(45 days)
Not Found
No
The document describes a software for pre-operative planning using image processing and a database of prosthetic materials. There is no mention of AI, ML, or related concepts like training sets, test sets, or performance metrics typically associated with AI/ML models. The validation focuses on measurement accuracy and usability, not algorithmic performance on a dataset.
No
The device is a pre-operative planning software that assists surgeons with surgical planning, not a therapeutic device that performs treatment.
No
The device is described as a software system for pre-operative planning based on existing diagnostic imaging studies, not for making a diagnosis itself. Its purpose is to help surgeons plan procedures, not to identify diseases or conditions.
Yes
The device is explicitly described as a "standalone software application" and a "software system" for pre-operative planning based on imaging studies and a database of prosthetic materials. There is no mention of accompanying hardware components that are part of the medical device itself.
Based on the provided information, PeekMed is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- PeekMed's Function: PeekMed's intended use is for pre-operative planning based on medical imaging studies (X-rays, CT, MRI). It helps surgeons visualize and plan surgical procedures and the placement of prosthetic materials.
- No Specimen Analysis: The software does not analyze any biological specimens from the patient. Its input is imaging data, not biological samples.
- Focus on Planning, Not Diagnosis: While the input images are diagnostic studies, the software's function is to aid in the planning of a surgical procedure, not to provide a diagnosis or information derived from analyzing biological samples.
In summary, PeekMed is a medical device that utilizes diagnostic imaging for surgical planning, but it does not meet the criteria of an In Vitro Diagnostic device because it does not analyze biological specimens.
N/A
Intended Use / Indications for Use
PeekMed is a software system designed to help surgeons' specialists carry out the pre-operative planning in a prompt and efficient manner for several surgical procedures, based on their patients' imaging studies.
The software imports diagnostics imaging studies such as x-rays, CT or magnetic resonance image (MRI). The import process can retrieve files from a CD ROM, a local folder or the PACS. In parallel, there is a database of digital representations related to prosthetic materials supplied by their producing companies.
PeekMed allows health professional to digitally perform the surgical planning without adding any additional steps to that process. This software system requires no imaging study acquisition specification (no protocol). Experience in usage and a clinical assessment are necessary for a proper use of the software.
Product codes
LLZ
Device Description
PeekMed is a standalone software application that helps specialist doctors and surgeons to perform the pre-surgical planning for different procedures in a fast and effective way, based on the imaging studies of the patients.
PeekMed is a 3D pre-operative planning software for surgery. This software system allows surgeons to plan a surgery procedure simulating various environments, from hybrid (2D/3D) to 3D or 2D environments.
The software imports diagnostic imaging studies such as X-rays, Computed Tomography (CT) or Magnetic Resonance Image (MRI). The import process can retrieve files from a local folder or the Picture Archiving and Communications System (PACS) of the hospital/health center. In parallel, there is a database containing digital representations related to prosthetic materials supplied by their respective manufacturers. This offers the possibility of inserting templates of the materials to be used in the surgery in addition to the measurements, making a complete overview of the surgery.
In the case of a 3D or hybrid environment, the surgeon can resort to 3D model generated from a previous imaging study on the patient and 3D digital representations of the prosthetic material to be used during surgery, i.e. screws, fixation plates or full prosthesis, deriving from several producing companies.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-rays, CT or magnetic resonance image (MRI)
Anatomical Site
Hip, Knee, Spine, Upper Limb, Foot and Ankle (for surgical procedures and planning)
Indicated Patient Age Range
Adults and pediatrics
Intended User / Care Setting
Surgeons
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
Validation tests performed internally prior to the release to the market by qualified personnel (personnel with background in anatomy and biomedical field), in an environment simulating the real end-user environment. This validation follows a pre-defined test script document, according to the tests defined in the Confluence sheets. To reassure that the lengths and angles measured with the internal functions of ‘ruler’ and ‘angle’ of the PeekMed software effectively and repeatedly match the real dimensions, validation consists the measuring of images of three implantable medical devices (prosthesis), CE marked and with strictly defined dimensions. Validation phase ensures that all product requirements have been fulfilled, meets the end-users needs, and ensure the safety and proper performance of the device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
Results from internal verification and validation testing performed in accordance with Peek Health' design control processes confirm that PeekMed product specifications have been met. Acceptance criteria were achieved for all tests. Supporting documentation is included in this 510(k) Premarket Notification and supports the claims of substantial equivalence to the predicate device.
