.
No
The device aids the physician in guiding endoscopic tools or catheters and marker placement. While it assists in procedures, it does not directly treat a disease or condition itself, which is the characteristic of a therapeutic device.
No
This device is specifically stated to "not make a diagnosis." Its purpose is to guide endoscopic tools and enable marker placement, essentially acting as a navigation and visualization system for interventions, rather than diagnosing conditions.
No
The device description explicitly states it is a "System" that guides a bronchoscope and bronchial tool, implying hardware components beyond just software. The performance studies also mention "design control process" and "design validations," which are typically associated with hardware development and verification.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "displaying images... to aid the physician in guiding endoscopic tools or catheters... and to enable marker placement." It explicitly states it "does not make a diagnosis." IVDs are designed to perform tests on samples from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on guiding tools and visualizing anatomical structures, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on laboratory results.
This device appears to be a medical imaging and guidance system used during procedures, which falls under a different regulatory category than IVDs.
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/Bronchus System is a device that guides a bronchoscope and bronchial tool to a target in or adjacent to the bronchial tree on a path indicated by CT scan, and visualizes the target and the interior of the tree. The superDimension/Bronchus also enables the 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, 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 changes to the Instructions for Use were subjected to the superDimension design control process. A hazard analysis was performed to analyze the potential hazards associated with the changes. Appropriate design validations were performed to assure the superDimension/Bronchus continues to meet the expanded user needs and intended uses.
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
510(k) Summary
superDimension, Ltd. Traditional 510(k) Indication Expansion
MAR 3 1 2008
Date Prepared:
01/31/2008
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 :
| Trade Name : | - superDimension®/Bronchus
- inReach™ System |
|----------------------|------------------------------------------------------------------------------|
| Common Name: | Bronchoscope |
| Classification Name: | Computed tomography x-ray system
21 CFR Part 892.1750
Product code JAK |
Equivalent Legally-Marketed Device:
superDimension/Bronchus Premium 2, K071473
1
Description:
The superDimension/Bronchus System is a device that guides a bronchoscope and bronchial tool to a target in or adjacent to the bronchial tree on a path indicated by CT scan, and visualizes the target and the interior of the tree. The superDimension/Bronchus also enables the 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 Instructions for Use to include guidance and instruction for deploying radiosurgical and dye markers into soft lung tissue with the superDimension/Bronchus System.
No changes are being made to the hardware or software design, or technological characteristics of the current marketed device.
Performance Data:
The changes to the Instructions for Use were subjected to the superDimension design control process. A hazard analysis was performed to analyze the potential hazards associated with the changes. Appropriate design validations were performed to assure the superDimension/Bronchus continues to meet the expanded user needs and intended uses.
Clinical Data:
Clinical tests were not required to validate the changes to the superDimension/Bronchus System. Multiple published studies have demonstrated the Bronchus is safe and effective when used to place radiosurgical and dye markers into soft lung tissue to guide radiosurgery and thoracic surgery.
Conclusion:
The superDimension/Bronchus is safe and effective for its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
superDimension, Ltd. % Mr. Jonathan Kovach Vice President, Quality and Regulatory Affairs superDimention, Incorporated 161 Cheshire Lane, Suite 100 MINNEAPOLIS MN 55441
MAR 3 1 2008
Re: K080271
Trade/Device Name: superDimension®/Bronchus inReach™ System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: January 31, 2008 Received: February 1, 2008
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 (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. In the center of the logo are the letters "FDA" in a bold, stylized font. There are three stars below the word Centennial. The text around the circle reads "International Association of Food Industry Suppliers".
Protecting and Promoting Public Health.
3
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); 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.
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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K 80271
Device Name: superDimension/Bronchus
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)
Aomi Whing
Page of of
Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number