(88 days)
No
The description focuses on optical tracking and linking instrument position to preoperative scan data, without mentioning AI/ML algorithms for image processing, data analysis, or decision support. The performance studies are based on accuracy metrics like TRE and ATE, which are standard for navigation systems and do not inherently indicate AI/ML use.
No.
The device is an instrument used during spinal surgery to assist the surgeon, not to provide a therapeutic effect itself.
No
Explanation: The device is described as navigation instruments used during spinal surgery to assist the surgeon in precisely locating anatomical structures. Its function is to guide surgical actions based on pre-operative scan data, not to diagnose a medical condition.
No
The device description explicitly states "The SeaSpine 7D Navigation Instruments are wireless optically tracked" and "utilize commercially available passive reflective marker spheres to determine the position and orientation of instruments." This indicates the device includes physical hardware components (instruments, markers, and a tracking system) beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro (outside the body) for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The SeaSpine 7D Navigation Instruments are used during spinal surgery to assist the surgeon in precisely locating anatomical structures. This is an in vivo (within the body) application, not an in vitro examination of specimens.
- Intended Use: The intended use clearly states the device is used "during spinal surgery to assist the surgeon in precisely locating anatomical structures." This is a surgical navigation tool, not a diagnostic test performed on a sample.
- Device Description: The description focuses on tracking instruments within the surgical field using optical tracking and linking this data to preoperative scans. This is consistent with surgical navigation, not IVD.
Therefore, the SeaSpine 7D Navigation Instruments fall under the category of surgical navigation systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The SeaSpine 7D Navigation Instruments are intended to be used during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SeaSpine 7D Navigation Instruments are specifically designed for use with the 7D Surgical System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure can be identified.
Product codes
OLO
Device Description
The SeaSpine 7D Navigation Instruments are used during the preparation and placement of SeaSpine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SeaSpine 7D Navigation Instruments are wireless optically tracked and specifically designed for use with the 7D Surgical system.
The SeaSpine 7D Navigation Instruments utilize commercially available passive reflective marker spheres to determine the position and orientation of instruments. Each tracked Instruments requires a unique marker position configuration to enable the tracking system to distinguish the tools from one to the other. Position and orientation data of tracked Spinal Instruments are linked to the preoperative scan data using the 7D Surgical System workstation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal
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
Non-Clinical System, Software, and Instrumentation Verification and Validation, Non-Clinical Performance Surgical Simulations Conducted on Phantom Models, Compliance Conformity Assessments. Device performance tests were performed to verify the absolute accuracy and repeatability of the accuracy of the device, and the navigation accuracy according to ASTM F2554-10. In addition, Target Registration Error (TRE) and Angular Trajectory Error (ATE) has been used to evaluate the clinical accuracy of the system on phantom models in a clinical simulated environment. TRE and ATE evaluates the error discrepancy between the position of the SeaSpine Navigation Adapter, Reference Clamp, and Pedicle Probe reported by the image guided surgery system and the ground truth position measured physically or otherwise. All accuracy specifications have been met for the SeaSpine® Navigation Adapter, Reference Clamp, and Pedicle Probe. Accuracy testing for Universal Tracking / non-tracked surgical probe Array/Navigation Adapter assembly have been verified in previous application K192140 and K162375.
Key Metrics
Target Registration Error (TRE), Angular Trajectory Error (ATE)
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).
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December 9, 2022
SeaSpine Orthopedics Corporation % Elena Marenny Regulatory Specialist 7D Surgical ULC 60 Scarsdale Road, Unit 118 Toronto, ON M3B 2R7 Canada
Re: K222753
Trade/Device Name: SeaSpine 7D Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: September 7, 2022 Received: September 12, 2022
Dear Elena Marenny:
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.
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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 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 medical devices and radiation-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 -S
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
Enclosure
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Indications for Use
510(k) Number (if known) K222753
Device Name SeaSpine 7D Navigation Instruments
Indications for Use (Describe)
The SeaSpine 7D Navigation Instruments are intended to be used during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SeaSpine 7D Navigation Instruments are specifically designed for use with the 7D Surgical System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure can be identified.
| 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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Image /page/3/Picture/1 description: The image contains the logo for SeaSpine. The logo features three curved lines in blue on the left side. To the right of the lines is the word "SeaSpine" in orange font. There is a period after the word "SeaSpine".
510(k) Summary of Safety and Effectiveness
The SeaSpine 7D Navigation Instruments
This summary of safety and effectiveness information is submitted in accordance with 21CFR §807.92.
