(261 days)
No
The summary focuses on the physical characteristics of the dental implants and their surface treatment, with no mention of AI or ML.
Yes
The device is a dental implant system intended to provide support for dental restorations, which directly addresses a medical condition (missing teeth) and improves patient health and quality of life.
No
This device is a dental implant system intended for placement in the jaw to support restorations, which is a therapeutic function, not a diagnostic one.
No
The device is a dental implant system, which is a physical medical device made of titanium with a surface treatment. The submission describes hardware components, manufacturing processes, and physical testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for placement in the maxillary or mandibular arch to support dental restorations. This is a surgical implant procedure performed directly on a patient.
- Device Description: The description details the physical characteristics of dental implants made from titanium and a surface treatment.
- Performance Studies: The performance studies focus on the biological response to the implant material and surface treatment (wettability, cell differentiation, bone regeneration) and the physical properties of the implant (sterilization, shelf life, biocompatibility, fatigue testing, MR compatibility). These are all related to the device's function within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
Therefore, based on the provided information, the S.I.N. Dental Implant System is a medical device intended for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Unitite Slim, Unitite, Unitite Compact, Strong SW CM S.I.N Dental Implant System implants with lengths less than 7 mm are intended for delayed loading only.
Epikut CM, Epikut Plus CM, Epikut S, Epikut S Plus S.I.N. Dental Implant System implants with lengths of 18, 20, 22, or 24 mm may be tilted up to 30°. When used in the mandible or maxilla with implants with lengths of 18, 20, 22, or 24 mm at an angulation of 30°, a minimum of four implants must be used and must be splinted. When placed in the maxilla with lengths of 18, 20, 22, or 24 mm at angulations between 0° and less than 30°, the S.I.N. Dental Implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.
Epikut CM, Epikut Plus CM, Strong SW CM Plus, Strong SW HE Plus, Strong SW HI Plus All digitally-designed custom abutments for use with Interface CAD-CAM abutments are to be sent to a S.I.N.-validated milling center for manufacture.
Product codes
DZE
Device Description
The purpose of this submission is to add labeling claims for a surface treatment designated HA™® (HAnano), which is applied to implants of the S.I.N. Dental Implant System, as previously cleared in K170392, K193096, K200992, K211921, K221453, and K222231. The new labeling claims and the information supporting the claims are shown below in Performance Data.
The previously cleared implants that are the subject of this submission includes eleven (11) product lines from six (6) 510(k)s. Implant body diameters, platform diameters and lengths for each product line are shown below in Table 10.1 Summary of Subject Device Designs and Sizes.
K170392: Unitite Slim, Unitite, Unitite Compact
K193096: Strong SW CM Plus, Strong SW HE Plus, Strong SW HI Plus
K200992: Strong SW Plus
K211921: Epikut Plus CM, Epikut Plus HE
K221453: Epikut Plus CM (additional lengths)
K22231: Epikut S Plus
All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. The HA1000 surface treatment is identical to that cleared in K211921.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular arch
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)
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included: in vitro testing and animal testing referenced from published literature to support the labeling claims for HAmano included in the submission, as shown below:
- The HAnano surface increases the surface wettability.
- The HAnano surface is hydrophilic.
- In vitro studies using pre-osteoblast cells, evaluating the HAnano coating by assessment of cell signaling dynamics, have demonstrated a greater transition from adhesion/proliferative-related signaling to differentiation-related signaling compared to uncoated titanium, thus culminating in changes in osteogenic gene marker expression, which is important in bone regeneration processes.
- Cells grown on HAnano surfaces demonstrated a spreading morphology different than that of cells grown on machined surfaces.
- The HAnano Surface promotes osteoblast differentiation by significantly upregulating RUNX2 and ALP activity when pre-osteoblasts were grown directly on titanium discs.
- Osteoblasts were observed to have a morphology that spread across the HAnano surface differently than over a hydrophilic dual acid-etched surface (SLActive) in in vitro experiments.
Other non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included:
- gamma irradiation sterilization for all subject devices (to a sterility assurance level of 10-6) by selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2 (referenced from K211921);
- bacterial endotoxin testing (referenced from K211921) including Limulus amebocyte lysate (LAL) test according to ANSI/AAMI ST72 on samples of water used in manufacturing on a weekly basis and on samples from sterilized product on a quarterly basis to demonstrate all sterile product meets a limit of
§ 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.
