HIP7

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June 2, 2020 Brainlab AG % Cherita James Regulatory Consultant M Squared Associates Inc. 575 8th Ave Suite 1212 New York, New York 10018 Re: K193307 Trade/Device Name: Hip7 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 1, 2020 Received: April 2, 2020 Dear Cherita James: 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. {1}------------------------------------------------ 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. 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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. Shumaya Ali, MPH 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K193307 Device Name HIP7 #### Indications for Use (Describe) HIP7 is intended to be an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system, to virtual computer image space either on a patient's preoperative image data being processed by Brainlab IGS platforms, or on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure, such as a long bone or vertebra, can be identified relative to a CT, X-Ray, or MR-based model of the anatomy. The system aids the surgeon to accurately navigate a hip endoprosthesis to the preoperatively or intraoperatively planned position. Example orthopedic surgical procedures for the Computer Assisted Total Hip Replacement – HIP7 use case include but are not limited to: - · Total Joint Replacement - · Minimally invasive orthopedic surgery | 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Cherita James 575 8th Ave, Suite 1212 New York, New York 10018 Ph. 347-954-0624 Fax. 703-562-9797 Date of Submission: March 26, 2020 Proprietary Name: HIP7 Common Name: Stereotaxic Instrument | Regulatory Class: | Class II | |----------------------|----------------------| | Regulation: | 21 CFR 882.4560 | | Product Codes: | OLO | | Predicate Device(s): | K122011 Brainlab Hip | The HIP7 system is intended to enable navigation in orthopedic hip replacement Device Description: surgery. It links a surgical instrument, tracked by flexible passive markers to virtual computer image space on an individual three-dimensional model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface or soft tissue. The HIP7 system uses the registered landmarks to navigate the necessary surgical tool, i.e., cup inserter, to the desired orientation. Additionally, it enables to intra-operatively measure the changes in leg length and offset. The HIP7 system provides a three-dimensional reconstruction of the relevant anatomical axes and planes of the femur and pelvis to aid the alignment of the implants and to determine leg length and offset parameters. Based on the selected procedure, the HIP7 system loads implant and instrument data that has been provided by the implant manufacturer. The implant is selected according to the available license and is then shown in the software in relation to the determined anatomical structures. A preoperative x-ray may optionally me loaded. The HIP7 system does not require CT-based imaging. {4}------------------------------------------------ Indications for Use: HIP7 is intended to be an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system, to virtual computer image space either on a patient's preoperative image data being processed by Brainlab IGS platforms, or on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure, such as a long bone or vertebra, can be identified relative to a CT, X-Ray, or MR-based model of the anatomy. The system aids the surgeon to accurately navigate a hip endoprosthesis to the preoperatively or intraoperatively planned position. Example orthopedic surgical procedures include but are not limited to: - Total Joint Replacement ● - Minimally invasive orthopedic surgery ● ### SE Table | Features/Technical<br>Information | Predicate device | New device | Substantial Equivalence | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Brainlab hip (Hip 6.0) | HIP7 | | | 510(k) number | K122011 | - | - | | Indication for Use | Total Hip Replacement<br>(THR) procedures The<br>Brainlab Hip system is<br>intended to be an<br>intraoperative image-<br>guided localization<br>system to enable<br>minimally invasive<br>surgery. It links a<br>freehand probe, tracked<br>by a passive marker<br>sensor system, to virtual<br>computer image space<br>either on a patient's<br>preoperative image data<br>being processed by<br>Brainlab IGS platforms,<br>or on an individual 3D-<br>model of the patient's<br>bone, which is generated<br>through acquiring<br>multiple landmarks on<br>the bone surface. The | HIP7 is intended to be an<br>intraoperative image-<br>guided localization<br>system to enable<br>minimally invasive<br>surgery. It links a<br>freehand probe, tracked<br>by a passive marker<br>sensor system, to virtual<br>computer image space<br>either on a patient's<br>preoperative image data<br>being processed by<br>Brainlab IGS platforms,<br>or on an individual 3D-<br>model of the patient's<br>bone, which is generated<br>through acquiring<br>multiple landmarks on<br>the bone surface.<br>The system is indicated<br>for any medical condition | Same indication for use<br>with limited intended<br>uses.