(323 days)
No
The document mentions "medical image processing software" and "image segmentation system" but does not explicitly mention AI, ML, or related terms like deep learning or neural networks. The performance studies focus on traditional verification and validation methods, not AI/ML specific metrics or training/test data descriptions.
No
The device is a pre-operative software tool for simulating/evaluating surgical treatment options and producing physical outputs like templates for maxillofacial surgery, not directly providing therapy.
No
The device is intended for software-based image segmentation, transfer of imaging information, and pre-operative simulation/evaluation, which are pre-surgical planning tools rather than diagnostic ones. It helps to plan and implement surgery, not to diagnose a condition.
No
The device description explicitly states that the system includes "applicable DigiGuide Templates, and optional anatomical models" which are physical outputs produced by a rapid prototyping portion of the system. The performance studies also include validation of materials, manufacturing process, cleaning, sterilization, and biocompatibility of these physical outputs, indicating it is not solely software.
Based on the provided information, the ProtoMED DigiGuide System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the system is for processing imaging information from medical scanners (like CT) to create physical outputs (templates and models) for use in maxillofacial surgery and for pre-operative simulation/evaluation of surgical treatment options. This is a surgical planning and guidance tool, not a diagnostic test performed on biological samples in vitro.
- Device Description: The description focuses on the components used for surgical planning and implementation (digital surgical plan, templates, anatomical models).
- Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples (blood, tissue, urine, etc.) to provide diagnostic information about a patient's health status.
- Focus on Imaging and Physical Outputs: The core function is processing medical images and producing physical guides for surgery.
IVDs are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ProtoMED DigiGuide System does not fit this definition.
N/A
Intended Use / Indications for Use
The ProtoMED DigiGuide 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 DigiGuide System and the result is an output data file that is used as the input to a rapid prototyping portion of the system that produces physical outputs including templates for use in maxillofacial surgery. The DigiGuide System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
Product codes
DZJ, LLZ
Device Description
System Overview:
The ProtoMED DigiGuide System consists of a digital surgical plan (DigiPlan), applicable DigiGuide Templates, and optional anatomical models in order to plan and implement a maxillofacial surgery.
DigiPlans:
A DigiPlan uses CT scans of patient anatomy and other patient data to create a computer based surgical simulation under the direction of a physician in conjunction with company technicians. The output is a report that represents the execution of that simulation at intraoperative and final conditions. The report may also include documentation of required osteotomies, cephalometric data if applicable, anatomy movements or details of any DigiGuide templates or Anatomical Models that will be used to support the surgical implementation.
Anatomical Models:
Anatomical models are physical representations of patient anatomy in a CT-scanned or DigiPlan (modified) position. Physical models are patient-specific and fabricated from a non-sterilizable polymer using an additive manufacturing process. Digital anatomical models are provided in STL or DICOM format for use to aid the physician in surgical planning and to provide a visual aid.
Anatomical models are for informational purpose only and do not have interaction or contact with the patient, device, or surgical field.
DigiGuide Templates:
DigiGuide Templates are patient-specific devices that register to anatomy that support a DigiPlan such as teeth arches or bony segments, direct planned osteotomies, and inspect the results of planned procedures. Templates are produced using an additive manufacturing process and are provided non-sterile. See Table 1 below for individual template functions and details. Design features may include:
-
- Inverse images of anatomy in intended application position.
-
- Mounting holes designed to secure templates to anatomy if needed.
-
- Partial or complete palatal support for maxillary surgeries.
-
- Bars, tabs, holes, or slots that indicate the position and direction of osteotomies and movements.
-
- Stiffening elements.
-
- Labels or other indicators.
The system may require (but does not include) FDA cleared fastening hardware (i.e. bone plates, bone screws, pins) that must be obtained by the physician from other sources prior to initiating the surgical procedure.
DigiGuide System patient-specific templates are solely intended to be designed and manufactured within the ProtoMED facility only, using manufacturing controls developed and validated by ProtoMED.
