(103 days)
No
The summary describes a navigated surgical instrument that uses electromagnetic tracking to display its position on pre-operative scans. There is no mention of AI or ML being used for image analysis, navigation, or any other function.
No.
A therapeutic device is one that treats a disease or condition. This device is described as an instrument to "manipulate, dissect and/or remove tissue, cartilage and bone during surgical procedures," which are surgical tools, not therapeutic actions in themselves.
No
The device is described as an instrument intended for manipulating, dissecting, and removing tissue, cartilage, and bone during surgical procedures. Its function is to aid in surgical treatment, not to diagnose a condition. While it is used with a navigation system that displays over CT/MRI scans to confirm access and locate anatomical structures, this is for surgical guidance, not for diagnostic purposes.
No
The device description clearly states the TruDi™ Curette is a physical instrument with a shaft, curette cup, and magnetic sensor, and is sold in sterile packaging with a bending tool. It is a hardware device used in conjunction with a navigation system.
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 samples) to provide information about a person's health. This testing is done outside of the body (in vitro).
- TruDi™ Curette Function: The TruDi™ Curette is a surgical instrument used during a surgical procedure inside the patient's body. It is used to manipulate, dissect, and remove tissue, cartilage, and bone. Its primary function is mechanical manipulation and removal of tissue, aided by navigation for precise placement.
- Navigation System: While it works with a navigation system that uses pre-operative imaging (CT/MRI), the curette itself is not performing a diagnostic test on a sample. The navigation system helps the surgeon guide the instrument, but the instrument's action is surgical, not diagnostic.
The description clearly indicates it's a surgical tool used in vivo (within the living body) during a procedure, not a device for testing samples in vitro.
N/A
Intended Use / Indications for Use
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.
Product codes
PGW
Device Description
The subject device, TruDi™ Curette (K201174), is a single-use and sterile electromagnetically (EM) navigated instrument, which is intended for use with the TruDi™ Navigation System (K192397) to manipulate, dissect and/or remove tissue, cartilage and bone during surgical procedures in ENT and ENT skull base surgery. The TruDi™ Curette consists of one configuration (straight 0°). The TruDi™ shaft, and a curette cup, which is located at the distal tip and houses a magnetic sensor. The device is sold in sterile packaging. Each package includes one TruDi™ Curette in conjunction with a disposable bending tool. The bending tool is provided to allow the user to customize the shape of the distal shaft as needed.
The TruDi™ Curette incorporates a sensor at the distal tip, 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, and to locate anatomical structures during ENT and ENT skull base surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT/MRI scan
Anatomical Site
ENT and ENT skull base
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician/clinical setting
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, connector joint separation force, distal shaft deflection/flexure, end to end joint strength, cable strain relief separation force, tip sharpness, bending tool functionality 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. The method used for sterilization validation is the overkill (half-cycle approach) in a fixed chamber. Ethylene oxide residuals have been tested and meet ISO 10993-7:2008 requirements. The subject device is not tested nor labeled as "non-pyrogenic".
Biocompatibility testing was successfully completed to determine that the TruDi™ Curette is biocompatible per ISO 10993-1.
Packaging shelf life for the TruDi™ Curette was established through accelerated aging via ASTM F1980-07, ASTM F88/F88M-09, 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™ Curette functions in accordance with its intended use and design specifications in a simulated clinical setting. The packaging and instructions for use were also successfully assessed by evaluators as part of the study.
The TruDi™ Curette passed all intended criteria in accordance with appropriate test criteria and standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The accuracy of TruDi™ Curette used in conjunction with the navigation views of the TruDi™ Navigation System is ≤ 2mm RMS over the entire navigation volume.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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August 12, 2020
Acclarent. Inc. Leena Sorathia Regulatory Affairs Program Lead 31 Technology Drive Irvine. California 92618
Re: K201174
Trade/Device Name: TruDi Curette Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: July 14, 2020 Received: July 16, 2020
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. 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 probibitions 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 (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-devices/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 (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 Michael J. Ryan Director DHT1C: Division of ENT. Sleep Disordered Breathing, Respiratory and Anesthesia 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) K201174
Device Name TruDi™ Curette
Indications for Use (Describe)
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.
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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Image /page/3/Picture/0 description: The image shows the logo for Acclarent, which is part of the Johnson & Johnson family of companies. Below the logo, the text "TruDi™ Curette" is displayed. The Acclarent logo features the company name in bold, black letters, with a purple arch above the "ent" portion of the name.
K201174 - 510(K) SUMMARY
| Sponsor/Submitter: | Acclarent, Inc.
