(104 days)
No
The summary describes a navigated surgical instrument (shaver blade) that works with a navigation system to display its position on pre-operative scans. There is no mention of AI or ML being used for image processing, diagnosis, treatment planning, or any other function. The navigation is based on electromagnetic tracking and displaying the position on existing scans.
No.
The device (TruDi® Shaver Blade) is an instrument used to aid in the incision and removal of tissue or bone during surgery, not to directly treat a medical condition. It's a surgical tool, not a therapeutic agent.
No
The device description and intended use clearly state that the TruDi® Shaver Blades are for surgical intervention (incision and removal of tissue/bone) and are used with a navigation system to guide these procedures, not to diagnose a medical condition.
No
The device description explicitly states that the TruDi® Shaver Blade is a "single-use and sterile electromagnetically (EM) navigated instrument" and describes its physical components and interaction with hardware (shaver handpiece and navigation system). This indicates it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The TruDi® Shaver Blades are surgical instruments used directly on the patient's body during surgery to cut and remove tissue and bone. They are guided by a navigation system using pre-operative imaging, but they do not analyze biological samples in vitro.
The device is a surgical instrument intended for use in vivo (within the living body) during surgical procedures, not for in vitro analysis of samples.
N/A
Intended Use / Indications for Use
TruDi® Shaver Blades are intended for use with the Bien-Air S120 Shaver Handpiece and the TruDi® Navigation System to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. Their use is indicated for any medical condition in which the use of navigated surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to a CT or MR based model.
TruDi® Shaver Blades may be used in, but is not limited to, the following procedures:
- Endoscopic sinus surgery (such as ethmoidectomy, polypectomy, septoplasty)
- Drainage of mucoceles or abscesses that have extended from the paranasal sinuses and up to the dura mater
- Orbital decompression
- Any other of a number of tumors involving the lateral nasal wall, paranasal sinuses and orbit
- Access to the sphenoid sinus
Product codes (comma separated list FDA assigned to the subject device)
PGW, ERL
Device Description
The subject device, TruDi® Shaver Blade, is a single-use and sterile electromagnetically (EM) navigated instrument, which is intended to be used with the Bien-Air S120 Shaver Handpiece (reference device, K083720) and the TruDi® Navigation System (K192397) to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. The device is tracked by the navigation system within the low energy magnetic field volume generated by the TruDi® Navigation System. The TruDi® Navigation System software displays the position of the shaver blade distal tip on preoperative scans (e.g. CT, MRI). The TruDi® Shaver Blade consists of several configurations ranging from straight to curved blades of different diameters.
Mentions image processing
No
Mentions AI, DNN, or ML
No
Input Imaging Modality
CT or MR based model
Anatomical Site
ENT, Maxillofacial, Head and Neck, ENT skull base, paranasal sinuses, dura mater, lateral nasal wall, orbit, sphenoid sinus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Bench testing has been performed and met all acceptance criteria for attributes, such as dimensional specifications, electrical tests, connector joint separation force, heat shrink slip, strain relief axial force, and navigational location accuracy.
Electrical safety and EMC tests were performed by a nationally recognized testing laboratory to verify compliance with the requirements of IEC 60601-1 (3rd Edition) and IEC60601-1-2 (4th Edition).
The sterilization process has been validated per ISO 11135:2014 and demonstrated a sterility assurance level of 10^-6.
Biocompatibility testing was successfully completed to determine that the TruDi® Shaver Blade is biocompatible per ISO 10993-1.
Packaging shelf life for the TruDi® Shaver Blade was established through accelerated aging via ASTM F1980-16, ASTM F88-15, and ASTM F2096-11 requirements and confirmed to meet a shelf life of three months.
Design validation testing (simulated use testing) on cadavers was successfully conducted to verify that the TruDi® Shaver Blade functions in accordance with its intended use and design specifications in a simulated clinical setting. The packaging, labeling, and instructions for use were also successfully assessed by evaluators as part of the study.
