(60 days)
The TruDi™ NAV Wire is intended for use as an electromagnetically navigable guidewire to provide access and confirmation of placement in the patient anatomy. The device is intended for use during ENT procedures where reference to a rigid anatomical structure can be identified relative to a CT-based model of the anatomy.
The subject device, TruDi™ NAV Wire, is a single-use electromagnetically (EM) navigated, flexible guidewire, which is compatible for use with the TruDi™ Navigation System to provide access and confirmation of placement in patient anatomy during intranasal and paranasal surgeries. The TruDi™ NAV Wire is intended to provide real-time tracking at the distal tip of the guidewire in the nasal anatomy and is intended to be used during ENT procedures where reference to a rigid anatomical structure can be identified relative to a CT-based model of the anatomy. The subject device, TruDi™ NAV Wire, may be used with compatible non-ferromagnetic instruments that have a lumen of greater than 1mm in diameter and a luer lock mechanism to fix the wire onto the instrument.
The provided text describes the "TruDi™ NAV Wire," an electromagnetically navigable guidewire. Here's a breakdown of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of acceptance criteria with numerical targets and the device's reported performance against those targets in a readily digestible format for certain tests. Instead, it states that "Bench testing has been performed and met all acceptance criteria for attributes..." and then lists the attributes. For sterility, it mentions a specific level.
Here's a table based on the provided text, outlining the tests performed and the general statement of performance:
| Test/Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated Use Testing | Met acceptance criteria | "met all acceptance criteria" |
| Dimensional Specs | Met acceptance criteria | "met all acceptance criteria" |
| Insertion Durability | Met acceptance criteria | "met all acceptance criteria" |
| Rotational Durability | Met acceptance criteria | "met all acceptance criteria" |
| Suction Durability | Met acceptance criteria | "met all acceptance criteria" |
| Joint Separation Force | Met acceptance criteria | "met all acceptance criteria" |
| Stiffness | Met acceptance criteria | "met all acceptance criteria" |
| Swivel Functional Perf. | Met acceptance criteria | "met all acceptance criteria" |
| Frictional Force | Met acceptance criteria | "met all acceptance criteria" |
| Location Accuracy (Sensor Sensitivity) | Met acceptance criteria | "met all acceptance criteria" |
| Sterilization | Sterility Assurance Level (SAL) of 10^-6 (per ISO 11135:2014) | "demonstrated a sterility assurance level of 10-6" |
| Ethylene Oxide Residuals | Meet ISO 10993-7:2008 requirements | "meet ISO 10993-7:2008 requirements" |
| Biocompatibility | Biocompatible per ISO 10993-1 | "successfully completed to determine...is biocompatible" |
| Packaging Shelf Life | Meet ASTM F1980-07, ASTM F88/F88M-09, and ASTM F2096-11 requirements for 3 months | "confirmed to meet a shelf life of three months" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set for any of the bench tests (simulated use, durability, etc.).
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin. Since these are bench tests, they are typically conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the studies described are bench tests on the device's physical and functional properties, not clinical studies requiring expert ground truth for interpretation of outcomes.
4. Adjudication Method for the Test Set
This information is not applicable as the studies described are bench tests and do not involve human interpretation or adjudication in the way clinical studies with ground truth establishment would. The tests would likely have pre-defined pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not necessary for the TruDi™ NAV Wire." The studies described are non-clinical bench tests.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not directly applicable as the TruDi™ NAV Wire is a physical medical device, not an algorithm, and its performance relies on interaction with a navigation system. The "Location Accuracy (Sensor Sensitivity)" test implicitly assesses the standalone performance of the guidewire's electromagnetic tracking capability, but it's not an algorithm in the typical sense of AI.
7. The Type of Ground Truth Used
For the bench tests, the "ground truth" would be established by engineering specifications, industry standards (e.g., ISO, ASTM), and design requirements. For example, a specified durability threshold or a precise dimensional measurement.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical guidewire and the studies described are bench tests, not machine learning studies that require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for a machine learning model.
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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 is in blue and includes the agency's name, "U.S. Food & Drug Administration."