31 Technology Drive
Irvine, CA 92618 |
|--------------------|------------------------------------------------------------|
| Contact Person: | Leena Sorathia |
Regulatory Affairs Program Lead Email: 1sorathi@its.jnj.com Tel: 949-923-4118
Date Summary Prepared: July 14, 2020
[807.92(a)(2)] Name of Device
| Device Trade
| Name: | TruDi™ Curette |
|---|---|
| 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 |
| Product Code: | PGW |
| [807.92(a)(3)] Legally Marketed Devices | |
| Predicate Device: | KARL STORZ EM Frontal Sinus Curette |
| (Cleared as part of KARL STORZ NAV1 Electromagnetic Navigation System | |
| under K161555) | |
| Reference Device: | TruDi™ Probe (K193453) |
| [807.92(a)(4)] Device Description | |
| Device Description: | The subject device, TruDi™ Curette (K201174), is a single-use and sterile |
| electromagnetically (EM) navigated instrument, which is intended for use with | |
| the TruDi™ Navigation System (K192397) to manipulate, dissect and/or remove | |
| tissue, cartilage and bone during surgical procedures in ENT and ENT skull | |
| base surgery. | |
| The TruDi™ Curette consists of one configuration (straight 0°). The TruDi™ |
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Image /page/4/Picture/1 description: The image shows the Acclarent logo, which is a black, bolded font with a purple swoosh above the "ent". Below the logo, in smaller red font, it says "PART OF THE Johnson-Johnson FAMILY OF COMPANIES". Underneath the logo is the text "TruDi Curette" in a bolded font. The text is black.
shaft, and a curette cup, which is located at the distal tip and houses a magnetic sensor. The device is sold in sterile packaging. Each package includes one TruDi™ Curette in conjunction with a disposable bending tool. The bending tool is provided to allow the user to customize the shape of the distal shaft as needed.
The TruDi™ Curette incorporates a sensor at the distal tip, 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, and to locate anatomical structures during ENT and ENT skull base surgery.
[807.92(a)(5)] Intended Use
| Indications for
Use: | 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. |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Difference in
Indications from
Predicate Device | The indications for use/intended use statement of the subject device is similar to
the predicate device. Both the subject and predicate devices are
electromagnetically-navigated instruments, which are intended to be used with
their compatible EM navigation systems to manipulate, dissect and/or remove
tissue, cartilage and bone during surgical procedures in ENT and ENT skull base
surgery.
For a comparison of the indications for use/intended use of the subject device and
its predicate device, please reference Table 1 on the following page. |
| [807.92(a)(6)] Technical Characteristics | |
| Technological
Characteristics: | The TruDi™ Curette is substantially equivalent in technological characteristics,
as there are no significant differences in fundamental scientific technology or
other features as compared to the predicate device, KARL STORZ EM Frontal
Sinus Curette (K161555) and reference device, TruDi™ Probe (K193453). |
Both the subject and predicate devices are electromagnetically-navigated instruments, which are intended to be used with their compatible EM navigation systems to manipulate, dissect and/or remove tissue, cartilage and bone during surgical procedures in ENT and ENT skull base surgery. Similar to the predicate device, the subject device incorporates a sensor within the distal shaft, which is tracked by the 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, and to locate anatomical structures during ENT and ENT skull base surgery.
The primary differences between the subject and predicate device are the following:
- The subject device is a single-use instrument, whereas the predicate ● device is reusable for up to 30 uses.
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Image /page/5/Picture/1 description: The image shows the logo for "Acclarent", which is part of the Johnson & Johnson family of companies. Below the logo, the text "TruDi Curette" is displayed. The Acclarent logo features the company name in a combination of black and purple, with a curved design above the text.
- The subject device is packaged with a bending tool, whereas the predicate device is not.
- . The subject device consists of one configuration (straight 0°), whereas the predicate devices consists of two configurations (curved 55°and 90°).
- . The distal shaft of the subject device is malleable and can be formed with the provided bending tool per physicians' preference, whereas the predicate device has a rigid distal shaft.
- . The sensor in both the subject and predicate devices are located within the distal shaft of the devices. While the sensor in the subject device is located ~1cm away from the distal tip, the sensor in the predicate device is located ~6cm away from the distal tip.
- . The total length of the subject device is 24cm, whereas the total length of the predicate device is 18cm.
- . The handle construction of subject device consists of polycarbonate material, whereas the predicate device handle consists of stainless steel.
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).
Additionally, the technological characteristics of the subject device are similar to the reference device. The subject device utilizes identical sensor subassembly (sensor, wire, PCB, and connector) and navigation platform as the reference device. Similar to the reference device, the sensor of the subject device is located at the distal tip for instrument tracking. See Table 1 for a comparison of the technological characteristics between the subject device and the predicate/reference devices.
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Image /page/6/Picture/0 description: The image shows the Acclarent logo, which is a black, bold font with a purple swoosh above the "ent". Below the logo, in a smaller font, it says "PART OF THE Johnson & Johnson FAMILY OF COMPANIES". Underneath that, it says "TruDi™ Curette" in a bold font.
