(101 days)
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.
The subject device, TruDi™ Probe, is a single-use and sterile electromagnetically (EM) navigated instrument, which is intended for use with the TruDi™ Navigation System (K192397) to locate anatomical structures during surgical procedures in ENT and ENT skull base surgery.
The TruDi™ Probe consists of two configurations, straight (0°) and frontal (70°). The TruDi™ Probe comprises of a fixed proximal connector, cable, handle, stainless steel shaft, and a distal tip that houses a magnetic sensor. The device is sold in sterile packaging. Each package includes one TruDi™ Probe (either straight or frontal) in conjunction with a disposable bending tool. The bending tool is provided to allow the user to customize the shape of distal tip as needed.
The TruDi™ Probe 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 scan to confirm access and locate anatomical structures during ENT surgery.
The document describes the Acclarent TruDi™ Probe, a single-use electromagnetically (EM) navigated instrument for locating anatomical structures during ENT and ENT skull base surgery. The device is intended for use with the TruDi™ Navigation System.
Here's an analysis of the acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines performance data from various non-clinical tests. Since specific quantified acceptance criteria are not presented in a direct table format alongside the reported performance values, I will infer them from the descriptions.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| - Dimensional specifications met | Bench testing performed and met all acceptance criteria |
| - Connector joint separation force met | Bench testing performed and met all acceptance criteria |
| - Tip flexure within limits | Bench testing performed and met all acceptance criteria |
| - Distal tube to handle separation force met | Bench testing performed and met all acceptance criteria |
| - Cable strain relief separation force met | Bench testing performed and met all acceptance criteria |
| - Bending tool functionality | Bench testing performed and met all acceptance criteria |
| Navigational Location Accuracy: | A mean bench accuracy of 0.43 mm (Standard deviation 0.15 mm) was measured for the device. With 95% confidence measured devices have location accuracy of ≤ 2 mm RMS over the entire navigation volume. |
| Electrical Safety and EMC: | Met requirements of IEC 60601-1 (3rd Edition) and IEC60601-1-2 (4th Edition). |
| Sterilization: | Sterility assurance level of 10-6 per ISO 11135:2014 (overkill/half-cycle approach). Ethylene oxide residuals meet ISO 10993-7:2008 requirements. |
| Biocompatibility: | Successfully completed per ISO 10993-1. |
| Packaging Shelf Life: | Confirmed to meet a shelf life of three months through accelerated aging per ASTM F1980-07, ASTM F88/F88M-09, and ASTM F2096-11. |
| Simulated Use Performance: | Successfully conducted on cadavers to verify function, intended use, and design specifications. Packaging and IFU also assessed. |
2. Sample Size for Test Set and Data Provenance:
The document mentions "bench testing" and "simulated use testing on cadavers." However, specific sample sizes for these tests are not provided. The provenance of the data is implied to be from the manufacturer's internal testing as part of their 510(k) submission, and it is retrospective (performed before the submission). There is no mention of country of origin for the data; it is assumed to be part of the manufacturer's internal development and testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document describes "simulated use testing on cadavers" where "packaging and instructions for use were also successfully assessed by evaluators." However, the number of experts and their qualifications used to establish ground truth for these tests are not mentioned.
4. Adjudication Method:
The document does not specify an adjudication method for the "simulated use testing" or any other performance evaluation involving human assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was not conducted or reported. The submission explicitly states "Clinical data was not necessary for the TruDi™ Probe. The performance data demonstrated that the device performs as intended." This indicates no study was done to assess human reader improvement with or without AI assistance.
6. Standalone Performance Study (Algorithm Only):
The document describes the standalone performance of the device concerning its navigational accuracy:
- A mean bench accuracy of 0.43 mm (Standard deviation 0.15 mm) was measured for the device.
- With 95% confidence, measured devices have a location accuracy of ≤ 2 mm RMS over the entire navigation volume.
This indicates algorithm-only performance testing for its core functionality (localization).