Verification testing consisted of specific software functionalities testing and system level testing. Acceptance criteria, defined in the product requirements, were met for each verification test and are described in JIRA. A risk analysis in accordance with ISO 14971 was completed as part of the software design and development effort.
Validation activities for the subject device consisted of:
- Validation tests performed internally prior to the release to the market by qualified personnel (personnel with background in anatomy and biomedical field), in an environment simulating the real end-user environment. This validation follows a pre-defined test script document, according to the tests defined in the Confluence sheets. To reassure that the lengths and angles measured with the internal functions of 'ruler' and 'angle' of the PeekMed software effectively and repeatedly match the real dimensions, validation consists the measuring of images of three implantable medical devices (prosthesis), CE marked and with strictly defined dimensions. Validation phase ensures that all product requirements have been fulfilled, meets the end-users needs, and ensure the safety and proper performance of the device.
- As a complementary validation, external validation is performed through a continuous follow-up from the Marketing and Sales team, follow-up on events registered in the platform mixpanel and user/customer surveys. Also, satisfaction questionnaires were made to assess the usability of the PeekMed software when comparing with others in the market, and also to make sure that the device operates as intended during the design stage.
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).
0
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October 25, 2018
Peek Health, S.A. % Rachel Paul Senior Consultant, QA&RA Emergo Europe Consulting Prinsessegracht 20 THE HAGUE, 2514 AP NETHERLANDS
Re: K182464
Trade/Device Name: PeekMed Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: September 6, 2018 Received: September 10, 2018
Dear Rachel Paul:
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.
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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the name Michael D. O'hara -S in a large font. Below the name is the text "Digitally signed by Michael D. O'hara -S". The image also contains the text "DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300 226759, cn=Michael D. O'hara -S Date: 2018.10.25 13:24:17-04'00'".
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182464
Device Name PeekMed
Indications for Use (Describe)
PeekMed is a software system designed to help surgeons' specialists carry out the pre-operative planning in a prompt and efficient manner for several surgical procedures, based on their patients' imaging studies.
The software imports diagnostics imaging studies such as x-rays, CT or magnetic resonance image (MRI). The import process can retrieve files from a CD ROM, a local folder or the PACS. In parallel, there is a database of digital representations related to prosthetic materials supplied by their producing companies.
PeekMed allows health professional to digitally perform the surgical planning without adding any additional steps to that process. This software system requires no imaging study acquisition specification (no protocol). Experience in usage and a clinical assessment are necessary for a proper use of the software.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
DEVICE NAME
K_182464
1. Submission Sponsor
Peek Health, S.A.
Praça Conde de Agrolongo, nº123
4700-312
Braga
Portugal
Sara Silva
Chief Quality Officer (CQO)
2. Submission Correspondent
Emergo Europe Consulting
Prinsessegracht 20
The Hague
2514 AP
The Netherlands
Rachel Paul
Senior Consultant, QA & RA
Email: LST.AUS.Projectmanagement@ul.com
3. Date Prepared
September 6, 2018
4. Device Identification
Trade/Proprietary Name: PeekMed
Common/Usual Name: Pre-operative planning software
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| Classification Name: | Picture Archiving and Communications System (PACS) |
|---|---|
| Regulation Number: | 892.2050 |
| Product Code: | LLZ, System, Image Processing, Radiological |
| Device Class: | Class II |
| Classification Panel: | Radiology |
5. Legally Marketed Predicate Device(s)
| 510(K) No. | K073714 |
|---|---|
| Clearance date | 03/19/2008 |
| Device Name | TraumaCad version 2.0 |
| Manufacturer | Orthocrat, Ltd |
6. Indications for Use Statement
PeekMed is a software system designed to help surgeons' specialists carry out the pre-operative planning in a prompt and efficient manner for several surgical procedures, based on their patients' imaging studies.
The software imports diagnostics imaging studies such as x-rays, CT or magnetic resonance image (MRI). The import process can retrieve files from a CD ROM, a local folder or the PACS. In parallel, there is a database of digital representations related to prosthetic materials supplied by their producing companies.
