ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106

K080547 · Aesculap Implant System, Inc. · HAW · May 23, 2008 · Neurology

Device Facts

• Record ID: K080547
• Device Name: ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106
• Applicant: Aesculap Implant System, Inc.
• Product Code: HAW · Neurology
• Decision Date: May 23, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Orthopilot® Next Generation Navigation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to optimally position endoprosthesis in arthroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for total endoprosthesis replacement surgery and provides intraoperative measurements of bone alignment. It indicates optimized angles and positions for implant placement.

Device Story

Computer-assisted surgical navigation system for arthroplasty; used in OR by surgeons. Inputs: spatial data from rigid body transmitters (bone-mounted or mobile) and ultrasound module; camera tracks spatial location of transmitters/instruments. Software processes inputs to calculate anatomical landmarks and alignment. Outputs: real-time navigation guidance, optimized angles, and positions for implant placement; displayed on monitors. Assists surgeon in positioning cutting guides, drills, and reamers. Benefits: improved accuracy in implant placement and bone alignment.

Clinical Evidence

No clinical data provided; bench testing only. Compliance with IEC 60601-1 and IEC 60601-1-2 standards confirmed. Software validated per FDA guidance.

Technological Characteristics

Stereotaxic navigation platform. Components: stereotaxic camera, computer, rigid body transmitters, ultrasound module, instruments. Connectivity: upgraded hardware/connectivity compared to predicate. Standards: IEC 60601-1 (Safety), IEC 60601-1-2 (EMC). Software: previously cleared modules.

Indications for Use

Indicated for patients undergoing total endoprosthesis replacement surgery (arthroplasty) requiring computer-aided navigation for instrument positioning and bone alignment measurement.

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 2 (K013569)

Submission Summary (Full Text)

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# K086547

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS C. (in Accordance with SMDA of 1990)

MAY 2 3 2008

### Aesculap Orthopilot Next Generation 27 February 2008

| COMPANY: | Aesculap® Implant Systems, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 3005673311 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Matthew M. Hull<br>800-258-1946 x 5072 (phone)<br>610-791-6882 (fax) |
| TRADE NAME: | Aesculap Orthopilot Next Generation |
| COMMON NAME: | Surgical Navigation Platform |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | 84 HAW |
| CLASSIFICATION: | 882.4560 - Stereotaxic Instrument |
| REVIEW PANEL: | Neurology |

## INDICATIONS FOR USE

The Orthopilot® Next Generation Navigation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to optimally position endoprosthesis in arthroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for total endoprosthesis replacement surgery and provides intraoperative measurements of bone alignment. It indicates optimized angles and positions for implant placement.

### DEVICE DESCRIPTION

Aesculap's OrthoPilot Next Generation is a computer assisted surgical navigation system that uses proprietary software to provide optimal anatomical information to a surgeon. The hardware in the system consists of the following primary components: stereotaxic camera, computer (w/ monitors), rigid bodies (transmitters), power supply, various taqged 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 also can 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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### PERFORMANCE DATA

No applicable performance standards have been promulgated under FDCA Section 514 for this system. The previously cleared software modules were developed in accordance with Aesculap's internal SOP's as well as CDRH's "General Principles of Software Validation; Final Guidance for Industry and FDA Staff. Aesculap's Orthopilot Next Generation navigation platform complies with the following FDA recognized standards:

- IEC 60601-1 International Electrotechnical Commission: Medical Electrical Equipment, Part 1: General Reguirements for Safety.
- IEC 60601-1-2 International Electrotechnical Commission: Medical Electrical Equipment, General Requirements for Safety: Electromagnetic Compatibility - Requirements and Tests.

### SUBSTANTIAL EQUIVALENCE

Aesculap® Implant Systems, Inc. believes that the OrthoPilot Next Generation navigation system is substantially equivalent to our currently marketed OrthoPilot 2 system cleared in Aesculap's 510(k) submission #K013569. The software that has been previously cleared for OrthoPilot 2 is compatible with OrthoPilot Next Generation and remains unchanged. The OrthoPilot Next Generation navigation system merely represents an across the board upgrade in hardware technology and connectivity.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aesculap Implant System, Inc. % Mr. Matthew M. Hull, RAC Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, Pennsylvania 18034

MAY 2 3 2008

Re: K080547

Trade/Device Name: Aesculap Orthopilot Next Generation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 23, 2008 Received: April 24, 2008

Dear Mr. Hull:

)

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.

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### Page 2 - Mr. Matthew M. Hull, RAC

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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,

Mark N. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE STATEMENT B.

510(k) Number:

### Device Name: Aesculap Orthopilot Next Generation

#### Indication for Use:

The OrthoPilot® Next Generation Navigation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to optimally position endoprosthesis in arthroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for total endoprosthesis replacement surgery and provides intraoperative measurements of bone alignment. It indicates optimized angles and positions for implant placement.

Prescription Use X (Part 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

the R.P. Dyke Goxx

Division of General, Restorative, and Neurological Devices

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510(k) Number K080547

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