Who is the manufacturer of PeekMed?

Peek Health, S.A. filed the 510(k) submission for PeekMed (K182464).

What is the FDA product code for PeekMed?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for PeekMed?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PeekMed?

TraumaCad version 2.0 (K140434).

Who can help prepare an FDA 510(k) submission like PeekMed?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

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.

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)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the U.S. Food and Drug Administration (FDA) and the Department of Health & Human Services. The FDA logo features the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. To the left of the FDA logo is the symbol of the Department of Health & Human Services, which consists of a stylized human figure. 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 {2}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 {4}------------------------------------------------ | 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. {5}------------------------------------------------ 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…

PeekMed

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

PeekMed

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Connected apps