(100 days)
No
The summary describes an electromagnetically-navigated surgical instrument that uses a sensor to track its position and display it on a pre-operative CT scan. There is no mention of AI or ML in the device description, intended use, or performance studies. The navigation system itself is a predicate device (K173628), and the summary focuses on the instrument's tracking and suction capabilities.
No.
The device is intended for navigation and evacuation during surgical procedures, not for treating a disease or condition itself.
No
The device is primarily a surgical instrument used to provide navigation and evacuate gases, liquids, and fragments during surgical procedures. While it uses real-time display over pre-operative CT scans, this is for guiding surgical instruments, not for diagnosing a condition.
No
The device description explicitly states that the TruDi™ NAV Suction Instruments are "reusable devices" and include an "EM trackable single axis sensor" integrated at the distal tip. This indicates the presence of physical hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The TruDi™ NAV Suction Instruments are surgical instruments used during surgical procedures to provide navigation and evacuate materials from the surgical site. They are used directly on the patient's anatomy, not on specimens taken from the patient.
- Intended Use: The intended use clearly states "during surgical procedures" and "to provide navigation of the instruments to the targeted anatomy, and evacuation of gases, liquids, and fragments." This is a surgical function, not a diagnostic function performed on a specimen.
The device is a surgical navigation and suction tool, not a device for testing biological samples.
N/A
Intended Use / Indications for Use
TruDi™ NAV Suction Instruments are intended for use with the TruDi™ System during surgical procedures in ENT medicine and skull base surgery to provide navigation of the targeted anatomy, and evacuation of gases, liquids, and fragments.
TruDi™ NAV Suction Instruments are intended to be used by ENT surgeons or support staff.
Product codes (comma separated list FDA assigned to the subject device)
PGW
Device Description
TruDi™ NAV Suction Instruments (0°, 70°, 90°) are electromagnetically-navigated reusable devices intended to be used in conjunction with the TruDi™ Navigation System. When used with the TruDi™ Navigation System, the TruDi™ NAV Suction Instruments provide navigation of the devices to targeted anatomy and evacuate gases, liquids, and fragments. The TruDi™ Navigation System is the trade name for the ACCLARENT® ENT Navigation System cleared in K173628.
TruDi™ NAV Suction Instrument Set consists a 0° suction instrument, 70° suction instrument, 90° suction instrument, and a single-use sterile cable called the TruDi™ NAV Cable. The TruDi™ NAV Cable may be used to connect the suction instruments to the TruDi™ Navigation System.
The TruDi™ NAV Suction Instruments include an EM trackable single axis sensor, which is integrated at the distal tip of the device. The TruDi™ Navigation System acquires the position and orientation of the distal tip of the device and displays it in real-time view over the patient's pre-operative CT scan to confirm access of target anatomy. Following confirmation, the physician operates the surgical instrument at the target anatomical structure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan
Anatomical Site
ENT medicine, skull base surgery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ENT surgeons or support staff
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)
Non-Clinical Performance Data: TruDi™ NAV Suction Instruments met all performance acceptance criteria including dimensional specifications, suction flow performance, deflection, location accuracy (sensor sensitivity), reprocessing reliability, electrical functionality, and EEPROM verification. TruDi™ NAV Suction Instruments are supplied non-sterile; they must be cleaned and sterilized prior to the initial use and before each subsequent use. Reprocessing and sterilization testing was conducted and met all acceptance criteria. When used in accordance with the Instructions for Use, the TruDi™ NAV Suction Instruments may be thoroughly cleaned and sterilized using, a combination of manual or automated cleaning methods, and steam or STERRAD sterilization. The TruDi™ NAV Cable is provided sterile and is for single use. The sterilization process has been validated per AAMI/ANSI/ISO 11135:2014 and demonstrated a sterility assurance level of 10⁻⁶ when the device is sterilized via either steam or STERRAD methods. The method used for steam and STERRAD sterilization validation was overkill (half-cycle approach) in a fixed chamber. Biocompatibility testing was successfully completed to determine that the TruDi™ NAV Suction Instruments are biocompatible per ISO 10993-1. Simulated use testing was performed with ENT surgeons and support staff, which successfully tested the mechanical aspects, suction performance, clinical accuracy of the subject device, along with the functionality of the TruDi™ NAV cable. The packaging and instructions for use were also successfully assessed by evaluators as part of the study. The testing demonstrated that the subject device functions in accordance with design specifications and intended use. Clinical data was not necessary for the TruDi™ NAV Suction Instruments Testing was performed to verify the navigation accuracy of the subject device when used with the TruDi™ Navigation System (K173628). Testing included sensitivity and connectivity verification. The performance data demonstrated that the device performs as intended. Packaging shelf life for the TruDi™ NAV Cable was established through accelerated aging via ASTM F1980-07, ASTM F88/F88M-09, and ASTM F2096-04 requirements and confirmed to meet a shelf life of two months.
