(181 days)
Not Found
No
The description focuses on the physical components and materials of the osseointegrated fixtures and their accessories, with no mention of AI or ML capabilities.
Yes
The device is described as an "Osseointegrated Fixtures" system that provides "bone anchorage for the prosthetic attachment" to restore a "physical defect". This indicates a therapeutic function of replacing or restoring a missing body part or function.
No
The device is an implantable fixture used for prosthetic attachment, providing bone anchorage. It is not used to diagnose a medical condition or disease.
No
The device description explicitly states it involves physical components like endosseous implants, drills, abutments, and instruments, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the attachment of an external prosthesis for the restoration of a physical defect, providing bone anchorage for prosthetic attachment in the maxillo-craniofacial region. This is a surgical implant used directly in the body.
- Device Description: The device is described as a system involving endosseous implants and accessories like drills, abutments, and placement tools. These are all components used in a surgical procedure.
- 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, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is implanted inside the body for structural support and prosthetic attachment.
N/A
Intended Use / Indications for Use
Southern Implants Osseointegrated Fixtures are indicated for the attachment of an external on prosthesis for the restoration of a physical defect when other means of attachment are inadequate. The endosseous implant provides the bone anchorage for the prosthetic attachment. These devices are in the maxillo-craniofacial region (including ear, nose and eye).
Product codes (comma separated list FDA assigned to the subject device)
FZE
Device Description
The device 'Osseointegrated Fixtures' refers to a system involving endosseous implants and their accessories. The endosseous implants are solid, screw-type, self-tapping implants made from commercially pure titanium, with the same enhanced surface as the Southern Implants dental implants. The accessories include drills to prepare the site, abutments and attachments to aid the prosthetic retention, placement tools, instruments and laboratory components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillo-craniofacial region (including ear, nose and eye)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K020617, K003620, K090630, K990458
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.3680 Nose prosthesis.
(a)
Identification. A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a series of lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 1, 2016
Southern Implants % Ms. Yolanda Smith Smith Associates 1468 Harwell Ave Crofton, Maryland 21114
Re: K161548
Trade/Device Name: Osseointegrated Fixtures Regulation Number: 21 CFR 878.3680 Regulation Name: Nose Prosthesis Regulatory Class: Class II Product Code: FZE Dated: November 1, 2016 Received: June 3, 2016
Dear Ms. Smith:
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161548
Device Name Osseointegrated Fixtures
Indications for Use (Describe)
Southern Implants Osseointegrated Fixtures are indicated for the attachment of an external on prosthesis for the restoration of a physical defect when other means of attachment are inadequate. The endosseous implant provides the bone anchorage for the prosthetic attachment. These devices are in the maxillo-craniofacial region (including ear, nose and eye).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CER 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
P.O. Box 605 Irene 0062 South Africa Tel: +27 12 667 1046 Fax: +27 12 667 1029
Osseointeqrated Fixtures 510(k) Application
SECTION 5 - 510(k) Summary
Submitter
Southern Implants (Pty) Ltd. 1 Albert Road Irene 0062 South Africa Tel: +27 12 667 1046 Fax: +27 12 667 1029
Contact person
Miss Lauranda Breytenbach +27 12 667 1046 Lauranda.B@southernimplants.com
Date prepared: December 1, 2016
Name of the device
| Trade name: | Osseointegrated Fixtures |
|---|---|
| Common name: | Implants for prosthetic retention External |
| Classification name: | Nose prosthesis |
| Regulation Number: | 21 CFR 878.3680 |
| Product Code: | FZE |
| Device Class: | Class II |
Legally marketed devices to which equivalence is claimed (predicate devices)
| Manufacturer | Device Name | K Number |
|---|---|---|
| NSI, Inc. | ||
| (Manufactured by Southern | ||
| Implants) | NSI Hexed and Non-Hexed Implant System | K020617 |
| NSI, Inc. | ||
| (Manufactured by Southern | ||
| Implants) | NSI Hexed and Non-Hexed Implant System | K003620 |
| Nobel Biocare | Nobel Biocare Endosseous Implants | |
| (Maxillofacial Indications) | K090630 | |
| Straumann USA | Straumann Extraoral Implant System | K990458 |
Device Description
The device 'Osseointegrated Fixtures' refers to a system involving endosseous implants and their accessories. The endosseous implants are solid, screw-type, self-tapping implants made from commercially pure titanium, with the same enhanced surface as the Southern Implants dental implants. The accessories include drills to prepare the site, abutments and attachments to aid the prosthetic retention, placement tools, instruments and laboratory components.
Indications for Use
Southern Implants Osseointegrated Fixtures is indicated for the attachment of an external aesthetic restoration prosthesis for the restoration of a physical defect when other means of attachment are inadequate. The endosseous implant provides the bone anchorage for the prosthetic attachment. These devices are indicated for use in the maxillo-craniofacial region (including ear, nose and eye).
4
K161548 P.O. Box 605 South Africa Tel. +27 12 667 1046 Fax: +27 12 667 1029
Osseointearated Fixtures 510(k) Application
SECTION 5 - 510(k) Summary
Intended use
The implants are placed in bone and are intended to osseointegrate to provide an attachment for an external aesthetic restoration prosthesis. The device provides a solution for the prosthetic restoration of a cosmetic defect when other means (such as adhesives or suction) are inadequate to retain the prosthesis.
