K Number
K052852
Device Name
SUPERDIMENSION/BRONCHUS PREMIUM
Date Cleared
2005-11-14

(34 days)

Product Code
Regulation Number
892.1750
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
The superDimension/Bronchus Premium 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 nearnet aod the interior of the tree. It has been modified to permit external video monitoring and recording devices. Other minor improvements have been made also.
More Information

Not Found

No
The summary explicitly states "no new technology is used" and there are no mentions of AI, ML, or related concepts. The device description focuses on guidance based on CT scans and visualization, not AI-driven analysis or decision-making.

No
The device aids in guiding endoscopic tools and visualizes the tracheobronchial tree, but it explicitly states it "does not make a diagnosis" and is "not an endoscopic tool." Its function is for guidance and visualization, not direct treatment or diagnosis, aligning more with an assistive imaging or navigation device rather than a therapeutic one.

No

The "Intended Use / Indications for Use" section explicitly states, "It does not make a diagnosis." The device is intended to aid in guiding endoscopic tools and displaying images for navigation, not for reaching a diagnostic conclusion.

No

The device description explicitly states it "guides a bronchoscope and bronchial tool" and has been modified to permit "external video monitoring and recording devices," indicating it includes hardware components beyond just software.

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 of the tracheobronchial tree to aid the physician in guiding endoscopic tools." It explicitly says it "does not make a diagnosis." IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment. This device is used for guidance during a procedure, not for analyzing biological samples.
  • Device Description: The description reinforces its role in guiding a bronchoscope and visualizing the bronchial tree. It doesn't mention any analysis of biological samples.
  • Anatomical Site: The device is used within the patient's body (upper airways and tracheobronchial tree), not for analyzing samples taken from the body.

Therefore, the function and intended use of this device fall outside the scope of an In Vitro Diagnostic device.

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.

Not for pediatric use.

Product codes

JAK

Device Description

The superDimension/Bronchus Premium 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 nearnet aod the interior of the tree. It has been modified to permit external video monitoring and recording devices. Other minor improvements have been made also.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT scan

Anatomical Site

upper airways and 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Non - clinical tests
The superDimension/Bronchus Premium 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)

K052260

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

superDimension Ltd. Special 510(k)

super/Dimension Bronchus Premium 510(k) Summary September 20, 2005

1. Submitter Information

K052852

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 Premium Common Name: Bronchoscope Classification name: System, x-ray, tomography, computed

3. Equivalent legally- marketed devices:

superDimension/Bronchus 4.1, K052260

4. Description

The superDimension/Bronchus Premium 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 nearnet aod

1

the interior of the tree. It has been modified to permit external video monitoring and recording devices. Other minor improvements have been made also.

5. Intended Use

The superDimension/Bronchus Premium is intended to image the upper airways and tracheobronchial tree to aid the physician in guiding endoscopic tools in the pulmonary tract. It does not make a diagnosis and is not a bronchial tool

6. Performance Data

Non - clinical tests

The superDimension/Bronchus Premium 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

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ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ

NOV 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

superDimension Ltd. c/o George H. Myers, Sc.D. Official Correspondent Medsys, Incorporated 377 Route 17 South HASBROUCK HEIGHTS NJ 07604

Re: K052852

Trade/Device Name: superDimension/Bronchus Premium Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 7, 2005 Received: October 11, 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 clectronic 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) 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.xxxx(Gastroenterology/Renal/Urology)240-276-0115
21 CFR 884.xxxx(Obstetrics/Gynecology)240-276-0115
21 CFR 892.xxxx(Radiology)240-276-0120
Other240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (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

Page 9

K052852

Indications fo

510(k) Number (if known):

K052852

Device Name: superDimension/Bronchus Premium

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 X (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)

Yancy C. Buradon

Division of Reproductive, At and Radiological De 510(k) Number

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