(194 days)
TECHFIT Patient-Specific Maxillofacial System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial/midface and mandibular skeletal regions.
TECHFIT Patient-Specific Maxillofacial system is comprised of patient-specific metallic bone plates used in conjunction with commercially available screws cleared by the US FDA, for stabilization. fixation, and reconstruction of the maxillofacial/midface and mandibular bones.
The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician only provides input for model manipulation and interactive feedback by viewing digital models of planned outputs, modified by trained TECHFIT engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated implant over a 3D model of the patient's anatomy to ensure that its dimensional properties allow an adequate fit.
Implants are provided non-sterile, range in thickness from 0.6 to 10 mm, and are manufactured using traditional (subtractive) methods from CP Titanium (ASTM F67).
The provided text describes the TECHFIT Patient-Specific Maxillofacial System and its substantial equivalence to predicate devices, focusing on non-clinical performance testing.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions specific non-clinical performance tests and their outcomes.
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Bending & Fatigue Testing (ASTM F382) | Substantially equivalent to K032442 plates. |
| Biocompatibility (ISO 10993-1:2018) | Procedures and provisions were applied. (Implies compliance, but no specific performance metric is stated beyond adherence to standards). |
| Sterilization (ISO 17665-1, ISO 17665-2, and ISO 14937 to SAL of 10^-6) | All test method acceptance criteria were met. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the numerical sample size for the bending & fatigue testing. It refers to comparing "the subject plates against plates previously cleared in reference device K032442," suggesting a comparative test, but the number of plates tested is not specified.
- Data Provenance: The data provenance is implicitly from laboratory testing ("Mechanical testing was conducted") as part of the regulatory submission by Industrias Medicas Sampedro S.A.S. The geographic origin of this specific testing (e.g., country) is not mentioned. It is non-clinical, ex-vivo data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the document describes non-clinical, mechanical, and biocompatibility testing, not studies requiring expert ground truth for a clinical test set.
4. Adjudication Method for the Test Set
This information is not applicable as the document describes non-clinical, mechanical, and biocompatibility testing, not studies requiring adjudication for a clinical test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary for the substantial equivalence determination."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not directly applicable in the context of this device. The TECHFIT Patient-Specific Maxillofacial System is a physical implant, not an algorithm. However, the design process involves "virtual planning" with "input from the physician during virtual planning and prior to finalization and production of the device." In this sense, the "device" (the physical implant) is designed with human-in-the-loop involvement, but there isn't an "algorithm only" performance that would typically be evaluated for AI/software devices. The verification involves "virtually fitting the generated implant over a 3D model of the patient's anatomy."
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests described:
- Bending & Fatigue Testing: The "ground truth" or reference was the performance of plates from the previously cleared reference device K032442, as measured by standard mechanical testing protocols (ASTM F382).
- Biocompatibility: The "ground truth" was compliance with established international standards (ISO 10993-1:2018) and FDA guidance for biological evaluation.
- Sterilization: The "ground truth" was achieving a Sterility Assurance Level (SAL) of 10^-6 according to international standards (ISO 17665-1, ISO 17665-2, and ISO 14937).
8. The Sample Size for the Training Set
This information is not applicable as the document describes a physical medical device and its non-clinical testing, not an AI/ML algorithm that would require a "training set" in the conventional sense. The device is manufactured based on patient-specific CT scan data, which informs the design of each individual implant rather than training a general model.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no "training set" in the context of this physical device. The device design relies on patient-specific medical imaging (CT scans) and physician input for virtual planning, not on a generalized training dataset with pre-established ground truth labels.
