SUPERDIMENSION/BRONCHUS

K042438 · Superdimension, Ltd. · JAK · Nov 8, 2004 · Radiology

Device Facts

• Record ID: K042438
• Device Name: SUPERDIMENSION/BRONCHUS
• Applicant: Superdimension, Ltd.
• Product Code: JAK · Radiology
• Decision Date: Nov 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

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.

Device Story

The superDimension/Bronchus is an image-guided navigation system designed to assist physicians in maneuvering bronchoscopic tools through the pulmonary tract. The device utilizes pre-operative CT scan data to generate a path to a target within the bronchial tree. It provides real-time visualization of the tracheobronchial tree interior to facilitate tool guidance. The system is intended for use by physicians in a clinical setting. It does not perform diagnostic functions and is not an endoscopic tool itself. By providing a visual roadmap based on patient-specific CT data, the device aids in the precise navigation of tools to target sites, potentially improving procedural accuracy.

Clinical Evidence

The device underwent extensive bench testing, including compliance with EN60601-1-2. Clinical evidence includes both animal studies and a clinical evaluation to support safety and effectiveness.

Technological Characteristics

System utilizes CT scan data for navigation and visualization. Complies with EN60601-1-2 standards for electromagnetic compatibility. System is designed for integration with bronchoscopic tools.

Indications for Use

Indicated for displaying images of the tracheobronchial tree to aid the physician 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

• Ultraguide CTG 2000sa (K022354)
• Olympus UM-2R/3R (K982323)
• Olympus BF 1T160 (K023984)

Submission Summary (Full Text)

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K042438

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. [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: 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

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# 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.

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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.

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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

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superDimension/Bronchus

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# 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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