DIGIMATCH ROBODOC SURGICAL SYSTEM

K072629 · Integrated Surgical Systems, Inc. · OJP · Aug 6, 2008 · Neurology

Device Facts

• Record ID: K072629
• Device Name: DIGIMATCH ROBODOC SURGICAL SYSTEM
• Applicant: Integrated Surgical Systems, Inc.
• Product Code: OJP · Neurology
• Decision Date: Aug 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The DigiMatch™ ROBODOC® Surgical System is intended for use as a device, which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan. The preoperative planning software and robotic surgical tool is used as an alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA). The DigiMatch ROBODOC Surgical System is indicated for Orthopedic procedures in which the broaching/reaming in primary total hip arthroplasty (THA) may be considered to be safe and effective and where references to rigid anatomical structures may be made.

Device Story

System comprises ORTHODOC preoperative planning workstation and ROBODOC robotic surgical tool. Inputs: patient CT scan data. ORTHODOC software allows surgeon to assess femoral anatomy, select implant size, and determine positioning. ROBODOC, an electromechanical arm, implements the plan under direct surgeon control. Used in clinical settings for primary total hip arthroplasty (THA) as an alternative to manual broaching/reaming. Surgeon monitors robotic implementation to ensure precise femoral canal preparation. Benefits include improved implant fit, alignment, and reduced gaps between bone and implant compared to manual techniques.

Clinical Evidence

Evidence includes bench, animal, cadaver, and clinical studies. Cadaver studies showed reduced gaps between implant and bone vs. manual. Animal study (20 greyhounds) showed better cortical bone continuity and implant apposition. Two U.S. clinical trials (G920035, G000071) demonstrated safety and efficacy; primary endpoint of Harris Hip Scores showed equivalence between ROBODOC and manual control groups.

Technological Characteristics

System includes ORTHODOC workstation and ROBODOC electromechanical arm with end effector. Uses CT scan data for preoperative planning. Registration via point-to-surface method. Software-driven control of robotic arm for precise implementation of surgical plan. Class II device.

Indications for Use

Indicated for patients requiring primary total hip arthroplasty (THA) where femoral canal preparation via broaching/reaming is appropriate and rigid anatomical structures can be referenced.

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

• Voyager/Tactile Guidance System - CT (K052851)
• Frameless Neuromate (K991081)
• da Vinci Surgical System (K043153)

Reference Devices

• ORTHODOC® Preoperative Planning Workstation (K960685)

Submission Summary (Full Text)

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### Summary of Safety and Effectiveness K072629

AUG - 6 2008

| Submitter: | Integrated Surgical Systems, Inc. |
|------------------------|----------------------------------------------------|
| Address: | 1433 N. Market Blvd., #1, Sacramento, CA 95834 USA |
| Phone Number: | 916-285-9943 |
| Fax Number: | 916-575-7918 |
| Contact Person: | Russ Hibbert |
| Date Submitted: | September 7, 2007 |
| Trade Name: | DigiMatch™ ROBODOC® Surgical System |
| Common Name: | Stereotaxic Instrument |
| Device Classification; | Class II |
| Regulation Number: | 21 CFR 882.4560 |

#### Substantial Equivalence Claim

The DigiMatch™ ROBODOC® Surgical System is substantially equivalent to the Voyager/Tactile Guidance System -- CT (K052851), the Frameless Neuromate (K991081) and the da Vinci Surgical System (K043153).

#### Device Description

The DigiMatch™ ROBODOC® Surgical System consists of the 510(k)-cleared (K960685) ORTHODOC® Preoperative Planning Workstation (ORTHODOC), and a Robot composed of an electromechanical arm, electronics control cabinet, display monitor and miscellaneous accessories (ROBODOC). The System (ORTHODOC and ROBODOC) is a threedimensional graphical preoperative planner and implementation tool and is indicated as an alternative to template planning and manual broaching for treatment of patients who require primary total hip arthroplasty (THA). The ORTHODOC component of the System allows a surgeon to preoperatively assess a patient's femoral anatomy and state of hip disease, select an optimally sized femoral stem implant from a library of prostheses, and determine where the implant should be positioned within the femur. Then ROBODOC component of the System, under direct control by the surgeon, will precisely implement the preoperative plan.

#### Indications for Use / Intended Use Statement

The DigiMatch™ ROBODOC® Surgical System is intended for use as a device, which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures, The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan.

The preoperative planning software and robotic surgical tool is used as an alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA).

The DigiMatch ROBODOC Surgical System is indicated for Orthopedic procedures in which the broaching/reaming in primary total hip arthroplasty (THA) may be considered to be safe and effective and where references to rigid anatomical structures may be made.

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## Summary of Safety and Effectiveness K072629

# Comparison of Technological Characteristics and Principles of Operation

Table 1 provides a comparison of technological characteristics and principles of operation between the DigiMatch™ ROBODOC® Surgical System and its predicate devices, the Voyager/Tactile Guidance System - CT, the Frameless Neuromate and the da Vinci Surgical System.