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May 19, 2021
Industrias Medicas Sampedro S.A.S. Leidy Gonzalez Regulatory Affairs Specialist Carrera 47 N 100 Sur 40 Centro Industrial Portal del Sur Bodega 14 La Estrella, Antioquia 055468 COLOMBIA
Re: K203282
Trade/Device Name: TECHFIT Patient-Specific Maxillofacial System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: April 16, 2021 Received: April 19, 2021
Dear Leidy Gonzalez:
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
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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 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/cdrl-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 Andrew Steen Assistant 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
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Indications for Use
510(k) Number (if known) K203282
Device Name
TECHFIT Patient-Specific Maxillofacial System
Indications for Use (Describe)
TECHFIT Patient-Specific Maxillofacial System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial/midface and mandibular skeletal regions.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K203282 510(k) Summary 21 CFR 807.92
| Submitter | Industrias Médicas Sampedro S.A.S.Carrera 47 Nº 100 Sur 40Centro Industrial Portal del Sur, Bodega 14La Estrella, Colombia, 055468 |
|---|---|
| Contact Person: | Leidy Johanna Toro-GonzálezRegulatory Affairs SpecialistPhone: +574 322 3375Email: leidy.toro@imsampedro.com |
| Date Prepared: | May 18, 2021 |
| Trade Name:Common Name: | TECHFIT Patient-Specific Maxillofacial SystemPlate, Bone |
| Clasification Name: | Bone plate |
| Regulatory Class: | II |
| Product Code: | JEY |
| Regulation Number: | 21 CFR 872.4760 |
| Primary Predicate: | KLS Martin Individual Patient Solutions (K191028) |
| Reference Devices: | AFFINITY - Variable Angle Distal Radius System (K191641)KLS Martin Mandibular / Reconstruction System II (K032442) |
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Image /page/4/Picture/0 description: The image shows the logo for "sampredro SISTEMAS DE FIJACION OSEA". The logo is in green and the "p" in "sampredro" is stylized to look like a medical device. The text "SISTEMAS DE FIJACION OSEA" is in a smaller font and is located below the main text.
ra 47 Nº 100 Sur 40 ustrial Portal del Sur. Bodega 14 strella. Colombia.
Image /page/4/Picture/2 description: The image shows the logo for Techfit Digital Surgery. The logo features a stylized graphic above the company name. The graphic consists of two overlapping circles, one larger and one smaller, both filled in black. Below the graphic, the word "TECHFIT" is written in a bold, sans-serif font. Underneath "TECHFIT", the words "Digital Surgery" are written in a smaller, lighter font.
Device Description:
TECHFIT Patient-Specific Maxillofacial system is comprised of patient-specific metallic bone plates used in conjunction with commercially available screws cleared by the US FDA, for stabilization. fixation, and reconstruction of the maxillofacial/midface and mandibular bones.
The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician only provides input for model manipulation and interactive feedback by viewing digital models of planned outputs, modified by trained TECHFIT engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated implant over a 3D model of the patient's anatomy to ensure that its dimensional properties allow an adequate fit.
Implants are provided non-sterile, range in thickness from 0.6 to 10 mm, and are manufactured using traditional (subtractive) methods from CP Titanium (ASTM F67).
Indications for Use
TECHFIT Patient-Specific Maxillofacial System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial/midface and mandibular skeletal regions.
Technological Characteristics & Substantial Equivalence Discussion
SISTEMAS DE FIJACIÓN ÓSEA The intended use of the subject device, TECHFIT Patient-Specific Maxillofacial System, is the same as the primary predicate device, KLS Martin Individual Patient Solutions (K191028). The only difference is that the predicate device can also be manufactured from another material, titanium alloy Ti6Al4V, through additive manufacturing and selective laser melting.
Similarities to Predicate
The subject and primary predicate devices are both intended for use in the stabilization, fixation, and reconstruction of the maxillofacial/midface and mandibular skeletal regions and share the same fundamental principles of operation - patient-specific metallic bone plates used in conjunction with metallic bone screws for facial reconstructive surgery.
Both the subject and predicate devices are manufactured to match the patient's anatomy. The design process for both the subject and the predicate device use image data obtained from medical scanners, such as a CT scan.
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Image /page/5/Picture/2 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a stylized graphic above the company name. The graphic appears to be two overlapping circles, one larger and solid black, and the other smaller and partially covering the larger one. Below the graphic, the word "TECHFIT" is written in a bold, sans-serif font, and below that, the words "Digital Surgery" are written in a smaller, lighter font.
The subject and predicate devices plates are manufactured from the same material. CP Titanium (ASTM F67), and they are manufactured using the traditional (subtractive) manufacturing method.
All subject and predicate devices are provided non-sterile and require the end-user to process the devices using validated cleaning and sterilization methods prior to use as recommended in the device labeling.
Differences from Predicate
The predicate device can also be manufactured from titanium alloy (Ti-6Al-4V) through additive manufacturing and selective laser melting, whereas the subject device is manufactured only from CP titanium through the traditional subtractive method.
Reference Devices
The AFFINITY - Variable Angle Distal Radius System (K191641) was selected as reference device as it is manufactured with identical material (CP Titanium) and follow similar manufacturing methods to those of the subject device. Screws from this system are manufactured from titanium alloy Ti6Al4V.
