Joimax Intracs System

K192663 · Joimax GmbH · OLO · Jul 30, 2020 · Neurology

Device Facts

• Record ID: K192663
• Device Name: Joimax Intracs System
• Applicant: Joimax GmbH
• Product Code: OLO · Neurology
• Decision Date: Jul 30, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended 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 access to the access to the area of interest, is a rigid landmark, such as: Transforaminal procedure Interlaminar procedure

Device Story

The joimax Intracs em System is an electromagnetic (EM) surgical navigation system for minimally invasive spine surgery. It tracks the position and orientation of specialized joimax surgical instruments relative to patient anatomy. The system uses EM sensors attached to instruments within a defined EM field to localize tools. Input data includes medical images (X-ray/fluoroscopy) imported via DICOM. The system processes this data to display instrument position on a screen, providing AP and lateral views to the surgeon. Used in clinical settings, it assists surgeons in navigating to target points defined by rigid anatomical landmarks. By providing real-time visual feedback of instrument location, the system aids in surgical precision, potentially improving procedural outcomes and reducing risks associated with minimally invasive access.

Clinical Evidence

Bench testing only. Evidence includes electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability, functional testing, software verification, and performance testing using phantoms and human cadavers. Biocompatibility (ISO 10993-1), cleaning, disinfection, and sterilization validations were performed. System accuracy demonstrated a mean positional error of ≤2.0 mm and a mean trajectory error of ≤2°.

Technological Characteristics

Electromagnetic (EM) tracking system. Components include EM sensors, EM field generator, and Intel-based PC. Connectivity via standard Ethernet and DICOM import. Accuracy: mean positional error ≤2.0 mm, mean trajectory error ≤2°. Biocompatibility per ISO 10993-1. Sterilization and disinfection validated for reusable components.

Indications for Use

Indicated for patients undergoing orthopedic procedures, including spinal or pelvic surgery, where stereotactic navigation is appropriate and rigid anatomical landmarks are identifiable. Applicable for transforaminal and interlaminar spinal procedures.

Regulatory Classification

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.

Predicate Devices

• StealthStation S8 Spine Software (K170011)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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)

| <div> <span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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### 510(k) Summary

- I. SUBMITTER
joimax® GmbH Amalienbadstrasse 41 RaumFabrik 61 76227 Karlsruhe, Germany

Contact person: Gary Mocnik Phone: [phone] 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<br>Software (K170011). |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of Operation | Localization of sensors attached to<br>instruments within a defined<br>electromagnetic field | Localization of sensors attached<br>to instruments within a defined<br>electromagnetic field or<br>localization of reflectors by<br>cameras |
| Anatomical Site | Spine | Spine |
| Surgical type | Minimally invasive | Minimally invasive,<br>open |
| Imaging modalities (Spine) | X-Ray (fluoroscopy) | X-Ray (fluoroscopy) |
| Control Mechanism<br>(hardware) | Tracked instruments, touch screen or mouse | touch screen or mouse |
| Scanner interface<br>Technology | Network Connectivity CD, DVD, USB<br>DICOM Import | Network Connectivity CD,<br>DVD, USB DICOM Import<br>DICOM Export |
| View (display features) | AP and Lateral View,<br>Video Input | Look Sideways 3D Anatomic<br>Orthogonal Trajectory 1 and 2<br>Trajectory Guidance Look<br>Ahead Probe's Eye AP and<br>Lateral Synthetic AP and Lateral<br>Maximum Intensity Projection<br>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<br>electromagnetic sensors which can be<br>attached to the instrument | Medtronic instruments tracked<br>via electromagnetic localization<br>technology located within the<br>instrument and patient trackers |
| Software Interface (GUI) | Basic white and black-style with 4 main<br>workflow steps.<br>Controls are located on the right side of<br>each view | Basic gray and black style with<br>4 main tasks and tab interface to<br>access tools. Controls on the<br>right. |
| Computer | Intel-based PC | Intel-based PC |
| Network Connectivity | Connection Type: Standard Ethernet | Connection Type: Standard<br>Ethernet 2.4 gHz and 5.0 gHz<br>Wireless connection |
| System Accuracy | System Level Accuracy with a mean<br>positional error of ≤2.0 mm and a mean<br>trajectory error of ≤2°. | System Level Accuracy with a<br>mean positional error of 2.0 mm<br>and a mean trajectory error of<br>2°. |

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#### 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.