(35 days)
No
The summary describes a computer-aided navigation system using optical tracking, not AI/ML. There are no mentions of AI, ML, or related concepts like training/test sets.
No
The device is a computer-aided navigation system for surgical instruments used in arthroplasty to optimally position endoprosthesis, it does not directly treat a disease or condition itself.
No
Explanation: The device is described as a "system for computer-aided navigation of surgical instruments" that "aids the surgeon in accurately positioning cutting guides, drills, and reamers." Its purpose is to guide surgical actions, not to diagnose a disease or condition.
No
The device description explicitly states it uses "optical transmitters in combination with a camera" to monitor instruments, indicating the presence of hardware components beyond just software.
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 "optimally position endoprosthesis in arthroplasty." This is a surgical guidance system used during a surgical procedure on a patient.
- Device Description: The description reinforces this by explaining how it uses optical transmitters and a camera to monitor instruments in relation to the patient's bones or anatomical landmarks.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The device is a surgical navigation system, which is a type of medical device used to assist surgeons during procedures, not an in vitro diagnostic device.
N/A
Intended Use / 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 intraoperative measurements of bone alignment. It indicates optimized angles and positions for implant placement.
Product codes
84 HAW
Device Description
The Total Hip Arthroplasty (THA) software module version 2.0 is an upgrade to the THA software module version 1 that was originally cleared in Aesculap’s 510(k) submission for Orthopilot 2. The Orthopilot 2 THA module version 2.0 and Orthopilot 2 provide computer aided navigation for hip arthroplasty using Aesculap’s Orthopilot 2 Navigation platform. The Orthopilot 2 uses markers that are mounted to the patients bones, or attached to instruments. The Orthopilot 2 uses optical triangulation with a camera to monitor the position of the markers to palpate anatomical landmarks and monitor the position of the markers in relation to each other and/or instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip (for total hip arthroplasty)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon / Not Found (implied surgical setting)
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
No applicable performance standards have been promulgated under FDCA Section 514. Software 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" dated January 2002. The Software Control of Navigation platform does comply with the following FDA recognized standards: 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.
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
1:3
Image /page/0/Picture/2 description: The image shows the date "APR 27 2005" and the code "K050752". The text is written in a simple, bold font. The date is written in all capital letters, and the code is written in a mix of capital and lowercase letters. The image is likely a scan or photograph of a document.
B. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
(in Accordance with SMDA of 1990)
Aesculap Orthopilot 2 THA V 2.0.4 23 March 2005
| COMPANY: | Aesculap®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 2916714 |
|-----------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Matthew M. Hull
800-258-1946 x 5072 (phone)
610-791-6882 (fax) |
| TRADE NAME: | Aesculap Orthopilot 2 THA V 2.0 |
| 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 The Orthopilor 2 Navigation Plation is a sition endoprosthesis in arthroplasty such as the Institution Knee system and the Gem Knee system in the patient. It aids the surgeon Search Evolution Rhee System and the cutting guides, drills and reamers for total endoprosthesis In accurately positioning the oating grative measurements of bone alignment. It indicates optimized angles and positions for implant placement.
DEVICE DESCRIPTION
The Total Hip Arthroplasty (THA) software module version 2.0 is an upgrade to the THA The Total Thp Arthopidocy ( . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . version 1 that was Onginally of are and hip arthroplasty using Aesculap's Orthopilot 2 provide computer alocu namagation for sear. that are mounted to the patients bones, or plation. The Orthopliot 2 dood transmation with a camera to monitor the are mobile to palpato anatomitters in relation to each other and/or instruments.
PERFORMANCE DATA
No applicable performance standards have been promulgated under FDCA Section 514 No applicable performance was developed in accordance with Aesculap's internal SOP's as well as CDRH's "General Principles of Software Validation; Final internal SOF 3 as well as OBR. For Control of Navigation platform does comply with the following FDA recognized standards:
1
Special 510(k) Premarket Notification
K0507S2
- 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®, Inc. believes that the Orthopilot 2 THA Software Module 2.0 is substantially Aesculap ', inc. bellovoo that the Od THA Module 1 that was cleared in Aesculap's 510(k) submission #K013569 for Orthopilot 2.
ﮯ
5
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
APR 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mathew M. Hull, RAC Regulatory Affairs Manager Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K050752
R050752
Trade/Device Name: Aesculap Orthopilot 2 THA Module V 2.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 21, 2005 Received: April 22, 2005
Dear Mr.Hull:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becaon - ro(x) presidentially equivalent (for the indications felerenced above and nave decembled we are and for use stated in the encrosule) to legally manative province to of the Medical Device Amendments, or to commerce prior to May 26, 1976, the enature with the provisions of the Federal Food, Drug. devices that have been recalised in accerative in a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket af the Agt, if th and Cosmetic Act (Act) that do not require appro the general controls provisions of the Act. The You may, therefore, market the devices, seejes of the counter for annual registration, listing of general controls provisions of the Fiel labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) into e. Existins major regulations affecting your device .
it may be subject to such additional controls. Existing major Leveldition it may be subject to such additional controls: "Bheilege":"
can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 minutes and can be found in the Code of I caeral cognition in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination mot of the other Please be advised that IDA s issualice of a became of the requirements of the Act
that FDA has made a determination that your device complies with other mast that FDA has made a determination administered by other Federal agencies. You must or any Federal Statutes and regulations and ing, but not limited to: registration and listing (21 let comply with an the Act 3 requirements, and manufacturing practice requirements as set Cr K Part 807), labeling (21 CFR Part 800), go a art 820); and if applicable, the electronic forth in the quality systems (QD) regalates (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Mr. Mathew M. Hull, RAC
This letter will allow you to begin marketing your device as described in your Section 5 10(k)
10 leval This letter will allow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, premarket notification. The PDA Inding of Substantal of a many of the spermits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs the regulation and 10, 2011 for Alex also as and the regulation entitled If you desire specific advice for your de not our our our our note the regulation entitled, the leavers of the regulation contact the Office of Collipialice at (246) 270 - 1 (2107R Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21 the African of Small "Misbranding by relerence to premarket notification of Set from the Division of Small
other general information on your responsibilities under the tall, from pumber (800) 638 other general information on your responsion.com its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-freevertry/support/in Manufacturers, International and Consulter Assistance at to voor virus virus virus variantes. html.
Sincerely yours,
signature
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT B.
14050752 510(k) Number:________________________________________________________________________________________________________________________________________________________________
Device Name: Aesculap Orthopilot 2 THA Module V 2.0
Indication for Use:
The Orthopilot® 2 Navigation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to optimally position endoprosities in arthroplasty such as the Search Evolution Knee system and the Gem Knee system in the patient. It aids the surgeon Search Evolution Knee system and the Och I the Present of Criter belopment of in accurately positioning the cutting guides intraoperative of bone alignment. It replacement "surgery" and promotions for implant placement.
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)
050752
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