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

Device Description

The HIP7 system is intended to enable navigation in orthopedic hip replacement 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.

AI/ML Overview

The provided document does not contain details about specific acceptance criteria, study design, or performance metrics for the HIP7 device in the format requested. The document is primarily a 510(k) summary for regulatory clearance, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical or performance study report.

Therefore, most of the requested information cannot be extracted directly from this document.

However, based on the nature of the device and the presented "SE Table" (Substantial Equivalence Table), we can infer general aspects:

The document clearly states: "The HIP7 system has been verified and validated according to Brainlab's procedures for product design and development." This implies that internal studies were conducted to ensure the device meets its design requirements.

It also mentions under "Cup Navigation": "Acceptance criteria for measuring inclination and anteversion had been defined for Hip 6.0. Verification tests have shown that these acceptance criteria are also met when inclination and anteversion are measured in relation to a functional plane (including automatic calculation of pelvic tilt)." This is the only direct reference to "acceptance criteria" and "verification tests" in the provided text.

Here's a breakdown of what can be inferred or stated as not available:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria Mentioned: "Acceptance criteria for measuring inclination and anteversion had been defined for Hip 6.0." (Specific values are not provided).
- Reported Device Performance: "Verification tests have shown that these acceptance criteria are also met when inclination and anteversion are measured in relation to a functional plane (including automatic calculation of pelvic tilt)." (Specific performance values or metrics are not provided).
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not provided in the document. The "verification tests" mentioned are likely internal engineering verification, not a clinical trial with a defined sample size as typically reported for AI/diagnostic devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable as this is a surgical navigation system, not a diagnostic AI system requiring expert image interpretation, and the details of "verification tests" are not specified.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable; details of verification tests are not provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, this is an intraoperative image-guided localization system, not a diagnostic AI system involving human "readers" in that context. The document does not describe such a study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Given it's a "localization system" and "aids the surgeon," its performance inherently involves integration into a surgical workflow. "Verification tests" for navigation systems typically assess accuracy of tracking and display, which can be seen as an 'algorithm only' performance component, but specific details are not provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For a navigation system, ground truth typically involves a highly accurate measurement system (e.g., optical tracking system with known accuracy, physical phantoms) to assess the accuracy of instrument positioning and display against a known reference. The document does not specify the ground truth mechanism used in their "verification tests."
The sample size for the training set:
- This device is not described as an AI/ML model that would require a separate "training set" in the context of deep learning. It's a navigation system. If there are underlying algorithms that were "trained," those details are not provided.
How the ground truth for the training set was established:
- Not applicable, as a distinct training set for an AI/ML model is not mentioned.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency name in a lighter blue. The text reads "FDA U.S. FOOD & DRUG ADMINISTRATION".

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. 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 (OS)

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.

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)

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.

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) Summary

The following information is provided as required by 21 CFR § 807.87 for Brainlab's HIP7 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.

Sponsor: Brainlab AG Olof-Palme-Str. 9 81829 Munich Germany Ph. +49 89 99 15 68 - 0 Fax. +49 89 99 15 68 - 5033 Contact: M Squared Associates, Inc. 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.

{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.

Example orthopedic surgical procedures include but are not limited to:

