NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP

K122011 · Brainlab AG · OLO · Nov 15, 2012 · Neurology

Device Facts

• Record ID: K122011
• Device Name: NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP
• Applicant: Brainlab AG
• Product Code: OLO · Neurology
• Decision Date: Nov 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

For Total Hip Replacement (THR) procedures The Brainlab hip system is intended to be an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system, to virtual computer image space either on a patient's preoperative image data being processed by Brainlab IGS platforms, or on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-Ray, or MR-based model of the anatomy. The system aids the surgeon to accurately navigate a hip endoprosthesis to the preoperatively or intraoperatively planned position. Example orthopedic surgical procedures include but are not limited to: Total Joint Replacement Minimally invasive orthopedic surgery Tumor resection and bone/joint reconstruction For Surface Replacement (SR) procedures The Brainlab hip system is intended as an intraoperative image-guided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on Brainlab IGS platforms. The image data is provided either in the form of preoperatively-acquired patient images or in the form of an individual 3D model of the patient's bone, which is generated by acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray, or MR-based model of the anatomy. The system aids the surgeon in accurately navigating a hip endoprothesis to the preoperatively or intraoperatively planned position. Example orthopedic surgical procedures include but are not limited to: Partial/hemi-hip resurfacing.

Device Story

Brainlab Hip is an intraoperative image-guided localization system for orthopedic hip replacement. It uses a passive marker sensor system to track a freehand probe and surgical instruments (e.g., cup reamer, cup inserter, stem broach) in real-time. Inputs include preoperative patient images (CT, X-ray, MR) or a 3D bone model generated by palpating landmarks. The system reconstructs anatomical axes and planes of the femur and pelvis to guide implant positioning. Surgeons use the system in the OR to navigate tools to planned positions and intraoperatively measure leg length and offset. It provides visual feedback on a display, aiding surgeons in accurate implant alignment. Benefits include improved surgical precision and potential for minimally invasive approaches.

Clinical Evidence

Prospective clinical validation study of 50 total hip replacement surgeries in patients >55 years. Evaluated accuracy of lateral and supine pelvis registration against a gold standard (post-operative CT). Primary endpoints: cup inclination and anteversion deviation. Results showed high accuracy: lateral registration (inclination -1.1° ± 3.1°; anteversion 0.9° ± 4.3°) and supine registration (inclination 0.5° ± 2.2°; anteversion -0.9° ± 3.9°). No cases exceeded the ±10° safe zone defined by Lewinnek et al. Study confirmed system performance for cup orientation measurement.

Technological Characteristics

Stereotactic image-guided localization system. Uses passive marker tracking, freehand probes, and surgical instruments. Integrates with Brainlab IGS platforms. Software-based 3D reconstruction of anatomical axes/planes. Supports preoperative image data or landmark-based 3D bone modeling. Connectivity via IGS platform. No specific material standards or energy sources listed beyond standard surgical instrumentation.

Indications for Use

Indicated for patients requiring stereotactic orthopedic surgery, including total hip replacement, surface replacement, minimally invasive orthopedic surgery, and tumor resection/reconstruction, where rigid anatomical structures (skull, long bone, vertebra) can be referenced to CT, X-ray, or MR-based models.

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

• BrainLAB hip unlimited (K083483)
• Vector Vision® hip SR (K063028)
• DASH hip (K110021)
• Brainlab Knee (K102990)
• Brainlab Trauma (K110204)

Submission Summary (Full Text)

