iExaminer System with Panoptic Plus by Welch Allyn, Inc.

The iExaminer system with PanOptic Plus, consisting of PanOptic Plus, SmartClip, iExaminer application, and one of the following: iPhone 11 Pro, iPhone 11 Pro Max, iPhone 12 Pro, is intended to be used to capture images as an aid to clinicians in the evaluation, and documentation of ocular health. The images from the iExaminer System with PanOptic Plus are not intended to be used as a sole means of diagnosis.

Device Description

The iExaminer System with PanOptic Plus is a medical device that allows the user to capture images through the use of a PanOptic Plus ophthalmoscope and a smart device. The iExaminer System with PanOptic Plus consists of (also see Figure 1):

PanOptic Plus Ophthalmoscope:
a. Ophthalmoscope Head
b. Compatible energy sources (i.e. battery handles or wall units)
c. Optional Patient Eyecup
Smart device attachment instrument (made of SmartBracket and SmartClip);
Compatible smart device (iPhone X, iPhone 11 Pro, iPhone 11 Pro Max, iPhone 12 Pro).
iExaminer Pro Software Application.
The iExaminer system with PanOptic Plus is intended to take photographs of the eye and surrounding area.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The document states that a non-clinical and clinical (image comparison) study was performed to demonstrate that the iExaminer System with PanOptic Plus images are substantially equivalent to the predicate device images in their usefulness for documentation and clinical referrals. The acceptance criteria themselves are not explicitly detailed in a table with specific numerical thresholds for metrics like sensitivity, specificity, or accuracy. Instead, the general acceptance criterion for the clinical study was that the new device's images are "substantially equivalent" in usefulness for documentation and clinical referrals compared to the predicate device.

Given that no specific performance metrics like sensitivity or specificity were reported for the device itself against a ground truth, it's not possible to create a table of acceptance criteria and reported device performance in those terms. The study focuses on comparative usefulness.

However, based on the conclusion, the device did meet the established acceptance criteria:
"The results of the image comparison study demonstrate that the iExaminer System with PanOptic Plus has passed all established acceptance criteria and is as safe and effective as the predicate device for its intended use."

Study Details:

A table of acceptance criteria and the reported device performance
As noted above, explicit numerical acceptance criteria for performance metrics (sensitivity, specificity) are not provided. The acceptance criterion was "substantially equivalent" usefulness of images for documentation and clinical referrals compared to the predicate device. The study concluded this criterion was met.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the test set (number of images or patients). It also does not mention the country of origin of the data or whether it was retrospective or prospective.
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)
The document does not describe the establishment of a "ground truth" by experts for specific pathologies. Instead, the study was an "image comparison study" where the new device's images were compared to the predicate device's images for "usefulness for documentation and clinical referrals." The number and qualifications of experts (if any specific graders were involved in comparing image usefulness) are not detailed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not provide details on any adjudication method used for comparing images or establishing usefulness.
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, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with or without AI assistance was not conducted or reported. The study was an "image comparison study" between two devices to show substantial equivalence. The device itself is an image capture system, not an AI-powered diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. The device is a system for capturing images for human clinicians to evaluate, not an automated diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The study did not use a traditional "ground truth" in the sense of confirmed diseases (e.g., pathology, outcomes data, or expert consensus on diagnosis). Instead, it focused on the "usefulness for documentation and clinical referrals" of images captured by the proposed device compared to images from the predicate device. The predicate device's images are assumed to be a sufficient and already accepted reference point for "usefulness."
The sample size for the training set
This information is not applicable. The device is an image capture system, not an AI model that requires a training set.
How the ground truth for the training set was established
This information is not applicable, as there is no training set for an AI model.

Summary

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

March 15, 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Welch Allyn, Inc. Jeffrey Thompson Manager, Regulatory Affairs (a subsidiary of Baxter Healthcare Corporation) 4341 State Street Road Skaneateles Falls, New York 13153

Re: K223381

Trade/Device Name: iExaminer System with Panoptic Plus Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: February 17, 2023 Received: February 17, 2023

Dear Jeffrey Thompson:

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

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

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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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,

Elvin Y. Ng -S

Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K223381

Device Name iExaminer System with PanOptic Plus

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/1 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly slanted to the right, giving it a dynamic appearance.