May 3, 2019
Acclarent, Inc. Leena Sorathia Sr. Regulatory Affairs Specialist 33 Technology Drive Irvine, California 92618
Re: K190532
Trade/Device Name: TruDi NAV Wire Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: PGW Dated: March 1, 2019 Received: March 4, 2019
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Michael 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name TruDi™ NAV Wire
Indications for Use (Describe)
TruDi™ NAV Wire is intended for use as an electromagnetically navigable guidewire to provide access and confirmation of placement in the patient anatomy. The device is intended for use during ENT procedures where reference to a rigid anatomical structure can be identified relative to a CT-based model of the anatomy.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (7/17)
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Image /page/3/Picture/1 description: The image contains the Acclarent logo, which is a medical technology company. Below the logo is the text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES". The image also contains the text "TruDi™ NAV Wire", which is likely a product name.
510(K) SUMMARY
[807.92(a)(1)] Submitter Information
| Sponsor/Submitter: | Acclarent, Inc.33 Technology DriveIrvine, CA 92618 |
|---|---|
| Contact Person: | Leena SorathiaSr. Regulatory Affairs SpecialistEmail: lsorathi@its.jnj.comTel: 949-923-4118 |
Date Summary Prepared: May 3, 2019
[807.92(a)(2)] Name of Device
| Device TradeName: | TruDi™ NAV Wire | ||
|---|---|---|---|
| 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: | Acclarent® NavWire Sinus Navigation Guidewire, (K161697) | ||
| Reference Device: | Relieva SpinPlus® Nav Balloon Sinuplasty System, (K171687) | ||
| [807.92(a)(4)] Device Description | |||
| Device Description: | The subject device, TruDi™ NAV Wire, is a single-use electromagnetically(EM) navigated, flexible guidewire, which is compatible for use with theTruDi™ Navigation System to provide access and confirmation of placement inpatient anatomy during intranasal and paranasal surgeries. The TruDi™ NAV |
Wire is intended to provide real-time tracking at the distal tip of the guidewire in the nasal anatomy and is intended to be used during ENT procedures where reference to a rigid anatomical structure can be identified relative to a CT-based model of the anatomy. The subject device, TruDi™ NAV Wire, may be used with compatible non-ferromagnetic instruments that have a lumen of greater than 1mm in diameter and a luer lock mechanism to fix the wire onto the instrument.
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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 is the text "TruDi™ NAV Wire". The Acclarent logo is in black and purple.
The subject device, TruDi™ NAV Wire, is a modification to the predicate device, Acclarent® NavWire Sinus Navigation Guidewire (K161697), and is similar to the guidewire construction of the reference device, Relieva SpinPlus® Nav Balloon Sinuplasty System (K171687). The TruDi™ NAV Wire, like the predicate Acclarent® NavWire Sinus Navigation Guidewire and reference Relieva SpinPlus® Nav Balloon Sinuplasty System consists of a 0.035" EM navigable guidewire with an EM trackable sensor incorporated at the distal tip to provide access to a rigid anatomical structure that can be identified relative to a CT-based model of the anatomy, and confirm placement in the accessed anatomy when used with the TruDi™ Navigation System. The same EM trackable sensor used in the subject TruDi™ NAV Wire device was cleared in the predicate Acclarent® NavWire Sinus Navigation Guidewire (K161697) and reference Relieva SpinPlus® Nav Balloon Sinuplasty System (K171687).
[807.92(a)(5)] Intended Use
| Indications forUse: | The TruDi™ NAV Wire is intended for use as an electromagnetically navigableguidewire to provide access and confirmation of placement in the patientanatomy. The device is intended for use during ENT procedures where referenceto a rigid anatomical structure can be identified relative to a CT-based model ofthe anatomy. |
|---|---|
| Difference inIndications fromPredicate Device | The indications for use statement of the subject TruDi™ NAV Wire device issimilar to the predicate NavWire device (K161697). The subject and predicatedevices are both indicated for use in ENT procedures where image-guidedsurgery is used to provide access to the patient anatomy and to confirm placementof the device in the accessed anatomy. |
| The subject device is compatible with non-ferromagnetic instruments that have alumen of greater than 1mm in diameter and a luer lock mechanism to fix the wireonto the instrument. Whereas, the predicate device is compatible with theRELIEVA ULTIRRA Nav™ Sinus Balloon Catheter (K161698). | |
| The changes in indications for use of the subject device do not raise anysignificant issues of safety and effectiveness when used as labeled, asdemonstrated by performance testing. | |
| The difference in indications for use between the subject device and thepredicate/reference devices is supported is presented in Table 1 of this summary. |
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Image /page/5/Picture/1 description: The image contains the logo for Acclarent, which is part of the Johnson & Johnson family of companies. Below the logo, the text "TruDi™ NAV Wire" is displayed in a bold font. The Acclarent logo features the company name in a combination of black and purple, with a stylized swoosh above the "ent" portion of the name.