The TruDi® Shaver Blade passed all intended criteria in accordance with appropriate test criteria and standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Navigational location accuracy.
The accuracy of TruDi® Shaver Blade used in conjunction with the navigation views of the TruDi® Navigation System is
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
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July 20, 2022
Acclarent, Inc. Leena Zalavadia Regulatory Affairs Program Lead 31 Technology Drive, Suite 200 Irvine, California 92618
Re: K221037
Trade/Device Name: TruDi Shaver Blade Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW, ERL Dated: June 16, 2022 Received: June 17, 2022
Dear Leena Zalavadia:
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
1
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 (QS) 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,
for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221037
Device Name TruDi® Shaver Blade
Indications for Use (Describe)
TruDi® Shaver Blades are intended for use with the Bien-Air S120 Shaver Handpiece and the TruDi® Navigation System to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. Their use is indical condition in which the use of navigated surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to a CT or MR based model.
TruDi® Shaver Blades may be used in, but is not limited to, the following procedures:
- · Endoscopic sinus surgery (such as ethmoidectomy, polypectomy, septoplasty)
- · Drainage of mucoceles or abscesses that have extended from the paranasal sinuses and up to the dura mater
- · Orbital decompression
- · Any other of a number of tumors involving the lateral nasal wall, paranasal sinuses and orbit
- · Access to the sphenoid sinus
| 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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3
Image /page/3/Picture/1 description: The image contains the logo for "Acclarent", which is partially covered by a purple arc. Below the logo, it says "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" in a smaller font. The text "TruDi® Shaver Blade" is at the bottom of the image.
510(K) SUMMARY- K221037
[807.92(a)(1)] Submitter Information
| Sponsor/Submitter: | Acclarent, Inc.
31 Technology Drive, Suite 200
Irvine, CA 92618 |
|--------------------|---------------------------------------------------------------------------------------------------|
| Contact Person: | Leena Zalavadia
Regulatory Affairs Manager
Email: lsorathi@its.jnj.com
Tel: 949-923-4118 |
Date Summary Prepared: July 20, 2022
[807.92(a)(2)] Name of Device
| Device Trade
| Name: | TruDi® Shaver Blade |
|---|---|
| Classification | |
| Name: | Stereotaxic Instrument |
| Common Name: | Image Guided Surgery System |
| Device | |
| Classification: | Class II |
| Regulation | |
| Number: | 21 CFR 882.4560 |
| Review Panel: | Ear, Nose, and Throat |
| Primary Product | |
| Code: | PGW |
| Secondary Product | |
| Code: | ERL |
| [807.92(a)(3)] Legally Marketed Devices | |
| Predicate Device: | Medtronic Navigated Quadcut Blades (K130608) |
| Reference Devices: | Bien-Air OSSEODUO S120 Shaver Handpiece |
| (Cleared OSSEODUO Shaver and Drill System under K083720) | |
| TruDi® Curette (K201174) |
4
Image /page/4/Picture/0 description: The image shows the logo for Acclarent, a medical technology company. The logo features the company name in a combination of black and purple lettering, with a curved purple line above the "ent" portion of the name. Below the name, in smaller font, is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES."
[807.92(a)(4)] Device Description
Device Description: The subject device, TruDi® Shaver Blade, is a single-use and sterile electromagnetically (EM) navigated instrument, which is intended to be used with the Bien-Air S120 Shaver Handpiece (reference device, K083720) and the TruDi® Navigation System (K192397) to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. The device is tracked by the navigation system within the low energy magnetic field volume generated by the TruDi® Navigation System. The TruDi® Navigation System software displays the position of the shaver blade distal tip on preoperative scans (e.g. CT, MRI). The TruDi® Shaver Blade consists of several configurations ranging from straight to curved blades of different diameters.
[807.92(a)(5)] Intended Use
TruDi® Shaver Blades are intended for use with the Bien-Air S120 Shaver Indications for Use: Handpiece and the TruDi® Navigation System to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. Their use is indicated for any medical condition in which the use of navigated surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to a CT or MR based model.
