IPLAN! DIGITAL TEMPLATING

K042543 · Brainlab AG · HAW · May 17, 2005 · Neurology

Device Facts

• Record ID: K042543
• Device Name: IPLAN! DIGITAL TEMPLATING
• Applicant: Brainlab AG
• Product Code: HAW · Neurology
• Decision Date: May 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The iPlan Hip Templating system is indicated for the preoperative planning of orthopedic treatments. It is specially developed for the preparation and display of anatomical patient data that has been acquired using xray, CT or MR equipment. iPlan Hip Templating creates treatment plans in conjunction with 2D / 3D implant models are provided by a separate database. Both 2D and 3D planning are supported, depending on the anatomical information available. The treatment plan can either be saved or printed as required.

Device Story

iPlan Hip Templating is a stand-alone software system for preoperative orthopedic planning. Input consists of anatomical images (x-ray, CT, MR) and 2D/3D implant models from a separate database. Surgeons perform image scaling using objects of known size, then use measurement tools to select optimal implants. Software overlays implant models onto patient images; displays preplanned and current values. Output is a saved or printed treatment plan, which may be exported to BrainLAB VectorVision systems for image-guided surgery. Used in clinical settings by surgeons to facilitate implant selection and surgical preparation, potentially improving surgical accuracy and patient outcomes.

Clinical Evidence

No clinical data. Verification and validation were performed according to manufacturer procedures to prove safety and effectiveness.

Technological Characteristics

Stand-alone software system for preoperative orthopedic planning. Utilizes digital image scaling and overlay of 2D/3D implant models. Compatible with x-ray, CT, and MR image data. Integrates with external implant databases. Supports data export to VectorVision systems.

Indications for Use

Indicated for preoperative planning of orthopedic treatments using anatomical patient data acquired via x-ray, CT, or MR imaging. Intended for use by clinicians.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• iPlan®2 (K020631)

Submission Summary (Full Text)

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MAY 1 7 2005

# KO4 2543 510 (k) Summary of Safety and Effectiveness for iPlan® Hip Templating

### Manufacturer:

| Address: | BrainLAB AG |
|-----------------|--------------------------|
| | Ammerthalstrasse 8 |
| | 85551 Heimstetten |
| | Germany |
| | Phone: [phone] |
| | Fax: [phone] |
| Contact Person: | Mr. Rainer Birkenbach |
| Summary Date: | February 2, 2005 |
| Device Name: | |
| Trade name: | iPlan® Hip Template |

Irade name:

Common/Classification Name:

iPlan® Hip Templating Planning System

Predicate Device: iPlan!®2 (K020631)

Device Classification Name: Stereotaxic instrument Requlatory Class: Class II

#### Intended Use:

The iPlan Hip Templating system is indicated for the preoperative planning of orthopedic treatments. It is specially developed for the preparation and display of anatomical patient data that has been acquired using xray, CT or MR equipment.

iPlan Hip Templating creates treatment plans in conjunction with 2D / 3D implant models are provided by a separate database. Both 2D and 3D planning are supported, depending on the anatomical information available.

The treatment plan can either be saved or printed as required.

# Device Description:

iPlan Hip Templating is a stand-alone system for preoperative orthopedic treatment planning which facilitates digital template planning for anatomical images. Once image scaling has been completed, using an object of known size that is positioned next to the anatomical area of interest during image acquisition, the surgeons can use a range of measurement tools in order to select the optimum implant for the patient. The software overlays 2D / 3D implant models onto the image data and displays the result. The measurement tools can also be used to display preplanned and current values where required.

The digital implant models are provided by a separate implant database. Both 2D implant contours and 3D implant models are available.

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K042543

Treatment plans can be saved and printed out as required. The information stored in the treatment plan can be loaded to other BrainLAB applications and used to support image guided surgery in a VectorVision system, for example.

## Substantial equivalence:

iPlan® Hip Templating has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system. The information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate device iPlan® (K020631).

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird or eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 7 2005

Mr. Oliver Fleig Project Manager BrainLAB AG Ammerthalstraße 8 85551 Heimstetten, Germany

Re: K042543

Trade/Device Name: iPlan Hip Templating Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 12, 2005 Received: April 19, 2005

Dear Mr. Fleig:

We have reviewed your Section 510(k) premarket notification of intent to market the device indicati We have reviewed your Section 910(x) premained issubstantially equivalent (for the indications ferenced above and nave decemined by marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manation posice Americal Device Ameral Food. For a commerce prior to May 26, 1776, the enaomine with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval or a of the Act and Cosment Act (Act) that to not require approvile of the general controls provisions of the Act. The You may, merelore, market the dovices, sayes to use include registration, listing of general controls provisions of the free labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is Classifica (Sec above) into v. Existing major regulations affecting your device . EDA it may be subject to such additional conferent in 21, Parts 800 to 898. In addition, FDA can be found in the Code of Feceral concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s Issualites of a succession in ther requirements of the Act
that FDA has made a determination that your device complies with other mat that FDA has made a decemination administered by other Federal agencies. You must or any Federal statures and regulations daministered of registration and listing (21 comply with all the Act STEquirements, moradian and manufacturing practice requirements as setting CFR Part 807), labeling (21 CFR Part 820), and if applicable, the electronic forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Oliver Fleig

This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin mankomig your as receive of your device to a legally premarket nouthcation. "The PDF Imaning of Essional 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 If you desire specific advice for your don't a most and mease note the regulation entitled, and Colliact the Office of Complance at (21 t r = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = " Misofanding by relectice to premailied.com in the Act from the Division of Small other general Information on your respensentation of its toll-free number [phone] or Manufacturers, International and Consultip://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Edin S. Ramic

-Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K 042543

Device Name:

iPlan Hip Templating

The iPlan Hip Templating system is indicated for the preoperative planning of orthopedic The iPlan Hip Templainig System is indicated for the properiation and display of anatomical patient data that has been acquired using x-ray, CT or MR equipment.

that has boon with the same in conjunction with 2D / 3D implant models.
iPlan Hip Templating creates treatment plans in clarge and 3D planning are supposition iPlan Hip Templating Creates ucatinent productions of the 2D and 3D planning are supported, miplain models anatomical information available.

..............................................................................................................................................................................

The treatment plan can either be saved or printed as required.

X Prescription Use __ (Per 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

General, Restorative
Logical Devices

K042843

K042543