(263 days)
No
The summary describes robotic-assisted and navigated instruments for spinal surgery, but there is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on mechanical instruments used in conjunction with a robotic system and navigation.
No.
The Robotic Integration 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." They are tools for surgical procedures, not devices that directly treat or mitigate a disease or condition.
No
The device is described as "Robotic Integration Instruments" used for the "preparation and placement of DePuy Synthes screws during spinal surgery." Its function is to assist in precisely locating anatomical structures and is used in conjunction with robotic-assisted solutions and imaging data (CT or 3D fluoroscopic image reconstruction). It is a surgical instrument designed for physical intervention/assistance during surgery, not for diagnosing conditions or diseases.
No
The device description explicitly lists physical instruments (Array Sleeves, Access Guides, Drills, Taps, Screwdrivers, accessories) and states they are reusable and can be operated manually or under power. This indicates the device includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device's intended use: The Robotic Integration Instruments are used during surgical procedures to assist in the placement of screws in the spine. They are physical instruments used directly on the patient's anatomy, guided by imaging and robotic assistance.
- No mention of analyzing biological samples: The description focuses on the mechanical function of the instruments and their integration with imaging and robotic systems for surgical guidance. There is no indication that these instruments are used to analyze any biological samples.
Therefore, the intended use and function of the Robotic Integration Instruments clearly fall outside the scope of In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Robotic Integration 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 Robotic Integration Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated and with the VELYS Robotic-Assisted Solution for Spine. The Robotic Integration Instruments are indicated for use in surgical spinal procedures, in which:
· the use of EXPEDIUM. VIPER. TriALTIS and SYMPHONY OCT 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 (eg. CT 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 Robotic Integration Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System.
The Robotic Integration Instruments used in conjunction with the SYMPHONY OCT system are intended to support indicated cervical and thoracic polyaxial screw placement only.
Product codes
OLO
Device Description
Robotic Integration Instruments are reusable instruments used for the preparation and placement of DePuy Synthes screws (EXPEDIUM, VIPER, TriALTIS and SYMPHONY OCT), in either open or percutaneous procedures. The Robotic Integration instruments consist of a collection of Array Sleeves. Access Guides, Drills, Taps and Screwdrivers as well as various accessories and are designed for robotic assisted, navigated and nonnavigated use. They can be operated manually or under power. Navigation and Robotic Guidance of these instruments is achieved using the VELYS Robotic-Assisted Solution for Spine and associated and compatible VELYS Spine Instrument Arrays. The Core Instrument is a Navigation Ready Instrument, navigation of this instrument is achieved using a Universal Navigation Adaptor Set (UNAS) Navigation Ring and compatible VELYS Spine Instrument Arrays.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or 3D fluoroscopic image reconstruction
Anatomical Site
Spinal, pelvis, vertebra, cervical, thoracic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, surgical spinal procedures
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)
Reference Device(s)
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
June 17, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
DePuy Synthes Nicole Aeschbacher Senior Regulatory Affairs Specialist Eimattstrasse 3 Oberdorf, 4436 Switzerland
Re: K233256
Trade/Device Name: Robotic Integration Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: October 13, 2023 Received: June 10, 2024
Dear Nicole Aeschbacher:
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 820.30 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,
| Jesse Muir - | Digitally signed by Jesse Muir -S |
|---|---|
| Date: 2024.06.17 | |
| 10:37:14 -04'00' |
or: Shumaya Ali, M.P.H.Fo 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
Robotic Integration Instruments
Indications for Use (Describe)
Robotic Integration 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 Robotic Integration Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated and with the VELYS Robotic-Assisted Solution for Spine. The Robotic Integration Instruments are indicated for use in surgical spinal procedures, in which:
· the use of EXPEDIUM. VIPER. TriALTIS and SYMPHONY OCT 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 (eg. CT 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 Robotic Integration Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System.
The Robotic Integration 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)
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: | Nicole Aeschbacher | |
| Senior Regulatory Affairs Specialist | ||
| Eimattstrasse 3 | ||
| 4436 Oberdorf BL | ||
| Switzerland | ||
| Telephone: | +41-61-5641798 | |
| Email: | naeschba@its.jnj.com | |
| B. | Date Prepared | 13 Oct 2023 |
| C. | Device Name | |
| Trade/Proprietary Name: | Robotic Integration 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: | ||
| E-GPS Navigated Instruments (K220862) – OLO | ||
| Reference Device: | ||
| TriALTIS Navigation Enabled Instruments (K231527) – OLO | ||
4
E. Device Description
Robotic Integration Instruments are reusable instruments used for the preparation and placement of DePuy Synthes screws (EXPEDIUM, VIPER, TriALTIS and SYMPHONY OCT), in either open or percutaneous procedures. The Robotic Integration instruments consist of a collection of Array Sleeves. Access Guides, Drills, Taps and Screwdrivers as well as various accessories and are designed for robotic assisted, navigated and nonnavigated use. They can be operated manually or under power. Navigation and Robotic Guidance of these instruments is achieved using the VELYS Robotic-Assisted Solution for Spine and associated and compatible VELYS Spine Instrument Arrays. The Core Instrument is a Navigation Ready Instrument, navigation of this instrument is achieved using a Universal Navigation Adaptor Set (UNAS) Navigation Ring and compatible VELYS Spine Instrument Arrays.
F. Indications for Use
Robotic Integration 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 Robotic Integration Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated and with the VELYS Robotic-Assisted Solution for Spine. The Robotic Integration Instruments are indicated for use in surgical spinal procedures, in which:
- the use of EXPEDIUM, VIPER, TriALTIS and SYMPHONY OCT 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 (eg. CT 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 Robotic Integration Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System.
The Robotic Integration Instruments used in conjunction with the SYMPHONY OCT system are intended to support indicated cervical and thoracic polyaxial screw placement only.
5
G. Summary of Similarities and Differences in Technological Characteristics, Performance, and Intended Use
Based upon the information provided in this premarket notification, it is concluded that the subject devices are as safe and effective and perform as well as the predicates. Substantial equivalence was established in terms of design features, technological characteristics and intended use as compared to the predicate devices.
Compared to the predicate devices, the Robotic Integration Instruments share similar design and dimensions, indications for use, materials, and principles of operations. This does not raise new questions of safety and effectiveness based on application of recognized consensus standards and design controls.
H. Materials
The Robotic Integration Instruments are manufactured from stainless steels, Titanium or PEEK (Polyethertherketone), from which several of these devices (Core Instrument Levers, Array Guide Levers, Array Sleeve Plungers, Array Sleeve Tubes, Array Sleeve Stop Wheel, Driver Threadlocker Handle) are coated with Tungsten Carbide Carbon and the Cervical CFX Taps with Titanium Nitride.
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 Robotic Integration Instruments are consistent with those of the predicate devices. The technological characteristics of the Robotic Integration Instruments in terms of design, materials and performance are consistent with those of the predicate devices. The Robotic Integration Instruments are substantially equivalent to the predicate devices.