(126 days)
Inversa Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. Inversa Implants are intended for immediate function when good primary stability with appropriate occlusal loading is achieved.
Inversa implants are fully threaded, tapered, root-form dental implants with a design feature known as body shift, where the body design of the implant has a narrow, straight coronal portion with an increased maximum diameter midway down the length of the implant tapering toward the apex. The body of the implant includes two thread types (square and V-shaped) that transition in the middle of the implant body. Inversa implants have a platform that is inclined 12° to the long axis of the implants are made of unalloyed titanium and provided in two connection types (External Hex and Deep Conical).
External Hex Inversa implants are provided in three sizes: coronal diameter 3.5 mm with maximum apical diameter 4.5 mm; coronal diameter 3.5 mm with maximum apical diameter 5.0 mm; and coronal diameter 4.2 mm with maximum apical diameter 5.0 mm. Each size of the External Hex Inversa implant is provided in four lengths (11.5, 13, 15, and 18 mm).
Deep Conical Inversa implants are provided in three sizes: coronal diameter 3.6 mm with maximum apical diameter 4.5 mm; coronal diameter 3.6 mm with maximum apical diameter 5.0 mm; and coronal diameter 4.0 mm with maximum apical diameter 5.0 mm. Each size of the Deep Conical Inversa implant is provided in four lengths (11.5, 13, 15, and 18 mm).
Inversa implants are made from unalloyed titanium conforming to ASTM F67.
This document is a 510(k) summary for the "Inversa Implants" dental implant system, submitted to the FDA. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study proving a device meets specific performance acceptance criteria for a new AI/software device.
Therefore, many of the requested elements (e.g., acceptance criteria for device performance, sample sizes for test sets, expert involvement, MRMC study results, training set details) are not applicable or not found in this type of regulatory submission for a physical medical device like a dental implant.
The "Performance Data" section of this document refers to non-clinical tests for physical characteristics and safety, not for performance of a software/AI device.
Here's an attempt to extract relevant information and explain why other information is absent:
1. A table of acceptance criteria and the reported device performance
This document does not present a table of acceptance criteria and reported device performance in the way one would for a software or AI device. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and intended use.
The "Performance Data" section mentions the following non-clinical tests performed or referenced:
| Test/Characteristic | Acceptance Criteria (Implicit) | Reported Performance (Implicit) |
|---|---|---|
| Sterilization Validation (according to ISO 11137-1 and ISO 11137-2) | Meets ISO standards (referenced from K163634 and K163060) | Deemed acceptable by reference to predicate data. |
| Biocompatibility Evaluation (according to ISO 10993-1) | Meets ISO standards (referenced from K163634 and K163060) | Deemed acceptable by reference to predicate data. |
| Bacterial Endotoxin Testing (in accordance with USP 40-NF 35) | Meets USP standards | Deemed acceptable. Specific results not in this summary. |
| Sterile Barrier Shelf Life | Meets requirements (referenced from K163634) | Deemed acceptable by reference to predicate data. |
| Dynamic Compression-Bending (to ISO 14801) | Implied to meet ISO 14801 standards, comparable to predicates. | Results not explicitly detailed in summary. |
| Insertion Torque Testing | Implied to be acceptable, comparable to predicates. | Results not explicitly detailed in summary. |
No clinical data were included in this submission. This means no human study was performed to "prove the device meets acceptance criteria" in a clinical setting.
2. Sample sizes used for the test set and the data provenance
- Sample Size for Test Set: Not applicable for this type of submission. The "test set" for a physical device like this refers to the samples of the device used for non-clinical bench testing (e.g., for mechanical strength, sterilization). The specific number of units tested for each non-clinical test (e.g., how many implants were tested for dynamic compression-bending) is not provided in this summary.
- Data Provenance: Not applicable. The data is primarily derived from bench testing (non-clinical) of prototype/production units and references to previously cleared predicate devices (K163634, K163060, K030463, K053478, K070841, K093562). The manufacturer is Southern Implants (Pty) Ltd., based in Irene, Gauteng, South Africa.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a submission for a diagnostic AI/software device that requires ground truth established by medical experts. The "ground truth" for a dental implant's performance would be engineering specifications and physical test results, not expert consensus on images.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of expert readings/assessments.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No. This type of study is typically done for diagnostic imaging devices/software to evaluate human reader performance with and without AI assistance. This submission is for a physical dental implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used
For the non-clinical performance data, the "ground truth" would be the physical and chemical properties of the materials and the mechanical performance consistent with engineering standards (e.g., ISO 14801 for dynamic compression-bending). For the regulatory submission, the primary "ground truth" is the demonstration of substantial equivalence to existing, legally marketed predicate devices based on design, materials, and intended use.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of an AI/machine learning model for this physical medical device submission.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/machine learning model.
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Image /page/0/Picture/0 description: The image contains 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, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
November 14, 2018
Southern Implants (Pty) Ltd % Kevin Thomas, PhD Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K181850
Trade/Device Name: Inversa Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: August 21, 2018 Received: August 22, 2018
Dear Kevin Thomas, PhD:
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.
