IMPLANT LOCATION SOFTWARE-T

K070713 · Tactile Technologies, Ltd. · LLZ · May 2, 2007 · Radiology

Device Facts

• Record ID: K070713
• Device Name: IMPLANT LOCATION SOFTWARE-T
• Applicant: Tactile Technologies, Ltd.
• Product Code: LLZ · Radiology
• Decision Date: May 2, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Implant Location Software-T (ILS-T) 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 pre-operative software for simulating / evaluating dental implant positioning. Surgical templates may also be fabricated based on the output of the pre-operative planning.

Device Story

Implant Location Software-T (ILS-T) is a software tool for dental practitioners to assist in pre-operative planning for dental implant surgery. The device ingests CT scan data via DICOM standards; performs image segmentation; and allows the user to visualize and place 'virtual implants' within the CT images. The system generates a summary report and supports the fabrication of surgical templates. Used in clinical settings by dental professionals; the software provides planning information but does not perform clinical decision-making. The output is used by the practitioner to guide surgical planning and template creation, potentially improving implant placement accuracy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based system; utilizes DICOM interface standards for CT image data; operates on standard computing hardware; supplied on disk-on-key. Functions as an image segmentation and visualization tool for pre-operative planning.

Indications for Use

Indicated for use by medically trained personnel for CT image transfer, image segmentation, and pre-operative simulation/evaluation of dental implant positioning. Supports fabrication of surgical templates.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• SimPlant System (K053592)

Submission Summary (Full Text)

{0}------------------------------------------------

K0707/3

MAY - 2 2007

# Tactile Technologies

10 Plaut Str., Rabin Scientific Park Rehovot 76122, ISRA日 Tel: [phone]

## 510(k) Summary:

Implant Location Software-T (ILS-T)

Company Name:

Tactile Technologies Ltd.

Contact Person: Unel Weinstein. Director of R&D

> Telephone: [phone]. Fax: [phone] E-mail: [e-mail]

US Agent: Thomas Gottenbos, 27030 Malibu Hills Road Calabasas, CA 91301

> Phone: [phone] Fax: [phone] E-mail : [e-mail]

Date prepared: March 5, 2007

Trade Name: Implant Location Software-T

Classification name: Picture archiving and communications system

Class: II

Panel identification: Radiological devices

Product code: LLZ

Regulation number: 882.2050

{1}------------------------------------------------

# Tactile Technologies

10 Plaut Str., Rabin Scientific Park Rehovot 76122, ISRAEL Tel: [phone]

Predicate Device: SimPlant System (Dr. James) from Materialise N.V cleared under 510(k) no. K053592.

### Device description:

The Implant Location Software-T is a computer program (software) intended for use as an aid to the dental practitioners in the location of dental implants. The Implant Location Software-T-T (ILS-T) guides dental practitioners through the process of pre-operative planning their patients' dental implant surgery. Surgical templates may also be fabricated based on the output of the pre-operative planning. 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-T is designed to use images acquired from Computer Tomography (CT) scanners, present a graphical image of the planned implants as "virtual implants" on the CT images using DICOM interface standards, provide a summary report that gives planning information for the procedure, and allow user to consult on-line views of the plan during operation.

### Indications for Use:

The Implant Location Software-T (ILS-T) 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 pre-operative software for simulating / evaluating dental implant positioning. Surgical templates may also be fabricated based on the output of the pre-operative planning.

#### Substantial Equivalence:

The Implant Location Software-T has the same intended use and the same principle of operation as the SimPlant System from Materialise N.V, Belgium, cleared under 510(k) no. K053592 and is therefore substantially equivalent to that device.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image contains the logo for Tactile Technologies. The logo consists of the letters "tt" in white on 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: [phone]

> 1 :

# Conclusion:

The evaluation of the Implant Location Software-T does not raise any additional concems regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate devices.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows a circular logo with text around the perimeter and a stylized symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The symbol in the center consists of three curved lines that resemble a stylized human figure or a wave pattern.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Uriel Weinstein Director of R&D Tactile Technologies Ltd. 10 Plaut St, Rabin Scientific Park Rechovot 76122 ISRAEL

Re: K070713

Trade/Device Name: Implant Location Software-T (ILS-T) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 7, 2007 Received: March 14, 2007

Dear Mr. Weinstein:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/3/Picture/10 description: The image is a circular seal with the text "1906-2006" at the top. The letters "PA" are in the center of the seal in a bold, sans-serif font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial". The seal appears to be a commemorative emblem, possibly for an organization or event.

Promoting and Promoting Public Health

{4}------------------------------------------------

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrlvindustry/support/index.html.

Sincerely yours,

Nancy C Hodgon

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):

Device Name: Implant Location Software-T (ILS-T)

Indications for Use:

The Implant Location Software-T (ILS-T) 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 pre-operative software for simulating / evaluating dental implant positioning. Surgical templates may also be fabricated based on the authut of the pre-operative planning.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __ 11/11/2

Page 1 of 1

4-2