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K!2011

## 510 (K) SUMMARY FOR BRAINLAB HIP

| Manufacturer: | Brainlab AG<br>Kapellenstrasse 12<br>85622 Feldkirchen<br>Germany |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: [phone]<br>Fax: [phone] |
| | NOV 1 5 2012 |
| Submitter: | Rainer Birkenbach |
| Contact Person: | Alexander Schwiersch |
| Summary Date: | 10/17/2012 |
| Device: | Brainlab Hip |
| Trade Name: | Navigation Software Hip - Universal<br>Navigation Software Hip THR - Aesculap<br>Navigation Software Hip THR - Biomet US<br>Navigation Software Hip THR - DePuy US<br>Navigation Software Hip THR - Smith&Nephew US<br>Navigation Software Hip THR - Zimmer<br>Navigation Software Hip Express<br>Navigation Software Hip SR Universal<br>Navigation Software Hip SR - Biomet US<br>Navigation Software Hip SR - Corin US<br>Navigation Software Hip SR - Wright Medical<br>Navigation Software Hip SR - Zimmer<br>Navigation Package Hip Unlimited US |
| Common/Classification<br>Name: | Brainlab Hip, Brainlab Image Guided Surgery System / Instrument, Stereotaxic |
| Predicate Device: | BrainLAB hip unlimited (K083483)<br>Vector Vision® hip SR (K063028)<br>DASH hip (K110021)<br>Brainlab Knee (K102990)<br>Brainlab Trauma (K110204) |
| Device Classification<br>Name: | Instrument, Stereotaxic |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 882.4560 |
| Product Code: | OLO / HAW |
| Intended Use: | For Total Hip Replacement (THR) procedures<br>The Brainlab hip system is intended to be an intraoperative image-guided<br>localization system to enable minimally invasive surgery. It links a<br>freehand probe, tracked by a passive marker sensor system, to virtual<br>computer image space either on a patient's preoperative image data being<br>processed by Brainlab IGS platforms, or on an individual 3D-model of the<br>patient's bone, which is generated through acquiring multiple landmarks |

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#### on the bone surface.

The system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-Ray, or MR-based model of the anatomy. The system aids the surgeon to accurately navigate a hip endoprosthesis to the preoperatively or intraoperatively planned position.

Example orthopedic surgical procedures include but are not limited to:

Total Joint Replacement

Minimally invasive orthopedic surgery

Tumor resection and bone/joint reconstruction

#### For Surface Replacement (SR) procedures

The Brainlab hip system is intended as an intraoperative image-guided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on Brainlab IGS platforms. The image data is provided either in the form of preoperatively-acquired patient images or in the form of an individual 3D model of the patient's bone, which is generated by acquiring multiple landmarks on the bone surface.

The system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray, or MR-based model of the anatomy. The system aids the surgeon in accurately navigating a hip endoprothesis to the preoperatively or intraoperatively planned position. Example orthopedic surgical procedures include but are not limited to: Partial/hemi-hip resurfacing

#### Device Description:

The Brainlab hip system is intended to enable operational planning and navigation in orthopedic hip replacement surgery. It links a surgical instrument, tracked by passive markers to virtual computer image space on an individual three-dimensional model of the patient's bone, which is generated through acquiring multiple landmarks either directly on the bone surface or by palpating bony landmarks through soft tissue and defining them directly on skin. The Brainlab hip system uses the registered landmarks to navigate the necessary surgical tools, e.g., cup reamer, cup inserter, stem broach handles and k-wires, to the planned position and orientation. Additionally, it enables to intra-operative measurement of implant position, including measurement of the changes in leg length and offset.

The Brainlab hip system provides a three-dimensional reconstruction of the relevant anatomical axes and planes of the femur and pelvis to aid the alignment of the implants and to determine leg length and offset parameters. Based on the selected procedure, the Brainlab hip system loads implant and instrument data that has been provided by the implant manufacturer. It is possible to individually choose the prostheses for each surgery, which are shown in the software in relation to the determined anatomical structures. If no implant data is available, to the user can enter