0
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 and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
S.I.N. - Sistema de Implante Nacional S.A. % Floyd Larson President PaxMed International, LLC 12264 EL Camino Real, Suite 400 San Diego, California 92130
May 31, 2024
Re: K232821
Trade/Device Name: S.I.N. Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: Mav 8, 2024 Received: May 8, 2024
Dear Floyd Larson:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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,
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known)
Device Name
S.I.N. Dental Implant System
Indications for Use (Describe)
S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Unitite Slim, Unitite, Unitite Compact, Strong SW CM S.I.N Dental Implant System implants with lengths less than 7 mm are intended for delayed loading only.
Epikut CM, Epikut Plus CM, Epikut S, Epikut S Plus
S.I.N. Dental Implant System implants with lengths of 18, 20, 22, or 24 mm may be tilted up to 30°. When used in the mandible or maxilla with implants with lengths of 18, 20, 22, or 24 mm at an angulation of 30°, a minimum of four implants must be used and must be splinted. When placed in the maxilla with lengths of 18, 20, 22, or 24 mm at angulations between 0° and less than 30°, the S.I.N. Dental Implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.
Epikut CM, Epikut Plus CM, Strong SW CM Plus, Strong SW HE Plus, Strong SW HI Plus All digitally-designed custom abutments for use with Interface CAD-CAM abutments are to be sent to a S.I.N.-validated milling center for manufacture.
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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4
510(k) Summary K232821 S.I.N. - Sistema de Implante Nacional S.A. S.I.N Dental Implant System
May 22, 2024
ADMINISTRATIVE INFORMATION
| Manufacturer Name | S.I.N. - Sistema de Implante Nacional S.A.
Avenida Vereador Abel Ferreira, 2140
São Paulo, São Paulo
03340-000 Brazil
Telephone +55-11-21693000 ext 3236 | | | | | | | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|
| Official Contact | Denise Domiciano, Quality and Regulatory Manager | | | | | | | |
| Representative/Consultant | Floyd G. Larson, MS, MBA
Kevin A. Thomas, PhD
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130
Telephone +1 858-792-1235
Fax +1 858-792-1236
Email flarson@paxmed.com
kthomas@paxmed.com | | | | | | | |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | S.I.N. Dental Implant System |
|---|---|
| Common Names | Endosseous dental implant |
| Regulation Number | 21 CFR 872.3640 |
| Regulation Name | Endosseous dental implant |
| Regulatory Class | Class II |
| Product Code | DZE |
| Classification Panel | Dental |
| Reviewing Office | Office of Health Technology 1 |
| (Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices) | |
| Reviewing Division | Division of Health Technology 1 B (Dental Devices) |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K170392, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A.
Reference Devices
| K193096, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A |
|---|
| K200992, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A |
| K211921, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A |
| K221453, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A |
| K222231, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A |
5
INDICATIONS FOR USE STATEMENT
S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Unitite Slim, Unitite, Unitite Compact, Strong SW CM
S.I.N Dental Implant System implants with lengths less than 7 mm are intended for delayed loading only.
Epikut CM, Epikut Plus CM, Epikut S, Epikut S Plus
S.I.N. Dental Implant System implants with lengths of 18, 20, 22, or 24 mm may be tilted up to 30°. When used in the mandible or maxilla with implants with lengths of 18, 20, 22, or 24 mm at an angulation of 30°, a minimum of four implants must be used and must be splinted. When placed in the maxilla with lengths of 18, 20, 22, or 24 mm at angulations between 0° and less than 30°, the S.I.N. Dental Implant System implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.
Epikut CM, Epikut Plus CM, Strong SW CM Plus, Strong SW HE Plus, Strong SW HI Plus All digitally-designed custom abutments for use with Interface CAD-CAM abutments are to a S.I.N.-validated milling center for manufacture.
SUBJECT DEVICE DESCRIPTION
The purpose of this submission is to add labeling claims for a surface treatment designated HA™®, which is applied to implants of the S.I.N. Dental Implant System, as previously cleared in K170392. K193096. K200992, K211921, K221453, and K222231. The new labeling claims and the information supporting the claims are shown below in Performance Data.
The following information is a summary of the designs of the subject device implants, as they have been previously cleared with the HA"" surface treatment. Note that there are no changes to any aspect of the design, nor to the HA" surface treatment, as described in the respective 510(k) Premarket Notifications referenced above.
The previously cleared implants that are the subject of this submission includes eleven (11) product lines from six (6) 510(k)s. Implant body diameters, platform diameters and lengths for each product line are shown below in Table 10.1 Summary of Subject Device Designs and Sizes.