-
- Submitter's name, address, telephone number, contact person. SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 Contact person: Jesse Albright Associate Manager, Regulatory Affairs Phone: (760) 216-5176 Fax: (760) 683-6874 Email: jesse.albright@seaspine.com
Date prepared: December 09, 2022
- Submitter's name, address, telephone number, contact person. SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 Contact person: Jesse Albright Associate Manager, Regulatory Affairs Phone: (760) 216-5176 Fax: (760) 683-6874 Email: jesse.albright@seaspine.com
-
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
| Common/usual name: | Stereotactic Instrument |
|---|---|
| Proprietary name: | SeaSpine 7D Navigation Instruments |
These devices are classified as follows:
| Classification Name | 21 CFR Section | Product Code |
|---|---|---|
| Stereotaxic instrument | 21 CFR §882.4560 | OLO |
3. Substantially Equivalent Devices
SeaSpine Orthopedics Corporation believes the SeaSpine Navigation Adapter is substantially equivalent to the following currently marketed devices:
| Product | 510(k) |
|---|---|
| 7D Surgical System- Universal Tracking Clamp | |
| (Primary) | K192140 |
| Envision 3D™: Image Guidance System (7D Surgical | |
| System was initially named “Envision 3D “) | K162375 |
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Image /page/4/Picture/1 description: The image shows the logo for SeaSpine. The logo consists of a stylized wave graphic in shades of blue on the left, followed by the word "SeaSpine" in orange. The wave graphic has three curved lines that start thick and taper off to the right. The word "SeaSpine" is in a sans-serif font and is slightly blurred.
The indications for use of the subject device are equivalent to the predicate device K192140 and K162375. Furthermore, the technological characteristics of the SeaSpine Navigation Adapter are substantially equivalent. The differences in the technological characteristics do not raise new questions of safety and effectiveness. Consequently, the subject is substantially equivalent to the predicate device.
4. Indications for Use
The SeaSpine 7D Navigation Instruments are intended to be used during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SeaSpine 7D Navigation Instruments are specifically designed for use with the 7D Surgical System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure can be identified.
5. Device Description and Technical Comparison to Predicate Devices
The SeaSpine 7D Navigation Instruments are used during the preparation and placement of SeaSpine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SeaSpine 7D Navigation Instruments are wireless optically tracked and specifically designed for use with the 7D Surgical system.
The SeaSpine 7D Navigation Instruments utilize commercially available passive reflective marker spheres to determine the position and orientation of instruments. Each tracked Instruments requires a unique marker position configuration to enable the tracking system to distinguish the tools from one to the other. Position and orientation data of tracked Spinal Instruments are linked to the preoperative scan data using the 7D Surgical System workstation.
SeaSpine Navigation Adapter (K192140) l.
The SeaSpine Navigation Adapter designed to connect to a 7D Surgical Universal Array (1 or 2) allows for rotation and continuous visualization of compatible SeaSpine Insert (SeaSpine Mariner Nav Insert) in the navigated 7D Surgical System. As with predicate Universal Tracking Clamp 510(K) 192140 device, calibration of the 7D Surgical Integration Tools is required for the surgeon to proceed with he intended workflow using the 7D Surgical System.
II. SeaSpine Reference Clamp (K162375)
The SeaSpine Reference Clamp (Radiolucent) is designed to be used when rigid fixation to the spinous process is required. As with predicate 7D Surgical Reference Clamp K162375, the SeaSpine Reference Clamp attaches rigidly to the spinous process in the region where
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Image /page/5/Picture/1 description: The image shows the logo for SeaSpine. The logo consists of a blue graphic on the left and the word "SeaSpine" in orange on the right. The graphic is made up of three curved lines that resemble waves or arcs.
the user plans to perform surgery. Once fixated, the user attaches the 7D Surgical Flex Array which holds the spherical markers which are tracked by the 7D Surgical System.
SeaSpine Pedicle Probe (K162375) III.
The SeaSpine Pedicle Probe is designed to extend the initial hole through the cancellous (soft) bone of the vertebra. As with predicate 7D Surgical Pedicle Probe K162375, the SeaSpine Pedicle probe Tracked Navigation Tool is used by the surgeon to perform imageguided surgery via 7D Surgical System integration, guiding the pedicle screws length selection and insertion into the vertebra.
6. Safety Considerations
The SeaSpine 7D Navigation Instruments add compatibility to the 7D System to include navigation and tracking of the SeaSpine compatible insert and tools did not impact conformity to regulatory compliance standards. Mechanical Design, and User Instructions risk control measures have been implemented to ensure all new risks associated with use of the SeaSpine 7D Navigation Instruments have been adequately controlled.
7. Technological Characteristics
The literature research and the comparison to the predicate devices show that the device makes use of equivalent technological characteristics and functionality and is intended for equivalent surgical procedures as compared to the predicate devices.
8. Nonclinical Performance Data
Verification and Validation activities have been conducted to provide assurance that the device meets the performance requirements under the indications for use conditions.