7. Type of Ground Truth Used (for standalone performance):
For the navigational accuracy, the ground truth would have been established by a highly precise engineering and metrology setup (e.g., using a known reference system or precision measurement tools) to determine the true position, against which the device's reported position was compared. This is typical for such electromagnetic navigation systems.
8. Sample Size for the Training Set:
The TruDi™ Probe is an electromagnetic navigation instrument, not an AI or machine learning algorithm in the typical sense that would require a "training set" of data to learn from. Its performance is based on physical principles and sensor technology. Therefore, a training set size is not applicable in this context.
9. How the Ground Truth for the Training Set Was Established:
As mentioned above, the concept of a "training set" and associated ground truth is not applicable to this device, which relies on direct physical measurement and not a learning algorithm.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
March 23, 2020
Acclarent, Inc. Leena Sorathia Regulatory Affairs Program Lead 31 Technology Drive Irvine, California 92618
Re: K193453
Trade/Device Name: TruDi Probe Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: PGW Dated: March 3, 2020 Received: March 4, 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 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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193453
Device Name TruDi™ Probe
Indications for Use (Describe)
The TruDi™ Probe is intended for use with the TruDi™ System to locate anatomical structures 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/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™ Probe" is displayed in a bold font. The Acclarent logo features the company name in a bold, sans-serif font, with a purple arc above the "ent" portion of the name.
510(K) SUMMARY
[807.92(a)(1)] Submitter Information
| Sponsor/Submitter: | Acclarent, Inc.31 Technology DriveIrvine, CA 92618 |
|---|---|
| Contact Person: | Leena SorathiaRegulatory Affairs Program LeadEmail: lsorathi@its.jnj.comTel: 949-923-4118 |
Date Summary Prepared: March 20, 2020
[807.92(a)(2)] Name of Device
| [807.92(a)(2)] Name of Device | |
|---|---|
| Device Trade Name: | TruDi™ Probe |
| 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: | Fiagon Navigation – FlexPointer 1.5, (K150473) |
| [807.92(a)(4)] Device Description | |
| Device Description: | The subject device, TruDi™ Probe, is a single-use and sterile electromagnetically (EM) navigated instrument, which is intended for use with the TruDi™ Navigation System (K192397) to locate anatomical structures during surgical procedures in ENT and ENT skull base surgery.The TruDi™ Probe consists of two configurations, straight (0°) and frontal (70°). The TruDi™ Probe comprises of a fixed proximal connector, cable, handle, stainless steel shaft, and a distal tip that houses a magnetic sensor. The device is sold in sterile packaging. Each package includes one TruDi™ Probe (either straight or frontal) in conjunction with a disposable bending tool. The bending tool is provided to allow the user to customize the shape of distal tip as needed. |
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Image /page/4/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™ Probe" is displayed in a bold font. The Acclarent logo features the company name in a combination of black and purple, with a curved line above the "ent" portion of the name.
The TruDi™ Probe 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 scan to confirm access and locate anatomical structures during ENT surgery.
[807.92(a)(5)] Intended Use
| Indications forUse: | The TruDi™ Probe is intended for use with the TruDi™ Navigation System tolocate anatomical structures during surgical procedures in ENT and ENT skullbase surgery. |
|---|---|
| Difference inIndications fromPredicate Device | The indications for use statement of the subject device is similar to the predicatedevice. Both the subject and predicate devices are electromagnetically-navigatedinstruments, which are intended to be used with their compatible EM navigationsystems to locate anatomical structures during ENT surgery. |
For a comparison of the indications for use of the subject device and its predicate device, please reference Table 1 on the following page.
