EXTRON5 and EXTRON 7 are a mobile fluoroscopic X-ray system with high output capacity, high thermal capacity and high resolution image processing system, which provides X-ray images of the patient's anatomy during surgery or treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, surgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis. Examples of a clinical application may include: Neurosurgery, Orthopedics, Anesthesiology, Urology, Internal Medicine (※ This device is not intended for mammography applications.)

Device Description

EXTRON 5 and EXTRON 7 are mobile fluoroscopic X-ray systems with high output capacity, high thermal capacity, and high-resolution image processing systems that provide X-ray images of the patient's anatomical structures during surgery or treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, neurosurgery surgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis.

The EXTRON 5 and EXTRON 7 are composed of a C-arm main body and a monitor cart. The Carm main body is composed of an X-ray tube, a flat panel detector, a collimator, a generator, a touch panel, foot switch, hand switch and an XConsoleOP program, while the monitor cart is composed of a monitor, a thermal transfer printer, a mouse, a keyboard and an XConsole program.

The operating principle of the device is designed to expose the patient to X-ray beams. The range of X-ray irradiation are adjusted by the collimator.

X-rays can penetrate into the human body through a two-step conversion process.

X-ray photons are converted into light. The light is then converted into electrical signals through the sensor. The electrical charges are transmitted as the sensor output and converted into signals. These signals are digitized and captured by memory. The captured images are processed and displayed on the monitor. The displayed images can be saved or transmitted to an external storage device, such as a network printer.

AI/ML Overview

The provided text describes a medical device submission (K230871) for the EXTRON 5 and EXTRON 7 mobile fluoroscopic X-ray systems. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/ML powered device submission.

This document is a 510(k) summary for a traditional medical imaging device (X-ray system), not an AI/ML diagnostic or prognostic tool. Therefore, many of the requested criteria in your prompt (e.g., sample size for test set, data provenance, ground truth experts, adjudication methods, MRMC studies, standalone performance, training set sample size) are not applicable or not provided in the context of an AI device.

The study described is a non-clinical study to demonstrate "substantial equivalence" to a predicate device, focusing on technical specifications and image quality of the X-ray system itself, not on the performance of an AI algorithm.

Here's a breakdown of the available information in relation to your request:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for an X-ray system affirming substantial equivalence to a predicate, the "acceptance criteria" discussed are primarily around meeting recognized consensus standards for safety and performance, and demonstrating comparable image quality to the predicate device.

Acceptance Criteria (Implied for X-ray System Equivalence)	Reported Device Performance
Compliance with International & FDA-Recognized Consensus Standards for Medical Electrical Equipment, Radiation Protection, Software, and Cybersecurity	The EXTRON 5 and EXTRON 7 comply with: - ISO 14971:2019 (Risk Management) - ANSI AAMI ES60601-1:2005/(R)2012 (Basic Safety & Essential Performance) - IEC 60601-1-2 Ed 4.1:2020 (Electromagnetic Disturbances) - IEC 60601-1-6 Ed 3.1:2013 (Usability) - IEC 62366-1 Ed 1.1:2020 (Usability Engineering) - IEC 60601-1-3 Ed 2.1:2013 (Radiation Protection) - IEC 60601-2-28 Ed 3.0:2017 (X-ray Tube Assemblies) - IEC 60601-2-54 Ed 1.2:2018 (Radiography & Radioscopy) - IEC 60601-2-43 Ed 2.2:2019 (Interventional Procedures) - IEC 62304 Ed 1.1:2015 (Medical Device Software) - ANSI UL 2900-1 First Ed 2017 (Software Cybersecurity)
Equivalent Image Quality to Predicate Device (Veradius Unity K142708)	Phantom images of various body parts for both EXTRON 5/7 and the predicate device were reviewed and compared by qualified clinical experts. It was confirmed that EXTRON 5 and EXTRON 7 devices provide equivalent image quality to the predicate device.
Substantial Equivalence based on Technological Characteristics	The device has the same fundamental scientific technologies as the predicate. Minor technological differences (Max. Output Power, Radiographic Mode, Fluoroscopic Mode, Dimension, Detector pixels) do not give rise to novel concerns or negatively impact the product's use, and in some cases offer greater convenience (e.g., wider range of movement).

Study Details (as provided for an X-ray system, not an AI algorithm)

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated as a numerical sample size of patient data. The evaluation involved "phantom images of various body parts." The number of phantoms or images is not quantified.
Data Provenance: Not applicable in the traditional sense of patient data. The images were generated using the subject devices and the predicate device. No country of origin for patient data as it was phantom-based. The study was "non-clinical."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Number of Experts: "qualified clinical experts" (number not specified).
Qualifications of Experts: Not specified beyond "qualified clinical experts."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not specified. The text simply states "These images have been reviewed and compared by qualified clinical experts."