<br>Difference does not<br>present new issues of<br>safety and effectiveness. | | Features/Technical<br>Information | Predicate device<br>Brainlab hip (Hip 6.0) | New device<br>HIP7 | Substantial Equivalence | | Intended Use | system is indicated for<br>any medical condition in<br>which the use of<br>stereotactic surgery may<br>be considered to be safe<br>and effective, and where<br>a reference to a rigid<br>anatomical structure,<br>such as the skull, a long<br>bone, or vertebra, can be<br>identified relative to a<br>CT, X-Ray, or MR-<br>based model of the<br>anatomy. The system<br>aids the surgeon to<br>accurately navigate a hip<br>endoprosthesis to the<br>preoperatively or<br>intraoperatively planned<br>position. Example<br>orthopedic surgical<br>procedures include but<br>are not limited to:<br>• Total Joint<br>Replacement<br>• Minimally<br>invasive<br>orthopedic<br>surgery<br>• Tumor<br>resection and<br>bone/joint<br>reconstruction<br>Surface Replacement<br>(SR) procedures | in which the use of<br>stereotactic surgery may<br>be considered to be safe<br>and effective, and where<br>a reference to a rigid<br>anatomical structure,<br>such as a long bone, or<br>vertebra, can be<br>identified relative to a<br>CT, X-Ray, or MR-based<br>model of the anatomy.<br>The system aids the<br>surgeon to accurately<br>navigate a hip<br>endoprosthesis to the<br>preoperatively or<br>intraoperatively planned<br>position.<br>Example orthopedic<br>surgical procedures<br>include but are not<br>limited to:<br>• Total Joint<br>Replacement<br>• Minimally<br>invasive<br>orthopedic<br>surgery<br>intraoperative image- | Tumor resection and<br>bone/joint reconstruction<br>and Surface replacement | | | intraoperative image-<br>guided localization<br>system to enable | guided localization<br>system to enable | | | Features/Technical<br>Information | Predicate device<br>Brainlab hip (Hip 6.0) | New device<br>HIP7 | Substantial Equivalence | | | minimally invasive<br>surgery including:<br>Total Joint Replacement Minimally invasive orthopedic surgery Tumor resection and bone/joint reconstruction Surface Replacement procedures | minimally invasive<br>surgery including:<br>Total Joint Replacement Minimally invasive orthopedic surgery Tumor resection and<br>bone/joint reconstruction<br>and Surface replacement<br>procedures have been<br>excluded. | procedures have been<br>excluded.<br>Difference does not<br>present new issues of<br>safety and effectiveness. | | Pelvis Registration | There is a pelvis<br>registration for supine<br>and one for lateral<br>patient position.<br>The ASIS-ASIS distance<br>is measured pre-<br>operatively with the<br>caliper. | The registration<br>procedures have been<br>modified:<br>- measurement of<br>ASIS-ASIS<br>distance<br>manually (with<br>caliper) or<br>digitally (on pre-<br>operative X-ray)<br>- elimination of<br>the acquisition of<br>one landmark<br>(anterior rim<br>point is now<br>constructed from<br>the calculated<br>acetabular<br>sphere) | Confirmed in verification<br>of device/system<br>performance.<br>Difference does not<br>present new issues of<br>safety and effectiveness. | | Plausibility checks | Contains plausibility<br>checks | Plausibility checks were<br>removed (due to<br>eliminated features), | Difference does not<br>present new issues of<br>safety and effectiveness. | | Features/Technical<br>Information | Predicate device | New device | Substantial Equivalence | | | Brainlab hip (Hip 6.0) | HIP7 | | | | | adjusted (tighter rules)<br>and added. | | | Cup Navigation | Cup orientation values<br>(inclination,<br>anteversion) are<br>displayed in<br>combination with a<br>visualization of a pelvis<br>model and the navigated<br>implant.<br>When pelvic tilt was<br>entered via a control, the<br>inclination and<br>anteversion values to<br>both the anterior pelvic<br>plane (APP) and<br>functional plane are<br>shown next to each other<br>in the controls. The<br>pelvic tilt value is shown<br>on the screen. | Cup orientation values<br>(inclination, anteversion)<br>are displayed in<br>combination with a<br>visualization of a pelvis<br>model, the navigated<br>implant and the reference<br>planes.<br>When a pelvic tilt (PT)<br>value is available, the<br>inclination and<br>anteversion values to<br>both the anterior pelvic<br>plane (APP) and<br>functional plane are<br>displayed in individual<br>controls. PT can be<br>entered manually via<br>control or calculated<br>automatically if<br>appropriate pre-operative<br>planning data is available<br>(X-ray planned with<br>specific TraumaCad<br>measurement tool). The<br>PT value is shown on the<br>screen. | In addition to the manual<br>entry of the pelvic tilt, the<br>value can now also be<br>calculated automatically<br>if TraumaCad planning<br>data is available.<br>Acceptance criteria for<br>measuring inclination and<br>anteversion had been<br>defined for Hip 6.0.<br>Verification tests have<br>shown that these<br>acceptance criteria are<br>also met when inclination<br>and anteversion are<br>measured in relation to a<br>functional plane<br>(including automatic<br>calculation of pelvic tilt).