The KLS Martin Mandibular Reconstruction System II (K032442) was selected as reference device solely for the side-by-side mechanical performance testing with the TECHFIT Patient-Specific Maxillofacial System. The KLS Martin Mandibular Reconstruction System II plates dimensions are comparable to the subject device. Both plate thickness and length of this reference device fall within the range of the subject device.
A device comparison table of the subject, predicate, and reference devices is provided below.
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Image /page/6/Picture/2 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a stylized graphic above the company name. The graphic is composed of two overlapping circles, one solid black and the other a partial circle. Below the graphic is the word "TECHFIT" in a bold, sans-serif font, with the words "Digital Surgery" in a smaller font size underneath.
| Subject Device | Predicate Device | Reference device 1 | Reference Device 2 | |
|---|---|---|---|---|
| Parameters | TECHFIT patient-specific MaxillofacialSystem | KLS Martin IndividualPatient Solutions | AFFINITY -Variable Angle DistalRadius System | KLS MartinMandibularReconstructionSystem II |
| 510K number | K203182 | K191028 | K191641 | K032442 |
| Indications forUse | TECHFIT Patient-Specific MaxillofacialSystem is intended foruse in the stabilization,fixation, andreconstruction of themaxillofacial/midfaceand mandibular skeletalregions. | KLS Martin IndividualPatient SpecificSolutions implantdevices are intended foruse in the stabilization,fixation, andreconstruction of themaxillofacial/midfaceand mandibular skeletalregions. | Fixation of simple andcomplex intraarticularand extraarticularfractures, and forosteotomies of thedistal radius in adults.Fractures AO typesA2, A3, B1, B3, C1,C2, C3. | The KLS MartinMandibularReconstructionSystem II is intendedfor use in thestabilization andfixation of mandibularfractures andmandibularreconstruction. |
| Patient-specific | Yes. Devices aremanufacturedpatient-specific, based ona CT scan of the patient. | Yes. Devices aremanufacturedpatient-specific, based ona CT scan of the patient. | No. Devices areprovided in standardshape. | No. Devices areprovided in standardshape. |
| Classification | Class II. CFR 872.4760;Bone plate | Class II. CFR 872.4760;Bone plate | Class II 21 CFR882.5320;Single/multiplecomponent metallicbone fixationappliances andaccessories | Class II 21 CFR872.4760; Bone plate |
| Product code | JEY (Bone plate) | JEY (Bone plate) | HRS (Single/multiplecomponent metallicbone fixationappliances andaccessories)HWC (Smooth orthreaded metallic bonefixation fastener) | MQN (ExternalMandibular FixatorAnd/or Distractor) |
| Plates Material | Plates: biocompatiblecommercially puretitanium grade 4 | Plates: biocompatiblecommercially puretitanium grade 4 | Plates: biocompatiblecommercially puretitanium grade 4(ASTM F67) | Commercially pure(CP)Titanium or Ti-6AL-4V Titanium Alloy |
| Subject Device | Predicate Device | Reference device 1 | Reference Device 2 | |
| Parameters | TECHFIT patient-specific MaxillofacialSystem | KLS Martin IndividualPatient Solutions | AFFINITY -Variable Angle DistalRadius System | KLS MartinMandibularReconstructionSystem II |
| 510K number | K203182 | K191028 | K191641 | K032442 |
| Biocompatible titaniumalloy (Ti6Al4V) | ||||
| ManufacturingMethod | Traditional (Subtractive) | CP Titanium: Traditional(Subtractive) Ti-6Al-4V:Traditional and 3D(Additive; SelectiveLaser Melting) | Traditional(Subtractive) | Traditional(Subtractive) |
| Sterilization | Steam Sterilization | Steam Sterilization | Steam Sterilization | Steam Sterilization |
| AnatomicalSites | Maxillofacial/ Midface& Mandible | Maxillofacial/ Midface& Mandible | Radius | Mandible |
| Plate specifications | ||||
| Thickness | Maxillofacialreconstruction: 0.6 mm –2.0 mmMidface reconstruction:0.6 mm – 10 mmMandibularreconstruction: 2.0 mm –3.0 mm | Maxillofacial / midfacereconstruction:0.6 mm –10 mmMandibularreconstruction:1.0 mm-3.0 mmOrbital:0.3 mm – 1.0mm | Extraarticular plates:From 1.9 mm to 2.5mmL-plates, T-plates,Straight plates: 1.6mm | 1.0 mm – 3.0 mm |
