(309 days)
Not Found
No
The summary describes a surgical navigation system based on electromagnetic tracking, which displays instrument position relative to anatomy. There is no mention of AI, ML, or related terms, nor is there a description of training or test sets typically associated with AI/ML development. The focus is on tracking technology and accuracy metrics.
No.
The device is a surgical navigation system that displays the position and orientation of surgical instruments relative to anatomy, which is an assistive tool for surgery rather than a direct therapeutic intervention.
No
Explanation: The device is described as a surgical navigation system that displays the position and orientation of surgical instruments relative to anatomy in medical image data. Its function is to assist in guiding surgical instruments during procedures, not to identify or diagnose conditions.
No
The device description explicitly states it is a surgical navigation system based on electromagnetic (EM) tracking technology, which requires hardware components (sensors, emitters, etc.) in addition to software.
Based on the provided information, this device 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.
- Device Function: The joimax® Intracs® em Navigation System is a surgical navigation system that uses electromagnetic tracking to display the position of surgical instruments relative to the patient's anatomy based on medical image data (X-ray/fluoroscopy).
- Intended Use: The intended use is for guiding surgical instruments during orthopedic procedures, specifically in the spine. This is an in vivo application (within the living body), not an in vitro application (outside the living body).
The device is a surgical navigation system, which falls under the category of medical devices used to assist in surgical procedures, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The joimax® Intracs® m Navigation System is intended to continuously display the position and orientation of joimax® surgical instruments relative to the anatomy in medical image data in either open or minimal invasive orthopedic procedures.
The use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy. This can include spinal procedures, where the target point for the access to the access to the area of interest, is a rigid landmark, such as:
· Transforaminal procedure
• Interlaminar procedure
Product codes
OLO
Device Description
The joimax® Intracs® em System is a surgical navigation system based on electromagnetic (EM) tracking technology, designed specifically for applications in minimally invasive spine surgery. The system displays instrument position relative to the patient's anatomy.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-Ray (fluoroscopy)
Anatomical Site
Spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 following performance data were provided in support of the substantial equivalence.
- Electrical safety (IEC 60601-1) I
- Electromagnetic compatibility (IEC 60601-1-2)
- Usability
- Performance testing (accuracy)
- Functional testing
- Software verification
- Performance testing with phantoms and human cadavers
- Biocompatibility evaluation (ISO 10993-1)
- Cleaning and disinfection validation
- Sterilization validation
The joimax® Intracs® em System met all specified criteria and did not raise new safety or performance questions. Based on the performance testing, the joimax® Intracs® em System was found to have a safety and effectiveness profile that is similar to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
System Level Accuracy with a mean positional error of ≤2.0 mm and a mean trajectory error of ≤2°.
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
July 30, 2020
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
joimax GmbH Gary Mocnik Official Correspondent Amalienbadstrasse 41, RaumFabrik 61 Karlsruhe, 76227 Germany
Re: K192663
Trade/Device Name: Joimax Intracs System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 26, 2020 Received: June 30, 2020
Dear Gary Mocnik:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192663
Device Name joimax® Intracs® em System
Indications for Use (Describe)
The joimax® Intracs® m Navigation System is intended to continuously display the position and orientation of joimax® surgical instruments relative to the anatomy in medical image data in either open or minimal invasive orthopedic procedures.
The use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy. This can include spinal procedures, where the target point for the access to the access to the area of interest, is a rigid landmark, such as:
· Transforaminal procedure
• Interlaminar procedure
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
- I. SUBMITTER
joimax® GmbH Amalienbadstrasse 41 RaumFabrik 61 76227 Karlsruhe, Germany
Contact person: Gary Mocnik Phone: (949) 433-0413 Date prepared: September 23, 2019
II. DEVICE
Name of the device: joimax® Intracs® em System Common or usual name: Surgical navigation system Classification name: Orthopedic Stereotaxic Instrument Regulatory Class: 2 Regulation Number: 21 CFR 882.4560 Product Code: OLO
- III. PREDICATE DEVICE StealthStation S8 Spine Software (K170011)
IV. DEVICE DESCRIPTION
The joimax® Intracs® em System is a surgical navigation system based on electromagnetic (EM) tracking technology, designed specifically for applications in minimally invasive spine surgery. The system displays instrument position relative to the patient's anatomy.