[807.92(a)(6)] Technical Characteristics
| TechnologicalCharacteristics: | The TruDi™ Probe is substantially equivalent in technological characteristics, asthere are no significant differences in fundamental scientific technology or otherfeatures as compared to the predicate device, Fiagon FlexPointer 1.5mm(K150473).Both the subject and predicate devices are electromagnetically-navigatedinstruments, which are intended to be used with their compatible EM navigationsystems to locate anatomical structures during ENT surgery. Similar to thepredicate device, the subject device incorporates a sensor at the distal tip, whichis tracked by the navigation system. The location of the distal tip of the device isidentified by the navigation system and displayed in real-time view over thepatient's pre-operative CT scan to confirm access and locate anatomicalstructures during ENT surgery.The primary differences between the subject and predicate devices are thefollowing:The subject device is a single-use instrument, whereas the predicate deviceis reusable for up to 10 uses. The subject device is packaged with a bending tool, whereas the predicatedevice is not. The distal tip diameter of the subject device is 1.65 mm, whereas the distaltip diameter of the predicate device is 1.5mm. The handle of subject device is different from the handle of predicate devicein length, shape, diameter and cross-section. However, these differences do not raise new concerns of safety and effectiveness for the subject device as demonstrated by performance testing and simulated use |
|---|---|
| ----------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Image /page/5/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 font, it says 'PART OF THE Johnson-Johnson FAMILY OF COMPANIES'. Underneath that, in a larger, bolded font, it says 'TruDi™ Probe'.
testing. See Table 1 for a comparison of the technological characteristics between the subject device and the predicate device.
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Image /page/6/Picture/0 description: The image shows the Acclarent logo, which is a medical technology company. Below the logo, it says "PART OF THE Johnson & Johnson FAMILY OF COMPANIES". Underneath that, the text "TruDi™ Probe" is displayed.
| Attribute | Predicate DeviceFiagon FlexPointer 1.5mm | Subject DeviceTruDi™ Probe | Substantial EquivalenceRationale |
|---|---|---|---|
| 510(k) number | K150473 | K193453 | N/A |
| Manufacturer | Fiagon GmbH | Acclarent, Inc. | N/A |
| Trade Name | Fiagon Navigation - FlexPointer 1.5 | TruDi™ Probe | N/A |
| Classification Name | Stereotaxic Instrument | Stereotaxic Instrument | Same |
| Class | II | II | Same |
| Product Code | PGW | PGW | Same |
| ClassificationSection | 21 CFR 882.4560 | 21 CFR 882.4560 | Same |
| Indications for Use | The FlexPointer 1.5 is intended as an aid forprecisely locating anatomical structures in eitheropen or percutaneous procedures. It is indicatedfor use with the Fiagon Navigation system usingelectromagnetic navigation.It is indicated for any medical condition in whichthe use of stereotactic surgery may beappropriate, and where reference to a rigidanatomical structure in the field of ENT surgery,such as the paranasal sinuses, mastoid anatomy,can be identified relative to a CT or MRbased model of the anatomy.Example procedures include, but are not limitedto:ENT Procedures:Transphenoidal access procedures.Intranasal procedures.Sinus procedures, such as Maxillaryantrostomies, Ethmoidectomies,Sphenoidotomies/Sphenoid explorations,Turbinate resections, and Frontal sinusotomies.ENT related anterior skull base procedures. | The TruDi™ Probe is intended for use withthe TruDi™ Navigation System to locateanatomical structures during surgicalprocedures in ENT and ENT skull basesurgery. | The indications for use of the subjectTruDi™ Probe device is aligned with theindications for use of the predicate device. |
Table 1: Comparison of Technological Characteristics between Subject Device and Predicate Device
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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 bold, sans-serif font, with the "A" and "ccla" in black and the "rent" in purple. Above the word "rent" is a purple arc. Below the word "Acclarent" is the phrase "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" in a smaller font, with "Johnson-Johnson" in red.