Clinical Performance Data: Clinical data was not necessary for the TruDi™ NAV Suction Instruments. The performance data demonstrated that the device performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Location accuracy (sensor sensitivity)
Navigation accuracy ≤ 2mm RMS over the entire navigation volume
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.
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.
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
§ 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
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.
July 20, 2018
Acclarent, Inc. Leena Sorathia Sr. Regulatory Affairs Specialist 33 Technology Drive Irvine, CA 92618
Re: K180948
Trade/Device Name: TruDi™ NAV Suction Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: June 21, 2018 Received: June 22, 2018
Dear Leena Sorathia:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours,
Srinivas Nandkumar -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180948
Device Name TruDi™ NAV Suction Instruments
Indications for Use (Describe)
TruDi™ NAV Suction Instruments are intended for use with the TruDi™ System during surgical procedures in ENT medicine and skull base surgery to provide navigation of the targeted anatomy, and evacuation of gases, liquids, and fragments.
TruDi™ NAV Suction Instruments are intended to be used by ENT surgeons or support staff.
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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Image /page/3/Picture/0 description: The image displays the logo for Acclarent, a company that is part of the Johnson & Johnson family of companies. Below the logo, the text "TruDi™ NAV Suction Instruments" is written in a bold font. The logo features the company name "Acclarent" in a large, bold font, with a purple curved line above it.
510(K) SUMMARY
[807.92(a)(1)] Submitter Information
| Sponsor/Submitter: | Acclarent, Inc.
33 Technology Drive
Irvine, CA 92618 |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Leena Sorathia
Sr. Regulatory Affairs Specialist
Email: lsorathi@its.jnj.com
Tel: 949-923-4118 |
| Date Summary Prepared: | July 18, 2018 |
| [807.92(a)(2)] Name of Device | |
| Device Trade
Name: | TruDi™ NAV Suction Instruments |
| Classification
Name: | Stereotaxic Instrument |
| Common Name: | EM Navigable Suction Instruments |
| Device
Classification: | Class II |
| Regulation
Number: | 21 CFR 882.4560 |
| Review Panel: | Ear, Nose, and Throat |
| Product Code: | PGW |
| [807.92(a)(3)] Legally Marketed Devices | |
| Predicate Device: | KARL STORZ EM Navigated Suction Tubes, (K161555)
(cleared as part of the KARL STORZ NAVI Electromagnetic Navigation System under
K161555) |
| Reference Device: | Medtronic EM ENT Navigated Suctions, (K153555) |
| [807.92(a)(4)] Device Description | |
| Device Description: | TruDi™ NAV Suction Instruments (0°, 70°, 90°) are electromagnetically-
navigated reusable devices intended to be used in conjunction with the TruDi™
Navigation System. When used with the TruDi™ Navigation System, the
TruDi™ NAV Suction Instruments provide navigation of the devices to targeted
anatomy and evacuate gases, liquids, and fragments. The TruDi™ Navigation
System is the trade name for the ACCLARENT® ENT Navigation System |
| Indications for
Use: | TruDi™ NAV Suction Instruments are intended for use with the TruDi™
Navigation System during surgical procedures in ENT medicine and skull base
surgery to provide navigation of the instruments to the targeted anatomy, and
evacuation of gases, liquids, and fragments. |
| | TruDi™ NAV Suction Instruments are intended to be used by ENT surgeons or
support staff. |
| Difference in
Indications from
Predicate Device | The difference in indications for use between the subject device and the
predicate/reference devices is supported is presented in Table 1 of this summary. |
| [807.92(a)(6)] Technical Characteristics | |
cleared in K173628.
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Image /page/4/Picture/0 description: The image shows the Acclarent logo, which includes the company name in bold black letters and a purple arc above the "ent" portion. Below the logo, it states "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" in smaller font. The text "TruDi™ NAV Suction Instruments" is displayed in bold black letters below the company information. The image is a product advertisement.
TruDi™ NAV Suction Instrument Set consists a 0° suction instrument, 70° suction instrument, 90° suction instrument, and a single-use sterile cable called the TruDi™ NAV Cable. The TruDi™ NAV Cable may be used to connect the suction instruments to the TruDi™ Navigation System.
