(463 days)
Not Found
No
The description focuses on CAD software for designing abutments based on scan data and pre-defined implant libraries, with no mention of AI or ML algorithms for design generation or analysis.
No
The device is a software for designing implant abutments, which are then manufactured by another entity. It aids in the restoration of chewing function, but it does not directly apply therapy to the patient.
No
The device is a design software for dental implant abutments, intended as an aid to restoration of chewing function, not for diagnosing a condition.
Yes
The device is described as "The 3Shape Abutment Designer™ Software" and its output is a digital file. While it runs on off-the-shelf PC hardware, the core medical device functionality is the software for designing abutments. The performance studies section also specifically mentions "Software, hardware, and integration verification and validation testing," indicating the software is the primary component being validated as a medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The 3Shape Abutment Designer Software is a CAD (Computer-Aided Design) software used to design patient-specific dental implant abutments based on scan data of teeth, impressions, or models. It does not analyze biological specimens from the human body.
- Intended Use: The intended use is to aid in the restoration of chewing function by designing a component of a dental implant. This is a mechanical/restorative function, not a diagnostic one based on analyzing biological samples.
- Input: The input is scan data of physical structures (teeth, impressions, models), not biological specimens.
Therefore, the 3Shape Abutment Designer Software falls under the category of a medical device, specifically a dental device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 3Shape Abutment Designer Software is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. The 3Shape Abutment Designer is intended for use by a dental practitioner or dental laboratory staff for designing the patient specific component of a two-piece, or hybrid dental implant abutment. The single or multi-unit abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
Product codes
PNP
Device Description
The 3Shape Abutment Designer™ Software receives scan data containing topographical characteristics of real teeth, dental impressions, or stone models. The software provides the user with the ability to create matching endosseous dental implant abutments using computer aided design.
The output of the device is a computer file containing the abutment(s) in digital form which can be used by manufacturers that hold an implant abutment 510(k) or are milling per the specific instructions provided by the holder of a 510(k) marketing clearance for a patient specific implant abutment. The 3Shape Abutment Designer Software output is restricted in the U.S. to be manufactured by a holder of an implant abutment 510(k) or milled per the specific instructions provided by the holder of a 510(k) marketing clearance for a patient specific implant abutment.
The 3Shape Abutment Designer™ Software can be run on properly configured "off-the-shelf" PC hardware running Microsoft® Windows and using a standard keyboard and mouse.
The 3Shape Abutment Designer™ Software requires the loading of implant libraries, which includes information such as implant type, maximum and minimum dimensional parameters for abutments, etc., created by separate abutment manufacturers and cleared by the FDA. In the US, the Implant Libraries are obtained via a 3Shape server after demonstration to 3Shape of the FDA clearance of the Implant Library.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scan data containing topographical characteristics of real teeth, dental impressions, or stone models.
Anatomical Site
Partially or fully edentulous mandibles and maxillae.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental practitioner or dental laboratory staff.
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
Prior to release, verification and validation testing of the 3Shape Abutment Designer™ Software has been completed using the approved acceptance criteria: Each user need has its own validation acceptance criteria; each specification has its own verification acceptance criteria; bug verification consists in ensuring issue is not reproducible; issues reported by beta partners must be reviewed and handled appropriately; beta partners must report functionality to be an improvement over previous version.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software, hardware, and integration verification and validation testing was performed in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Issued on May 11, 2005) as well as the FDA Guidance Document "Off-The-Shelf Software Use in Medical Devices (Issued on September 9, 1999).
The validation suite includes validation of implemented mitigations related to device hazards identified in the risk management procedures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6, 2016
3Shape A/S Hanne Nielsen Regulatory Affairs Manager Holmens Kanal 7 Copenhagen, 1060 DENMARK
Re: K151455
Trade/Device Name: 3Shape Abutment Designer™ Software Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: PNP Dated: January 8, 2016 Received: January 11, 2016
Dear Hanne Nielsen:
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.
