CADIMPLANT

K040224 · Praxim, Inc. · JAK · Apr 6, 2004 · Radiology

Device Facts

• Record ID: K040224
• Device Name: CADIMPLANT
• Applicant: Praxim, Inc.
• Product Code: JAK · Radiology
• Decision Date: Apr 6, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The CADImplant software is intended for pre-treatment planning for the placement of dental implants using a CT scan which has been input into the CADImplant treatment planning software.

Device Story

CADImplant is a pre-treatment dental planning software system. It accepts CT scan data as input to assist dentists in dental implant procedures. The software allows clinicians to visualize and locate dental implants across three planes (axial, sagittal, and frontal) in real-time. It also facilitates the pre-drilling of prosthetic templates based on the surgical plan. The device uses a physical Reference Cube attached to the patient's prosthetic template during image acquisition for alignment calibration. By enabling precise 3D visualization and template preparation, the system assists the clinician in surgical planning, potentially improving implant placement accuracy and patient outcomes.

Clinical Evidence

Bench testing for compliance with software standards was performed. Accuracy testing was conducted using phantoms. Clinical experience with the system was provided to support the safety and effectiveness of the planning software.

Technological Characteristics

Software-based dental implant planning system. Utilizes CT scan input for 3D visualization. Employs a physical Reference Cube accessory for patient-to-image alignment calibration. Requires decontamination of accessories. Operates as a pre-treatment planning tool.

Indications for Use

Indicated for pre-treatment planning for dental implant placement in patients requiring dental implants, utilizing input CT scan data.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Columbia Scientific SimPlant (K924810)

Submission Summary (Full Text)

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

K040224

# 510(k) Summary for CADImplant

#### Submitter Name and Address 1.

Praxim "Le Grand Sablon" 4, Avenue de l'Obiou 38 700 La Tronche France

Contact Name: Stéphane Lavallée Telephone: [phone]

Date Prepared: October 22, 2003

#### 2. Device Name

Proprietary Name: CADImplant™ Common/Usual Name: Pre-treatment dental software system Computed tomography x-ray system (accessory) Classification Name:

#### 3. Predicate Device

Columbia Scientific SimPlant (K924810)

## 4. Intended Use

The CADImplant software is intended for pre-treatment planning for the placement of dental implants using a CT scan which has been input into the CADImplant treatment planning software.

## 5. Device Description

The CADImplant software is specifically designed for use in dental implant procedures. It allows the dentist to locate dental implants on three planes (axial, sagittal and frontal) on a pre-treatment CT scan in real-time. Additionally, the software allows for the patient's prosthetic template to be pre-drilled according to the planning.

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

## Technological Characteristics and Substantial Equivalence 6.

The CADImplant software is substantially equivalent to other predicate software planning systems (e.g., Columbia Scientific SimPlant, K924810) that are currently marketed. It is similar to the other software planning systems in its technological characteristics. It uses a pre-treatment CT scan for 3-D planning as other previously cleared software planning systems. Like the predicate products, it uses accessories during the pre-treatment image acquisition and require decontamination prior to use. The various predicate software systems use a variety of methods for calibration of the alignment of the patient with an image. CADIMplant uses a Reference Cube attached to the outside of the patient's prosthetic template during image acquisition.

## 7. Performance Testing

The CADImplant software was tested for compliance with software standards. In addition, summaries of accuracy testing using phantoms and clinical experience with the system were provided.

{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 depiction of an eagle with its wings spread, rendered in a simple, bold line style. The eagle is positioned to the right of a circular emblem containing the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. The text is in all caps and is set in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 6 2004

Ms. Christine Meehan General Manager Praxim, Inc 486 High Plain Street WALPOLE MA 02081 Re: K040224

Trade/Device Name: CADImplant™ Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and Communications system Product Code: 90 JAK and 90 LLZ Dated: January 30, 2004 Received: February 3, 2004

Dear Ms. Meehan:

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 (PMA), 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.

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 (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.

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

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 the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brygdon

Nancy C. Brogdon Director, Division of Reproductive Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known): K04 0224

Device Name: CADIMPLANT Indications for Use:

CADImplant is intended for pre-treatment software planning for the placement of dental implants using a CT scan which has been input into the CADImplant treatment planning software.

(Please do not write below this line -Continue on another page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Burgdon

(Division Sigh-Of Division of Reproduc ive. Abdor and Radiological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)