PeekMed allows health professional to digitally perform the surgical planning without adding any additional steps to that process. This software system requires no imaging study acquisition (no protocol). Experience in usage and a clinical assessment are necessary for a proper use of the software.
7. Device Description
PeekMed is a standalone software application that helps specialist doctors and surgeons to perform the pre-surgical planning for different procedures in a fast and effective way, based on the imaging studies of the patients.
PeekMed is a 3D pre-operative planning software for surgery. This software system allows surgeons to plan a surgery procedure simulating various environments, from hybrid (2D/3D) to 3D or 2D environments.
The software imports diagnostic imaging studies such as X-rays, Computed Tomography (CT) or Magnetic Resonance Image (MRI). The import process can retrieve files from a local folder or the Picture Archiving and Communications System (PACS) of the hospital/health center. In parallel, there is a database containing digital representations related to prosthetic materials supplied by their respective manufacturers. This offers the possibility of inserting templates of the materials to be used in the surgery in addition to the measurements, making a complete overview of the surgery.
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In the case of a 3D or hybrid environment, the surgeon can resort to 3D model generated from a previous imaging study on the patient and 3D digital representations of the prosthetic material to be used during surgery, i.e. screws, fixation plates or full prosthesis, deriving from several producing companies.
8. Substantial Equivalence Discussion
The following table compares PeekMed to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.
| Manufacturer | 510(K) Submitter | Predicate | Significant Differences |
|---|---|---|---|
| Peek Health, S.A. | Orthocrat, Ltd | ||
| Device Trade Name | PeekMed | TraumaCad version 2.0 | |
| 510(k) Number | N/A | K140434 | N/A |
| Product Code | LLZ | LLZ | N/A |
| Regulation | |||
| Number | 21 CFR 892.2050 | 21 CFR 892.2050 | N/A |
| Regulation Name | System, Image | ||
| Processing, Radiological | System, Image Processing, | ||
| Radiological | N/A | ||
| Intended for use | PeekMed is a pre- | ||
| operative planning | |||
| software for surgery. | TraumaCad is a pre- | ||
| operative planning | |||
| software for surgery. | N/A | ||
| Indications for use | PeekMed is a software | ||
| system designed to help | |||
| surgeons' specialists | |||
| carry out the pre- | |||
| operative planning in a | |||
| prompt and efficient | |||
| manner for several | |||
| surgical procedures, | |||
| based on their patients' | |||
| imaging studies. | |||
| The software imports | |||
| diagnostics imaging | |||
| studies such as x-rays, CT | The TraumaCAD program | ||
| is indicated for assisting | |||
| healthcare professionals | |||
| in preoperative planning | |||
| of orthopedic surgery. The | |||
| device allows for | |||
| overlaying of prosthesis | |||
| templates on radiological | |||
| images and includes tools | |||
| for performing | |||
| measurements on the | |||
| image and for positioning | |||
| the template. Clinical | In more to 2D, PeekMed can offer a 3D pre-surgical planning or a hybrid 2D/3D environment in addition to isolated 2D and 3D. PeekMed has been tested and validated for 3D and hybrid planning. | ||
| Manufacturer | 510(K) Submitter | Predicate | Significant Differences |
| Peek Health, S.A. | Orthocrat, Ltd | ||
| Device Trade | |||
| Name | PeekMed | TraumaCad version 2.0 | |
| or magnetic resonance | |||
| image (MRI). The import | |||
| process can retrieve files | |||
| from a CD ROM, a local | |||
| folder or the PACS. In | |||
| parallel, there is a | |||
| database of digital | |||
| representations related | |||
| to prosthetic materials | |||
| supplied by their | |||
| producing companies. | |||
| PeekMed allows health | |||
| professional to digitally | |||
| perform the surgical | |||
| planning without adding | |||
| any additional steps to | |||
| that process. This | |||
| software system requires | |||
| no imaging study | |||
| acquisition specification | |||
| (no protocol). Experience | |||
| in usage and a clinical | |||
| assessment are | |||
| necessary for a proper | |||
| use of the software. | judgments and experience | ||
| are required to properly | |||
| use the software. | |||
| Subspecialties | PeekMed allows the | ||
| surgeon to perform the | |||
| pre-surgical planning | |||
| efficiently in the | |||
| following subspecialties: |
- Hip
- Knee
- Spine
- Upper Limb
- Foot and Ankle | TraumaCad provides easy-
to-use solutions for
various orthopedic
subspecialties: - Hip
- Knee
- Pediatric
- Trauma
- Deformity
- Analysis | Orthopedic subspecialties
supported by PeekMed
are also covered in
TraumaCad. The
majorities of the
procedures supported by
PeekMed are also
supported by TraumaCad.
