(234 days)
Not Found
No
The summary describes image processing and segmentation but does not mention AI, ML, or related concepts like neural networks, training data, or performance metrics typically associated with AI/ML models. The focus is on standard image manipulation and additive manufacturing.
No
Explanation: EmbedMed is a software system for image processing and the creation of anatomical models/surgical guides. It is used for pre-operative planning and aiding in surgical procedures, not for treating diseases or conditions directly.
No
The device is intended for image segmentation and transfer, leading to outputs for additive manufacturing of anatomical models and surgical guides, and as a pre-operative software tool for simulating/evaluating surgical treatment options. It processes imaging information but does not actively diagnose a medical condition based on that information.
No
The device description explicitly states that the system includes an "additive manufacturing portion" which produces "physical outputs including anatomical models and surgical guides." This indicates the system is not solely software.
Based on the provided information, EmbedMed is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVDs are used to examine specimens from the human body. The primary purpose of an IVD is to provide information about a patient's health status by analyzing samples like blood, urine, or tissue.
- EmbedMed's intended use is focused on processing medical imaging data. It takes imaging information (like CT scans), processes it, and produces digital models or physical outputs (anatomical models and surgical guides).
- The output of EmbedMed is not a diagnostic result derived from a biological specimen. It's a tool for surgical planning and creating physical aids for surgery, based on anatomical information from imaging.
While EmbedMed uses medical data and is a medical device, its function falls under the category of surgical planning software and additive manufacturing for medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
EmbedMed is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The is processed by the system, and the result is an output data file. This file may then be provided as digital models or used an input to an additive manufacturing portion of the system. The additive manufacturing portion of the system produces physical outputs including anatomical models and surgical guides for use in maxillofacial surgeries. EmbedMed is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
Product codes (comma separated list FDA assigned to the subject device)
DZJ, LLZ
Device Description
EmbedMed utilizes Commercial Off-The-Shelf (COTS) software to manipulate 3D medical images to create digital and additive manufactured, patient-specific physical anatomical models and surgical guides for use in surgical procedures.
Imaging data files are obtained from the surgeons for treatment planning and various patient-specific products that are manufactured with biocompatible photopolymer resins using additive manufacturing (stereolithography).
EmbedMed receives patient specific medical imaging files from the prescribing clinician which is then then further processed. The processing includes a software program to segment the image file from 3D medical scan images and creates a patient-specific digital output. The digital output is then reviewed and approved by the prescribing clinician prior to delivery of the final outputs (physical or digital). A trained 3D LifePrints employee utilizes additive manufacturing (3D printing, SLA) to manufacture physical outputs which include anatomical models and surgical guides for use in maxillofacial surgeries. All outputs are provided non-sterile. All surgical guides are provided with the steps for sterilization prior to use in surgery. Anatomical models may also be provided with the steps for sterilization. The outputs of the subject device include:
- Anatomical models are physical replicas used to aid in surgical planning. They are intended to be used in conjunction with other diagnostic tools and expert clinical judgement. Anatomical models are not intended to come into contact with the patient or Surgical Guide
- Surgical Guides are used in surgical procedures to aid in bone cutting, bone marking, or bone repositioning. Drill sleeves are recommended to be used with the drilling guides. Clinicians use these cutting guides as they aid in cutting, by marking the angle and plane
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, CBCT, MRI, PET, DICOM images or CBCT of mouth/teeth) if applicable, Patients' digital photos if applicable
Anatomical Site
Maxillofacial
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing as described below has been performed to demonstrate the outputs of the EmbedMed manufacturing process conforms to the device specifications.
Testing performed and documented in this submission was also in accordance with FDA Guidance Document Technical Considerations for Additive Manufactured Medical Devices (December 5th, 2017).
