K Number

Device Name

Perseus

Manufacturer

Orthokey Italia S.r.l.

Date Cleared

2020-09-09

(351 days)

Product Code

OLO

Regulation Number

882.4560

Intended Use

PERSEUS is a computer-controlled system, intended to assist in distal femoral resection and tibial resection during Total Knee Arthroplasty, determining reference alignment axes in relation to anatomical and instrumentation structures during stereotaxic orthopaedic surgical procedures.

Device Description

PERSEUS is a computer assisted system, that helps surgeon in the positioning of implant components, during total knee implant surgical procedure, according to the conventional reference axes in relation to anatomical landmarks. Perseus System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The device assists the surgeon in: Establishing the mechanical axis of the femur, determining the varus/valgus angle and the flexion/extension angle of the cutting block relative to the femur. Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia. Perseus system utilizes triaxial accelerometer and triaxial gyroscope to determine, through limb movement, reference axes of femur and tibia and relative orientation of distal femoral and tibial cutting guide with respect to frontal and sagittal planes of the limb.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K163379

Reference Devices

K141601

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on sensor-based measurements and calculations based on anatomical landmarks and instrumentation, without mentioning AI or ML algorithms. The performance studies also describe traditional statistical analysis of accuracy and alignment, not AI/ML model performance metrics.

Therapeutic

No.
therapeutic devices are used to cure, treat, or prevent diseases/conditions. This device assists the surgeon in the positioning of implant components, during total knee implant surgical procedures, it is not used to treat, cure, or prevent a disease/condition.

Diagnostic

The device is described as assisting in surgical procedures by providing measurements and guidance for implant positioning, not for diagnosing a condition or disease.

SaMD (Software as a Medical Device)

The device description explicitly states that the system utilizes "triaxial accelerometer and triaxial gyroscope" to determine measurements, indicating the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is a computer-controlled system intended to assist in surgical procedures (Total Knee Arthroplasty) by determining reference alignment axes. This is a surgical guidance and planning tool, not a diagnostic test performed on biological samples.
Device Description: The description details how the system uses sensors (accelerometer and gyroscope) to measure and display angular and positional changes during surgery. This is related to surgical navigation and instrumentation, not in vitro analysis of samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status based on laboratory tests.

The device's function is to aid the surgeon during the surgical procedure itself, which falls under the category of surgical instruments or computer-assisted surgical systems, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

OLO

Device Description

The device assists the surgeon in:

Establishing the mechanical axis of the femur, determining the varus/valgus angle and the flexion/extension angle of the cutting block relative to the femur.
Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia.

Perseus system utilizes triaxial accelerometer and triaxial gyroscope to determine, through limb movement, reference axes of femur and tibia and relative orientation of distal femoral and tibial cutting guide with respect to frontal and sagittal planes of the limb.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

knee

Indicated Patient Age Range

Not Found

Intended User / Care Setting

For professional use in operating room

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

A set of bench tests have been designed in order to:

Verify the measurement repeatability on a controlled setup, with different cursor positions of the jig
Verify the error introduced by mispositioning of the ankle instrumentation
Verify the repeatability of the measurement with different sensors
Verify the repeatability of the measurement with different instrument positioning

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench tests performance evaluation of Perseus has been done, verifying the orientation of femoral or tibial resections. Clinical evaluation has been done with the same performance requirement when possible or, in alternative, looking at final leg alignment with post-operative x-rays. The clinical evaluation has been prepared considering:

Bench testing
Pre-clinical evaluation testing
Aftermarket Clinical evaluation (Europe)
Data generated from literature

Bench testing: conducted introducing controlled variables within an appropriate test setup throughout the subject device's operational range, to quantify the accuracy of the device.

Pre-clinical activities: conducted to verify accuracy, repeatability and reproducibility in a simulated OR setup and to verify the consistency of the procedure when performed by different users with different level of experience.

Aftermarket clinical evaluation (Europe): Studies were conducted involving research centers in order to verify clinical results and performances of Perseus.