<br>Difference does not<br>present new issues of<br>safety and effectiveness. | | Leg Length &<br>Offset<br>Measurement | The global leg length<br>and offset change<br>(combined change<br>resulting from implanted<br>cup and stem) can be<br>measured<br>intraoperatively with<br>trial and final implants.<br>There are two options:<br>with a reference array<br>attached to the femur<br>with pins or with a | The global leg length and<br>offset change can be<br>measured<br>intraoperatively with trial<br>and final implants. There<br>is only one option: with a<br>reference array attached<br>to the lower thigh with<br>adhesive foil. | The functionality of the<br>remaining measurement<br>procedure is unchanged.<br>Difference does not<br>present new issues of<br>safety and effectiveness. | | Features/Technical<br>Information | Predicate device | New device | Substantial Equivalence | | | Brainlab hip (Hip 6.0) | HIP7 | | | | reference array attached<br>to the lower thigh with<br>adhesive foil. | | | | Compatible<br>platforms | - Kolibri<br>Navigation<br>Station 2.0<br>(Windows XP<br>SP 3) | - Kick (Windows<br>7 (64 Bit))* | Difference does not<br>present new issues of<br>safety and effectiveness | | | - VectorVision<br>Compact<br>(Workstation 6<br>with Windows<br>XP SP 3) | - Kick 2 (with<br>Spectra and Vega<br>camera)<br>(Windows 8.1<br>(64 Bit))* | | | | - VectorVision2<br>(Workstation 6<br>with Windows<br>XP SP 3) | - Curve (Windows<br>7 (64 Bit))* | | | | - VectorVision<br>Sky<br>(Workstation 6<br>with Windows<br>XP SP 3) | - Curve Ceiling-<br>Mounted<br>(Windows 7 (64<br>Bit)) ** | | | | - VectorVision<br>Flex<br>(Workstation 6<br>with Windows<br>XP SP 3) | - Curve 1.2 Dual<br>Navigation<br>Station<br>(Windows 8.1<br>(64 Bit))* | | | | - Curve<br>(Windows 7 (64<br>Bit)) | - Curve 1.2.1 Dual<br>Navigation<br>Station<br>(Windows 10 (64<br>Bit))* | | | | - Kick (Windows<br>7 (64 Bit))* | - BUZZ<br>Navigation<br>(Ceiling-<br>Mounted)<br>(Windows 10 (64<br>Bit))* | | | | - Kick 2 (with<br>Spectra camera<br>only) (Windows<br>8.1 (64 Bit))* | All platforms marked<br>with * received FDA<br>clearance with K183605 | | | | - Curve Ceiling-<br>Mounted | | | | Features/Technical<br>Information | Predicate device | New device | Substantial Equivalence | | Brainlab hip (Hip 6.0) | (Windows 7 (64 Bit))*<br>- Curve 1.2 Dual Navigation Station<br>(Windows 8.1 (64 Bit))*<br>* letter to file | HIP7<br>Spine & Trauma<br>Navigation.<br>The platform marked<br>with ** received FDA<br>clearance with K092467<br>Cranial Navigation. | | | Compatible<br>instruments | Contains a large number<br>of compatible<br>instruments for allavailable workflow<br>steps.<br>See Hip and Knee<br>Instrument User Guide<br>of original submission | The list of compatible<br>instruments has been<br>reduced in accordance<br>with the features<br>removed.<br>The Bone Fixator 2-Pin<br>Flip Flop was added to<br>the list of compatible<br>instruments (received<br>FDA clearance with<br>K183605 Spine &<br>Trauma Navigation<br>System)<br>The following<br>instruments / accessories<br>have been added:<br>Cup Impactor Universal<br>Straight, Pin Driver<br>Adapter for AO<br>Coupling, KingMark<br>Calibration Device<br>See Section 8 Device<br>Description and<br>Appendix 11-1, 11-2<br>Instrument User Guide<br>Hip | New<br>instruments/accessories<br>have been verified to<br>perform as intended.<br>Difference does not<br>present new issues of<br>safety and effectiveness | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ Similarities: - same type of platform (computer, touchscreen, tracking camera) - - same tracking technology (infrared tracking with passive marker spheres) - most instruments are the same (available selection was reduced, four instruments / accessories added) - workflows (available selection was only reduced) - registration procedure and landmarks to be registered (required number of landmarks was only reduced) - navigated values (inclination, anteversion; leg length (longer/shorter), offset (medial/lateral)) - content of GUI (displayed pictures) - Differences: - new GUI design - optional use of data from pre-operatively planned X-ray for calculation of ASIS-ASIS distance - optional use of data from pre-operatively planned X-ray for calculation of pelvic tilt - compatibility to old platforms removed and compatibility to new platforms added (All compatible platforms have already received FDA clearance with the predicate device K122011, or with K183605 or K092467.) - added Bone Fixator 2-Pin Flip Flop to list of compatible instruments (received FDA clearance with K183605 Spine & Trauma Navigation System) - three new instruments / accessories ### Technological Characteristics and Substantial Equivalence The HIP7 system has been verified and validated according to Brainlab's procedures for product design and development. ### Summary The changes described above do not alter intended use or the fundamental scientific technology of the device because they do not change the operating principle. The changes to the HIP7 do not present any new issues of safety and effectiveness when compared to the predicate device. The HIP7 system described in this submission is, in our opinion, substantially equivalent to the predicate.