TruDi® Shaver Blades may be used in, but is not limited to, the following procedures:
- · Endoscopic sinus surgery (such as ethmoidectomy, polypectomy, septoplasty)
- · Drainage of mucoceles or abscesses that have extended from the paranasal sinuses and up to the dura mater
- · Orbital decompression
· Any other of a number of tumors involving the lateral nasal wall, paranasal sinuses and orbit
- Access to the sphenoid sinus
Difference in The indications for use and intended use of the subject device, TruDi® Shaver Indications from Blade, are similar to the predicate device and reference device (Bien-Air Predicate Device OSSEODUO S120 Shaver Handpiece). Both the subject device and predicate device are electromagnetically navigated shaver blades intended to aid in the incision and removal of soft and hard tissue or bone during head and neck and ENT surgery. One of the reference devices, Bien-Air S120 Shaver Handpiece (K083720), is intended to be used with the subject device, therefore relevant parts of the indications for use of the reference device have been added to the indications for use for the subject device.
For a comparison of the indications for use/intended use of the subject device and its predicate device, please reference Table 1.
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| [807.92(a)(6)] Technical Characteristics | |
|---|---|
| Technological | |
| Characteristics: | The subject device, TruDi® Shaver Blade, is substantially equivalent in |
| technological characteristics, as there are no significant differences in design, | |
| fundamental scientific technology, or other features of the device from the | |
| predicate device. | |
| Both the subject device and predicate device (Medtronic Navigated Quadcut | |
| Blades, K130608) are electromagnetically navigated shaver blades, which are | |
| intended to aid in the incision and removal of soft and hard tissue or bone during | |
| head and neck and ENT surgery. Similar to the predicate device, the subject | |
| device incorporates a sensor, which is tracked by its navigation system. The | |
| location of the sensor is identified by the navigation system and displayed in | |
| real-time view over the patient's pre-operative CT/MRI scan to confirm access, | |
| and to locate anatomical structures during ENT surgical procedures. | |
| The primary differences between the subject and predicate device are the | |
| following: | |
| The subject device has a sensor integrated at the distal tip of the device, | |
| whereas the predicate device has a tracker with a sensor inside mounted | |
| on the proximal end of the blade to allow for navigation during the ENT | |
| surgical procedures The subject device is available in a variety of blade angles, 0° (straight), | |
| 15°, 40°, and 60° angles, while the predicate device is only available in | |
| 0° (straight) angle. The subject device uses a different handpiece and navigation system to | |
| operate the device than the predicate device. The subject device is | |
| intended for use with the Bien-Air S120 Shaver Handpiece (K083720), | |
| OSSEODUO control unit (K083720) and TruDi® Navigation System | |
| (K192397), whereas the predicate device is intended for use with the | |
| Medtronic M4 and M5 hand piece and Medtronic's navigation system. | |
| However, these differences do not raise new concerns of safety and effectiveness | |
| for the subject device as demonstrated by performance testing and design | |
| validation testing (simulated use testing). See Table 1 for a comparison of the | |
| technological characteristics between the subject device and the predicate | |
| device. | |
| In order to operate the subject device, it must connect to the Bien-Air S120 | |
| Shaver Handpiece (K083720), which is why it was selected as the reference |
device. The TruDi® Curette (K201174) is also presented as a reference device
due to similarities in testing methods.
6
Image /page/6/Picture/0 description: The image shows the logo for Acclarent, a company that is part of the Johnson & Johnson family of companies. Below the logo is the text "TruDi® Shaver Blade". The Acclarent logo is in black font, while the Johnson & Johnson text is in red font.
