SUPERDIMENSION/BRONCHUS PREMIUM 2

K062315 · Superdimension, Ltd. · JAK · Sep 8, 2006 · Radiology

Device Facts

• Record ID: K062315
• Device Name: SUPERDIMENSION/BRONCHUS PREMIUM 2
• Applicant: Superdimension, Ltd.
• Product Code: JAK · Radiology
• Decision Date: Sep 8, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The superDimension/Bronchus Premium 2 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

Device Story

The superDimension/Bronchus Premium 2 is an image-guided navigation system for the pulmonary tract. It takes CT scan data as input to generate a 3D visualization of the tracheobronchial tree. The device has been modified to support PACS connectivity and PET/CT image data import. It is used by physicians in a clinical setting to assist in navigating endoscopic tools toward targets within or adjacent to the bronchial tree. The system provides visual guidance to the clinician but does not perform diagnostic functions or act as an endoscopic tool itself. It serves as an adjunct to standard bronchoscopy procedures to improve navigation accuracy.

Clinical Evidence

No clinical data provided. The manufacturer states that since no new technology is used, clinical tests are not required. Evidence consists of extensive bench testing and compliance with EN60601-1 and EN 60601-1-2 standards.

Technological Characteristics

Computed tomography x-ray system (Product Code: JAK). Features PACS connectivity and PET/CT image data import. Complies with EN60601-1 and EN 60601-1-2 electrical safety standards.

Indications for Use

Indicated for displaying images of the tracheobronchial tree to aid physicians in guiding endoscopic tools in the pulmonary tract. Not for pediatric use. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• superDimension/Bronchus Premium (K052852)

Submission Summary (Full Text)

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superDimension Ltd. Special 510(k)

SEP - 8 2006

Modification to super/Dimension Bronchus Premium 2 510(k) Summary July 26, 2006

#### 1. Submitter Information

Name: superDimension Ltd.

Address:

8 Hamenofim St., POB 2045 Herzliya 46120 Israel

Tel. [phone] Fax [phone]

Contact person:

Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Tel.: [phone] Fax: [phone]

Date prepared: July 26, 2006

#### 2. Name of Device

Trade Name: superDimension/Bronchus Premium 2 Common Name: Bronchoscope Classification name: System, x-ray, tomography, computed

### 3. Equivalent legally- marketed devices:

superDimension/Bronchus Premium, K052852

#### 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

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visualizes target and the interior of the tree. It has been modified to permit connection to PACS and import of PET/CT image data. Other minor improvements have been made also.

## 5. Intended Use

The superDimension/Bronchus Premium 2 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 2 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 Premium is safe and effective for its intended use.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

# SEP - 8 2006

George H. Myers, Sc.D. Official Correspondent Medsys, Inc. 377 Route 17 S HASBROUCK HGTS NJ 07604

Re: K062315

Trade/Device Name: superDimension/Bronchus Premium 2 Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: August 8, 2006 Received: August 9, 2006

#### Dear Mr. Myers:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your boower to see is substantially equivalent (for the indications for referented in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass stated in the entrebute) was ment 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 nate (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 therefore, mainer 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 11 your de rise to such additional controls. Existing major regulations affecting your Apployally, It the J oe book 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 or seal. The text "1906 - 2006" is at the top of the logo. The letters "FDA" are in the center of the logo. The word "Centennial" is below the letters "FDA". Three stars are below the word "Centennial".

romoting Public He

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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 listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Erth 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 [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrlv/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

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superDimension Bronchus Premium 2 Page 4-1

#### Ko 6 2315 Indications for Use

510(k) Number (if known):

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 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)

David A. Legmann

(Division Sign Off Division of Repand Radiological Penna 510(k) Number