The procedures that are
not common to both
devices have been tested |
| Manufacturer | 510(K) Submitter | Predicate | Significant Differences |
| | Peek Health, S.A. | Orthocrat, Ltd | |
| Device Trade
Name | PeekMed | TraumaCad version 2.0 | |
| | - Trauma | - Spine - Foot and Ankle
- Upper Limb
The following
measurements can be
made using TraumaCad
measurements tools:
-Hip: Hip Deformity
Analysis, Polyethylene
Wear Wizard, Leg Length
Discrepancy Tool,
Acetabular Index, VCA
Angle of Lequesne, Cup
Version, Center of
Rotation, Stem Version | and validated through
PeekMed development. It
does not raise different
questions of safety or
effectiveness. |
| | For each subspecialty,
there are several
procedures:
-Hip: Hip Dysplasia
Correction, Limb Length
Discrepancy, Center of
Rotation – Ranawat
method, Acetabular
Angle, Total Hip
Arthroplasty
-Knee: Leg Deformity
Correction, AP Knee
Resection, AP Full Leg
resection, High Tibial
Osteotomy, ACL Tunnel
Reconstruction, Medial
Patellofemoral Ligament
-Spine: Single Cobb
Angle, Thoracic Kyphosis
Angle, Lumbar Lordosis
Angle, Sagittal Vertical
Axis, Pelvic Angles,
Coronal Balance, Sacro-
femoral Angle, Sagittal
Balance, Smith-Petersen
Osteotomy, Pedicle
Subtraction Osteotomy | -Knee: Limb Alignment
Analysis, Center Line
Finder, Simple Line, High
Tibial Osteotomy, Tibial
Cutting, Joint Line
-Spine: Vertebrae
Labeling, Cobb Angle,
Double Cobb Angle, Triple
Cobb Angle, Pelvic Radius
Angle, Sacral Obliquity, ,
Coronal Balance, Sagittal
Balance,
Spondylolysthesis,
Thoracic Kyphosis Angle,
Thoracic Trunk Shift, T1
Tilt Angle, Lumbar
Lordosis, Spine Slip Angle | |
| Manufacturer | 510(K) Submitter | Predicate | Significant Differences |
| | Peek Health, S.A. | Orthocrat, Ltd | |
| Device Trade | PeekMed | TraumaCad version 2.0 | |
| Name | | | |
| | -Upper Limb: Total
Shoulder Replacement, | Upper Limb: Center Line
Finder, Simple Line, Joint
Line | |
| | Clavicular Angle,
Shoulder Resurfacing | -Foot and ankle: Foot
Osteotomies Wizard, | |
| | -Foot and Ankle: Talar
Tilt, Hallux Valgus,
Moreau-Costa-Bertani
Internal Angle, Moreau-
Costa-Bertani External
Angle, Maestro Formula | Hallux Valgus Angle,
Hallux Valgus
Interphalangeus Angle,
Intermetatarsal Angle,
Distal Metatarsal Articular
Angle (DMAA), Proximal
Metatarsal Articular Angle
(PMAA), Talar Tilt | |
| | -Trauma: Diaphyseal
Shaft Fracture Angle,
Metaphyseal Shaft
Fracture Angle, Roof Arc | -Trauma: Limb Alignment
Analysis, Diaphyseal
Fracture Angulation,
Metaphyseal Fracture
Angulation, Center Line
Finder, Simple Line, Roof
Arc, Joint Line | |
| | | -Pediatric: Hip Deformity
Analysis, Limb Alignment
Analysis, Acetabular
Index, Reimer's Index, VCA
Angle of Lequesne | |
| Patient Population | Adults and pediatrics | Adults and pediatrics | N/A |
| End users | Surgeons | Surgeons | N/A |
| Computer | Personal Computer or
Workstation | Personal Computer or
Workstation | N/A |
| Manufacturer | 510(K) Submitter | Predicate | Significant Differences |
| | Peek Health, S.A. | Orthocrat, Ltd | |
| Device Trade
Name | PeekMed | TraumaCad version 2.0 | |
| Operating System | Windows or OS X | Windows | PeekMed can run through
Windows or OSX and has
been tested and validated
for the both systems. |
| Device availability | It can be set to start from
a workstation or
standalone for planning
procedures | It can be set to start from
a workstation or
standalone for planning
procedures | N/A |
| Images source | Receives medical images
from various sources
(including PACS) | Receives medical images
from various sources
(including PACS) | N/A |
| Data processing | The software processes
data in order to provide
an overlap and
dimensioning of digital
representations of the
prosthetic material | The software processes
data in order to provide