V. INDICATIONS FOR USE
The joimax® Intracs® em Navigation System is intended to continuously display the position and orientation of joimax® surgical instruments relative to the anatomy in medical image data in either open or minimal invasive orthopedic procedures. The use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy. This can include spinal procedures, where the target point for the procedure itself or for the access to the area of interest, is a rigid landmark, such as:
- Transforaminal procedure .
- . Interlaminar procedure
- COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
At a high level, the subject and predicate device are based on the following same technological elements:
- Both devices are design to facilitate spinal surgical procedures by .
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localization of surgical instruments and patient anatomy
- . Both devices utilize electromagnetic (EM) technology to facilitate localization of the instruments and patient anatomy
The subject joimax® Intracs® em System has the same technological characteristics as the predicate device including design, intended use, major system components and function. The similarities and differences are summarized in the table below:
| | joimax® Intracs® em System | StealthStation S8 Spine
Software (K170011). |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of Operation | Localization of sensors attached to
instruments within a defined
electromagnetic field | Localization of sensors attached
to instruments within a defined
electromagnetic field or
localization of reflectors by
cameras |
| Anatomical Site | Spine | Spine |
| Surgical type | Minimally invasive | Minimally invasive,
open |
| Imaging modalities (Spine) | X-Ray (fluoroscopy) | X-Ray (fluoroscopy) |
| Control Mechanism
(hardware) | Tracked instruments, touch screen or mouse | touch screen or mouse |
| Scanner interface
Technology | Network Connectivity CD, DVD, USB
DICOM Import | Network Connectivity CD,
DVD, USB DICOM Import
DICOM Export |
| View (display features) | AP and Lateral View,
Video Input | Look Sideways 3D Anatomic
Orthogonal Trajectory 1 and 2
Trajectory Guidance Look
Ahead Probe's Eye AP and
Lateral Synthetic AP and Lateral
Maximum Intensity Projection
Video Input |
| Localization Technology | EM | Optical or EM |
| Instrument interface | EM | Optical or EM |
| EM Emitter Types | Side | Side, Flat |
| EM Instrumentation | joimax® instruments are tracked by
electromagnetic sensors which can be
attached to the instrument | Medtronic instruments tracked
via electromagnetic localization
technology located within the
instrument and patient trackers |
| Software Interface (GUI) | Basic white and black-style with 4 main
workflow steps.
Controls are located on the right side of
each view | Basic gray and black style with
4 main tasks and tab interface to
access tools. Controls on the
right. |
| Computer | Intel-based PC | Intel-based PC |
| Network Connectivity | Connection Type: Standard Ethernet | Connection Type: Standard
Ethernet 2.4 gHz and 5.0 gHz
Wireless connection |
| System Accuracy | System Level Accuracy with a mean
positional error of ≤2.0 mm and a mean
trajectory error of ≤2°. | System Level Accuracy with a
mean positional error of 2.0 mm
and a mean trajectory error of
2°. |
5
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence.
- Electrical safety (IEC 60601-1) I
- Electromagnetic compatibility (IEC 60601-1-2)
- Usability
- 트 Performance testing (accuracy)
- I Functional testing
- Software verification
- I Performance testing with phantoms and human cadavers
- Biocompatibility evaluation (ISO 10993-1)
- I Cleaning and disinfection validation
- I Sterilization validation
The joimax® Intracs® em System met all specified criteria and did not raise new safety or performance questions. Based on the performance testing, the joimax® Intracs® em System was found to have a safety and effectiveness profile that is similar to the predicate device.
VIII. CONCLUSIONS
The testing performed for the joimax® Intracs® em System demonstrated, that the performance of the device is equal to the legally marketed predicate device.