(104 days)
TruDi® Shaver Blades are intended for use with the Bien-Air S120 Shaver Handpiece and the TruDi® Navigation System to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. Their use is indicated for any medical condition in which the use of navigated surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to a CT or MR based model.
TruDi® Shaver Blades may be used in, but is not limited to, the following procedures:
- · Endoscopic sinus surgery (such as ethmoidectomy, polypectomy, septoplasty)
- · Drainage of mucoceles or abscesses that have extended from the paranasal sinuses and up to the dura mater
- · Orbital decompression
- · Any other of a number of tumors involving the lateral nasal wall, paranasal sinuses and orbit
- · Access to the sphenoid sinus
The subject device, TruDi® Shaver Blade, is a single-use and sterile electromagnetically (EM) navigated instrument, which is intended to be used with the Bien-Air S120 Shaver Handpiece (reference device, K083720) and the TruDi® Navigation System (K192397) to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. The device is tracked by the navigation system within the low energy magnetic field volume generated by the TruDi® Navigation System. The TruDi® Navigation System software displays the position of the shaver blade distal tip on preoperative scans (e.g. CT, MRI). The TruDi® Shaver Blade consists of several configurations ranging from straight to curved blades of different diameters.
The TruDi® Shaver Blade underwent various performance tests to demonstrate its substantial equivalence to its predicate device. This device is an electromagnetically (EM) navigated instrument intended for use with the Bien-Air S120 Shaver Handpiece and the TruDi® Navigation System to aid in incision and removal of soft and hard tissue or bone in various ENT and maxillofacial surgeries.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional Specifications | All specified dimensions are within established tolerances. | Met all acceptance criteria for attributes such as dimensional specifications. |
| Electrical Tests | Compliance with relevant electrical safety and performance standards. | Met all acceptance criteria for attributes such as electrical tests. Electrical safety and EMC tests were performed to verify compliance with IEC 60601-1 (3rd Edition) and IEC60601-1-2 (4th Edition). |
| Connector Joint Separation Force | Connector joint separation force meets established minimum requirements to ensure secure connection during use. | Met all acceptance criteria for attributes such as connector joint separation force. |
| Heat Shrink Slip | Heat shrink components remain securely in place, without slipping, under specified conditions. | Met all acceptance criteria for attributes such as heat shrink slip. |
| Strain Relief Axial Force | Strain relief mechanisms exhibit sufficient axial force to prevent damage or unintended disconnections. | Met all acceptance criteria for attributes such as strain relief axial force. |
| Navigational Location Accuracy | Accuracy of the TruDi® Shaver Blade when used with the TruDi® Navigation System is $\le$ 2mm RMS over the entire navigation volume. (Predicate device requirement: 95% confidence / 99.5% reliability, of $\le$ 3.00 mm). | The accuracy of TruDi® Shaver Blade used in conjunction with the navigation views of the TruDi® Navigation System is $<$ 2mm RMS over the entire navigation volume. (This meets the reference device (TruDi® Curette) criteria and exceeds the predicate device criteria). |
| Sterilization Assurance Level (SAL) | Achieves a sterility assurance level of 10-6. | Validation per ISO 11135:2014 demonstrated a sterility assurance level of 10-6. |
| Biocompatibility | Biocompatible per ISO 10993-1. | Biocompatibility testing was successfully completed to determine that the TruDi® Shaver Blade is biocompatible per ISO 10993-1. |
| Packaging Shelf Life | Meets a shelf life of three months. | Packaging shelf life was established through accelerated aging via ASTM F1980-16, ASTM F88-15, and ASTM F2096-11 requirements and confirmed to meet a shelf life of three months. |
| Simulated Use (Functional Performance) | Functions in accordance with its intended use and design specifications in a simulated clinical setting, including effective tissue incision and removal, and proper display of navigational information. Packaging, labeling, and instructions for use are successfully assessed. | Design validation testing (simulated use testing) on cadavers was successfully conducted to verify that the TruDi® Shaver Blade functions in accordance with its intended use and design specifications in a simulated clinical setting. The packaging, labeling, and instructions for use were also successfully assessed by evaluators as part of the study. The TruDi® Shaver Blade passed all intended criteria in accordance with appropriate test criteria and standards. |
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated for each bench test, but the design validation testing involved "cadavars." The number of cadavers used is not specified.