510(k) Summary

DATE PREPARED: 09 MAR 2023

OWNER:

Welch Allyn Inc. (a subsidiary of Baxter Healthcare Corporation) 4341 State Street Road Skaneateles Falls, NY 13153-0220

CONTACT PERSON:

Jeffrey E. Thompson Manager, Regulatory Affairs Baxter Healthcare Corporation 32650 N. Wilson Road Round Lake, IL 60073 T 224.270.3806

IDENTIFICATION OF THE DEVICE:

Trade/Device Name: iExaminer System with PanOptic Plus Classification Panel: Ophthalmic Regulation Number: 21 CFR 886.1120 Regulation Name: Camera, Ophthalmic, Ac-Powered Regulatory Class: Class II Product Code: HKI

Table 1. Proposed Model number for iExaminer System with PanOptic Plus
------------------------------------------------------------------------	--

Model Number	Name
901161	iExaminer System with PanOptic Plus

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

Image /page/4/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font is sans-serif and appears to be slightly italicized. The word is the logo for the healthcare company Baxter International.

Figure 1. Proposed Product Diagram for iExaminer System with PanOptic Plus

Image /page/4/Picture/2 description: The image shows a medical device with a smartphone attached to it. The device has a camera lens at the top, labeled as 1 and 2. The smartphone is mounted on the device and displays a medical image, labeled as 3 and 4. The device appears to be designed for capturing and displaying medical images, possibly for diagnostic purposes.

1. PanOptic Plus ophthalmoscope
1. Smart device attachment mechanism (made of SmartBracket and SmartClip)
1. Compatible Smart device
1. iExaminer Pro Software Application

Predicate Device

Table 2. Predicate Device

Device	Company	Predicate 510(k)	Clearance Date
iExaminer withPanOptic	Welch Allyn, Inc.	K121405	December 20, 2012

Description of the Device

1. PanOptic Plus Ophthalmoscope:
- a. Ophthalmoscope Head
- b. Compatible energy sources (i.e. battery handles or wall units)
- c. Optional Patient Eyecup
1. Smart device attachment instrument (made of SmartBracket and SmartClip);
1. Compatible smart device (iPhone X, iPhone 11 Pro, iPhone 11 Pro Max, iPhone 12 Pro).

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

Image /page/5/Picture/0 description: The image contains the word "Baxter" in a bold, blue font. The word is slightly slanted to the right, giving it a dynamic appearance. The font is sans-serif, and the letters are closely spaced together.

1. iExaminer Pro Software Application.
  The iExaminer system with PanOptic Plus is intended to take photographs of the eye and surrounding area.

The device is for prescription use only.

Indications For Use

The iExaminer system with PanOptic Plus, consisting of PanOptic Plus, SmartBracket, SmartClip, iExaminer application, and one of the following: iPhone X, iPhone 11 Pro, iPhone 11 Pro Max, iPhone 12 Pro, is intended to be used to capture images as an aid to clinicians in the evaluation, and documentation of ocular health. The images from the iExaminer System with PanOptic Plus are not intended to be used as a sole means of diagnosis.

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

Image /page/6/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The word is slightly italicized, giving it a sense of movement. The background is plain white, which makes the word stand out.

