As a disposable medical device, the product is used along with the company's image processor, to enter human body through the urethra and provide images via video monitor, and realize endoscopy inspection or operation to the patient's ureter and renal pelvis.

Device Description

The Single-Use Digital Flexible Ureteroscope (Model: PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) is an endoscope which is used with the Monitor for Single-Use Endoscopy (Model:P1-D) produced by ENDOSO LIFE TECHNOLOGY for providing endoscopic imaging of the ureter and the renal pelvis for the purpose of diagnosis and treatment. The Single-Use Digital Flexible Ureteroscope is integrated with a working channel which allowing the use of flexible endoscopic accessories (e.g. stone basket, forceps, laser fibers for lithotripsy, etc.). The insertion portion of the endoscope is flexible, and the shape changes corresponding to the shape of the cavity. Anatomical images are captured by a CMOS chip at the distal end of the endoscope and the electronic signals are transmitted to the Monitor. Then, the resulting picture images are sent to and shown on a visual display.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device called "Single-Use Digital Flexible Ureteroscope". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific acceptance criteria via clinical performance data (like sensitivity, specificity, or reader improvement with AI).

The document details the device's technical specifications and compares them to a predicate device. It also outlines the non-clinical testing performed to ensure safety and performance, which is typical for 510(k) submissions seeking substantial equivalence.

Therefore, many of the requested items related to clinical performance studies, such as sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, and ground truth establishment for training sets, are not applicable or not explicitly stated in this type of submission.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device, the "acceptance criteria" are primarily related to meeting performance standards and showing similarity to the predicate device, rather than specific clinical performance metrics. The "reported device performance" is largely based on non-clinical tests.

Acceptance Criteria (based on standards/comparison)	Reported Device Performance (Non-Clinical Tests)
Optical Characteristics:
Field of View (similar to predicate)	Subject Device: 120° ± 10% (Predicate: 110°) - deemed similar
Direction of View (same as predicate)	Subject Device: 0° (Predicate: 0°)
Mechanical Characteristics:
Bending Angle (similar to predicate)	Subject Device: 260° - 300° (Predicate: Up: 285°, Down: 285°) - deemed similar
Maximum Insertion Portion Width (similar to predicate)	Subject Device: ≤ 2.6mm (7.7Fr) (Predicate: 3.15mm) - deemed similar (thinner)
Minimum Insertion Channel Width (same as predicate)	Subject Device: 1.2mm (Predicate: 1.2mm)
Working Length (similar to predicate)	Subject Device: 670 ± 3% (Predicate: 700mm) - deemed similar
Image Acquisition:
Sensor Type (same as predicate)	Subject Device: CMOS (Predicate: CMOS)
Illumination Source (same as predicate)	Subject Device: LED (Predicate: LED)
Color performance (color reproduction)	Tested (results met)
Optical performance (resolution, depth of field, image intensity uniformity, distortion)	Tested (results met ISO 8600 series)
Dynamic Range	Tested (results met)
Leakage tightness	Tested (results met)
Bending/deflection endurance	Tested (results met)
Withstand of channel	Tested (results met)
Photobiological safety of lamps	Tested (according to IEC 62471)
Biocompatibility (ISO 10993-1, FDA Guidance):
Cytotoxicity	Tested (results met)
Sensitization, Intracutaneous reactivity/irritation	Tested (results met)
Material-mediated pyrogenicity	Tested (results met)
Acute systemic toxicity	Tested (results met)
Sterilization (ISO 11135:2014, ISO 10993-7:2008):
Validation of sterilization method	Validated (EO)
EO/ECH residual test	Tested (results met)
Shelf Life (ASTM F1980-16):
Product performance after aging	Tested (results met)
Sterile testing after aging	Tested (results met)
Package Integrity (ISO 11607-1:2019, ISO 11607-2:2019, ASTM F88/F88M-15, ASTM F1929-15):
Package validation	Conducted
Transport and shipping testing (ASTM D4169-16)	Conducted
Package integrity after aging	Tested (results met)
Electrical Safety and EMC (ANSI/AAMI ES:60601-1:2005/A2:2010, IEC 60601-2-18:2009, IEC 60601-1-2:2014):
Compliance with standards	Compliant

Study Proving Device Meets Acceptance Criteria:

The document states: "The subject of this premarket submission, did not require clinical studies to support substantial equivalence." This means the "study" proving the device meets acceptance criteria is primarily a series of non-clinical (benchtop) tests and comparisons to a predicate device, demonstrating that the new device is as safe and effective as the legally marketed predicate.

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

Sample Size: Not applicable. The document describes non-clinical tests. For example, for biocompatibility, specific tests were performed on "patient contacting components," but no sample size for a clinical "test set" is mentioned as clinical studies were not required.
Data Provenance: The tests appear to be conducted by the manufacturer or their designated testing facilities, likely in China (Hunan, where the manufacturer is located). The data is generated retrospectively as part of the device development and submission process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical test set with corresponding ground truth established by experts is described. The "ground truth" for this submission are the established engineering standards, biocompatibility standards, and the performance characteristics of the predicate device.

