(59 days)
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.
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.
The provided 510(k) summary (K080271) for the superDimension/Bronchus inReach™ System does not contain a study that proves the device meets specific acceptance criteria with reported performance metrics. Instead, it is an indication expansion for an already cleared device, where the key change is an update to the Instructions for Use (IFU) to include guidance for deploying radiosurgical and dye markers into soft lung tissue.
Therefore, the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable to this particular 510(k) submission as it focuses on software or algorithm performance. The submission explicitly states:
- "Clinical tests were not required to validate the changes to the superDimension/Bronchus System."
- "No changes are being made to the hardware or software design, or technological characteristics of the current marketed device."
The basis for the expanded indication is:
- "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." (However, these studies are not detailed or provided within this K080271 submission.)
- A hazard analysis and appropriate design validations were performed to assure the device continues to meet expanded user needs.
Because this 510(k) is an indication expansion based on existing evidence and no new performance data or clinical studies were submitted, most of the requested fields cannot be filled.
Here's a breakdown of the information that can be extracted or deduced from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable. The submission does not detail specific acceptance criteria for device performance or report new performance data as part of this K080271 submission. The changes pertain to expanded indications for use based on the existing device's established safety and effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. No new test set data was generated or submitted for this indication expansion.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. No new test set requiring ground truth establishment was conducted for this submission. The claim refers to "Multiple published studies" but does not detail their methodology or expert involvement within this document.
4. Adjudication Method for the Test Set:
Not applicable. No new test set requiring adjudication was conducted for this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. An MRMC comparative effectiveness study was not done as part of this submission. The submission states, "Clinical tests were not required to validate the changes to the superDimension/Bronchus System."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The superDimension/Bronchus System is a guidance system for human-operated bronchoscopes and tools; it is not a standalone diagnostic or completely autonomous device in the context of this submission. No new algorithm-only performance studies were conducted.
7. The Type of Ground Truth Used:
Not applicable for this submission. The reliance is on "Multiple published studies" which would have established their own ground truth based on clinical outcomes, pathology, or direct observation, but these are not detailed here.
8. The Sample Size for the Training Set:
Not applicable. This submission is not about developing or training a new algorithm or AI model; it's an indication expansion for an existing device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This submission is not about developing or training a new algorithm or AI model.
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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 system21 CFR Part 892.1750Product code JAK |
Equivalent Legally-Marketed Device:
superDimension/Bronchus Premium 2, K071473
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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.
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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.
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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
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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
§ 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.