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| Substantial<br>Equivalence: | Brainlab hip system has been verified and validated according to Brainlab's<br>procedures for product design and development. The information provided<br>by Brainlab in this 510 (k) application was found to be substantially<br>equivalent with the predicate devices:<br><br>• BrainLAB hip unlimited (K083483)<br>• Vector Vision® hip SR (K063028)<br>• DASH hip (K110021)<br>• Brainlab Knee (K102990)<br>• Brainlab Trauma (K110204) |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Changes to Predicate<br>Device: | Brainlab Hip has changed in the following from the predicate devices:<br><br>• Elements of the user interface and workflows have been<br>redesigned to reduce the user interaction with the system<br>and enable a faster run through the registration and<br>navigation procedures.<br><br>• Modified registration techniques have been integrated which<br>reduce the number of landmarks to be acquired. For the<br>pelvis, an indirect reconstruction of the anterior pelvic plane<br>can be performed based on a reduced set of landmarks.<br>Information about pelvic tilt can be used to adapt the cup<br>orientation, e.g., to a coronal plane when the patient is<br>standing upright.<br><br>• A distance measurement tool has been integrated which<br>allows to check how well seated a cup implant is on the<br>acetabular floor during cup insertion.<br><br>• For hip surface replacement procedures, a method for the<br>verification of the head implant has been integrated.<br><br>• New implants and instruments have been integrated<br>(including a new pointer device, a caliper to measure<br>anatomical relationships of the pelvis, and new data of<br>FDA-cleared implants provided by the implant<br>manufacturers).<br><br>All modifications of the new device are covered by the indications for<br>use of new and predicate devices and are only minor changes, as<br>the basic technology has not changed. |
| Technological<br>Characteristics: | The literature research and the comparison to the predicate devices show that<br>the device makes use of equivalent technological characteristics and<br>functionality and is intended for equivalent surgical procedures as compared to<br>the predicate devices. |
| Non-clinical<br>Performance Data | The following non-clinical tests have been performed to ensure correct system<br>functionality according to its specifications: |

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:

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- . Specific test objectives have been used to show the correctness of new features in the Brainlab hip system.
- . A detailed verification of the signed specifications was performed covering the detailed functionality of the software (e.g. workflows, GUI elements, usage of instruments).
- t The measures have been tested against the defined risks of the Risk Analysis.
- Literature research has been performed to ensure that . Brainlab hip conforms to user needs and intended uses as well.
- Non-clinical tests were performed to confirm the system . targets. Specific OR setups and surgical procedures were simulated in laboratory environments and cadaver labs.

#### Clinical Performance Data ·

A prospective clinical validation study was performed to analyze the accuracy of lateral and supine pelvis registration in Brainlab Hip. The study included 50 total hip replacement surgeries on patients over 55 years of age. Patients with previous ipsilateral hip surgery affecting the pelvic or acetabular anatomy, pelvic fracture, ipsilateral acetabular fracture and women with childbearing potential were excluded. Two patients had to be excluded because of a loss of the navigation data (one case) and loosening of the pelvic reference array (one case). No intra- or post-operative complications occurred in the remaining cases except one calcar fissure which was unrelated to the navigation and caused no post-operative problems.

The surgical procedure was performed using the previous version of Brainlab Hip, the Brainlab Hip 5.1 navigation system, including an epicutaneous acquisition of the anterior pelvis plane (APP) as the basic reference for intraoperative navigation. This reflects an established registration procedure. The final position of the cup was verified based on this registration. Additionally, all landmarks required for Brainlab Hip registration procedures were acquired. Based on this information, the verified cup orientation was virtually adapted to the registration methods of Brainlab Hip. Post-operative CT scans were performed to determine a gold standard reqistration by defining the APP points directly on bone. Cup orientation was measured for this reference and then compared to the virtually adapted cup orientation. This enabled a direct comparison of the lateral and supine registration methods in Brainlab Hip with the gold standard.