Study 1: A study involved 3 cohorts of 10 patients each randomly selected, operated by the same surgical equipe, where perseus was used only for distal femoral resection. The cohorts were dividend in: EM Perseus; patients operated with Perseus; EM Nav; patients operated with surgical navigation system, IM Conv; patients operated with conventional mechanical instrumentations. Final limb alignment on frontal and lateral planes and blood loss have been measured postoperatively. Perseus has demonstrated to fulfil surgical goal of final HKA alignment within 3° of deviation and femoral distal resection within 2° of deviation, and a reduced blood loss, compared to conventional technique.
Study 2: A second study only on femoral resection has been performed on a multicentric study involving two centers. The goal of the study was to verify blood loss and angular deviation of femoral distal resection on frontal and lateral planes, for two cohorts of 18 patients: 1 operated with the use of Perseus; 2 operated with conventional instrumentation. Perseus for the femoral resection has confirmed to satisfy the requirements of have a deviation

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

Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 9, 2020

Orthokey Italia S.r.l. % Guido Bonapace Regulatory Affair Isemed srl Via P. Togliatti, 19/X Imola, 40026 Italy

Re: K192653

Trade/Device Name: Perseus Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 6, 2020 Received: August 10, 2020

Dear Guido Bonapace:

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.

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, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K192653

Device Name PERSEUS

Indications for Use (Describe)

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)

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510(k) Summary

This 510(k) Summary is being submitted as required by 21 CFR 807.92.

5.1 General Information

Submitter :	ORTHOKEY Italia S.r.l
	Piazza Nazioni Unite, 15
	54033 Carrara (MS)-Italy
	Tel. +39 055 354829
	Fax +39 055 3246012

Consultant/ Contact:

Guido Bonapace ISEMED srl Via Palmiro Togliatti 19/X Imola, BO 40026 ITALY Tel. +39 0542 683803 Fax +39 0542 698456 Email: regulatory@isemed.eu

Summary Prepared Date:

September the 7th, 2020

5.2 Names

Device Name:	PERSEUS
Common Name:	Orthopedic Stereotaxic Instrument
Regulation Name:	Stereotaxic Instrument
Product Code:	OLO
Classification:	21 CFR 882.4560, Class II

5.3 Predicate Devices

The medical device PERSEUS is substantially equivalent to the following device legally marketed in the US:

Applicant	PREDICATE Device name	510(k) Number
OrthAlign Inc.	KneeAlign 2 System	K163379

Moreover, the following reference device has been considered:

Applicant	REFERENCE Device name	510(k) Number
Zimmer CAS	iASSIST™ Knee System	K141601

5.4 Device Description

The device assists the surgeon in:

Establishing the mechanical axis of the femur, determining the varus/valgus angle and the flexion/extension angle of the cutting block relative to the femur.
Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia.

5.5 Indications for Use

PERSEUS is a computer-controlled system, intended to assist in distal femoral resection and tibial resection during Total Knee Arthroplasty, by determining reference alignment axes in relation to anatomical and instrumentation structures during stereotaxic orthopedic surgical procedures.