Biocompatibility Testing:
EmbedMed was evaluated for the overall biological safety giving consideration to the following: type of patient contact and intended clinical use, potential hazards associated with the material of construction, biocompatibility data available on the 3D-printed raw material, the history of clinical use of the material of construction, manufacturing process information, and other information available according to ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, and FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." Endpoints assessed include: cytotoxicity, sensitization, acute systemic toxicity, and material-mediated pyrogenicity.
The results of the biological risk assessment and endpoint testing confirm biocompatibility. Embed is considered to meet the requirements of ISO 10993-1:2018, ISO 14971:2019, and FDA Guidance Document Use of International Standard ISO 10993-1:2016, for an implant device that has short term (
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
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September 30, 2022
3D LifePrints UK Ltd. % Sam Murray Principal Consultant Olympus Regulatory Solutions 5 Seaconnet Ave Portsmouth, Rhode Island 02871
Re: K220366
Trade/Device Name: EmbedMed Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: August 30, 2022 Received: September 1, 2022
Dear Sam Murray:
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.
1
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 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.
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices 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) K220366
Device Name EmbedMed
Indications for Use (Describe)
EmbedMed is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The is processed by the system, and the result is an output data file. This file may then be provided as digital models or used an input to an additive manufacturing portion of the system. The additive manufacturing portion of the system produces physical outputs including anatomical models and surgical guides for use in maxillofacial surgeries. EmbedMed is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
| 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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5. 510(K) SUMMARY K220366
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR § 807.92.
5.1. Submitter's Information
| Name: | 3D LifePrints UK Ltd. |
|---|---|
| Address: | The Innovation Hub, Alder Hey Children's NHS Foundation Trust, |
| Eaton Road West Derby, Liverpool Merseyside, England, L12 2AP | |
| United Kingdom | |
| Phone: | +44 15152 86830 |
| Contact Person: | Henry Pinchbeck |
| CEO | |
| Preparation Date: | 29 September 2022 |
5.2. Device Name
| Trade Name: | EmbedMed™ |
|---|---|
| Common Name: | System for the creation of patient specific anatomical models and surgical guides |
| Classification Name: | Bone Cutting Instruments and Accessories |
| Regulation | 21 CFR § 872.4120 |
| Regulatory Class: | Class II |
| Product Code | DZJ, LLZ |
5.3. Legally Marketed Predicate Device
CenterMed Patient Matched Assisted Surgical Planning (ASP) System (K201353)
5.4. Device Description
EmbedMed utilizes Commercial Off-The-Shelf (COTS) software to manipulate 3D medical images to create digital and additive manufactured, patient-specific physical anatomical models and surgical guides for use in surgical procedures.
Imaging data files are obtained from the surgeons for treatment planning and various patient-specific products that are manufactured with biocompatible photopolymer resins using additive manufacturing (stereolithography).
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Image /page/4/Picture/0 description: The image is a logo for a company called "3DLIFE PRINTS". The logo is set against a blue background. The text is white and stacked on top of each other. The logo is simple and modern.
