The Omega Medical Imaging, LLC Nyquist.IQ Image Processor is intended for use in Radiographic/fluoroscopic applications including cardiac, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging. The Nyquist.IQ is intended solely to be integrated only with Omega Medical Imaging CS-series-FP Systems.

Device Description

Nyquist.IQ is a dynamic digital image processing system. The system application is based on a PC Windows operating system functioning on a PC based CPU. The object-oriented software performs real-time image processing and full procedure storage. The DICOM compliant connectivity provides the tools to transmit patient demographics, examination, and image data digitally.

Nyquist.IQ is not a standalone device, but functions as a component for FDA cleared Omega CS-series-FP platform. Nyquist IQ is an image processor that interfaces, with to acquire and digitize x-ray exposure from the Omega medical CS-series-FP.

The Nyquist.IQ operates in connection with the Varex's 3030 or the Teledyne 3030 flat panel detectors. This is demonstrated in the substantial equivalence section of the Nyquist.IQ is intended for the Omega CS-series-FP with Optional Accessory Device CA-100S / FluoroShield platform.

The Nyquist.IQ is intended solely to be integrated only with Omega Medical Imaging CS-series-FP systems.

The Nyquist.IQ image processor. The fundamental performance characteristics of the Nyquist.IQ interventional fluoroscopic imaging Processor system consists of:

) Real-time image visualization of patient anatomy during procedures
Imaging techniques and tools to assist interventional procedures.
2 Post-processing functions after interventional procedures.
2 Storage of reference/control images for patient records.
Σ Compatibility to images of other modalities via DICOM
2 Compatibility with the already FDA cleared CA-100S / FluoroShield AI Exposure Reduction Technology. (K182834)

This array of functions provides the physician the imaging information required to achieve minimally invasive interventional procedures.

The Nyquist.IQ image processor is available as a Model IPS-100 configuration and is similar to the currently marketed and predicate image processor MX-200 in CS-series-FP with optional CA-100S / FluoroShield Device.

AI/ML Overview

This document is an FDA 510(k) clearance letter for the Omega Medical Imaging, LLC Nyquist.IQ Image Processor. It is a declaration of substantial equivalence to a predicate device, not a detailed study report with acceptance criteria and performance metrics for an AI/ML-driven device.

Therefore, this document does not contain the specific information required to answer your request regarding acceptance criteria and a study proving a device meets those criteria for an AI/ML product.

The information provided in the input primarily focuses on regulatory classification, indications for use, technological characteristics, and a comparison to predicate devices for a traditional medical imaging processor. It explicitly states:

"The Nyquist.IQ did not require clinical study data since substantial equivalence to the currently marketed predicate device Omega CS-series-FP with Optional Accessory Device CA-100S / FluoroShield was demonstrated with the following attributes:
- ∑ Indication for use.
- A Technological characteristics.
- ) Non-clinical performance testing; and
- ∑ Safety and effectiveness." (Page 6)
It also mentions a "FluoroShield AI Exposure Reduction Technology" associated with a predicate device (K182834), but it does not describe a performance study for the Nyquist.IQ as an AI/ML device itself. The Nyquist.IQ appears to be an image processor that interfaces with this existing technology, rather than being the AI/ML device itself.

To answer your specific questions, I would need a document that details a performance study, including acceptance criteria, for a software component with AI/ML functionality. This document does not provide such details.

Summary

{0}------------------------------------------------

December 13, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Omega Medical Imaging, LLC % Mr. John Newman Regulatory Specialist 3400 St. Johns Parkway, Suite 1020 SANFORD FL 32771

Re: K212890

Trade/Device Name: Nyquist.IO Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified Fluoroscopic X-ray System Regulatory Class: Class II Product Code: JAA, MQB Dated: November 10, 2021 Received: November 12, 2021

Dear John Newman:

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

{1}------------------------------------------------

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,

Digitally signed by
Laurel M. Burk -S
Date: 2021.12.13
13:53:02 -05'00'

. for

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K212890

Device Name Nyquist.IQ

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image contains the logo for Omega Medical Imaging. The logo consists of a stylized blue "O" shape on the left, followed by the word "OMEGA" in blue, block letters. Below the word "OMEGA" is the phrase "Medical Imaging" in a smaller, lighter font, also in blue. The overall design is clean and professional, suggesting a company in the healthcare or medical technology sector.