an overlap and
dimensioning of digital
representations of the
prosthetic material | N/A |
| Manufacturer | 510(K) Submitter | Predicate | Significant Differences |
| | Peek Health, S.A. | Orthocrat, Ltd | |
| Device Trade
Name | PeekMed | TraumaCad version 2.0 | |
| Digital overlap of
prosthetic material | Allows the overlap of
models and the
intersection of the
models | Allows the overlap of
models | The additional feature
from PeekMed of allowing
the intersection of the
models has been tested
and validated and does
not raise different
questions of safety or
effectiveness. |
| Interactive model
positioning | Yes | Yes | N/A |
| Interactive model
dimensioning | Yes | Yes | N/A |
| Model rotation | Yes | Yes | N/A |
| Support for digital
prosthetic
materials provided
by the
manufacturers | Yes | Yes | N/A |
| Automatic
calibration | Yes | Yes | N/A |
| Pre-surgical
planning | Yes | Yes | N/A |
| Contact with the
patient | No | No | N/A |
| Control of life
supporting devices | No | No | N/A |
| Human
intervention for
image
interpretation | Yes | Yes | N/A |
| Manufacturer | 510(K) Submitter | Predicate | Significant Differences |
| | Peek Health, S.A. | Orthocrat, Ltd | |
| Device Trade
Name | PeekMed | TraumaCad version 2.0 | |
| Ability to add
additional modules
when available | Yes | Yes | N/A |
Table 5A – Comparison of Characteristics
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9. Non-Clinical Performance Data
Results from internal verification and validation testing performed in accordance with Peek Health' design control processes confirm that PeekMed product specifications have been met. Acceptance criteria were achieved for all tests. Supporting documentation is included in this 510(k) Premarket Notification and supports the claims of substantial equivalence to the predicate device.
Verification testing consisted of specific software functionalities testing and system level testing. Acceptance criteria, defined in the product requirements, were met for each verification test and are described in JIRA. A risk analysis in accordance with ISO 14971 was completed as part of the software design and development effort.
Validation activities for the subject device consisted of:
- Validation tests performed internally prior to the release to the market by qualified personnel ● (personnel with background in anatomy and biomedical field), in an environment simulating the real end-user environment. This validation follows a pre-defined test script document, according to the tests defined in the Confluence sheets. To reassure that the lengths and angles measured with the internal functions of 'ruler' and 'angle' of the PeekMed software effectively and repeatedly match the real dimensions, validation consists the measuring of images of three implantable medical devices (prosthesis), CE marked and with strictly defined dimensions. Validation phase ensures that all product requirements have been fulfilled, meets the end-users needs, and ensure the safety and proper performance of the device.
- . As a complementary validation, external validation is performed through a continuous follow-up from the Marketing and Sales team, follow-up on events registered in the platform mixpanel and user/customer surveys. Also, satisfaction questionnaires were made to assess the usability of the PeekMed software when comparing with others in the market, and also to make sure that the device operates as intended during the design stage.
10. Statement of Substantial Equivalence
PeekMed, as designed and developed by Peek Health, S.A., is determined to be substantially equivalent to the predicate device. Differences between the two devices do not raise new questions about the safety and effectiveness of PeekMed.