5.4.1. Brief Written Description of the Device
EmbedMed receives patient specific medical imaging files from the prescribing clinician which is then then further processed. The processing includes a software program to segment the image file from 3D medical scan images and creates a patient-specific digital output. The digital output is then reviewed and approved by the prescribing clinician prior to delivery of the final outputs (physical or digital). A trained 3D LifePrints employee utilizes additive manufacturing (3D printing, SLA) to manufacture physical outputs which include anatomical models and surgical guides for use in maxillofacial surgeries. All outputs are provided non-sterile. All surgical guides are provided with the steps for sterilization prior to use in surgery. Anatomical models may also be provided with the steps for sterilization. The outputs of the subject device include:
- . Anatomical models are physical replicas used to aid in surgical planning. They are intended to be used in conjunction with other diagnostic tools and expert clinical judgement. Anatomical models are not intended to come into contact with the patient or Surgical Guide
- . Surgical Guides are used in surgical procedures to aid in bone cutting, bone marking, or bone repositioning. Drill sleeves are recommended to be used with the drilling guides. Clinicians use these cutting guides as they aid in cutting, by marking the angle and plane
| Output
Device | Model/Design
Type Examples | Mechanism of Action/Narrative Description |
|---------------------|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Surgical
Guide | Jaw Cutting Guide | Guides with positional indicators, cutting planes and/or drilling holes that are affixed to
patients during surgery to determine the locations and angles of osteotomies on the
mandible and/or maxilla |
| | Orthognathic
Splint | Guides that rest upon the patient's teeth during surgery to reposition the maxilla and/or
mandible during orthognathic surgery |
| | Orthognathic
Guide | Guides with positional indicators, cutting planes and drilling holes which are affixed to
patients during surgery to indicate angle and location of osteotomy facilitating
repositioning of the maxilla and mandible during orthognathic surgery |
| Anatomical
Model | Sterilizable
physical replica
model | Physical representation of patients' facial anatomy and pathology used for the planning
of maxillofacial surgeries (e.g. reconstructive, TMJ, resection, orbital, mid-face, dental,
orthognathic, cosmetic). The models are used to better understand the anatomy, for
decision making, reference, implant sizing, simulation etc. and that are intended to be
sterilized so they can be used within an the operating theater |
| | Non-sterilizable
physical replica
model | Physical representation of patients' facial anatomy and pathology used for the planning
of maxillofacial surgeries (e.g. reconstructive, TMJ, resection, orbital, mid-face, dental,
orthognathic, cosmetic). The models are used to better understand the anatomy, for
decision making, reference, implant sizing, simulation etc. |
Table 1: Output Device Descriptions
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| Output
Device | Model/Design
Type Examples | Mechanism of Action/Narrative Description |
|------------------|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Digital
Model | Digital replica
anatomical model | Digital representation of patients' facial anatomy and pathology used for the planning of
maxillofacial surgeries (e.g., reconstructive, TMJ, resection, orbital, mid-face, dental,
orthognathic, cosmetic). The models are used to better understand the anatomy, for
decision making, reference, implant sizing, simulation etc. |
The Surgical Guides are compatible with legally marketed bone screws and compatible metal sleeves
5.4.2. Materials of Use
EmbedMed physical outputs are additively manufactured by SLA utilizing medical-grade, acrylate-based photopolymers.
5.5. Intended Use
EmbedMed is intended for use as a software system and image segmentation system, for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the system, and the result is an output data file that is then used as input to an additive manufacturing portion of the system. The additive manufacturing portion of the system produces physical outputs including anatomical models and surgical guides.
Anatomical models are intended to be physical replicas used for to aid in surgical planning. They are intended to be used in conjunction with other diagnostic tools and expert clinical judgment. Surgical Guides are intended to be used in surgical procedures where they aid in bone cutting, bone marking, or bone repositioning.
5.6. Indications for Use
EmbedMed is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The is processed by the system, and the result is an output data file. This file may then be provided as digital models or used an input to an additive manufacturing portion of the system. The additive manufacturing portion of the system produces physical outputs including anatomical models and surgical guides for use in maxillofacial surgeries. EmbedMed is also intended as a pre-operative software tool for simulating surgical treatment options.
5.7. Substantial Equivalence Discussion
A comparison of the similarities and differences between EmbedMed and predicate devices are provided in Table 2.
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Image /page/6/Picture/0 description: The image shows a logo for a company called "3D LIFE Prints". The logo is set on a blue square with rounded corners. The text "3D LIFE" is stacked on top of the word "Prints" in a bold, sans-serif font. The text is white, contrasting with the blue background.
