(254 days)
Not Found
No
The description focuses on image capture, storage, and basic image manipulation tools (filters). There is no mention of automated analysis, pattern recognition, or learning algorithms that would indicate AI/ML. The analysis relies on the health specialist's visual review and manual placement of markers.
No
The device is described as a tool to quantify angles on digital photograph depictions related to postural asymmetries, and for health specialists to review anatomical and morphological features related to a patient’s posture. It is explicitly indicated as a "tool" for assessment and analysis, not for treatment or therapy.
Yes
The device quantifies angles on digital photograph depictions of body angles related to postural asymmetries, which health specialists use to visually review anatomical and morphological features related to a patient’s posture, supporting a professional medical diagnosis.
No
The device description explicitly states that the CryoVizion System is composed of both hardware and software sections, and details the hardware components (cameras, lighting units, column, booth, control center).
Based on the provided information, the CryoVizion device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- CryoVizion's Function: The CryoVizion system is described as a tool to quantify angles on digital photograph depictions of the body. It uses external imaging (digital photographs) of the patient's body to assess postural asymmetries.
- No Specimen Analysis: The description clearly states that the system is "non-invasive" and involves taking images of the patient directly, not analyzing samples taken from the patient's body.
Therefore, the CryoVizion falls under the category of a medical device used for external assessment and measurement, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CryoVizion is indicated as a tool to quantify angles on digital photograph depictions such as body angles related to postural asymmetries. It is intended for use in professional health specialists such as podiatrists, orthopedist, physiotherapists, chiropractors, osteopaths, and kinesiotherapists
Product codes (comma separated list FDA assigned to the subject device)
LDK
Device Description
The CryoVizion System is a non-invasive and radiation-free system. Patients, suitably undressed, are placed in an observation booth. Two digital colour cameras mounted on a column are placed facing the patient booth. Patients are illuminated by two LED lighting units-one on each side of the imaging column. Using the CryoVizion System, the health specialist can then take images of the patient at various heights and in different positions. These images are then saved in the patient's file.
The health specialists can then visually review anatomical and morphological features related to the patient's posture. To do this, the CryoVizion System provides an image analysis toolbox including a palette of six graphic filters.
Surface markers corresponding to the anatomical body landmarks placed using palpation by healthcare professionals, prior to taking the photographs, may also be used to help identify and reference anatomical landmarks in the photographs.
The CryoVizion System is composed of two sections: hardware and software. The data and the images collected with the CryoVizion System are available immediately for clinical use and may be downloaded to a computer for storage or further analysis or comparison.
The hardware section comprises the above noted two digital colour cameras and two LED lighting units, mounted on a column and a positioning booth. The two cameras are mounted in the central tube of the imaging column. The LED lighting systems are vertically disposed to each side of the column. The column also houses the control centre which, linked to a computer, controls the two digital cameras and the intensity of the lighting.
The software comprises image manipulation functions, including the user selectable filters noted above and controls to operate each of the cameras.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital photograph depictions
Anatomical Site
body
Indicated Patient Age Range
Adult or pediatric populations
Intended User / Care Setting
professional health specialists such as podiatrists, orthopedist, physiotherapists, chiropractors, osteopaths, and kinesiotherapists / professional health care facilities
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)
Angle Measurement Accuracy and Single Tester's Measurement Repeatability
The system angle measurement functionality was verified for accuracy by comparing its output relative to that of a manual goniometer which is a “gold standard” method currently used for body segment angle measurements.
This included two variance analysis (ANOVA) studies to assess intra and inter user accuracy variability, as well as a bias and linearity study of the variability of repeated measurements, both as compared to goniometer measurements.
Software Verification and Validation Testing
The software validation activities were performed in accordance with IEC 62304:2006- Medical device software - Software life cycle processes, in addition to the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices."
Clinical Studies
A clinical study specific to the CryoVizion System complemented by information from clinical studies selected within the literature and concerned about the reproducibility of photogrammetry was provided as valid scientific evidence to demonstrate that the Cryo Vizion System is safe and effective for its intended use, substantially equivalent to the currently cleared predicate device (K923792), and raises no new questions of safety and effectiveness.
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.
Not Found
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
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
August 28, 2019
Cryos Technologies Inc. % Louis-Paul Martin President LOK North America Inc. 2025 rue Michelin Laval, CA H7L 5B7 Quebec
Re: K183485
Trade/Device Name: CryoVizion System Regulatory Class: Unclassified Product Code: LDK Dated: July 26, 2019 Received: July 30, 2019
Dear Louis-Paul Martin:
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. 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 located 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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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-regulatoryassistance/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.