Device Comparison and Substantial Equivalence

Characteristic	Predicate - iExaminer with PanOptic(K121405)	Proposed Device - iExaminer System withPanOptic Plus	Discussion of Differences
FDA Product Code	HKI; Camera Ophthalmic, AC-Powered	Same	N/A
FDA Regulation #	21 CFR 886.1120	Same	N/A
Indications forUse/Intended Use	The iExaminer is an attachment and softwareused only with the iPhone 4 and iPhone 4S inconjunction with the Welch Allyn PanOpticOphthalmoscope to allow users to capture,send, store, and retrieve images of the eye. Thedevice is intended to be used by trainedpersonnel within a medical or schoolenvironment.	The iExaminer system with PanOptic Plus,consisting of PanOptic Plus, SmartBracket,SmartClip, iExaminer application, and one ofthe following: iPhone X, iPhone 11 Pro,iPhone 11 Pro Max, iPhone 12 Pro, isintended to be used to capture images as anaid to clinicians in the evaluation, anddocumentation of ocular health. The imagesfrom the iExaminer System with PanOpticPlus are not intended to be used as a solemeans of diagnosis.	The proposed device uses similarhardware components includinga different list of smart devicesas clearly listed in the WelchAllyn® iExaminer® ProOphthalmoscopes Instructionsfor Use (IFU).The proposed device IFU doesnot constitute a new IntendedUse from the predicate device asboth the predicate and theproposed devices are intended toaid the clinician in the evaluationand documentation of ocularhealth. The use environment anduse conditions are the same asthe predicate device for which itis intended to be used.
Components	Ophthalmoscope, adapter for aligning smartdevice optics and ophthalmoscope optics,smart device and the iExaminer softwareapplication.	Same	N/A
CompatibleSmartphones	iPhone 4, iPhone 4S	iPhone X, iPhone 11 Pro, iPhone 11 Pro Max,and iPhone 12 Pro	The proposed device usesdifferent list of smart devices asclearly listed in the WelchAllyn® iExaminer® Pro
Characteristic	Predicate - iExaminer with PanOptic(K121405)	Proposed Device - iExaminer System withPanOptic Plus	Discussion of Differences
			Ophthalmoscopes Instructionsfor Use (IFU). The proposeddevice IFU does not constitute anew Intended Use from thepredicate device as both thepredicate device and theproposed device are intended toallow users to capture images ofthe eye.Design control activities havebeen conducted and confirmedthat there is no impact to safetyor effectiveness for thisapplication.
Intended Population	Adult, Pediatric	Same	N/A
Characteristic	Predicate - iExaminer with PanOptic(K121405)	Proposed Device - iExaminer System withPanOptic Plus	Discussion of Differences
Prescription UseOnly	Yes	Same	N/A
Minimum PupilDiameter Size	2mm (per PanOptic)	3mm (per PanOptic Plus)	Both ophthalmoscopes providethe ability to function on patientswith small pupil sizes.
Working Distance	25.4mm	24.4mm	Both ophthalmoscopes provide asimilar working distance.
Pixel Pitch	Measured5.37 microns for iPhone 4 High Res4.25 microns for iPhone 4S High Res	MeasuredApproximately 2 microns for each of thecompatible smartphones	Both opthalmascopes provide theappropriate pixel pitch based onthe models of iphones used. Theproposed device has a lowerpixel pitch due to advancementsin the resolution of the cameraand the telephoto lens.
OpticalMagnification	1.183 (per PanOptic)	0.90 (per PanOptic Plus)	Both ophthalmoscopes providesimilar magnification (~1x).
Data Output/ OutputTerminals	iExaminer App iOS (version 1.0)	iExaminer Pro App iOS (version 4.0.0.13)	Minor differences have beenmade to the application since thepredicate device, but do notimpact the safety or effectivenessof the product.Design control activities havebeen conducted and confirmedthat there is no impact to safetyor effectiveness for thisapplication.
Use Conditions	With or without mydriatic	Same	N/A
Characteristic	Predicate - iExaminer with PanOptic(K121405)	Proposed Device - iExaminer System withPanOptic Plus	Discussion of Differences
Photographic LightSource	As per PanOptic observation light source:Halogen lamp visible light	As per PanOptic Plus observation lightsource: LED visible light	See "Observation Light Source"in this table.
Observation LightSource	As per PanOptic observation light source:Halogen lamp visible light	As per PanOptic Plus observation lightsource: LED visible light	Both provide a light output thatallows for the clinician to viewanatomy. Also see "ExposureParameters" in this table below
Observation anddisplay system	As per iPhone 4 or 4S: 3.5" screen size	iPhone X and 11 Pro - 5.8"inch screen sizeiPhone 11 Pro Max – 6.5" inch screen sizeiPhone 12 Pro - 6.1" inch screen size	The proposed system includes alarger display, which shouldpermit easier viewing. Otherscreen parameters of the user'ssystem are verified via the "Testthe Resolution" section of theIFU.
Camera Spec	5 megapixel / 8 megapixel	12 megapixels	Both opthalmascopes provide theappropriate camera spec basedon the models of iphones used.The proposed device has a highercamera spec due toadvancements in the resolutionof the camera.
DiopterCompensation	As per PanOptic: -20D to +20D	As per PanOptic Plus: -20D to +25D	PanOptic Plus provides a widerdiopter range, which is a benefitto the user.
Apertures	As per PanOptic: Multiple	Same	N/A
Picture Angle	25 degrees	20 degrees	Both provide a relatively largefield of view for performing eyeexams.
Characteristic	Predicate - iExaminer with PanOptic(K121405)	Proposed Device - iExaminer System withPanOptic Plus	Discussion of Differences
Storage Media	Internal storage capacity	Same	N/A
Exposure Parameters	As per PanOptic: Compliance with ISO 15004-1 as Group 1 (ophthalmic instrument for whichno potential light hazard exists)	As per PanOptic Plus: Compliance with ANSIZ80.36 as Group 2 (ophthalmic instrument forwhich a potential light hazard exists.)	Both devices comply withapplicable eye safety standards(e.g. ISO 15004-2 and ANSIZ80.36: 2021) at the time of therespective submission dates.
Image Data Format	JPEG	Same	N/A

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

Image /page/7/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The word is slightly italicized, giving it a sense of movement. The background is plain white, which makes the word stand out.