- Data provenance: The testing was non-clinical (bench testing and simulated use on cadavers). The country of origin for the data is not specified, but the submission is for the US FDA, implying testing was conducted to meet US regulatory requirements. The testing is considered prospective as it was conducted to demonstrate the performance of the specified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- The document mentions "evaluators" for assessing packaging, labeling, and instructions for use during the simulated use study. However, the number and qualifications of these evaluators or other experts establishing ground truth for the bench tests or cadaver study are not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No specific adjudication method is mentioned for the test set. The data appears to be derived from direct measurements and objective assessments against predefined technical specifications.
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:
- No MRMC comparative effectiveness study was mentioned. This device is a surgical instrument with navigation capabilities, not an AI-assisted diagnostic device typically evaluated with MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- A "standalone" performance for the navigation accuracy component was assessed as part of the system accuracy requirement, stating "The accuracy of TruDi® Shaver Blade used in conjunction with the navigation views of the TruDi® Navigation System is < 2mm RMS over the entire navigation volume." This refers to the accuracy of the system's tracking and display. However, the overall device performance in terms of surgical outcome inherently involves human-in-the-loop (the surgeon). The simulated use on cadavers assesses both the device's technical function and its usability for a surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For bench testing, the ground truth was based on engineering specifications and established test standards (e.g., dimensional tolerances, electrical safety standards, sterilization standards, biocompatibility standards).
- For navigational accuracy, the ground truth would be established by precision measurement systems (e.g., optical tracking systems) used to verify the reported position of the instrument within the navigation volume.
- For the simulated use on cadavers, the "ground truth" for functional performance would be assessed against the intended surgical actions and design specifications for incision and removal of tissue/bone, likely through expert observation and potentially post-procedure assessment of the cadaver.
8. The sample size for the training set:
- The document does not provide information about a separate "training set" as it would for a machine learning or AI-based device. The development and validation of medical devices typically involve design verification and validation testing, which are distinct from the training/test set paradigm of AI.
9. How the ground truth for the training set was established:
- Not applicable, as no external "training set" in the context of machine learning was described. The device's design and engineering would be based on established medical and engineering principles rather than learn from a labeled dataset.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 20, 2022
Acclarent, Inc. Leena Zalavadia Regulatory Affairs Program Lead 31 Technology Drive, Suite 200 Irvine, California 92618
Re: K221037
Trade/Device Name: TruDi Shaver Blade Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW, ERL Dated: June 16, 2022 Received: June 17, 2022
Dear Leena Zalavadia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221037
Device Name TruDi® Shaver Blade
Indications for Use (Describe)
TruDi® Shaver Blades are intended for use with the Bien-Air S120 Shaver Handpiece and the TruDi® Navigation System to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. Their use is indical condition in which the use of navigated surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to a CT or MR based model.
TruDi® Shaver Blades may be used in, but is not limited to, the following procedures:
- · Endoscopic sinus surgery (such as ethmoidectomy, polypectomy, septoplasty)
- · Drainage of mucoceles or abscesses that have extended from the paranasal sinuses and up to the dura mater
- · Orbital decompression
- · Any other of a number of tumors involving the lateral nasal wall, paranasal sinuses and orbit
- · Access to the sphenoid sinus
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image contains the logo for "Acclarent", which is partially covered by a purple arc. Below the logo, it says "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" in a smaller font. The text "TruDi® Shaver Blade" is at the bottom of the image.