[807.92(a)(6)] Technical Characteristics
| TechnologicalCharacteristics: | The subject TruDi™ NAV Wire device is a modification to the predicateNavWire device (K161697) and is similar to the guidewire construction of thereference SpinPlus Nav device (K171687). | |
|---|---|---|
| The subject TruDi™ NAV Wire device, like the predicate NavWire device andreference SpinPlus Nav device, consists of a 0.035" EM navigable guidewirewith an EM trackable sensor incorporated at the distal tip to provideconfirmation in the accessed anatomy when used with the TruDi™ NavigationSystem. The same EM trackable sensor used in the TruDi™ NAV Wire devicewas cleared in the predicate NavWire device (K161697) and reference SpinPlusNav device (K171687). | ||
| Similar to the reference SpinPlus Nav device, the subject TruDi™ NAV Wiredevice consists of a fixed proximal connector, a flexible spiral coil instrumentbody, and a pre-shaped atraumatic distal tip housing a sensor. Like the referenceSpinPlus Nav device, the subject device incorporates a feature, which allowsrotation of the distal tip of guidewire for steering functionality. | ||
| The TruDi™ NAV Wire, like the predicate NavWire device and referenceSpinPlus Nav device, connects with the TruDi™ Navigation System to track theEM navigable guidewire within an electromagnetic field, which displays themagnetic sensor position relative to a patient's pre-operative CT scan. | ||
| The only difference in technological characteristics between the subject TruDi™NAV Wire device and reference SpinPlus Nav device is how the rotation of thedistal region of the device is achieved. This feature is similar in the subjectdevice and reference device and do not raise any significant issues of safety andeffectiveness when used as labeled, as demonstrated by performance testing. | ||
| See Table 1 for a comparison of the technological characteristics between thesubject 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, 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, the text 'TruDi™ NAV Wire' is displayed in a bold font.
| Attribute | Primary Predicate Device(Acclarent® NavWire) | Reference Device(Relieva SpinPlus Nav™ BalloonSinuplasty System) | Subject Device(TruDi™ NAV Wire) |
|---|---|---|---|
| Manufacturer | Acclarent, Inc. | Acclarent, Inc. | Acclarent, Inc |
| 510(k) Number | K161697 | K171687 | K190532 |
| Proprietary TradeName | Acclarent® NavWire Sinus NavigationGuidewire | Relieva SpinPlus Nav™ Balloon SinuplastySystem | TruDi™ NAV Wire |
| Common Name | Stereotaxic Instrument | Sinus Dilation System | Stereotaxic Instrument |
| Class | Class II | Class I | Class II |
| Product Code | PGW | LRC | PGW |
| Classification Section | 21 CFR 882.4560 | 21 CFR 874.4420 | 21 CFR 882.4560 |
| Indications for Use | The NavWire is intended for use as anavigable guidewire to provide accessto nasal and sinus spaces, andconfirmation of placement in theaccessed anatomy. The NavWire isdesigned for use during procedureswhere reference to a rigid anatomicalstructure in the field of ENT surgery,such as the paranasal sinuses, can beidentified relative to a CT-based modelof the anatomy. | The RELIEVA SPINPLUS™ Nav BalloonSinuplasty System is intended to provide ameans to access the sinus space, within andacross nasal and sinus structures; dilate thesinus ostia and spaces associated with theparanasal sinus cavities for diagnostic andtherapeutic procedures; and irrigate fromwithin a target sinus for therapeuticprocedures and to facilitate diagnosticprocedures.For children aged 17 and under, theRELIEVA SPINPLUS™ Nav BalloonSinuplasty System is intended to provide ameans to access the sinus space, within andacross nasal and sinus structures; dilate sinusostia and spaces associated with themaxillary sinus for diagnostic andtherapeutic procedures; and irrigate fromwithin the maxillary sinus for therapeuticprocedures and to facilitate diagnosticprocedures. | The TruDi™ NAV Wire is intended foruse as an electromagneticallynavigable guidewire to provide accessand confirmation of placement in thepatient anatomy. The device isintended for use during ENTprocedures where reference to a rigidanatomical structure can be identifiedrelative to a CT-based model of theanatomy. |
| Attribute | Primary Predicate Device(Acclarent® NavWire) | Reference Device(Relieva SpinPlus Nav™ BalloonSinuplasty System) | Subject Device(TruDi™ NAV Wire) |