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This type of study is typically done for AI-assisted diagnostic devices to measure the impact of AI on human reader performance. This submission is for a classic X-ray system.

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

No, this device is not an algorithm that would have standalone performance. It is an X-ray imaging system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the image quality comparison, the "ground truth" was essentially the visual assessment and comparison of images from the subject devices against images from an established predicate device by qualified clinical experts, validating that the new device produces images of equivalent quality.

8. The sample size for the training set:

Not applicable. This device is a hardware X-ray system, not an AI/ML algorithm that requires a training set of data.

9. How the ground truth for the training set was established:

Not applicable. No training set data or ground truth establishment relevant to AI/ML.

In summary, the provided document details the regulatory submission for a mobile fluoroscopic X-ray system where the primary "study" is a non-clinical comparison of technical specifications and image quality between the new devices and a predicate device to establish substantial equivalence. It does not describe an AI/ML powered device or a clinical study in the conventional sense of establishing performance metrics for an autonomous or AI-assisted diagnostic tool.

Summary

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August 17, 2023

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 & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

DRTECH Corporation % Kim Minjeong Manager Suite No. 1, 2 Floor/Suite No. 2, 3 Floor, 29, Dunchon-Daero 541 Beon-Gil, Jungwon-Gu Seongnam-si. Gyeonggi-do 13216 SOUTH KOREA

Re: K230871

Trade/Device Name: Extron 5, Extron 7 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, OXO, JAA Dated: March 31, 2023 Received: July 21, 2023

Dear Kim Minjeong:

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 mediation-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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of 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) K230871

Device Name EXTRON 5, EXTRON 7

Indications for Use (Describe)

(※ This device is not intended for mammography applications.)

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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DRT

510(k) Summary

K230871

[As required by 21 CFR 807.92]

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92

1. Date Prepared [21 CFR 807.92(a) (1)]

03/31/2023

●

2. Submitter's Information [21 CFR 807.92(a) (1)]

Name of Sponsor: . DRTECH Corporation
- Suite No.1, 2 Floor / Suite No. 2, 3 Floor, 29, Dunchon-daero541 beon-gil, Address: Jungwon-gu, Seongnam-si, Gyeonggi-do, 13216, Republic of Korea
Contact Name: Minjeong Kim
Telephone No.: + 82-31-779-7783 ●
Fax No.: + 82-31-779-7790
Email Address : drtechra@drtech.com ●
Registration Number: 3005172103 ●
. Name of Manufacturer: Same as Sponsor

3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]

• Trade Name:	EXTRON 5, EXTRON 7
• Common Name:	Mobile Fluoroscopic X-ray System
• Classification Name:	Image-intensified fluoroscopic x-ray system
• Classification Panel:	Radiology

Classification Regulation: 21 CFR 892.1650 ●
Product Code: OWB, OXO, JAA
Device Class: ● II

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4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]

510(k) Number: K142708 ●
Applicant: ● GENERAL ELECTRIC COMPANY
Trade Name: VERADIUS UNITY
Classification Name: Image-intensified fluoroscopic x-ray system ●
Classification Panel: Radiology
Classification Regulation: 21 CFR 892.1650
Product Code: OWB, JAA, OXO ●
Device Class: ● II

5. Description of the Device [21 CFR 807.92(a) (4)]

The operating principle of the device is designed to expose the patient to X-ray beams. The range of X-ray irradiation are adjusted by the collimator.

X-rays can penetrate into the human body through a two-step conversion process.

6. Indication for Use [21 CFR 807.92(a)(5)]

EXTRON5 and EXTRON 7 are a mobile fluoroscopic X-ray system with high output capacity, high thermal capacity and high resolution image processing system, which provides X-ray images of the patient's anatomy during surgery or treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, neurosurgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis.

Examples of a clinical application may include: Neurosurgery, Orthopedics, Anesthesiology, Urology, Gynecology, Internal Medicine

(※ This device is not intended for mammography applications.)

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7. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device [21 CFR 807.92(a)(6), 21 CFR 807.92(b)]

The EXTRON 5 and EXTRON 7 are designed as a combination of components, including a C-arm, X-ray tube and housing, flat panel detector, digital imaging system, collimator, generator, and monitor cart. Its purpose is to provide X-ray images of a patient's anatomy during surgery or treatment.

The subject device has the same fundamental scientific technologies as the predicate devices. The technological comparison table below demonstrates the comparability of the technological characteristics of the new device and the currently cleared predicate devices. The Technological differences do not affect the intended use of the device.