Table 1: Comparison of Technological Characteristics between Subject Device and Predicate/Reference Devices
| Attribute | Predicate Device
KARL STORZ EM Frontal
Sinus Curette | Reference Device
TruDi™ Probe | Subject Device
TruDi™ Curette | Substantial Equivalence
Rationale |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K161555 | K193453 | K201174 | N/A |
| Manufacturer | KARL STORZ Endoscopy
America, Inc. | Acclarent, Inc. | Acclarent, Inc. | N/A |
| Trade Name | KARL STORZ EM Frontal Sinus
Curette (Cleared as part of KARL
STORZ NAV1 Electromagnetic
Navigation System under K161555) | TruDi™ Probe | TruDi™ Curette | N/A |
| Classification
Name | Stereotaxic Instrument | Stereotaxic Instrument | Stereotaxic Instrument | Same |
| Class | II | II | II | Same |
| Product Code | PGW | PGW | PGW | Same |
| Classification
Section | 21 CFR 882.4560 | 21 CFR 882.4560 | 21 CFR 882.4560 | Same |
| Indications for
Use | The KARL STORZ NAV 1
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. | The TruDi™ Probe is intended for
use with the TruDi™ Navigation
System to locate anatomical
structures during surgical
procedures in ENT and ENT skull
base surgery. | 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. | The indications for use for the subject
device TruDi™ Curette is aligned with
the indications for use/intended use of
the predicate device. |
| Attribute | Predicate Device
KARL STORZ EM Frontal Sinus
Curette | Reference Device
TruDi™ Probe | Subject Device
TruDi™ Curette | Substantial Equivalence
Rationale |
| Intended Use | Navigated spoons and curettes aid
orientation and the manipulation,
dissection and/or removal of tissue,
cartilage and bone during invasive
and surgically invasive interventions
in ENT medicine and skull base
surgery not involving contact with
the central nervous system. | The TruDi™ Probe is intended for
use with the TruDi™ Navigation
System to locate anatomical
structures during surgical
procedures in ENT and ENT skull
base surgery. | 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. | The intended use for the subject
device TruDi™ Curette is aligned with
the intended use of the predicate
device. |
| Technological
Characteristics | The KARL STORZ EM Frontal
Sinus Curette is a reusable
electromagnetically-navigated
instrument, which is intended to be
used with the KARL STORZ NAV1
electromagnetic navigation system.
The device incorporates a sensor
within the distal shaft, which is
tracked by the 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 TruDi™ Probe is a single-use
instrument intended to be used
with the TruDi™ Navigation
System. The instrument is an
electromagnetically navigated
device that is a navigated pointing
device (malleable, sensor within
the tip).
The device incorporates a sensor
at the distal tip, 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
and locate anatomical structures
during ENT surgery. | The TruDi™ Curette 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
between the subject device and
predicate/reference devices are
similar.
Both the subject and predicate devices
are electromagnetically-navigated
instruments, which are intended to be
used with their compatible EM
navigation systems to manipulate,
dissect and/or remove tissue, cartilage
and bone during surgical procedures
in ENT and ENT skull base surgery.
Similar to the predicate device, the
subject device incorporates a sensor
within the distal shaft, which is
tracked by the navigation system.
The subject device utilizes identical
sensor subassembly (sensor, wire,
PCB, and connector) and navigation
platform as the reference device.
Similar to the reference device, the
sensor of the subject device is located
at the distal tip for instrument |
| Attribute | Predicate Device
KARL STORZ EM Frontal Sinus
Curette | Reference Device
TruDi™ Probe | Subject Device
TruDi™ Curette | Substantial Equivalence
Rationale |
| Localization
Technology | Electromagnetic (sensor integrated
within the distal shaft of the
instrument) | Electromagnetic (sensor
integrated into distal tip of the
instrument) | Electromagnetic (sensor
integrated within the distal
shaft of the instrument) | Same |
| Location
Accuracy | Unknown | The accuracy of TruDi™ Probe
used in conjunction with the
navigation views of the TruDi™
Navigation System is ≤ 2mm
RMS over the entire navigation
volume. | The accuracy of TruDi™
Curette used in conjunction
with the navigation views of the
TruDi™ Navigation System is ≤
2mm RMS over the entire
navigation volume. | Location accuracy specifications are
identical between the subject and
reference devices. |
| Instrument
Shaft
Configurations | Curved (55°), Curved (90°) | Straight (0°), Frontal (70°) | Straight (0°) | The subject device is packaged with a
bending tool to allow the user to
customize the distal shaft of the
device to surgical profiles ranging
from a straight configuration to curve
90°. This range also includes curved
65°. Additionally, the IFU includes
detailed instructions on how to bend
the distal shaft per the user's
preference. The clinical acceptability
of the bending process has been
successfully validated as part of the
design validation testing. |
| Attribute | Predicate Device
KARL STORZ EM Frontal Sinus
Curette | Reference Device
TruDi™ Probe | Subject Device
TruDi™ Curette | Substantial Equivalence
Rationale |
| Total
Length | 18cm | 24 cm | 24cm | The total length specifications are
identical between the subject and
reference devices.