K170392: Unitite Slim, Unitite, Unitite Compact K193096: Strong SW CM Plus, Strong SW HE Plus, Strong SW HI Plus K200992: Strong SW Plus K211921: Epikut Plus CM, Epikut Plus HE K221453: Epikut Plus CM (additional lengths) K22231: Epikut S Plus
6
| 510k | Implant Line | Image
Not to
Scale | Body Ø,
mm | Platform
Ø,
mm | Length, mm | | | | | | |
|---------|-------------------|--------------------------|---------------|----------------------|------------|-----|------|------|----|----|--|
| | Unitite Slim | Image: Unitite Slim | 2.9 | 2.9 | | 10 | 11.5 | 13 | | | |
| K170392 | Unitite | Image: Unitite | 3.5 | 3.5 | 8.5 | 10 | 11.5 | 13 | 15 | | |
| | | Image: Unitite | 4.3 | 4.3 | 8.5 | 10 | 11.5 | 13 | 15 | | |
| | | Image: Unitite | 5.0 | 5.0 | 8.5 | 10 | 11.5 | 13 | 15 | | |
| | Unitite Compact | Image: Unitite Compact | 4.0 | 4.0 | 5 | 6 | 7 | | | | |
| | | Image: Unitite Compact | 5.0 | 5.0 | 5 | 6 | 7 | | | | |
| | | Image: Unitite Compact | 6.0 | 6.0 | 5 | 6 | 7 | | | | |
| K193096 | Strong SW CM Plus | Image: Strong SW CM Plus | 3.5 | 3.5 | 8.5 | 10 | 11.5 | 13 | 15 | | |
| | | Image: Strong SW CM Plus | 3.8 | 3.8 | 8.5 | 10 | 11.5 | 13 | 15 | | |
| | | Image: Strong SW CM Plus | 4.5 | 4.5 | 8.5 | 10 | 11.5 | 13 | 15 | | |
| | | Image: Strong SW CM Plus | 5.0 | 5.0 | 8.5 | 10 | 11.5 | 13 | 15 | | |
| | Strong SW HE Plus | Image: Strong SW HE Plus | 3.5 | 3.65 | 7 | 8.5 | 10 | 11.5 | 13 | 15 | |
| | | Image: Strong SW HE Plus | 3.75 | 4.1 | 7 | 8.5 | 10 | 11.5 | 13 | 15 | |
| | | Image: Strong SW HE Plus | 4.0 | 4.1 | 7 | 8.5 | 10 | 11.5 | 13 | 15 | |
| | | Image: Strong SW HE Plus | 4.5 | 4.5 | | 8.5 | 10 | 11.5 | 13 | 15 | |
| | | Image: Strong SW HE Plus | 5.0 | 5.0 | 7 | 8.5 | 10 | 11.5 | 13 | 15 | |
| | Strong SW HI Plus | Image: Strong SW HI Plus | 3.8 | 3.8 | | 8.5 | 10 | 11.5 | 13 | 15 | |
| | | Image: Strong SW HI Plus | 4.5 | 4.5 | | 8.5 | 10 | 11.5 | 13 | 15 | |
| | | Image: Strong SW HI Plus | 5.0 | 5.0 | | 8.5 | 10 | 11.5 | 13 | 15 | |
| K200992 | Strong SW Plus | Image: Strong SW Plus | 3.5 | 3.5 | | 8.5 | 10 | 11.5 | 13 | 15 | |
| | | Image: Strong SW Plus | 3.8 | 3.8 | | 8.5 | 10 | 11.5 | 13 | 15 | |
| | | Image: Strong SW Plus | 4.5 | 4.5 | | 8.5 | 10 | 11.5 | 13 | 15 | |
| | | Image: Strong SW Plus | 5.0 | 5.0 | | 8.5 | 10 | 11.5 | 13 | 15 | |
| K211921 | Epikut Plus CM | Image: Epikut Plus CM | 3.5 | 3.5 | | 8.5 | 10 | 11.5 | 13 | 15 | |
| | | | 3.8 | 3.8 | | 8.5 | 10 | 11.5 | 13 | 15 | |
| | | | 4.5 | 4.5 | | 8.5 | 10 | 11.5 | 13 | 15 | |
| | | Image: Epikut Plus CM | 5.0 | 5.0 | | 8.5 | 10 | 11.5 | 13 | 15 | |
| | Epikut Plus HE | Image: Epikut Plus HE | 3.5 | 3.65 | 7 | 8.5 | 10 | 11.5 | 13 | 15 | |
| | | Image: Epikut Plus HE | 4.5 | 4.5 | | 8.5 | 10 | 11.5 | 13 | 15 | |
| | | Image: Epikut Plus HE | 5.0 | 5.0 | 7 | 8.5 | 10 | 11.5 | 13 | 15 | |
Table 10.1 – Summary of Subject Device Designs and Sizes
7
| 510k | Implant Line | Image
Not to
Scale | Body Ø, mm | Platform Ø, mm | Len
gth, mm | | | | | | | | | | |
|---------|----------------|--------------------------|------------|----------------|----------------|-----|----|------|----|----|----|----|----|----|----|
| K221453 | Epikut Plus CM | Image: Epikut Plus CM | 3.8 | 3.8 | | | | | | | | 18 | 20 | 22 | 24 |
| | | | 4.0 | 4.0 | | | | | | | | 18 | 20 | 22 | 24 |
| | | | 4.5 | 4.5 | | | | | | | | 18 | 20 | 22 | 24 |
| K222231 | Epikut S Plus | Image: Epikut S Plus | 3.5 | 3.5 | | 8.5 | 10 | 11.5 | 13 | 15 | | | | | |
| | | | 3.8 | 3.8 | | 8.5 | 10 | 11.5 | 13 | 15 | 18 | 20 | 22 | 24 | |
| | | | 4.0 | 4.0 | | 8.5 | 10 | 11.5 | 13 | 15 | 18 | 20 | 22 | 24 | |
| | | | 4.5 | 4.5 | | 8.5 | 10 | 11.5 | 13 | 15 | 18 | 20 | 22 | 24 | |
| | | | 5.0 | 5.0 | | 8.5 | 10 | 11.5 | 13 | 15 | | | | | |
All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. The HA1000 surface treatment is identical to that cleared in K211921.
PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included: in vitro testing and animal testing referenced from published literature to support the labeling claims for HAmano included in the submission, as shown below:
| Labeling Claim | Reference** | Discussion |
|---|---|---|
| The HAnano surface increases the surface wettability.* | Bezerra, et al., | |
| 2017 | Page 6: Water contact angle was | |
| significantly less on HAnano treated | ||
| titanium surface than on dual acid- | ||
| etched titanium surface | ||
| The HAnano surface is hydrophilic.* | Bezerra, et al., | |
| 2017 | Page 6: Water contact angle was | |
| significantly less on HAnano treated | ||
| titanium surface than on dual acid- | ||
| etched titanium surface | ||
| In vitro studies using pre-osteoblast cells, evaluating the HAnano | ||
| coating by assessment of cell signaling dynamics, have demonstrated a | ||
| greater transition from adhesion/proliferative-related signaling to | ||
| differentiation-related signaling compared to uncoated titanium, thus | ||
| culminating in changes in osteogenic gene marker expression, which is | ||
| important in bone regeneration processes.* | Bezerra, et al., | |
| 2017 | Page 10, correcting name of surface | |
| (HAnano vs. Nano Hydroxyapatite- | ||
| Blasted) | ||
| Cells grown on HAnano surfaces demonstrated a spreading morphology | ||
| different than that of cells grown on machined surfaces.* | Bezerra, et al., | |
| 2017 | Page 4, Figure 2 caption, correcting | |
| name of surface | ||
| The HAnano Surface promotes osteoblast differentiation by significantly | ||
| upregulating RUNX2 and ALP activity when pre-osteoblasts were | ||
| grown directly on titanium discs.* | Bezerra, et al., | |
| 2017 | Page 10 | |
| Osteoblasts were observed to have a morphology that spread across the | ||
| HAnano surface differently than over a hydrophilic dual acid-etched | ||
| surface (SLActive) in in vitro experiments.* | da Silva, et al., | |
| 2020 | Page 7. "Firstly, our data shows there | |
| is a differential behavior of | ||
| osteoblasts adhering on both surfaces; | ||
| osteoblast spreads better over | ||
| HAnano®, while osteoblast on | ||
| SLActive presented a fusiform | ||
| morphology." |
*Results of in vitro testing are not necessarily predictive of human clinical performance.
8
** References
Bezerra F, Ferreira MR, Fontes GN, da Costa Fernandes CJ, Andia DC, Cruz NC, da Silva RA, Zambuzzi WF. Nano hydroxyapatite-blasted titanium surface affects pre-osteoblast morphology by modulating critical intracellular pathways. Biotechnol Bioeng. 2017 Aug;114(8):1888-1898.
da Silva RA, da Silva Feltran G, Ferreira MR, Wood PF, Bezerra F, Zambuzzi WF. The Impact of Bioactive Surfaces in the Early Stages of Osseointegration: An In Vitro Comparative Study Evaluating the HAnano® and SLActive® Super Hydrophilic Surfaces. Biomed Res Int. 2020 Sep 13.
Other non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included:
- · gamma irradiation sterilization for all subject devices (to a sterility assurance level of 10 % by selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2 (referenced from K211921);
- bacterial endotoxin testing (referenced from K211921) including Limulus amebocyte lysate (LAL) test according to ANSI/AAMI ST72 on samples of water used in manufacturing on a weekly basis and on samples from sterilized product on a quarterly basis to demonstrate all sterile product meets a limit of