- Labels or other indicators.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
CT based system
Anatomical Site
maxillofacial
Indicated Patient Age Range
Adult
Intended User / Care Setting
Physician, Surgical clinic
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
Verification and validation testing were performed on the planning/design process, materials, manufacturing process, and the cleaning and recommended sterilization methods of the ProtoMED DigiGuide System. The intention of these tests was to provide objective evidence that the system conforms to specifications, is fit for its intended use, and that its performance is substantially equivalent to the predicate device.
Sterilization
Sterilization validation was conducted in accordance with international standard ISO 17665 and FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," to a sterility Assurance Level (SAL) of 1x10-6. All test method acceptance criteria were met.
Biocompatibility
Biocompatibility validation was conducted in accordance with international standard ISO 10993-1 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". The results of the testing adequately address biocompatibility for the output devices and their intended use. Biocompatibility testing on the final finished device included: cytotoxicity, sensitization, acute systemic toxicity, material mediated pyrogenicity, and implantation.
Because the ProtoMED DigiGuide System is a combination of a manufacturing process and the patient-specific outputs of the manufacturing process (models and templates), performance testing for the device includes methods of process validation, installation, operational, and process validations. ProtoMED determined that successful execution of the validations would be comprised of the following: 1) use STL files from patient anatomy as input for both anatomical model and template manufacturing input, 2) process the files using currently validated software versions and procedures, 3) output digital files that meet requirements, and 4) manufacture models and templates from output digital files that meet requirements.
The final output STL files and physical models/templates demonstrated dimensional and clinical equivalency to STL files used as inputs. The equivalency was demonstrated through overlay of parts for comparison analysis.
All Design, Process, and other Verification and Validation testing which were conducted as a result of risk analyses and design impact assessments, showed conformity to pre-established specifications and acceptance criteria. The acceptance criteria were established in order to demonstrate device performance and substantial equivalence of the system to predicate devices.
Key Metrics
Not Found.
Predicate Device(s)
Medical Modeling, Inc. VSP System (K133907)
Reference Device(s)
KLS Martin Individual Patient Solutions (K180962)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found.
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 4, 2020
ProtoMED, Inc. Rick Miller Director of Quality 1329 W 121st Ave Westminster, Colorado 80234
Re: K193499
Trade/Device Name: DigiGuide System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: October 2, 2020 Received: October 5, 2020
Dear Rick Miller:
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
1
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 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-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 Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193499
Device Name DigiGuide System
Indications for Use (Describe)
The ProtoMED DigiGuide 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 DigiGuide System and the result is an output data file that is used as the input to a rapid prototyping portion of the system that produces physical outputs including templates for use in maxillofacial surgery. The DigiGuide System 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) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
K193499
MANUFACTURER INFORMATION
| Company Name: | ProtoMED, Inc. |
|---|---|
| Company Address: | 1329 West 121st Westminster, CO 80234 USA |
| Company Phone: | (303) 466-5610 |
| Company Contact: | Richard Miller |
PREPARATION DATE
November 2nd. 2020
DEVICE IDENTIFICATION
| Device Trade Name: | DigiGuide System |
|---|---|
| Device Common Name: | DigiGuide System |
| Classification Name: | Bone cutting instrument and accessories |
| Regulation Number: | 21 CFR 872.4120 |
| Product Code: | DZJ, LLZ |
| Device Class: | Class II |
| Classification Panel: | Dental |
PREDICATE/REFERENCE DEVICES
| Predicate: | Medical Modeling, Inc. VSP System (K133907) |
|---|---|
| Reference: | KLS Martin Individual Patient Solutions (K180962) |
DEVICE DESCRIPTION
System Overview:
The ProtoMED DigiGuide System consists of a digital surgical plan (DigiPlan), applicable DigiGuide Templates, and optional anatomical models in order to plan and implement a maxillofacial surgery.
