(61 days)
No
The summary does not mention AI, ML, or related terms, and the device description focuses on guidance based on CT scans rather than AI-driven analysis or processing.
No
The device aids in guiding endoscopic tools and visualizing the bronchial tree, but it explicitly states "It does not make a diagnosis and is not an endoscopic tool," indicating it supports a therapeutic procedure rather than being a therapeutic device itself. Its function is guidance and visualization, not treatment.
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 bronchial tool," implying interaction with and control of hardware components (bronchoscope and bronchial tool), which are not software-only. The performance studies also mention testing of "the entire system," further suggesting hardware is included.
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 used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on guiding a bronchoscope and visualizing the interior of the bronchial tree. This is an in-vivo procedure, not an in-vitro test on a specimen.
- Anatomical Site: The device is used within the tracheobronchial tree and pulmonary tract, which are internal anatomical sites. IVDs typically involve testing samples taken from the body.
The device is a medical device used for image-guided navigation during a medical procedure, not for diagnostic testing of biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
The superDimension/Bronchus is a device that guides a bronchoscope and bronchial tool to a target in the bronchial tree on a path indicated by CT scan, and to visualize the interior of the tree and target
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan
Anatomical Site
tracheobronchial tree, pulmonary tract, bronchial tree
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 satisfies the requirements of EN60601-1-2. The entire system has had extensive bench testing.
Clinical tests
The superDimension/Bronchus has had both animal tests and a clinical evaluation.
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.
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.
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
NOV - 8 2004
Page A 2
510(k) Summary
superDimension Ltd. 510(k) Submission Bronchus August 13, 2004
1. Submitter Information
Name: superDimension Ltd.
Address:
14 Shenkar 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: August 30, 2004
2. Name of Device
Trade Name: superDimension/Bronchus Common Name: Bronchoscope Classification name: Bronchoscope (flexible or rigid) Regulation: 21 CRF 874.4680
3. Equivalent legally- marketed devices:
| Ultraguide CTG 2000sa K022354 | JAK |
|---|---|
| Olympus UM-2R/3R K982323 | ITX |
| Olympus BF 1T160 K023984 | EOG - ENT |
4. Description
1
SuperDimension/Bronchus
The superDimension/Bronchus is a device that guides a bronchoscope and bronchial tool to a target in the bronchial tree on a path indicated by CT scan, and to visualize the interior of the tree and target
5. Intended Use
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
6. Performance Data
Non – clinical tests
The superDimension/Bronchus satisfies the requirements of EN60601-1-2. The entire system has had extensive bench testing.
Clinical tests
The superDimension/Bronchus has had both animal tests and a clinical evaluation.
7. Conclusion
The superDimension/Bronchus is safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 8 2004
superDimension Ltd. % Mr. George Myers President *Medsys, Inc. 377 Route 17 S HASBROUCK HEIGHTS NJ 07604 Re: K042438
Trade/Device Name: superDimension/Bronchus Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system
Regulatory Class: II Product Code: 90 JAK
Dated: September 5, 2004 Received: September 8, 2004
Dear Mr. Myers:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have levewed your Scellon 910(ts) premantially equivalent (for the indications for use stated in above and have decemined the devices marketed in interstate commerce prior to the enclosure) to regary marketed precisations and Device Amendments, or to devices that have been May 26, 1970, the clacultion date 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 do not require approval of a premance approvince of the Act. The general controls provisions of the Act device, subject to the general controly prove, 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 If your device is classified (Sec ao ro) into call additional controls. Existing major regulations affecting your Apploval), it thay be subject to such aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA wevice can of round in the occerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please or advised mar 1 DA s tosalites of evice complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the rederal statues and regulations administrited 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) (21 CFN Fall 801), good managians pratis. 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 510(k) I his letter will anow you to begin manteting of substantial equivalence of your device to a legally premarket nothleation: "The I Driving or our 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 specific advice for your correst on 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" (21 CFR Also, please note the regulation on your responsibilities under the Act from the 807.97). You may outlined there general missistance at its toll-free number (800) DVNSIon of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmamain.html
Sincerely yours,
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
superDimension/Bronchus
Page 8
Indications for Use
KC42438 510(k) Number (if known):
Device Name: superDimension/Bronchus
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 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Broudon
Division Sign Division of Reproduc and Radiological Devi 510(k) Number
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