(172 days)
No
The summary describes image processing and visualization software, but there is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/test sets for such algorithms. The performance evaluation focuses on measurement accuracy compared to a predicate device, not on the performance of an AI/ML model.
No.
The device is intended as an aid for assessing patient images for diagnosis, preoperative planning, and during intervention/surgery, but it does not directly treat or alleviate a disease or condition.
No.
The device is intended as an aid for assessing patient images and preoperative planning, not for diagnosis. It explicitly states it is not meant to be used for diagnosis.
Yes
The device description explicitly states "SpectoMed (v1.0) is a software-only device". While it can be used with compatible VR and AR headsets, the device itself is the software.
Based on the provided information, SpectoMed (v1.0) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- SpectoMed's Function: SpectoMed processes and visualizes medical imaging data (CT and MRI) which are generated from the patient's body, not from a specimen taken from the body. It aids in the interpretation and planning based on these images.
- Intended Use: The intended use clearly states it provides "real-time spatial-visualization of medical imaging," "aids the clinician in the preparation of a surgical intervention," and is an "aid for assessing patient images." None of these activities involve the analysis of in vitro specimens.
Therefore, SpectoMed (v1.0) falls under the category of medical imaging software or surgical planning software, not an IVD.
N/A
Intended Use / Indications for Use
SpectoMed (v1.0) provides real-time spatial-visualization of medical imaging the manipulation, processing, review, analysis, communication and media interchange of multi-dimages of several modalities as defined by the DICOM standard, such as CT or MRI imaging datasets. Furthermore, SpectoMed (v1.0) aids the clinician in the preparation of a surgical intervention with measurements and import of compatible objects within the realistic spatial visuals of the patient's anatomy as well as their intraoperative display. SpectoMed (v1.0) is intended as an aid for assessing patient images.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
SpectoMed (v1.0) is a software-only device that allows trained medical professionals to review CT and MRI image data in three-dimensional (3D) format and/or in virtual reality (VR) and/or Augmented reality (AR) interfaces. The 3D rendered images are accessible through the software desktop application and, if desired, through compatible VR and AR headsets which are used by users for preoperative surgical planning and for display during intervention/surgery.
SpectoMed (v1.0) product is to be used to assist in medical image review. Intended users are trained medical professionals, including imaging technicians, clinicians and surgeons.
The 3D images generated using SpectoMed (v1.0) are intended as an aid for assessing CT or MR images that are used for diagnosis, preoperative planning and/or during intervention/surgery. SpectoMed (v1.0) is intended to be used in environments where the usage of a computer display or an XR system is safe such as:
- Office spaces
- · Operating rooms under these two scenarios:
- · Display of the SpectoMed (v1.0) visual output on existing monitors/screens in the operating room
- Use of XR displays in a non-sterile situation as e.g. before draping the patient or outside the sterility area, and thus strictly in compliance with sterility protocols.
SpectoMed (v1.0) is not meant to:
- · be used in a sterile environment,
- · to register 3D images to patients,
- · to be used with the user's hands on the patient during an interventional or surgical procedure.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended users are trained medical professionals, including imaging technicians, clinicians and surgeons.
SpectoMed (v1.0) is intended to be used in environments where the usage of a computer display or an XR system is safe such as:
- Office spaces
- Operating rooms under these two scenarios:
- Display of the SpectoMed (v1.0) visual output on existing monitors/screens in the operating room
- Use of XR displays in a non-sterile situation as e.g. before draping the patient or outside the sterility area, and thus strictly in compliance with sterility protocols.
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)
Measurement performance testing was conducted by leveraging reference digital phantoms and the comparison with a cleared device (Osirix MD K101342), which was also used by the predicate device as its performance reference device.
