(53 days)
Not Found
No
The summary describes a system for augmented reality guidance in spine procedures using infrared tracking and registration with CT images. It focuses on displaying tracked instrument location relative to patient anatomy and planned trajectories. There is no mention of AI or ML being used for image analysis, planning, or any other function. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is an aid for precisely locating anatomic structures and guiding instrument placement in spine procedures, not a device that directly treats a medical condition.
No
This device is intended as an aid for precisely locating anatomic structures during surgical procedures, specifically for guidance and visualization, rather than for diagnosing medical conditions.
No
The device description explicitly mentions "Infrared track to track the patient's anatomy as well as surgical instrumentation," indicating the presence of hardware components 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The OnPoint Augmented Reality Spine System is a surgical navigation system that uses imaging (CT scans) and tracking technology to guide surgeons during spine procedures. It provides visual information and guidance based on the patient's anatomy and surgical instruments.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. Its function is entirely based on image data and real-time tracking of instruments relative to the patient's anatomy.
Therefore, the OnPoint Augmented Reality Spine System falls under the category of a surgical navigation or guidance system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OnPoint Augmented Reality Spine System, with OnPoint Augmented Reality Spine System Software, is intended as an aid for precisely locating anatomic structures in either open or percutaneous spine procedures. The use of the OnPoint Augmented Reality Spine System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a bony anatomical structure, such as the spine or pelvis, can be identified relative to CT images of the anatomy. This can include spinal implant procedures, such as pedicle screw placement, where the surgeon wants to see a tracked instrument location in relationship to the CT images of the anatomy.
The optical head mounted display of the OnPoint Augmented Reality Spine System displays 2D stereotaxic screens and an optional virtual anatomy screen, paired with optional graphical targeting tools and alphanumeric displays. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient images. The virtual screen is indicated for displaying the virtual in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning. The graphical targeting tools and alphanumeric display are indicated for providing visual and quantitative tracking information of the tracked instrument location from plan.
The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.
Product codes (comma separated list FDA assigned to the subject device)
SBF
Device Description
The OnPoint Augmented Reality Spine System is intended as an aid for precisely locating anatomic structures in either open or percutaneous spine procedures. Infrared track to track the patient's anatomy as well as surgical instrumentation. The tracking information is registered with image information of the patient's anatomy in a common coordinate system. To quide the surgeon through the pedicle screw placement process, the system will display a visual representation of the following elements in an augmented reality optical head mounted display in addition to being displayed on a workstation monitor:
- Target position and orientation of the instrument path
- Current position and orientation of the instrument
- · Cross sectional images
· 3D model of the patient's spine
Depending on surgeon preference, different combinations of these elements can be displayed. Optional planning steps allow the surgeon to define the target position and orientation as well as the length and diameter of the pedicle screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images
Anatomical Site
Spine, pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, clinical/surgical setting
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)
Registration testing was successfully completed using an additional 3D scanner with the OnPoint Augmented Reality Spine System; Testing demonstrated that the device is safe for its intended use and is substantially equivalent to the predicate device.
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
Image /page/0/Picture/0 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 16, 2024
OnPoint Surgical, Inc. Amy O'Donnell Sr. Director Quality and Regulatory Affairs 555 Virginia Rd, Suite 103 Concord, Massachusetts 01742
Re: K241870
Trade/Device Name: OnPoint Augmented Reality Spine System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: SBF Dated: August 14, 2024 Received: August 14, 2024
Dear Amy O'Donnell:
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"
1
(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).
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 (OS) 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).
Sincerelv.
Shumaya Ali -S
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
510(k) Number (if known) K241870
Device Name OnPoint Augmented Reality Spine System
Indications for Use (Describe)
The OnPoint Augmented Reality Spine System, with OnPoint Augmented Reality Spine System Software, is intended as an aid for precisely locating anatomic structures in either open or percutaneous spine procedures. The use of the OnPoint Augmented Reality Spine System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a bony anatomical structure, such as the spine or pelvis, can be identified relative to CT images of the anatomy. This can include spinal implant procedures, such as pedicle screw placement, where the surgeon wants to see a tracked instrument location in relationship to the CT images of the anatomy.