| Attribute | Predicate DeviceFiagon FlexPointer 1.5mm | Subject DeviceTruDi™ Probe | Substantial EquivalenceRationale |
|---|---|---|---|
| Intended Use | The FlexPointer 1.5 is intended as an aid forprecisely locating anatomical structures in eitheropen or percutaneous procedures. It is indicatedfor use with the Fiagon Navigation system usingelectromagnetic navigation. | The TruDi™ Probe is intended for use withthe TruDi™ Navigation System to locateanatomical structures during surgicalprocedures in ENT and ENT skull basesurgery. | The intended use of the subject TruDi™ Probe device is aligned with the intendeduse of the predicate device. |
| It is indicated for any medical condition inwhich the use of stereotactic surgery may beappropriate, and where reference to a rigidanatomical structure in the field of ENT surgery,such as the paranasal sinuses, mastoid anatomy,can be identified relative to a CT or MR basedmodel of the anatomy. | |||
| Example procedures include, but are not limitedto:ENT Procedures;Transphenoidal access procedures.Intranasal procedures.Sinus procedures, such as Maxillaryantrostomies, Ethmoidectomies,Sphenoidotomies/Sphenoid explorations,Turbinate resections, and Frontal sinusotomies.ENT related anterior skull base procedures. | |||
| Attribute | Predicate DeviceFiagon FlexPointer 1.5mm | Subject DeviceTruDi™ Probe | Substantial EquivalenceRationale |
| TechnologicalCharacteristics | The Fiagon Navigation - FlexPointer 1.5 is areusable instrument intended to be used with theFiagon Navigation system. The instrument is anelectromagnetically navigated device that is anavigated pointing device (malleable, sensorwithin the tip). | The TruDi™ Probe is a single-useinstrument intended to be used with theTruDi™ Navigation System. The instrumentis an electromagnetically navigated devicethat is a navigated pointing device(malleable, sensor within the tip). | The technological characteristics have beentested through non-clinical testing and theydo not impact substantial equivalence. Thedifferences do not raise any new concerns. |
| The device incorporates a sensor at the distal tip,which is tracked by the navigation system. Thelocation of the distal tip of the device isidentified by the navigation system anddisplayed in real-time view over the patient'spre-operative CT/MRI scan to confirm accessand locate anatomical structures during ENTsurgery. | The device incorporates a sensor at thedistal tip, which is tracked by the TruDi™Navigation System. The location of thedistal tip of the device is identified by thenavigation system and displayed in real-time view over the patient's pre-operativeCT/MRI scan to confirm access and locateanatomical structures during ENT surgery. | ||
| LocalizationTechnology | Electromagnetic (sensor integrated into distal tipof the instrument) | Electromagnetic (sensor integrated intodistal tip of the instrument) | Same |
| System or InstrumentAccuracyRequirements | A mean bench accuracy of 1.1 mm (Standarddeviation 0.27 mm) was measured for thedevice. | A mean bench accuracy of 0.43 mm(Standard deviation 0.15 mm) wasmeasured for the device. | The system and instrument accuracyrequirements have been tested through non-clinical testing and they do not impactsubstantial equivalence. The differences do |
| All 95% confidence levels were < 2mm whichcompares to the values 0.9 mm and 1.2 mm(mean) resp. <2 mm (95% confidence) reportedfor the unmodified devices. | With 95% confidence measured deviceshave location accuracy of ≤ 2 mm RMSover the entire navigation volume. | not raise any new concerns. | |
| Instrument ShaftConfigurations | Straight (0°) | Straight (0°), Frontal (70°) | The instrument shaft configurations havebeen tested through non-clinical testing andthey do not impact substantial equivalence.The differences do not raise any newconcerns. |
| Distal Tip Diameter | 1.5mm | 1.65mm | The distal tip diameter has been testedthrough non-clinical testing and does notimpact substantial equivalence. Thedifferences do not raise any new concerns. |
| Attribute | Predicate DeviceFiagon FlexPointer 1.5mm | Subject DeviceTruDi™ Probe | Substantial EquivalenceRationale |
| Handle | Length: ~ 1 inchShape: Rectangular profileCross-section: Rectangular (~ 1.0 inch x0.7 inches x 0.4 inches) | Length: 4.5 inchesShape: Cylindrical profileCross-section: CircularDiameter: 0.45 inches | The handle design of the subject devicecomplies with ANSI/AAMI/HE75:2009/(R)2018. Handle design features i.e. length,shape, cross-section and diameter wereevaluated and verified through several VOCactivities to ensure that the handle metergonomic and functional expectations ofprospective users. In addition, the clinicalacceptability and functionality of the handledesign were validated through designvalidation testing (simulated use testing).Therefore, the handle differences of thesubject and predicate devices do not affectsafety and effectiveness of the subjectdevice. |
| Supplied as"Reusable Use" | Yes, 10x reusable | No, supplied sterile single use | This attribute has been tested through non-clinical testing and does not impactsubstantial equivalence. The differences donot raise any new concerns. |
| Location of Sensor | Sensor is built-in at the distal tip of theinstrument | Sensor is built-in at the distal tip of theinstrument | Same |
| CompatibleNavigation System | Fiagon FlexPointer 1.5mm is compatible withthe Fiagon Navigation system. | TruDi™ Probe is compatible with theTruDi™ Navigation System. | This attribute has been tested through non-clinical testing and does not impactsubstantial equivalence. The differences donot raise any new concerns. |
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Image /page/8/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 stylized purple arc above the "ent" portion of the name. Below the name, in smaller font, it says "PART OF THE Johnson & Johnson FAMILY OF COMPANIES".
