The HyperVue™ Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

The Starlight™ Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter.

The Starlight Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass procedure.

The NIRS capability of the HyperVue Imaging System is intended for the detection of lipid core containing plaques of interest.

The NIRS capability of the HyperVue Imaging System is intended for the assessment of coronary artery lipid core burden.

The NIRS capability of the HyperVue Imaging System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.

Device Description

The HyperVue™ Imaging System is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure by combining Optical Coherence Tomography (OCT) and Near Infrared Spectroscopy (NIRS) in a single catheter-based system.

The HyperVue™ Imaging System consists of the following components:

Console: A mobile platform containing the optical and computing engine, physician and technologist touch displays, power distribution system, and input/output interface.
Software: A proprietary application software that orchestrates the control, acquisition, processing, and display of the OCT-NIRS data.
Catheter Interface Unit (CIU): A tethered CIU that controls the motion of the fiber optic imaging core within the Catheter sheath and connects the Catheter to the Console.
Imaging Catheter: A sterile, single patient use 2.5 French dual-modality imaging catheter containing a rotating fiber optic imaging core inside a protective sterile sheath.

AI/ML Overview

The provided text is a 510(k) Summary for the HyperVue™ Imaging System, focusing on a software update. It is important to note that this document does not contain the detailed performance testing results, acceptance criteria, or the study design (e.g., sample size, ground truth establishment, expert qualifications, MRMC study details) that would prove the device meets specific acceptance criteria for clinical performance.

The document states:

"Design verification and validation (V&V) of the HyperVue™ Imaging System with the updated software were performed in compliance with external standards and internal design control procedures. V&V testing comprised of system/software verification and summative usability testing to confirm device performance."
"Software verification and validation were conducted to FDA regulations, standards, and guidance document requirements. The results of this testing conclude the software has met these requirements."
"Benchtop testing of the entire device was conducted to evaluate certain system-level features, such as measurements, that require both hardware and software to evaluate. The results of this testing conclude the system has met these requirements."
"Usability evaluation was conducted to establish that the updated software for the HyperVue™ Imaging System meets the needs of the intended users to perform OCT-NIRS imaging safely and effectively according to ANSI/AAMI/IEC 62366-1."
"No clinical testing is provided in this pre-market notification."

The FDA's 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device. For software updates like this, the focus is often on verifying that the changes do not introduce new safety or effectiveness concerns and that the device continues to perform as intended. Detailed clinical performance studies (like MRMC studies) with specific acceptance criteria are often reserved for novel devices or significant changes that introduce new claims or potential risks not addressed by the predicate.

Therefore,Based on the provided text, I cannot complete the requested information regarding specific acceptance criteria and the study that clinically proves the device meets them because the document explicitly states "No clinical testing is provided in this pre-market notification." The performance testing described is primarily focused on software verification, bench testing of system-level features, and usability, demonstrating that the software update does not adversely affect the known performance characteristics of the predicate device.

Here's what I can extract and what remains unknown based on the provided text:

Acceptance Criteria and Reported Device Performance

Since no specific clinical performance metrics or thresholds are provided in this regulatory document for the software update, a table for clinical acceptance criteria and reported device performance cannot be generated from the given text. The "acceptance" by the FDA in this context is based on demonstrating substantial equivalence and ensuring the software update does not negatively impact existing validated performance.

Study Details (as much as can be inferred from the document)

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative clinical performance metrics (e.g., sensitivity, specificity, accuracy for disease detection). The criteria are implicitly related to software verification, usability, and system-level functional performance (e.g., measurements, image display) as demonstrated by bench testing.
- Reported Device Performance:
  - "The results of this testing conclude the software has met these requirements." (Referring to FDA regulations, standards, and guidance document requirements for software V&V).
  - "The results of this testing conclude the system has met these requirements." (Referring to benchtop testing of system-level features).
  - "The updated software for the HyperVue™ Imaging System has been found to be safe and effective for the intended users, uses, and use environments." (From Usability Study).
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not specified for any performance testing.
- Data Provenance: Not specified. The testing seems to be internal verification and validation, possibly using simulated data, phantom data, or existing (de-identified) data for bench testing. The document states "No clinical testing is provided in this pre-market notification," meaning patient data for new clinical performance claims was not used for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. Given that no clinical testing was performed for this submission, there's no mention of expert-established ground truth for a clinical test set. Usability testing would involve users, but they are evaluating the software interface, not providing ground truth for diagnostic accuracy.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not specified. No clinical test set requiring ground truth adjudication is described.
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, an MRMC study was NOT done. The document explicitly states: "No clinical testing is provided in this pre-market notification." Therefore, no effect size of human reader improvement can be reported from this document.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that "software verification and validation" and "benchtop testing" evaluate the software's functional performance. However, specific standalone performance metrics (e.g., for automated detection of features) are not provided in this summary. The software "orchestrates the control, acquisition, processing, and display of the OCT-NIRS data" and provides "computer-aided measurement tools." Whether these tools have undergone standalone performance validation (and what those metrics are) is not detailed here.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not specified for clinical performance. For software verification and bench testing, ground truth would likely be established through engineering specifications, known correct behaviors, or physical measurements on phantoms, but this is not a clinical ground truth.
The sample size for the training set:
- Not applicable / Not specified. This document describes a software update and its verification, not the original development and training of a machine learning model. If any ML components were part of the predicate device, their training details are not provided here, and no new training due to this software update is indicated.
How the ground truth for the training set was established:
- Not applicable / Not specified. See point 8.