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Inversa Implants
Indications for Use (Describe)
Inversa Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. Inversa Implants are intended for immediate function when good primary stability with appropriate occlusal loading is achieved.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K181850 Inversa Implants Southern Implants (Pty) Ltd.
November 14, 2018
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Southern Implants (Pty) Ltd.1 Albert RoadIrene, Gauteng, South Africa 0062 |
|---|---|
| Telephone: +27 12 667 1046 | |
| Fax: +27 12 667 1029 | |
| Official Contact | Lauranda BreytenbachRegulatory Affairs and Quality |
| Representative/Consultant | Kevin A. Thomas, PhDFloyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130 |
| Telephone: +1-858-792-1235 | |
| Fax: +1-858-792-1236 | |
| Email: kthomas@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Inversa Implants |
|---|---|
| Common Name | Dental implant |
| Classification Name | Implant, endosseous, root form |
| Classification Regulations | 21 CFR 872.3640, Class II |
| Product Code | DZE |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
PREDICATE DEVICE INFORMATION
Primary Predicate K163634, External Hex Implants, Southern Implants (Pty) Ltd.
Reference Devices K163060, Deep Conical (DC) Implants and Accessories, Southern Implants (Pty) Ltd. K 030463, The Maestro System™ 7 mm & 10.5 Endosseous Implants, BioHorizons Implant Systems, Inc. K003620, NSI Hexed and Non-Hexed Implant System, NSI K053478, Endosseous Dental Implant System, Northern Implants, LLC K070841, Endosseous Dental Implant System, Southern Implants, Inc. K093562, Zygomatic Implant System, Southern Implants, Inc.
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INDICATIONS FOR USE STATEMENT
Inversa Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. Inversa Implants are intended for immediate function when good primary stability with appropriate occlusal loading is achieved.
SUBJECT DEVICE DESCRIPTION
Inversa implants are fully threaded, tapered, root-form dental implants with a design feature known as body shift, where the body design of the implant has a narrow, straight coronal portion with an increased maximum diameter midway down the length of the implant tapering toward the apex. The body of the implant includes two thread types (square and V-shaped) that transition in the middle of the implant body. Inversa implants have a platform that is inclined 12° to the long axis of the implants are made of unalloyed titanium and provided in two connection types (External Hex and Deep Conical).
External Hex Inversa implants are provided in three sizes: coronal diameter 3.5 mm with maximum apical diameter 4.5 mm; coronal diameter 3.5 mm with maximum apical diameter 5.0 mm; and coronal diameter 4.2 mm with maximum apical diameter 5.0 mm. Each size of the External Hex Inversa implant is provided in four lengths (11.5, 13, 15, and 18 mm).
Deep Conical Inversa implants are provided in three sizes: coronal diameter 3.6 mm with maximum apical diameter 4.5 mm; coronal diameter 3.6 mm with maximum apical diameter 5.0 mm; and coronal diameter 4.0 mm with maximum apical diameter 5.0 mm. Each size of the Deep Conical Inversa implant is provided in four lengths (11.5, 13, 15, and 18 mm).
Inversa implants are made from unalloyed titanium conforming to ASTM F67.
PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: sterilization validation according to ISO 11137-1 and ISO 11137-2 (referenced from K163634 and K163060); biocompatibility evaluation according to ISO 10993-1 (referenced from K163634 and K163060); bacterial endotoxin testing in accordance with USP 40-NF 35; sterile barrier shelf life (referenced from K163634); dynamic compression-bending to ISO 14801, and insertion torque testing. No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICES
Southern Implants (Pty) Ltd. submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the substantially equivalent in indications and design principles to the legally marketed predicate devices.
The subject device is substantially equivalent to the primary predicate device K163634 in intended use, indications for use, material, surface, design, and function. Differences in the design features between the subject device and the primary predicate device K163634 are addressed by comparison to the reference devices as listed below.
The Indications for Use Statement for the subject device is the same as that of the primary predicate device K163634, except for the names of the devices.
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The body diameter sizes for the subject device External Hex Inversa implants are substantially equivalent to the range of body diameters of the primary predicate device K163634. The body diameter sizes for the subject device Deep Conical Inversa implants are substantially equivalent to the range of body diameters of the reference device K163360. The body shift design feature is not included in the primary predicate or identified reference devices: however, the combined max/min dimensions of platform and body for any design of the submission device is within the dimension of the identified predicates.
The platform diameter sizes for the subject device External Hex Inversa implants are substantially equivalent to the range of platform diameters of the primary predicate device K163634. The platform diameter size for the subject device Deep Conical Inversa implants is the same as a platform diameter size of the reference device K163360.
The implant lengths for the subject device External Hex Inversa the Deep Conical Inversa implants are substantially equivalent to the range of lengths of the primary predicate device K163634.
All subject device implants have the identical platform orientation (12° to the long axis of the implant) as the primary predicate device K163634.
The subject device External Hex Inversa implants have the identical implant-abutment connection as the primary predicate device K163634. The subject device Deep Conical Inversa implants have the identical implant-abutment connection as the reference device K163060.