The TruDi™ NAV Suction Instruments include an EM trackable single axis sensor, which is integrated at the distal tip of the device. The TruDi™ Navigation System acquires the position and orientation of the distal tip of the device and displays it in real-time view over the patient's pre-operative CT scan to confirm access of target anatomy. Following confirmation, the physician operates the surgical instrument at the target anatomical structure.
[807.92(a)(5)] Intended Use
Technological See Table 1 for a comparison of the technological characteristics between the Characteristics: subject device and the predicate/reference devices.
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Image /page/5/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™ NAV Suction Instruments". The Acclarent logo is in black and purple.
Table 1: Comparison of Technological Characteristics between ACCLARENT® Navigable Suction Instruments and Predicate and Reference devices.
| Attribute | Predicate Device
(KARL STORZ EM Navigated
Suction Tubes) | Reference Device
(Medtronic EM ENT Navigated
Suctions) | Subject Device
(TruDi™ NAV Suction
Instruments) |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K161555 | K153555 | K180948 |
| Manufacturer | KARL STORZ Endoscopy
America, Inc. | Medtronic Navigation, Inc. | Acclarent, Inc. |
| Trade Name | KARL STORZ EM Navigated
Suction Tubes
(Cleared as part of KARL STORZ
NAV 1 Electromagnetic Navigation
System under K161555) | Medtronic EM ENT
Navigated Suctions | TruDi™ NAV Suction
Instruments |
| Classification Name | Stereotaxic Instrument | Stereotaxic Instrument | Stereotaxic Instrument |
| Class | II | II | II |
| Product Code | PGW | PGW | PGW |
| Classification Section | 21 CFR 882.4560 | 21 CFR 882.4560 | 21 CFR 882.4560 |
| Attribute | Predicate Device
(KARL STORZ EM Navigated
Suction Tubes) | Reference Device
(Medtronic EM ENT Navigated
Suctions) | Subject Device
(TruDiTM NAV Suction
Instruments) |
| Indications for Use | The KARL STORZ NAV1
electromagnetic navigation system and
its associated applications are intended
as an aid for precisely locating
anatomical structures in either open or
percutaneous procedures under visual
control. Their use is indicated for any
medical condition in which use of
stereotactic surgery may be
appropriate, and where reference to a
rigid anatomical structure in the field of
ENT surgery, such as paranasal
sinuses, mastoid anatomy, can be
identified relative to radiological image
data or digitized landmarks of the
anatomy. | EM ENT Instruments are indicated for
use in navigated ENT procedures to
locate points on patient anatomy relative
to a CT-based or MR-based digital model
and to remove fluids, semi-fluid
substances, tissue, and bone dust. EM
ENT Instruments are indicated for use
with Medtronic computer-assisted
surgery systems. The EM ENT
instruments are indicated for use in ENT
procedures such as: | TruDiTM NAV Suction Instruments
are intended for use with the TruDiTM
Navigation System during surgical
procedures in ENT medicine and
skull base surgery to provide
navigation of the instruments to the
targeted anatomy, and evacuation of
gases, liquids, and fragments. |
| | | • CSF leak repairs related to ENT
procedure
• Intranasal procedures
• Orbital decompression procedures
• Polyposis procedures
• Endoscopic dacryocystorhinostomy
• Sinus procedures, such as maxillary
antrostomies
• Ethmoidectomies
• Sphenoidotomies/sphenoid explorations
• Turbinate resections and frontal
sinusotomies | |
| | | | The EM ENT instruments can also be
used in the ENT surgical approach for the
following procedures: |
| | | | • Pituitary tumor removal
• Skull base procedures
• Transsphenoidal procedures
• Optic nerve decompression procedures
• Encephalocele procedures |
| Attribute | Predicate Device
(KARL STORZ EM Navigated
Suction Tubes) | Reference Device
(Medtronic EM ENT Navigated
Suctions) | Subject Device
(TruDi™ NAV Suction
Instruments) |
| Intended Use | The navigated suction tubes aid
orientation and the suctioning of gases,
liquids, and fragments during invasive
interventions in ENT medicine and
lateral skull base surgery not involving
contact with the central nervous
system. | 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. Their use is indicated for
any medical condition in which the use
of stereotactic surgery may be
appropriate, and where MR-based
model, or digitized landmarks of the
anatomy.
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 judgement. | TruDi™ NAV Suction Instruments
are intended for use with the
TruDi™ Navigation System during
surgical procedures in ENT
medicine and skull base surgery to
provide navigation of the
instruments to the targeted anatomy,
and evacuation of gases, liquids,
and fragments.
