A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repar, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement.

The users of the 1688 Video Camera are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, neurosurgeons and urologists.

780 nm L11 LED Light Source with AIM and Safelight Cable:

Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the 780 nm L11 LED Light Source with AIM and SafeLight™ Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The 780 mm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging.

Fluorescence imaging of biliary ducts with the 780 nm L11 LED Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.

Additionally, the 780 nm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.

Upon interstitial administration of SPY AGENT GREEN, the 780 nm L11 LED Light Source with AIM and SafeLight Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The 780 nm L11 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

Device Description

The 780nm Advanced Imaging Modality (AIM) System is an endoscopic real-time 4K visible white light and near-infrared light illumination and imaging system. Near-infrared illumination is used for both fluorescence imaging using SPY AGENT TM GREEN (indocyanine green for injection, USP) and transillumination of the ureters during minimally invasive and open surgical procedures, respectively. The 780nm AIM System includes the following components: (1) A Camera System for processing nearinfrared and visible light images; (2) A Light Source and SafeLight Cable for emitting light within the visible light as well as near-infrared light spectrum; (3) An Endoscope for visible light and near-infrared light illumination and imaging; (4) The IRIS Ureteral Kit for transillumination of the ureters; and. (5) SPY AGENT "M GREEN (indocyanine green for injection, USP) used for fluorescence imaging.

AI/ML Overview

This document describes the 780 nm Advanced Imaging Modality (AIM) System (K214046) and its substantial equivalence to a predicate device (K211202). The provided text mentions various performance tests but does not detail any specific clinical study that establishes acceptance criteria for device performance related to diagnostic accuracy or clinical outcomes.

Instead, the performance data section focuses on engineering and safety standards, as well as bench and animal studies (referencing the predicate AIM system) to demonstrate the device's technical specifications and safety.

Therefore, I cannot fulfill the request for information regarding clinical acceptance criteria, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for clinical evaluation, or training set sample sizes from the given text.

However, I can extract the information that is present regarding technical performance testing:

1. Table of Acceptance Criteria and Reported Device Performance (Technical/Safety):

The document lists various tests and their results, indicating compliance with established standards or device input specifications. These are not clinical performance metrics in the traditional sense (e.g., sensitivity, specificity) but rather technical and safety assessments.

Test Category	Specific Test / Method	Acceptance Criteria (Implied)	Reported Device Performance
Electrical Safety	ANSI IEC 60601-1:2005 + A1:2012	Compliance with Standard	PASS
	IEC 60601-2-18:2009	Compliance with Standard	PASS
	IEC 60601-1-6:2013	Compliance with Standard	PASS
EMC Testing	IEC 60601-1-2:2014	Compliance with Standard	PASS
Laser Safety	IEC 60825-1:2014	Compliance with Standard	PASS
Sterilization	AAMI TIR12:2020	Compliance with Standard	PASS
	ISO 17664-1:2021	Compliance with Standard	PASS
	AAMI ST58:2013	Compliance with Standard	PASS
	ISO 14937:2009	Compliance with Standard	PASS
Software Validation & Verification	IEC 62304:2015	Compliance with Standard	PASS
Usability	IEC 62366-1:2020	Compliance with Standard	PASS
Performance - Bench	In accordance with device input specifications	Meets Specifications	PASS
	Spatial Uniformity	Meets Specifications	PASS
	Minimum Detectable Fluorescence	Meets Specifications	PASS
	Fluorescence Detection Depth	Meets Specifications	PASS
	Clinically Meaningful Limits of Detection	Meets Specifications	PASS
	Signal to noise	Meets Specifications	PASS
	Dynamic Range	Meets Specifications	PASS
	Localization	Meets Specifications	PASS
Performance - Animal	Testing completed utilizing predicate AIM System, in accordance with device user needs	Meets User Needs/Performance of Predicate	PASS

Missing Information (Not present in the provided text):