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

Not applicable, as no clinical test set requiring adjudication of findings is 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

Not applicable. This device is a ureteroscope (an
endoscope), not an AI diagnostic/assistive tool for human readers. No MRMC study was conducted.

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

Not applicable. This is a medical instrument, not an AI algorithm.

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

The "ground truth" for this submission is based on:
- Validated engineering and medical device standards (e.g., ISO 8600, IEC 62471, ISO 10993, ISO 11135, ASTM F1980, ISO 11607, ASTM D4169, IEC 60601 series).
- Performance characteristics of the legally marketed predicate device (K230200).
- Pass/fail criteria for the various non-clinical tests performed.

8. The sample size for the training set

Not applicable. There is no mention of a training set for an AI algorithm.

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

Not applicable. There is no mention of a training set for an AI algorithm within this document.

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). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

January 22, 2025

Hunan Endoso Life Technology Co., Ltd. % Eric Zhang RA manager Landlink Healthcare Technology (Shanghai) Co., Ltd Room 1308, Baohua International Plaza, West Guangzhong Road 555, Jingan District Shanghai, 200000 CHINA

Re: K241956

Trade/Device Name: Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Dated: December 23, 2024 Received: December 23, 2024

Dear Eric Zhang:

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 (OS) 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 (QS) 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-udi-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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

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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,

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)

K241956

Device Name

Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)

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.

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510(k) Summary

Date Prepared:	April 3. 18th, 2024
Manufacturer:	Hunan Endoso Life Technology Co., Ltd.4th floor, Building 10, Innovation andEntrepreneurship Center, 31 Dongfeng Road, HepingStreet, Xiangtan Economic DevelopmentDistrict,HuNan,China 411199
Contact Person:	WangFu/RA ManagerHunan Endoso Life Technology Co., Ltd.Tel: (86) 0731-52331999Email: wangfu@endoso.com.cn
Submission Correspondent:	Mr.Eric ZhangLandlink Healthcare Technology (Shanghai) Co., Ltd.Email: eric.zhang@landlink-health.com
Identification of the Device:
Proprietary/Trade Name:	Single-Use Digital Flexible Ureteroscope
Model:	PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5,PUR12-6, PUR12-S, PUR12-S1, PUR12-S2
Common Name:	Ureteroscope and accessories, flexible/rigid
Regulatory Number:	21 CFR Part 876.1500
Product Code:	FGB
Device Class:	Class II
Review Panel:	Gastroenterology/Urology
Predicate Device:
510(k) Number :	K230200
Trade name :	Single-Use Flexible Ureteroscope
Classification Name:	Endoscope and accessories
Regulatory Number:	21 CFR Part 876.1500
Product Code:	FGB
Device Class:	Class II

Device Description:

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the renal pelvis for the purpose of diagnosis and treatment. The Single-Use Digital Flexible Ureteroscope is integrated with a working channel which allowing the use of flexible endoscopic accessories (e.g. stone basket, forceps, laser fibers for lithotripsy, etc.). The insertion portion of the endoscope is flexible, and the shape changes corresponding to the shape of the cavity. Anatomical images are captured by a CMOS chip at the distal end of the endoscope and the electronic signals are transmitted to the Monitor. Then, the resulting picture images are sent to and shown on a visual display. Mechanism of action:

The light emitted by the LED cold light source at the distal tip of the disposable Single-Use Digital Flexible Ureteroscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Monitor via the VI circuit. The Monitor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the attached monitor. The Monitor also controls the brightness of the LEDs on the endoscope.

Single-Use Digital Flexible Ureteroscope has the following physical and performance characteristics:

Maneuverable tip controlled by the user
Flexible insertion cord
Camera and LED light source at the distal tip
Sterilized by Ethylene Oxide
For single use

Indications for Use:

Comparison with Predicate Device:

The Single-Use Digital Flexible Ureteroscope and its predicate device, Hunan Vathin Medical Instrument Co., Ltd. (K230200) have the same intended use, sterilization Methods and similar physical characteristics, optical characteristics.