TruDi™ NAV Suction Instruments
are intended to be used by ENT
surgeons or support staff. |
| Attribute | Predicate Device
(KARL STORZ EM Navigated
Suction Tubes) | Reference Device
(Medtronic EM ENT Navigated
Suctions) | Subject Device
(TruDi™ NAV Suction
Instruments) |
| Technological
Characteristics | The KARL STORZ EM Navigated
Suction Tubes are electromagnetically-
navigated when used in conjunction
with the KARL STORZ NAV1
electromagnetic navigation system.
A sensor is integrated at the distal tip of
the suction tubes. The location of the
distal tip of the device is identified by
the KARL STORZ NAV1
electromagnetic navigation system, and
displayed in real-time view over the
patient's pre-operative CT/MTI scan to
confirm access of target anatomy.
Following confirmation, the physician
operates the suction instrument at the
target anatomical structure. | The Medtronic EM Navigated Suction
Instruments are electromagnetically-
navigated when used in conjunction
with the Medtronic StealthStation®
System System.
The EM ENT Instrument Tracker,
which includes a single user sensor, is
attached to the EM ENT navigated
suction to track its position. The
location of the instrument tracker is
identified by the Medtronic
StealthStation® 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
surgical instrument at the target
anatomical structure. Following
confirmation, the physician operates the
suction instrument at the target
anatomical structure. | TruDi™ NAV Suction Instruments
are electromagnetically-navigated
when used in conjunction with the
TruDi™ Navigation System.
A single-axial sensor (SAS) is
integrated into the distal tip of the
suction instruments. The location of
the distal tip of the device is
identified by the TruDi™ Navigation
System electromagnetic navigation
system, and displayed in real-time
view over the patient's pre-
operative CT scan to confirm access
of target anatomy. Following
confirmation, the physician operates
the suction instrument at the target
anatomical structure. |
| Localization Technology | Electromagnetic (sensor integrated into
distal tip of suction instrument) | Electromagnetic (proximal tracker
attached to suction instrument)
EM ENT Navigated Suctions | Electromagnetic (sensor integrated
into distal tip of suction instrument) |
| System or Instrument
Accuracy Requirements | Unknown | Within a standard controlled
environment: navigated peg errors of
1.54 mm at 95% confidence and 99%
reliability
Within a simulated surgical
environment: navigated peg errors of
1.73 mm at 5% confidence and 99%
reliability | ≤ 2mm RMS over the entire
navigation volume |
| Attribute | Predicate Device
(KARL STORZ EM Navigated
Suction Tubes) | Reference Device
(Medtronic EM ENT Navigated
Suctions) | Subject Device
(TruDi™ NAV Suction
Instruments) |
| Suction Functionality | Yes | Yes | Yes |
| Rigid Suction Device | Yes | Yes | Yes |
| Instrument Tip
Configurations | Standard (straight)
Olive | Standard (straight)
Angle
Olive
Ball/Angle | Standard (straight)
Olive |
| Materials | EM ENT Navigated Suction Tubes:
Stainless Steel | EM ENT Navigated Suctions
Stainless Steel, Titanium | TruDi™ NAV Suction Instruments
Stainless Steel 316L |
| | Cable
Unknown | Patient and Instrument Trackers
Patient contacting cable: AES
Santoprene® 8281-90 material with
Colorant Pantone 301C | TruDi™ NAV Cable
Polycarbonate, Polyvinyl Chloride
(PVC), copper |
| Instrument Shaft
Configurations | Straight 0° & Curved (~70°) | Fixed- Straight, Small Straight, 45°
frontal, 70º curve, 90° curve, 90° frontal | Straight 0°, 70° curve, 90° curve |
| Supplied as
"Reusable Use" | EM ENT Navigated Suction Tubes:
Yes
Cable:
Yes (attached to the Suction Tubes) | EM ENT Navigated Suctions
Yes
Patient and Instrument Trackers
Supplied Sterile Single Use | TruDi™ NAV Suction
Instruments
Yes
TruDi™ NAV Cable
Supplied Sterile Single Use |
| | Location of Sensor | Sensor is built-in at the distal tip of the
suction tube | Single-use sensor that is clipped onto
the suction instrument |
| Reprocessing methods | Manual Cleaning, Steam Sterilization,
STERRAD® 100NX® Standard
sterilization cycle, and V-PRO® 1 Plus
Lumen sterilization cycle | Manual Cleaning & Steam Sterilization | Manual Cleaning, Automated
Cleaning, Steam Sterilization
(autoclave) & STERRAD |
| Compatible Navigation
System | KARL STORZ EM Navigated Suction
Tubes are compatible with KARL
STORZ NAV1 Electromagnetic
Navigation System | Medtronic EM ENT Navigated
Suctions are compatible with
Medtronic StealthStation® System | TruDi™ NAV Suction Instruments
are electromagnetically-navigated
when used in conjunction with the
TruDi™ Navigation System |
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Image /page/6/Picture/0 description: The image displays the Acclarent logo, which is the company's name in bold, black font with a purple arch above the "ent." Below the logo, it states "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller font. The text "TruDi™ NAV Suction Instruments" is written in bold, black font below the company information.