COMPARISON OF TECHNICAL CHARACTERISTICS
Substantial equivalence
This device and the predicates are all used in the same way: they are screwed into bone where they are intended to osseointegrate to provide an attachment for a prosthesis. The material for all implants is titanium and the operating principle which is primary fixation by means of an external thread, and permanent fixation by osseointegration are the same. Torque for placement is transferred through the connection interface in the implants. Osseointegration is enhanced by means of a moderately rough titanium surface
In comparison to predicates NSI Hexed and Non-Hexed Implant System (K020617 & K003620) are indicated for the attachment of dental prosthetics, and the Southern Implants Osseointegrated Fixtures are used to attach extraoral cosmetic prosthetics. Thus, it will not be subject to the kind of loads experienced by dental implants. Additionally, the extraoral environment is typically biologically cleaner than the oral environment.
The Nobel Biocare Endosseous Implants (Maxillofacial Indications) (K090630) and Straumann Extraoral Implant System are indicated for the attachment of an external aesthetic restoration prosthesis in the maxillofacial region. In comparison, the use of the Southern Implants Osseointegrated Fixtures is not restricted to the craniofacial region. However, its use remains the same, for the mechanical retention of a cosmetic prosthesis. This device enables other external aesthetic prosthetic restorations which would benefit from the availability of bone-anchorage in the same way as maxillofacial/craniofacial prostheses do.
After safety and testing was performed, Southern Implants has concluded that the device does not introduce any significant questions of safety and is substantially equivalent to the predicate devices.
| Standard | Standard Title |
|---|---|
| ISO 11137-1 | Sterilization of Health Care Products – Radiation – Part 1: Requirements for |
| Development, Validation & Routine Control of a Sterilization Process for Medical | |
| Devices | |
| ISO 11137-2 | Sterilization of Health Care Products – Radiation – Part 1: Establishing the Sterilization |
| Dose | |
| ISO 11737-1 | Sterilization of Medical Devices – Microbiological Methods – Part 1: Estimation of |
| Population of Microorganisms on Products | |
| ISO 11737-2 | Sterilization of medical devices - Microbiological Methods - Part 2: Tests of Sterility |
| Performed | |
| in the Validation of a Sterilization Process | |
| EN 556-1 | Sterilization of Medical Devices - Requirements for Medical Devices to be designated |
Safety Testing
5
K161548 P.O. Box 605 Irene 0062 South Africa Tel: +27 12 667 1046
Fax: +27 12 667 1029
Osseointegrated Fixtures 510(k) Application
SECTION 5 - 510(k) Summary
| SECTION 5 – 510(k) Summary | |
|---|---|
| "STERILE" - Part 1: Requirements for Terminally Sterilized Medical Devices | |
| ISO 10993-1 | Biological evaluation of medical devices- part 1: Evaluation and testing within a risk |
| management process | |
| ISO 14971 | Medical Devices - Application of Risk Management to Medical Devices |
| ISO 10993-5 | Biological evaluation of medical devices – Part 5; Tests for in vitro cytotoxicity |
| ISO 10993-18 | Biological evaluation of medical devices – Part 18: Chemical characterization of |
| materials. | |
| ISO 11607-1 | Packaging for terminally sterilized medical devices - part 1: requirements for materials, |
| sterile barrier systems and packaging systems [including: amendment 1 | |
| (2014)]. (Sterility) | |
| ISO 11607-2 | Packaging for terminally sterilized medical devices - part 2: validation requirements for |
| forming, sealing and assembly processes [including: amendment 1 (2014)]. (Sterility) | |
| ASTM D4169-14 | Standard practice for performance testing of shipping containers and systems. (Sterility) |
| ASTM F1929-12 | Standard test method for detecting seal leaks in porous medical packaging by dye |
| penetration. (Sterility) | |
| ASTM | |
| F88/F88M-09 | Standard test method for seal strength of flexible barrier materials. (Sterility) |
| ASTM F1980-07 | Standard guide for accelerated aging of sterile barrier systems for medical |
| devices. (Sterility) | |
| ISO 5832- | |
| 3:1996 | Implants for surgery -- metallic materials -- part 3: wrought titanium 6-aluminium 4- |
| vanadium alloy. (Materials) | |
| ASTM F136-13 | Standard specification for wrought titanium-6 aluminum-4 vanadium ELI (extra low |
| interstitial) alloy for surgical implant applications (Uns R56401). (Materials) | |
| ASTM F67-13 | Standard specification for unalloyed titanium for surgical implant applications (Uns |
| R50250, Uns R50400, Uns R50550, Uns R50700). (Materials) | |
| IEC 62366-1 | Medical devices - part 1: application of usability engineering to medical |
| devices. (General I (QS/RM)) | |
| ISO 14644-1 | Cleanrooms and associated controlled environments - part 1: classification of air |
| cleanliness. (Sterility) | |
| ISO 15223-1 | Medical devices - symbols to be used with medical device labels, labelling, and |
| information to be supplied - part 1: general requirements. (General I (QS/RM)) | |
| BS EN 1041 | Information supplied by the manufacturer of medical devices |
| ASTM E899-12h | Standard Specification for Wrought Stainless Steels for Surgical Instruments |
CONCLUSION
The technological characteristics of this device and its predicates are substantially equivalent. They are all composed of commercially pure titanium, with a moderately rough surface for osseointegration. They are all self-tapping, screw-type implants. They all have similar systems of drills, abutments, placement tools and prosthetic aids. After safety testing was performed, Southern Implants has concluded that the device does not introduce any significant questions of safety and is substantially equivalent to the predicate devices.