DigiPlans:
A DigiPlan uses CT scans of patient anatomy and other patient data to create a computer based surgical simulation under the direction of a physician in conjunction with company technicians. The output is a report that represents the execution of that simulation at intraoperative and final conditions. The report may also include documentation of required osteotomies, cephalometric data if applicable, anatomy movements or details of any DigiGuide templates or Anatomical Models that will be used to support the surgical implementation.
Anatomical Models:
Anatomical models are physical representations of patient anatomy in a CT-scanned or DigiPlan (modified) position. Physical models are patient-specific and fabricated from a non-sterilizable polymer using an additive manufacturing process. Digital anatomical models are provided in STL or DICOM format for use to aid the physician in surgical planning and to provide a visual aid.
4
Anatomical models are for informational purpose only and do not have interaction or contact with the patient, device, or surgical field.
DigiGuide Templates:
DigiGuide Templates are patient-specific devices that register to anatomy that support a DigiPlan such as teeth arches or bony segments, direct planned osteotomies, and inspect the results of planned procedures. Templates are produced using an additive manufacturing process and are provided non-sterile. See Table 1 below for individual template functions and details. Design features may include:
-
- Inverse images of anatomy in intended application position.
-
- Mounting holes designed to secure templates to anatomy if needed.
-
- Partial or complete palatal support for maxillary surgeries.
-
- Bars, tabs, holes, or slots that indicate the position and direction of osteotomies and movements.
-
- Stiffening elements.
-
- Labels or other indicators.
The system may require (but does not include) FDA cleared fastening hardware (i.e. bone plates, bone screws, pins) that must be obtained by the physician from other sources prior to initiating the surgical procedure.
DigiGuide System patient-specific templates are solely intended to be designed and manufactured within the ProtoMED facility only, using manufacturing controls developed and validated by ProtoMED.
| Table 1: DigiGuide Template Functions and Details | |||||
|---|---|---|---|---|---|
| Occlusal | Marking | Placement | Inspection | ||
| Intraoperative | Final | ||||
| Nature of Body | |||||
| Contact Category | External Communicating Device | ||||
| Nature of Body | |||||
| Contact Type | Mucosal membrane | ||||
| (teeth/palette/gum tissue also) | Tissue/Bone | ||||
| Contact Duration | Limited (less than | ||||
| 24 hours) | Prolonged (up | ||||
| to 30 days) | Limited (less than 24 hours) |
- . Occlusal Templates: Register jaws in relation to each other the desired intermediate and/or final positions, as well as provide stability during the healing process (final template only). The final template may be used up to 30 days after surgery for stability during the healing process.
- Marking Templates: Indicate the location/orientation of osteotomies or screw holes. Templates are placed directly on exposed bone to mark osteotomy and/or hole locations, then removed prior to performing cuts or drills.
- Placement Templates: Position and hold anatomy into the planned occlusion or position, allowing the physician to fixate any required permanent placement hardware such as bone plates (not included in the DigiGuide System), then removed and discarded.
- Inspection Templates: Verify that the osteotomies were performed as planned and/or the appropriate ● amount of bony anatomy was removed.
Templates are not intended to be in place while cuts or drills are applied.
INDICATIONS FOR USE
The ProtoMED DigiGuide 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 DigiGuide System and the result is an output data file that is used as the input to a rapid prototyping portion of the system that produces physical outputs including templates for use in maxillofacial surgery. The DigiGuide System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
5
INTENDED USE
The DigiGuide System is intended to be used on adult patients as follows:
-
- A digital surgical plan (DigiPlan) is developed by company technicians with the collaboration of the involved physician as follows:
- a) A CT scan or physical representation of a patient's bony anatomy is translated into a set of 3D objects in STL format using medical image processing software.
- b) The STL models of the patient's teeth are integrated with the then-bony anatomy as needed.
- c) Indicated osteotomies are performed in digital space and cephalometric landmarks are established.
- d) Various sections of maxillofacial bony anatomy are virtually moved to a desired location by either written instruction or during a live, online meeting with ProtoMED engineers, technicians, and the physician.
- e) The resulting set of STL objects represents the anatomy in the final position and a set of measurements that both indicate the proposed cephalometric position and identify relative movements of all of the objects.
