AESCULAP ORTHOPILOT NEXT GENERATION

K141694 · Aesculap Implant Systems, LLC · OLO · Feb 24, 2015 · Neurology

Device Facts

• Record ID: K141694
• Device Name: AESCULAP ORTHOPILOT NEXT GENERATION
• Applicant: Aesculap Implant Systems, LLC
• Product Code: OLO · Neurology
• Decision Date: Feb 24, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The OrthoPilot® Next Generation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to position endoprosthesis in arthroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for endacement surgery (such as total knee, revision knee, unicondylar knee, and total hip systems) and provides intraoperative measurement. It indicates angles and positions for implant placement.

Device Story

Computer-assisted surgical navigation system; provides anatomical information to surgeons during arthroplasty. System inputs: spatial data from rigid body transmitters mounted to patient bones or mobile instruments; anatomical landmark data via ultrasound module. Camera monitors spatial location of transmitters/instruments. Proprietary software processes inputs to calculate bone alignment, angles, and positions for implant placement. Output: real-time navigation data displayed on monitors to guide positioning of cutting guides, drills, and reamers. Used in OR by surgeons. Benefits: improved accuracy in endoprosthesis positioning.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation included sterilization, shelf life, navigation performance, software acceptance tests, and software life cycle testing.

Technological Characteristics

System includes stereotaxic camera, computer with monitors, rigid bodies (transmitters), passive markers, power supply, tagged instruments, ultrasound module, and cart. Complies with IEC 60601-1 (safety/performance), IEC 62304 (software life cycle), and ISO 14971 (risk management).

Indications for Use

Indicated for patients undergoing endoprosthesis replacement surgery, including total knee, revision knee, unicondylar knee, and total hip systems, to assist surgeons in positioning surgical instruments and implants.

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

• OrthoPilot Next Generation (K090375)

Submission Summary (Full Text)

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

February 24, 2015

AESCULAP IMPLANT SYSTEMS, LLC Ms. Julie Tom Wing Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K141694

Trade/Device Name: Aesculap OrthoPilot Next Generation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: January 27, 2015 Received: January 28, 2015

Dear Ms. Wing:

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 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

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Page 2 - Ms. Julie Tom Wing

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson -S

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

Enclosure

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# Indications for Use

510(k) Number (if known) K141694

#### Device Name Aesculap OrthoPilot Next Generation

### Indications for Use (Describe)

The OrthoPilot® Next Generation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to position endoprosthesis in arthroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for endacement surgery (such as total knee, revision knee, unicondylar knee, and total hip systems) and provides intraoperative measurement. It indicates angles and positions for implant placement.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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#### B. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

## Aesculap OrthoPilot Next Generation

January 27, 2015

| COMPANY: | Aesculap® Implant Systems, LLC<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 300567331 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Julie Tom Wing<br>610-984-9147 (phone)<br>610-791-6882 (fax)<br>[e-mail] |
| DEVICE | |
| TRADE NAME: | Aesculap OrthoPilot Next Generation |
| COMMON NAME: | Surgical Navigation Platform |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | OLO |
| REGULATION NUMBER: | 882.4560 |

Orthopedic

# SUBSTANTIAL EQUIVALENCE

CLASSIFICATION NAME:

REVIEW PANEL:

Aesculap® Implant Systems, L.L.C. believes the introduction of alternate marker spheres, a camera update and software integration of OrthoPilot® Next Generation navigation system remains substantially equivalent to the currently marketed OrthoPilot Next Generation system previously cleared in 510(K) K090375.

Orthopedic Stereotaxic Instrument

# DEVICE DESCRIPTION

Aesculap's OrthoPilot® Next Generation is a computer assisted surgical navigation system that uses proprietary software to provide anatomical information to a surgeon. The hardware in the system consists of the following primary components: stereotaxic camera, computer (w/ monitors), rigid bodies (transmitters), passive markers, power supply, various tagged instruments, an ultrasound module, transport cart and stand. The computer accepts input from the transmitters on the rigid bodies either mounted to the patients bones or mobile to palpate anatomical landmarks in conjunction with a camera to monitor the spatial location of the transmitters in relation to each other and/or instruments. The computer can also accept spatial input for anatomical landmarks from an ultrasound unit. The software modules for the OrthoPilot Next Generation consist of modules for both a knee suite and a hip suite.

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# INDICATIONS FOR USE

The OrthoPilor® Next Generation Platform is a system for computer-aided navigation of surqical instruments. Its purpose is to position endoprosthesis in the patient. It aids the surgeon in accurately positioning the cutting quides, drills and reamers for endoprosthesis replacement surgery (such as total knee, revision knee, unicondylar knee, and total hip systems) and provides intraoperative measurements of bone alignment. It indicates angles and positions for implant placement.

# TECHNOLOGICAL CHARACTERISTICS (Compared to the Predicate)

OrthoPilot® Next Generation navigation system was cleared under K090375. The intended use and fundamental scientific technology of the OrthoPilot® Next Generation Navigation system remain unchanged. The only difference is a design modification of the passive marker spheres and it's integration with the current software modules.

# PERFORMANCE DATA

OrthoPilot® Next Generation system was developed in accordance with 'General Principles of Software Final Guidance for Industry and FDA Staff; 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' and Aesculap's procedures.

As a result of the risk assessment, design modification of the marker spheres and it's integration with the current software modules was verified and validated via sterilization; shelf life; navigation performance; software acceptance tests and software life cycle testing.

In addition, Aesculap's OrthoPilot® Next Generation navigation platform complies with the following internationally recognized standards:

| IEC 60601-1 | International Electrotechnical Commission Medical Electrical Equipment<br>Part 1: General Requirements for Basic Safety and Essential<br>Performance |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 62304 | International Electrotechnical Commission Medical Device Software –<br>Software Life Cycle Processes |
| ISO 14971 | International Standards Organization Medical Devices – Application of<br>Risk Management to Medical Devices |