Predicate Devices

Unknown

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a process of creating physical 3D models from segmented DICOM images using FDA-cleared software and additive manufacturing. There is no mention of AI or ML being used in the segmentation, model creation, or printing process. The performance studies focus on geometric accuracy and shipping validation, not AI/ML performance metrics.

Therapeutic

No.
The device is described as a physical replica of patient anatomy for diagnostic purposes, not for treating or preventing disease.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the Ricoh 3D Anatomic Models are "intended as physical replicas of patient anatomy to be used for diagnostic purposes."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the device is a "patient-specific physical replica of an anatomic structure or site, produced via additive manufacturing." This indicates a physical product, not a software-only device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD devices are used to examine specimens derived from the human body. This device is a physical replica of patient anatomy, not a test performed on a biological sample.
The intended use is for diagnostic purposes in conjunction with other tools and clinical judgment. While it aids in diagnosis, it does so by providing a physical model for visualization and planning, not by analyzing a biological sample to provide diagnostic information.
The device description clearly states it's a "patient-specific physical replica." This reinforces that it's a physical model, not a diagnostic test kit or instrument that analyzes biological material.

The device falls under the category of medical devices used for diagnostic and potentially surgical planning purposes, but it does not meet the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Ricoh 3D Anatomic Models are intended as physical replicas of patient anatomy to be used for diagnostic purposes in the fields of craniomaxillofacial and orthopedic applications. The Anatomic Models are based on DICOM imaging information from a medical scanner and output files from FDA cleared software intended for the creation and output of digital files suitable for the fabrication of physical replicas. The models should be used in conjunction with other diagnostic tools and expert clinical judgement.

Product codes

LLZ

Device Description

The subject device, each "Ricoh 3D Anatomic Model," is a patient-specific physical replica of an anatomic structure or site, produced via additive manufacturing from a user generated 3D print file. The input 3D print file is created from medical images in DICOM format that have been seqmented to a specific reqion of interest within an FDA cleared application, IBM iConnect Access (K203104). The input 3D print file is then transferred to Ricoh for production and delivery of the physical replica.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

DICOM imaging information from a medical scanner

Anatomical Site

craniomaxillofacial and orthopedic applications

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Validation testing included assessment of the workflow from input digital 3D file to output physical replica. Similar to the predicate device, the geometric accuracy of printed orthopedic and craniomaxillofacial physical models was assessed via bench testing. Testing showed that the physical models can be printed accurately at less than 1mm mean deviation when compared against the input digital 3D file, and all clinically relevant acceptance criteria was met.
Simulated distribution and handling testing was performed to assess the packaging for Ricoh 3D Anatomic Models. Testing showed that the packaging adequately protects the product from damage throughout the distribution process.

Key Metrics

geometric accuracy of printed orthopedic and craniomaxillofacial physical models was assessed via bench testing. Testing showed that the physical models can be printed accurately at less than 1mm mean deviation when compared against the input digital 3D file, and all clinically relevant acceptance criteria was met.

Predicate Device(s)

K173619

Reference Device(s)

K203104

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION".

Ricoh USA, Inc. % Mr. Scott Brewer Sr. Manager, Regulatory Compliance, Additive Manufacturing 5575 Venture Drive Unit A PARMA OH 44130

Re: K220205

June 3, 2022

Trade/Device Name: Ricoh 3D Anatomic Models Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: May 2, 2022 Received: May 3, 2022

Dear Mr. Brewer:

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

1

for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220205

Device Name Ricoh 3D Anatomical Models

Indications for Use (Describe)

Ricoh 3D Anatomic Models are intended as physical replicas of patient anatomy to be used for diagnostic purposes in the fields of craniomaxillofacial and orthopedic applications. The Anatomic Models are based on DICOM imaging information from a medical scanner and output files from FDA cleared software intended for the creation and output of digital files suitable for the fabrication of physical replicas. The models should be used in conjunction with other diagnostic tools and expert clinical judgement.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

-SUBMITTER

Ricoh USA, Inc. 5575 Venture Drive Unit A Parma, Ohio | USA | 44130 Tel: +1.954.648.5680 Email: Gary.Turner@RicohUSA.com

Contact Person:	Scott Brewer
Date Prepared:	May 31, 2022

DEVICE .

Name of Device: Ricoh 3D Anatomic Models Classification Name: Radiological Image Processing System Regulation: 21 CFR §892.2050 Requlatory Class: Class II Product Classification Code: LLZ

= PREDICATE & REFERENCE DEVICES

Predicate Manufacturer:	Materialise NV
Predicate Trade Name:	Mimics inPrint
Predicate 510(k):	K173619

DEVICE DESCRIPTION IV.

The subject device, each "Ricoh 3D Anatomic Model," is a patient-specific physical replica of an anatomic structure or site, produced via additive manufacturing from a user generated 3D print file. The input 3D print file is created from medical images in DICOM format that have been seqmented to a specific reqion of interest within an FDA cleared application, IBM iConnect Access (K203104). The input 3D print file is then transferred to Ricoh for production and delivery of the physical replica.

