(97 days)
The TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES 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
As the equivalent TOTAL KNEE SURGETICS NAVIGATION SYSTEM, the TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES consists of the following major components and subsystems:
- The Station (Surgetics or NanoStation), consisting of a mobile computer . system and an optical localizer
- Ancillary instruments, specific motorized cutting block and reflective . markers used for reference and registration
- TOTAL KNEE SURGETICS with Praxiteles software ●
The main modification to the predicate device K060282 concerns the use of a new motorized cutting block PRAXITELES®.
The provided text describes the 510(k) summary for the TOTAL KNEE SURGETICS Navigation System with Praxiteles. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state numerical acceptance criteria. Instead, it refers to a qualitative assessment against the predicate device.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| No new safety and efficiency issues are raised. | Analyses show that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicate device. |
| Accuracy and performance are adequate for intended use. | Analyses show that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicate device. |
| Performance is not reduced compared to the predicate device (K060282). | The underlying technology... is the same as for the predicate device K060282. The system is based on the same operating principle and control mechanism to provide the user with the same kind of information and guidance for the same surgery... The accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated. The study involved "non clinical setting (bench testing, specimen)." The number of specimens used is not specified.
- Data Provenance: The study was conducted in a "non clinical setting (bench testing, specimen)." This indicates it was a laboratory or cadaveric study, not on live human patients. The country of origin of the data is not specified, but the submitter is based in France.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The study was non-clinical, so expert involvement in establishing ground truth for clinical cases would not be applicable in the same way.
4. Adjudication Method for the Test Set:
This information is not provided in the document. Given the nature of the non-clinical testing, a typical adjudication method for clinical studies (e.g., 2+1) would not be relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through non-clinical testing, comparing the modified device to a predicate, rather than human reader performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The description of the "bench testing" and "specimen" analysis, focusing on "accuracy and performance of the system," suggests that standalone performance of the device's navigation and motorized cutting block components was evaluated. The device's function is to "aid the surgeon in locating anatomical structures and aligning the endoprostheses," implying the algorithm's performance in guiding and positioning.
7. The Type of Ground Truth Used:
The type of ground truth used is not explicitly stated but can be inferred from the "bench testing, specimen" context. For mechanical accuracy assessments in a non-clinical setting, ground truth would likely be established through:
- Precise measurements using calibrated instruments or reference standards.
- Verification against known anatomical landmarks or pre-defined surgical plans on cadaveric specimens.
8. The Sample Size for the Training Set:
This information is not applicable/provided. The document describes a 510(k) submission for a device, TOTAL KNEE SURGETICS Navigation System with Praxiteles, which is an image-guided surgical navigation system with a motorized cutting block. This type of device typically does not involve machine learning algorithms that require a "training set" in the conventional sense for image classification or prediction tasks. Its core functionality relies on optical tracking and pre-programmed algorithms for surgical guidance and positioning.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/provided for the same reason as in point 8.
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K08/232
Page 1 of 3
510(k) Summary AUG - 6 2008 for TOTAL KNEE SURGETICS Navigation System with Praxiteles
1. Submitter Name and Address:
Praxim "Le Grand Sablon" 4, Avenue de l'Obiou 38 700 La Tronche France
Contact Name: Annie Pollier Telephone: (0033) 4 76 54 95 03
Date Prepared: April 25th 2008
2. Device Name:
| Proprietary Name: | TOTAL KNEE SURGETICS Navigation System withPraxiteles |
|---|---|
| Common/Usual Name: | Image guided surgical navigation system |
| Classification Name: | Computed tomography x-ray system (accessory) |
2. Equivalent to:
| 510(k) number | K060282 | K061362 | K063408 |
|---|---|---|---|
| Proprietary Name | PRAXIM | PLUSORTHOPEDICS AG | PRAXIM |
| Common/UsualName | TOTAL KNEESURGETICSNavigation System | PIGALILEOTOTAL KNEEREPLACEMENT(TKR) SYSTEM | CTLOGICSNavigation System |
| ClassificationName | instrument,stereotaxic | instrument,stereotaxic | instrument,stereotaxic |
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Page 83
4. Intended Use:
The TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES 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
న. Device Description:
As the equivalent TOTAL KNEE SURGETICS NAVIGATION SYSTEM, the TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES consists of the following major components and subsystems:
- The Station (Surgetics or NanoStation), consisting of a mobile computer . system and an optical localizer
- Ancillary instruments, specific motorized cutting block and reflective . markers used for reference and registration
- TOTAL KNEE SURGETICS with Praxiteles software ●
The main modification to the predicate device K060282 concerns the use of a new motorized cutting block PRAXITELES®.
Technological Characteristics and Substantial Equivalence 6.
The underlying technology of the TOTAL KNEE SURGETICS Navigation System with PRAXITELES is the same as for the predicate device K060282. The system is based on the same operating principle and control mechanism to provide the user with the same kind of information and guidance for the same surgery. The main changes with respect to the predicate device concern the addition of a motorized cutting block Praxiteles. Praxiteles is a motorized cutting block controlled by the navigation system that automatically positions the cutting slot to the desired cut. Then the position of the motorized cutting block is controlled and the surgeon can proceed to the cut as it is done in the conventional way. The system enables the cutting slot to be positioned either automatically or manually.
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Ko81232
Page 3 of 3
7. Performance Testing
The TOTAL KNEE SURGETICS Navigation System with Praxiteles was tested in a non clinical setting (bench testing, specimen) to assess that no new safety and efficiency 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 to the predicate device.
In conclusion the modified device TOTAL KNEE SURGETICS Navigation System with Praxiteles is substantially equivalent to the predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol. The logo is simple, yet recognizable, and represents the department's role in protecting the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2008
Praxim % Ms. Annie Pollier VP, Operations, Quality & Regulatory Le Grand Sablon 4. Avenue de l'Obiou 38 700 La Tronche France
Re: K081232
Trade/Device Name: TOTAL KNEE SURGETICS Navigation System with Praxiteles Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: July 10, 2008 Received: July 17, 2008
Dear Ms. Pollier:
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 such 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); good manufacturing practice requirements as set
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Page 2 - Ms. Annie Pollier
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.
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 N. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the logo for PRAXIM Computer Integrated Surgery. The logo is in all caps and has a unique font. The words "COMPUTER INTEGRATED SURGERY" are written in a smaller font below the main logo.
PRAXIM S.A. le Grand Sablon 4, Avenue DE L'Oblou 38700 LA TRONCHE FRANCE
PHONE : 33 4 76 54 95 03 FAX +33 4 76 51 98 29
S.A. AU CAPITAL DE 2'769'610 € NO SIRET 400 491 304 00020 CODE APE 331 B
STATEMENT OF INDICATIONS FOR USE TOTAL KNEE SURGETICS Navigation System with Praxiteles
510(k) Number (if known):
K08/232
Device Name: TOTAL KNEE SURGETICS Navigation System with Praxiteles
The TOTAL KNEE SURGETICS Navigation System with Praxiteles is intended for use during
stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning they
endoprostheses with the anatomical structures.
It is specifically indicated for :
- Total Knee Arthroplasty
Mark X Millhouse
Division of General, Restorative, and Neurological I
510(k) Number
K0812 S2
Prescription Use X AND / OR (Part 21 CFR 801 Subpart D)
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)
Praxim 510(k) [04/25/2008] TOTA KNEE SURGETICS Navigation System with Praxiteles
Confidential Page 1 / 1
§ 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).