Conclusion from the document's perspective:

The submission for the HyperVue™ Imaging System (K230691) is for a software update to an existing cleared device. The manufacturer demonstrated substantial equivalence to its predicate (SpectraWAVE Imaging System and Catheter, K221257) by showing that the software modifications do not introduce new questions of safety or effectiveness. This was supported by:

Software verification and validation in compliance with IEC 62304 and FDA requirements.
Benchtop testing to confirm system-level features and measurements.
Human factors engineering (HFE) usability testing to ensure safe and effective use.

The application explicitly states that no clinical testing was provided as part of this pre-market notification, indicating that the clearance is based on the equivalence and rigorous non-clinical verification of the software update.

Summary

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June 7, 2023

SpectraWAVE, Inc. Farzad Parsaie VP, Quality Assurance & Regulatory Affairs 12 Oak Park Drive Bedford, Massachusetts 01730

Re: K230691

Trade/Device Name: HyperVue™ Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: NQQ, ORD, OGZ, IYO Dated: March 13, 2023 Received: March 13, 2023

Dear Farzad Parsaie:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Aneesh S. Deoras -S

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K230691

Device Name

HyperVue™ Imaging System

Indications for Use (Describe)

The HyperVue™ Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

The Starlight™ Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter.

The Starlight Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass procedure.

The NIRS capability of the HyperVue Imaging System is intended for the detection of lipid core containing plaques of interest.

The NIRS capability of the HyperVue Imaging System is intended for the assessment of coronary artery lipid core burden.

The NIRS capability of the HyperVue Imaging System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Traditional 510(k) Summary

1. Submitter Name & Address:

510(k) Owner:	SpectraWAVE, Inc.
Address:	12 Oak Park DriveBedford, MA 01730(781) 701-8148
Official Contact:	Farzad ParsaieVP, Quality Assurance & Regulatory Affairs(781) 701-8148fparsaie@spectrawave.com
Date Prepared:	6/5/2023

2. Device Name:

Trade Name:	HyperVue™ Imaging System
Model Number:	System: 931
Common Name:	Optical Coherence Tomography Imaging System
Classification Name:	System, Imaging, Optical Coherence TomographyDiagnostic intravascular catheter
Regulation Numbers:	21 CFR 892.1560, 21 CFR 870.1200
Product Code:	NQQ, ORD, OGZ, IYO
Classification:	Class II

3. Predicate Device:

. K221257, SpectraWAVE Imaging System and Catheter

Device Description: 4.

The HyperVue™ Imaging System consists of the following components:

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. Console: A mobile platform containing the optical and computing engine, physician and technologist touch displays, power distribution system, and input/output interface.
Software: A proprietary application software that orchestrates the control, . acquisition, processing, and display of the OCT-NIRS data.
. Catheter Interface Unit (CIU): A tethered CIU that controls the motion of the fiber optic imaging core within the Catheter sheath and connects the Catheter to the Console.
. Imaging Catheter: A sterile, single patient use 2.5 French dual-modality imaging catheter containing a rotating fiber optic imaging core inside a protective sterile sheath.

5. Indications for Use Statement:

The HyperVue™ Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

The Starlight™ Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter.

The Starlight Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass procedure.

The NIRS capability of the HyperVue Imaging System is intended for the detection of lipid core containing plaques of interest.

The NIRS capability of the HyperVue Imaging System is intended for the assessment of coronary artery lipid core burden.

The NIRS capability of the HyperVue Imaging System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.

