The Cios Select is a mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine.

The Cios Select can operate in four different modes, Digital Radiography, Fluoroscopy and Cassette exposure which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of an intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

Device Description

Theis 510(k) submission, Cios Select (VA21C) with Imagine Intensifier is a Mobile Carm X-ray System, which is a modification of the Cios Select (VA21) Image Intensifier originally cleared under Premarket Notification K210307 on March 04, 2021.

The Cios Select consists of two major units:

One is the acquisition unit with the C-arm and movable base containing the generator, power unit, system control, and tube housing assembly on one side of the C-arm and the image intensifier on the opposite side.

The second unit is the image display station with a moveable trolley for the image processing and storage system, image display, and documentation. Both units are connected to each other with a cable. The main unit is connected to the main power outlet and the trolley is connected to a data network.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Cios Select (VA21) Image Intensifier." This is a special 510(k) submission, meaning it concerns minor modifications to an already cleared predicate device (K210307). As such, the focus of the documentation is on demonstrating that the modified device remains substantially equivalent to the predicate, rather than proving novel performance.

Therefore, the document does not contain a typical "study" proving the device meets acceptance criteria in the sense of a clinical trial or performance study against specific, quantified metrics with a defined ground truth and expert review. Instead, the "acceptance criteria" are implied by compliance with safety and performance standards for an image-intensified fluoroscopic x-ray system, and the "study" is a series of verification and validation (V&V) tests to confirm that the modifications do not introduce new safety or effectiveness issues.

Based on the provided information, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a special 510(k) for modifications, the "acceptance criteria" are primarily related to maintaining safety and performance equivalence to the predicate device and adhering to recognized standards. Specific quantitative performance metrics are not explicitly listed in a table format for the device's image quality or diagnostic accuracy in this submission narrative.

Acceptance Criteria (Implied)	Reported Device Performance
Safety & Performance Standards Compliance:	The Cios Select (VA21C) Imagine Intensifier has been tested to meet the requirements for conformity to multiple industry standards.
21 CFR Federal Performance Standards:	Complies with 21 CFR 1020.30 (Diagnostic X-Ray System), 1020.31(h)(2)(3) (Alignment of X-ray field & spot-film cassette), 1020.32 (Fluoroscopic Equipment), 1040.10 (Laser products).
Electrical Safety, Performance, & EMC:	Certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply with: AAMI ANSI ES60601-1:2005/(R)2012, IEC 60601-1-2:2014, IEC 60601-1-3:2013, IEC 60601-1-6:2010/A1:2013, IEC 60825-1:2014, IEC 62304:2015, IEC 60601-2-28:2017, IEC 60601-2-43:2019, IEC 60601-2-54:2018, IEC 62366-1:2015, ISO 14971:2019.
Software Functionality & Safety:	Software documentation for a Moderate Level of Concern software included, demonstrating continued conformance with special controls. Risk analysis completed, risk control implemented. All software specifications met acceptance criteria. Verification and validation testing for software performance and regression testing performed successfully.
Hardware Functionality (Collimator, PC, Camera):	Collimator: The new collimator has the same functionality as the cleared predicate and does not raise new safety or effectiveness issues. PC Hardware: The new mini-PC has the same functionality as the cleared predicate and does not raise new safety or effectiveness issues. Image Intensifier Camera: The camera was updated to CMOS technology (from CCD). Testing for image quality was performed and test results indicate substantial equivalence for this component. The new camera has the same functionality as the cleared predicate and does not raise new safety or effectiveness issues.
Overall Equivalence to Predicate:	The device functions as intended and is as safe and effective as the predicate device. Bench testing results, including unit, subsystem, and system integration testing, evaluated the performance and functionality of new features, hardware, and software updates. All testable requirements in Engineering Requirements Specifications, Subsystem Requirements Specifications, and Risk Management Hazard keys were successfully verified and traced. All conducted testing and clinical assessments were found acceptable and do not raise any new issues of safety or effectiveness. Clinical testing was not necessary.
Human Factors/Usability:	Human Factor Usability Validation showed human factors are addressed in system tests (operator’s manual, clinical use tests with customer reports and feedback forms).
Cybersecurity:	Conforms to cybersecurity requirements, preventing unauthorized access, modifications, misuse, or denial of use. Cybersecurity statement provided, considering IEC 80001-1:2010 (responsibility for compliance for IEC 80001-1-2010 is the hospital).

