(171 days)
Not Found
No
The document describes standard image viewing, measurement, and surgical planning tools without mentioning any AI or ML capabilities.
No.
The device is a software solution for viewing, storing, measuring images, and planning orthopedic surgeries, but it does not directly treat or diagnose a disease or condition. Its function is to assist healthcare professionals in planning procedures.
No
Explanation: The device is described as assisting healthcare professionals in viewing, storing, measuring images, and planning orthopedic surgeries, specifically focusing on the spine. It does not state that it provides a diagnosis or aids in making a diagnosis, but rather helps with surgical planning and measurement.
Yes
The device description explicitly states "Surgimap Spine is a software solution developed for the medical community" and "SurgiSmap Spine is a standalone application developed for windows environment." It is downloaded and run on a digital storage device or personal computer, indicating it is purely software.
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.
- Surgimap Spine's Function: Surgimap Spine is a software tool that works with medical images (like X-rays or CT scans) to assist healthcare professionals in viewing, measuring, and planning surgical procedures. It operates on images, not on biological samples from the patient.
The description clearly indicates that the software is used for image manipulation, measurement, and surgical planning based on those images. This falls under the category of medical imaging software or surgical planning software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Surgimap Spine software is intended for assisting healthcare professionals in viewing, storing, measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as spine related measurements on images, to plan surgical procedures (osteotomies), and includes tools for measuring anatomical components for placements of surgical implants. Clinical judgment and experience are required to properly use the software.
Product codes
LLZ
Device Description
Surgimap Spine is a software solution developed for the medical community. It is intended to be used to view, store, and transport images as well as perform spine related measurements and plan surgical procedures. The image formats supported encompass the standard image formats (jpeg, tiff, png, ....) and also the DICOM images. Images can be stored in a database and measurements (generic or spine specific) can be overlaid to each image. Surgimap Spine also offers the ability for the end user to plan certain surgical procedures such as osteotomies of the spine and templating generic implants (screws and interbody cages). SurgiSmap Spine is a standalone application developed for windows environment. Surgimap Spine can be downloaded directly from www.surgimap.com via the Internet and run off a digital storage such as USB or personal computer hard drive
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Can receive digital images from various sources
Anatomical Site
Spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals
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)
Not Applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
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510(k) Summary of Safety and Effectiveness
KI11019
Contact Information
Submitter's Address:
Nemaris Inc 306 East 15th Street Suite 1R New York, NY 10003 Phone: (646)-794-8650 Fax: (646)-602-6925
Contact Person
Virginie Lafage, PhD Vice President and Chief Technology Officer:
Date
February 14, 2011
Device Name and Classification
| Tradename | Surgimap Spine |
|---|---|
| Common Name: | Picture Archiving and Communication System (PACS) |
| Section: | 892.2050 |
| Class | II |
| Product Code: | LLZ |
Predicate Device
| Tradename | TraumaCad 2.0 |
|---|---|
| 510(k) number: | K073714 |
| Common Name: | Picture Archiving and Communication System (PACS) |
| Section: | 892.2050 |
| Class | II |
| Product Code: | LLZ |
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Device description
Surgimap Spine is a software solution developed for the medical community. It is intended to be used to view, store, and transport images as well as perform spine related measurements and plan surgical procedures. The image formats supported encompass the standard image formats (jpeg, tiff, png, ....) and also the DICOM images. Images can be stored in a database and measurements (generic or spine specific) can be overlaid to each image. Surgimap Spine also offers the ability for the end user to plan certain surgical procedures such as osteotomies of the spine and templating generic implants (screws and interbody cages). SurgiSmap Spine is a standalone application developed for windows environment. Surgimap Spine can be downloaded directly from www.surgimap.com via the Internet and run off a digital storage such as USB or personal computer hard drive
Intended Use
The Surgimap Spine software is intended for assisting healthcare professionals in viewing, storing, measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as spine related measurements on images, to plan surgical procedures (osteotomies), and includes tools for measuring anatomical components for placements of surgical implants. Clinical judgment and experience are required to properly use the software.
Comparison of Technological Characteristics
The tabulated comparison of technological characteristics between Surgimap Spine and its predicated device is outlined in the table hereafter:
| Feature | TraumaCad 2.0 | Surgimap Spine |
|---|---|---|
| Computer | PC Compatible | Same |
| Operating System | Windows | Same |
| Image Input | Can receive digital images from | |
| various sources | Same | |
| Number of images that can be | ||
| simultaneously viewed on the | ||
| screen | Four | Four |
| Runs on Server | Yes | No |
| Trauma Module | Yes | No |
| Osteotomy Module | Yes | Yes |
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| Pre-operative planning | Allowed | Same |
|---|---|---|
| Patient Contact | None | Same |
| Control of life-saving devices | None | Same |
| Human Intervention for interpretation and manipulation of images | Required | Same |
| Ability to add additional Modules when available | Yes | Yes |
| Database | Yes | Yes |
| Measurements | Yes | Yes |
| Templating | Yes | Yes (partial) |
| Web Content | unknown | Yes |
Performance data
.
Not Applicable
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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Nemaris. Inc. % Mr. Keith Barritt Attorney Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 WASHINGTON DC 20005
ECN 30 2011
Re: K111019
Trade/Device Name: Surgimap Spine Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 22, 2011 Received: August 23, 2011
Dear Mr. Barritt:
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 avvroval 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary S Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known):
Device Name: Surgimap Spine
Indications for Use: The Surgimap Spine software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as spine related measurements of the images, to plan surgical procedures (osteotomies), and includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.
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 In Vitro Diagnostic Devices (OIVD)
Division Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K111019
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