| Width | Maxillofacial / midface:Min: ≥ 4.5 mm (aroundscrew holes)Min: ≥ 3 mm (not aroundscrew hole)Max: Dependent onscrew-holeMandibular:Min: 6.63 mm | Maxillofacial / midface:Min: ≥ 4.5 mm (aroundscrew holes)Min: ≥ 3 mm (not aroundscrew hole)Max: Dependent onscrew-holeMandibular:Min: 7 mm | Extraarticular wideplates:27 mm (head)9.8 mm (body)Extraarticularintermediate plates:25 mm (head)9.8 mm (body) | Unknown |
| Subject Device | Predicate Device | Reference device 1 | Reference Device 2 | |
| Parameters | TECHFIT patient-specific MaxillofacialSystem | KLS Martin IndividualPatient Solutions | AFFINITY -Variable Angle DistalRadius System | KLS MartinMandibularReconstructionSystem II |
| 510K number | K203182 | K191028 | K191641 | K032442 |
| Extraarticular narrowplates:22.8 mm (head)9.8 mm (body)L-plates, T-plates:14 mm (head)7 mm (body)Straight plate:7 mm (body) | ||||
| Length | Maxillofacial / midface:Min: 18 mmMax: 350 mmMandibular:Min: 78 mmMax: 320 mm | Maxillofacial / midface:Min: 18 mmMax: 350 mmMandibular:Min: 31 mmMax: 320 mm | Extraarticularintermediate plates:37 mm53 mm94 mmExtraarticular wideplates:53 mmExtraarticular narrowplates:37 mm53 mmL-plates, T-plates,Straight plate:38 mm52 mm | Unknown |
| Degree ofCurvature (in-plane) | Maxillofacial/midface:Min: 30°Max: 180°Mandibular:Min: 90°Max: 180° | Maxillofacial/midface:Min: 30°Max: 180°Mandibular:Min: 90°Max: 180° | Extraarticular plates:There is no degree ofcurvature (in-plane).L-plates, T-plates,Straight plate: | Unknown |
| Subject Device | Predicate Device | Reference device 1 | Reference Device 2 | |
| Parameters | TECHFIT patient-specific MaxillofacialSystem | KLS Martin IndividualPatient Solutions | AFFINITY -Variable Angle DistalRadius System | KLS MartinMandibularReconstructionSystem II |
| 510K number | K203182 | K191028 | K191641 | K032442 |
| There is no degree ofcurvature (in-plane). | ||||
| Degree ofCurvature(out-of-plane) | Maxillofacial/midface:Min: 15°Max: 180°Mandibular:Min: 60°Max: 180° | Maxillofacial/midface:Min: 15°Max: 180°Mandibular:Min: 60°Max: 180° | Extraarticular plates:22°L-plates, T-plates,Straight plate:10° | Unknown |
| Hole Spacing | Maxillofacial: ≥ 4.5 mmMidface: ≥ 4.0 mmMandibular: ≥ 8 mm | Orbital & Maxillofacial /midface:≥4.5 mmMandibular:≥8mm | Extraarticular plates:Min: 6 mm (body)Max: 7.8 mm (body)Min: 4.8 mm (head)Max: 7.89 mm (head)L-plates, T-plates,Straight plate:Min: 7 mmMax: 7.5 mm | Unknown |
| Number ofHoles | Maxillofacial/midface:Min: ≥ 2 per side ofdefectMax: Dependent onlength & hole spacingMandibular:Min: 4Max: Dependent onlength & hole spacing | Orbital & Maxillofacial /midface:Min: ≥ 2 per side ofdefectMax: Dependent onlength & hole spacingMandibular:Min: 4Max: Dependent onlength & hole spacing | Extraarticular plates:Head: 6 VA holesBody:3 segments plates:2 VA holes2 locking holes1 Oblong hole2 segments plates:2 VA holes1 Oblong holeL-plates, T-plates:3 segments plates:3 VA holes1 Oblong hole4 segments plates: | Unknown |
| Subject Device | Predicate Device | Reference device 1 | Reference Device 2 | |
| Parameters | TECHFIT patient-specific MaxillofacialSystem | KLS Martin IndividualPatient Solutions | AFFINITY -Variable Angle DistalRadius System | KLS MartinMandibularReconstructionSystem II |
| 510K number | K203182 | K191028 | K191641 | K032442 |
| 4 VA holes1 Oblong hole6 segments plates:6 VA holes1 Oblong holeStraight plate:3 segments plates:2 VA holes1 Oblong hole4 segments plates:3 VA holes1 Oblong hole6 segments plates:5 VA holes1 Oblong hole | ||||
| Fixationmethod | The implant is attachedto the bone with FDAcleared commerciallyavailable screws. | These patient-specificdevices are fixated withpreviously cleared KLSMartin screws. | AFFINITY – VariableAngle Distal RadiusSystem is fixed withscrews. | KLS MartinMandibularReconstructionSystem II is fixed withscrews. |
| Manufacturer | Industrias MédicasSampedro | KLS Martin L.P. | Industrias MédicasSampedro | KLS Martin L.P. |
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Image /page/8/Picture/0 description: The image shows the logo for "sampredro SISTEMAS DE FIJACIÓN ÓSEA". The word "sampredro" is written in a sans-serif font in green. The letter "p" in "sampredro" is stylized with a green line that extends below the word. Below "sampredro" is the phrase "SISTEMAS DE FIJACIÓN ÓSEA" in a smaller, sans-serif font.
