SUPERDIMENSION/BRONCHUS PREMIUM

K052852 · Superdimension, Ltd. · JAK · Nov 14, 2005 · Radiology

Device Facts

• Record ID: K052852
• Device Name: SUPERDIMENSION/BRONCHUS PREMIUM
• Applicant: Superdimension, Ltd.
• Product Code: JAK · Radiology
• Decision Date: Nov 14, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

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

Device Story

The superDimension/Bronchus Premium is an image-guided navigation system for the pulmonary tract. It takes CT scan data as input to map a path to a target within or adjacent to the bronchial tree. The device guides a bronchoscope and bronchial tool along this path while visualizing the interior of the bronchial tree. It is operated by a physician in a clinical setting. The system has been modified to support external video monitoring and recording. The output is a visual display used by the physician to navigate endoscopic tools; it does not provide a diagnosis. The device benefits patients by assisting in the precise placement of endoscopic tools during pulmonary procedures.

Clinical Evidence

No clinical data provided. The device relies on bench testing to demonstrate substantial equivalence. The system was tested for compliance with EN60601-1 and EN60601-1-2 standards.

Technological Characteristics

The device is a computed tomography x-ray system (Product Code: JAK). It functions as an image-guided navigation system for bronchoscopy. Key technical features include external video monitoring and recording interfaces. The system complies with EN60601-1 (general safety) and EN60601-1-2 (electromagnetic compatibility) 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 4.1 (K052260)

Submission Summary (Full Text)

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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. [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, 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

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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.

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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.

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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 |
| Other | | 240-276-0100 |

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 [phone] or [phone] 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

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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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