(44 days)
Not Found
No
The summary does not mention AI, ML, or related terms, nor does it describe any training or test sets typically associated with AI/ML development. The performance studies focus on design control and risk analysis, not AI/ML performance metrics.
No
The device aids in guiding endoscopic tools and visualizing anatomical structures, but it is explicitly stated that it does not make a diagnosis and is not an endoscopic tool, nor does it deliver any therapy.
No
The "Intended Use / Indications for Use" section explicitly states, "It does not make a diagnosis." The device is intended for guiding endoscopic tools and visualizing the tracheobronchial tree.
No
The device description explicitly states it "guides a bronchoscope and bronchial tool" and "visualizes the target and the interior of the tree," implying interaction with and control of hardware components (bronchoscope, bronchial tool, visualization system), which is not characteristic of a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to display images to aid in guiding endoscopic tools. It explicitly states it "does not make a diagnosis." IVDs are typically used to diagnose diseases or conditions.
- Device Description: The description focuses on guiding a bronchoscope and visualizing the bronchial tree, not on analyzing biological samples for diagnostic purposes.
- Input: The input is a CT scan, which is an imaging modality, not a biological sample. IVDs typically analyze biological samples like blood, urine, or tissue.
- Anatomical Site: The device interacts with the tracheobronchial tree and pulmonary tract, which are anatomical structures within the body, not biological samples collected from the body.
Therefore, the function and application of this device fall outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The superDimension/Bronchus Premium 2 is indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools in the pulmonary tract. It does not make a diagnosis and is not an endoscopic tool. It is not for pediatric use.
Product codes
JAK, EOQ
Device Description
The superDimension/Bronchus Premium 2 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan
Anatomical Site
tracheobronchial tree, pulmonary tract
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
Clinical tests were not required to validate the changes made to the superDimension/Bronchus Premium 2.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
510(k) Summary
JUL 12 2007
superDimension Ltd. Special 510(k) Changes to superDimension/Bronchus Premium 2
Date Prepared:
05/25/2007
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:
Clay Anselmo President and COO Reglera 555 Zang St., Suite 100 Lakewood, CO 80228 303-223-4303 Ph: 303-907-2955 Cell: 303-832-6700 Fax: Email: anselmoc@reglera.com
Name of Device:
superDimension/Bronchus Premium 2 Trade name: Common name: Bronchoscope Computed tomography x-ray system Classification name: 21 CFR 892.1750 Product code JAK
Equivalent Legally-Marketed Device:
superDimension/Bronchus Premium 2, K062315
1
Description:
The superDimension/Bronchus Premium 2 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.
Intended Use:
The superDimension/Bronchus Premium 2 is indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools in the pulmonary tract. It does not make a diagnosis and is not an endoscopic tool. It is not for pediatric use.
Summary of Characteristics Compared to Predicate Device:
Changes are being made to the superDimension/Bronchus Premium 2 to include modifications to some of its disposable components and changes to portions of its labeling.
The intended use and indications for use of the modified device, as described in its labeling, are the same as the intended use and indications for use of the 510(k) Applicant's unmodified predicate device.
The modified device has the same technological characteristics as the unmodified predicate device.
Performance Data:
The changes being made to the superDimension/Bronchus Premium 2 were subjected to superDimension's design control process. A risk analysis was performed to analyze the hazards associated with the changes. Appropriate verification and validation tests were performed to assure that the design output met the design input requirements and that the modified device continues to meet its user needs and intended uses.
Clinical Data:
Clinical tests were not required to validate the changes made to the superDimension/Bronchus Premium 2.
Conclusion:
The superDimension/Bronchus Premium 2 is safe and effective for its intended use.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with three wing-like shapes and a stylized body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SuperDimension Ltd. % Mr. Clay Anselmo President and CEO Reglera 555 Zang Street, Suite 100 LAKEWOOD CO 80228
JUL 1 2007
Re: K071473
Trade/Device Name: superDimension/Bronchus Premium 2 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulation Numer: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: II Product Code: JAK and EOQ Dated: May 25, 2007 Received: May 29, 2007
Dear Mr. Anselmo:
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 shows a circular logo with the text "1906-2006" at the top. Below that is the acronym "FDA" in a stylized font. The word "Centennial" is written below the acronym. There are three stars below the word "Centennial".
closing and Premoting Public Hoatth
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Page 2 -
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 fisting (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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrlv/industry/support/index.html.
Sincerely vours.
Nancy C. Hogdon
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): ___ Ko714 73
Device Name: ___superDimension/Bronchus Premium 2
Indications for Use:
Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools in the pulmonary tract. 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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulut Reiner
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __
Page _ of _
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