6. Technological Characteristics:

Three of the four system components in the HyperVue™ Imaging System - Console, CIU and Imaging Catheter - are the same as the predicate device. The subject of this application is for the Software module which contains updates with similar technological characteristics and substantially equivalent performance to the cited predicate. Table 1 below provides a comparative summary (predicate vs proposed device) for the relevant system characteristics/features.

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Predicate Device Comparison
Manufacturer& Model	PREDICATE DEVICESpectraWAVE, Inc.SpectraWAVE Imaging System (K221257)	PROPOSED DEVICESpectraWAVE, Inc.HyperVue™ Imaging System	Discussion ofEquivalence &Differences
Product Code	NQQ - System, imaging, optical coherencetomographyORD - Optical Coherence Tomography,Intravascular CatheterOGZ - Catheter, Intravascular, PlaqueMorphology EvaluationIYO - System, Imaging, Pulsed Echo,Ultrasonic	NQQ - System, imaging, optical coherencetomographyORD - Optical Coherence Tomography,Intravascular CatheterOGZ - Catheter, Intravascular, PlaqueMorphology EvaluationIYO - System, Imaging, Pulsed Echo,Ultrasonic	Same
Intended Use	The SpectraWAVE Imaging System and theSpectraWAVE Imaging Catheter are intendedfor the imaging of coronary arteries.	The HyperVue™ Imaging System and theStarlight™ Imaging Catheter are intended forthe imaging of coronary arteries.	SameAdded tradenamesonly
IntendedUsers	Physicians and healthcare professionals	Physicians and healthcare professionals	Same
OperationalEnvironment	Cardiac catheterization laboratory	Cardiac catheterization laboratory	Same
IndicationsFor Use	The SpectraWAVE Imaging System is intendedfor the imaging of coronary arteries and isindicated in patients who are candidates fortransluminal interventional procedures.The SpectraWAVE Imaging Catheter isintended for use in vessels 2.0 to 5.2 mm indiameter.The SpectraWAVE Imaging Catheter is notintended for use in a target vessel which hasundergone a previous bypass procedure.	The HyperVue™ Imaging System is intendedfor the imaging of coronary arteries and isindicated in patients who are candidates fortransluminal interventional procedures.The Starlight™ Imaging Catheter is intendedfor use in vessels 2.0 to 5.2 mm in diameter.The Starlight Imaging Catheter is not intendedfor use in a target vessel which has undergonea previous bypass procedure.The NIRS capability of the HyperVue ImagingSystem is intended for the detection of lipidcore containing plaques of interest.	SameAdded tradenamesonly
Predicate Device Comparison
Manufacturer& Model	PREDICATE DEVICESpectraWAVE, Inc.SpectraWAVE Imaging System (K221257)	PROPOSED DEVICESpectraWAVE, Inc.HyperVue™ Imaging System	Discussion ofEquivalence &Differences
	The NIRS capability of the SpectraWAVEImaging System is intended for the detection oflipid core containing plaques of interest.The NIRS capability of the SpectraWAVEImaging System is intended for theassessment of coronary artery lipid coreburden.The NIRS capability of the SpectraWAVEImaging System is intended for theidentification of patients and plaques atincreased risk of major adverse cardiac events.	The NIRS capability of the HyperVue ImagingSystem is intended for the assessment ofcoronary artery lipid core burden.The NIRS capability of the HyperVue ImagingSystem is intended for the identification ofpatients and plaques at increased risk of majoradverse cardiac events.
PrimaryFunctions	Delivers energy (infrared light) to the tissue.Measures the depth and pattern of reflectionsfrom the tissue from the return near-infraredlight to create high-resolution, real-timeimages.Stores images for evaluation and review.	Delivers energy (infrared light) to the tissue.Measures the depth and pattern of reflectionsfrom the tissue from the return near-infraredlight to create high-resolution, real-timeimages.Stores images for evaluation and review.	Same
ImageCreation.Display andStorage	Process reflected optical signals to constructimages.Display images.Store images.	Process reflected optical signals to constructimages.Display images.Store images.	Same
MeasureVessel CrossSectional Area	Calculate and report vessel cross-sectionalarea	Calculate and report vessel cross-sectionalarea	Same
MeasureVessel LinearDimensions	Calculate and display vessel diameter at userspecified locations within the displayed image	Calculate and display vessel diameter at userspecified locations within the displayed image	Same
Predicate Device Comparison
Manufacturer& Model	PREDICATE DEVICESpectraWAVE, Inc.SpectraWAVE Imaging System (K221257)	PROPOSED DEVICESpectraWAVE, Inc.HyperVue™ Imaging System	Discussion ofEquivalence &Differences
CalculateVesselPhysicalParameters	Calculate and display mathematicalcomparisons of image data such as %reduction from average, length of narrowing.	Calculate and display mathematicalcomparisons of image data such as %reduction from average, length of narrowing.	Same
ProceduralSteps	System set-up, patient data entry, catheterpreparation insertion of catheter into the arteryunder fluoroscopic guidance, properpositioning of the catheter distal to the targetvessel, image acquisition, and evaluation of theacquired images.	System set-up, patient data entry, catheterpreparation insertion of catheter into the arteryunder fluoroscopic guidance, properpositioning of the catheter distal to the targetvessel, image acquisition, and evaluation of theacquired images.	Same
Use of Results	Physicians evaluate the images in combinationwith other tests and evaluations to assess thepatient's coronary arteries.	Physicians evaluate the images in combinationwith other tests and evaluations to assess thepatient's coronary arteries.	Same
OperatingSystem (OS)	Windows-based (Windows ProfessionalDesktop)	Windows-based (Windows Enterprise IoT)Windows Enterprise IoT OS providesconfigurability for deploying a single-purpose dedicated system.	SubstantiallyequivalentThere is nodifference in thefundamentalperformance andintended use of thesoftware due tochange to OS
UserConvenienceFeatures	Computer-aided measurement tools, such asborder contours, computation of cross-sectional area, and percent stenosis.Display of live angiography imagery on theSpectraWAVE Imaging System displaymonitors.	Computer-aided measurement tools, such asborder contours, computation of cross-sectional area, and percent stenosis.Display of live angiography imagery on theHyperVue™ Imaging System display monitors.	SubstantiallyequivalentThe additionalfeatures are minorchanges comparedto the predicate andwere added to the
Predicate Device Comparison
Manufacturer& Model	PREDICATE DEVICE	PROPOSED DEVICE	Discussion ofEquivalence &Differences
	SpectraWAVE, Inc.SpectraWAVE Imaging System (K221257)	SpectraWAVE, Inc.HyperVue™ Imaging System	proposed device toprovide user-selectable andoptional userconveniencefeatures.No changes weremade to theintended use orindications of use ofthe device.
		The following updates have been addedcompared to the predicate device:• Addition of new user-selectable andoptional image overlays on the displayedviewports (Angiography & OCT-NIRS) tohighlight OCT/NIRS-derived features.• Update to User Interface (UI) look-and-feeland clinical workflow