The optical head mounted display of the OnPoint Augmented Reality Spine System displays 2D stereotaxic screens and an optional virtual anatomy screen, paired with optional graphical targeting tools and alphanumeric displays. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient images. The virtual screen is indicated for displaying the virtual in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning. The graphical targeting tools and alphanumeric display are indicated for providing visual and quantitative tracking information of the tracked instrument location from plan.
The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| 510(k) #: | K241870 | 510(k) Summary | Prepared on: | 2024-08-19 |
|---|---|---|---|---|
| ----------- | --------- | ---------------- | -------------- | ------------ |
| Contact Details | 21 CFR 807.92(a)(1) |
|---|---|
| ----------------- | --------------------- |
| Applicant Name | OnPoint Surgical, Inc. |
|---|---|
| Applicant Address | 555 Virginia Rd Suite 103 Concord MA 01742 United States |
| Applicant Contact Telephone | 585-880-0356 |
| Applicant Contact | Ms. Amy O'Donnell |
| Applicant Contact Email | amy.odonnell@onpointsurgical.com |
| Device Name | 21 CFR 807.92(a)(2) |
|---|---|
| ------------- | --------------------- |
| Device Trade Name | OnPoint Augmented Reality Spine System |
|---|---|
| Common Name | Stereotaxic instrument |
| Classification Name | Orthopedic Augmented Reality |
| Regulation Number | 882.4560 |
| Product Code(s) | SBF |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
|---|---|
| ------------------------------------ | --------------------- |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K231284 | OnPoint Augmented Reality Spine System | OLO |
| Device Description Summary | 21 CFR 807.92(a)(4) |
|---|---|
| ---------------------------- | --------------------- |
The OnPoint Augmented Reality Spine System is intended as an aid for precisely locating anatomic structures in either open or percutaneous spine procedures. Infrared track to track the patient's anatomy as well as surgical instrumentation. The tracking information is registered with image information of the patient's anatomy in a common coordinate system. To quide the surgeon through the pedicle screw placement process, the system will display a visual representation of the following elements in an augmented reality optical head mounted display in addition to being displayed on a workstation monitor:
- Target position and orientation of the instrument path
- Current position and orientation of the instrument
- · Cross sectional images
· 3D model of the patient's spine
Depending on surgeon preference, different combinations of these elements can be displayed. Optional planning steps allow the surgeon to define the target position and orientation as well as the length and diameter of the pedicle screws.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The OnPoint Augmented Reality Spine System, with OnPoint Augmented Reality Spine System Software, is intended as an aid for precisely locating anatomic structures in either open or percutaneous spine procedures. The use of the OnPoint Augmented Reality Spine System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a bony anatomical structure, such as the spine or pelvis, can be identified relative to CT images of the anatomy. This can include spinal implant procedures such as pedicle screw placement, where the surgeon wants to see a tracked instrument location in relationship to the stereotaxic display of the CT images of the anatomy.
The optical head mounted display of the OnPoint Augmented Reality Spine System displays 2D stereotaxic screens and an optional
4
virtual anatomy screen, pared with optional targeting tools and alphanumeric displays. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient images. The virtual screen is indicated for displaying the virtual instrument location in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning. The graphical targeting tools and alphanumeric display are indicated for providing visual and quantitative tracked instrument location including deviation from plan.
The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.
Indications for Use Comparison
The indications for use for the OnPoint Augmented Reality Spine System are the predicate device.
Technological Comparison
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
The OnPoint Augmented Reality Spine System is the same in its technological features to the predicate device. Both systems include the same hardware and software components, with the following basic components: software, optical head mounted display, tracking camera, rigid spinal or pelvic reference point, and reusable instrument adapters.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Registration testing was successfully completed using an additional 3D scanner with the OnPoint Augmented Reality Spine System; Testing demonstrated that the device is safe for its intended use and is substantially equivalent to the predicate device.
The modified OnPoint Augmented Reality Spine System is substantially equivalent to its predicate, the cleared OnPoint Augmented Reality Spine System. The modified OnPoint Augmented Reality Spine System has the same intended use, technological characteristics, and principles of operation as the predicate. None of the minor differences in compatibility raise new types of safety or effectiveness questions. Performance data demonstrated that the modified OnPoint Augmented Reality Spine System functions as intended.