This Single-use Flexible Ureteroscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra. bladder, ureter and renal pelvis.

This Single-use Flexible Cystoscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra, bladder and renal pelvis.

This Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on the monitor detected within the field of view from the body cavity.

Device Description

The subject device, Urology Videoscope System is consisting of a Single-use Flexible Ureteroscope (SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-24-P SUV-2B-B SUB-2B-P SUV-2C-B SUV-2C-P) or Single-use Flexible Cystoscope (SUV-1D-B SUV-1D-P) and an Endoscopic Image Processor (HDVS-S100A, HDVS-S100D) including the foot switch. The subject device has been designed to be used for endoscopic diagnosis and therapies within the urinary system such as urethra, bladder, ureter and renal pelvis.

The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are single use devices. They are intended to be used in conjunction with Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra, bladder, ureter and renal pelvis. There are ten models of Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope, with four kinds of insertion portion widths (2.5mm, 2.7mm, 2.8mm and 5.4 mm), four working lengths (380mm, 550mm, 635mm and 680mm), two different treatment section (with or without suction section).

The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are single-channel is in the distal end of the endoscope, and it bifurcates to two channels leading to the irrigation valve and suction section.

The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the shelf life of three years.

The Endoscopic Image Processor is a reusable device. The Endoscopic Image Processor has two models. The only difference between the two models is that the HDVS-S100A has Enhance function and the HDVS-S100D does not have the Enhance function.

AI/ML Overview

The provided text is an FDA 510(k) clearance letter and summary for a Urology Videoscope System. It details acceptance criteria based on non-clinical performance data and various tests. However, it does not include information about a study proving device meets acceptance criteria related to human reader performance with or without AI assistance, a multi-reader multi-case (MRMC) comparative effectiveness study, or any AI component for which such an evaluation would be relevant.

The document primarily focuses on bench testing and technical performance of the Ureteroscope, Cystoscope, and Image Processor, rather than the diagnostic interpretive performance of an AI algorithm.

Therefore, many of the requested points in the prompt (2-9) are not applicable or cannot be answered from the provided text, as they pertain to AI/machine learning model evaluation in a diagnostic context.

Here's the information that can be extracted or deduced from the text, with explanations for what cannot be answered:

1. A table of acceptance criteria and the reported device performance

The document lists various performance tests conducted to demonstrate compliance with standards, implying these are the acceptance criteria for the respective tests. However, it does not provide specific numerical acceptance thresholds or detailed "reported device performance" values for each criterion, only that "The test results demonstrated that the subject device complies with the standard requirements" or that testing was "conducted on the subject device" to "demonstrate the subject endoscope can function as intended."

Acceptance Criteria Category	Specific Tests/Standards Mentioned	Reported Device Performance (Summary)
Electrical Safety and Electromagnetic Compatibility (EMC)	IEC 60601-1 :2012+A2:2020	Complies with standard requirements
	IEC 60601-2-18:2009	Complies with standard requirements
	IEC 60601-1-2:2014+A1:2020	Complies with standard requirements
Biocompatibility	ISO 10993-1 and FDA guidance	Tests conducted in accordance with requirements
	Cytotoxicity (ISO 10993-5:2009)	Tests conducted in accordance with requirements
	Sensitization (ISO 10993-10:2021)	Tests conducted in accordance with requirements
	Irritation (ISO 10993-23:2021)	Tests conducted in accordance with requirements
	Acute Systemic Toxicity (ISO 10993-11:2017)	Tests conducted in accordance with requirements
	Pyrogen (ISO 10993-11:2017)	Tests conducted in accordance with requirements
Endoscope Specific Standards	ISO 8600-3:2019	Designed to comply with applicable parts
	ISO 8600-4:2014	Designed to comply with applicable parts
Optical Performance	Field of View & Direction of View	Testing conducted
	Signal-Noise Ratio & Dynamic Range	Testing conducted
	Color Reproduction	Testing conducted
	Geometric Distortion	Testing conducted
	Image Frame Frequency & System Delay	Testing conducted
	Intensity Uniformity	Testing conducted
	Depth of Field & Resolution	Testing conducted
Mechanical Performance	Leakage testing	Testing conducted to demonstrate intended function
	Suction testing	Testing conducted to demonstrate intended function
Shelf Life and Service Life	Use-life of image processor is six years	Demonstrated (referenced K210379)
Photobiological Safety	IEC 62471:2006	Tested in accordance with standard
Software and Cybersecurity	FDA guidance ("Content of Premarket Submissions" and "Cybersecurity in Medical Device")	Verification and validation testing, cybersecurity testing conducted. Documentation provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document as the studies described are non-clinical, bench-top, and engineering performance tests, not studies on image datasets. The device is manufactured in China.

