(314 days)
No
The summary describes software for surgical planning and visualization based on CT data and 3D modeling, but there is no mention of AI or ML algorithms being used for image processing, analysis, or decision support. The focus is on displaying pre-calculated plans and providing guidance based on known landmarks.
No
Explanation: This device is a surgical planning and guidance tool for hip arthroplasty, not a device that directly treats or prevents a medical condition.
No
The device is a surgical planning and alignment system used during hip arthroplasty procedures, not for diagnosing medical conditions. It uses existing CT image data to plan surgery and guide tool alignment, rather than to identify or characterize disease.
No
The device description explicitly mentions "manual surgical instrument" and the use of the Microsoft HoloLens2 mixed reality headset, indicating hardware components are part of the system.
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 HipXpert and Hiplnsight systems are designed for surgical planning and guidance during hip arthroplasty procedures. They use imaging data (CT) to create 3D models and provide visual guidance to the surgeon during the operation.
- No Sample Analysis: The device does not analyze any biological samples from the patient. Its function is based on processing and displaying medical imaging data and providing spatial guidance.
Therefore, the device falls under the category of surgical planning and guidance systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The HipXpert system is a manual surgical instrument and associated software application designed for use in planning surgery and aligning the acetabular components during hip arthroplasty procedures.
The Hiplnsight system with the HoloLens2 is indicated for visualization of the HipXpert surgical plan and alignment of acetabular implants and instrumentation during hip arthroplasty when pin-based fixation of the HipXpert tools is utilized.
Product codes
OSF, SBF
Device Description
The Hiplnsight System was cleared in K200384 and utilizes the Microsoft HoloLens2 mixed reality headset to display 3D images from the HipXpert planning application. The 3D images are superimposed on the actual patient using known anchoring landmarks relative to the anterior pelvic plane.
The HipXpert software planning application uses CT patient image data to create a detailed 3D model of the pelvis as well as the instrument settings necessary for proper acetabular cup orientation. The HipXpert planning application has the ability to show implant and instrument templates that are either generic or manufacturer specific. The templates can be positioned in relation to the patient's pelvis and femur bones in the surgical plan.
The surgical plan, including all tool settings and usage instructions, is posted to the surgeon's secure folder on the HipXpert website. The operating surgeon can then download the plan to a desktop or laptop computer and use the HipXpert viewer application to view and adjust the plan according to his/her best surgical judgment.
The purpose of this submission is to introduce additional options for the Hiplnsight system. Additional surgeon needs include being able to:
- Use mixed-reality guidance with additional 3D objects
- Use mixed-reality quidance without using the HipXpert mechanical docking tools
- Use mixed-reality guidance that provides position accuracy in addition to orientation accuracy
- Use mixed-reality guidance for limb length measurements
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT patient image data
Anatomical Site
Pelvis, femur bones. Used for hip arthroplasty.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating surgeon, Hip arthroplasty 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)
Simulated cadaveric specimens were used to evaluate the accuracy of the design changes described in this 510(k). All results in terms of orientation and position accuracy of the subject device were equivalent to those of the predicate. No clinical testing was conducted to support the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
0
August 8, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo, which includes the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text.
Surgical Planning Associates, Inc % Kellen Hills Biomedical Engineer Hills Quality and Regulatory Services, LLC 8971 Oakwood Lane Olive Branch, Mississippi 38654
Re: K233315
Trade/Device Name: HipXpert and HipInsight System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OSF, SBF Dated: May 10, 2024 Received: May 10, 2024
Dear Kellen Hills:
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,
Tejen D. Soni -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
2
Indications for Use
Submission Number (if known)
Device Name
HipXpert and HipInsight Systems
Indications for Use (Describe)
The HipXpert system is a manual surgical instrument and associated software application designed for use in planning surgery and aligning the acetabular components during hip arthroplasty procedures.
The Hiplnsight system with the HoloLens2 is indicated for visualization of the HipXpert surgical plan and alignment of acetabular implants and instrumentation during hip arthroplasty when pin-based fixation of the HipXpert tools is utilized.
