(126 days)
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No
The document describes a computer-assisted surgical navigation system that uses spatial tracking and ultrasound input, but there is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML details.
No
The device aids the surgeon in accurately positioning instruments for implant placement, but it does not directly treat or prevent a disease or condition. Its primary function is navigational assistance, not therapeutic intervention.
No
The device is described as a "computer-aided navigation system of surgical instruments" that "aids the surgeon in accurately positioning the cutting guides, drills and reamers" and "provides intraoperative measurements of bone alignment." It is a surgical aid for navigation and positioning during surgery, not for diagnosing a disease or condition.
No
The device description explicitly lists multiple hardware components including a stereotaxic camera, computer, rigid bodies, power supply, instruments, ultrasound module, transport cart, and stand.
Based on the provided information, the Orthopilot® Next Generation Navigation Platform is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Orthopilot's Function: The Orthopilot system is a surgical navigation platform used during surgery to aid the surgeon in positioning instruments and implants. It uses computer-aided navigation, cameras, transmitters, and ultrasound to provide real-time spatial information and measurements within the patient's body.
- No Sample Analysis: The system does not analyze any samples taken from the patient's body. Its function is entirely focused on guiding surgical procedures based on anatomical landmarks and spatial relationships.
Therefore, the Orthopilot® Next Generation Navigation Platform falls under the category of a surgical navigation system or computer-assisted surgery device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Orthopilot® Next Generation Navigation 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 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.
Product codes
OLO
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 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 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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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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C. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
(in Accordance with SMDA of 1990)
| Aesculap Orthopilot Next Generation | JUN 23 2009 | |
|---|---|---|
| April 3, 2009 | ||
| COMPANY: | Aesculap® Implant Systems, Inc. | |
| 3773 Corporate Parkway | ||
| Center Valley, PA 18034 | ||
| Establishment Registration Number: 3005673311 | ||
| CONTACT: | Lisa M. Boyle | |
| 800-258-1946 x 5274 (phone) | ||
| 610-791-6882 (fax) | ||
| TRADE NAME: | Aesculap Orthopilot Next Generation | |
| COMMON NAME: | Surgical Navigation Platform | |
| DEVICE CLASS: | Class II | |
| PRODUCT CODE: | OLO | |
| CLASSIFICATION: | 882.4560 - Orthopedic Stereotaxic Instrument | |
| REVIEW PANEL: | Orthopedic |
INDICATIONS FOR USE
The Orthopilot® Next Generation Navigation 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 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.
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 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 also can accept spatial input for anatomical landmarks from an ultrasound unit.
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The software modules for the OrthoPilot Next Generation consist of modules for both a knee suite and a hip suite.
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.
SUBSTANTIAL EQUIVALENCE
Aesculap® Implant Systems, Inc. believes that the OrthoPilot Unicondylar Knee Arthroscopy (UKA) software module is substantially equivalent to our currently marketed OrthoPilot Total Knee Arthroscopy (TKA) software module cleared in Aesculap's 510(k) submission #K080547.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
JUN 23 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aesculap Implant System, Incorporated % Ms. Lisa M. Boyle Sr. Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K090375
Trade/Device Name: Aesculap Orthopilot Next Generation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotactic Instrument Regulatory Class: II Product Code: OLO Dated: May 18, 2009 Received: May 20, 2009
Dear Ms. Boyle:
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 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
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Page 2-Ms. Lisa M. Boyle
practice requirements as set forth in the quality systems (OS) 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrl/mdr/ 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 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 M. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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B. INDICATIONS FOR USE STATEMENT
1,090378 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 position endoprosthesis in arthroplasty 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.
AND/OR Over-The-Counter Use Prescription Use × (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
H, Office of Device Evaluation (ODE) Concurrence of C
Nukl R.E.L. for mth
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090375
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