(118 days)
The Orthopilot® 2 Navigation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to optimally position endoprosthesis in arthroplasty such as the Search Evolution Knee system and the Gem Knee system 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.
The Total Hip Arthroplasty (THA) software module version 3.0 is an upgrade to the THA version 2.0 that was cleared for the Aesculap Orthopilot 2. It is designed to provide computer aided navigation for total hip arthroplasty using Aesculap's Orthopilot 2 platform. The Orthopilot 2 uses transmitters that are mounted to the patients bones, or are 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. THA version 3.0 also allows for the use of ultrasound to provide data for anatomical landmarks.
The provided text describes an upgrade to a surgical navigation system, the Aesculap Orthopilot 2 THA V 3.0, and its substantial equivalence to a previously cleared device. However, it does not contain specific performance data, acceptance criteria, or details of a study that would prove the device meets such criteria.
The document primarily focuses on:
- Device Description and Indications for Use: Explaining what the device does (computer-aided navigation for total hip arthroplasty) and its upgrades (THA version 3.0, ultrasound data integration).
- Regulatory Compliance: Mentioning adherence to Aesculap's internal SOPs and FDA guidance, as well as recognized international standards (IEC 60601-1, IEC 60601-1-2) for safety and electromagnetic compatibility.
- Substantial Equivalence: Stating that the device is substantially equivalent to its predecessor (THA Module 2.0, K050752), which was cleared based on its equivalence to an even earlier version (THA Module 1.0, K013569). This is the primary method of demonstrating safety and effectiveness in a 510(k) submission when no applicable performance standards have been promulgated.
Therefore, I cannot provide the requested information in the table format or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.
The document explicitly states under "PERFORMANCE DATA": "No applicable performance standards have been promulgated under FDCA Section 514 for this system." This indicates that the FDA did not require specific performance testing against predefined external standards to grant market clearance for this particular device upgrade as a 510(k). Instead, clearance was based on demonstrating substantial equivalence to a legally marketed predicate device.
To answer your questions, one would need to refer to the original 510(k) submissions (K050752 and K013569) for the predicate devices, or other documentation that might contain detailed performance testing if such testing was performed internally by the manufacturer and submitted as part of the equivalence argument.
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K072899
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS C. (in Accordance with SMDA of 1990)
Aesculap Orthopilot 2 THA V 3.0 8 October 2007
| COMPANY: | Aesculap®Implant Systems, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 3005673311 | FEB - 6 |
|---|---|---|
| CONTACT: | Matthew M. Hull800-258-1946 x 5072 (phone)610-791-6882 (fax) | |
| TRADE NAME: | Aesculap Orthopilot 2 THA V 3.0 | |
| 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® 2 Navigation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to optimally position endoprosthesis in arthroplasty such as the Search Evolution Knee system and the Gem Knee system 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
The Total Hip Arthroplasty (THA) software module version 3.0 is an upgrade to the THA version 2.0 that was cleared for the Aesculap Orthopilot 2. It is designed to provide computer aided navigation for total hip arthroplasty using Aesculap's Orthopilot 2 platform. The Orthopilot 2 uses transmitters that are mounted to the patients bones, or are 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. THA version 3.0 also allows for the use of ultrasound to provide data for anatomical landmarks.
PERFORMANCE DATA
No applicable performance standards have been promulgated under FDCA Section 514 for this system. This software module was 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 2 Navigation platform does comply with the following FDA recognized standards:
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- International Electrotechnical Commission; Medical Electrical IEC 60601-1 Equipment, Part 1: General Requirements for Safety.
- International Electrotechnical Commission; Medical Electrical IEC 60601-1-2 Equipment, General Requirements for Safety: Electromagnetic Compatibility - Requirements and Tests.
SUBSTANTIAL EQUIVALENCE
Aesculap® Implant Systems, Inc. believes that the Orthopilot 2 THA Software Module 3.0 is substantially equivalent to our currently marketed THA Module 2.0 that was cleared in Aesculap's 510(k) submission #K050752 and THA Module 1.0 in the original submission #K013569 for Orthopilot 2.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a 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, with three wavy lines below the eagle.
Public Health Service
FEB - 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aesculap Implant Systems, Inc. % Mr. Matthew M. Hull Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K072899
Trade/Device Name: Aesculap Orthopilot 2 THA Module V 3.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: January 8, 2008 Received: January 9, 2008
Dear Mr Hull:
We have reviewed your Section 510(k) premarket notification of intent to market the device w f nave a sove 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 for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner of they 2011-11-11 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 r ou may, mercess, morely in the Act include requirements for annual registration, listing of general voltable provincitice, 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 If your device is enabilional controls. Existing major regulations affecting your device can may or subject to deen as a segulations, 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 I that FDA has made a determination that your device complies with other requirements of the Act that I Drimas intatutes and regulations administered by other Federal agencies. You must or any I cacial suitates and reguirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK in the quality systems (DS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by sions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Matthew M. Hull
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 (240) 276-0115. 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 (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Mulkerson
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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B. INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K072899 |
|---|---|
| ---------------- | --------- |
Device Name: Aesculap Orthopilot 2 THA Module V 3.0
Indication for Use:
The Orthopilot® 2 Navigation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to optimally position endoprosthesis in arthroplasty such as the Search Evolution Knee system and the Gem Knee system 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(Part 21 CFR 801 Subpart D) | X |
|---|---|
| ------------------------------------------------- | --- |
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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | 1672899 |
|---|---|
| Page | 1 of 1 |
§ 882.4560 Stereotaxic instrument.
(a)
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.(b)
Classification. Class II (performance standards).