BRAINLAB KNEE ARTHROSCOPY

K093118 · Brainlab AG · OLO · Jun 11, 2010 · Neurology

Device Facts

• Record ID: K093118
• Device Name: BRAINLAB KNEE ARTHROSCOPY
• Applicant: Brainlab AG
• Product Code: OLO · Neurology
• Decision Date: Jun 11, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

BrainLAB ACL is intended to be used as an intraoperative image-guided navigation system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system, to a virtual computer image space on the model of a bone, overlaid with individually acquired patient landmarks. The system is indicated for any surgical anterior cruciate ligament procedure in which the use of stereotactic surgery for the planning and navigation of interosseous canals may be appropriate, and where a reference to a rigid anatomical structure can be established.

Device Story

BrainLAB ACL is an intraoperative image-guided navigation system for ACL reconstruction. It uses a freehand probe tracked by a passive marker sensor system to map patient anatomy. The system registers intra-operatively acquired landmarks to a virtual computer model of the bone. Surgeons use this navigation to plan and drill transplant canals to restore knee joint stability. The system is used in an operating room setting by surgeons to facilitate minimally invasive procedures. By providing real-time visualization of surgical instruments relative to patient anatomy, the device assists in accurate tunnel placement, potentially improving surgical outcomes and knee stability.

Clinical Evidence

No specific clinical trial data or performance metrics (e.g., sensitivity, specificity) are provided in the summary. Substantial equivalence is supported by design verification, system testing (Xtool), software validation, and evaluation under real-world conditions.

Technological Characteristics

Image-guided surgery system utilizing passive marker tracking. Components include a freehand probe and a sensor system for spatial tracking. Software-based navigation platform for intraoperative planning and drilling. Connectivity involves integration with surgical navigation hardware. Sterilization requirements for surgical instruments apply.

Indications for Use

Indicated for patients undergoing anterior cruciate ligament (ACL) surgery where stereotactic planning and navigation of interosseous canals is appropriate and a rigid anatomical reference can be established.

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

• VectorVision® ACL (K042512)
• BrainLAB Knee (K073615)

Submission Summary (Full Text)

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# 1093118 510 (k) Summary of Safety and Effectiveness for BrainLAB ACL

# Manufacturer:

Address:

BrainLAB AG Kapellenstrasse 12 85622 Feldkirchen Germany Phone: [phone] Fax: [phone]

Contact Person: Mr. Alexander Schwiersch

May 21, 2010 Summary Date:

## Device Name:

Trade name:

BrainLAB ACL

Common/Classification Name:

BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

## Predicate Device:

VectorVision® ACL (K042512) BrainLAB Knee (K073615)

Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II

#### Intended Use:

Indications For Use:

BrainLAB ACL is intended to be used as an intraoperative image-guided navigation system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system, to a virtual computer image space on the model of a bone, overlaid with individually acquired patient landmarks.

The system is indicated for any surgical anterior cruciate ligament procedure in which the use of stereotactic surgery for the planning and navigation of interosseous canals may be appropriate, and where a reference to a rigid anatomical structure can be established.

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#### Device Description:

ACL is an image quided surgery system for the replacement of torn ligaments in the knee joint. It is based on intra-operatively acquired landmarks that are used for planning and navigation. It supports the surgeon in the planning and drilling of transplants canals in the position to regain the stability of the knee joint.

#### Substantial equivalence:

BrainLAB ACL has been verified and validated according to BrainLAB's procedures for product design and development.

To conclude the substantial equivalence, the following verification aspects were performed:

- . Design review meetings
- Evaluation at special sites t
- Tracking of software versions .
- Subsystem & System Verification using Xtool .
- Non-Xtool tests .
- License group tests .
- Installer tests .
- Startup tests .

To conclude the substantial equivalence, the following validation aspects were performed:

- Testing and evaluation under real world conditions .
- Desian reviews .
- Software validation .
- Literature research .
- Literature evaluation ◆
- Comparison with a previously marketed medical device .
- Indications for use/Changed indications for use .
- . Non-clinical validation
- Preclinical and clinical validation .
- Side effects .

The information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate device VectorVision® ACL (K042512) and BrainLAB Knee (K073615)

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

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

BrainLAB AG % Mr. Stefan Wimmer Kapellenstrasse 12 85622 Feldkirchen Germanv

JUN 1 1 2010

Re: K093118

Trade/Device Name: BrainLAB ACL Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: June 04, 2010 Received: June 09, 2010

Dear Mr. Wimmer:

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.

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

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#### Page 2 - Mr. Stefan Wimmer

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Mark A. Milliken

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K09318

Device Name: ACL

Indications For Use:

BrainLAB ACL is intended to be used as an intraoperative image-guided navigation system to enable minimally invasive surgery. It links a freehand probe, tracked by a bystein to enable minimal computer image space on the model of a bone, overlaid with individually acquired patient landmarks.

The system is indicated for any surgical anterior cruciate ligament procedure in which the use of stereotactic surgery for the planning and navigation of interosseous canals may be appropriate, and where a reference to a rigid anatomical structure can be established.

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)

Nilses. Ryden Loc. mnr

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number K093118