Since the document focuses on demonstrating substantial equivalence based on technical and safety testing rather than a clinical performance study measuring specific diagnostic accuracy or clinical outcomes, the following information cannot be extracted:

Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of human reader improvement with AI vs without AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical performance.
The sample size for the training set (as this is not an AI/ML device in the context of clinical decision support, but rather an imaging system).
How the ground truth for the training set was established.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 25, 2022

Stryker Michelle Hughes Senior Staff Regulatory Affairs Specialist 5900 Optical Court San Jose, California 95138

Re: K214046

Trade/Device Name: 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ, OWN, FCS, FCW, GWG Dated: April 22, 2022 Received: April 25, 2022

Dear Michelle Hughes:

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.

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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 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.

Purva Pandya, D.Eng. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K214046

Device Name

780nm Advanced Imaging Modality (AIM) System

Indications for Use (Describe)

780 nm 1688 4K Camera System :

780 nm L11 LED Light Source with AIM and Safelight Cable:

The 780 nm L11 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

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Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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Strykt

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R Part 807.92(c).

510(k) Number: K214046

Submitter:

Applicant:	Stryker Endoscopy5900 Optical CourtSan Jose, CA 95138
Contact Person:	Michelle HughesSenior Staff Regulatory Affairs SpecialistEmail: michelle.hughes@stryker.com
Date Prepared:	December 22, 2021

Subject Device:

The subject device is the 780 nm AIM (Advanced Imaging Modality) System, specifically the following system components:

Name of Device:	780 nm 1688 4K Camera System
Common or UsualName	3-chip Video Camera
ClassificationName:	Laparoscope, General and Plastic Surgery (21 C.F.R. §876.1500)Endoscope, Neurological (21 C.F.R. §882.1480)
Regulatory Class:	II
Product Code:	GCJGWG
510(k) ReviewPanel:	General & Plastic SurgeryNeurology

Name of Device:	780 nm L11 LED Light Source with Advanced Imaging Modality
Common or Usual Name	Light Source, Illuminator
Classification Name:	Confocal Optical Imaging1 (21 C.F.R. §876.1500)Fiberoptic light ureteral catheter2 (21 C.F.R. §876.4020)Light Source, Fiberoptic, Routine3 (21 C.F.R. §876.4020)Endoscope, Neurological4 (21 C.F.R. §882.1480)
Regulatory Class:	II
Product Code:	OWN1FSC2FCW3GWG4
510(k) Review Panel:	General & Plastic Surgery1Gastroenterology/ Urology2,3Neurology4

1When used for assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging

2When used to transilluminate the ureter during open or laparoscopic surgical procedures

3When used to provide standard endoscopic visible light to support real-time endoscopic visible imaging.

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4When used to provide standard endoscopic visible light and near-infrared imaging during minimally invasive cranial neurosurgery and endonasal skull base surgery.

Predicate Device(s):

AIM System: 1688 4K Camera System, L11 LED Light Source with AIM and K211202 SafeLight Cable

NOTE: The predicate device has not been subject to a design-related recall.

Device Description:

Indications for Use:

780 nm 1688 4K Camera System with Advanced Imaging Modality:

The 1688 4K Camera System is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ endoscope/ arthroscope/ sinuscope is indicated for use. The 1688 4K Camera System is indicated for adults and pediatric patients. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the 1688 Video Camera are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, orthopedic surgeons, ENT surgeons, neurosurgeons and urologists.