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

Image /page/8/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly blurred, giving it a sense of depth.

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly blurred, giving it a sense of depth.

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The word is slightly blurred, giving it a sense of depth. The background is plain white, which makes the blue text stand out.

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font is sans-serif and the letters are slightly italicized. The word is centered and takes up most of the image.

DISCUSSION OF NONCLINICAL TESTS:

Non-Clinical testing of the iExaminer System with PanOptic Plus has been performed against requirements for performance, physical attributes, environmental conditions and safety, and to provide objective evidence that the device's intended use is met. A summary of testing performed is identified in the summary below.

. Software: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005.
. Software: Guidance for Off-the-Shelf Software Use in Medical Devices. September 2019.
Software: General Principles of Software Validation; January 2002.
FDA Guidance on Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices.
. Biocompatibility: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process", Issued June 2016.

The iExaminer System with PanOptic Plus was tested to evaluate its safety and effectiveness based on the standards and associated methods below:

. ISO 10940 (Second edition 2009-08-01) Ophthalmic Instruments—Fundus Cameras
. ANSI Z80.36 (2021) American National Standard for Ophthalmics—Light Hazard Protection for Ophthalmic Instruments
. EN/IEC 62304 (2006/A1:2016) Medical Device Software – Software Life Cycle Processes
. EN/IEC 60601-1-60 (ED 3.1 2013-10) Medical Electrical Equipment – Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard Usability
. IEC 62366-1 (2015+AMD1: 2020) Medical devices – Part 1: Application of usability engineering to medical devices
. EN/ISO 10993-1 (Fifth edition 2018-08) Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process

{12}------------------------------------------------

Image /page/12/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly italicized, giving it a sense of movement.

. EN ISO/ISO 15004-1 (Second edition 2020-5) Ophthalmic Instruments-Fundamental Requirements and Test Methods - Part 1: General Requirements Applicable to all Ophthalmic Instruments
EN IEC 60601-1-2 (2014) Medical Electrical Equipment Part 1-2: General . Requirements for Basic Safety and Essential Performance - Collateral Standard Electromagnetic Compatibility – Requirements and Tests

In addition to the above, and in consideration of IEC 62366-1: 2015+AMD1: 2020, Medical devices - Part 1: Application of usability engineering to medical devices as well as FDA guidance, "Applying Human Factors and Usability Engineering to Medical Devices - Guidance For Industry And Food And Drug Administration Staff (document Issued On: February 3, 2016), results demonstrated that the iExaminer System with PanOptic Plus is suitable for its intended use.

The results of verification and validation demonstrate that the iExaminer System with PanOptic Plus has passed all established acceptance criteria and is as safe and effective as the predicate device for its intended use. Based on the comparison analysis and test results, Welch Allyn has concluded that the iExaminer System with PanOptic Plus to be substantially equivalent to the predicate device.

DISCUSSION OF CLINICAL TESTS:

Image Comparison Study: An image comparison study was performed on the iExaminer System with PanOptic Plus. The primary objective of this study was to demonstrate that the iExaminer System with PanOptic Plus images are substantially equivalent to the predicate device (i.e. PanOptic with iPhone 4/4S and iExaminer (version 1.0) FDA 510(k) K121405) images in their usefulness for documentation and clinical referrals.

The results of the image comparison study demonstrate that the iExaminer System with PanOptic Plus has passed all established acceptance criteria and is as safe and effective as the predicate device for its intended use. Based on the image comparison study results, Welch Allyn has concluded the iExaminer System with PanOptic Plus to be substantially equivalent to the predicate device.

CONCLUSION:

The iExaminer System with PanOptic Plus has been verified and validated against design input requirements, user needs and intended uses. The non-clinical and clinical testing (image comparison study) demonstrate that the subject device raises no new questions

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly italicized, giving it a sense of movement.

concerning safety and effectiveness, is substantially equivalent, and performs comparably to the predicate device that is currently marketed for the same intended use.

Regulation Number and Section

§ 886.1120 Ophthalmic camera.

(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.