Vivek Pinto, Ph.D. Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183485
Device Name CryoVizion System
Indications for Use (Describe)
The CryoVizion is indicated as a tool to quantify angles on digital photograph depictions such as body angles related to postural asymmetries. It is intended for use in professional health specialists such as podiatrists, orthopedist, physiotherapists, chiropractors, osteopaths, and kinesiotherapists
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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3
Image /page/3/Picture/0 description: The image shows the logo for Cryos. The logo consists of the word "cryos" in white, sans-serif font, set against a dark purple rounded rectangle. The rectangle is surrounded by overlapping translucent shapes in blue, green, orange, and purple, creating a layered, colorful effect.
510(k) Summary
| 1. | Type of Submission | Traditional |
|---|---|---|
| 2. | Preparation Date | August 23rd, 2019 |
| 3. | Submitter Address | Cryos Technologies Inc. |
| 385 rue Salaberry | ||
| Joliette (Québec) Canada | ||
| J6E 4G4 | ||
| Phone: 1 (450) 753-3704 | ||
| Contact: John Stimpson, President | ||
| 4. | Contact Person | Louis-Paul Marin |
| President of LOK North America Inc. | ||
| Phone: 1 (450) 781-1578 ext. 225 | ||
| Fax: 1 (450) 681-9663 | ||
| Email: marin.lp@lok-northamerica.com |
5. Identification of the Device
| Proprietary Name/Trade Name | CryoVizion System |
|---|---|
| Regulation Description | Device, Sensing, Optical Contour |
| Device Classification | Unclassified (Pre-Amendment) |
| Regulation Number | n/a |
| Panel | Physical Medicine |
| Product Code | LDK |
6. Identification of the Predicate
Predicate Device Name: Quantec Spinal Measurement System
510(k) Number: K923792
7. Intended Use and Indication for Use
The CryoVizion is indicated as a tool to quantify angles on digital photograph depictions such as body angles related to postural asymmetries. It is intended for use in professional health care facilities by health specialists such as podiatrists, orthopedist, physiotherapists, osteopaths, and kinesiotherapists.
8. Device Description
The CryoVizion System is a non-invasive and radiation-free system.
4
Image /page/4/Picture/0 description: The image shows the logo for Cryos, a company specializing in sperm and egg donation. The logo features the word "cryos" in a sans-serif font, colored white. The word is set against a circular background with overlapping translucent layers of blue, green, purple, and orange, creating a vibrant and modern design.
Patients, suitably undressed, are placed in an observation booth. Two digital colour cameras mounted on a column are placed facing the patient booth. Patients are illuminated by two LED lighting units-one on each side of the imaging column. Using the CryoVizion System, the health specialist can then take images of the patient at various heights and in different positions. These images are then saved in the patient's file.
The health specialists can then visually review anatomical and morphological features related to the patient's posture. To do this, the CryoVizion System provides an image analysis toolbox including a palette of six graphic filters.
Surface markers corresponding to the anatomical body landmarks placed using palpation by healthcare professionals, prior to taking the photographs, may also be used to help identify and reference anatomical landmarks in the photographs.
The CryoVizion System is composed of two sections: hardware and software. The data and the images collected with the CryoVizion System are available immediately for clinical use and may be downloaded to a computer for storage or further analysis or comparison.
The hardware section comprises the above noted two digital colour cameras and two LED lighting units, mounted on a column and a positioning booth. The two cameras are mounted in the central tube of the imaging column. The LED lighting systems are vertically disposed to each side of the column. The column also houses the control centre which, linked to a computer, controls the two digital cameras and the intensity of the lighting.
The software comprises image manipulation functions, including the user selectable filters noted above and controls to operate each of the cameras.
9. Performance Data
The following performance data were provided in support of the substantial equivalence determination:
Electrical safety and electromagnetic compatibility (EMC)
The CryoVizion System complies with the following recognized standards:
- -IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance;
- IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests; and
- IEC 60601-1-6 Medical electrical equipment Part 1-6: General requirements for safety --Collateral safety: Usability.
Angle Measurement Accuracy and Single Tester's Measurement Repeatability
- The system angle measurement functionality was verified for accuracy by comparing its output relative to that of a manual goniometer which is a "gold standard" method currently used for body segment angle measurements.
- -This included two variance analysis (ANOVA) studies to assess intra and inter user accuracy variability, as well as a bias and linearity study of the variability of repeated measurements, both as compared to goniometer measurements.
5
Image /page/5/Picture/0 description: The image shows the logo for Cryos. The logo consists of the word "cryos" in lowercase, sans-serif font, with the letters in white. The word is set against a background of overlapping, translucent shapes in various colors, including blue, green, purple, and pink. The overall effect is modern and vibrant.
Software Verification and Validation Testing
The software validation activities were performed in accordance with IEC 62304:2006- Medical device software - Software life cycle processes, in addition to the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices."
Animal Study
The 510(k) does not contain animal study test results for the subject device.