Type of Use (Select one or both, as applicable)
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) #: K233315 | 510(k) Summary | Prepared on: 2024-08-08 | |
|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | ||
| Applicant Name | Surgical Planning Associates, Inc | ||
| Applicant Address | New England Baptist Hospital 125 Parker Hill Ave Suite 545 Boston MA | ||
| 02120 United States | |||
| Applicant Contact Telephone | 617-277-4434 | ||
| Applicant Contact | Dr. Stephen Murphy | ||
| Applicant Contact Email | stephenbmurphymd@gmail.com | ||
| Correspondent Name | Hills Quality and Regulatory Services, LLC | ||
| Correspondent Address | 8971 Oakwood Lane Olive Branch MS 38654 United States | ||
| Correspondent Contact Telephone | 901-352-6350 | ||
| Correspondent Contact | Mr. Kellen Hills | ||
| Correspondent Contact Email | HillsQRServicesLLC@comcast.net | ||
| Device Name | 21 CFR 807.92(a)(2) | ||
| Device Trade Name | HipXpert and HipInsight Systems | ||
| Common Name | Stereotaxic instrument | ||
| Classification Name | Patient Specific Manual Orthopedic Stereotaxic System | ||
| Regulation Number | 882.4560 | ||
| Product Code(s) | OSF, SBF | ||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K200384 | HipXpert System | OSF | |
| Device Description Summary | 21 CFR 807.92(a)(4) |
The Hiplnsight System was cleared in K200384 and utilizes the Microsoft HoloLens2 mixed reality headset to display 3D images from the HipXpert planning application. The 3D images are superimposed on the actual patient using known anchoring landmarks relative to the anterior pelvic plane.
The HipXpert software planning application uses CT patient image data to create a detailed 3D model of the pelvis as well as the instrument settings necessary for proper acetabular cup orientation. The HipXpert planning application has the ability to show implant and instrument templates that are either generic or manufacturer specific. The templates can be positioned in relation to the patient's pelvis and femur bones in the surgical plan.
The surgical plan, including all tool settings and usage instructions, is posted to the surgeon's secure folder on the HipXpert website.
4
The operating surgeon can then download the plan to a desktop or laptop computer and use the HipXpert viewer application to view and adjust the plan according to his/her best surgical judgment.
The purpose of this submission is to introduce additional options for the Hiplnsight system.
Additional surgeon needs include being able to:
- Use mixed-reality guidance with additional 3D objects
- Use mixed-reality quidance without using the HipXpert mechanical docking tools
- Use mixed-reality guidance that provides position accuracy in addition to orientation accuracy
- Use mixed-reality guidance for limb length measurements
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
The HipXpert system is a manual surgical instrument and associated software application designed for use in planning surgery and aligning the acetabular components during hip arthroplasty procedures.
The Hiplnsight system with the HoloLens2 is indication of the HipXpert surgical plan and alignment of acetabular implants and instrumentation during hip arthroplasty when pin-based fixation of the HipXpert tools is utilized.
Indications for Use Comparison
The indications were amended to additional 3D objects being displayed by the Hiplnsight system. The software allows for additional 3D objects to be aligned using the HoloLens2, including instruments. The indications were also amended to clarify that the "HipXpert surgical plan" would also be in the display of the Hiplnsight system, which has always been the case. All 3D objects would be oriented relative to the anterior pelvic plane as defined during the HipXpert planning process. There is no change to the intended users, patient population, or surgical intervention.
There are no significant differences between the subject and predicate devices that would raise new questions of safety or effectiveness. The FDA classification is identical between the devices as is the intended use, despite slight differences in the exact verbiage of the indications for use.
Technological Comparison
The Hiplnsight system uses software and the Microsoft HoloLens2 to display 3D models generated by the HipXpert Planning application. The proposed updates to the Hiplnsight systems will allow for orientation alignment and positional placement of additional 3D objects including instruments and implants without the requirement to use the physical HipXpert mechanical tool.
The performance testing methodology utilized in K200384 is also utilized to evaluate the proposed software updates. All results in terms of orientation and position accuracy of the subject device were equivalent to those of the predicate.
There are no significant differences between the subject and predicate devices that would raise new questions of safety or effectiveness. The subject and predicate devices utilize identical materials, design, sterility, and packaging. The software movide additional options to the surgeon.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Simulated cadaveric specimens were used to evaluate the accuracy of the design changes described in this 510(k). All results in terms of orientation and position accuracy of the subject device were equivalent to those of the predicate.
No clinical testing was conducted to support the determination of substantial equivalence.
Based on the information provided in this premarket notification, we believe that the subject HipXpert/HipInsight systems demonstrate substantial equivalence to the predicate.