The table 1 below compares the main performance data of the subject device with the predicate devices to substantiate equivalence of the subject device and predicates.

Parameter	Subject Device	Predicate Device	Discussion
510(K)Number	Unknown	K142708	-
Manufacturer	DRTECH Corporation	Philips Medical SystemsNederland B.V.	-
Model Name	EXTRON 5, EXTRON 7	Veradius Unity	-
ClassificationName	Image-intensifiedfluoroscopic x-ray system	Image-intensifiedfluoroscopic x-ray system	Identical
ClassificationPanel	Radiology		Identical
ClassificationRegulation	21 CFR 892.1650	21 CFR 892.1650	Identical
Product Code	OWB, OXO, JAA	OWB, OXO, JAA	Identical
Device Class	Class II	Class II	Identical
Intended Use	EXTRON5 and EXTRON 7are a mobile fluoroscopic X-ray system with high outputcapacity, high thermalcapacity and high resolutionimage processing system,which provides X-rayimages of the patient'sanatomy during surgery ortreatment. This device playsan important role inemergency injury treatment,orthopedic surgery,neurosurgery surgery, bonesurgery, etc. This device hasa function to save importanta specific images as records,so you can easily search forthe images and transmit it tothe PACS system in thehospital to help the medicalstaff in diagnosis.	The proposed VeradiusUnity device is intended tobe used and operated by:adequately trained,qualified, and authorizedhealth care professionalssuch as physicians,surgeons, cardiologists,radiologists, andradiographers, who have fullunderstanding of the safetyinformation and emergencyprocedures as well as thecapabilities and functions ofthe device.The device is used forradiological guidance andvisualization duringdiagnostic, interventional,and surgical procedures onall patients except neonates(birth to one month), within	Identical
	Examples of a clinicalapplication may include:Neurosurgery, Orthopedics,Anesthesiology, Urology,Gynecology, InternalMedicine(※ This device is notintended for mammographyapplications.)	the limits of the device. Thedevice is to be used inhealthcare facilities bothinside and outside theoperating room, in sterile aswell as non-sterileenvironments, in a variety ofprocedures.Applications• Orthopedic• Neuro• Abdominal• Vascular• Thoracic• Cardiac
Targetpopulation	Patients who need X-rayradiography or fluoroscopyimagesAdults and Pediatrics	Patients who needdiagnostic, interventionaland surgical procedures,except neonates (birth to onemonth)	Identical
MobilePlatform	Yes	Yes	Identical
Max. OutputPower	EXTRON 5: 4.8kWEXTRON 7: 15kW	15kW	Equivalent :The specificationshave beenenhanced to enableoperation at powerlevels up to 4.8kW.That does not giverise to any novelconcerns regardingsafety andeffectiveness.
X-ray tube	Rotating Anode	Rotating Anode	Identical
RadiographicMode	kV Range : 40 to 120kVmA Range : Up to 150mA※ EXTRON 7 only	kV Range : 40 to 120kVmA Range : Up to 125mA	Equivalent :Alteration in themA does not giverise to any novelconcerns regardingsafety andeffectiveness.
FluoroscopicMode	kV Range : 40 to 120kVmA Range :EXTRON 5 - Up to 40mAEXTRON 7 - Up to 60mA	kV Range : 40 to 120kVmA Range : 1 to 60mA	Equivalent :Alteration in themA does not giverise to any novelconcerns regardingsafety andeffectiveness.
Dimension	Immersion Depth : 74cm	Immersion Depth : 73cm	Equivalent :

	Free Space : 80cmOrbital movement : 165°	Free Space : 77cmOrbital movement : 145°	Alteration in thedimension does notgive rise to anynovel concernsregarding safetyand effectiveness.Additionally, due tothe greater scope ofmovement, theSubject deviceoffers a higherdegree ofconveniencecompared to thePredicate device.
Laser Guide	Yes	Yes	Identical
Foot Switch	Wired Foot SwitchWireless Foot Switch	Wired Foot SwitchWireless Foot Switch	Identical
Detector pixels	EXPD 2121P : 1500 x 1500 pixelsEXPD 3030P : 2048 x 2048 pixels	1560 x 1420 pixels	Equivalent :Alteration in thedetector pixels donot give rise to anynovel concernsregarding safetyand effectiveness.

Table 1. Comparison of the Subject Device (EXTRON 7) to the Predicate Device (Veradius Unity)Substantial Equivalence

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DRTECH

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DRTI

The predicate devices (K142708) and the subject device, EXRON 7 are equivalent in terms of the following matters:

Intended Use
Target population
Mobile Platform
X-ray tube
Laser Guide
Foot Switch

A few differences are as follows:

Max. Output Power
Radiographic Mode
· Fluoroscopic Mode
Dimension
Detector pixels

There are no significant differences between the EXTRON 7 and the predicate device that would have a negative impact on the product's use. Therefore, the subject device is considered substantially equivalent to the predicate device.

