Predicate Devices

K122011 Brainlab Hip

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a traditional image-guided navigation system based on landmark registration and 3D reconstruction, with no mention of AI or ML terms or concepts.

Therapeutic

No.
The device is an image-guided localization and navigation system that aids surgeons during orthopedic hip replacement surgery, rather than directly treating a medical condition.

Diagnostic

No

The device is an image-guided localization and navigation system used during surgery, not a diagnostic device that identifies medical conditions. Its purpose is to aid the surgeon in accurately positioning medical devices and measuring anatomical parameters intraoperatively.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions linking a freehand probe and a passive marker sensor system, indicating the inclusion of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided text, 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.
HIP7 Function: The HIP7 system is described as an intraoperative image-guided localization system used during surgery. It uses imaging data (CT, X-Ray, MR) and anatomical landmarks to help surgeons navigate and position implants.
No Sample Analysis: The description does not mention the analysis of any biological samples from the patient. The system operates on imaging data and physical landmarks on the patient's body.

Therefore, the HIP7 system falls under the category of a surgical navigation or guidance system, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 for the Computer Assisted Total Hip Replacement – HIP7 use case include but are not limited to:

Total Joint Replacement
Minimally invasive orthopedic surgery

Product codes (comma separated list FDA assigned to the subject device)

OLO

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT, X-Ray, or MR-based model of the anatomy.

Anatomical Site

Hip (long bone or vertebra)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Surgeon, intraoperative

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)

The HIP7 system has been verified and validated according to Brainlab's procedures for product design and development.

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.

K122011 Brainlab Hip

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.

K183605, K092467

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

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).

Summary

0

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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. 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

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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)

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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.

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.

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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

Information	Predicate device	New device	Substantial Equivalence
	Brainlab hip (Hip 6.0)	HIP7
510(k) number	K122011	-	-
Indication for Use	Total Hip Replacement
(THR) procedures The
Brainlab Hip system 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	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	Same indication for use
with limited intended
uses.
Difference does not
present new issues of
safety and effectiveness.
Features/Technical
Information	Predicate device
Brainlab hip (Hip 6.0)	New device
HIP7	Substantial Equivalence
Intended Use	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 the skull, 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
• Tumor
resection and
bone/joint
reconstruction
Surface Replacement
(SR) procedures	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
intraoperative image-	Tumor resection and
bone/joint reconstruction
and Surface replacement
	intraoperative image-
guided localization
system to enable	guided localization
system to enable
Features/Technical
Information	Predicate device
Brainlab hip (Hip 6.0)	New device
HIP7	Substantial Equivalence
	minimally invasive
surgery including:
Total Joint Replacement Minimally invasive orthopedic surgery Tumor resection and bone/joint reconstruction Surface Replacement procedures	minimally invasive
surgery including:
Total Joint Replacement Minimally invasive orthopedic surgery Tumor resection and
bone/joint reconstruction
and Surface replacement
procedures have been
excluded.	procedures have been
excluded.
Difference does not
present new issues of
safety and effectiveness.
Pelvis Registration	There is a pelvis
registration for supine
and one for lateral
patient position.
The ASIS-ASIS distance
is measured pre-
operatively with the
caliper.	The registration
procedures have been
modified:

