(263 days)
Not Found
No
The summary describes navigation-enabled instruments that work with existing navigation systems (VELYS Spine System, Medtronic StealthStation). There is no mention of AI or ML in the intended use, device description, or performance studies. The navigation is based on referencing anatomical structures relative to acquired images or models, which is a standard navigation approach, not necessarily involving AI/ML.
No.
The device is an instrument used during surgical procedures to assist in the placement of screws, not to treat a condition itself.
No
The device is described as "reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures." It is a surgical tool, not a device used for diagnosis.
No
The device description explicitly states that the device includes reusable instruments such as drills, taps, and screwdrivers, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes.
- Device Function: The description clearly states that the Navigation Enabled Instruments are reusable instruments used during surgical procedures to assist the surgeon in precisely locating anatomical structures and preparing for and placing screws. They are used on the patient during surgery, not for testing specimens from the patient.
- Intended Use: The intended use is to aid in surgical navigation and instrument placement during spinal surgery. This is a surgical aid, not a diagnostic test performed on a sample.
The device's function and intended use fall squarely within the realm of surgical instruments and navigation systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Navigation Enabled Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated; and with the VELYS Spine System as well as the with the Medtronic StealthStation® System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which:
• the use of EXPEDIUM, VIPER, SYMPHONY OCT and the TriALTIS Spine System is indicated,
- · the use of stereotactic surgery may be appropriate, and
· reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System.
The Navigation Enabled Instruments used in conjunction with the SYMPHONY OCT System are intended to support indicated cervical and thoracic polyaxial screw placement only.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
Navigation Enabled Instruments are reusable instruments used for the preparation and placement of DePuy Synthes EXPEDIUM™, VIPER™, SYMPHONY™ OCT and TriALTISTM screws, in either open or percutaneous procedures. The Navigation Enabled Instruments include drills, taps and screwdrivers and can be operated manually or under power. These instruments are designed for navigated and non-navigated use. Navigation Enabled Instruments also include the CROSSNAV™ Adaptor to facilitate navigation of the Navigation Enabled Instruments with the VELYS Spine System. Navigation of these instruments is achieved using the VELYS Robotic-Assisted Solution for Spine as well as the Medtronic StealthStation navigation system and associated tracking arrays.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction
Anatomical Site
Spine, pelvis, vertebra, cervical, thoracic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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 performance data for the subject devices consists of the following evaluations:
- . Accuracy Verification through engineering analysis,
- Fulfillment of navigation systems instrument accuracy requirements as stated by . the navigation manufacturer,
- . CAD Model Evaluation,
- . Simulated Use Evaluation.
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
June 14, 2024
Image /page/0/Picture/1 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right is the FDA (U.S. Food & Drug Administration) logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text to the right of the square.
Depuy Synthes Daniel Meyer Regulatory Affairs Manager Eimattstrasse 3 Oberdorf, 4436 Switzerland
Re: K233255
Trade/Device Name: CROSSNAV Navigation Enabled Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: October 12, 2023 Received: June 10, 2024
Dear Daniel Meyer:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Image /page/1/Picture/6 description: The image shows a digital signature. The signature is from Jesse Muir. The date of the signature is 2024.06.17 and the time is 10:48:44 -04'00'.
For 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
2
Indications for Use
Submission Number (if known)
Device Name
CROSSNAV Navigation Enabled Instruments
Indications for Use (Describe)
Navigation Enabled Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated; and with the VELYS Spine System as well as the with the Medtronic StealthStation® System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which:
• the use of EXPEDIUM, VIPER, SYMPHONY OCT and the TriALTIS Spine System is indicated,
- · the use of stereotactic surgery may be appropriate, and
· reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System.
