CLIMB MAMMOGRAPHY VIEWER SOFTWARE

K141364 · Climb Medical Systems, Inc. · LLZ · Aug 29, 2014 · Radiology

Device Facts

• Record ID: K141364
• Device Name: CLIMB MAMMOGRAPHY VIEWER SOFTWARE
• Applicant: Climb Medical Systems, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Aug 29, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Climb-Mammography Viewer is intended to be used by radiologists for the reading, manipulation and interpretation of DICOM digital breast images including mammography. Radiologists are able to select, display, manipulate, quantify, mark-up, print and exchange images. Lossy compressed mammographic images must not be reviewed for primary image interpretations. Images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA for digital mammography. All images must conform to regulatory requirements. Image quality must conform to applicable quality guidance.

Device Story

Climb Mammography Viewer Software is a breast imaging workstation application; receives DICOM images from PACS or modalities via push data; allows radiologists to select, display, manipulate, quantify, mark-up, print, and exchange images; automatically opens images and corresponding reporting pages; used in clinical settings by radiologists; output viewed on FDA-cleared displays; assists in clinical interpretation of breast images; supports diagnostic decision-making.

Clinical Evidence

Bench testing only. Software verification and validation testing performed per protocol; results met or exceeded requirements, demonstrating substantial equivalence to predicate devices.

Technological Characteristics

Breast imaging workstation software; DICOM-compliant; supports image display, manipulation, quantification, and mark-up; operates on standard hardware (requires FDA-cleared display for primary interpretation); software-based image processing.

Indications for Use

Indicated for radiologists for reading, manipulation, and interpretation of DICOM digital breast images, including mammography. No specific patient population age or gender restrictions stated, though implied for breast imaging.

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

• Cedara I-SoftView / Cedara-I ReadMammo (K040468)
• WorkstationOne™ Breast Imaging Workstation (K073272)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 29, 2014

Climb Medical Systems, Inc. % Kenneth Wade International Marketing Manager Senri Life Science Center Bldg. 10F 1-4-2 Shinsenri Higashimachi TOYONAKA-SHI OSAKA 560-0082 JAPAN

Re: K141364

Trade/Device Name: Climb Mammography Viewer Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 14, 2014 Received: August 18, 2014

Dear Mr. Wade:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D'Hara
for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K141364

Device Name Climb Mammography Viewer Software

#### Indications for Use (Describe)

Climb-Mammography Viewer is intended to be used by radiologists for the reading, manipulation and interpretation of DICOM digital breast images including mammography. Radiologists are able to select, display, manipulate, quantify, mark-up, print and exchange images.

Lossy compressed mammographic images must not be reviewed for primary image interpretations. Images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA for digital mammography. All images must conform to regulatory requirements. Image quality must conform to applicable quality guidance.

## Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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#

| Submitter | Climb Medical Systems, Inc. |
|-----------|------------------------------------------------------------------|
| | Senri Life Science Center Bldg. 10F 1-4-2 Shinsenri Higashimachi |
| | Toyonaka-shi |
| | Osaka 560-0082 Japan |
| Telephone | [phone] |
| Fax | [phone] |

| Contact Person | Kenneth Wade | Aya Ishimura |
|----------------|------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Address | 6259 Sturbridge CT<br>Sarasota, FL 34238 | Senri Life Science Center Bldg. 10F 1-4-2<br>Shinsenri Higashimachi<br>Toyonaka-shi<br>Osaka 560-0082 Japan |
| Telephone | 941 (961) 5472 | [phone] |
| Fax | 941 (925) 9414 | [phone] |
| Email | [e-mail] | [e-mail] |

Date Prepared May 21, 2014

| Trade Name | Climb Mammography Viewer |
|---------------------|--------------------------------------------|
| Common Name | Display |
| Classification Name | Picture Archiving and Communication System |
| Class | Class II, Special Controls |
| Regulation Number | 21 CFR 892.2050 |
| Product Code | LLZ: Radiological Image Processing System |

| Predicate Devices | Cedara I-SoftView / Cedara-I<br>ReadMammo | K040468 | Cedara Software Corporation |
|-------------------|-----------------------------------------------|---------|-----------------------------|
| | WorkstationOne™ Breast<br>Imaging Workstation | K073272 | Three Palm Software, LLC |

| Description | Climb Mammography Viewer Software is breast imaging workstation software.<br>The system allows for the display and manipulation of images that have been<br>obtained from PACS or modalities. Source images are obtained as the recipient<br>of push data for the images. The system can also automatically open images and<br>the corresponding reporting page. The product includes features that allow the<br>qualified medical professional to view patient medical images |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Indications and<br>Intended Use | Climb Mammography Viewer is intended to be used by radiologists for the<br>reading, manipulation and interpretation of DICOM digital breast images<br>including mammography. Radiologists are able to select, display, manipulate,<br>quantify, mark-up, print and exchange images. |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Lossy compressed mammographic images must not be reviewed for primary<br>image interpretations. Images may only be interpreted using an FDA cleared<br>display that meets technical specifications reviewed and accepted by FDA for<br>digital mammography. All images must conform to regulatory requirements.<br>Image quality must conform to applicable quality guidance. |

| Technological | Documentation was provided to demonstrate that the Climb Mammography- |
|---------------------|----------------------------------------------------------------------------------|
| Characteristics and | Viewer is substantially equivalent to the predicates Cedara I-SoftView / Cedara- |

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| Substantial<br>Equivalence | I ReadMam (K040468) and WorkstationOne™ Breast Imaging Workstation<br>(K073272). The Climb Mammography-Viewer device is substantially equivalent<br>to the predicate devices in intended use, indications for use, technological<br>characteristics, and labeling. |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data | The potential hazards have been evaluated and controlled through a Risk<br>Management Plan.<br>All software verification and validation testing met or exceeded the requirements<br>as established by the test protocol and applicable standards. The resultsdemonstrated that the Subject device presents no new worst case for<br>performance testing and the Subject device was therefore found to be<br>substantially equivalent to the Predicate. |
| Conclusion | Based on the indications for use, technological characteristics, and comparison<br>to predicate devices, the Subject Climb Mammography-Viewer has been shown<br>to be substantially equivalent to legally marketed predicate devices, and safe and<br>effective for its intended use. |