Table 1: Substantial Equivalence Table
| Attribute | Predicate Device:
Medtronic Navigated
Quadcut Blades | Reference Device:
Bien-Air OSSEODUO S120
Shaver Handpiece | Reference Device:
TruDi® Curette | Subject Device:
TruDi® Shaver Blade | Substantial Equivalence
Rationale |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
number | K130608 | K083720 | K201174 | K221037 | N/A |
| Manufacturer | Medtronic Navigation, Inc. | Bien-Air Surgery SA | Acclarent, Inc. | Acclarent, Inc. | N/A |
| Trade Name | Quadcut | OSSEODUO Shaver and Drill
System | TruDi® Curette | TruDi® Shaver Blade | N/A |
| Classification
Name | Neurological Stereotaxic
Instrument | Drill, Surgical, ENT (Electric
or Pneumatic) including
Handpiece | Ear, Nose, and Throat
Stereotaxic Instrument | Ear, Nose, and Throat
Stereotaxic Instrument | Same as the reference
device (TruDi® Curette). |
| Class | II | II | II | II | Same |
| Classification
Product Code | HAW | ERL | PGW | PGW | Same as reference device
(TruDi® Curette). |
| Secondary
Product Code | N/A | N/A | N/A | ERL | Same as reference device
(Bien-Air OSSEODUO
S120 Shaver Handpiece). |
| Classification
Section | 21 CFR 882.4560 | 21 CFR 874.4250 | 21 CFR 882.4560 | 21 CFR 882.4560 | Same as predicate and
reference device (TruDi®
Curette). |
| | | | | | |
| Attribute | Predicate Device:
Medtronic Navigated
Quadcut Blades | Reference Device:
Bien-Air OSSEODUO S120
Shaver Handpiece | Reference Device:
TruDi® Curette | Subject Device:
TruDi® Shaver Blade | Substantial
Equivalence
Rationale |
| Indications
for Use | The XPS/IPC System is
intended for the incision and
removal of soft and hard tissue
or bone in general
otorhinolaryngology, head and
neck, and otoneurological
surgery.
The Medtronic computer-
assisted surgery system and its
associated applications are
intended as an aid for
precisely locating anatomical
structures in either open or
percutaneous procedures.
The system and its associated
applications should be used
only as an adjunct for surgical
guidance. They do not replace
the surgeon's knowledge,
expertise, or judgment. | The OSSEODUO is a drill and
shaver system that has been
designed for drilling and shaping
bone and for
"the resection of soft and hard
tissues as part of surgical
operations in the areas of
otorhinolaryngology,
otoneurology, maxillofacial
surgery, and head and neck
surgery."
The shaver handpiece S80 or
S120 is designed for cutting and
removal of soft and hard tissue
in the fields of:
- Endoscopic sinus surgery (such
as ethmoidectomy,
polypectomy, septoplasty) - Endoscopic
dacryocystorhinostomy (DCR) - Nasopharyngeal and laryngeal
prodedures (such as
adenoidectomy, polypectomy,
tonsillectomy) - Head and neck surgery (such
as acoustic-neuroma removal,
tumor removal, rhinoplasty,
adipose tissue
removal, plastic, reconstructive | TruDi® Curette is intended
for use with the TruDi®
Navigation System to
manipulate, dissect and/or
remove tissue, cartilage and
bone during surgical
procedures in ENT and
ENT skull base surgery. | TruDi® Shaver Blades are intended
for use with the Bien-Air S120
Shaver Handpiece and the TruDi®
Navigation System to aid in the
incision and removal of soft and hard
tissue or bone in ENT, Maxillofacial
surgery, Head and Neck and ENT
skull base surgery. Their use is
indicated for any medical condition
in which the use of navigated surgery
may be appropriate, and where
reference to a rigid anatomical
structure can be identified relative to
a CT or MR based model.