-
- DigiGuide Templates are created from the inverse images of the anatomy with added alignment and/or support structures.
- a) Biocompatible polymers are used to additively manufacture all templates.
- b) Templates must be sterilized according to instructions provided before use in surgery.
- c) Templates may be temporarily affixed to the patient to assist in the transfer of the DigiPlan from computer space to the patient.
- d) Templates are not implanted and do not include any fastening hardware.
- e) Templates must be removed from the patient prior to the surgery, except for the final DigiGuide occlusal templates, as required by the surgeon. If remaining affixed to the patient following surgery, they must not be affixed for more than 30 days after surgery.
- After removal, all templates are disposed with local biohazardous disposal procedures. f)
-
- Anatomical models are physical or electronic (STL) models of patient anatomy in the CT scanned or DigiPlan position.
- a) Physical models are additively manufactured and may be used as physical references to design planning and as a visual aid.
- b) STL models are representations of CT scan anatomy or anatomy changes resulting from a DigiPlan.
- c) Anatomical models are for informational purpose only and do not have interaction or contact with the patient, device, or surgical field.
COMPARISON TO PREDICATE DEVICES
The intended use of the DigiGuide System and its predicate device, Medical Modeling VSP System (K133907), are substantially equivalent as discussed below. Table 2 compares the DigiGuide System to both the predicate device and reference device KLS Martin Individual Patient Solutions (K180962).
- The DigiGuide System employs substantially equivalent fundamental technologies as the identified 1. predicate including:
- a) The application of commercial Off-The Shelf (COTS) Software for image transfer, manipulation, and surgical planning,
- b) Material and manufacturing of patient-specific templates.
- Both of the systems are intended to facilitate maxillofacial procedures by producing patient-specific 2. anatomical models, surgical positioning and osteotomy templates, and case reports.
-
- Both require the development of digital surgical plans by trained personnel with active support from the physician.
- Both require the fabrication of surgical components from a physician-approved digital plan in an 4. additive manufacturing environment.
6
-
- Both are patient-specific devices.
-
- Both are single-use devices.
-
- Both provide non-sterile templates which require sterilization to SAL 1x10 by the end user (physician).
-
- Both utilize metal sleeve inserts to eliminate hardware interaction with bone screws.
-
- The DigiGuide System has substantially equivalent technical characteristics to the predicate device, including:
- a) System Inputs: Images from medical scanners (i.e., CT) or physical data (i.e. stone teeth models)
- b) System Outputs: Physical outputs such as patient-specific anatomical models, surgical positioning and osteotomy templates, and case reports
- c) Materials used in Physical Outputs: Biocompatible polymers and surgical grade stainless steel
-
- Differences between the DigiGuide System and its predicate device include:
- a) The predicate system includes surgical guides intended to remain affixed to the patient to guide cutting tools. The DigiGuide System does not provide these surgical (or cutting) guides. The templates provided by the DigiGuide System are only intended to mark where the cuts are to be applied. The DigiGuide System is substantially equivalent to the predicate since both result in identifying the proper drilling and cutting location(s). The predicate device uses "patientspecific" in the Summary of the predicate device submission. Thus, the DigiGuide System is substantially equivalent to the predicate device.
- b) The predicate system uses a surgical grade stainless steel sleeve insert, whereas the DigiGuide System and the reference device both utilize a titanium surgical sleeve insert. Both metals are surgical grade, FDA-cleared materials intended to eliminate interaction between hardware and template material. Therefore, the DigiGuide System is equivalent to both the predicate and reference devices.
7
Table 2: Comparison to Predicate and Reference Devices
| | ProtoMED, Inc. | Medical Modeling, Inc.