780 nm L11 LED Light Source with Advanced Imaging Modality

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stryker

standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization. Additionally, the 780 mm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging. Upon interstitial administration of SPY AGENT GREEN, the 780 nm L11 LED Light Source with AIM and SafeLight Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. The 780 nm L11 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

Item	Subject Device780 nm AdvancedImaging Modality(AIM) System	Predicate DeviceAdvanced Imaging Modality (AIM)System
Manufacturer	Stryker	Same as subject device.
Submission Reference	Current Submission	K211202
Intended Use	Endoscopic visible andnear-infrared lightillumination and imagingduring surgicalendoscopic procedures	Same as subject device
Indications for Use	NOTE 1	Same as subject device
Imaging Modes	White LightNear-infrared –fluorescenceNear-infrared –transillumination	Same as subject device.
System Components	Camera SystemLight Source and LightCableEndoscopesIRIS Ureteral KitSPY AGENT GREEN	Same as subject device.
Principles of Operations	Via an optical endoscopeand coupler, light isprojected from a lightsource onto one or morecomplementary metaloxide semiconductorimage sensors whichacquire a continuousstream of image data.The image data isprocessed to provide avideo stream that is thensent to a display forviewing.	Same as subject device.

Comparison of Technological Characteristics with the Predicate Device:

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Item	Subject Device780 nm AdvancedImaging Modality(AIM) System	Predicate DeviceAdvanced Imaging Modality (AIM)System
Safety Standards	IEC 60601-1IEC 60601-2-18IEC 60601-1-2IEC 60601-1-6IEC 60825-1	Same as subject device.
Camera System	Image Processing/Video OutputDigital	Same as subject device.
Light Source	Light Source/LaserRGB LEDsInfrared Laser	Same as subject device.
	Laser SafetyClassificationClass 1M	Same as subject device.
	InfraredWavelengths780nm (used for NIRfluorescence)830nm (used for NIRtransillumination)	806nm (used for NIR fluorescence)830nm (used for NIR transillumination).

NOTE 1: The 1688 4K Camera System is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ sinuscope/ sinuscope/ sinuscope is indicated for use. The 1688 4K Camera System is indicated for adults and pediatric patients. A few examples of the more common endoscope surgeries are Laparoscopic cholectorny, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the 1688 Video Camera are general and pediatric surgeons, gyneoologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, neurosurgeons and urologists.

Upon intravenous administration of SPY AGENT™ GREEN (indocyanine green for injection, USP), the 780 nm L11 LED Light Source with AIM and SafeLight™ Cable are used with SPY AGENT GREEN to provide real-time endoscopic visual and near infrared fluorescence imaging. The 780 nm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels. blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of the major extra-hepatic bile ducts (cystic duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging of biliary ducts with the 780 nm L11 LED Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization. Additionally, the 780 mm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging. Upon interstital administration of SPY AGENT GREEN, the 780 nm L11 LED Light Source with AIM and SafeLight Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic vessels and lymph nodes. The 780 nm L11 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

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Performance Data:

Testing was completed in accordance with the following:

Test	Method	Result
Electrical Safety	ANSI IEC 60601-1:2005 + A1:2012	PASS
	IEC 60601-2-18:2009	PASS
	IEC 60601-1-6:2013	PASS
EMC Testing	IEC 60601-1-2:2014	PASS
Laser Safety	IEC 60825-1:2014	PASS
Sterilization	AAMI TIR12:2020	PASS
	ISO 17664-1:2021	PASS
	AAMI ST58:2013	PASS
	ISO 14937:2009	PASS
Software Validation &	IEC 62304:2015	PASS
Verification
Usability	IEC 62366-1:2020	PASS
Performance - Bench	In accordance with device input specifications	PASS
	Spatial Uniformity	PASS
	Minimum Detectable Fluorescence	PASS
	Fluorescence Detection Depth	PASS
	Clinically Meaningful Limits of Detection	PASS
	Signal to noise	PASS
	Dynamic Range	PASS
	Localization	PASS
Performance - Animal	Testing completed utilizing predicate AIM System, in	PASS
	accordance with device user needs	PASS

Conclusions:

The 780 nm AIM System is substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate devices. In summary, the 780 nm Advanced Imaging Modality System is substantially equivalent with respect to safety and effectiveness to the legally marketed predicate device.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.