#### Comparison of Technological Characteristics and Principles of Operation Table 1

| | Patient | Pre- | Surgical Plan | Machine | Patient/Robot | Robot |
|---------------------------------------------------------|--------------------|---------------------|-------------------------------------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| | Image | Surgical | Data | Instructions | Registration | Electromechanic |
| | Data | Plan | | | Requirement | al Arm(s) |
| DigiMatch™<br>ROBODOC®<br>Surgical System | Yes<br>CT Scan | Yes<br>pre-surgery | Yes<br>high level<br>operative plan | Yes<br>robotic arms<br>driven by<br>validated control<br>software and<br>hardware | Yes<br>point to surface<br>registration | Yes<br>Robot with single<br>electromechanical<br>arm and end<br>effector implement<br>control file<br>instructions |
| Voyager<br>Tactile Guidance<br>System - CT<br>(K052851) | Yes<br>CT Scan | Yes<br>pre-surgery | Yes<br>high level<br>operative plan | Yes<br>robotic arms<br>driven by<br>validated control<br>software and<br>hardware | Yes<br>surface to<br>surface<br>registration | Yes<br>Robot with single<br>electromechanical<br>arm and end<br>effector implement<br>control file<br>instructions |
| Frameless<br>Neuromate<br>(K991081) | Yes<br>CT Scan | Yes<br>pre-surgery | Yes<br>high level<br>operative plan | Yes<br>robotic arms<br>driven by<br>validated control<br>software and<br>hardware | Yes<br>fiducial marker<br>registration | Yes<br>Robot with single<br>electromechanical<br>arm and end<br>effector implement<br>control file<br>instructions |
| da Vinci®<br>Surgical System<br>(K043153) | No<br>visual image | No<br>intra-surgery | No<br>control file<br>developed in<br>real time during<br>surgery | Yes<br>robotic arms<br>driven by<br>validated control<br>software and<br>hardware | Yes<br>visual<br>registration | Yes<br>Robot with<br>multiple<br>electromechanical<br>arms and end<br>effector implement<br>control file<br>instructions |

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### Summary of Safety and Effectiveness K072629

#### Summary of Performance Testing

ISS has completed bench, animal, cadaver and clinical testing that assess the safety and efficacy of the ROBODOC System.

#### Nonclinical Studies

Nonclinical cadaver and animal studies provide an accurate means of determining cavity accuracy and placement. The value of such studies is that they allow a measurement of the gap between the bone and implant. They also permit histological examinations of the cavity/implant interface, which has value in determining whether the implant apposition within the cavity is sufficiently narrow.

#### Cadaver Study

The cadaver study compared the accuracy of cutting the femur with the ROBODOC versus manual broaching. The results showed that the ROBODOC was more accurate than manual broaching and led to significantly reduced gaps between the implant and bone.

#### Animal Study

The animal study, involving 20 male greyhounds, also supports the conclusion that the ROBODOC is more accurate than manual broaching in cutting the femur. Histological examination revealed many instances of fracture or osteotomy in the control group, compared to none in the ROBODOC group. In addition, histological examination revealed that the ROBODOC group had more consistent cortical bone continuity, better apposition of implants with cortical and cancellous bone, and appeared to have less cancellous bone hypertrophy.

### Clinical Studies

The First U.S. Trial (G920035) was conducted using the "pin-based" technology, which required three locator (fiduciary) pins to register the robotic device to the patient. The primary endpoints of efficacy that demonstrated precise and reliable implantation of the preoperative plan were fit and alignment of the femoral implant. Primary clinical efficacy was demonstrated showing equivalence in Harris Hip Scores between the ROBODOC group and the manual control group.

The Second U.S. Trial (IDE # G000071) was undertaken with the "pinless" DigiMatch™ ROBODOC® Surgical System. The DigiMatch™ technology modified the ROBODOC System so as not to require pre-operative placement of fiduciary pins. The data from this trial also confirmed the safety and efficacy of the ROBODOC System. As with the First IDE Trial, primary clinical efficacy was demonstrated showing equivalence in Harris Hip Scores between the ROBODOC group and the manual control group.

### Conclusion

The DigiMatch™ ROBODOC® Surgical System, which is substantially equivalent to the Voyager/Tactile Guidance System - CT, the Frameless Neuromate and the da Vinci Surgical System, has been shown to be safe and effective for its intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 6 2008

Intergrated Surgical Systems, Inc. % Mr. Russ Hibbert Director, Clinical & Regulatory Affairs 1433 N. Market Boulevard #1 Sacramento, California 95834

Re: K072629

Trade/Device Name: DigiMatch™ ROBODOC® Surgical System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: OJP, HAW Dated: March 31, 2008 Received: April 3, 2008

Dear Mr. Hibbert:

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. Russ Hibbert

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 10gally 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 Postmarlet, Surveillance at [phone]. For questions regarding the reporting 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. Mullison

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

510(k) Number (if known): Unknown at this time K072629

Device Name: DigiMatch™ ROBODOC® Surgical System

Indications for Use:

The DigiMatch™ ROBODOC® Surgical System is intended for use as a device, which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan.

The preoperative planning software and robotic surgical tool is used as an alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA).

The DigiMatch ROBODOC Surgical System is indicated for Orthopedic procedures in which the broaching/reaming in primary total hip arthroplasty (THA) may be considered to be safe and effective and where references to rigid anatomical structures may be made.

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)

Mark A. Wilkerson

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number K0 to