Image /page/8/Picture/2 description: The image shows the logo for TECHFIT Digital Surgery. The logo consists of a stylized graphic above the company name. The graphic is a black circle with a smaller, crescent-shaped piece taken out of the upper right quadrant, creating a modern and abstract design. Below the graphic, the word "TECHFIT" is written in a bold, sans-serif font, and beneath that, the words "Digital Surgery" are written in a smaller, lighter font.
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Image /page/9/Picture/0 description: The image shows the logo for "sampredro SISTEMAS DE FIJACIÓN ÓSEA". The word "sampredro" is written in a sans-serif font in green. The letter "p" in "sampredro" is stylized with a green line that extends below the word. Below "sampredro" is the phrase "SISTEMAS DE FIJACIÓN ÓSEA" in a smaller, sans-serif font.
Image /page/9/Picture/2 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a stylized graphic above the company name. The graphic is composed of two overlapping circles, one solid black and the other a partial circle. Below the graphic, the word "TECHFIT" is written in a bold, sans-serif font, and below that, the words "Digital Surgery" are written in a smaller, lighter font.
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Image /page/10/Picture/0 description: The image shows the logo for "sampedro SISTEMAS DE FIJACIÓN ÓSEA". The word "sampedro" is written in a green sans-serif font, with the "p" stylized to resemble a medical device. Below the word "sampedro" is the phrase "SISTEMAS DE FIJACIÓN ÓSEA", which is written in a smaller, sans-serif font.
Image /page/10/Picture/2 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a stylized graphic above the company name. The graphic features a black circle with a white crescent shape cut out of it, and a smaller black circle overlapping the larger one. Below the graphic, the word "TECHFIT" is written in a bold, sans-serif font, and below that, the words "Digital Surgery" are written in a smaller, lighter font.
Performance Testing – Non-clinical
Bending & Fatigue testing:
Mechanical testing was conducted in accordance with ASTM F382 to compare the bending properties of the subject plates against plates previously cleared in reference device K032442. The bending
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Image /page/11/Picture/2 description: The image shows the logo for Techfit Digital Surgery. The logo features a stylized graphic of two overlapping circles, one black and one white, above the word "TECHFIT" in a bold, sans-serif font. Below "TECHFIT" are the words "Digital Surgery" in a smaller, lighter font.
resistance and fatigue life of the subject devices was determined to be substantially equivalent to the K032442 plates.
Biocompatibility:
For the assessment of biological endpoints, the procedures and provisions of ISO 10993-1:2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process", as well as FDA Guidance "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process", dated 16. June 2016, were applied.
Sterilization:
Sterilization validation was conducted in accordance with international standard ISO 17665-1, ISO 17665-2, and ISO 14937 to a sterility Assurance Level (SAL) of 10th. All test method acceptance criteria were met.
Performance Testing - Clinical:
Clinical testing was not necessary for the substantial equivalence determination.
Substantial Equivalence Conclusion
SISTEMAS DE FIJACION OSEA
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate / reference devices, the TECHFIT Patient-Specific Maxillofacial System shows to be substantially equivalent to the predicate devices.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.