510(K) SUMMARY- K221037
[807.92(a)(1)] Submitter Information
| Sponsor/Submitter: | Acclarent, Inc.31 Technology Drive, Suite 200Irvine, CA 92618 |
|---|---|
| Contact Person: | Leena ZalavadiaRegulatory Affairs ManagerEmail: lsorathi@its.jnj.comTel: 949-923-4118 |
Date Summary Prepared: July 20, 2022
[807.92(a)(2)] Name of Device
| Device TradeName: | TruDi® Shaver Blade |
|---|---|
| ClassificationName: | Stereotaxic Instrument |
| Common Name: | Image Guided Surgery System |
| DeviceClassification: | Class II |
| RegulationNumber: | 21 CFR 882.4560 |
| Review Panel: | Ear, Nose, and Throat |
| Primary ProductCode: | PGW |
| Secondary ProductCode: | ERL |
| [807.92(a)(3)] Legally Marketed Devices | |
| Predicate Device: | Medtronic Navigated Quadcut Blades (K130608) |
| Reference Devices: | Bien-Air OSSEODUO S120 Shaver Handpiece(Cleared OSSEODUO Shaver and Drill System under K083720) |
| TruDi® Curette (K201174) |
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Image /page/4/Picture/0 description: The image shows the logo for Acclarent, a medical technology company. The logo features the company name in a combination of black and purple lettering, with a curved purple line above the "ent" portion of the name. Below the name, in smaller font, is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES."
[807.92(a)(4)] Device Description
Device Description: The subject device, TruDi® Shaver Blade, is a single-use and sterile electromagnetically (EM) navigated instrument, which is intended to be used with the Bien-Air S120 Shaver Handpiece (reference device, K083720) and the TruDi® Navigation System (K192397) to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. The device is tracked by the navigation system within the low energy magnetic field volume generated by the TruDi® Navigation System. The TruDi® Navigation System software displays the position of the shaver blade distal tip on preoperative scans (e.g. CT, MRI). The TruDi® Shaver Blade consists of several configurations ranging from straight to curved blades of different diameters.
[807.92(a)(5)] Intended Use
TruDi® Shaver Blades are intended for use with the Bien-Air S120 Shaver Indications for Use: Handpiece and the TruDi® Navigation System to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. Their use is indicated for any medical condition in which the use of navigated surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to a CT or MR based model.
TruDi® Shaver Blades may be used in, but is not limited to, the following procedures:
- · Endoscopic sinus surgery (such as ethmoidectomy, polypectomy, septoplasty)
- · Drainage of mucoceles or abscesses that have extended from the paranasal sinuses and up to the dura mater
- · Orbital decompression
· Any other of a number of tumors involving the lateral nasal wall, paranasal sinuses and orbit
- Access to the sphenoid sinus
Difference in The indications for use and intended use of the subject device, TruDi® Shaver Indications from Blade, are similar to the predicate device and reference device (Bien-Air Predicate Device OSSEODUO S120 Shaver Handpiece). Both the subject device and predicate device are electromagnetically navigated shaver blades intended to aid in the incision and removal of soft and hard tissue or bone during head and neck and ENT surgery. One of the reference devices, Bien-Air S120 Shaver Handpiece (K083720), is intended to be used with the subject device, therefore relevant parts of the indications for use of the reference device have been added to the indications for use for the subject device.
For a comparison of the indications for use/intended use of the subject device and its predicate device, please reference Table 1.
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Image /page/5/Picture/0 description: The image shows the logo for Acclarent, a company that is part of the Johnson & Johnson family of companies. The logo features the word "Acclarent" in a bold, sans-serif font, with a purple swoosh above the "ent". Below the word "Acclarent" is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller font. The Johnson & Johnson part of the phrase is in red.