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of diagnostic performance involving patient data. The "tests" mentioned are non-clinical (bench testing, verification, and validation).
Data Provenance: The study described is primarily non-clinical validation and verification. There is no indication of patient data being used for the performance evaluation in this specific 510(k) submission, as it relates to system modifications and demonstrating substantial equivalence. The predicate device's prior clearance would have relied on such data. Since clinical testing was deemed "not necessary" for this special 510(k), no patient data (retrospective or prospective, or country of origin) is specified for the current submission's performance evaluation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable as this submission describes non-clinical testing for substantial equivalence, not a diagnostic performance study requiring expert ground truth for patient data.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

Not applicable for the same reason as above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

No, an MRMC study was not performed. This device is an image intensifier system (mobile C-arm X-ray), not an AI-based diagnostic algorithm that assists human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

No, this is a medical imaging hardware system with integrated software, not a standalone AI algorithm. The performance evaluation focuses on the safety and functionality of the modified system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical tests described, the "ground truth" is defined by established engineering specifications, performance standards (e.g., IEC, AAMI, CFR), and functional requirements rather than medical ground truth like pathology or expert consensus on clinical cases. The tests verify that the device performs according to these engineering and regulatory specifications.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI model that underwent a separate and distinct training phase using a specific dataset. The "software" updates mentioned are for system control and image processing, not for a trainable machine learning model.

9. How the Ground Truth for the Training Set was Established:

Not applicable for the same reason as above.

Summary

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December 6, 2022

Siemens Medical Solutions USA, Inc. % Patricia Jones Regulatory Affairs Professional 40 Liberty Boulevard MALVERN PA 19355

Re: K223409

Trade/Device Name: Cios Select (VA21) Image Intensifier Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, OXO, JAA Dated: November 4, 2022 Received: November 9, 2022

Dear Ms. Jones:

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,

2022.12.06
19:31:17
Lu Jiang
-05'00'

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health 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) K223409

Device Name Cios Select (VA21) Image Intensifier

Indications for Use (Describe)

The Cios Select is a mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine.

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 shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" are several orange dots arranged in a circular pattern.

510(k) Summary: Cios Select (VA21) Image Intensifier Submission Number: K223409

Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355

Date Prepared: December 5, 2022

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

1. General Information: Importer / Distributor: Siemens Medical Systems USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number: 2240869

Manufacturing Site:

Siemens Shanghai Medical Equipment Ltd. 278 Zhou Zhu Road, Shanghai 201318. China Establishment Registration Number: 3003202425

2. Contact Person:

Patricia D. Jones Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Phone: (678) 575-8832 Email: patricia.jones@siemens-healthineers.com

3. Device Name and Classification:

Trade Name: Classification Name: Classification Panel: Requlation Number: Device Class: Product Codes:

Cios Select (VA21) Image Intensifier

Image-Intensified Fluoroscopic x-ray System Radiology 21 CFR §892.1650 Class II OWB, OXO, JAA

4. Legally Marketed Predicate Device
Trade Name:	Cios Select (VA21) Image Intensifier
510(k) Clearance	K210307
Clearance Date	March 4, 2021
Classification Name:	Image-intensified fluoroscopic x-ray System
Classification Panel:	Radiology

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Image /page/4/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a cluster of orange dots of varying sizes.