Clinical Studies
A clinical study specific to the CryoVizion System complemented by information from clinical studies selected within the literature and concerned about the reproducibility of photogrammetry was provided as valid scientific evidence to demonstrate that the Cryo Vizion System is safe and effective for its intended use, substantially equivalent to the currently cleared predicate device (K923792), and raises no new questions of safety and effectiveness.
10. General Safety and Effectiveness Concerns
The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device. Risk Management is ensured and documented in compliance with ISO 14971 to identify and provide mitigation to potential hazards. To minimize risks, Cryos Technologies adheres to recognized and established industry practices and standards. Furthermore, the operators are healthcare professionals familiar with and responsible for the evaluation and postprocessing of the surface topography images.
11. Substantial Equivalence Determination
The overall technological comparisons, based upon the results of a literature search, between the subject device and the predicate, are summarized in the following table:
| Items | Predicate Device | Subject Device |
|---|---|---|
| Quantec Spinal Measurement | ||
| System | ||
| (K923792) | CryoVizion System | |
| (K183485) | ||
| Classification | Unclassified | Unclassified |
| Code of Federal | ||
| Regulations | Unclassified | Unclassified |
| Product Code | LDK | LDK |
| Classification Name | Device, Sensing, Optical | |
| Contour | Device, Sensing, Optical | |
| Contour | ||
| Prescription Medical | ||
| Devices | Yes | Yes |
| Intended Use / | ||
| Indication for Use | Indicated as an optical contour | |
| sensing device to provide | ||
| topographical images for the 3D | ||
| assessment of back asymmetries. | The CryoVizion is indicated as a | |
| tool to quantify angles on digital | ||
| photograph depictions such as | ||
| body angles related to postural | ||
| asymmetries. It is intended for | ||
| use in professional health care | ||
| facilities by health specialists | ||
| such as podiatrists, orthopedist, | ||
| physiotherapists, chiropractors, | ||
| osteopaths, and | ||
| kinesiotherapists. | ||
| Populations | Adult or pediatric populations | Adult or pediatric populations |
| Intended Users | Health specialists such as | |
| podiatrists, pedorthists, | ||
| orthopedist, physiotherapists, | ||
| chiropractors, osteopaths, and | ||
| kinesiotherapists. | Health specialists such as | |
| podiatrists, pedorthists, | ||
| orthopedist, physiotherapists, | ||
| chiropractors, osteopaths, and | ||
| kinesiotherapists. | ||
| Environment | Health care facilities | Health care facilities |
| Technique | Surface Topography - structured | |
| light projection | Surface Topography - structured | |
| light projection | ||
| Method | Non-Tactile | Non-Tactile |
| Measurement | Static | Static |
| Principle of Operation | Based upon raster stereography/ | |
| photogrammetry | Based upon digital | |
| photogrammetry | ||
| Hardware Component | • Digital Camera; | |
| • Quartz halogen light; and | ||
| • Booth | • Digital Camera; | |
| • LED | ||
| • Booth | ||
| Software | Software to control the camera, | |
| measure the | ||
| 3D trunk images and to record | ||
| and quantify deformities (3D | ||
| assessment) | Software to control the camera, | |
| filter pictures for analysis, | ||
| perform angular measurements | ||
| of user selected features, and | ||
| record the images and results. | ||
| Use of Body Markers | Yes | Yes |
| Components | - Digital camera |
- Software
- Quartz halogen light
- Booth | - Digital camera
- Software
- LED
- Booth |
6
Image /page/6/Picture/0 description: The image shows the logo for Cryos. The logo features the word "cryos" in white, sans-serif font, centered within a rounded, abstract shape. The shape is composed of overlapping translucent layers of different colors, including purple, blue, green, and orange, creating a vibrant and modern design.
The general intended use and technology are equivalent between the predicate and the Cryo Vizion. The main difference is that the predicate outputs 3D surface models of the patient's trunk and quantifies related alignment and deformity parameters corresponding to given anatomical markers placed by the user, whereas in comparison the CryoVizion provides 2D images of the patient's body areas of interest with image filters adjusted by the user to help the user identify asymmetries along with the use of markers in order to help assess deviations and deformities in body segments.
7
Image /page/7/Picture/0 description: The image is a logo for Cryos. The logo features the word "cryos" in white, lowercase letters, set against a dark purple oval. The oval is surrounded by overlapping translucent shapes in blue, green, and orange, creating a colorful, layered effect. The overall design is modern and corporate.
The method was found to be appropriate and reproducible for its intended use per a clinical study and other clinically available data in the literature.
12. Performance Specifications
The following performance specifications were determined specific to the proposed device to establish its safety and effectiveness were evaluated and found to be met:
- Biocompatibility -
- Electrical, including Usability -
- -EMC/EMI Safety
- Software -
13. Conclusion
The information provided by Cryos Technologies in this submission demonstrate that the subject device, the Cryo Vizion System, is safe and effective for its intended use, substantially equivalent to the currently cleared predicate device (K923792) and raises no new questions of safety and effectiveness.