| [807.92(a)(6)] Technical Characteristics | |
|---|---|
| TechnologicalCharacteristics: | The subject device, TruDi® Shaver Blade, is substantially equivalent intechnological characteristics, as there are no significant differences in design,fundamental scientific technology, or other features of the device from thepredicate device. |
| Both the subject device and predicate device (Medtronic Navigated QuadcutBlades, K130608) are electromagnetically navigated shaver blades, which areintended to aid in the incision and removal of soft and hard tissue or bone duringhead and neck and ENT surgery. Similar to the predicate device, the subjectdevice incorporates a sensor, which is tracked by its navigation system. Thelocation of the sensor is identified by the navigation system and displayed inreal-time view over the patient's pre-operative CT/MRI scan to confirm access,and to locate anatomical structures during ENT surgical procedures. | |
| The primary differences between the subject and predicate device are thefollowing:The subject device has a sensor integrated at the distal tip of the device,whereas the predicate device has a tracker with a sensor inside mountedon the proximal end of the blade to allow for navigation during the ENTsurgical procedures The subject device is available in a variety of blade angles, 0° (straight),15°, 40°, and 60° angles, while the predicate device is only available in0° (straight) angle. The subject device uses a different handpiece and navigation system tooperate the device than the predicate device. The subject device isintended for use with the Bien-Air S120 Shaver Handpiece (K083720),OSSEODUO control unit (K083720) and TruDi® Navigation System(K192397), whereas the predicate device is intended for use with theMedtronic M4 and M5 hand piece and Medtronic's navigation system. | |
| However, these differences do not raise new concerns of safety and effectivenessfor the subject device as demonstrated by performance testing and designvalidation testing (simulated use testing). See Table 1 for a comparison of thetechnological characteristics between the subject device and the predicatedevice. | |
| In order to operate the subject device, it must connect to the Bien-Air S120Shaver Handpiece (K083720), which is why it was selected as the reference |
device. The TruDi® Curette (K201174) is also presented as a reference device
due to similarities in testing methods.
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Image /page/6/Picture/0 description: The image shows the logo for Acclarent, a company that is part of the Johnson & Johnson family of companies. Below the logo is the text "TruDi® Shaver Blade". The Acclarent logo is in black font, while the Johnson & Johnson text is in red font.
Table 1: Substantial Equivalence Table
| Attribute | Predicate Device:Medtronic NavigatedQuadcut Blades | Reference Device:Bien-Air OSSEODUO S120Shaver Handpiece | Reference Device:TruDi® Curette | Subject Device:TruDi® Shaver Blade | Substantial EquivalenceRationale |
|---|---|---|---|---|---|
| 510(k)number | K130608 | K083720 | K201174 | K221037 | N/A |
| Manufacturer | Medtronic Navigation, Inc. | Bien-Air Surgery SA | Acclarent, Inc. | Acclarent, Inc. | N/A |
| Trade Name | Quadcut | OSSEODUO Shaver and DrillSystem | TruDi® Curette | TruDi® Shaver Blade | N/A |
| ClassificationName | Neurological StereotaxicInstrument | Drill, Surgical, ENT (Electricor Pneumatic) includingHandpiece | Ear, Nose, and ThroatStereotaxic Instrument | Ear, Nose, and ThroatStereotaxic Instrument | Same as the referencedevice (TruDi® Curette). |
| Class | II | II | II | II | Same |
| ClassificationProduct Code | HAW | ERL | PGW | PGW | Same as reference device(TruDi® Curette). |
| SecondaryProduct Code | N/A | N/A | N/A | ERL | Same as reference device(Bien-Air OSSEODUOS120 Shaver Handpiece). |
| ClassificationSection | 21 CFR 882.4560 | 21 CFR 874.4250 | 21 CFR 882.4560 | 21 CFR 882.4560 | Same as predicate andreference device (TruDi®Curette). |
| Attribute | Predicate Device:Medtronic NavigatedQuadcut Blades | Reference Device:Bien-Air OSSEODUO S120Shaver Handpiece | Reference Device:TruDi® Curette | Subject Device:TruDi® Shaver Blade | SubstantialEquivalenceRationale |