Requlation Number: Device Class: Product Code: Subsequent Product Codes: Total Product Life Cycle:

21 CFR §892.1650 Class II OWB JAA. OXO There are no Recalls nor MDR incidents for this cleared device.

5. Device Description:

The Cios Select consists of two major units:

The following modifications were made to the Predicate Device the Cios Select Mobile X-ray System cleared under Premarket Notification K210307 on March 04, 2021. Siemens Medical Solutions USA, Inc. submits this Special 510(k) to request clearance for the Subject Device the Cios Select (VA21C) with Imagine Intensifier. The following minor modifications are incorporated in the Predicate Device to create the Subject Device, for which Siemens is seeking 510(k) clearance:

1. Updated Software from VA21B to VA21C to support the following hardware changes.
- New collimator a.
- New PC hardware (Mini PC) b.
- Replaced Camera in Image Intensifier C.
1. Updated 510(k) Information

6. Indications for Use:

The Cios Select is a mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine.

The Cios Select can operate in four different modes, Digital Radiography, Fluoroscopy, and Pulsed Fluoroscopy and Cassette exposure which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of an intra-medullary nail implants in various positions,

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Image /page/5/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a cluster of orange dots of varying sizes.

low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

Substantial Equivalence: 7.

The Cios Select (VA21C) with Imagine Intensifier system is within the same classification regulation with the same indications for use as the legally marketed predicates listed in Table 1. below:

Table 1: Predicate Device Comparable Properties for Subject Device Modifications:

Predicate Device Name andManufacturer	510(k) Number	Clearance Date	Comparable Properties
Predicate DeviceCios Select (VA21) ImageIntensifierSiemens Shanghai MedicalEquipment Ltd.	K210307	3/4/2021	Indications for use X-ray technology Image processing Mechanical design Cybersecurity Software Collimator PC Hardware

8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:

The Indications for Use Statement is exactly the same as the cleared Predicate Device "Cios Select (VA21) Image Intensifier, K210307".

The Cios Select (VA21) with system software version VA21C contains the following minor modifications that were made to the predicate device. Provided in Table 2 is a summary of the comparison of Technological Characteristics to the Predicate Device.

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Table 2: Summary of Comparison of Technological Characteristics

Modifications	Subject DeviceCios Select(VA21C) withImage Intensifier	Predicate DeviceCios Select (VA21B)Image IntensifierK210307	Comparable Properties
1. Software	Updated Softwareto VA21(C)	VA21(B)	Modified:Update the software from VA21(B) to VA21(C) tosupport the following hardware change, no newsoftware features are included in this software version.
a. Collimator	New Collimator	Collimator	Comparable:The new collimator has the same functionality ascleared in the Predicate Device Cios Select (VA21)Image Intensifier K210307 and does not raise any newor effectiveness issues.
b. PC hardware	New Mini-PC	W550 PC	Comparable:The new mini-PC has the same functionality as clearedin the Predicate Device Cios Select (VA21) ImageIntensifier K210307 and does not raise any new oreffectiveness issues.
c. Image Intensifier	Updated Camera inImage Intensifier	Image Intensifier	Comparable:The only major change from the predicate device is theupgrade of the image intensifier camera. The camerahas been updated to CMOS technology (from CCD inthe predicate fluoro system). Testing for image qualityhas been performed and test results indicate substantialequivalence for this image intensifier component. Thenew camera within Image Intensifier has the samefunctionality as cleared in the Predicate Device CiosSelect VA21 Image Intensifier K210307 and does notraise any new or effectiveness issues.

Nonclinical Performance Testing: 9.

