(103 days)
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 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.
The provided document is a 510(k) summary for the TruDi™ Curette, which seeks to demonstrate substantial equivalence to a predicate device. While it includes a lot of information about bench testing and design validation, it does not detail a study involving AI performance or human readers. Therefore, several requested sections, particularly those related to AI and human reader studies, cannot be extracted from this document.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-Clinical Performance Data: | |
| Dimensional specifications | Met all acceptance criteria |
| Connector joint separation force | Met all acceptance criteria |
| Distal shaft deflection/flexure | Met all acceptance criteria |
| End to end joint strength | Met all acceptance criteria |
| Cable strain relief separation force | Met all acceptance criteria |
| Tip sharpness | Met all acceptance criteria |
| Bending tool functionality | Met all acceptance criteria |
| Navigational location accuracy | Met all acceptance criteria; Accuracy of TruDi™ Curette in conjunction with TruDi™ Navigation System is ≤ 2mm RMS over the entire navigation volume. |
| Electrical safety and EMC | Compliance with IEC 60601-1 (3rd Edition) and IEC60601-1-2 (4th Edition) |
| Sterilization process | Validated per ISO 11135:2014, demonstrated a sterility assurance level of 10^-6 |
| Ethylene oxide residuals | Met ISO 10993-7:2008 requirements |
| Biocompatibility | Successfully completed per ISO 10993-1 |
| Packaging shelf life | Established for three months via accelerated aging (ASTM F1980-07, ASTM F88/F88M-09, ASTM F2096-11) |
| Design Validation (Simulated Use Testing): | |
| Functionality in simulated clinical setting | Successfully conducted and verified that the TruDi™ Curette functions in accordance with its intended use and design specifications |
| Packaging and instructions for use assessment | Successfully assessed by evaluators |
| Overall Product Performance | Passed all intended criteria in accordance with appropriate test criteria and standards |
2. Sample size used for the test set and the data provenance
The document mentions "Design validation testing (simulated use testing) on cadavers" but does not specify the sample size (number of cadavers or test cases) used for this test set nor the detailed provenance beyond "cadavers". It is a prospective study in a simulated clinical setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified in the provided document. The document mentions "evaluators" for assessing packaging and instructions for use, but not for establishing ground truth regarding clinical performance.
4. Adjudication method for the test set
Not specified in the provided document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The TruDi™ Curette is a physical surgical instrument, not an AI or imaging diagnostic device that would involve human readers or AI assistance in the way typically assessed by MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The TruDi™ Curette is a physical surgical instrument, not an algorithm. Its navigation capability is part of the TruDi™ Navigation System, which has a stated accuracy of ≤ 2mm RMS. This accuracy is a standalone measurement of the system's ability to track the instrument's tip.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the navigational location accuracy, the ground truth would typically be established through precise metrological measurements using a known standard or reference system. For the simulated use testing on cadavers, the "ground truth" or successful performance would be based on the device functioning as intended in manipulating, dissecting, and/or removing tissue, cartilage, and bone, as verified by the evaluators. Specific methods for establishing this ground truth (e.g., expert observation, quantitative assessment of tissue removal) are not detailed.
8. The sample size for the training set
Not applicable. The TruDi™ Curette is a physical device, and the document describes performance testing and design validation, not the development or training of an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or AI model in the context of this device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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.