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DRT

9. Summary of Non-Clinical Data [21 CFR 807.92(b)(1)]

The EXTRON 5 and EXTRON 7 comply with the following international and FDA-recognized consensus standards list in Table 2.

Standards developmentorganization, referencenumber, and date	Standard name
ISO 14971: Third Edition2019-12	Medical devices - Application of risk management to medical devices
ANSI AAMI ES60601-1:2005/(R)2012 andA1:2012	Medical electrical equipment - Part 1: General requirements for basicsafety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2 Edition 4.12020-09CONSOLIDATEDVERSION	Medical electrical equipment - Part 1-2: General requirements for basicsafety and essential performance - Collateral Standard: Electromagneticdisturbances - Requirements and tests
IEC 60601-1-6 Edition 3.12013-10	Medical electrical equipment - Part 1-6: General requirements for basicsafety and essential performance - Collateral standard: Usability
IEC 62366-1 Edition 1.12020-06CONSOLIDATEDVERSION	Medical devices - Part 1: Application of usability engineering tomedical devices
IEC 60601-1-3 Edition 2.12013-04	Medical electrical equipment - Part 1-3: General requirements for basicsafety and essential performance - Collateral Standard: Radiationprotection in diagnostic X-ray equipment
IEC 60601-2-28 Edition3.0 2017-06	Medical electrical equipment - Part 2-28: Particular requirements for thebasic safety and essential performance of X-ray tube assemblies formedical diagnosis
IEC 60601-2-54 Edition1.2 2018-06CONSOLIDATEDVERSION	Medical electrical equipment - Part 2-54: Particular requirements for thebasic safety and essential performance of X-ray equipment forradiography and radioscopy
IEC 60601-2-43 Edition2.2 2019-10CONSOLIDATEDVERSION	Medical electrical equipment - Part 2-43: Particular requirements for thesafety and essential performance of X-ray equipment for interventionalprocedures
IEC 62304 Edition 1.12015-06CONSOLIDATEDVERSION	Medical device software - Software life cycle processes
ANSI UL 2900-1 FirstEdition 2017	Standard for Safety, Standard for Software Cybersecurity Network-Connectable Products. Part 1: General Requirements

Table 2. International and FDA-recognized consensus standards

And EXTRON 5 and EXTRON 7 comply with the FDA guidance documents listed in Table 3.

Table 3. FDA Guidance Documents

Title of Guidance Document	Issue Date
Guidance for Industry and Food and Drug Administration Staff: The 510(k)Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]	July 28, 2014
Guidance for Industry and FDA Staff: Guidance for the Content of PremarketSubmission for Software in Medical Devices	May 11, 2005
Guidance for Industry and Food and Drug Administration Staff: Medical X-Ray	May 8, 2019

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Title of Guidance Document	Issue Date
Imaging Devices Conformance with IEC Standards
Guidance for Industry and FDA Staff: Information to Support a Claim ofElectromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices	July 11, 2016
Guidance for Industry and FDA Staff: Applying Human Factors and UsabilityEngineering to Medical Devices	February 3, 2016
Guidance for Industry and FDA Staff: Content of Premarket Submissions forManagement of Cybersecurity in Medical devices	October 2, 2014

Phantom images of various body parts for both the proposed devices, EXTRON 5 and EXTRON 7, and the predicate device, Veradius Unity, have been taken. These images have been reviewed and compared by qualified clinical experts. As a result of this evaluation, it has been confirmed that the EXTRON 5 and EXTRON 7 devices provide equivalent image quality to the predicate device (Veradius Unity).

10. Summary of Clinical Data [21 CFR 807.92(b)(2)]

Not Applicable

Clinical studies were not performed, but phantom images were taken to support SE.

11. Conclusion [21 CFR 807.92(b)(3)]

The EXTRON 5 and EXTRON 7 are substantially equivalent to the currently marketed predicate device (Veradius Unity (K142708)) in terms of design, fundamental scientific technology, and indications for use, safety, and effectiveness.

Substantial equivalence for Mobile fluoroscopic X-ray System(EXTRON 5, EXTRON 7) was demonstrated through the non-clinical performance in compliance with the requirements specified in the international and FDA recognized consensus standards, ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, IEC 60601-2-43, IEC 62304 and ANSI UL 2900-1.

The comparison of technological characteristics, non-clinical performance data and safety testing demonstrate that the EXTRON 7 are substantially equivalent to the predicate devices.

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.