Key results: No statistical difference between distributions of measurements obtained for SpectoMed (v1.0) or the reference device Osirix MD, as evaluated per t-test statistics. Tests performed at varying reference CT phantom scan resolutions. This applies to both Distance Measurements and Angle Measurements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Specto Medical % Charly Leprince Head of Quality Assurance and Regulatory Affairs Elisabethenstrasse 18 4051 BASEL, SWITZERLAND
January 14, 2025
Re: K242205
Trade/Device Name: SpectoMed (v1.0) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: December 12, 2024 Received: December 12, 2024
Dear Charly Leprince:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb
Jessica Lamb Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242205
Device Name SpectoMed (v1.0)
Indications for Use (Describe)
SpectoMed (v1.0) provides real-time spatial-visualization of medical imaging the manipulation, processing, review, analysis, communication and media interchange of multi-dimages of several modalities as defined by the DICOM standard, such as CT or MRI imaging datasets. Furthermore, SpectoMed (v1.0) aids the clinician in the preparation of a surgical intervention with measurements and import of compatible objects within the realistic spatial visuals of the patient's anatomy as well as their intraoperative display. SpectoMed (v1.0) is intended as an aid for assessing patient images.
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) |
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Image /page/4/Picture/1 description: The image contains the logo for Specto Medical. The logo consists of a stylized geometric shape to the left of the company name. The geometric shape is made up of overlapping squares. The text "Specto" is in a larger, bold font, while "Medical" is in a smaller font below it.
510(k) Summary SpectoMed (v1.0)
K242205
1 General Information
| 510(k) Sponsor | Specto Medical |
|---|---|
| Address | Elisabethenstrasse 18 |
| 4051 Basel, Switzerland | |
| Correspondence Person | Charly Leprince |
| Head of Quality Assurance and Regulatory Affairs | |
| Contact Information | Email: QM@spectomedical.com |
| Phone: +41 61 294 60 60 | |
| Date of preparation | January 13, 2025 |
2 Subject Device
| Device Name: | SpectoMed (v1.0) |
|---|---|
| Classification Name: | System, Image Processing, Radiological |
| Regulation Number: | 21 CFR 892.2050 |
| Regulation Name: | Medical Image Management and Processing System |
| Review Panel | Radiology |
| Product Code | LLZ |
| Regulatory Class | Class II |
3 Predicate Device
| Device Name: | Avatar Medical Software V1 |
|---|---|
| Premarket Notification: | K222035 |
| Classification Name: | System, Image Processing, Radiological |
| Regulation Number: | 21 CFR 892.2050 |
| Regulation Name: | Medical Image Management and Processing System |
| Review Panel: | Radiology |
| Product Code: | LLZ |
| Regulatory Class | Class II |
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Image /page/5/Picture/0 description: The image shows the logo for Specto Medical. The logo consists of a stylized icon on the left and the text "Specto Medical" on the right. The icon is a geometric shape that looks like two overlapping diamonds. The word "Specto" is in a larger, bolder font than the word "Medical," which is placed below it.
4 Device Description:
SpectoMed (v1.0) is a software-only device that allows trained medical professionals to review CT and MRI image data in three-dimensional (3D) format and/or in virtual reality (VR) and/or Augmented reality (AR) interfaces. The 3D rendered images are accessible through the software desktop application and, if desired, through compatible VR and AR headsets which are used by users for preoperative surgical planning and for display during intervention/surgery.
SpectoMed (v1.0) product is to be used to assist in medical image review. Intended users are trained medical professionals, including imaging technicians, clinicians and surgeons.
The 3D images generated using SpectoMed (v1.0) are intended as an aid for assessing CT or MR images that are used for diagnosis, preoperative planning and/or during intervention/surgery. SpectoMed (v1.0) is intended to be used in environments where the usage of a computer display or an XR system is safe such as:
- Office spaces
- · Operating rooms under these two scenarios:
- · Display of the SpectoMed (v1.0) visual output on existing monitors/screens in the operating room
- Use of XR displays in a non-sterile situation as e.g. before draping the patient or outside the sterility area, and thus strictly in compliance with sterility protocols.
SpectoMed (v1.0) is not meant to:
- · be used in a sterile environment,
- · to register 3D images to patients,
- · to be used with the user's hands on the patient during an interventional or surgical procedure.
5 Intended Use and Indications for Use
SpectoMed (v1.0) provides real-time spatial-visualization of medical imaging allowing the manipulation, processing, review, analysis, communication and media interchange of multi-dimensional digital images of several modalities as defined by the DICOM standard, such as CT or MRI imaging datasets. Furthermore, SpectoMed (v1.0) aids the clinician in the preparation of a surgical intervention with measurements and import of compatible objects within the realistic spatial visuals of the patient's anatomy as well as their intraoperative display. SpectoMed (v1.0) is intended as an aid for assessing patient images.
