PeekMed

K182464 · Peek Health, S.A. · LLZ · Oct 25, 2018 · Radiology

Device Facts

• Record ID: K182464
• Device Name: PeekMed
• Applicant: Peek Health, S.A.
• Product Code: LLZ · Radiology
• Decision Date: Oct 25, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended 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.

Device Story

PeekMed is a standalone 3D pre-operative planning software for surgeons; imports diagnostic imaging (X-ray, CT, MRI) from PACS, local folders, or CD-ROM; integrates a database of digital prosthetic templates. Surgeons use the software to perform 2D, 3D, or hybrid (2D/3D) surgical planning; allows interactive positioning, dimensioning, and rotation of prosthetic models; supports intersection of models. Output provides a visual overview of the surgical plan, including measurements and template placement. Used in clinical settings to assist surgical decision-making; benefits patient by facilitating efficient, accurate pre-operative planning. Operates on Windows or OS X workstations.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed product specifications and requirements were met. Validation included measuring images of three CE-marked implantable devices to confirm accuracy and repeatability of ruler and angle measurement functions. Usability was assessed via user surveys and satisfaction questionnaires.

Technological Characteristics

Standalone software application; runs on Windows or OS X; supports 2D, 3D, and hybrid (2D/3D) environments. Features include image import (DICOM/PACS), digital prosthetic template database, interactive measurement tools (ruler, angle), and model manipulation (rotation, positioning, intersection). Risk management performed per ISO 14971.

Indications for Use

Indicated for surgeons performing pre-operative planning for orthopedic surgical procedures (hip, knee, spine, upper limb, foot and ankle, trauma) in adult and pediatric patients using diagnostic imaging (X-ray, CT, MRI). Requires clinical assessment and user experience.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• TraumaCad version 2.0 (K140434)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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: [e-mail]

