SUPERDIMENSION/BRONCHUS 4.1

K052260 · Superdimension, Ltd. · JAK · Sep 8, 2005 · Radiology

Device Facts

• Record ID: K052260
• Device Name: SUPERDIMENSION/BRONCHUS 4.1
• Applicant: Superdimension, Ltd.
• Product Code: JAK · Radiology
• Decision Date: Sep 8, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The superDimension/Bronchus 4.1 is intended to image the upper airways and tracheobronchial tree to aid. In a bronchial tool

Device Story

The superDimension/Bronchus 4.1 is an image-guided navigation system for the tracheobronchial tree. It utilizes pre-operative CT scan data to generate a visual path for bronchoscopic procedures. The system transforms CT image data into a navigable map, allowing the physician to visualize the target and the interior of the bronchial tree during the procedure. It is used in a clinical setting by physicians to assist in the navigation of endoscopic tools to targets within or adjacent to the bronchial tree. The device does not perform diagnostic functions and is not an endoscopic tool itself. It serves as a navigational aid to improve the precision of tool placement, potentially benefiting patients by facilitating access to difficult-to-reach pulmonary targets.

Clinical Evidence

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

Technological Characteristics

Computed tomography x-ray system (Product Code: JAK). The system processes CT scan data for visualization and navigation. It complies with EN60601-1 (general safety) and EN 60601-1-2 (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 (K042438)

Submission Summary (Full Text)

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K052260

#### 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. [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 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.

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## 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.

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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.

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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 [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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## 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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