6 Comparison of Technological Characteristics
| Feature/ Function | Subject Device:
SpectoMed (v1.0) | Predicate Device:
AMS V1 (K222035) | Substantial Equivalent |
|------------------------|--------------------------------------------------------|--------------------------------------------------------|------------------------|
| Classification Name | System, Image
Processing, Radiological | System, Image
Processing, Radiological | Yes |
| Regulatory Number | 892.2050 | 892.2050 | Yes |
| Product Code | LLZ | LLZ | Yes |
| Device Class | Class II | Class II | Yes |
| Review Panel | Radiology | Radiology | Yes |
| Intended Users | Health care
Professionals | Health care Professionals | Yes |
| Intended Environment | Healthcare facilities such
as hospitals and clinics | Healthcare facilities such
as hospitals and clinics | Yes |
| Preoperative Use | Yes | Yes | Yes |
| Intraoperative Display | Yes | Yes | Yes |
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Image /page/6/Picture/1 description: The image contains the logo for Specto Medical. The logo consists of a stylized icon to the left of the company name. The icon is made up of two overlapping squares, each with rounded corners and a smaller square cut out of the center. To the right of the icon is the company name, "Specto" in a larger font size, with "Medical" underneath in a smaller font size.
| Feature/ Function | Subject Device: SpectoMed (v1.0) | Predicate Device: AMS V1 (K222035) | Substantial Equivalent |
|---|---|---|---|
| Image Analysis Features | Interactive manipulation, filtering, create annotations and measurements | Interactive manipulation, filtering, create annotations and measurements | Yes |
| Measurements | Yes - Linear, angular measurements only | Yes - linear and diameter measurements only | Yes |
| Remote Streaming | No | Yes | No, Subject Device does not provide remote streaming. This functionality does not impact safety or efficacy of the product. |
| Pan image | Pan image in any direction | Pan image in any direction | Yes |
7 Predicate Device Comparison
The subject device and predicate device have equivalent indications for use. Both devices are intended for viewing CT and MR data in multi-dimensional views as well as for preoperative and intraoperative surgical planning using equivalent technologies. Additionally, both devices have equivalent technological characteristics with only one minor difference being that the subject device does not provide remote streaming capability, this functionality does not affect safety or effectiveness of the subject device.
8 Performance Data
Safety and performance of the SpectoMed (v1.0) has been evaluated and verified in accordance with software specifications and applicable performance standards throughout software verification and validation testing activities. Moreover, the software validation activities were performed in accordance with ANSI AAMI IEC 62304:2006/A1:2016 - Medical device software - Software life cycle processes, in addition to the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Device Software Functions" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions." All functional and performance testing occurred on the minimum hardware configuration and the specified operating systems and VR/AR platforms.
Measurement performance testing was conducted by leveraging reference digital phantoms and the comparison with a cleared device (Osirix MD K101342), which was also used by the predicate device as its performance reference device.
| Feature/
Function | Tool in Subject
Device:
SpectoMed (v1.0) | Tool in Reference
Device:
Osirix MD (K101342) | Acceptance criteria |
|--------------------------|------------------------------------------------|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Distance
Measurements | Distance | Region of Interest (ROI)
• 3D coordinates | No statistical difference
between distributions of
measurements obtained for
SpectoMed (v1.0) or the reference
device Osirix MD, as evaluated
per t-test statistics.
Tests performed at varying
reference CT phantom scan
resolutions. |
| Angle
Measurements | Angle | Region of Interest (ROI)
• 3D coordinates | |
1 Measurements Performance Testing
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Image /page/7/Picture/1 description: The image contains the logo for Specto Medical. The logo consists of a stylized icon on the left and the text "Specto Medical" on the right. The icon is a geometric shape, resembling two overlapping squares or diamonds. The word "Specto" is in a larger font size than "Medical", and it is placed above the word "Medical".
9 Conclusion
Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing, the SpectoMed (v1.0) raises no new questions of safety and effectiveness and demonstrates substantial equivalence to the predicate device.