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7. Performance Testing:

7.1 Summary of Performance Testing:

Design verification and validation (V&V) of the HyperVue™ Imaging System with the updated software were performed in compliance with external standards and internal design control procedures. V&V testing comprised of system/software verification and summative usability testing to confirm device performance.

7.2 Sterilization and Shelf Life:

No change from K221257. Sterilization and shelf life are not impacted since this 510(k) submission covers only a software update for the HyperVue™ Imaging System.

7.3 Biocompatibility:

No change from K221257. Biocompatibility is not impacted since this 510(k) submission covers only a software update for the HyperVue™ Imaging System.

7.4 Software:

HyperVue™ Imaging System and Application Software were developed and tested in compliance with IEC 62304. Software verification and validation were conducted to FDA requlations, standards, and quidance document requirements. The results of this testing conclude the software has met these requirements.

7.5 EMC/Basic Electrical Safety:

No change from K221257. This 510(k) submission covers only a software update package for the HyperVue™ Imaging System. EMC & Basic Electrical Safety are not impacted by this software update.

7.6 Bench testing:

In addition to the software verification testing described above, benchtop testing of the entire device was conducted to evaluate certain system-level features, such as measurements, that require both hardware and software to evaluate. The results of this testing conclude the system has met these requirements.

7.7 Animal Testing:

Not applicable. No animal testing was necessary to demonstrate equivalence.

7.8 Human Factors Engineering (HFE) Usability Study:

Usability evaluation was conducted to establish that the updated software for the HyperVue™ Imaging System meets the needs of the intended users to perform OCT-NIRS imaging safely and effectively according to ANSI/AAMI/IEC 62366-1.

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The updated software for the HyperVue™ Imaging System has been found to be safe and effective for the intended users, uses, and use environments.

7.9 Clinical Testing:

No clinical testing is provided in this pre-market notification.

8. Conclusion and Statement of Equivalence:

Modifications to the software of the device presented in this 510(k) submission do not raise new questions of safety or effectiveness. As demonstrated by risk management activities, software verification, and HFE usability study testing, the proposed HyperVue™ Imaging System does not raise new questions of safety or effectiveness and is therefore considered substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.