Table 2: Predicate Comparison
| Specification/
| Characteristic | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| EmbedMed (K220366) | CenterMed Patient Matched Assisted Surgical | ||
| Planning (ASP) System (K201353) | |||
| Classification | 21 CFR 872.4120, Class II | ||
| 21 CFR 892.2050, Class II | 21 CFR 872.4120, Class II | ||
| 21 CFR 892.2050, Class II | Identical | ||
| Product Code | DZJ, LLZ | DZJ, LLZ | Identical |
| Indications for Use | EmbedMed is intended for use as a software system and | ||
| image segmentation system for the transfer of imaging | |||
| information from a medical scanner such as a CT based | |||
| system. The input data file is processed by the system, | |||
| and the result is an output data file. This file may then be | |||
| provided as digital models or used an input to an additive | |||
| manufacturing portion of the system. The additive | |||
| manufacturing portion of the system produces physical | |||
| outputs including anatomical models and surgical guides | |||
| for use in maxillofacial surgeries. EmbedMed is also | |||
| intended as a pre-operative software tool for | |||
| simulating/evaluating surgical treatment options. | CenterMed Patient Matched Assisted Surgical Planning | ||
| (ASP) System is intended for use as a software system | |||
| and image segmentation system for the transfer of | |||
| imaging information from a medical scanner such as a CT | |||
| based system. The input data file is processed by the ASP | |||
| system and the result is an output data file. This file may | |||
| then be provided as digital models or used as input to a | |||
| rapid prototyping portion of the system that produces | |||
| physical outputs including anatomical models, surgical | |||
| guides, surgical splints and surgical planning case reports | |||
| for use in maxillofacial surgery. CenterMed Patient | |||
| Matched ASP System is also intended as a pre-operative | |||
| software tool for simulating/evaluating surgical treatment | |||
| options. | Identical | ||
| Specification/ | |||
| Characteristic | Subject Device | Predicate Device | |
| EmbedMed (K220366) | CenterMed Patient Matched Assisted Surgical | ||
| Planning (ASP) System (K201353) | Comparison | ||
| Contraindications | 1. Significant changes to the patient's anatomy have | ||
| occurred since the medical scan used for planning | |||
| purposes was obtained. |
- Hypersensitivity to acrylate resins. | 1. Active infections (obvious, or clinically apparent).
- Hypersensitivity to foreign bodies.
- Circulatory problems, systematic diseases, or
metabolic disorders. - Insufficient or inadequate bone tissue.
- Secondary diseases such as degenerative processes
that may have negative influences. - Interventions carried out in a non-sterile
environment - Regions exposed to inappropriate forces or
excessive weight loads - Patients unwilling to follow instructions during the
postoperative phase due to their mental,
neurological, or physical condition. - Obvious drug or alcohol abuse
- Significant changes to the patient's anatomy have
occurred since the medical scan used for planning
purposes was obtained. | Substantially
Equivalent |
| Clinical
Application | Maxillofacial Surgeries | Maxillofacial Surgeries | Identical |
| Inputs | CT, CBCT, MRI, PET, DICOM images or CBCT of
mouth/teeth) if applicable, Patients' digital photos if
applicable | CT, CBCT DICOM images, Teeth models (stone models,
STL file or CBCT of mouth/teeth) if applicable, Patients'
digital photos if applicable | Identical |
| Segmentation
Software | Simpleware Scan IP | Materialise Mimics | Substantially
Equivalent |
| Outputs | Anatomical Models, Surgical Guides, Digital Models | Anatomical models, Surgical splints, Surgical guides,
Surgical planning case reports | Substantially
Equivalent |
| Materials | Anatomical models: Medical Grade Resin, acrylate
Surgical guides: Medical Grade Resin, acrylate
Sleeve: Medical Grade Stainless Steel or Titanium | Anatomical models: Medical Grade Polyamide (PA-12)
Surgical guides: Medical Grade Polyamide (PA-12)
Sleeve: Medical Grade Stainless Steel 316L | Substantially
Equivalent |
| Manufacturing
Method | 3D printing (additive) | 3D printing (additive) | Identical |
| Patient Specific | Yes | Yes | Identical |
| Provided Sterile | No | No | Identical |
| Specification/
Characteristic | Subject Device | Predicate Device | Comparison |
| | EmbedMed (K220366) | CenterMed Patient Matched Assisted Surgical
Planning (ASP) System (K201353) | |
| Sterilization
Method | Steam Sterilization | Steam Sterilization | Identical |
| Provided Single
Use | Yes | Yes | Identical |
| Recommended
Temporary fixation
style | Drill free | Drill-Free, Tapping-Free | Substantially
Equivalent |
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Image /page/7/Picture/0 description: The image is a logo for a company called "3D Life Prints". The logo is set on a blue square with rounded corners. The text "3D LIFE" is stacked on top of the word "PRINTS" in a bold, sans-serif font. The text is white, which contrasts with the blue background.