Substantial Equivalence:

The Single-Use Digital Flexible Ureteroscope employs the same fundamental scientific technology as its predicate devices, as below table:

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	Subject Device	Predicate Device K230200	Comparison
Trade Name	Single-Use DigitalFlexible Ureteroscope	Single-Use FlexibleUreteroscope	/
ClassificationName	Endoscope andaccessories	Endoscope and accessories	/
ProductCode	FGB	FGB	/
RegulationNumber	21 CFR 876.1500	21 CFR 876.1500	/
Indicationsforuse	As a disposablemedical device, theproduct is used alongwith the company'simage processor, toenter human bodythrough the urethraand provide imagesvia video monitor, andrealize endoscopyinspection oroperation to thepatient's ureter andrenal pelvis.	The Single-use FlexibleUreteroscope isdesigned for use withVathin DisplayUnits, endotherapyaccessories and otherancillary devices for theendoscopy andendoscopic surgery withinurinary tractand kidney in adults.	Same
Applicationfield	The device is for usein a hospital orqualified medicalinstitution.	The device is for use in ahospital orqualified medicalinstitution.	Same
Intendeduser	Use in a Healthcarefacility/hospitalenvironment bytrained surgicalphysicians who arefamiliar withendoscopicprocedures.	The device is only to beused by skilledmedical staff trained inclinical endoscopictechniques and procedures.	Same
Patientpopulation	Adults	Adults	Same
	Subject Device	Predicate Device K230200	Comparison
Field ofview(degree)	$120°±10%$	$110°$	Similar 1
Direction ofview(degree)	$0°$	$0°$	Same
Bendingangle(degree)	$260°~300°$	Up: $285°$Down: $285°$	Similar 2
Maximuminsertionportionwidth(mm)	$≤2.6mm$ (7.7Fr)	3.15	Similar 3
Minimuminsertionchannelwidth(mm)	1.2	1.2	Same
Workinglength(mm)	$670±3%$	700	Similar 4
Workinglength(mm)	CMOS	CMOS	Same
Illuminationsource	LED	LED	Same
Single-use	Yes	Yes	Same
Sterilization	EO	EO	Same

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Analysis of similar1:

The Field of View of the subject device is similar as the predicate device.The optical performance of the subject device was tested and the results met the ISO 8600 series, this difference will not raise any issues in safety and effectiveness.

Analysis of similar 2:

The Bending angle (degree) of the subject device is similar as the predicate device.All the performance was tested and the results met the standard requirements, this difference will not raise any issues in safety and effectiveness.

Analysis of similar 3:

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The Maximum insertion width(mm of the subject device is thinner than the predicate device. All the performance was tested and the results met the standard requirements, this difference will not raise any issues in safety and effectiveness.

Analysis of similar 4:

The Working length (mm) of the subject device is similar as the predicate device.All the performance was tested and the results met the standard requirements, this difference will not raise any issues in safety and effectiveness.

Non-Clinical and/or Clinical Tests Summary & Conclusions

The Single-Use Digital Flexible Ureteroscope was designed to comply with applicable parts of ISO 8600. Optical measurements were performed according to applicable part of ISO 8600 standard.

Mechanical characteristics were tested and include leakage tightness, bending, deflection endurance, withstand of channel. Photobilogical safety of lamps test according to IEC 62471.

In addition, comparative testing related to image quality parameters including Color performance (color reproduction), optical performance (resolution, depth of field and image intensity uniformity, distortion), and dynamic range test was performed for submitted Single-Use Digital Flexible Ureteroscope and the predicate device to support substantial equivalence.

In addition to above, subject device has also performed following non-clinical performances testing:

Biocompatibility

The biocompatibility evaluation for the patient contacting components of the Single-Use Digital Flexible Ureteroscope was performed according to ISO 10993-1 and FDA Guidance. The following tests were conducted based contact category of "Surface-Breached or compromised surface" with a contact duration of "Limited (< 24 hours):

Cytotoxicity: ISO 10993-5:2009/(R) 2014
· Sensitization, Intracutaneous reactivity/irritation: ISO 10993-10:2010
· Material-mediated pyrogenicity: ISO 10993-11:2017
· Acute systemic toxicity: ISO 10993-11:2017

Sterilization and sterile testing

The sterilization method has been validated to ISO 11135:2014, which has thereby determined the routine control and monitoring parameters.

EO/ECH residual test was performed according to ISO 10993-7:2008.

The shelf life of the Single-Use Digital Flexible Ureteroscope is determined based on stability study which includes ageing test according to ASTM F1980-16, Standard

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Guide for Accelerated Aging of Sterile Barrier.Both product performance and sterile testing were tested after aging test.

Package integrity testing

Package validation was conducted according to ISO 11607-1:2019 and ISO 11607-2:2019, and F88/F88M-15, ASTM F 1929-15.

Transport and shipping testing as per ASTM D4169-16.Package integrity testing was performed after aging testing.

Electrical Safety and EMC

The electrical safety and EMC data included in the submission is in compliance with the following FDA recognized standards: •ANSI/AAMI ES:60601-1:2005/A2:2010 •IEC 60601-2-18:2009 •IEC 60601-1-2:2014

Clinical Tests:

The subject of this premarket submission, did not require clinical studies to support substantial equivalence.

Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that the subject device, the Single-Use Digital Flexible Ureteroscope is substantially equivalent to the 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.