(20 days)
Not Found
No
The summary explicitly states "no new technology is used" and there are no mentions of AI, ML, or related terms. The device description focuses on guiding based on CT scans and visualizing, which are standard functionalities for this type of system.
Yes
The device is described as guiding endoscopic tools in the pulmonary tract and visualizing the target and interior of the tree, which directly aids in medical procedures, classifying it as a therapeutic device.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "It does not make a diagnosis." The device aids in guiding endoscopic tools and visualizing targets rather than diagnosing conditions.
No
The device description explicitly states it "guides a bronchoscope and bronchial tool," implying interaction with and control of hardware components (bronchoscope and bronchial tool), which is not characteristic of a software-only medical device. The performance studies also mention testing of the "entire system," further suggesting hardware components are part of the 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 in the pulmonary tract. It explicitly states it "does not make a diagnosis". IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device guides a bronchoscope and bronchial tool and visualizes the target and interior of the tree. This is an image-guided navigation system for a medical procedure, not a test performed on a biological sample.
- Anatomical Site: The device operates within the upper airways and tracheobronchial tree, which are internal anatomical structures, not biological specimens being tested.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing laboratory tests, or providing diagnostic information based on such analysis.
The device is clearly intended for image-guided navigation during a medical procedure, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The superDimension/Bronchus 4.1 is intended to image the upper airways and tracheobronchial tree to aid . In a bronchial tool
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.
Product codes
JAK
Device Description
The superDimension/Bronchus 4.1 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 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
upper airways and tracheobronchial tree, bronchial 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non – clinical tests
The superDimension/Bronchus 4.1 satisfies the requirements of EN60601-1 and EN 60601-1-2. The entire system has had extensive bench testing.
Clinical tests
Since no new technology is used, clinical tests are not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
superDimension/Bronchus, K042438
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
superDimension/Bronchus 4.1
510(k) Summary
Page A 2 SEP - 8 2005
superDimension Ltd. Special 510(k) Submission super/Dimension Bronchus 4.1 510(k) Summary July 26, 2005
Submitter Information 1.
Name: superDimension Ltd.
Address:
8 Hamenofim St., POB 2045 Herzliya 46120 Israel
Tel. +972-(0)9-971-3700 Fax +972-(0)9-971-3701
Contact person:
Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Tel.: 201-727-1703 Fax: 201-727-1708
Date prepared: July 26, 2005
2. Name of Device
Trade Name: superDimension/Bronchus 4.1 Common Name: Bronchoscope Classification name: System, x-ray, tomography, computed
3. Equivalent legally- marketed devices:
superDimension/Bronchus, K042438
4. Description
The superDimension/Bronchus 4.1 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 target and the interior of the tree.
1
5. Intended Use
The superDimension/Bronchus 4.1 is intended to image the upper airways and tracheobronchial tree to aid
. In a bronchial tool
6. Performance Data
Non – clinical tests
The superDimension/Bronchus 4.1 satisfies the requirements of EN60601-1 and EN 60601-1-2. The entire system has had extensive bench testing.
Clinical tests
Since no new technology is used, clinical tests are not required.
7. Conclusion
The superDimension/Bronchus is safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features a stylized bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
SEP = 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
superDimension Ltd. % George H. Myers, Sc.D. Official Correspondent Medsys, Inc. 377 Route 17 South HASBROUCK HEIGHTS NJ 07604 Re: K052260
Trade/Device Name: superDimension/Bronchus 4.1 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system
Regulatory Class: II
Product Code: JAK Dated: August 17, 2005 Received: August 19, 2005
Dear Dr. Myers:
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.
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.
3
This letter will allow you to begin marketing your device as described in your Section 5 I 0(k) This letter will anow you to begin mancing your avoice of your device of your device to a legally premarket notification. The PDA Inding of Sacsantal Pryour 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 If you desire spectic advice for your device on our be of the regulation 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" (21 CFR Also, please note the regulation childer, "hisorizion on your responsibilities under the Art from the 180 807.97). You may outlin outcr general mionitance on the programer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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):
Device Name: superDimension/Bronchus 4.1
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.
X 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 Device Evaluation (ODE)
Nanarc Broodon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number V052260
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