V. INDICATIONS FOR USE

Ricoh 3D Anatomic Models are intended as physical replicas of patient anatomy to be used for diagnostic purposes in the fields of craniomaxillofacial and orthopedic applications. The Anatomic Models are based on DICOM imaging information from a medical scanner and output files from FDA cleared software intended for the creation and output of digital files suitable for the fabrication of physical replicas. The models should be used in conjunction with other diagnostic tools and expert clinical judgement.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVCE

The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:

	Anatomic Models	Mimics inPrint K173619	Comments on SE
Trade Name	Anatomic Models, Ricoh
3D	Mimics inPrint, Materialise	-
Common Name	Image processing system	Image processing system	Same
Classification Name	System, Image
processing, Radiological	System, Image
processing, Radiological	Same
Classification	LLZ	LLZ	Same
Product Code	892.2050	892.2050	Same
Indications for Use	Ricoh 3D Anatomic
Models are intended as
physical replicas of patient
anatomy to be used for
diagnostic purposes in the
fields of craniomaxillofacial
and orthopedic
applications. The
Anatomic Models are
based on DICOM imaging
information from a medical
scanner and output files
from FDA cleared software
intended for the creation
and output of digital files
suitable for the fabrication
of physical replicas. The
models should be used in
conjunction with other
diagnostic tools and expert
clinical judgement.	Mimics inPrint is intended
for use as a software
interface and image
segmentation system for
the transfer of DICOM
imaging information from a
medical scanner to an
output file. It is also used as
pre-operative software for
treatment planning. For this
purpose, the Mimics inPrint
output file can be used for
the fabrication of physical
replicas of the output file
using traditional or additive
manufacturing methods.
The physical replica can be
used for diagnostic
purposes in the field of
orthopedic, maxillofacial
and cardiovascular
applications. Mimics inPrint
should be used in
conjunction with other
diagnostic tools and expert
clinical judgement.	The indications for
use of the subject
device are a subset
of the predicate
device.
The subject device
does not provide
diagnostic image
segmentation or the
transfer of medical
imaging information
to an output file.
Instead, the device
utilizes output files
from a cleared Class
II medical device.
The subject device
includes a subset of
anatomical regions,
including only
craniomaxillofacial
and orthopedic
applications.
Design (key
components/features)	The Ricoh 3D Anatomical
Models are produced from
a 3D print file. The 3D print
file is imported from a
Class II medical device,
IBM iConnect Access,
which allows for advanced
image segmentation and
editing tools for the
purpose of creating digital
3D anatomical models.
Once the 3D print file is
imported, the surgical
team, radiological team	Mimics inPrint is image
processing software that
allows the user to import,
visualize and segment
medical images, check and
correct the segmentations,
and create digital 3D
models. The models can be
used in Mimics inPrint for
measuring, treatment
planning and producing an
output file to be used for
additive manufacturing (3D
printing). Mimics inPrint is	The subject device
design is a subset of
the predicate device.
The subject device
utilizes an imported
3D print file for
design and
fabrication of the
physical replica.
	Anatomic Models	Mimics inPrint K173619	Comments on SE
	(segmentation team) and
Ricoh production team
can:
• Communicate about
project needs/scope,
establish/track project
timelines,
• Approve final STL file for
fabrication
Under the direction of the
clinical user, the Ricoh
Biomedical Engineering
team will generate a
printable anatomic model.
Once final approval of the
model is achieved from the
clinical user, the
anatomical model will be
printed, post-processed,
and undergo a quality
validation process. After
inspection and approval,
the anatomical model is
labeled and distributed to
the customer.	structured as a modular
package. This includes the
following functionality:
• Importing medical
images in DICOM format
and other formats (such
as BMP, TIFF, JPG and
raw images)
• Viewing images and
DICOM data
• Selecting a region of
interest using generic
segmentation tools
• Segmenting specific
anatomy using dedicated
semi-automatic tools or
fully automatic
algorithms
• Verifying and editing a
region of interest
• Calculating a digital 3D
model and editing the
model
• Planning treatments
(surgical cuts etc.) on the
3D models
The output digital 3D model
is suitable for production of
a physical model using
compatible 3D printers and
materials.
Performance Testing	• Geometric accuracy of
the physical replicas	• Software measurement
accuracy and calculate
3D study
• Geometric Accuracy of
physical replicas.	The subject device
includes a subset of
the testing of the
predicate device, and
only includes
geometric accuracy
testing of physical
replicas.

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Validation Testing

Validation testing included assessment of the workflow from input digital 3D file to output physical replica. Similar to the predicate device, the geometric accuracy of printed orthopedic and craniomaxillofacial physical models was assessed via bench testing. Testing showed that the physical models can be printed accurately at less than 1mm mean deviation when compared against the input digital 3D file, and all clinically relevant acceptance criteria was met.

6

Shipping Validation

Simulated distribution and handling testing was performed to assess the packaging for Ricoh 3D Anatomic Models. Testing showed that the packaging adequately protects the product from damage throughout the distribution process.

VIII. CONCLUSIONS

A comparison of intended use and technological characteristics combined with performance data demonstrates that Ricoh 3D Anatomical Model is substantially equivalent to the predicate device.