TruDi® Shaver Blades may be used
in, but is not limited to, the following
procedures:
• Endoscopic sinus surgery (such as
ethmoidectomy, polypectomy,
septoplasty)
• Drainage of mucoceles or abscesses
that have extended from the
paranasal sinuses and up to the dura
mater
• Orbital decompression
• Any other of a number of tumors
involving the lateral nasal wall,
paranasal sinuses and orbit
• Access to the sphenoid sinus | The indications for use
for the subject device is
aligned with the
indications for use of
the predicate and
reference device (Bien-
Air OSSEODUO S120
Shaver Handpiece). |
| | Predicate Device: | Reference Device: | Reference Device: | Subject Device: | Substantial Equivalence |
| Attribute | Medtronic Navigated
Quadcut Blades | Bien-Air OSSEODUO S120
Shaver Handpiece | TruDi® Curette | TruDi® Shaver Blade | Rationale |
| Intended Use | The Quadcut blades are
intended for the incision and
removal of soft and hard tissue
or bone in general
otorhinolaryngology, head and
neck, and otoneurological
surgery. | The shaver handpiece S80 or
S120 is designed for cutting
and removal of soft and hard
tissue | TruDi® Curette is intended
for use with the TruDi®
Navigation System to
manipulate, dissect and/or
remove tissue, cartilage and
bone during surgical
procedures in ENT and
ENT skull base surgery. | TruDi® Shaver Blades are
intended for use with the Bien-
Air S120 Shaver Handpiece and
the TruDi® Navigation System
to aid in the incision and removal
of soft and hard tissue or bone in
ENT, Maxillofacial surgery, Head
and Neck and ENT skull base | The intended use for the
subject device is aligned
with the intended use of
the predicate and reference
device (Bien-Air
OSSEODUO S120 Shaver
Handpiece). |
| Technological
Characteristics | Quadcut is intended for
attachment to the Medtronic
M4 hand piece for use in
conjunction with Fusion ENT
software on a Medtronic
computer-assisted surgery
system. Each blade has a
tracker mounted on it to allow
for navigation during the ENT
surgical procedure. The
system's mobile emitter
generates a low-energy
magnetic field to locate the
tracker mounted on the blade.
Then, the software displays the
location of the blade's tip
within multiple patient image
planes and other anatomical
renderings. | The Bien-Air S120 shaver
handpiece includes a
micromotor, a gear set, a
coupling system for shaver
blades and connections for
irrigation and suction. Through
the control unit it can operate
in oscillating modus (reversing
after a user-defined number of
turns in each direction) or in
continuous CW and CCW
rotation. | The TruDi® Curette is a
single-use electro-
magnetically-navigated
instrument, which is
intended to be used with the
TruDi® Navigation System.
The device incorporates a
sensor within the distal
shaft, which is tracked by
the TruDi® Navigation
System. The location of the
distal tip of the device is
identified by the navigation
system and displayed in
real-time view over the
patient's pre-operative
CT/MRI scan to confirm
access of target anatomy.
Following confirmation, the
physician operates the
instrument at the target
anatomical structure. | surgery.
The TruDi® Shaver Blade is a
single-use electromagnetically-
navigated instrument, which is
intended to be used with the
TruDi® Navigation System.
The device incorporates a sensor
within the distal shaft, which is
tracked by the TruDi®
Navigation System. The location
of the distal tip of the device is
identified by the navigation
system and displayed in real-time
view over the patient's pre-
operative CT/MRI scan to
confirm access of target anatomy.
Following confirmation, the
physician operates the instrument
at the target anatomical structure. | The technological
characteristics of the
subject device are
similar to the predicate and
reference devices. |
| Attribute | Predicate Device:
Medtronic Navigated
Quadcut Blades | Reference Device:
Bien-Air OSSEODUO S120
Shaver Handpiece | Reference Device:
TruDi® Curette | Subject Device:
TruDi® Shaver Blade | Substantial Equivalence
Rationale |
| Localization
Technology | Electromagnetic | N/A | Electromagnetic | Electromagnetic | Same as predicate device
and reference device
(TruDi® Curette). |
| System
Accuracy
Requirement | 95% confidence / 99.5%
reliability, as dictated by risk
analysis,
of $\le$ 3.00 mm. | N/A | The accuracy of TruDi®
Curette used in conjunction
with the navigation views of
the TruDi® Navigation
System is $\le$ 2mm RMS over
the entire navigation volume. | The accuracy of TruDi® Shaver
Blade used in conjunction with
the navigation views of the
TruDi® Navigation System is
$