The following tests were performed to ensure the safety and effectiveness of the SeaSpine 7D Navigation Instruments:
- Non-Clinical System, Software, and Instrumentation Verification and Validation
- Non-Clinical Performance Surgical Simulations Conducted on Phantom Models
- Compliance Conformity Assessments
- ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems
Device performance tests were performed to verify the absolute accuracy and repeatability of the accuracy of the device, and the navigation accuracy according to ASTM F2554-10. In addition, Target Registration Error (TRE) and Angular Trajectory Error (ATE) has been used to evaluate the clinical accuracy of the system on phantom models in a clinical simulated environment. TRE and ATE evaluates the error discrepancy between the position of the SeaSpine Navigation Adapter, Reference Clamp, and Pedicle Probe reported by the image guided surgery system and the ground truth position measured physically or otherwise.
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Image /page/6/Picture/1 description: The image contains the logo for SeaSpine. The logo features a stylized wave graphic in shades of blue on the left. To the right of the wave is the company name "SeaSpine" in orange lettering.
The following Table 1 contains a summary of verification and validation performed on the 7D Surgical System:
| Verification and Validation | Description | Conclusion |
|---|---|---|
| System Verification | Scope of the test is to verify the | |
| design requirement specifications | ||
| of the SeaSpine Navigation | ||
| Adapter, Reference Clamp, | ||
| Pedicle Probe compatibility with | ||
| the 7D Surgical System under test | ||
| case protocols. | Verification successful, all design | |
| requirements have been fulfilled. | ||
| System Validation | Scope of the test is to validate the | |
| Indications for Use and Customer | ||
| Requirements of the SeaSpine | ||
| Navigation Adapter, Reference | ||
| Clamp, Pedicle Probe | ||
| compatibility with the 7D Surgical | ||
| System under simulated use case | ||
| situations. | Validation successful, all user | |
| needs met. | ||
| Safety regarding risk analysis | Implementation and effectiveness | |
| of all risk control requirements | ||
| specified in the SeaSpine | ||
| Navigation Adapter, Reference | ||
| Clamp, Pedicle Probe risk | ||
| analysis are tested and verified. | Risk Control requirements are | |
| effective and mitigate the | ||
| associated risks to an acceptable | ||
| level. | ||
| Product Safety standards | The SeaSpine Navigation | |
| Adapter, Reference Clamp, | ||
| Pedicle Probe was tested to the | ||
| following recognized standards: | ||
| ISO 10993-1, and ISO 17665-1. | Compliance with recognized | |
| standards have been verified in | ||
| the previous application. Previous | ||
| test results have not been affected | ||
| by this change. | ||
| Non-Clinical Accuracy | System's accuracy is tested using | |
| the SeaSpine Navigation Adapter, | ||
| Reference Clamp, Pedicle Probe | ||
| compatibility with the 7D Surgical | ||
| System on phantom models | ||
| following the ASTM F2554-10 | ||
| Standard Practice for | ||
| Measurement of Positional | ||
| Accuracy of Computer Assisted | ||
| Surgical Systems in addition to | ||
| Target Registration Error. | All accuracy specifications have | |
| been met for the SeaSpine® | ||
| Navigation Adapter, Reference | ||
| Clamp, and Pedicle Probe. | ||
| Accuracy testing for Universal | ||
| Tracking / non-tracked surgical | ||
| probe Array/Navigation Adapter | ||
| assembly have been verified in | ||
| previous application K192140 and | ||
| K162375. |
All non-clinical tests successfully passed demonstrating that the subject device performs as safely and effectively as the predicate device and supporting substantial equivalence.
9. Clinical Data
A clinical trial was not required to demonstrate that the SeaSpine 7D Navigation Instruments perform as safely and effectively as the predicate device. Clinical validation is unnecessary as the SeaSpine 7D Navigation Instruments introduce no new indications for use, and device features are equivalent to the previously cleared predicate device identified. The clinical safety and effectiveness of the SeaSpine 7D Navigation Instruments are historically accepted for both the predicate and subject device.
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Image /page/7/Picture/1 description: The image contains the logo for SeaSpine. The logo consists of a blue graphic on the left and the word "SeaSpine" in orange on the right. The graphic is made up of three curved lines that are stacked on top of each other. The word "SeaSpine" is written in a sans-serif font.
10. Conclusion
The SeaSpine 7D Navigation Instruments is substantially equivalent in safety and effectiveness to the predicate devices identified above:
- . The predicate devices and The SeaSpine 7D Navigation Instruments use equivalent technologies.
The non-clinical verification and validation performed support the safety and effectiveness of The SeaSpine 7D Navigation Instruments compatibility and useability with the 7D Surgical System. The conclusions drawn from the non-clinical tests demonstrate that The SeaSpine 7D Navigation Instruments perform as safely and effectively as the legally marketed device according to the comparison based on the requirements of 21 CFR §882.4560 and the information provided herein. It is concluded that The SeaSpine 7D Navigation Instruments is substantially equivalent to the predicate device with respect to its indications for use, technological characteristics, and performance characteristics.