1
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 (OS) 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 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,
Tina
Kiang -S
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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Indications for Use
510(k) Number (if known) K151455
Device Name
3Shape Abutment Designer™ Software
The 3Shape Abutment Designer Software is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. The 3Shape Abutment Designer is intended for use by a dental practitioner or dental laboratory staff for designing the patient specific component of a two-piece, or hybrid dental implant abutment. The single or multi-unit abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
| 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) |
| 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: | |
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| "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."
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510(K) SUMMARY - Traditional 510(K)
Submitter Information
| A Company Name: | 3Shape A/S | ||||
|---|---|---|---|---|---|
| B Company Address: | Holmens Kanal 7 | ||||
| DK-1060 Copenhagen K | |||||
| C Company Phone: | |||||
| Company Fax: | +45 7027 2620 | ||||
| +45 7027 2621 | |||||
| D Contact Person: | Hanne Nielsen | ||||
| Regulatory Affairs Manager | |||||
| E Date Summary Prepared: | June 28, 2016 | ||||
| Device Identification | |||||
| A Trade/proprietary Name: | 3Shape Abutment Designer™ | ||||
| Software | |||||
| B Common Name: | Abutment design software for dental | ||||
| laboratory | |||||
| C Device Classification Name: | Endosseous Dental Implant Abutment | ||||
| C Requlation Number: | 872.3630 | ||||
| C Classification: | Class II | ||||
| D Product Code: | PNP |
Predicate Device
Sirona Dental CAD/CAM System (K100152).
Intended Use
The 3Shape Abutment Designer Software is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. The 3Shape Abutment Designer Software is intended for use by a dental practitioner or dental laboratory staff for designing the patient specific component of a two-piece, one-piece or hybrid dental
4
implant abutment. The single or multi-unit abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
Device Description
The 3Shape Abutment Designer™ Software receives scan data containing topographical characteristics of real teeth, dental impressions, or stone models. The software provides the user with the ability to create matching endosseous dental implant abutments using computer aided design.
The output of the device is a computer file containing the abutment(s) in digital form which can be used by manufacturers that hold an implant abutment 510(k) or are milling per the specific instructions provided by the holder of a 510(k) marketing clearance for a patient specific implant abutment. The 3Shape Abutment Designer Software output is restricted in the U.S. to be manufactured by a holder of an implant abutment 510(k) or milled per the specific instructions provided by the holder of a 510(k) marketing clearance for a patient specific implant abutment.
The 3Shape Abutment Designer™ Software can be run on properly configured "off-the-shelf" PC hardware running Microsoft® Windows and using a standard keyboard and mouse.
The 3Shape Abutment Designer™ Software requires the loading of implant libraries, which includes information such as implant type, maximum and minimum dimensional parameters for abutments, etc., created by separate abutment manufacturers and cleared by the FDA. In the US, the Implant Libraries are obtained via a 3Shape server after demonstration to 3Shape of the FDA clearance of the Implant Library.