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)

This information is not applicable/not provided. The ground truth for the non-clinical tests would be established by engineering specifications, physical measurements, and adherence to international standards, not by clinical experts reading images.

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

This information is not applicable/not provided. Adjudication methods are relevant for clinical image interpretation studies, not for the technical performance tests described.

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

There is no mention of an AI component or any MRMC study in this document. The device is an endoscope system for visualization and therapy, not an AI-assisted diagnostic tool. The document explicitly states: "The clinical data is not applicable."

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

There is no mention of an AI algorithm in this document, therefore no standalone algorithm performance study was indicated.

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

For the non-clinical tests described, the "ground truth" would be the engineering specifications, physical parameters, and established international standards (e.g., ISO, IEC) against which the device's performance is measured. It is not clinical ground truth.

8. The sample size for the training set

This information is not applicable/not provided, as there is no AI or machine learning model mentioned that would require a training set.

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

This information is not applicable/not provided, as there is no AI or machine learning model mentioned.

Summary

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Image /page/0/Picture/0 description: The image shows 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.

March 27, 2025

Scivita Medical Technology Co., Ltd. Dan Jiang Senior Regulatory Affairs Specialist No.2, Qingqiu Street, Suzhou Industrial Park Suzhou, Jiangsu 215000 CHINA

Re: K243708

Trade/Device Name: Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB, FAJ Dated: February 28, 2025 Received: February 28, 2025

Dear Dan Jiang:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510/k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

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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,

Mark J. Antonino -S

Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K243708

Device Name

Urology Videoscope System

(Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)

Indications for Use (Describe)

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)

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."

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510(k) #:	K243708	Prepared on: 2025-03-27
Contact Details		21 CFR 807.92(a)(1)
Applicant Name	Scivita Medical Technology Co.,Ltd.
Applicant Address	No.2, Qingqiu Street, Suzhou Industrial Park, 215000 Suzhou, Jiangsu Prov., P.R.CHINA Suzhou 215000 China
Applicant Contact Telephone	86-512-81877788
Applicant Contact	Mrs. Ruqin Wu
Applicant Contact Email	wuruqin@scivitamedical.com
Correspondent Name	Scivita Medical Technology Co.,Ltd.
Correspondent Address	No.2, Qingqiu Street, Suzhou Industrial Park, 215000 Suzhou, Jiangsu Prov., P.R.CHINA Suzhou Suzhou 215000 China
Correspondent Contact Telephone	86-512-81877788
Correspondent Contact	Ms. Dan Jiang
Correspondent Contact Email	ra@scivitamedical.com
Device Name		21 CFR 807.92(a)(2)
Device Trade Name	Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)
Common Name	Endoscope and accessories
Classification Name	Ureteroscope And Accessories, Flexible/Rigid
Regulation Number	876.1500
Product Code(s)	FGB
Legally Marketed Predicate Devices		21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K172098	Medical Video Endoscope System	FGB
Device Description Summary		21 CFR 807.92(a)(4)
The subject device, Urology Videoscope System is consisting of a Single-use Flexible Ureteroscope (SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-24-P SUV-2B-B SUB-2B-P SUV-2C-B SUV-2C-P) or Single-use Flexible Cystoscope (SUV-1D-B SUV-1D-P) and an Endoscopic Image

SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-P) or Single-use Flexible Cystoscope (SUV-1D-P) and an Endoscopic Image Processor (HDVS-S100A, HDVS-S100D) including the foot switch. The subject device has been designed to be used for endoscopic diagnosis and therapies within the urinary system such as urethra, bladder, ureter and renal pelvis.