Total Joint Replacement ●
Minimally invasive orthopedic surgery ●

SE Table

Features/TechnicalInformation	Predicate device	New device	Substantial Equivalence
	Brainlab hip (Hip 6.0)	HIP7
510(k) number	K122011	-	-
Indication for Use	Total Hip Replacement(THR) procedures TheBrainlab Hip system isintended to be anintraoperative image-guided localizationsystem to enableminimally invasivesurgery. It links afreehand probe, trackedby a passive markersensor system, to virtualcomputer image spaceeither on a patient'spreoperative image databeing processed byBrainlab IGS platforms,or on an individual 3D-model of the patient'sbone, which is generatedthrough acquiringmultiple landmarks onthe bone surface. The	HIP7 is intended to be anintraoperative image-guided localizationsystem to enableminimally invasivesurgery. It links afreehand probe, trackedby a passive markersensor system, to virtualcomputer image spaceeither on a patient'spreoperative image databeing processed byBrainlab IGS platforms,or on an individual 3D-model of the patient'sbone, which is generatedthrough acquiringmultiple landmarks onthe bone surface.The system is indicatedfor any medical condition	Same indication for usewith limited intendeduses.Difference does notpresent new issues ofsafety and effectiveness.
Features/TechnicalInformation	Predicate deviceBrainlab hip (Hip 6.0)	New deviceHIP7	Substantial Equivalence
Intended Use	system is indicated forany medical condition inwhich the use ofstereotactic surgery maybe considered to be safeand effective, and wherea reference to a rigidanatomical structure,such as the skull, a longbone, or vertebra, can beidentified relative to aCT, X-Ray, or MR-based model of theanatomy. The systemaids the surgeon toaccurately navigate a hipendoprosthesis to thepreoperatively orintraoperatively plannedposition. Exampleorthopedic surgicalprocedures include butare not limited to:• Total JointReplacement• Minimallyinvasiveorthopedicsurgery• Tumorresection andbone/jointreconstructionSurface Replacement(SR) procedures	in which the use ofstereotactic surgery maybe considered to be safeand effective, and wherea reference to a rigidanatomical structure,such as a long bone, orvertebra, can beidentified relative to aCT, X-Ray, or MR-basedmodel of the anatomy.The system aids thesurgeon to accuratelynavigate a hipendoprosthesis to thepreoperatively orintraoperatively plannedposition.Example orthopedicsurgical proceduresinclude but are notlimited to:• Total JointReplacement• Minimallyinvasiveorthopedicsurgeryintraoperative image-	Tumor resection andbone/joint reconstructionand Surface replacement
	intraoperative image-guided localizationsystem to enable	guided localizationsystem to enable
Features/TechnicalInformation	Predicate deviceBrainlab hip (Hip 6.0)	New deviceHIP7	Substantial Equivalence
	minimally invasivesurgery including:Total Joint Replacement Minimally invasive orthopedic surgery Tumor resection and bone/joint reconstruction Surface Replacement procedures	minimally invasivesurgery including:Total Joint Replacement Minimally invasive orthopedic surgery Tumor resection andbone/joint reconstructionand Surface replacementprocedures have beenexcluded.	procedures have beenexcluded.Difference does notpresent new issues ofsafety and effectiveness.
Pelvis Registration	There is a pelvisregistration for supineand one for lateralpatient position.The ASIS-ASIS distanceis measured pre-operatively with thecaliper.	The registrationprocedures have beenmodified:- measurement ofASIS-ASISdistancemanually (withcaliper) ordigitally (on pre-operative X-ray)- elimination ofthe acquisition ofone landmark(anterior rimpoint is nowconstructed fromthe calculatedacetabularsphere)	Confirmed in verificationof device/systemperformance.Difference does notpresent new issues ofsafety and effectiveness.
Plausibility checks	Contains plausibilitychecks	Plausibility checks wereremoved (due toeliminated features),	Difference does notpresent new issues ofsafety and effectiveness.
Features/TechnicalInformation	Predicate device	New device	Substantial Equivalence
	Brainlab hip (Hip 6.0)	HIP7
		adjusted (tighter rules)and added.
