Who is the manufacturer of PeekMed web?

Peek Health, S.A. filed the 510(k) submission for PeekMed web (K250042).

What is the FDA product code for PeekMed web?

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

What is the regulatory pathway for PeekMed web?

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

Does PeekMed web use AI or machine learning?

Yes. PeekMed web (K250042) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

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

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.

Can an AI/ML device like PeekMed web get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

PeekMed web

K250042 · Peek Health, S.A. · QIH · Mar 19, 2025 · Radiology

Device Facts

Record ID	K250042
Device Name	PeekMed web
Applicant	Peek Health, S.A.
Product Code	QIH · Radiology
Decision Date	Mar 19, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Segmentation	—	DICE >= 90%, HD-95 <= 8, STD DICE +/- 10%, Precision > 85%, Recall > 90%	—	Training: 80% of 2852 CR and 1903 CT datasets; Development: 10% of 2852 CR and 1903 CT datasets; Testing: 10% of 2852 CR and 1903 CT datasets	—	External validation: 375 unique datasets	>1 (labelers)
Landmarking	—	MRE <= 7mm, STD MRE +/- 5mm	—	Training: 80% of 2852 CR and 1903 CT datasets; Development: 10% of 2852 CR and 1903 CT datasets; Testing: 10% of 2852 CR and 1903 CT datasets	—	External validation: 345 unique datasets	>1 (labelers)
Classification	—	Accuracy >= 90%, Precision >= 85%, Recall >= 90%, F1 score >= 90%	—	Training: 80% of 2852 CR and 1903 CT datasets; Development: 10% of 2852 CR and 1903 CT datasets; Testing: 10% of 2852 CR and 1903 CT datasets	—	External validation: 347 unique datasets	>1 (labelers)
Detection	—	MAP >= 90%, Precision >= 85%, Recall >= 90%	—	Training: 80% of 2852 CR and 1903 CT datasets; Development: 10% of 2852 CR and 1903 CT datasets; Testing: 10% of 2852 CR and 1903 CT datasets	—	External validation: 198 unique datasets	>1 (labelers)

Indications for Use

PeekMed web is a system designed to help healthcare professionals carry out pre-operative planning for several surgical procedures, based on their imported patients' imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the output of the planning. The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers. This medical device consists of a decision support tool for qualified healthcare professionals to quickly and efficiently perform the pre-operative planning for several surgical procedures, using medical imaging with the additional capability of planning the 2D or 3D environment. The system is designed for the medical specialties within surgery and no specific use environment is mandatory, whereas the typical use environment is a room with a computer. The patient target group is adult patients who have an injury or disability diagnosed previously. There are no other considerations for the intended patient population.

Device Story

PeekMed web is a cloud-based decision support software for orthopedic pre-operative planning. It ingests medical imaging (X-ray, CT) to provide 2D/3D visualization, automated bone segmentation, landmarking, and classification. Surgeons use the system to overlay digital templates of prosthetic materials onto patient anatomy to simulate and plan surgical procedures. The software operates on standard web browsers in clinical environments. It produces a final planning report containing measurements, selected templates, and procedural information. By facilitating precise pre-surgical visualization and template positioning, the device assists surgeons in optimizing surgical strategy, potentially improving procedural efficiency and patient outcomes. The system requires clinical assessment and revision by a qualified healthcare professional to approve the final plan.

Clinical Evidence

Bench testing only. Performance of ML models (segmentation, landmarking, classification, detection) was validated using independent datasets (2852 CR, 1903 CT). Segmentation DICE >= 90%, HD-95 <= 8; Landmarking MRE <= 7mm; Classification Accuracy >= 90%; Detection MAP >= 90%. Validation confirmed generalization across diverse patient demographics and imaging equipment.

Technological Characteristics

Cloud-based software; distributed system architecture. Functions as a medical image management and processing system. Utilizes ML models for automated segmentation, landmarking, classification, and detection. Requires internet connection. Platform-agnostic (web browser-based).

Indications for Use

Indicated for adult patients with previously diagnosed injury or disability requiring pre-operative surgical planning. Used by qualified healthcare professionals for orthopedic planning in hip, knee, upper limb, and foot procedures.

