(245 days)
No
The summary describes a computer-assisted surgical navigation system that uses proprietary software and hardware to provide anatomical information and guide instrument placement. It relies on spatial tracking and measurement based on physical markers and ultrasound input. There is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms. The description focuses on traditional navigation techniques.
No
The device is a computer-aided surgical navigation system, which assists the surgeon in accurately positioning instruments and provides intraoperative measurements during arthroplasty. It is not intended to treat or prevent a disease or condition itself.
No
The device is described as a computer-aided navigation system for surgical instruments that provides intraoperative measurement and indicates angles and positions for implant placement. While it provides "anatomical information," its primary purpose is to guide surgical actions rather than to diagnose medical conditions or diseases.
No
The device description explicitly lists multiple hardware components including a stereotaxic camera, computer, rigid bodies, passive markers, power supply, tagged instruments, and an ultrasound module. The software is described as proprietary software that utilizes input from these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "computer-aided navigation of surgical instruments" to "position endoprosthesis in arthroplasty in the patient." This describes a surgical guidance system used during a surgical procedure on a patient.
- Device Description: The description details hardware components like a camera, computer, rigid bodies, markers, and an ultrasound module, all used for tracking and providing spatial information in vivo (within the living patient).
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information about a patient's health status, which is the core function of an IVD.
IVDs are devices used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical navigation tool used to assist the surgeon during the procedure itself.
N/A
Intended Use / Indications for 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.
Product codes
OLO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and unity.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
B. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Aesculap OrthoPilot Next Generation
January 27, 2015
| COMPANY: | Aesculap® Implant Systems, LLC
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 300567331 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Julie Tom Wing
610-984-9147 (phone)
610-791-6882 (fax)
Julie.TomWing@aesculap.com |
| 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.
4
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
Part 1: General Requirements for Basic Safety and Essential
Performance |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 62304 | International Electrotechnical Commission Medical Device Software –
Software Life Cycle Processes |
| ISO 14971 | International Standards Organization Medical Devices – Application of
Risk Management to Medical Devices |