The descriptive statistics (mean ± standard deviation) of the deviations to the gold standard, as well as the percentage of cases within a ±10° safe zone, as defined by Lewinnek et al in Lewinnek GE, Lewis JL, Tarr R, Compere CL, Zimmerman JR. Dislocations after total hip-replacement arthroplasties. J Bone Joint Surg Am. 1978 Mar;60(2):217-20, were calculated according to the radiographic definition specified by Murray DW in The definition and measurement of acetabular orientation. J Bone Joint Surg Br. 1993 Mar: 75(2): 228-32. The percentages were calculated based on the actual numbers of cases, as well as a statistical calculation where error distribution was modeled as a normal distribution.

- . Deviation between gold standard and Brainlab Hip lateral registration:
- Inclination: -1.1° ± 3.1°, statistically 0.25% of the cases were ー

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outside the ±10° safe zone

- Anteversion: 0.9° ± 4.3°, statistically 2.32% of the cases were outside the ±10° safe zone
- Deviation between gold standard and Brainlab Hip supine registration:
- Inclination: 0.5° ± 2.2°, statistically 0.0% of the cases were outside the ±10° safe zone
- Anteversion: -0.9° ± 3.9°, statistically 1.2% of the cases were outside the ±10° safe zone

The deviation was not outside the safe zone in any of the actual cases. This was true for both lateral and supine registration methods. These results describe the basic accuracy of cup orientation measurement in Brainļab Hip.

#### Conclusion

All non-clinical and clinical tests have been successfully performed. Thus, it has been demonstrated that the device is as safe, as effective, and performs as well as the predicate device.

Ooh
(Division Sign-Off)
Orthopedic,

(Division Sign-Off)
Division of Surgion : Orthopedic, Division of Surgious Devices Division of Surs.
and Restorative Devices

510(k) Number 2

REVISION 1

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Brainlab AG % Mr. Alexander Schwiersch Regulatory Affairs Manager Kapellenstrasse 12 Feldkirchen, Germany 85622

November 15, 2012

Re: K122011

Trade/Device Name: Brainlab Hip Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: OLO Dated: October 24, 2012 Received: October 26, 2012

Dear Mr. Schwiersch:

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

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Page 2 - Mr. Alexander Schwiersch

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.

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 [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 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/industry/support/index.html.

Sincerely yours, --

# Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATION FOR USE

510(k) Number (if known):

K122011

Device name: Brainlab Hip

Indication for use:

### Total Hip Replacement (THR) procedures

The Brainlab Hip system is intended to be an intraoperative image-guided localization system to enable rice Brunnal This eyettern it links a freehand probe, tracked by a passive marker sensor system, to milling in room of a gol your either on a patient's preoperative image data being processed by Brainlab Virtual computer innage opation of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface.

The system is indicated for any medical condition in which the use of stereotactic surgery may be r the system to be safe and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-Ray, or MR-based model of the anatomy. The system aids the surgeon to accurately navigate a hip endoprosthesis to the preoperatively aniatonly. The eyesting and thopedic surgical procedures include but are not limited to: Total Joint Replacement

Minimally invasive orthopedic surgery Tumor resection and bone/joint reconstruction

#### Surface Replacement (SR) procedures

The Brainlab Hip system is intended as an intraoperative image-guided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on Brainlab Institutions. The image data is provided either in the form of preoperatively-acquired patient images or in the form of an individual 3D model of the patient's bone, which is generated by acquiring multiple landmarks on the bone surface.

The system is indicated for any medical condition in which the use of stereotactic surgery may be r no system is manage room a reference to a rigid anatomical structure, such as the skull, a oundidored to be appropriate i identified relative to a CT, X-ray, or MR-based model of the anatomy. The system aids the surgeon in accurately navigating a hip endoprothesis to the preoperatively or intraoperatively planned position. Example orthopedic surgical procedures include but are not limited to: Partial/hemi-hip resurfacing.

Prescription Use X (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)

-Duri/Aw-focMXM

(Division Sign-Off) Division of Surgical, Orthopediatence of CDRH, Office of Device Evaluation (ODE) and Restorative Devices

510(k) Number K122011