(Predicate Device) | KLS Martin
(Reference Device) |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | DigiGuide System | VSP® System | Individual Patient Solutions (IPS) Planning
System |
| 510K Number | TBD | K133907 | K181241 |
| Regulatory Class | II | II | II |
| Classification | 872.4120 | 872.4120, 892.2050 | 872.4120, 892.2050 |
| Product Codes | DZJ, LLZ | DZJ, LLZ | DZJ, LLZ |
| Indications for
Use | The ProtoMED DigiGuide 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 DigiGuide System
and the result is an output data file
that is used as the input to a rapid
prototyping portion of the system that
produces physical outputs including
templates for use in maxillofacial
surgery. The DigiGuide System is
also intended as a pre-operative
software tool
for simulating/ evaluating surgical
treatment options. | The Medical Modeling VSP® 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 VSP® System and the result is an
output data file that is used as the input
to a rapid prototyping portion of the
system that produces physical outputs
including anatomical models and
templates for use in maxillofacial
surgery. The VSP® System is also
intended as a pre-operative software tool
for simulating / evaluating surgical
treatment options. | The KLS Martin Individual Patient Solutions
(IPS) Planning 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
IPS Planning System and the result is an output
data file that 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, guides,
splints, and case reports for use in
maxillofacial surgery. The IPS Planning
System is also intended as a pre-operative
software tool for simulating / evaluating
surgical treatment options. |
| Device Type | Patient specific | Patient specific | Patient specific |
| Usage | Patient-Specific, Single Use | Single Use | Patient-Specific, Single Use |
| Sterilization | By end user | By end user | By end user |
| Patient Group | Adult | Adult | Adult |
| Environment of
Use | Surgical clinic | Surgical clinic | Surgical clinic |
| Device Disposition | Removed from patient | Removed from patient | Removed from patient |
| Template Material | Biocompatible polymers and titanium
alloy | Biocompatible polymers and surgical
grade stainless steel | Anatomical Models: Epoxy/Resin, Acrylic
Cutting/Marking Guides: Polyamide, Titanium
Alloy (Ti-6Al-4V), CP Titanium Splints:
methacrylate |
8
SUMMARY OF TESTING AND PERFORMANCE DATA
This is not an energized device. Electromagnetic Compatibility, Electrical, and Immunity testing is not applicable.
Electromagnetic Compatibility, Immunity Testing and Electrical Safety Testing are not applicable.
Verification and validation testing were performed on the planning/design process, materials, manufacturing process, and the cleaning and recommended sterilization methods of the ProtoMED DigiGuide System. The intention of these tests was to provide objective evidence that the system conforms to specifications, is fit for its intended use, and that its performance is substantially equivalent to the predicate device.
Sterilization
Sterilization validation was conducted in accordance with international standard ISO 17665 and FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," to a sterility Assurance Level (SAL) of 1x10-6. All test method acceptance criteria were met.
Biocompatibility
Biocompatibility validation was conducted in accordance with international standard ISO 10993-1 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". The results of the testing adequately address biocompatibility for the output devices and their intended use. Biocompatibility testing on the final finished device included: cytotoxicity, sensitization, acute systemic toxicity, material mediated pyrogenicity, and implantation
Because the ProtoMED DigiGuide System is a combination of a manufacturing process and the patient-specific outputs of the manufacturing process (models and templates), performance testing for the device includes methods of process validation, installation, operational, and process validations. ProtoMED determined that successful execution of the validations would be comprised of the following: 1) use STL files from patient anatomy as input for both anatomical model and template manufacturing input, 2) process the files using currently validated software versions and procedures, 3) output digital files that meet requirements, and 4) manufacture models and templates from output digital files that meet requirements.
The final output STL files and physical models/templates demonstrated dimensional and clinical equivalency to STL files used as inputs. The equivalency was demonstrated through overlay of parts for comparison analysis.
All Design, Process, and other Verification and Validation testing which were conducted as a result of risk analyses and design impact assessments, showed conformity to pre-established specifications and acceptance criteria. The acceptance criteria were established in order to demonstrate device performance and substantial equivalence of the system to predicate devices.
CONCLUSION
It is the conclusion of ProtoMED, Inc. that the DigiGuide System is substantially equivalent in intended use, materials, technological characteristics, and performance characteristics to the predicate device already on the market.