(105 days)
No
The summary describes a process of creating physical replicas from segmented DICOM images using additive manufacturing. It explicitly states that the segmentation is done using an FDA-cleared application (IBM iConnect Access, K203104), and there is no mention of AI or ML being used in the segmentation, 3D file creation, or printing process. The validation focuses on the geometric accuracy of the physical model compared to the digital file.
No
The device is described as a physical replica of patient anatomy for diagnostic purposes, not for treating or alleviating disease.
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." It also mentions that the models "should be used in conjunction with other diagnostic tools."
No
The device is a physical replica of patient anatomy produced via additive manufacturing, which is a hardware component.
Based on the provided information, the Ricoh 3D Anatomic Models are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a patient's health. This testing is performed in vitro (outside the body).
- Ricoh 3D Anatomic Models' Function: The Ricoh 3D Anatomic Models are physical replicas of patient anatomy. They are used in conjunction with other diagnostic tools and clinical judgment, but they themselves are not performing a test on a biological specimen. They are a visual and tactile aid for diagnostic purposes, based on existing imaging data.
- Intended Use: The intended use clearly states they are "physical replicas of patient anatomy to be used for diagnostic purposes." This aligns with being a tool for understanding and planning, not a test performed on a sample.
Therefore, while they are used in the diagnostic process, they do not fit the definition of an In Vitro Diagnostic device.
N/A
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, orthopedic, cardiovascular, neurological, gastrointestinal, genitourinary, and breast 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, orthopedic, cardiovascular, neurological, gastrointestinal, genitourinary, and breast
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 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 were 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 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 were met.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol on the left is a stylized representation of a human figure. The text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "U.S. FOOD & DRUG" are on the top line, and the word "ADMINISTRATION" is on the bottom line.
Ricoh USA, Inc. % Scott Brewer Director, Regulatory Affairs and Quality, Additive Manufacturing 5575 Venture Drive, Unit A PARMA OH 44130
Re: K230119
May 2, 2023
Trade/Device Name: 3D Anatomic Model Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: March 28, 2023 Received: March 29, 2023
Dear Scott 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); 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/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.
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
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Indications for Use
510(k) Number (if known)
Device Name 3D Anatomic Model
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, orthopedic, cardiovascular, neurological, gastrointestinal, genitourinary, and breast 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: January 16, 2023
DEVICE =
Name of Device: 3D Anatomic Model Classification Name: Radiological Image Processing System 21 CFR §892.2050 Regulation: Requlatory Class: Class II Product Classification Code: LLZ
= PREDICATE & REFERENCE DEVICES
Ricoh USA, Inc. Predicate Manufacturer: Predicate Trade Name: 3D Anatomic Models Predicate 510(k): K220205
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, orthopedic, cardiovascular, neurological, gastrointestinal, genitourinary, and breast 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 | Ricoh 3D Anatomic Models
K220205 | Comments on SE |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Anatomic Models
(Subject Device) | Anatomic Models | - |
| Common Name | Anatomic Models, Ricoh 3D
Image processing system | Anatomic Models, Ricoh 3D
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,
orthopedic, cardiovascular,
neurological,
gastrointestinal,
genitourinary, and breast
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. | 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. | The indications for
use of the subject
device expand the
scope of anatomic
regions from those
listed for the
predicate device.
Expanded
applications include
cardiovascular,
neurological,
gastrointestinal,
genitourinary, and
breast. |
| 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, 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
(segmentation team) and
Ricoh production team can:
• Communicate about | The Ricoh 3D Anatomical
Models are produced from
a 3D print file. The 3D print
file is imported from a Class
II medical device, 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
(segmentation team) and
Ricoh production team can:
• Communicate about | Same |
| | Anatomic Models
(Subject Device) | Ricoh 3D Anatomic Models
K220205 | Comments on SE |
| | 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. | 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. | |
| Performance Testing | • Geometric accuracy of
the physical replicas | • Geometric accuracy of
the physical replicas | Same |
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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 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 were met.
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.
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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.