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

PeekMed web (K240926)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below it, also in blue. The logo is clean and professional, reflecting the organization's role in regulating food and drugs. Peek Health, S.A. Sara Silva Chief Quality Officer (CQO) Centro de Negócios Ideia Atlântico, Rua Padres Carmelitas Braga, 4719-005 Portugal March 19, 2025 Re: K250042 Trade/Device Name: PeekMed web Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH, LLZ Dated: January 8, 2025 Received: January 8, 2025 Dear Sara Silva: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory {2}------------------------------------------------ assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jessica Lamb Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use Submission Number (if known) K250042 Device Name PeekMed web Indications for Use (Describe) PeekMed web is a system designed to help healthcare professionals carry out pre-operative planning for several surgical procedures, based on their imported patients' imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the output of the planning. The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers. This medical device consists of a decision support tool for qualified healthcare professionals to quickly and efficiently perform the pre-operative planning for several surgical procedures, using medical imaging with the additional capability of planning the 2D or 3D environment. The system is designed for the medical specialties within surgery and no specific use environment is mandatory, whereas the typical use environment is a room with a computer. The patient target group is adult patients who have an injury or disability diagnosed previously. There are no other considerations for the intended patient population. 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) #### 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." {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for PeekMed. The logo features a stylized, three-dimensional cube shape in a teal color. Within the cube, there is a white eye shape, suggesting a focus on vision or medical imaging. Below the cube, the text "PeekMed" is written in a simple, sans-serif font, also in teal. # 510(k) summary This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92. ## 1. Submitter Peek Health, S.A. Centro de Negócios Ideia Atlântico Rua Padres Carmelitas 4719-005 Braga Portugal | Contact Person: | Sara Silva Chief Quality Officer (CQO) | |-----------------|-------------------------------------------| | | | | Email: | sara.silva@peekmed.com | | Office number: | + 351 253 128 941 | Date Summary Prepared: March 17, 2025 #### 2. Device #### 2.1 PeekMed web | Trade Name: | PeekMed web | |-----------------------|------------------------------------------------------------------| | Common or Usual Name: | Medical image management and processing system | | Classification Name: | System, Image Processing, Radiological (21 C.F.R. § 892.2050) | | Regulatory Class: | Class II | | Product Code: | QIH, LLZ | ## 3. Legally Marketed Predicate Device #### 3.1 PeekMed web | 510(k) | Product Name | Clearance Date | |---------|--------------|------------------| | K240926 | PeekMed web | December 6, 2024 | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for PeekMed. The logo features a stylized, geometric shape in blue, resembling a cube with a section cut out to reveal a white eye in the negative space. Below the geometric shape, the text "PeekMed" is written in a simple, sans-serif font, also in blue. ## 4. Device Description Summary PeekMed web is a system designed to help healthcare professionals carry out pre-operative planning for several surgical procedures, based on their imported patients' imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the output of the planning. The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers. As PeekMed web is capable of representing medical images in a 2D or 3D environment, performing relevant measurements on those images, and also capable of adding templates, it then can perform a total overview of the surgery. Being software it does not interact with any part of the body of the user and/or patient. ## 5. Intended Use/Indications for Use PeekMed web is a system designed to help healthcare professionals carry out pre-operative planning for several surgical procedures, based on their imported patients' imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the output of the planning. The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers. This medical device consists of a decision support tool for qualified healthcare professionals to quickly and efficiently perform the pre-operative planning for several surgical procedures, using medical imaging with the additional capability of planning the 2D or 3D environment. The system is designed for the medical specialties within surgery and no specific use environment is mandatory, whereas the typical use environment is a room with a computer. The patient target group is adult patients who have an injury or disability diagnosed previously. There are no other considerations for the intended patient population. ## 5.1. Contraindications No contraindications specific to this device. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for PeekMed. The logo is a stylized, geometric shape in blue, resembling a cube with a section cut out to form the shape of an eye. Below the geometric shape, the word "PeekMed" is written in a simple, sans-serif font, also in blue. The logo is clean and modern, suggesting a focus on vision or medical imaging. ## 5.2 Indications for Use Comparison There are NO differences between the indications for use of this device and its predicate. ## 6. Technological Comparison to Predicate PeekMed web was compared to its respective predicate device in intended use, indications for use, design, function, and technology and it was demonstrated that they are substantially equivalent. Any technological differences within this 510(k), between the subject device and the predicate device, do not impact substantial equivalence, or safety and effectiveness. The subject device and its predicate are both medical software that allows healthcare professionals to perform orthopedic pre-surgical planning efficiently in the musculoskeletal system of adults in a healthcare environment, therefore sharing the same intended user and intended patient population. To properly and fully use both devices, clinical judgment, and experience are mandatory. Both devices have the same workflows, use requirements (e.g., internet connection, output validation), and planning features (e.g., model representation, digital overlap of prosthetic material, possible 2D and 3D environments). Both devices generate a final report of the planning which consists of the selected images with templates, measurements, and textual information describing the patient and/or the surgical procedure to be performed. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for PeekMed. The logo is a stylized blue square with a white eye in the center. Below the logo, the word "PeekMed" is written in blue font. The logo is simple and modern. ### Table 1: Summary of Predicate and Subject Device Characteristics to Demonstrate Substantial Equivalence | Characteristic | PeekMed web Predicate device K240926 | PeekMed web Subject device | Substantially Equivalent? | Justification and rationale | |------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | QIH, LLZ | LLZ, QIH | Yes | --- | | Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | Yes | --- | | Regulation Name | Medical Image Management And Processing System | Medical Image Management And Processing System | Yes | --- | | Intended use/Indications for use | PeekMed web is a system designed to help healthcare professionals carry out pre-operative planning for several surgical procedures, based on their imported patients' imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the output of the planning. The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers. This medical device consists of a decision support tool for qualified healthcare professionals to quickly and efficiently perform the pre-operative planning for several surgical procedures, using medical imaging with the additional | PeekMed web is a system designed to help healthcare professionals carry out pre-operative planning for several surgical procedures, based on their imported patients' imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the output of the planning. The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers. This medical device consists of a decision support tool for qualified healthcare professionals to quickly and efficiently perform the pre-operative planning for several surgical procedures, using medical imaging with the additional capability of | Yes | --- | | Characteristic | PeekMed web Predicate device K240926 | PeekMed web Subject device | Substantially Equivalent? | Justification and rationale | | | capability of planning the 2D or 3D environment. The system is designed for the medical specialties within surgery and no specific use environment is mandatory, whereas the typical use environment is a room with a computer. The patient target group is adult patients who have an injury or disability diagnosed previously. There are no other considerations for the intended patient population. | planning the 2D or 3D environment. The system is designed for the medical specialties within surgery and no specific use environment is mandatory, whereas the typical use environment is a room with a computer. The patient target group is adult patients who have an injury or disability diagnosed previously. There are no other considerations for the intended patient population. | | | | Contraindications | No contraindications specific to this device. | No contraindications specific to this device | Yes | --- | | Clinical purpose | PeekMed web allows the surgeon to perform orthopedic pre-surgical planning efficiently in the musculoskeletal system (e.g., Hip procedures, Knee procedures) | PeekMed web allows the surgeon to perform orthopedic pre-surgical planning efficiently in the musculoskeletal system (e.g., Hip procedures, Knee procedures) | Yes | --- | | Anatomical regions | PeekMed web allows the surgeon to perform the pre-surgical planning efficiently in the following anatomical regions: - Hip - Knee - Upper limb - Foot | PeekMed web allows the surgeon to perform the pre-surgical planning efficiently in the following anatomical regions: - Hip - Knee - Upper limb - Foot | Yes | --- | | Patient Population | Adults | Adults | Yes | --- | | Characteristic | PeekMed web Predicate device K240926 | PeekMed web Subject device | Substantially Equivalent? | Justification and rationale | | End users | Healthcare Professionals | Healthcare Professionals | Yes | --- | | Device availability | Software is cloud-based (not installable) and can be displayed on any personal device or workstation that can run on a web browser | Software is cloud-based (not installable) and can be displayed on any personal device or workstation that can run on a web browser | Yes | --- | | Software Architecture | Distributed system (cloud-based). This distributed system is a combination of software modules placed on servers that are able to communicate with each other. | Distributed system (cloud-based). This distributed system is a combination of software modules placed on servers that are able to communicate with each other. | Yes | --- | | Workflow | The workflow is as follows: Import case images, configure images, identify the case, pre-surgical planning, and export the case. | The workflow is as follows: Import case images, configure images, identify the case, pre-surgical planning, and export the case. | Yes | --- | | Internet connection | Required | Required | Yes | --- | | Images source | Receives medical images from various sources | Receives medical images from various sources | Yes | --- | | Data processing | The software processes data to provide an overlap and dimensioning of digital representations of the prosthetic material | The software processes data to provide an overlap and dimensioning of digital representations of the prosthetic material | Yes | --- | | Digital overlap of templates | Allows the overlap of models and the intersection of the models | Allows the overlap of models and the intersection of the models | Yes | --- | | Interactive model positioning | Yes | Yes | Yes | --- | | Interactive model | Yes | Yes | Yes | --- | | Characteristic | PeekMed web Predicate device K240926 | PeekMed web Subject device | Substantially Equivalent? | Justification and rationale | | dimensioning | | | | | | Model rotation | Yes | Yes | Yes | --- | | Support for digital prosthetic materials provided by the manufacturers | Yes | Yes | Yes | --- | | Pre-surgical planning | Yes | Yes | Yes | --- | | Type of pre-surgical planning | Automatic or Manual | Automatic or Manual | Yes | --- | | Contact with the patient | No | No | Yes | --- | | Control of life supporting devices | No | No | Yes | ---…

PeekMed web

Device Facts

AI Performance

Indications for Use

Device Story

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Technological Characteristics

Indications for Use

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PeekMed web

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AI Performance

Indications for Use

Device Story

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Technological Characteristics

Indications for Use

Regulatory Classification

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Special Controls

Predicate Devices

Submission Summary (Full Text)

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