The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are single use devices. They are intended to be used in

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K243708. Page 2 of 3

conjunction with Endoscopic Image Processor to provide images thi יום יום רוב בין היינו בין יולי ביני של כל כל כל כל כל כל כל כל כל כל כל כל כל כל כל כל כל כל כל כל כל כל כל and treatment of the urinary system such as urethra, bladder, ureter and renal pelvis. There are ten models of Singleouse Prievise Ureteroscope and Single-use Flexible Cystoscope, with four kinds of insertion portion widths (2.5mm, 2.7mm, 2.8mm and 5.4 mm), four working lengths (380mm, 550mm, 635mm and 680mm), two differe ntreation section (1) him, included in the or without suction section.

The Single-use Flexible Ureteroscope and Single-use Flexible Cystos cope are single-channel is in the distal end of the endoscope, and it bifurcates to two channels le ading to the irrigation valve and suction section.

The Single-use Flexible Ureteroscope and Single-use Flexible Cystos cope are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the shelf life of three years.

The Endoscopic Image Processor is a reusable device. The Endoscop ic Image Processor has two models. The only difference between the two models is that the HDVS-S100A has Enhance function and the H DVS-S100D does not have the Enhance function.

Intended Use/Indications for Use

This Single-use Flexible Ureteroscope is intended to use in conjunction with endoscopic images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra, bladder, ureter and renal pelvis.

This Single-use Flexible Cystoscope is intended to use in conjunction with endoscopic image through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra, bladder and renal pelvis.

This Endoscopic Image Processor is used for endoscopic diagnosis and the electronic endoscopes, displaying the images on the monitor detected within the field of view from the body cavity.

Indications for Use Comparison

Both the subject device and predicate device are used for endoscopic diagnosis within the urinary system. The subject and predicate device contain no differences in intended use, they are both Ureteroscopes that obtain visualization with an image processor.

Technological Comparison

The subject endoscope Single-use Flexible Ureteroscope or Single-use Flexible Cystoscope and the predicate Uscope (K172098) share the similar technological characteristics, including one CMOS image sensors for visualization, two LED illumination light modules for lighting and a working channel in the distal end of the endoscope.

The technological characteristics difference between the subject and predicate endoscope is only in dimensions, such as depth of field, outer diameter of insertion section, up/down deflection, working length and inner diameler instrument channel. These differences do not raise different questions of safety and effectiveness of the subject device.

The subject image processor is basically the same as the predicate Eview (K172098) in technological characteristic. Both of them receive the signals from endoscope and transmit them to the monitor and display endoscope image on the monitor. They are different in video signal output interface. This difference will not affectiveness of the subject device.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

The following performance data were provided in substantial equivalence determination. The test results demonstrated that the subject device complies with the standard requirements.

Electrical Safety and Electromagnetic Compatibility (EMC) Testing: The electromagnetic compatibility testing were conducted in accordance with IEC 60601-1 :2012+A2:2020, IEC 60601-2-18:2009 and IEC 60601-1-2:2014+A 1 :2020.

Biocompatibility Testing The biocompatibility tests were conducted in accordance with the requirements of ISO 10993-1 and FDA guidance, including Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2021), Iritation (ISO 10993-23:2021), Acute Systemic Toxicity (ISO 10993-11 :2017) and Pyrogen (I SO 10993-11:2017) tests.

ISO 8600 Testing

The subject device was designed to comply with applicable parts of ISO 8600-3:2019, ISO 8600-4: 2014.

21 CFR 807.92(a)(6)

21 CFR 807.92(a)(5)

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K243708

Page 3 of 3

Optical performance:

Optical performance comparison testing was conducted on the subject device. The optical performance test titems include Field of View & Direction of View, Signal-Noise Ratio & Dynamic Range, Color Reproduction, Geometric Distortion, Image Frame Frequency & System Delay, Intensity Uniformity, Depth of Field & Resolution.

Mechanical Performance Testing:

The mechanical performance testing was conducted to demonstrate the subject endoscope can function as intended. The mechanical performance testing includes the leakage testing and suction testing.

Shelf Life and Service Life (Use Life): The use-life of image processor is six years. The use-life of the image processor has been demonstrated in K210379.

Photobiological safety: The photobiological safety testing was tested in accordance with IEC 62471:2006.

Software and Cybersecurity Testing:

Software verification and validation testing and cybersecurity testing were conducted on the documentation was provided as recommended by FDA's guidance, "Content of Premarket Submissions" and "Cybersecurity in Medical Device: Quality System Considerations and Content of Premarket Submissions".

The clinical data is not applicable.

The nonclinical test were conducted to demonstrate that the subject is as safe and effective as the predicate.

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.