| Indicationsfor Use | The XPS/IPC System isintended for the incision andremoval of soft and hard tissueor bone in generalotorhinolaryngology, head andneck, and otoneurologicalsurgery.The Medtronic computer-assisted surgery system and itsassociated applications areintended as an aid forprecisely locating anatomicalstructures in either open orpercutaneous procedures.The system and its associatedapplications should be usedonly as an adjunct for surgicalguidance. They do not replacethe surgeon's knowledge,expertise, or judgment. | The OSSEODUO is a drill andshaver system that has beendesigned for drilling and shapingbone and for"the resection of soft and hardtissues as part of surgicaloperations in the areas ofotorhinolaryngology,otoneurology, maxillofacialsurgery, and head and necksurgery."The shaver handpiece S80 orS120 is designed for cutting andremoval of soft and hard tissuein the fields of:- Endoscopic sinus surgery (suchas ethmoidectomy,polypectomy, septoplasty)- Endoscopicdacryocystorhinostomy (DCR)- Nasopharyngeal and laryngealprodedures (such asadenoidectomy, polypectomy,tonsillectomy)- Head and neck surgery (suchas acoustic-neuroma removal,tumor removal, rhinoplasty,adipose tissueremoval, plastic, reconstructive | TruDi® Curette is intendedfor use with the TruDi®Navigation System tomanipulate, dissect and/orremove tissue, cartilage andbone during surgicalprocedures in ENT andENT skull base surgery. | TruDi® Shaver Blades are intendedfor use with the Bien-Air S120Shaver Handpiece and the TruDi®Navigation System to aid in theincision and removal of soft and hardtissue or bone in ENT, Maxillofacialsurgery, Head and Neck and ENTskull base surgery. Their use isindicated for any medical conditionin which the use of navigated surgerymay be appropriate, and wherereference to a rigid anatomicalstructure can be identified relative toa CT or MR based model.TruDi® Shaver Blades may be usedin, but is not limited to, the followingprocedures:• Endoscopic sinus surgery (such asethmoidectomy, polypectomy,septoplasty)• Drainage of mucoceles or abscessesthat have extended from theparanasal sinuses and up to the duramater• Orbital decompression• Any other of a number of tumorsinvolving the lateral nasal wall,paranasal sinuses and orbit• Access to the sphenoid sinus | The indications for usefor the subject device isaligned with theindications for use ofthe predicate andreference device (Bien-Air OSSEODUO S120Shaver Handpiece). |
| Predicate Device: | Reference Device: | Reference Device: | Subject Device: | Substantial Equivalence | |
| Attribute | Medtronic NavigatedQuadcut Blades | Bien-Air OSSEODUO S120Shaver Handpiece | TruDi® Curette | TruDi® Shaver Blade | Rationale |
| Intended Use | The Quadcut blades areintended for the incision andremoval of soft and hard tissueor bone in generalotorhinolaryngology, head andneck, and otoneurologicalsurgery. | The shaver handpiece S80 orS120 is designed for cuttingand removal of soft and hardtissue | TruDi® Curette is intendedfor use with the TruDi®Navigation System tomanipulate, dissect and/orremove tissue, cartilage andbone during surgicalprocedures in ENT andENT skull base surgery. | TruDi® Shaver Blades areintended for use with the Bien-Air S120 Shaver Handpiece andthe TruDi® Navigation Systemto aid in the incision and removalof soft and hard tissue or bone inENT, Maxillofacial surgery, Headand Neck and ENT skull base | The intended use for thesubject device is alignedwith the intended use ofthe predicate and referencedevice (Bien-AirOSSEODUO S120 ShaverHandpiece). |
| TechnologicalCharacteristics | Quadcut is intended forattachment to the MedtronicM4 hand piece for use inconjunction with Fusion ENTsoftware on a Medtroniccomputer-assisted surgerysystem. Each blade has atracker mounted on it to allowfor navigation during the ENTsurgical procedure. Thesystem's mobile emittergenerates a low-energymagnetic field to locate thetracker mounted on the blade.Then, the software displays thelocation of the blade's tipwithin multiple patient imageplanes and other anatomicalrenderings. | The Bien-Air S120 shaverhandpiece includes amicromotor, a gear set, acoupling system for shaverblades and connections forirrigation and suction. Throughthe control unit it can operatein oscillating modus (reversingafter a user-defined number ofturns in each direction) or incontinuous CW and CCWrotation. | The TruDi® Curette is asingle-use electro-magnetically-navigatedinstrument, which isintended to be used with theTruDi® Navigation System.The device incorporates asensor within the distalshaft, which is tracked bythe TruDi® NavigationSystem. The location of thedistal tip of the device isidentified by the navigationsystem and displayed inreal-time view over thepatient's pre-operativeCT/MRI scan to confirmaccess of target anatomy.Following confirmation, thephysician operates theinstrument at the targetanatomical structure. | surgery.The TruDi® Shaver Blade is asingle-use electromagnetically-navigated instrument, which isintended to be used with theTruDi® Navigation System.The device incorporates a sensorwithin the distal shaft, which istracked by the TruDi®Navigation System. The locationof the distal tip of the device isidentified by the navigationsystem and displayed in real-timeview over the patient's pre-operative CT/MRI scan toconfirm access of target anatomy.Following confirmation, thephysician operates the instrumentat the target anatomical structure. | The technologicalcharacteristics of thesubject device aresimilar to the predicate andreference devices. |
