(174 days)
No
The description focuses on computer-aided navigation using spatial tracking and proprietary software, with no mention of AI, ML, or related concepts like image processing or training/test sets for algorithms.
No
The device is a computer-aided surgical navigation system that assists surgeons in positioning endoprostheses. It does not directly treat or cure a disease or condition.
No
The device is described as a computer-aided navigation system for surgical instruments used to position endoprostheses and aid surgeons with accurate positioning during arthroplasty, and provides intraoperative measurements. Its purpose is to guide surgical actions rather than to diagnose conditions or diseases.
No
The device description explicitly lists multiple hardware components (stereotaxic camera, computer, rigid bodies, passive markers, etc.) that are integral to the system's function. It is not solely software.
Based on the provided information, the OrthoPilot® Next Generation Platform is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "computer-aided navigation of surgical instruments" to "position endoprosthesis in athroplasty in the patient." This describes a device used during a surgical procedure to guide the surgeon, not a device used to perform tests on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details hardware components like a camera, computer, rigid bodies, and instruments used for tracking and navigation within the surgical field. It doesn't mention any components or processes related to analyzing biological samples (blood, tissue, etc.).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on laboratory tests.
- Measuring biomarkers or other biological indicators.
The OrthoPilot® Next Generation Platform is a surgical navigation system, which falls under the category of medical devices used to assist in surgical procedures.
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 athroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for endoprosthesis replacement surgery (such as total 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, 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 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The profiles are rendered in black against a white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 16, 2016
Aesculap Implant Systems, LLC Mr. Paul Amudala Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K153396
Trade/Device Name: OrthoPilot® Next Generation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: April 12, 2016 Received: April 14, 2016
Dear Mr. Amudala:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/ResourcesforYou/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 yours,
Lori A. Wiggins -S
for
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)
Device Name 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 athroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for endoprosthesis replacement surgery (such as total 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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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B. 510(k) SUMMARY (as required by 21 CFR 807.92)
Aesculap OrthoPilot® Next Generation
Apr 12, 2016
| COMPANY: | Aesculap®Implant Systems(AIS), LLC.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 300567331 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Paul Amudala
610-984-9303 (phone)
610-791-6882 (fax)
paul.amudala@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 |
| CLASSIFICATION NAME: | Orthopedic Stereotaxic Instrument |
| REVIEW PANEL: | Orthopedic |
SUBSTANTIAL EQUIVALENCE
Aesculap® Implant Systems, L.L.C. believes that the updates to OrthoPilot® Next Generation TKA, TKR, and UKA software modules are substantially equivalent to the currently marketed OrthoPilot® Next Generation UKA software module cleared in the primary predicate K090375; OrthoPilot® Next Generation TKA & TKR software modules cleared in reference predicate K080547 and the CAP markers/Polaris Spectra 14 camera cleared in reference predicate K141694.
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, 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
4
other and/or instruments. The software modules for the OrthoPilot® Next Generation consist of modules for both a knee suite and a hip suite.
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 guides, 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 originally cleared under K080547 and recent subsequently updates cleared under K141694. The intended use and fundamental scientific technology of the OrthoPilot® Next Generation Navigation system remain unchanged including the integration of passive marker spheres cleared as part of K141694. The only difference is an update to the knee software modules (TKA, TKR and UKA) for the integration of passive marker spheres cleared as part of K141694 and the other minor improvements.
PERFORMANCE DATA
OrthoPilot® Next Generation navigation 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. There is no change to previous performance data for the OrthoPilot® Next Generation navigation system.
In addition, the software updates continue to comply with:
- IEC 62304 International Electrotechnical Commission Medical Device Software - Software Life Cycle Processes