(46 days)
Not Found
No
The document describes image segmentation and planning software but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.
No.
The device is described as software for planning dental implant placement and does not directly treat or diagnose a disease or condition. It is an aid to dental practitioners, providing information rather than performing a therapeutic function.
No
Explanation: The device is planning software for dental implant placement, aiding practitioners in locating implants and providing information, but it explicitly states it "does not make any clinical decisions for the user." This indicates it is an aid for planning purposes rather than a diagnostic tool that identifies diseases or conditions.
Yes
The device is described as a "computer program (software)" and is supplied on a "disk-on-key". While it interacts with a CT scanner for input, the device itself is the software for processing and planning, not the CT scanner hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Implant Location Software (ILS) is described as a software interface and image segmentation system that uses CT scan images (which are in vivo - from within the living body) to plan dental implant placement. It aids in visualizing and planning, not in analyzing biological samples.
- Intended Use: The intended use is for planning dental implant placement based on imaging data, not for diagnosing a condition from a biological sample.
The software is a medical device, specifically a medical image processing and planning software, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Implant Location Software (ILS) is indicated for use by medically trained people as a software interface and image segmentation system for the transfer of imaging information from a CT scanner and as planning software for dental implant placement.
Product codes
LLZ
Device Description
The Implant Location Software is a computer program (software) intended for use as an aid to the dental practitioners in the location of dental implants. The system provides information but does not make any clinical decisions for the user. The software is supplied on disk-on-key. The Implant location Software is designed to use images acquired from [The Implant Totation Boleval scanners], present a graphical image of the planned implants as "virtual implants" on the CT images using DICOM interface miplands, provide a summary report that gives planning information for the standards, provided buser to consult on-line views of the plan during operation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanner
Anatomical Site
Dental
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medically trained people / dental practitioners
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
K05034|
MAR 2 9 2005
Image /page/0/Picture/2 description: The image shows the logo for Tactile Technologies. The logo consists of the letters "tt" in a stylized font, with the letters overlapping each other. The letters are white and are set against a black square with rounded corners. To the right of the logo is the text "Tactile Technologies" in a simple, sans-serif font.
10 Plaut Str., Rabin Scientific Park Rehovot 76122, ISRAEL Tel: 08-9484740
510(k) Summary:
Implant Location Software (ILS)
Company Name:
Tactile Technologies Ltd.
Contact Person: Zvika Slovin, Ph.D. CEO
Telephone: +972-8-948-4740. +972-8-948-4772 Fax:
Authorized US Agent:
Rosemarie Traverse, 27030 Agoura Road, Suite 110 Calabasas, CA 91301
Phone: (818) 444-3323 Fax: (818) 444-3403 E-mail: rtraverse@paragonimplant.com
Date prepared: February 7, 2005
Trade Name: Implant Location Software.
Classification name: Picture archiving and communications system
Class: II
Panel identification: Radiology devices
Product code: LLZ
1
10 Plaut Str., Rabin Scientific Park Rehovot 76122, ISRAEL Tel: 08-9484740
Tactile Technologies
Regulation number: 892.2050
Predicate Device: SimPlant System, Materialise N.V, Belgium cleared under 510(k) no. K033849
Device description:
The Implant Location Software is a computer program (software) intended for use as an aid to the dental practitioners in the location of dental implants. The use as an all to the demal practitioners through the process through the process of Information bystem (120) gaan surgery. The system provides information but does not make any clinical decisions for the user.
The software is supplied on disk-on-key.
The Implant location Software is designed to use images acquired from The Implant Totation Boleval scanners, present a graphical image of the planned implants as "virtual implants" on the CT images using DICOM interface miplands, provide a summary report that gives planning information for the standards, provided buser to consult on-line views of the plan during operation.
Indications for Use:
The Implant Location Software (ILS) is indicated for use by medically trained people as a software interface and image segmentation system for the transfer of imaging information from a CT scanner and as planning software for dental implant placement.
Substantial Equivalence:
The Implant Location Software has the same intended use and the same principle of operation as the SimPlant System, Materialise N.V Belgium, cleared under 510(k) no. K033849 and is therefore substantially equivalent to that device.
2
Conclusion:
The evaluation of the Implant Location Software does not raise any additional The evaluation of the Implant Location Soltware association of therefore be considered concerns regarding sant to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2005
Zvika Slovin, Ph.D. CEO Tactile Technologies 10 Plaut Str., Rabin Scientific Park Rehovot 76122 ISRAEL
Re: K050341 Trade/Device Name: Implant Location Software (ILS) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 7, 2005 Received: February 11, 2005
Dear Dr. Slovin:
We have reviewed your Section 510(k) premarket notification of intent to maket the device in We have reviewed your Section 710(x) premarities indications for use stated in
above and have determined the device is substantially equivalent (for the subscripe microsos mi above and have decemined the de needicate devices marketed in interstate commerce prior to the enclosure) to regally marketed predical Device Amendments, or to devices that have been May 28, 1978, the ellacinem and of the Hearea. be Federal Food, Drug, and Cosmetic Act (Act) that feciassified in accordatice win the provile approval application (PMA). You may, therefore, market the do not require approval of a premance approvisions of the Act. The general controls provisions of the Act device, subject to the general connois provisions of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is classince (see ao re) alitional controls. Existing major regulations affecting your Approval), It may be subject to such adations. Title 21, Parts 800 to 898. In addition, FDA device can be nound in the courseming your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Picase be advised that 177A is textailed of tevice complies with other requirements of the Act or any FDA has made a decemmanon mar your do roceral agencies. You must comply with all the rederal slatues and regulations administer to registration and listing (21 CFR Pati 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); good manufacting product radiation control product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manteaning your and equivalence of your device to a legally premarket notification: "The PDA midning or basisian ------------------------------------------------------------------------------------------------------------------------proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please if you desire spective advice for your corres on for a combine numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entired, formation on your responsibilities under the Act from the 807.97). You may outlain other general information on your Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): _K_05034 |
Device Name: Implant Location Software (ILS)
Indications for Use:
The Implant Location Software (ILS) is indicated for use by medically trained people as a
ndormation The Implant Location Software (ILS) Is indicated for the transfer of incolner information
software interface and image segmentation system for the sement software interface and image segmentation system see in
from a CT scanner and as planning software for dental implant placement.
Prescription Use X (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 (
) (PLEASE DO NOT WRITE OF OF OF OF OF AFFEDED) OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ilincy C brigdon
(Division Sign-Off) Division of Reproductive, Abdominal, Division of Reploductive, Abdomical
and Particlogical Devices KOSC 34 510(k) Number __
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