Summary of the technological characteristics
The 3Shape Abutment Designer™ is a software only device programmed in the Delphi programming language and has the following PC/laptop requirements and other technological characteristics as compared to the predicate device:
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| Item | Submission
Device Minimum
Requirements | Submission
Device
Recommended | Predicate Device |
|------------------------|----------------------------------------------|---------------------------------------|-------------------------------------------|
| OS | Windows 7 32-bit
Professional* | Windows 7 64-bit
Professional | Windows Vista 32- bit |
| RAM | 4GB | 8GB (16GB) | 6GB |
| Video Card | 512MB DirectX
10 (1GB DirectX
10) | 1GB DirectX 11
(2GB DirectX
11) | 512 MB DirectX 10
NVIDIA Quadro |
| Available
HDD Space | 250GB | 500GB (1TB) | 500GB |
| CPU | Intel Core i5
or equivalent | Intel Core i7
or equivalent | Intel Core i7 |
| Monitor
resolution | 1440 x 900 pixels | 1920 x 1080
pixels | Unknown |
| 3D Mouse | None | 3DConnexion
SpaceMouse™ | Unknown |
| Network | Internet connection | | Unknown |
| Ports | USB 2.0 port for 3Shape
desktop scanner | | Serial Port PCI card for inEOS
scanner |
| Mouse | Mouse with wheel button support | | Unknown |
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| Indications
for Use | The 3Shape Abutment Designer Software is
intended as an aid in the restoration of
chewing function in partially or fully
edentulous mandibles and maxillae. The
3Shape Abutment Designer Software is
intended for use by a dental practitioner or
dental laboratory staff for designing the
patient specific component of a two-piece,
one-piece or hybrid dental implant
abutment. The single or multi-unit
abutment design is intended to be used by
the manufacturer of an endosseous dental
implant abutment to create the final device. | The Sirona Dental CAD/CAM System
is intended for use in partially or fully
edentulous mandibles and maxillae in
support of single or multi-unti cement
retained restorations. The system
consists of three major parts:
TiBase, InCoris mesostructure, and
CAD/CAM software. Specifically, the
InCoris mesostructure and TiBase
components make up a two-piece
abutment which is used in
conjunction with endosseous dental
implants to restore the function and
asesthetics in the oral cavity. The
InCoris mesostructure may also be
used in conjunction with the CAMlog
Titanium base CAD/CAM (types
K2244.xxxx) (K083496) in the
Camlog Implant System. The
CAD/CAM software is intended to
design and fabricate the InCoris
mesostructure. The InCoris
mesostructure and TiBase two-piece
abutment is compatible with the
following implant systems: Nobel
Biocare Replace (K020646), Nobel
Biocare Branemark (K022562),
Friadent Xive (K013867), Biomet 3i
Osseotite (K980549), Astra Tech
Osseospeed (K091239), Zimmer
Tapered Screw-Vent (K061410), and
Straumann SynOcta (K061176). |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software
Output | Digital encrypted or non-encrypted
proprietary or .STL file including only the
patient-specific abutment component for
one-piece, two-piece, or hybrid abutment
designs. The digital output does not include
the abutment-to-implant connection
interface. | .STL file of the ceramic mesostrucutre
sent to Sirona Dental CAD/CAM
System milling unit |
| Physical -
Output | N/A – Submission device relies on separate
regulatory clearance and manufacture of the
abutment by a separate company | Two-piece Tibase abutment - pre-
milled titanium base combined with
ceramic mesostructure designed in
Sirona CAD/CAM software. |
| Milling
Location | Abutment Manufacturer or Dental laboratory
per the 510(k) clearance of the dental
abutment | Local milling of the ceramic abutment
component. |
The predicate Sirona device includes in the marketing clearance the twopiece TiBase Abutments (titanium bases and ceramic blocks) as a physical output as well as a validated milling unit and directions for assembly of the final dental abutment. The 3Shape Abutment Designer™ Software does not provide any physical parts that can come into contact with the patient. The 3Shape Abutment Designer Software instead provides only the digital design as an accessory to the physical dental abutment systems cleared by other manufacturers. The differences between the Indications for Use
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Statement of the submission device and the predicate are related to the lack of physical output from the submission device and reliance on previous or subsequent FDA clearance of the physical abutment by a separate manufacturer. However, the difference does not change the intended use of the device.
Nonclinical Testing
Software, hardware, and integration verification and validation testing was performed in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Issued on May 11, 2005) as well as the FDA Guidance Document "Off-The-Shelf Software Use in Medical Devices (Issued on September 9, 1999).
Prior to release, verification and validation testing of the 3Shape Abutment Designer™ Software has been completed using the approved acceptance criteria: Each user need has its own validation acceptance criteria; each specification has its own verification acceptance criteria; bug verification consists in ensuring issue is not reproducible; issues reported by beta partners must be reviewed and handled appropriately; beta partners must report functionality to be an improvement over previous version.
The validation suite includes validation of implemented mitigations related to device hazards identified in the risk management procedures.
Conclusion
Based on a comparison of intended use, principle of operations, features and technical data, and the verification/validation test results, the 3Shape Abutment Designer™ Software is found to be substantially equivalent with the Predicate Device.