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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 bold, black letters, with a purple arc above the "ent" portion of the name. Below the name, in smaller red letters, is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES".
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Image /page/10/Picture/0 description: The image shows the Acclarent logo, which is part of the Johnson & Johnson family of companies. Below the logo, the text "Traditional 510(k)" is displayed, followed by "TruDi™ Probe". The text suggests that the image is related to a medical device or product that has undergone the traditional 510(k) approval process.
[807.92(b) (1)] Determination of Substantial Equivalence
| Non-Clinical PerformanceData: | Bench testing has been performed and met all acceptance criteria forattributes, such as dimensional specifications, connector joint separationforce, tip flexure, distal tube to handle separation force, cable strainrelief separation force, bending tool functionality and navigationallocation accuracy.Electrical safety and EMC tests were performed by a nationallyrecognized testing laboratory to verify compliance with therequirements of IEC 60601-1 (3rd Edition) and IEC60601-1-2 (4thEdition).The sterilization process has been validated per ISO 11135:2014 anddemonstrated a sterility assurance level of 10-6. The method used forsterilization validation is the overkill (half-cycle approach) in a fixedchamber. Ethylene oxide residuals have been tested and meet ISO10993-7:2008 requirements. The subject device is not tested nor labeledas "non-pyrogenic".Biocompatibility testing was successfully completed to determine thatthe TruDi™ Probe is biocompatible per ISO 10993-1.Packaging shelf life for the TruDi™ Probe was established throughaccelerated aging via ASTM F1980-07, ASTM F88/F88M-09, andASTM F2096-11 requirements and confirmed to meet a shelf life ofthree months.Simulated use testing on cadavers was successfully conducted to verifythat the TruDi™ Probe functions in accordance with its intended use anddesign specifications in a simulated clinical setting. The packaging andinstructions for use were also successfully assessed by evaluators as partof the study.The TruDi™ Probe passed all intended criteria in accordance withappropriate test criteria and standards. |
|---|---|
| [807.92(b) (2)] Determination of Substantial Equivalence | |
| Clinical Performance Data | Clinical data was not necessary for the TruDi™ Probe. The performancedata demonstrated that the device performs as intended. |
| Conclusion from Non- | Based on the information provided in this premarket notification, |
| Clinical and Clinical Tests | Acclarent concludes that the TruDi™ Probe is as safe and effective as thepredicate device. |
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Image /page/11/Picture/0 description: The image shows the Acclarent logo, which is a medical device company that is part of the Johnson & Johnson family of companies. Below the logo, the text "Traditional 510(k)" and "TruDi™ Probe" are displayed. The text indicates that the image is related to a medical device, specifically the TruDi™ Probe, and its regulatory pathway, which is the Traditional 510(k) clearance.
[807.92(b) (3)] Conclusion
§ 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).