(406 days)
No
The summary describes a dental implant and its physical characteristics, materials, and intended use. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
No
The device is an implant for dental prostheses, which is a structural component and not described as providing therapy for a disease or condition.
No
The device description and intended use indicate that the I Macro Implant system is an implantable medical device used for dental prostheses, not for diagnosing conditions.
No
The device description clearly states it is a physical implant (threaded screws made of Titanium Alloy) and describes its dimensions and surface treatment. It also mentions fatigue and biocompatibility testing, which are relevant to hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the I Macro Implant system is a physical implant intended for surgical placement in the jawbone to support dental prostheses. It is a device that is surgically implanted into the body, not used to test samples from the body.
The information provided focuses on the physical characteristics of the implant, its surgical placement, and its function in supporting dental restorations. This aligns with the definition of a medical device used for treatment or restoration, not for diagnostic testing.
N/A
Intended Use / Indications for Use
The I Macro Implant system is intended for implantation in the mandibular molar region where bone exists and the surgeon has determined that placement of a narrower diameter implant would increase the chance of failure due to poor primary stability, or increased surgical procedures leading to complications. This I Macro implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or complete arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with proper occlusal loading, to restore the chewing function.
Product codes
DZE
Device Description
The I Macro implants are self-tapping; commercially pure; Titanium Alloy threaded screws, with light grit blasting or roughened surface treatment. These materials and procedures are exactly the same as cleared in the OCO Biomedical submission K090174. The I Macro Implant is available in a 6.0, 7.0, 8.0 & 9.0mm diameter and is available in 8, 10, and 12mm lengths.
Titanium Chemical Compositions:
6AL/4V ELI Carbon - 0.08% Vanadium - 3.5%-4.5% Nitrogen - 0.05% Aluminum - 5.5%-6.5% Oxygen - 0.013 Hydrogen - 0.015% Iron - 0.25% Titanium -- Balance
The compatible abutments for the I Macro Implants where cleared under 510 K090174. Abutment Unit Numbers:
- . 4 CB 5.5 TSI
- 4 IOT 0 TSI .
- 4100 TSI .
- 5150 TSI
- 4200 TSI .
- 5250 TSI .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular molar region
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
Fatigue testing was conducted according to ISO 14801, biocompatibility testing was conducted according to ISO 10993-5 and ISO 10993-1 and SEM analysis of the implant surface after RBM blasting and acid etching.
Key Metrics
Not Found
Predicate Device(s)
K033392, K023336, K090174, K081302, K061319, K071161
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
MAR 1 6 2012
Contact Person:
David D. Dalise President/ Owner OCO Biomedical, Inc. 8500 Washington St. N.E., Suite A-1 Albuquerque, NM 87113 Phone: (505) 293-0025
Trade Name: I Macro Implant System Common Name: Dental Implant Classification Name: Dental Implant Endosseous, Root-Form
Substantial Equivalence to:
Immediate Stabilizing Implant (ISI) OCO 5.0mm Taper Implant OCO Biomedical TSI & ERI Mega Gen Implant Direct Southern Implants
K033392 (Cleared 12/11/03) K023336 (Cleared 10/9/02) K090174 (Cleared 9/14/09) K081302 (Cleared 8/15/08) K061319 (Cleared 9/29/06) K071161 (Cleared 11/16/07)
Description of Device:
The I Macro implants are self-tapping; commercially pure; Titanium Alloy threaded screws, with light grit blasting or roughened surface treatment. These materials and procedures are exactly the same as cleared in the OCO Biomedical submission K090174. The I Macro Implant is available in a 6.0, 7.0, 8.0 & 9.0mm diameter and is available in 8, 10, and 12mm lengths.
Titanium Chemical Compositions:
6AL/4V ELI Carbon - 0.08% Vanadium - 3.5%-4.5% Nitrogen - 0.05% Aluminum - 5.5%-6.5% Oxygen - 0.013 Hydrogen - 0.015% Iron - 0.25% Titanium -- Balance
1
The compatible abutments for the I Macro Implants where cleared under 510 K090174. Abutment Unit Numbers:
- . 4 CB 5.5 TSI
- 4 IOT 0 TSI .
- 4100 TSI .
- 5150 TSI �
- 4200 TSI .
- 5250 TSI .