	Proposed Device	Predicate Device	Reference Devices
Product Name	PERSEUS	KneeAlign 2 System	iASSIST Knee System
Manufacturer	Orthokey Italia S.r.l.	OrthAlign Inc.	Zimmer CAS
510(K) No.		K163379	K141601
Classification
Name	Orthopedic Stereotaxic
Instrument	Orthopedic Stereotaxic
Instrument	Orthopedic Stereotaxic
Instrument
Figure	Image: PERSEUS	Image: KneeAlign 2 System	Image: iASSIST Knee System
Regulation
Number	882.4560	882.4560	882.4560
Regulatory Class	II	II	II
Classification
Product Code	OLO	OLO	OLO
Intended use
Indications for
use	PERSEUS is a computer-
controlled system, intended
to assist in distal femoral
resection and tibial	The OrthAlign Plus®System is a
computer-controlled system
intended to assist the surgeon
in determining reference	The iASSIST Knee System is a
computer assisted stereotaxic
surgical instrument system to
assist the surgeon in the
	Proposed Device	Predicate Device	Reference Devices
Product Name	PERSEUS	KneeAlign 2 System	iASSIST Knee System
	resection during Total Knee
Arthroplasty, by
determining reference
alignment axes in relation to
anatomical and
instrumentation structures
during sterotactic
orthopaedic surgical
procedures.	alignment axes in relation to
anatomical structures during
stereotactic orthopedic surgical
procedures. The KneeAlign
system facilitates the accurate
positioning of implants and
instrumentation, relative to
these alignment axes.
Orthopedic surgical procedures
include but are not limited to:
Total Knee Arthroplasty
Unicompartmental Knee
Arthroplasty – Tibial Transverse
Resection	positioning of orthopedic
implant system components
intra-operatively. It involves
surgical instruments and
position sensors to determine
alignment axes in relation to
anatomical landmarks and to
precisely position alignment
instruments and implant
components relative to these
axes. Example orthopedic
surgical procedures include
but are not limited to: Total
Knee Arthroplasty.
Target
population	Orthopedic surgical
procedures include:
Total knee arthroplasty	Orthopedic surgical procedures
include but are not limited to:
Total Knee Arthroplasty
Uni-compartmental Knee
Arthroplasty - Tibial Transverse
Resection	Orthopedic surgical
procedures include but are
not limited to:
Total knee arthroplasty
Anatomical site	knee	knee	Knee
Where used
(hospital, home,
ambulance, etc)	For professional use in
operating room	For professional use in
operating room	For professional use in
operating room
Technology
Energy used
and/or
delivered	• Navigation unit, reference
sensor: DC battery power.
• Instruments: manual
position and orientation	• Navigation unit, reference
sensor and laser module: DC
battery power
• Instruments: manual position
and orientation	• Reference sensor: DC
battery power.
• Instruments: manual
position and orientation
User Interface	Graphical user interface, on
computer unit, outside
sterile field.	Integrated graphical user
interface, on an electronic unit
that attaches to
instrumentation.	Integrated graphical user
interface, on an electronic
unit that attaches to
instrumentation.
Control
Mechanism	Computer generation of
positional information, using
inertial sensors,
microcontroller, digital
signal processor and
physical positions of
registration instruments.	Computer generation of
positional information, using
inertial sensors,
microcontroller, digital signal
processor and physical
positions of registration
instruments.	Computer generation of
positional information, using
inertial sensors,
microcontroller, digital signal
processor and physical
positions of registration
instruments.
Operating
Principles
Registration of
anatomy	Electronics attached to
movable instruments,
placed in specified
procedural positions, for
recording sensor data.	Electronics attached to movable
instruments, placed in specified
procedural positions, on or in
contact with bony anatomy, for
recording sensor data.	Electronics attached to
movable instruments, placed
in specified procedural
positions, on or in contact
with bony anatomy, for
recording sensor data.
Measurement
of change in
angular
orientations	• Computer displayed
values based on internal
calculations.
• Accelerometer	• Computer displayed values
based on internal calculation.
• Accelerometer measurement
of angular change in	• Computer displayed values
based on internal
calculation.
• Accelerometer
	Proposed Device	Predicate Device	Reference Devices
Product Name	PERSEUS	KneeAlign 2 System	iASSIST Knee System
	change in instrument
positions.		change in instrument
positions.
Patient interface	Instrument fixation to bone
with pins or screws.
Instrument indications and
engagement of bony
anatomy via physical surface
contact	Instrument fixation to bone
with pins or screws. Instrument
indications and engagement of
bony anatomy via physical
surface contact	Instrument fixation to bone
with pins or screws.
Instrument indications and
engagement of bony anatomy
via physical surface contact
Main System
Components	• Non sterile reusable
computer unit
• Navigation and
measurement software
• Reusable instrument sets
• Single-use sensor	• Single-use computer unit
• Navigation and measurement
software
• Reusable instrument sets	• Non sterile reusable
computer unit
• Navigation and
measurement software
• Reusable instrument sets
• Single-use sensor
Performance	HKA angle within 3°	HKA angle within 3°	HKA angle within 3°
Electrical Safety
and EMC	IEC 60601-1
IEC 60601-1-2	IEC 60601-1
IEC 60601-1-2	IEC 60601-1
IEC 60601-1-2
Materials	Stainless Steel grades
common to orthopedic
surgical instruments
Polymer grades common to
orthopedic surgical
instruments
Internal electronics	Stainless Steel grades common
to orthopedic surgical
instruments
Polymer grades common to
orthopedic surgical instruments
Internal electronics	Stainless Steel grades
common to orthopedic
surgical instruments
Polymer grades common to
orthopedic surgical
instruments
Internal electronics
Biocompatibility	Per ISO 10993-1, External
Communicating Device,
Tissue/Bone/Dentin
Communicating, with
subsystems that have
potential indirect contact
for a limited contact
duration (