| Attribute | Predicate Device:Medtronic NavigatedQuadcut Blades | Reference Device:Bien-Air OSSEODUO S120Shaver Handpiece | Reference Device:TruDi® Curette | Subject Device:TruDi® Shaver Blade | Substantial EquivalenceRationale |
| LocalizationTechnology | Electromagnetic | N/A | Electromagnetic | Electromagnetic | Same as predicate deviceand reference device(TruDi® Curette). |
| SystemAccuracyRequirement | 95% confidence / 99.5%reliability, as dictated by riskanalysis,of $\le$ 3.00 mm. | N/A | The accuracy of TruDi®Curette used in conjunctionwith the navigation views ofthe TruDi® NavigationSystem is $\le$ 2mm RMS overthe entire navigation volume. | The accuracy of TruDi® ShaverBlade used in conjunction withthe navigation views of theTruDi® Navigation System is$<$ 2mm RMS over the entirenavigation volume. | Same as reference device(TruDi® Curette). |
| Materials-blades | 304L stainless steel | N/A | N/A | 304L stainless steel | Same as predicate device. |
| Blade sizesand angles | 3.0 mm Straight (0)4.0 mm Straight (0)4.3 mm Straight (0) | N/A | N/A | 3.0mm Straight (0)4.0mm Straight (0)4.0mm 15° Curved4.0mm 40° Curved4.0mm 60° Curved | The subject device includesadditional blade anglescompared to the predicatedevice. However, thisdifference does not raisenew concerns of safety andeffectiveness for the subjectdevice as demonstrated byperformance testing anddesign validation testing. |
| Sterilization | Ethlyene Oxide sterilization | Steam Sterilization | Ethlyene Oxidesterilization | Ethlyene Oxide sterilization | Same as predicate deviceand reference device(TruDi® Curette). |
| Single use | Yes | No (reusable) | Yes | Yes | Same as predicate deviceand reference device(TruDi® Curette). |
| CompatibleNavigationSystem | Medtronic computer-assistedsurgery system - Fusion™ andStealthStation™ ENT system | N/A | TruDi® Navigation System | TruDi® Navigation System | The subject device andreference device (TruDi®Curette) connect to thesame navigation system. |
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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 first letter in black and the rest of the letters in black. Above the word "Acclarent" is a purple swoosh. Below the word "Acclarent" is the phrase "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" in a smaller font.
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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 letters "ent" in purple and the rest in black. Above the "ent" is a purple arc. Below the word "Acclarent" is the text "PART OF THE Johnson-Johnson FAMILY OF COMPANIES", with "Johnson-Johnson" in red.
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Image /page/9/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 first part of the word in black and the "ent" in purple. Above the word "Acclarent" is a purple swoosh design. Below the word "Acclarent" is the text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES".
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Image /page/10/Picture/0 description: The image shows the logo for Acclarent, which is part of the Johnson & Johnson family of companies. Below the logo is the text "TruDi® Shaver Blade". 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, electrical tests, connectorjoint separation force, heat shrink slip, strain relief axial force, andnavigational 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.Biocompatibility testing was successfully completed to determine thatthe TruDi® Shaver Blade is biocompatible per ISO 10993-1.Packaging shelf life for the TruDi® Shaver Blade was establishedthrough accelerated aging via ASTM F1980-16, ASTM F88-15, 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® Shaver Blade functionsin accordance with its intended use and design specifications in asimulated clinical setting. The packaging, labeling, and instructions foruse were also successfully assessed by evaluators as part of the study.The TruDi® Shaver Blade passed all intended criteria in accordancewith appropriate test criteria and standards. |
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| [807.92(b) (2)] Determination of Substantial Equivalence | |
| Clinical Performance Data | Clinical data was not necessary for the TruDi® Shaver Blade. 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® Shaver Blade is substantiallyequivalent to 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).