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
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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
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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 DriveIrvine, 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 TradeName: | TruDi™ Curette |
|---|---|
| ClassificationName: | Stereotaxic Instrument |
| Common Name: | Image Guided Surgery System |
| DeviceClassification: | Class II |
| RegulationNumber: | 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 Systemunder 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 sterileelectromagnetically (EM) navigated instrument, which is intended for use withthe TruDi™ Navigation System (K192397) to manipulate, dissect and/or removetissue, cartilage and bone during surgical procedures in ENT and ENT skullbase 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 forUse: | TruDi™ Curette is intended for use with the TruDi™ Navigation System tomanipulate, dissect and/or remove tissue, cartilage and bone during surgicalprocedures in ENT and ENT skull base surgery. |
|---|---|
| Difference inIndications fromPredicate Device | The indications for use/intended use statement of the subject device is similar tothe predicate device. Both the subject and predicate devices areelectromagnetically-navigated instruments, which are intended to be used withtheir compatible EM navigation systems to manipulate, dissect and/or removetissue, cartilage and bone during surgical procedures in ENT and ENT skull basesurgery.For a comparison of the indications for use/intended use of the subject device andits predicate device, please reference Table 1 on the following page. |
| [807.92(a)(6)] Technical Characteristics | |
| TechnologicalCharacteristics: | The TruDi™ Curette is substantially equivalent in technological characteristics,as there are no significant differences in fundamental scientific technology orother features as compared to the predicate device, KARL STORZ EM FrontalSinus 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 DeviceKARL STORZ EM FrontalSinus Curette | Reference DeviceTruDi™ Probe | Subject DeviceTruDi™ Curette | Substantial EquivalenceRationale |
|---|---|---|---|---|
| 510(k) number | K161555 | K193453 | K201174 | N/A |
| Manufacturer | KARL STORZ EndoscopyAmerica, Inc. | Acclarent, Inc. | Acclarent, Inc. | N/A |
| Trade Name | KARL STORZ EM Frontal SinusCurette (Cleared as part of KARLSTORZ NAV1 ElectromagneticNavigation System under K161555) | TruDi™ Probe | TruDi™ Curette | N/A |
| ClassificationName | Stereotaxic Instrument | Stereotaxic Instrument | Stereotaxic Instrument | Same |
| Class | II | II | II | Same |
| Product Code | PGW | PGW | PGW | Same |
| ClassificationSection | 21 CFR 882.4560 | 21 CFR 882.4560 | 21 CFR 882.4560 | Same |
| Indications forUse | The KARL STORZ NAV 1electromagnetic navigation systemand its associated applications areintended as an aid for preciselylocating anatomical structures ineither open or percutaneousprocedures under visual control.Their use is indicated for anymedical condition in which use ofstereotactic surgery may beappropriate, and where reference toa rigid anatomical structure in thefield of ENT surgery, such asparanasal sinuses, mastoid anatomy,can be identified relative toradiological image data or digitizedlandmarks of the anatomy. | The TruDi™ Probe is intended foruse with the TruDi™ NavigationSystem to locate anatomicalstructures during surgicalprocedures in ENT and ENT skullbase surgery. | TruDi™ Curette is intended foruse with the TruDi™Navigation System tomanipulate, dissect and/orremove tissue, cartilage andbone during surgicalprocedures in ENT and ENTskull base surgery. | The indications for use for the subjectdevice TruDi™ Curette is aligned withthe indications for use/intended use ofthe predicate device. |
| Attribute | Predicate DeviceKARL STORZ EM Frontal SinusCurette | Reference DeviceTruDi™ Probe | Subject DeviceTruDi™ Curette | Substantial EquivalenceRationale |
| Intended Use | Navigated spoons and curettes aidorientation and the manipulation,dissection and/or removal of tissue,cartilage and bone during invasiveand surgically invasive interventionsin ENT medicine and skull basesurgery not involving contact withthe central nervous system. | The TruDi™ Probe is intended foruse with the TruDi™ NavigationSystem to locate anatomicalstructures during surgicalprocedures in ENT and ENT skullbase surgery. | TruDi™ Curette is intended foruse with the TruDi™ NavigationSystem to manipulate, dissectand/or remove tissue, cartilageand bone during surgicalprocedures in ENT and ENTskull base surgery. | The intended use for the subjectdevice TruDi™ Curette is aligned withthe intended use of the predicatedevice. |
| TechnologicalCharacteristics | The KARL STORZ EM FrontalSinus Curette is a reusableelectromagnetically-navigatedinstrument, which is intended to beused with the KARL STORZ NAV1electromagnetic navigation system.The device incorporates a sensorwithin the distal shaft, which istracked by the navigation system.The location of the distal tip of thedevice is identified by thenavigation system and displayed inreal-time view over the patient'spre-operative CT/MRI scan toconfirm access of target anatomy.Following confirmation, thephysician operates the instrument atthe target anatomical structure. | The TruDi™ Probe is a single-useinstrument intended to be usedwith the TruDi™ NavigationSystem. The instrument is anelectromagnetically navigateddevice that is a navigated pointingdevice (malleable, sensor withinthe tip).The device incorporates a sensorat the distal tip, which is trackedby the TruDi™ NavigationSystem. The location of the distaltip of the device is identified bythe navigation system anddisplayed in real-time view overthe patient's pre-operativeCT/MRI scan to confirm accessand locate anatomical structuresduring ENT surgery. | The TruDi™ Curette is a single-use electromagnetically-navigated instrument, which