Non-clinical tests were conducted for the Cios Select (VA21C) with Imagine Intensifier during product development. The Siemens Cios Select (VA21C) Imagine Intensifier has been tested to meet the requirements for conformity to multiple industry standards. Performance testing confirmed, that the Siemens Cios Select (VA21C) Imagine Intensifier complies with the following 21 CFR Federal Performance Standards

Code of Federal Requlations Title 21 Subchapter J- Radiological Health, applicable sections include:

1020.30 Diagnostic X-Ray System and their major component ●
1020.31(h)(2)(3) Alignment of the X-ray field and spot-film cassette ●
1020.32 Fluoroscopic Equipment
1040.10 Laser products

The Cios Select (VA21C) with Imagine Intensifier was certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply with the following standards for Electrical safety, performance and Electromagnetic Compatibility:

AAMI ANSI ES60601-1:2005/(R)2012 ●
IEC 60601-1-2:2014 ●
IEC 60601-1-3:2013
IEC 60601-1-6:2010/A1:2013
IEC 60825-1:2014 ●
IEC 62304:2015 ●

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Image /page/7/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a cluster of orange dots.

IEC 60601-2-28:2017 ●
IEC 60601-2-43:2019 ●
IEC 60601-2-54:2018 ●
IEC 62366-1:2015 ●
ISO 14971:2019

The modifications described in this Premarket Notification are supported with verification and validation testing.

Verification and Validation:

Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, and "Off-The-Shelf Software Use in Medical Devices" is also included as part of this submission. The performance data demonstrate continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the Subject Device Cios Select with Image Intensifier software version VA21C during product development. The device software is based on the predicate software package and no major changes were performed on the software.

The Risk analysis was completed, and risk control was implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.

Bench testing in the form of Unit, Subsystem, and System Integration testing was performed to evaluate the performance and functionality of the new features, hardware, and software updates. All testable requirements in the Engineering Requirements Specifications keys, Subsystem Requirements Specifications keys, and the Risk Management Hazard keys have been successfully verified and traced in accordance with the Siemens product development (lifecycle) process. The software verification and regression testing have been performed successfully to meet their previously determined acceptance criteria as stated in the test plans.

Electrical safety and EMC testing were conducted on the Cios Select, consisting of the acquisition unit (C-arm system) and the image processing and display station. The system complies with the IEC 60601-1, IEC 60601- 2-43, and IEC 60601-2-54 standards for safety and the IEC 60601-1-2 standard for EMC.

The Cios Select with Image Intensifier software (VA21C) was tested and found to be safe and effective for intended users, uses, and use environments through the design control verification and validation process. The Human Factor Usability Validation showed that Human factors are addressed in the system test according to the operator's manual and in clinical use tests with customer reports and feedback forms. Customer employees are adequately trained in the use of this equipment.

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Image /page/8/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots.

Siemens conforms to the cybersecurity requirementing a process of preventing unauthorized access, modifications, misuse, or denial of use, or the unauthorized use of information that is stored, accessed or transferred from a medical device to an external recipient. Provided in this submission is a cybersecurity statement that considers IEC 80001-1:2010. The responsibility for compliance with IEC 80001-1-2010 is the hospital. Provided in the Software Section is the required cybersecurity information.

Summary:

Performance tests were conducted to test the functionality of the Cios Select (VA21C). These tests have been performed to assess the functionality of the Subject Device. The results of all conducted testing and clinical assessments were found acceptable and do not raise any new issues of safety or effectiveness. Clinical testing is not necessary, based on the changes to the predicate device. Successful Bench Testing results should be sufficient in showing that the Cios Select fluoro system is safe and effective for use.

10. General Safety and Effectiveness Concerns:

Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner.

Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification, and validation testing. To minimize electrical and mechanical hazards, Siemens adheres to recognized and established industry practices, and all equipment is subject to final performance testing. Furthermore, the operators are healthcare professionals familiar with and responsible for the evaluation and postprocessing of X-ray images.

11. Conclusion as to Substantial Equivalence:

The predicate devices were cleared based on non-clinical supportive information and clinical images and data. Similar non-clinical test results demonstrate that the Cios Select (VA21C) with Imagine Intensifier System acceptance criteria is adequate for the intended use of the device. The comparison of technological characteristics, nonclinical performance data, and software validation data demonstrates that the Subject Device is as safe and effective when compared to the Predicate Devices that is currently marketed for the same intended use.

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.