| The RELIEVA SPINPLUS™ Nav BalloonSinuplasty System may be utilized inconjunction with the ACCLARENT® ENTNavigation System, to provide access tonasal and sinus spaces, and to confirmplacement in the accessed anatomy. | |||
| Single-Use | Yes | Yes | Yes |
| Sterile | EtO Sterile | EtO Sterile | EtO Sterile |
| Direct Patient Contact | YesLimited Duration < 24 hours | YesLimited Duration < 24 hours | YesLimited Duration < 24 hours |
| Labeled as Non-pyrogenic? | No | No | No |
| Guidewire Diameter | 0.035 inches | 0.035 inches | 0.035 inches |
| Tracking Method | Electromagneticwith Magnetic Sensorat Distal Wire Tip | Electromagneticwith Magnetic Sensorat Distal Wire Tip | Electromagneticwith Magnetic Sensorat Distal Wire Tip |
| Flexible | Yes- flexible guidewire | Yes- flexible sinus balloon catheter andguidewire | Yes- flexible guidewire |
| Principle of Operation | The Acclarent® NavWire SinusNavigation Guidewire utilizeselectromagnetic image-guided sinussurgery and is used in conjunction witha compatible surgical navigationsystem which consists of computer-aided software, CT-imaging, patienttracker, registration probe, and variousinstruments used in sinus surgery.Acclarent® NavWire Sinus NavigationGuidewire provides real-time tracking | Combines a Sinus Guide Catheter andHandle Assembly (integrated with SinusBalloon Catheter, Sinus Irrigation and SinusNavigation System) into a single device.The device is connected to the TruDi™Navigation System to provide locationinformation via EM navigation relative to apre-loaded scan. | The TruDi™ NAV Wire utilizeselectromagnetic image-guided ENTsurgery and is used in conjunction witha compatible surgical navigationsystem which consists of computer-aided software, CT-imaging, patienttracker, registration probe, and variousinstruments used in sinus surgery.TruDi™ NAV Wire provides real-timetracking at the distal tip of theguidewire in the nasal anatomy. |
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Image /page/7/Picture/0 description: The image contains the logo for Acclarent, a company that is part of the Johnson & Johnson family of companies. Below the logo, the text "TruDi™ NAV Wire" is displayed in a bold font. The logo features the company name in a stylized font, with a purple arc above it.
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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 a bold, sans-serif font, with the "ent" portion of the name in purple and slightly curved upwards. Below the name, in smaller text, it says "PART OF THE Johnson & Johnson FAMILY OF COMPANIES". The logo is simple and modern, reflecting the company's focus on innovation in the medical field.
| Attribute | Primary Predicate Device(Acclarent® NavWire) | Reference Device(Relieva SpinPlus Nav™ BalloonSinuplasty System) | Subject Device(TruDi™ NAV Wire) |
|---|---|---|---|
| at the distal tip of the guidewire in thenasal anatomy. | |||
| Compatible devices | TruDi™ Navigation System andUltirraNav™ Sinus Balloon Catheter | TruDi™ Navigation System | TruDi™ Navigation System and non-ferromagnetic instruments that have alumen of greater than 1mm in diameterand a luer lock mechanism to fix thewire onto the instrument. |
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Image /page/9/Picture/0 description: The image shows the Acclarent logo, which includes the company name in a stylized font with a purple arc above it. Below the logo, it states "PART OF THE Johnson & Johnson FAMILY OF COMPANIES". The text "Traditional 510(k)" and "TruDi™ NAV Wire" are also present, indicating the document relates to a medical device submission.
[807.92(b) (1)] Determination of Substantial Equivalence
| Non-Clinical PerformanceData: | Bench testing has been performed and met all acceptance criteria forattributes, such as simulated use testing, dimensional specifications,insertion durability, rotational durability, suction durability, jointseparation force, stiffness, swivel functional performance, frictionalforce, and location accuracy (sensor sensitivity).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™ NAV Wire is biocompatible per ISO 10993-1.Packaging shelf life for the TruDi™ NAV Wire 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.The TruDi™ NAV Wire 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™ NAV Wire. 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™ NAV Wire is as safe andeffective and substantially equivalent 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).