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Image /page/7/Picture/0 description: The image shows the logo for Acclarent, a company that is part of the Johnson & Johnson family of companies. The word "Acclarent" is written in a combination of black and purple font. Below the company name is the text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES".
TruDi™ NAV Suction Instruments
8
Image /page/8/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in a combination of black and purple font. Below the name is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES".
TruDi™ NAV Suction Instruments
9
Image /page/9/Picture/0 description: The image shows the Acclarent logo. The word "Acclarent" is written in a bold, sans-serif font, with the "A" and "ccla" in black and the "rent" in purple. Above the word "rent" is a purple swoosh. Below the word "Acclarent" is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller font.
TruDi™ NAV Suction Instruments
10
Image /page/10/Picture/0 description: The image shows the Acclarent logo, which includes the company name in bold, black font and a purple arc above the "ent" portion of the name. Below the logo, it states "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller font. The text "TruDi™ NAV Suction Instruments" is displayed in bold, black font below the company information.
[807.92(b) (1)] Determination of Substantial Equivalence
| Non-Clinical Performance
Data: | TruDi™ NAV Suction Instruments met all performance acceptance
criteria including dimensional specifications, suction flow performance,
deflection, location accuracy (sensor sensitivity), reprocessing
reliability, electrical functionality, and EEPROM verification.
TruDi™ NAV Suction Instruments are supplied non-sterile; they must be
cleaned and sterilized prior to the initial use and before each subsequent
use. Reprocessing and sterilization testing was conducted and met all
acceptance criteria. When used in accordance with the Instructions for
Use, the TruDi™ NAV Suction Instruments may be thoroughly cleaned
and sterilized using, a combination of manual or automated cleaning
methods, and steam or STERRAD sterilization. The TruDi™ NAV
Cable is provided sterile and is for single use. |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The sterilization process has been validated per AAMI/ANSI/ISO
11135:2014 and demonstrated a sterility assurance level of 10⁻⁶ when
the device is sterilized via either steam or STERRAD methods. The
method used for steam and STERRAD sterilization validation was
overkill (half-cycle approach) in a fixed chamber.
Biocompatibility testing was successfully completed to determine that
the TruDi™ NAV Suction Instruments are biocompatible per ISO
10993-1. | |
| Simulated use testing was performed with ENT surgeons and support
staff, which successfully tested the mechanical aspects, suction
performance, clinical accuracy of the subject device, along with the
functionality of the TruDi™ NAV cable. The packaging and instructions
for use were also successfully assessed by evaluators as part of the
study. The testing demonstrated that the subject device functions in
accordance with design specifications and intended use. Clinical data
was not necessary for the TruDi™ NAV Suction Instruments | |
| Testing was performed to verify the navigation accuracy of the subject
device when used with the TruDi™ Navigation System (K173628).
Testing included sensitivity and connectivity verification.
The performance data demonstrated that the device performs as
intended. | |
| Packaging shelf life for the TruDi™ NAV Cable was established through
accelerated aging via ASTM F1980-07, ASTM F88/F88M-09, and
ASTM F2096-04 requirements and confirmed to meet a shelf life of two
months. | |
| Clinical Performance Data | Clinical data was not necessary for the TruDi™ NAV Suction Instruments. The performance data demonstrated that the device performs as intended. |
| [807.92(b) (3)] Conclusion | |
| Conclusion from Non-Clinical and Clinical Tests | Based on the information provided in this premarket notification, Acclarent concludes that the TruDi™ NAV Suction Instruments are safe and effective and substantially equivalent to the predicate and reference devices. |
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Image /page/11/Picture/0 description: The image shows the Acclarent logo, which includes the company name in bold, black letters and a purple arc above the "ent" portion of the name. Below the logo, it states "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in smaller font. The text "TruDi™ NAV Suction Instruments" is displayed in bold, black letters below the company information.