All subject device implants have a thread design that includes a V-shaped design that is identical to the threads of the primary predicate device K163634. All subject device implants also have a square thread design (in the coronal aspect) that is substantially equivalent to the threads of the reference device K030463.
All subject device implants are manufactured from unalloyed titanium that is identical to the primary predicate device K163634. The surface treatment applied to the endosseous threads of the subject device implants also is identical to that cleared in the primary predicate device K163634.
The subject device implants are compatible with abutments and abutment screws cleared in the primary predicate K163436 and in the reference device K163060. The reference devices K003620. K053478. K070841, and K093562 are included in this summary to reference additional abutments and abutment screws that are compatible with the subject device.
The subject device and the predicate devices all incorporate the same materials and encompass similar ranges of dimensions. All subject device components are for single-patient, single-use, and all are provided sterile.
A comparison of the technological characteristics for the subject device, the primary predicate device, and the reference devices K163060 and K030463 is provided in the following table.
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| Comparison of Technological Characteristics | ||
|---|---|---|
| -- | --------------------------------------------- | -- |
| Comparison | Subject Device | Primary Predicate | Reference Device | Reference Device | |
|---|---|---|---|---|---|
| K181850Inversa ImplantsSouthern Implants (Pty) Ltd. | K163634External Hex ImplantsSouthern Implants (Pty) Ltd. | K163060Deep Conical (DC) Implants andAccessoriesSouthern Implants (Pty) Ltd. | K030463The Maestro System™7 mm & 10.5 Endosseous ImplantsBioHorizons Implant Systems, Inc. | ||
| Indications for UseStatement | Inversa Implants are intended forsurgical placement in the upper orlower jaw to provide a means forprosthetic attachment of crowns,bridges or overdentures utilizingdelayed or immediate loading.Inversa Implants are intended forimmediate function when goodprimary stability with appropriateocclusal loading is achieved. | Southern Implants' External HexImplants are intended for surgicalplacement in the upper or lowerjaw to provide a means forprosthetic attachment of crowns,bridges or overdentures utilizingdelayed or immediate loading.Southern Implants' External HexImplants are intended forimmediate function when goodprimary stability with appropriateocclusal loading is achieved. | Southern Implants Dental Implantsare intended for both one- and two-stage surgical procedures in thefollowing situations and with thefollowing clinical protocols:• replacing single and multiplemissing teeth in the mandibleand maxilla,• immediate placement inextraction sites and in situationswith a partially or completelyhealed alveolar ridge,• immediate loading in allindications, except in singletooth situations on implantsshorter than 8mm or in soft bone(type IV) where implant stabilitymay be difficult to obtain andimmediate loading may not beappropriate.The intended use for 3.0 DeepConical implants is limited toreplacement of maxillary lateralincisors and mandibular incisors. | The Maestro System™ endosseousimplants may be used in themandible and maxilla for use as anartificial root structure for singletooth replacement or as abutmentsfor fixed bridgework and dentalretention. | |
| Product Codes | DZE | DZE, NHA | DZE, NHA | DZE | |
| Implant Design | |||||
| Implant BodyDiameter (Ø), mm | 3.25, 3.75, 4.0, 4.7, 5.0,5.7, 6.0 | 3.0, 3.5, 4.0, 5.0 | 3.5, 4, 5 | ||
| Coronal Ø /Apical Ø (max) | Ex Hex | 3.5 / 4.53.5 / 5.04.2 / 5.0 | n/a | n/a | n/a |
| Coronal Ø /Apical Ø (max) | DeepConical | 3.6 / 4.53.6 / 5.04.0 / 5.0 | n/a | n/a | n/a |
| Implant Platform Ø,mm | Ex HexDeepConical | 3.45, 3.77, 4.073.1 | 3.43, 4.07, 5.0, 6.0 | 3.1, 3.5, 4.0, 5.0 | 3.5, 4, 5 |
| Implant Lengths, mm | Ex HexDeepConical | 11.5, 13, 15, 1811.5, 13, 15, 18 | 6, 7, 8.5, 10,11.5, 13, 15,18, 20 | 6, 8, 9, 11, 13, 15 | 7, 10.5 |
| Platform Incline | 12° | 0°, 12°, 24° | 0°, 12° | 0° | |
| Implant Interface | External HexInternal Conical | External Hex | Internal Conical | External Hex | |
| Thread design | Square and V-Shape | V-Shape | V-Shape | Square | |
| Material | Unalloyed Titanium | Unalloyed Titanium | Unalloyed Titanium | Unalloyed Titanium | |
| Surface | Grit Blasted | Grit Blasted | Grit Blasted | RBM HA |
CONCLUSION
The subject device and the primary predicate device and the reference devices have the same intended use, have similar technological characteristics, and are materials. The subject devices are packaged in materials and are sterilized using methods that are identical to the primary predicate device K163634. The data included in this submission demonstrate substantial equivalence to the primary predicate and reference devices listed above.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.