The Navigation Enabled Instruments used in conjunction with the SYMPHONY OCT System are intended to support indicated cervical and thoracic polyaxial screw placement only.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| A. | Submitter Information | |
|---|---|---|
| 510(k) Sponsor: | Medos International, SARL | |
| Contact Person: | Daniel Meyer | |
| Regulatory Affairs Manager | ||
| Eimattstrasse 3 | ||
| 4436 Oberdorf BL | ||
| Switzerland | ||
| Telephone: | +41-61-9656856 | |
| Email: | dmeyer1@its.jnj.com | |
| B. | Date Prepared | 12 October 2023 |
| C. | Device Name | |
| Trade/Proprietary Name: | CROSSNAV Navigation Enabled Instruments | |
| Common/Usual Name: | Orthopedic Stereotaxic Instrument | |
| Device Classification and | ||
| Regulation: | Class II | |
| OLO – 21 CFR §882.4560 | ||
| Classification Product and | ||
| Panel Code | OLO – Neurology | |
| D. | Predicate Device Names | |
| Primary Predicate Device: | ||
| Navigation Enabled Instruments (K200791) – OLO | ||
| Additional Predicate Device: | ||
| TriALTIS Navigation Enabled Instruments (K231527) -OLO |
4
E. Device Description
Navigation Enabled Instruments are reusable instruments used for the preparation and placement of DePuy Synthes EXPEDIUM™, VIPER™, SYMPHONY™ OCT and TriALTISTM screws, in either open or percutaneous procedures. The Navigation Enabled Instruments include drills, taps and screwdrivers and can be operated manually or under power. These instruments are designed for navigated and non-navigated use. Navigation Enabled Instruments also include the CROSSNAV™ Adaptor to facilitate navigation of the Navigation Enabled Instruments with the VELYS Spine System. Navigation of these instruments is achieved using the VELYS Robotic-Assisted Solution for Spine as well as the Medtronic StealthStation navigation system and associated tracking arrays.
Indications for Use F.
Navigation Enabled Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated; and with the VELYS Spine System as well as the with the Medtronic StealthStation® System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which:
- the use of EXPEDIUM™, VIPER™, SYMPHONY™ OCT and the TriALTISTM Spine . System is indicated,
- . the use of stereotactic surgery may be appropriate, and
- reference to a rigid anatomical structure, such as the pelvis or a vertebra can be . identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System.
The Navigation Enabled Instruments used in conjunction with the SYMPHONY OCT System are intended to support indicated cervical and thoracic polyaxial screw placement only.
Summary of Similarities and Differences in Technological Characteristics, G. Performance, and Intended Use
The technological characteristics, including design, material and performance as well as intended use of the CROSSNAV Navigation Enabled Instruments are consistent with those of the predicate devices.
5
Compared to the predicate devices, the subject devices expand the scope of the Navigation Enabled Instruments for compatibility with an additional Navigation System, the VELYS Spine System. Similarly to predicate devices, CROSSNAV Navigation Enabled Instruments include drills, taps and screwdrivers and are indicated for use when implanting DePuy Synthes screws. This does not raise new questions of safety and effectiveness based on application of recognized consensus standards and design controls.
H. Materials
The subject devices are manufactured from stainless steel alloys and titanium alloys (Ti-6Al-4V). Several of the devices have coatings including AlTiN (Aluminum Titanium Nitride Coating), TiN (Titanium Nitride Coating) and Tungsten Carbide coating.
I. Performance Data
The performance data for the subject devices consists of the following evaluations:
- . Accuracy Verification through engineering analysis,
- Fulfillment of navigation systems instrument accuracy requirements as stated by . the navigation manufacturer,
- . CAD Model Evaluation,
- . Simulated Use Evaluation.
J. Conclusion
The indications for use of the CROSSNAV Navigation Enabled Instruments are consistent with those of the predicate devices. The technological characteristics of the CROSSNAV Navigation Enabled Instruments in terms of design, materials and performance are consistent with those of the predicate devices. The CROSSNAV Navigation Enabled Instruments are substantially equivalent to the predicate devices.