(97 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on hardware components and software for navigation and alignment, which are typical of traditional surgical navigation systems.
No.
The device is a surgical navigation system intended to aid the surgeon in locating anatomical structures and aligning endoprostheses during total knee arthroplasty, which is an assistive tool for surgery, not a therapeutic device itself.
No
The device aids surgeons in locating anatomical structures and aligning endoprostheses during stereotaxic surgery for total knee arthroplasty, which is a surgical aid, not a diagnostic function.
No
The device description explicitly lists hardware components such as a mobile computer system, optical localizer, ancillary instruments, a motorized cutting block, and reflective markers. While software is a component, it is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures." This describes a surgical navigation system used during a procedure, not a test performed in vitro (outside the body) on biological samples to diagnose or monitor a condition.
- Device Description: The components listed (computer system, optical localizer, instruments, markers, software) are consistent with a surgical navigation system, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES is a surgical navigation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
HAW
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®.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, stereotaxic surgery
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 with
Praxiteles |
|----------------------|-----------------------------------------------------------|
| 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 | PLUS | |
| ORTHOPEDICS AG | PRAXIM | ||
| Common/Usual | |||
| Name | TOTAL KNEE | ||
| SURGETICS | |||
| Navigation System | PIGALILEO | ||
| TOTAL KNEE | |||
| REPLACEMENT | |||
| (TKR) SYSTEM | CTLOGICS | ||
| Navigation System | |||
| Classification | |||
| Name | instrument, | ||
| stereotaxic | instrument, | ||
| stereotaxic | instrument, | ||
| stereotaxic |
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Ke 8/232
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.
2
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
4
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