K Number
K141364
Device Name
CLIMB MAMMOGRAPHY VIEWER SOFTWARE
Date Cleared
2014-08-29

(98 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 Description
Climb Mammography Viewer Software is breast imaging workstation software. The system allows for the display and manipulation of images that have been obtained from PACS or modalities. Source images are obtained as the recipient of push data for the images. The system can also automatically open images and the corresponding reporting page. The product includes features that allow the qualified medical professional to view patient medical images
More Information

Not Found

No
The document describes a standard mammography viewer software with image manipulation capabilities, and explicitly states "Mentions AI, DNN, or ML: Not Found". There is no mention of AI/ML in the intended use, device description, or performance studies.

No
This device is a viewer/workstation for interpreting medical images, not a device that provides therapy or directly treats a condition. Its purpose is diagnostic image display and manipulation.

Yes

Explanation: The device is a "Mammography Viewer" intended for radiologists to read, manipulate, and interpret DICOM digital breast images, including mammography, to aid in the diagnosis of breast conditions.

Yes

The device is explicitly described as "Climb Mammography Viewer Software" and its function is the display and manipulation of images obtained from PACS or modalities. The description focuses solely on software functionalities and does not mention any associated hardware components that are part of the device itself.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
  • Device Function: The Climb-Mammography Viewer is a software workstation used by radiologists to view, manipulate, and interpret medical images (DICOM digital breast images). It does not perform any tests on biological samples.
  • Intended Use: The intended use clearly states it's for "reading, manipulation and interpretation of DICOM digital breast images." This is a function related to medical imaging, not in vitro testing.

Therefore, the Climb-Mammography Viewer falls under the category of medical imaging software or a picture archiving and communication system (PACS) component, not an in vitro diagnostic device.

N/A

Intended Use / Indications for 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.

Product codes

LLZ

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

DICOM digital breast images including mammography

Anatomical Site

breast

Indicated Patient Age Range

Not Found

Intended User / Care Setting

radiologists

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The potential hazards have been evaluated and controlled through a Risk Management Plan. All software verification and validation testing met or exceeded the requirements as established by the test protocol and applicable standards. The results demonstrated that the Subject device presents no new worst case for performance testing and the Subject device was therefore found to be substantially equivalent to the Predicate.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K040468, K073272

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three heads, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

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.

1

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .

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EF

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

3

SubmitterClimb Medical Systems, Inc.
Senri Life Science Center Bldg. 10F 1-4-2 Shinsenri Higashimachi
Toyonaka-shi
Osaka 560-0082 Japan
Telephone+816-6835-8055
Fax+816-6835-8056
Contact PersonKenneth WadeAya Ishimura
Address6259 Sturbridge CT
Sarasota, FL 34238Senri Life Science Center Bldg. 10F 1-4-2
Shinsenri Higashimachi
Toyonaka-shi
Osaka 560-0082 Japan
Telephone941 (961) 5472+816-6835-8055
Fax941 (925) 9414+816-6835-8056
Emailkwade@climb-ms.comishimura@climb-ms.com

Date Prepared May 21, 2014

Trade NameClimb Mammography Viewer
Common NameDisplay
Classification NamePicture Archiving and Communication System
ClassClass II, Special Controls
Regulation Number21 CFR 892.2050
Product CodeLLZ: Radiological Image Processing System

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

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

---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| Indications and
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. |

TechnologicalDocumentation was provided to demonstrate that the Climb Mammography-
Characteristics andViewer is substantially equivalent to the predicates Cedara I-SoftView / Cedara-

4

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