(219 days)
The BLUE NAVIGATION SYSTEM is intended for use during stereotaxic surgery to help surgeons locate anatomical structures and align endoprostheses. It is specifically indicated for Total Knee Arthroplasty.
The BLUE NAVIGATION SYSTEM is an image guided, or navigation, system for orthopedic surgical procedures. It is intended to intraoperatively compute and display information such as distances and angles related to surgical instrument position. It provides this data to help surgeons make decisions, and is not intended to make surgical decisions or replace surgical actions. The station is composed of an optical localizer system, a computer, and a screen. The localizer tracks in real time the positions of trackers rigidly attached to patient bone or surgical instruments. The BLUE NAVIGATION SYSTEM is imageless, meaning there is no need for preoperative images (CR or MRI), but is based on intraoperative patient anatomical landmarks that are digitized at the beginning of the procedure by the surgeon. The station uses these landmarks to compute useful information that is displayed on a screen to help surgeons position prosthetic components.
The provided document focuses on the 510(k) summary for the BLUE NAVIGATION SYSTEM, detailing its intended use, comparison to predicate devices, and a general statement about performance testing. However, it does not provide specific quantitative acceptance criteria or detailed results of a study demonstrating the device meets such criteria.
The document states:
"Analyses show that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison the predicate devices."
"BLUE NAVIGATION SYSTEM was tested in a non-clinical setting and anatomical testing) to assess that no new safety and effectiveness issues were raised in the device."
This is a general statement of compliance, not a presentation of specific acceptance criteria and the data to show they were met.
Therefore, for most of your questions, the information is not available in the provided text.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific quantitative criteria are not provided in the document. | "the accuracy and performance of the system was adequate for its intended use and not reduced in comparison the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document only mentions "non-clinical setting and anatomical testing."
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set:
- Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done? Not mentioned. The focus is on the device's standalone performance relative to predicate devices.
- Effect size: Not applicable, as an MRMC study is not mentioned.
6. Standalone (Algorithm Only) Performance Study:
- Was it done? Yes, implicitly. The "Performance Testing" section describes testing of the "BLUE NAVIGATION SYSTEM" itself to assess its accuracy and performance. This implies a standalone evaluation of the device's capabilities without human-in-the-loop performance measurement.
7. Type of Ground Truth Used:
- Not explicitly stated. Given the context of an imageless navigation system relying on "intraoperative patient anatomical landmarks that are digitized," the ground truth for accuracy measurements would likely involve physical measurements or highly accurate reference systems in the non-clinical and anatomical testing settings, rather than expert consensus on images or pathology.
8. Sample Size for the Training Set:
- Not specified.
- The device is "imageless," meaning there's "no need for preoperative images (CR or MRI)," which typically form the basis of training sets for image-based AI. This suggests that if machine learning is involved, the 'training' might be related to internal calibration or statistical models derived from engineering data, rather than a traditional medical image training set. However, the document does not elaborate on any machine learning or AI components specifically, beyond its function as a navigation system.
9. How Ground Truth for the Training Set was Established:
- Not applicable as a traditional training set with established ground truth, as understood in machine learning contexts, is not described or implied. If there are internal models, their 'ground truth' would be derived from precisely engineered physical measurements during development and calibration, rather than clinical consensus.
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/00742
OCT 2 1 2010
510(k) Summary BLUE NAVIGATION SYSTEM
The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92.
510(k) Submitter:
BLUE ORTHO 5 avenue du Grand Sablon 38700 La Tronche France Phone : +33 476549546
Contact Name: Anthony BOYER, President anthony.boyer@blue-ortho.com
Date Prepared: March 5th, 2010.
Proposed Device:
| Trade Name: | Exactech GPSBlue Navigation System |
|---|---|
| Common Name: | Image Guided Surgery System |
| Classification Name: | Sterotaxic Instruments |
| Device Class: | II |
| Product Code: | HAW |
Predicate Device:
BLUE NAVIGATION SYSTEM is substantially equivalent to the STRYKER NAVIGATION SYSTEM - KNEE MODULE cleared under 510(k) #K022579 and the TOTAL KNEE SURGETICS NAVIGATION SYSTEM cleared under #K060282.
Device Description:
The BLUE NAVIGATION SYSTEM is an image guided, or navigation, system for orthopedic surgical procedures. It is intended to intraoperatively compute and display information such as distances and angles related to surgical instrument position. It provides this data to help surgeons make decisions, and is not intended to make surgical decisions or replace surgical actions.
The station is composed of an optical localizer system, a computer, and a screen. The localizer tracks in real time the positions of trackers rigidly attached to patient bone or surgical instruments.
The BLUE NAVIGATION SYSTEM is imageless, meaning there is no need for preoperative images (CR or MRI), but is based on intraoperative patient anatomical landmarks that are digitized at the beginning of the procedure by the surgeon. The station uses these landmarks to compute useful information that is displayed on a screen to help surgeons position prosthetic components.
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Intended Use:
The BLUE NAVIGATION SYSTEM is intended for use during stereotaxic surgery to help surgeons locate anatomical structures and align endoprostheses.
It is specifically indicated for Total Knee Arthroplasty.
Contraindications:
The surgeon needs to determine if a patient's condition is appropriate for treatment including the BLUE NAVIGATION SYSTEM. Advanced osteoporosis and a dysplastic or stiff hip joint are examples of conditions precluding use of the BLUE NAVIGATION SYSTEM.
Comparison of Technological Characteristics:
The BLUE NAVIGATION SYSTEM shares the same main components with predicate devices: a computer, a display screen, a 6D optical localized trackers rigidly attached to patient bone and surgical instruments, , and a localized pointer also used to digitize intraoperative anatomical landmarks.
Both the BLUE NAVIGATION SYSTEM and the predicate devices intraoperatively digitize anatomical patient landmarks with a localized pointer in order to model patient anatomy.
The main technological difference between the BLUE NAVIGATION SYSTEM and the predicate devices is the BLUE NAVIGATION SYSTEM station is smaller and attached to the OR table, making use of a dedicated sterile drape necessary. Any differences in technology do not raise questions or issues regarding safety and effectiveness of the BLUE NAVIGATION SYSTEM.
Performance Testing:
BLUE NAVIGATION SYSTEM was tested in a non-clinical setting and anatomical testing) to assess that no new safety and effectiveness issues were raised in the device. Analyses show that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison the predicate devices.
In conclusion, the BLUE NAVIGATION SYSTEM is substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Blue Ortho % Mr. Anthony Boyer President 5 avenue du Grand Sablon 38700 La Tronche France
Re: K100742
Trade/Device Name: Blue Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrucment Regulatory Class: II Product Code: OLO, HAW Dated: October 11, 2010 Received: October 12, 2010
Dear Mr. Boyer:
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
OCT 2 1 2010
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Page 2 - Mr. Anthony Bover
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 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 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/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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
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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Indications for use
510(k) Number: Not know yet.
Device Name: Blue Navigation System OCT 2 1 2010
Indications For Use:
The BLUE NAVIGATION SYSTEM is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.
It is specifically indicated for Total Knee Arthroplasty.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Ogden Forman
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100742
§ 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).