measurement of
ASIS-ASIS
distance
manually (with
caliper) or
digitally (on pre-
operative X-ray)
elimination of
the acquisition of
one landmark
(anterior rim
point is now
constructed from
the calculated
acetabular
sphere) | Confirmed in verification
of device/system
performance.
Difference does not
present new issues of
safety and effectiveness. |
| Plausibility checks | Contains plausibility
checks | Plausibility checks were
removed (due to
eliminated features), | Difference does not
present new issues of
safety and effectiveness. |
| Features/Technical
Information | Predicate device | New device | Substantial Equivalence |
| | Brainlab hip (Hip 6.0) | HIP7 | |
| | | adjusted (tighter rules)
and added. | |
| Cup Navigation | Cup orientation values
(inclination,
anteversion) are
displayed in
combination with a
visualization of a pelvis
model and the navigated
implant.
When pelvic tilt was
entered via a control, the
inclination and
anteversion values to
both the anterior pelvic
plane (APP) and
functional plane are
shown next to each other
in the controls. The
pelvic tilt value is shown
on the screen. | Cup orientation values
(inclination, anteversion)
are displayed in
combination with a
visualization of a pelvis
model, the navigated
implant and the reference
planes.
When a pelvic tilt (PT)
value is available, the
inclination and
anteversion values to
both the anterior pelvic
plane (APP) and
functional plane are
displayed in individual
controls. PT can be
entered manually via
control or calculated
automatically if
appropriate pre-operative
planning data is available
(X-ray planned with
specific TraumaCad
measurement tool). The
PT value is shown on the
screen. | In addition to the manual
entry of the pelvic tilt, the
value can now also be
calculated automatically
if TraumaCad planning
data is available.
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).
Difference does not
present new issues of
safety and effectiveness. |
| Leg Length &
Offset
Measurement | The global leg length
and offset change
(combined change
resulting from implanted
cup and stem) can be
measured
intraoperatively with
trial and final implants.
There are two options:
with a reference array
attached to the femur
with pins or with a | The global leg length and
offset change can be
measured
intraoperatively with trial
and final implants. There
is only one option: with a
reference array attached
to the lower thigh with
adhesive foil. | The functionality of the
remaining measurement
procedure is unchanged.
Difference does not
present new issues of
safety and effectiveness. |
| Features/Technical
Information | Predicate device | New device | Substantial Equivalence |
| | Brainlab hip (Hip 6.0) | HIP7 | |
| | reference array attached
to the lower thigh with
adhesive foil. | | |
| Compatible
platforms | - Kolibri
Navigation
Station 2.0
(Windows XP
SP 3) | - Kick (Windows
7 (64 Bit))* | Difference does not
present new issues of
safety and effectiveness |
| | - VectorVision
Compact
(Workstation 6
with Windows
XP SP 3) | - Kick 2 (with
Spectra and Vega
camera)
(Windows 8.1
(64 Bit))* | |
| | - VectorVision2
(Workstation 6
with Windows
XP SP 3) | - Curve (Windows
7 (64 Bit))* | |
| | - VectorVision
Sky
(Workstation 6
with Windows
XP SP 3) | - Curve Ceiling-
Mounted
(Windows 7 (64
Bit)) ** | |
| | - VectorVision
Flex
(Workstation 6
with Windows
XP SP 3) | - Curve 1.2 Dual
Navigation
Station
(Windows 8.1
(64 Bit))* | |
| | - Curve
(Windows 7 (64
Bit)) | - Curve 1.2.1 Dual
Navigation
Station
(Windows 10 (64
Bit))* | |
| | - Kick (Windows
7 (64 Bit))* | - BUZZ
Navigation
(Ceiling-
Mounted)
(Windows 10 (64
Bit))* | |
| | - Kick 2 (with
Spectra camera
only) (Windows
8.1 (64 Bit))* | All platforms marked
with * received FDA
clearance with K183605 | |
| | - Curve Ceiling-
Mounted | | |
| Features/Technical
Information | 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 | HIP7
Spine & Trauma
Navigation.
The platform marked
with ** received FDA
clearance with K092467
Cranial Navigation. | |
| Compatible
instruments | Contains a large number
of compatible
instruments for allavailable workflow
steps.
See Hip and Knee
Instrument User Guide
of original submission | The list of compatible
instruments has been
reduced in accordance
with the features
removed.
The Bone Fixator 2-Pin
Flip Flop was added to
the list of compatible
instruments (received
FDA clearance with
K183605 Spine &
Trauma Navigation
System)
The following
instruments / accessories
have been added:
Cup Impactor Universal
Straight, Pin Driver
Adapter for AO
Coupling, KingMark
Calibration Device
See Section 8 Device
Description and
Appendix 11-1, 11-2
Instrument User Guide
Hip | New
instruments/accessories
have been verified to
perform as intended.
Difference does not
present new issues of
safety and effectiveness |

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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.