	Traditional 510(k) SUMMARY K212890
Company Name:	Omega Medical Imaging, LLC
Address:	3400 St. Johns Parkway, Suite 1020, Sanford, FI 32771
Telephone No:	407-323-9400
Registration No:	1052701
Contact person:	John Newman (Regulatory Affairs Specialist)
Date Prepared:	09/02/2021
Device (trade) name:	Nyquist.IQ
Common/usual name:	Image Processor
Classification Name:	Image Processor
Classification Panel:	Radiology
CFR section:	892.1650
Device Class:	Class II
Primary Product code:	JAA
Secondary product code:	MQB
	Predicate Device K182834
Company Name:	Omega Medical Imaging, LLC
Address:	3400 St. Johns Parkway, Suite 1020
Telephone No:	407-323-9400
Registration No:	1052701
Contact person:	John Newman
Date Prepared:	03/29/2019
Device (trade) name:	CS-series-FP with Optional Accessory Device CA-100S (FluoroShield
Common/usual name:	Fluoroscopic/Radiographic X-ray system
Classification Name:	System, X-Ray, Fluoroscopic, Image -Intensified
Classification Panel:	Radiology
CFR section:	892.1650
Device Class:	Class II
Primary Product code:	JAA
Secondary Product code:	OWB
Company Name:	Omega Medical Imaging, LLC
Address:	675 Hickman Circle, Sanford, FI 32771
Telephone No:	407-323-9400
Registration No:	1052701
Contact person:	John Newman
Date Prepared:	04/20/2012
Device (trade) name:	CS-series-FP with 3030+ Option
Common/usual name:	Fluoroscopic/Radiographic X-ray system
Classification Name:	System, X-Ray, Fluoroscopic, Image -Intensified
Classification Panel:	Radiology
CFR section:	892.1650
Device Class:	Class II
Primary Product codes:	JAA
Secondary Product code:	OWB

K212890

{4}------------------------------------------------

Reference Predicate Device K121293

Indication of use:

The Omega Medical Imaging, LLC IPS-100, Nyquist.IQ Image Processor is intended for use in Radiographic/fluoroscopic applications including cardiac, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging

The Nyquist.IQ is intended solely to be integrated only with Omega Medical Imaging CS-series-FP systems.

Device description:

{5}------------------------------------------------

The Nyquist.IQ is intended solely to be integrated only with Omega Medical Imaging CS-series-FP systems.

The Nyquist.IQ image processor. The fundamental performance characteristics of the Nyquist.IQ interventional fluoroscopic imaging Processor system consists of:

) Real-time image visualization of patient anatomy during procedures
Imaging techniques and tools to assist interventional procedures.
2 Post-processing functions after interventional procedures.
2 Storage of reference/control images for patient records.
Σ Compatibility to images of other modalities via DICOM
2 Compatibility with the already FDA cleared CA-100S / FluoroShield AI Exposure Reduction Technology. (K182834)

This array of functions provides the physician the imaging information required to achieve minimally invasive interventional procedures.

Patient Population:

General Population, special concerns must be taken for pediatric use.

Based on the information provided above, the Nyquist.IQ system is considered substantially equivalent to the current marketed predicate device CS- series-FP with optional CA-100S / FluoroShield Device. Both share the same Indications for use.

Technological characteristics

The Nyquist.IQ system has similar technological characteristics compared to the predicate device with some improvements to it. Below are the key improvements between the new Nyquist.IQ image processor and the predicate device.

2 Integration of a New Flat Panel Detector (Teledyne Xineos 3030HS CMOS x-ray detector) with the already FDA cleared FluoroShield AI Exposure Reduction Technology.
The difference between the Nyquist.IQ system and the predicate device does not raise any new question regarding safety or effectiveness. Based on the information provided in this 510K submission, Nyquist.IQ is considered substantially equivalent to the current marketed predicate CS-series-FP with optional CA-100S / FluoroShield Device in terms of fundamental technology

{6}------------------------------------------------

Summary of Non- Clinical Performance

Non-clinical performance testing has been performed on the Nyquist.IQ Image processor and demonstrated compliance with the following International and FDA approved consensus standard and FDA guidance documents:

1. IEC 62304 Medical device software Software life cycle processes (Edition 1.1, 2015-06). FDA/CDRH recognition number 13-79.
1. ISO 14971 Medical devices Application of risk management to medical devices (Edition 2.0, 2007-03-01). FDA/CDRH recognition number 5-40.
1. Guidance for Industry and FDA Staff Guidance for the Content of premarket Submissions for Software Contained in Medical Devices, May 11, 2005 (document number 337).
1. "Guidance for Industry and FDA Staff The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]", July 28, 2014 (document number 1766).

Software verification testing of the functional and non-functional requirements, as well as performance, reliability, and safety, have been performed to verify that all conditions of System requirements Specifications, as well as the safety risk control measures from the detailed Risk management and the privacy and security requirements, have been implemented. Results demonstrated that executed verification test was passed.

Non- clinical validation testing has been performed to validate that the Nyquist.IQ Image Processor conforms to the intended use, claims, user, and service needs, effectively satisfying measures and instruction for use.

The Nyquist.IQ did not require clinical study data since substantial equivalence to the currently marketed predicate device Omega CS-series-FP with Optional Accessory Device CA-100S / FluoroShield was demonstrated with the following attributes:

Σ Indication for use.
A Technological characteristics.
) Non-clinical performance testing; and
∑ Safety and effectiveness.

Substantial equivalence Conclusion:

The Nyquist.IQ system is substantially equivalent to the currently marketed predicate device CS- series- with the Optional Accessory Device CA-100S / FluoroShield in terms of indications for use, technological characteristics, safety and effectiveness.

