(154 days)
Not Found
Not Found
No
The description focuses on CAD/CAM technology for milling patient-specific bars based on scans, which is a standard digital manufacturing process and does not explicitly mention or imply the use of AI/ML for design or analysis.
Yes
The device is described as supporting a prosthetic device in a patient, indicating it provides a therapeutic benefit by aiding in the restoration of dental function.
No
The device is described as an accessory to dental implants to support a prosthetic device. Its description details a manufacturing process based on patient impressions, not a diagnostic function.
No
The device description explicitly states the bars are "milled from either titanium alloy or CP titanium," indicating a physical hardware component. While CAD/CAM software is used in the design process, the final product is a physical medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to support a prosthetic device in a patient using dental implants. This is a direct clinical application within the body, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The device is a physical bar milled from titanium, designed to be implanted or attached to implants in the patient's mouth.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The 3i Patient-Specific CAM StructSURE® Precision Milled Bars are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient.
Product codes (comma separated list FDA assigned to the subject device)
CSDXX, CSPXX, CSHXX, CSHYXX, CSCMXX, NHA
Device Description
All CAM StructSURE® Precision Milled Bars (Dolder, Primary, Hader, Hybrid and Copy Milled) are designed to match an individual patient. The bars are designed from a three-dimensional optical and/or digital scanner system that scans the casting of a patient's impression and then machined using a CAD/CAM software system. The bars are milled from either titanium alloy or CP titanium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical and/or digital scanner system
Anatomical Site
Dental implants in a partially or edentulous patient.
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)
Validation performed on scanning equipment and software to ensure accuracy of scanning 3D models and performed Install Qualification.
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.
Not Found
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
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
0
BIOMET 3i Special 510(k) Premarket Notification – BIOMET 3i Patient Specific CAM StructSURE Bars
510(k) SUMMARY
NOV - 8 2010
BIOMET 3i - CAM StructSURE Overdenture Bars
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92
| Submitter: | BIOMET 3i |
|---|---|
| Address: | 4555 Riverside Drive |
| Palm Beach Gardens, FL 33410 | |
| Establishment Registration | |
| Number: | 1038806 |
| Contact Person: | Jose E. Cabrera |
| Telephone/Fax/Email: | Phone: 561-776-6840 |
| Fax: 561-514-6316 | |
| Jose.cabrera@biomet.com | |
| Date Prepared: | June 3, 2010 |
| Trade/Proprietary Name: | CAM StructSURE Precision Milled Bars |
| Common/Usual Name: | Overdenture Bars |
| Classification Name: | Endosseous Dental Abutments |
| Device Classification: | 872.3630 |
| Predicate Device(s) : | BIOMET 3i - PSR Overdenture Bar |
| BIOMET 3i - CAM StructSURE Overdenture Bar | |
| Product Codes: | |
| CSDXX | |
| CSPXX | |
| CSHXX | |
| CSHYXX | |
| CSCMXX | |
| bars-are-designed-from-a-three-dimensional-optical- | |
| and/or digital scanner system that scans the casting | |
| of a patient's impression and then machined using a | |
| CAD/CAM software system. The bars are milled | |
| from either titanium alloy or CP titanium. | |
| Purpose of Special 510(k): | BIOMET 3i Patient-Specific CAM StructSURE® |
| Precision Milled Bars are currently scanned and | |
| designed with CAD/CAM Delcam and 3Shape | |
| scanners and software - BIOMET 3i intends to use | |
| Renishaw's scanning, design and milling system | |
| which is compatible with currently cleared BIOMET | |
| 3i Patient-Specific CAM StructSURE® Precision | |
| Milled Bars. | |
| Intended Use: | The 3i Patient-Specific CAM StructSURE® |
| Precision Milled Bars are intended for use as an | |
| accessory to endosseous dental implants to support a | |
| prosthetic device in a partially or edentulous patient. | |
| Nonclinical Performance Data: | Validation performed on scanning equipment and |
| software to ensure accuracy of scanning 3D models | |
| and performed Install Qualification. | |
| Clinical Data: | N/A |
| Substantial Equivalence: | The BIOMET 3i Patient-Specific CAM StructSURE |
| Overdenture Bars have the same intended use and | |
| indications, principles of operation, and | |
| technological characteristics as BIOMET 3i Patient- | |
| Specific CAM StructSURE Overdenture Bars. The | |
| difference in scanning and milling do not raise any | |
| new questions of safety or effectiveness. Validation | |
| data demonstrates that the modified process results | |
| in a finished device that is as safe and effective as | |
| BIOMET 31 's Patient-Specific CAM StructSURE | |
| Overdenture Bars that are currently cleared with | |
| previous scanner systems. Thus, the BIOMET 3i | |
| Patient-Specific CAM StructSURE Overdenture | |
| Bars are substantially equivalent to its predicate | |
| devices. |
Device Description:
All CAM StructSURE® Precision Milled Bars (Dolder, Primary, Hader, Hybrid and Copy Milled) are designed to match an individual patient. The
1
BIOMET 3i Special 510(k) Premarket Notification – BIOMET 3i Patient Specific CAM StructSURE Bars
: :
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Jose E. Cabrera Senior Manager, Regulatory Affairs BIOMET 3i, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
NOV - 8 2010
Re: K101582
Trade/Device Name: BIOMET 3i Patient Specific CAM StructSURE Bars Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 14, 2010 Received: October 15, 2010
Dear Mr. Cabrera:
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.
3
Page 2- Mr. Cabrera
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/ucm115809.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 tollofmen number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/dofault.htm.
Sincerely yours.
Nh 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
4
BIOMET 3i Special 510(k) Premarket Notification - BIOMET 3i Patient Specific CAM StructSURE Bars
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
NOV - 8 2010
Device Name:
BIOMET 3i Patient Specific CAM StructSURE Bars
Indications for Use:
The 3i Patient-Specific CAM StructSURE Overdenture Bars are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | Over-The-Counter Use |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation Anesthesiology, General Hospital Infection Control, Dental Devices
| 16 | 510(k) Number: K101582 |
|---|---|
| ---- | ------------------------ |