INREACH PLANNING LAPTOP

K082386 · Superdimension, Ltd. · LLZ · Sep 16, 2008 · Radiology

Device Facts

• Record ID: K082386
• Device Name: INREACH PLANNING LAPTOP
• Applicant: Superdimension, Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Sep 16, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

Device Story

The inReach Planning Laptop is a workstation for bronchoscopy planning and CT-viewing. It processes CT image data to display the tracheobronchial tree, assisting physicians in navigating endoscopic tools or catheters and placing markers in soft lung tissue. Used by physicians in clinical settings, the device serves as a visualization aid rather than a diagnostic tool. It does not perform automated diagnosis. The system operates as a standalone unit or in conjunction with other system components outside the endoscopy room. It provides visual guidance to improve the accuracy of endoscopic procedures and marker placement, potentially benefiting patients by facilitating access to pulmonary lesions. No changes to hardware, software, or firmware were introduced in this modification; the update solely expands the operational context for the existing planning laptop.

Clinical Evidence

No clinical data was required or provided for this modification.

Technological Characteristics

The device is a laptop-based Picture Archiving and Communications System (PACS) (21 CFR 892.2050). It functions as a visualization workstation for CT images. No changes to materials, energy sources, or software algorithms were made compared to the predicate device.

Indications for Use

Indicated for adult patients requiring visualization of the tracheobronchial tree to assist physicians in guiding endoscopic tools/catheters and marker placement in soft lung tissue. Not for pediatric use.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• inReach System (K081379)

Submission Summary (Full Text)

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K062386

# SEP 1 6 2008

510(k) Summary

superDimension, Ltd. Special 510(k) Proposed Minor Modifications to inReach™ Planning Laptop

#### Date Prepared:

08/18/2008

#### 510(k) Applicant:

superDimension, Ltd. 8 Hamenofim St., P.O. Box 2045 Herzliya 46120 Israel Ph: [phone] Fax: [phone]

#### 510(k) Application Correspondent:

Margarct DePuydt, P.E., RAC Regulatory Affairs Manager superDimension, Inc. 161 Cheshire Lane, Suite 100 Minneapolis, MN 55441 Phone: [phone] Cell : 612-845-7771 Fax : [phone] Email : [e-mail]

#### Name of Device :

| Trade Name : | - superDimension®/ inReach™ Planning Laptop<br>- inReach™ Planning Laptop |
|----------------------|---------------------------------------------------------------------------|
| Common Name: | inReach™ Planning Laptop - Bronchoscopy Planning/CT-Viewing |
| Classification Name: | Picture Archiving and Communications System |
| | 21 CFR 892.2050 |
| | Product code LLZ |

## Equivalent Legally-Marketed Device: inReach System, K081379

**FDA CDRH DMC**

*AUG 19 2008*

**Received**

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#### Description;

superDimension is proposing that the inReach™ Planning Laptop, with its current software be approved to be used either as a stand-alone for performing bronchoscopy planning, as currently approved (K081379, June 11, 2008) or for CT-Viewing, or with the other system components in places outside of the endoscopy room.

There are no modifications proposed to the software, firmware, firmware, product design or specifications, or manufacturing processes as currently approved.

#### Intended Use:

Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

#### Summary of Characteristics Compared to Predicate Device:

Minor modifications are being proposed to the Instruction for Use (inReach User Manual) to reflect the proposal that the Planning Laptop be used as a stand-alone for bronchoscopy planning or CT-Viewing, or with the other system components,

No changes are being made to the hardware or intended use, or technological characteristics of the current marketed device.

#### Performance Data:

The planned modifications were subjected to the superDimension design control process. There are no modifications proposed to the software, firmware, product design or specifications, or manufacturing processes as currently approved (K081379, June 11, 2008). The inReach System and software design input/output requirements are not changing and will continue to meet the user needs and intended uses, performing to design specifications. Therefore software and design validations/verifications are not required to be performed.

There are no new, increased, altered, or eliminated risks associated with this minor modification. A risk analysis is not required to be performed. The risk analysis documents presented in K081379 have not changed, and still apply to the Planing Laptop.

Appropriate labeling changes are identified in the User Manual and summarized in the User Manual Change Revision Table.

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## Clinical Data:

Clinical tests were not required to validate the changes to the inReach System to incude the Planning Laptop.

# Conclusion:

The inReach System is safe and effective for its intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2008

superDimension, Ltd. % Ms. Margaret DePuydt Regulatory Affairs Manager superDimension, Inc. 161 Cheshire Lane, Suite 100 MINNEAPLOIS MN 55441

Re: K082386

Trade/Device Name: inReach Planning Laptop Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 15, 2008 Received: August 19, 2008

Dear Ms. DePuydt:

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 (PMA), 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.

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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 complive oth 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.

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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

hope M. Whang

Joyce M. Whang, Ph.D. Acting 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): _ K 082386

Device Name: inReach Planning Laptop

Indications for Use:

Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. 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 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulda Reimer

(Division Sign-Off) Division of Reproductive, Abdominal ar Radiological Devices 510(k) Number _

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