(Please see Abutment Attachment)
Indications for Use:
The I Macro Implant system is intended for implantation in the mandibular molar region where bone exists and the surgeon has determined that placement of a narrower diameter implant would increase the chance of failure due to poor primary stability, or increased surgical procedures leading to complications. This I Macro implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or complete arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with proper occlusal loading, to restore the chewing function.
Substantial Equivalence:
OCO Biomedical, Inc. has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the I Macro Implants are substantially equivalent in indications and design principles to predicate devices previously cleared by the FDA: Immediate Stabilizing Implant (ISI) K033392 (Cleared 12/11/03), OCO Biomedical 5.0mm Taper Implant K023336 (Cleared 10/9/02). Mega Gen K081302 (Cleared 8/15/2008),OCO Biomedical TSI ERI K090174 (Cleared 9/14/09), Implant Direct K061319 (Cleared 9/29/06) and Southern Implants K071161 (Cleared 11/16/07).
The I Macro Implant has the following similarities to the predicate devices:
- -has the same intended use
- -incorporates the same materials and design
- -is packaged and sterilized using the same materials and processes
Summary of Technological Comparison:
The fundamental scientific technology of the device is identical or very similar to referenced predicate devices. including materials, processing, packaging, and sterilization methods. See comparison table in the Executive Summary section of this application.
2
Fatigue testing was conducted according to ISO 14801, biocompatibility testing was conducted according to ISO 10993-5 and ISO 10993-1 and SEM analysis of the implant surface after RBM blasting and acid etching.
Conclusion:
OCO Biomedical, Inc. has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the I Macro Implants are substantially equivalent in indications and design principles to predicate devices previously cleared by the FDA.
Standards to which OCO Biomedical claims compliance:
- ISO 14801:2007, Dentistry Implants Dynamic fatigue test for endosseous dental implants
- ・ ISO 14971:2007, Medical devices - Application of risk management to medical devices
- ISO 10993-1:2009, Biological evaluation of medical devices part 1: evaluation and testing
- ISO 868-5:2009, Packaging materials and systems for medical devices which are to be sterilized; Part 5: Self-sealable pouches and reels of paper and plastic film construction; Requirements and test methods
- -ISO 11607-1:2009. Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- -ISO 11607-2:2006, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
- -ASTM F 1980:2007, Standard guide for accelerated aging of sterile medical device packages
- -ISO 11137-1:2006, Sterilization of health care products - Radiation Part 1: Requirements for development, validation, routine control of a sterilization process for medical devices.
- -ISO 11137-2:2007, Sterilization of health care products - Radiation Part 2: Establishing the sterilization dose.
- ISO 17665-1:2006 Sterilization of health care products Moist heat Part 1: -Requirements for the development, validation and routine control of a sterilization process for medical devices.
-
- ISO 1041:2008, Information supplied by the manufacturer with medical devices
- -ISO 980:2008, Graphical symbols for use in the labelling of medical devices
- -ISO 15223:2007. Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied
- ISO 14155-1:2003. Clinical investigation of medical devices for human subjects --Part 1: General requirements
- ISO 1041:2008 Information supplied by the manufacturer of medical devices -
3
- ISO 11137-3 Sterilization of health care products Radiation -
- ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- -ISO 10993-5:2009 Biological evaluation of medical devices
- -ISO 10993-5:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- -ISO 10993-11:2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
- -ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
- ISO 11607 Packaging for Terminally Sterilized Medical Devices -
- EN 868-5:2009 Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous and plastic film construction. Requirements and test methods
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle faces left and appears to be in flight. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
MAR 1 6 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Mr. Jack Bloom Regulatory Manager OCO Biomedical 8500 Washington Street, NE Suite A-1 Albuquerque, New Mexico 87113
Re: K110337
Trade/Device Name: I Macro Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: March 10, 2012 Received: March 12, 2012
Dear Mr Bloom:
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.
5
Page 2 - Mr. Bloom
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number: K110337
Device Name: I Macro Implant System
Indications for use:
The I Macro Implant system is intended for implantation in the mandibular molar region where bone exists and the surgeon has determined that placement of a narrower diameter implant would increase the chance of failure due to poor primary stability, or increased surgical procedures leading to complications. This I Macro implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or complete arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with proper occlusal loading, to restore the chewing function.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
hn
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anest Dested Devices Division Control, Dental Devices
510(k) Number. K110337