The Nyquist.IQ Image Processor is within the controls and predetermined specifications. Additionally, substantial equivalence was demonstrated by non-clinical performance tests provided in these 510(k) premarket notifications. These tests demonstrate that the Nyquist.IQ system complies with the user need requirements and the requirements specified in the FDA-recognized consensus standards and guidance documents.

Therefore, Nyquist.IQ is as safe and effective as its predicate device and does not raise any new safety and/or effectiveness concerns.

{7}------------------------------------------------

Comparison with Predicate Devices:

Indications for use comparison:
510(k)Number andDeviceName	K121293 (Ref. PredicateDevice)	K182834 (Predicate Device)	(This Submission)
	CS-series-FP with 3030+option	CS-series-FP with OptionalAccessory Device CA-100S /FluoroShield	Nyquist.IQ
IntendedUse	The Omega MedicalImaging, LLC CS-series-FPwith 3030+ Option systemsare intended for use inradiographic/fluoroscopicapplications includingcardiac, vascular, generalradiographic/fluoroscopicdiagnostic, andinterventional X-Rayimaging.	The Omega Medical Imaging,LLC CS-series-FP (SSXI)systems with optional accessorydevice CA-100S as amodification device to provide anautomated Region of interest thatmanages exposure to the patientand operator. The system isintended for use inRadiographic/fluoroscopicapplications including cardiac,vascular, general radiographic/fluoroscopic diagnostic, andinterventional x-ray imaging forGeneral Populations. At no timewill the CA-100S be consideredas a replacement for the primarycollimator. The primary collimatorshall always be used, inaccordance with good medicalpractice, to define a Region ofInterest	The Omega Medical Imaging,LLC IPS-100, Nyquist.IQ ImageProcessor is intended for use inRadiographic/fluoroscopicapplications including cardiac,vascular, generalradiographic/fluoroscopicdiagnostic, and interventional X-Ray imaging.(The Nyquist.IQ is intendedsolely to be integrated only withOmega Medical Imaging CS-series-FP systems.)
ClassificationName:	Image-intensifiedFluoroscopic X-ray system	Image-intensified FluoroscopicX-ray system	Image-intensified FluoroscopicX-ray system
CFRRegulation #:	892.1650	892.1650	892.1650
Device Class	Class II	Class II	Class II
ClassificationProduct Code:	JAA, OWB	JAA, OWB	JAA, MQB

PRODUCT OVERVIEW

Substantial Equivalence:

Detailed in the Bench testing section of this submission.

Safety information:

∑ The Omega Nyquist.IQ Image Processor complies with the applicable requirements of 21 CFR 820.
∑ The Omega Nyquist.IQ Image Processor complies with the international safety standards EN 60601-1, IEC 60601-1-2, EN ISO 15223-1 and EN ISO 14971.
2 The Omega Nyquist.IQ Image Processor system comply with UL 60601-1 and CAN/USA C22.2 No.601.1-M90.
∑ The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with applicable parts of the IEC60601-1 standards and its collateral standards. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020, that apply to this device will be met and reported in this initial report.

{8}------------------------------------------------

Safety is assured through a risk management process and manufacturing is in compliance with the Quality System Regulations.

Referenced Guidance Documents:

∑ Guidance for this submission of 510(k) for Indications of use as provided in: Pediatric Information for X-rav Imaging Device Premarket Notifications (Document issued on November 28º, 2017) Guidance for Industry and Food and Drug Administration Staff.
2 Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. (Document issued on October 2018)
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (Document issued on May 11, 2005)
S Guidance for Industry and FDA Staff: Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-powered Medical Devices. (Document issued on July11, 2016)
S Guidance for this submission of 510(k) for (SSXID) Solid State X-ray Imaging Devices issued on: September 1, 2016 was used to establish substantial equivalence
S Guidance for industry and FDA Staff User Fees and Refunds for Premarket Notifications 510(k)s, (Document issued on October 2, 2017)
Guidance for industry and FDA Staff Refuse to Accept Policy for 510(k) (Document issued on September 2019)
∑ Guidance for industry and FDA Staff -Format for Traditional and Abbreviated 510(k)s (Document issued on September 2019)
Guidance for industry and FDA Staff Deciding when to submit a 510(k) for a change to an existing device. (Document issued on October 25, 2017)
2 Guidance for industry and FDA Staff The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (Document Issued on July 28, 2014)
Guidance for industry and FDA Staff Guidance for Off-The-Shelf Software Use in Medical Devices (Document issued on September 2019)
Guidance for industry and FDA Staff Guidance for the Content of Premarket Submission for Software in Medical Devices. (Document issued May 11th, 2005)
S Guidance for industry and Food and Drug Administration Staff Policy Clarification for Certain Fluoroscopic Equipment Requirements (Document issued on May 8, 2019)
S Guidance for Industry and FDA Staff Medical X-Ray Imaging Devices Conformance with IEC Standards. (Document issued on May 8,2019)
Guidance for Industry and FDA Staff Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment. (Document issued on December 17, 2018)
Guidance for Industry and FDA Staff Guidance for the submission of 510(k)s for Solid state X-ray Imaging Devices. (Document issued on September 1, 2016)

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.