(98 days)
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.
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
The provided text contains information about the Climb Mammography Viewer Software and its FDA 510(k) clearance. However, it does not include the specific details required to answer all parts of your request regarding acceptance criteria, study methodologies, and performance metrics.
The document is a 510(k) clearance letter and a summary of the device for submission. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study report.
Here's a breakdown of what can be extracted and what information is missing:
Information Available:
- Device Name: Climb Mammography Viewer Software
- Intended Use: Used by radiologists for reading, manipulation, and interpretation of DICOM digital breast images (mammography).
- Predicates: Cedara I-SoftView / Cedara-I ReadMammo (K040468) and WorkstationOne™ Breast Imaging Workstation (K073272).
- Conclusion: The device was found to be substantially equivalent to predicate devices in intended use, indications for use, technological characteristics, and labeling.
- Performance Data Mentioned: "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."
Information NOT Available in the Provided Text:
- Specific acceptance criteria (e.g., minimum sensitivity, specificity, accuracy).
- Reported device performance values against specific criteria.
- Sample size used for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study results or effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used (beyond implying expert interpretation of DICOM images).
- Sample size for the training set.
- How ground truth for the training set was established.
Based on the available text, here's what can be provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, AUC) or report specific performance metrics for the Climb Mammography Viewer Software against such criteria. The focus of this 510(k) summary is on demonstrating substantial equivalence to predicate devices. The "Performance Data" section broadly states that "All software verification and validation testing met or exceeded the requirements as established by the test protocol and applicable standards." This indicates functional and safety performance, rather than diagnostic accuracy metrics.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| (Not specified in the document beyond meeting "requirements" and "standards") | (Not specified in the document. The filing emphasizes substantial equivalence to predicates for intended use, indications, and technological characteristics.) |
| Software Verification & Validation | Met or exceeded requirements as established by test protocol and applicable standards. |
| Functional Equivalence | Demonstrated substantial equivalence to predicate devices (Cedara I-SoftView / Cedara-I ReadMammo and WorkstationOne™ Breast Imaging Workstation) in intended use, indications for use, technological characteristics, and labeling. |
| Safety Profile | Presents no new worst case for performance testing compared to predicates, and deemed safe and effective for intended use. |
2. Sample size used for the test set and the data provenance
This information is not provided in the document. The 510(k) summary focuses on general software verification and validation, and substantial equivalence, not a clinical performance study with a specific test set of patient cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document.
4. Adjudication method for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of an MRMC comparative effectiveness study or AI assistance in the provided text. The device is described as "breast imaging workstation software" for reading, manipulation, and interpretation of images by radiologists, implying it's a viewing and analysis tool, not necessarily an AI-driven CAD or decision support system that would typically be evaluated with MRMC studies comparing human performance with and without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. Given the description as "Viewer Software" for radiologists to "interpret" images, a standalone algorithm performance study is unlikely to be relevant to this product's primary claim, as it is designed for human-in-the-loop use.
7. The type of ground truth used
This information is not explicitly stated. However, considering the device's function as a "Mammography Viewer" for radiologists to "interpret DICOM digital breast images," the implied ground truth would likely involve expert consensus, potentially linked to pathology or follow-up outcomes in a clinical validation study if one were described (which it is not here).
8. The sample size for the training set
This information is not provided in the document. A "training set" would typically be relevant for machine learning or AI-based devices, which this document does not present the Climb Mammography Viewer as. The software verification and validation mentioned would refer to testing the software's functional specifications, not a machine learning model's training.
9. How the ground truth for the training set was established
This information is not provided in the document, as a training set, as typically understood in AI/ML contexts, is not mentioned.
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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.
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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 (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)
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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 | +816-6835-8055 |
| Fax | +816-6835-8056 |
| Contact Person | Kenneth Wade | Aya Ishimura |
|---|---|---|
| Address | 6259 Sturbridge CTSarasota, FL 34238 | Senri Life Science Center Bldg. 10F 1-4-2Shinsenri HigashimachiToyonaka-shiOsaka 560-0082 Japan |
| Telephone | 941 (961) 5472 | +816-6835-8055 |
| Fax | 941 (925) 9414 | +816-6835-8056 |
| kwade@climb-ms.com | ishimura@climb-ms.com |
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-IReadMammo | K040468 | Cedara Software Corporation |
|---|---|---|---|
| WorkstationOne™ BreastImaging 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 beenobtained from PACS or modalities. Source images are obtained as the recipientof push data for the images. The system can also automatically open images andthe corresponding reporting page. The product includes features that allow thequalified medical professional to view patient medical images |
|---|---|
| ------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Indications andIntended Use | Climb Mammography Viewer is intended to be used by radiologists for thereading, manipulation and interpretation of DICOM digital breast imagesincluding mammography. Radiologists are able to select, display, manipulate,quantify, mark-up, print and exchange images. |
|---|---|
| Lossy compressed mammographic images must not be reviewed for primaryimage interpretations. Images may only be interpreted using an FDA cleareddisplay that meets technical specifications reviewed and accepted by FDA fordigital mammography. All images must conform to regulatory requirements.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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| SubstantialEquivalence | I ReadMam (K040468) and WorkstationOne™ Breast Imaging Workstation(K073272). The Climb Mammography-Viewer device is substantially equivalentto the predicate devices in intended use, indications for use, technologicalcharacteristics, and labeling. |
|---|---|
| Performance Data | The potential hazards have been evaluated and controlled through a RiskManagement Plan.All software verification and validation testing met or exceeded the requirementsas established by the test protocol and applicable standards. The resultsdemonstrated that the Subject device presents no new worst case forperformance testing and the Subject device was therefore found to besubstantially equivalent to the Predicate. |
| Conclusion | Based on the indications for use, technological characteristics, and comparisonto predicate devices, the Subject Climb Mammography-Viewer has been shownto be substantially equivalent to legally marketed predicate devices, and safe andeffective for its intended use. |
§ 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).