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Image /page/8/Picture/0 description: The image is a logo for a company called "3D Life Prints". The logo is set on a blue square with rounded corners. The text "3D LIFE" is stacked on top of the word "PRINTS" in white, bold font. The overall design is simple and modern.
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Image /page/9/Picture/0 description: The image is a logo for a company called "3D Life Prints". The logo is set against a bright blue square background. The text "3D LIFE" is stacked on top of the word "PRINTS" in a bold, sans-serif font. The text is white, which contrasts with the blue background.
5.7.1. Statement on Substantial Equivalence
EmbedMed is substantially equivalent to the legally marketed predicate device CenterMed Patient Matched Assisted Surgical Planning (ASP) System (K201353) with respect to intended use, design, materials, performance, and labeling.
5.8. Performance Data
Testing as described below has been performed to demonstrate the outputs of the EmbedMed manufacturing process conforms to the device specifications.
Testing performed and documented in this submission was also in accordance with FDA Guidance Document Technical Considerations for Additive Manufactured Medical Devices (December 5th, 2017).
5.8.1. Biocompatibility Testing
EmbedMed was evaluated for the overall biological safety giving consideration to the following: type of patient contact and intended clinical use, potential hazards associated with the material of construction, biocompatibility data available on the 3D-printed raw material, the history of clinical use of the material of construction, manufacturing process information, and other information available according to ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, and FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." Endpoints assessed include: cytotoxicity, sensitization, acute systemic toxicity, and material-mediated pyrogenicity.
The results of the biological risk assessment and endpoint testing confirm biocompatibility. Embed is considered to meet the requirements of ISO 10993-1:2018, ISO 14971:2019, and FDA Guidance Document Use of International Standard ISO 10993-1:2016, for an implant device that has short term (≤ 24 hours) contact with tissue and bone.
5.8.2. Sterilization Validation
The physical outputs of the subject device including the surgical guides and anatomical models are intended to be sterilized by the end user prior to use. The sterilization process was validated using the over-kill method according to ISO 17665-1: Sterilization of health care products - Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices. The sterilization cycle identified in the Instructions for Use were validated to a sterility assurance level (SAL) of 10-6. Drying time validation was also conducted.
5.8.3. Verification and Validation Testing
The performance testing performed on EmbedMed were conducted as part of formal design verification and validation. The testing confirmed EmbedMed physical outputs meet the requirements across the range of possible patient-specific devices. Testing included:
- Installation, Operational, and Performance Oualification
- Feature Accuracy
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Image /page/10/Picture/0 description: The image is a logo for a company called "3DLIFE prints". The logo is set against a blue square background. The text "3DLIFE" is stacked on top of the word "PRINTS" in a bold, sans-serif font. The text is white, which contrasts with the blue background.
- Dimensional Accuracy ●
- . Simulated Use Testing
5.8.4. Clinical Studies
Clinical testing was not necessary for the demonstration of substantial equivalence.
Conclusions 5.9.
EmbedMed has the same intended use and similar technological characteristics as the predicate device. Minor differences have been addressed by verification and validation testing. The testing demonstrates the subject device is substantially equivalent to the predicate device