isintended to be used with theTruDi™ Navigation System.The device incorporates asensor within the distal shaft,which is tracked by the TruDi™Navigation System. Thelocation of the distal tip of thedevice is identified by thenavigation system anddisplayed in real-time viewover the patient's pre-operativeCT/MRI scan to confirm accessof target anatomy. Followingconfirmation, the physicianoperates the instrument at thetarget anatomical structure. | The technological characteristicsbetween the subject device andpredicate/reference devices aresimilar.Both the subject and predicate devicesare electromagnetically-navigatedinstruments, which are intended to beused with their compatible EMnavigation systems to manipulate,dissect and/or remove tissue, cartilageand bone during surgical proceduresin ENT and ENT skull base surgery.Similar to the predicate device, thesubject device incorporates a sensorwithin the distal shaft, which istracked by the navigation system.The subject device utilizes identicalsensor subassembly (sensor, wire,PCB, and connector) and navigationplatform as the reference device.Similar to the reference device, thesensor of the subject device is locatedat the distal tip for instrument |
| Attribute | Predicate DeviceKARL STORZ EM Frontal SinusCurette | Reference DeviceTruDi™ Probe | Subject DeviceTruDi™ Curette | Substantial EquivalenceRationale |
| LocalizationTechnology | Electromagnetic (sensor integratedwithin the distal shaft of theinstrument) | Electromagnetic (sensorintegrated into distal tip of theinstrument) | Electromagnetic (sensorintegrated within the distalshaft of the instrument) | Same |
| LocationAccuracy | Unknown | The accuracy of TruDi™ Probeused in conjunction with thenavigation views of the TruDi™Navigation System is ≤ 2mmRMS over the entire navigationvolume. | The accuracy of TruDi™Curette used in conjunctionwith the navigation views of theTruDi™ Navigation System is ≤2mm RMS over the entirenavigation volume. | Location accuracy specifications areidentical between the subject andreference devices. |
| InstrumentShaftConfigurations | Curved (55°), Curved (90°) | Straight (0°), Frontal (70°) | Straight (0°) | The subject device is packaged with abending tool to allow the user tocustomize the distal shaft of thedevice to surgical profiles rangingfrom a straight configuration to curve90°. This range also includes curved65°. Additionally, the IFU includesdetailed instructions on how to bendthe distal shaft per the user'spreference. The clinical acceptabilityof the bending process has beensuccessfully validated as part of thedesign validation testing. |
| Attribute | Predicate DeviceKARL STORZ EM Frontal SinusCurette | Reference DeviceTruDi™ Probe | Subject DeviceTruDi™ Curette | Substantial EquivalenceRationale |
| TotalLength | 18cm | 24 cm | 24cm | The total length specifications areidentical between the subject andreference devices.The difference in total length betweenthe subject and predicate devices isdriven by the differences in the lengthof the handle and working length ofthe devices.The working length of the predicatedevice is 7.6 cm as opposed toworking length of the subject deviceat 12.7 cm. The handle length of thesubject device is 11.4 cm while handlelength of the predicate device is 10.2cm.The difference in the working lengthof the predicate and subject devices isbased on several Voice of Customer(VOC) activities and has beensuccessfully validated during designvalidation testing. This differenceimproves usability of the subjectdevice and does not introduce anyadditional risks.The differences between the handlesof the subject and predicate devicesare based on guidelines ofANSI/AAMI/HE75:2009/ (R)2018 toenhance human factors characteristics |
| Attribute | Predicate DeviceKARL STORZ EM Frontal SinusCurette | Reference DeviceTruDi™ Probe | Subject DeviceTruDi™ Curette | Substantial EquivalenceRationale |
| of the subject device. The handle ofthe subject device is identical tohandle of the reference device and hasbeen successfully validated duringdesign validation testing. | ||||
| Supplied as"ReusableUse" | Yes, 30x reusable | No, supplied sterile single use | No, supplied sterile single use | Both the subject and referencesdevices are supplied single use andsubjected to identical sterilizationprocesses. |
| CompatibleNavigationSystem | KARL STORZ EM Frontal SinusCurette is compatible with theKARL STORZ NAV 1Electromagnetic Navigation System. | TruDi™ Probe is compatible withthe TruDi™ Navigation Systemversions V2.0or later | TruDi™ Curette is compatiblewith the TruDi™ NavigationSystem versions V2.0or later | Both the subject and referencesdevices are compatible with theTruDi™ Navigation System versionsV2.0 or later.All functional and simulated usetesting has been performed with theTruDi™ Navigation System. As such,the subject device is only compatiblewith 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 PerformanceData: | Bench testing has been performed and met all acceptance criteria forattributes, such as dimensional specifications, connector joint separationforce, distal shaft deflection/flexure, end to end joint strength, cablestrain relief separation force, tip sharpness, bending tool functionalityand navigational location 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™ Curette is biocompatible per ISO 10993-1. | |
| Packaging shelf life for the TruDi™ Curette 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. | |
| Design validation testing (simulated use testing) on cadavers wassuccessfully conducted to verify that the TruDi™ Curette functions inaccordance with its intended use and design specifications in asimulated clinical setting. The packaging and instructions for use werealso successfully assessed by evaluators as part of the study. | |
| The TruDi™ Curette 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™ Curette. Theperformance 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 equivalentto the predicate device. |
§ 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).