# 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<br>Number | 21 CFR 892.2050 | 21 CFR 892.2050 | N/A |
| Regulation Name | System, Image<br>Processing, Radiological | System, Image Processing,<br>Radiological | N/A |
| Intended for use | PeekMed is a pre-<br>operative planning<br>software for surgery. | TraumaCad is a pre-<br>operative planning<br>software for surgery. | N/A |
| Indications for use | PeekMed is a software<br>system designed to help<br>surgeons' specialists<br>carry out the pre-<br>operative planning in a<br>prompt and efficient<br>manner for several<br>surgical procedures,<br>based on their patients'<br>imaging studies.<br>The software imports<br>diagnostics imaging<br>studies such as x-rays, CT | The TraumaCAD program<br>is indicated for assisting<br>healthcare professionals<br>in preoperative planning<br>of orthopedic surgery. The<br>device allows for<br>overlaying of prosthesis<br>templates on radiological<br>images and includes tools<br>for performing<br>measurements on the<br>image and for positioning<br>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<br>Name | PeekMed | TraumaCad version 2.0 | |
| | or magnetic resonance<br>image (MRI). The import<br>process can retrieve files<br>from a CD ROM, a local<br>folder or the PACS. In<br>parallel, there is a<br>database of digital<br>representations related<br>to prosthetic materials<br>supplied by their<br>producing companies.<br>PeekMed allows health<br>professional to digitally<br>perform the surgical<br>planning without adding<br>any additional steps to<br>that process. This<br>software system requires<br>no imaging study<br>acquisition specification<br>(no protocol). Experience<br>in usage and a clinical<br>assessment are<br>necessary for a proper<br>use of the software. | judgments and experience<br>are required to properly<br>use the software. | |
| Subspecialties | PeekMed allows the<br>surgeon to perform the<br>pre-surgical planning<br>efficiently in the<br>following subspecialties:<br>- Hip<br>- Knee<br>- Spine<br>- Upper Limb<br>- Foot and Ankle | TraumaCad provides easy-<br>to-use solutions for<br>various orthopedic<br>subspecialties:<br>- Hip<br>- Knee<br>- Pediatric<br>- Trauma<br>- Deformity<br>- Analysis | Orthopedic subspecialties<br>supported by PeekMed<br>are also covered in<br>TraumaCad. The<br>majorities of the<br>procedures supported by<br>PeekMed are also<br>supported by TraumaCad.<br>The procedures that are<br>not common to both<br>devices have been tested |
| Manufacturer | 510(K) Submitter | Predicate | Significant Differences |
| | Peek Health, S.A. | Orthocrat, Ltd | |
| Device Trade<br>Name | PeekMed | TraumaCad version 2.0 | |
| | - Trauma | - Spine<br>- Foot and Ankle<br>- Upper Limb<br>The following<br>measurements can be<br>made using TraumaCad<br>measurements tools:<br>-Hip: Hip Deformity<br>Analysis, Polyethylene<br>Wear Wizard, Leg Length<br>Discrepancy Tool,<br>Acetabular Index, VCA<br>Angle of Lequesne, Cup<br>Version, Center of<br>Rotation, Stem Version | and validated through<br>PeekMed development. It<br>does not raise different<br>questions of safety or<br>effectiveness. |
| | For each subspecialty,<br>there are several<br>procedures:<br>-Hip: Hip Dysplasia<br>Correction, Limb Length<br>Discrepancy, Center of<br>Rotation – Ranawat<br>method, Acetabular<br>Angle, Total Hip<br>Arthroplasty<br><br>-Knee: Leg Deformity<br>Correction, AP Knee<br>Resection, AP Full Leg<br>resection, High Tibial<br>Osteotomy, ACL Tunnel<br>Reconstruction, Medial<br>Patellofemoral Ligament<br><br>-Spine: Single Cobb<br>Angle, Thoracic Kyphosis<br>Angle, Lumbar Lordosis<br>Angle, Sagittal Vertical<br>Axis, Pelvic Angles,<br>Coronal Balance, Sacro-<br>femoral Angle, Sagittal<br>Balance, Smith-Petersen<br>Osteotomy, Pedicle<br>Subtraction Osteotomy | -Knee: Limb Alignment<br>Analysis, Center Line<br>Finder, Simple Line, High<br>Tibial Osteotomy, Tibial<br>Cutting, Joint Line<br><br>-Spine: Vertebrae<br>Labeling, Cobb Angle,<br>Double Cobb Angle, Triple<br>Cobb Angle, Pelvic Radius<br>Angle, Sacral Obliquity, ,<br>Coronal Balance, Sagittal<br>Balance,<br>Spondylolysthesis,<br>Thoracic Kyphosis Angle,<br>Thoracic Trunk Shift, T1<br>Tilt Angle, Lumbar<br>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<br>Shoulder Replacement, | Upper Limb: Center Line<br>Finder, Simple Line, Joint<br>Line | |
| | Clavicular Angle,<br>Shoulder Resurfacing | -Foot and ankle: Foot<br>Osteotomies Wizard, | |
| | -Foot and Ankle: Talar<br>Tilt, Hallux Valgus,<br>Moreau-Costa-Bertani<br>Internal Angle, Moreau-<br>Costa-Bertani External<br>Angle, Maestro Formula | Hallux Valgus Angle,<br>Hallux Valgus<br>Interphalangeus Angle,<br>Intermetatarsal Angle,<br>Distal Metatarsal Articular<br>Angle (DMAA), Proximal<br>Metatarsal Articular Angle<br>(PMAA), Talar Tilt | |
| | -Trauma: Diaphyseal<br>Shaft Fracture Angle,<br>Metaphyseal Shaft<br>Fracture Angle, Roof Arc | -Trauma: Limb Alignment<br>Analysis, Diaphyseal<br>Fracture Angulation,<br>Metaphyseal Fracture<br>Angulation, Center Line<br>Finder, Simple Line, Roof<br>Arc, Joint Line | |
| | | -Pediatric: Hip Deformity<br>Analysis, Limb Alignment<br>Analysis, Acetabular<br>Index, Reimer's Index, VCA<br>Angle of Lequesne | |
| Patient Population | Adults and pediatrics | Adults and pediatrics | N/A |
| End users | Surgeons | Surgeons | N/A |
| Computer | Personal Computer or<br>Workstation | Personal Computer or<br>Workstation | N/A |
| Manufacturer | 510(K) Submitter | Predicate | Significant Differences |
| | Peek Health, S.A. | Orthocrat, Ltd | |
| Device Trade<br>Name | PeekMed | TraumaCad version 2.0 | |
| Operating System | Windows or OS X | Windows | PeekMed can run through<br>Windows or OSX and has<br>been tested and validated<br>for the both systems. |
| Device availability | It can be set to start from<br>a workstation or<br>standalone for planning<br>procedures | It can be set to start from<br>a workstation or<br>standalone for planning<br>procedures | N/A |
| Images source | Receives medical images<br>from various sources<br>(including PACS) | Receives medical images<br>from various sources<br>(including PACS) | N/A |
| Data processing | The software processes<br>data in order to provide<br>an overlap and<br>dimensioning of digital<br>representations of the<br>prosthetic material | The software processes<br>data in order to provide<br>an overlap and<br>dimensioning of digital<br>representations of the<br>prosthetic material | N/A |
| Manufacturer | 510(K) Submitter | Predicate | Significant Differences |
| | Peek Health, S.A. | Orthocrat, Ltd | |
| Device Trade<br>Name | PeekMed | TraumaCad version 2.0 | |
| Digital overlap of<br>prosthetic material | Allows the overlap of<br>models and the<br>intersection of the<br>models | Allows the overlap of<br>models | The additional feature<br>from PeekMed of allowing<br>the intersection of the<br>models has been tested<br>and validated and does<br>not raise different<br>questions of safety or<br>effectiveness. |
| Interactive model<br>positioning | Yes | Yes | N/A |
| Interactive model<br>dimensioning | Yes | Yes | N/A |
| Model rotation | Yes | Yes | N/A |
| Support for digital<br>prosthetic<br>materials provided<br>by the<br>manufacturers | Yes | Yes | N/A |
| Automatic<br>calibration | Yes…