The difference in total length between
the subject and predicate devices is
driven by the differences in the length
of the handle and working length of
the devices.
The working length of the predicate
device is 7.6 cm as opposed to
working length of the subject device
at 12.7 cm. The handle length of the
subject device is 11.4 cm while handle
length of the predicate device is 10.2
cm.
The difference in the working length
of the predicate and subject devices is
based on several Voice of Customer
(VOC) activities and has been
successfully validated during design
validation testing. This difference
improves usability of the subject
device and does not introduce any
additional risks.
The differences between the handles
of the subject and predicate devices
are based on guidelines of
ANSI/AAMI/HE75:2009/ (R)2018 to
enhance human factors characteristics |
| Attribute | Predicate Device
KARL STORZ EM Frontal Sinus
Curette | Reference Device
TruDi™ Probe | Subject Device
TruDi™ Curette | Substantial Equivalence
Rationale |
| | | | | of the subject device. The handle of
the subject device is identical to
handle of the reference device and has
been successfully validated during
design validation testing. |
| Supplied as
"Reusable
Use" | Yes, 30x reusable | No, supplied sterile single use | No, supplied sterile single use | Both the subject and references
devices are supplied single use and
subjected to identical sterilization
processes. |
| Compatible
Navigation
System | KARL STORZ EM Frontal Sinus
Curette is compatible with the
KARL STORZ NAV 1
Electromagnetic Navigation System. | TruDi™ Probe is compatible with
the TruDi™ Navigation System
versions V2.0
or later | TruDi™ Curette is compatible
with the TruDi™ Navigation
System versions V2.0
or later | Both the subject and references
devices are compatible with the
TruDi™ Navigation System versions
V2.0 or later.
All functional and simulated use
testing has been performed with the
TruDi™ Navigation System. As such,
the subject device is only compatible
with the TruDi™ Navigation System. |
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Image /page/7/Picture/0 description: The image shows the logo for Acclarent, a medical technology company. The logo features the company name in bold, black letters, with a purple arc above the "ent" portion of the name. Below the name, in smaller letters, it says "PART OF THE Johnson & Johnson FAMILY OF COMPANIES".
TruDi™ Curette
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Image /page/8/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 bold, sans-serif font, with the "ent" portion of the word in purple. Below the company name is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller font.
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Image /page/9/Picture/0 description: The image shows the logo for Acclarent, a medical technology company. The logo features the company name in a bold, sans-serif font, with the letters "ent" in a lighter shade of purple. Below the company name, in smaller letters, is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES". The logo is simple and modern, and it conveys a sense of innovation and expertise.
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Image /page/10/Picture/0 description: The image shows the logo for Acclarent, a medical technology company. The logo features the company name in a bold, sans-serif font, with the letters "ent" in a lighter shade of purple. Below the company name, there is a tagline that reads "PART OF THE Johnson-Johnson FAMILY OF COMPANIES". The logo is simple and modern, and it conveys a sense of innovation and expertise.
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Image /page/11/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™ Curette". The Acclarent logo is in black and purple.
[807.92(b) (1)] Determination of Substantial Equivalence
| Non-Clinical Performance
Data: | Bench testing has been performed and met all acceptance criteria for
attributes, such as dimensional specifications, connector joint separation
force, distal shaft deflection/flexure, end to end joint strength, cable
strain relief separation force, tip sharpness, bending tool functionality
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. The method used for
sterilization validation is the overkill (half-cycle approach) in a fixed
chamber. Ethylene oxide residuals have been tested and meet ISO
10993-7:2008 requirements. The subject device is not tested nor labeled
as "non-pyrogenic". |
| | Biocompatibility testing was successfully completed to determine that
the TruDi™ Curette is biocompatible per ISO 10993-1. |
| | Packaging shelf life for the TruDi™ Curette was established through
accelerated aging via ASTM F1980-07, ASTM F88/F88M-09, 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™ Curette functions in
accordance with its intended use and design specifications in a
simulated clinical setting. The packaging and instructions for use were
also successfully assessed by evaluators as part of the study. |
| | The TruDi™ Curette passed all intended criteria in accordance with
appropriate test criteria and standards. |
| [807.92(b) (2)] Determination of Substantial Equivalence | |
| Clinical Performance Data | Clinical data was not necessary for the TruDi™ Curette. 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™ Curette is substantially equivalent
to the predicate device. |