Cup Navigation	Cup orientation values(inclination,anteversion) aredisplayed incombination with avisualization of a pelvismodel and the navigatedimplant.When pelvic tilt wasentered via a control, theinclination andanteversion values toboth the anterior pelvicplane (APP) andfunctional plane areshown next to each otherin the controls. Thepelvic tilt value is shownon the screen.	Cup orientation values(inclination, anteversion)are displayed incombination with avisualization of a pelvismodel, the navigatedimplant and the referenceplanes.When a pelvic tilt (PT)value is available, theinclination andanteversion values toboth the anterior pelvicplane (APP) andfunctional plane aredisplayed in individualcontrols. PT can beentered manually viacontrol or calculatedautomatically ifappropriate pre-operativeplanning data is available(X-ray planned withspecific TraumaCadmeasurement tool). ThePT value is shown on thescreen.	In addition to the manualentry of the pelvic tilt, thevalue can now also becalculated automaticallyif TraumaCad planningdata is available.Acceptance criteria formeasuring inclination andanteversion had beendefined for Hip 6.0.Verification tests haveshown that theseacceptance criteria arealso met when inclinationand anteversion aremeasured in relation to afunctional plane(including automaticcalculation of pelvic tilt).Difference does notpresent new issues ofsafety and effectiveness.
Leg Length &OffsetMeasurement	The global leg lengthand offset change(combined changeresulting from implantedcup and stem) can bemeasuredintraoperatively withtrial and final implants.There are two options:with a reference arrayattached to the femurwith pins or with a	The global leg length andoffset change can bemeasuredintraoperatively with trialand final implants. Thereis only one option: with areference array attachedto the lower thigh withadhesive foil.	The functionality of theremaining measurementprocedure is unchanged.Difference does notpresent new issues ofsafety and effectiveness.
Features/TechnicalInformation	Predicate device	New device	Substantial Equivalence
	Brainlab hip (Hip 6.0)	HIP7
	reference array attachedto the lower thigh withadhesive foil.
Compatibleplatforms	- KolibriNavigationStation 2.0(Windows XPSP 3)	- Kick (Windows7 (64 Bit))*	Difference does notpresent new issues ofsafety and effectiveness
	- VectorVisionCompact(Workstation 6with WindowsXP SP 3)	- Kick 2 (withSpectra and Vegacamera)(Windows 8.1(64 Bit))*
	- VectorVision2(Workstation 6with WindowsXP SP 3)	- Curve (Windows7 (64 Bit))*
	- VectorVisionSky(Workstation 6with WindowsXP SP 3)	- Curve Ceiling-Mounted(Windows 7 (64Bit)) **
	- VectorVisionFlex(Workstation 6with WindowsXP SP 3)	- Curve 1.2 DualNavigationStation(Windows 8.1(64 Bit))*
	- Curve(Windows 7 (64Bit))	- Curve 1.2.1 DualNavigationStation(Windows 10 (64Bit))*
	- Kick (Windows7 (64 Bit))*	- BUZZNavigation(Ceiling-Mounted)(Windows 10 (64Bit))*
	- Kick 2 (withSpectra cameraonly) (Windows8.1 (64 Bit))*	All platforms markedwith * received FDAclearance with K183605
	- Curve Ceiling-Mounted
Features/TechnicalInformation	Predicate device	New device	Substantial Equivalence
Brainlab hip (Hip 6.0)	(Windows 7 (64 Bit))- Curve 1.2 Dual Navigation Station(Windows 8.1 (64 Bit))* letter to file	HIP7Spine & TraumaNavigation.The platform markedwith ** received FDAclearance with K092467Cranial Navigation.
Compatibleinstruments	Contains a large numberof compatibleinstruments for allavailable workflowsteps.See Hip and KneeInstrument User Guideof original submission	The list of compatibleinstruments has beenreduced in accordancewith the featuresremoved.The Bone Fixator 2-PinFlip Flop was added tothe list of compatibleinstruments (receivedFDA clearance withK183605 Spine &Trauma NavigationSystem)The followinginstruments / accessorieshave been added:Cup Impactor UniversalStraight, Pin DriverAdapter for AOCoupling, KingMarkCalibration DeviceSee Section 8 DeviceDescription andAppendix 11-1, 11-2Instrument User GuideHip	Newinstruments/accessorieshave been verified toperform as intended.Difference does notpresent new issues ofsafety 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.

Regulation Number and Section

§ 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).