The Reedgyn disposable hysteroscope RH-2D-01 is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures in an outpatient or office setting. Generally recognized indications for diagnostic hysteroscopy include: abnormal bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain.

The Reedgyn disposable hysteroscope RH-2S-01 is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures and to obtain an endometrial tissue sample (biopsy) in an outpatient or office setting. The sample is used for cytologic and histologic diagnosis. Generally recogmized indications for diagnostic hysteroscopy include: abnormal bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain.

Device Description

The Reedgyn disposable hysteroscopes, which include models RH-2S-01 and RH-2D-01, are used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures (both RH-2S-01 and RH-2D-01) and to obtain an endometrial tissue sample (biopsy) in an outpatient or office setting (RH-2S-01 only).

RH-2S-01 and RH-2D-01 are similar in design. The only difference between RH-2S-01 and RH-2D-01 is: RH-2S-01 is intended for performing diagnostic procedures and obtaining an endometrial tissue sample (biopsy), while the RH-2D-01 is intended for performing diagnostic procedures only.

The Reedgyn disposable hysteroscopes consist of a lightweight handle, a cannula integrated with a camera and a light source at the distal end to illuminate the area for visualizing images. The distal end of the cannula is equipped with a camera module including a camera and LED lightling. LED irradiates the surface of the object, and the reflected light enters the image processor through a lens and converts it into electrical signals, and then converted into a digital image signal , which is transmitted to the digital signal processing chip. After chip processing, the signal is transmitted to PC through USB interface.

The Reedgyn disposable hysteroscopes should be operated together with Reedgyn hysteroscope imaging software which was installed to a Microsoft Windows PC station. (Note: the Windows PC station is not included in the product configuration.)

AI/ML Overview

The provided text describes the Reedgyn disposable hysteroscope and its substantial equivalence to a predicate device, primarily through non-clinical performance testing. It focuses on engineering specifications and adherence to international standards rather than AI/algorithm performance. Therefore, I cannot provide a detailed answer to your request as it pertains to AI/algorithm acceptance criteria and studies for human performance improvement, ground truth establishment, or multi-reader studies, as this information is not present in the provided text.

However, I can extract and present the device's performance specifications mentioned in the text, which serve as acceptance criteria for its physical and optical characteristics.

Here's an attempt to fulfill the request based only on the provided document, acknowledging the limitations regarding AI/algorithm-specific details:

Device: Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)

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

The document does not explicitly present acceptance criteria in a pass/fail table format derived from a study. Instead, it lists the device's design specifications and then states that "The following performance data were provided to verify that the subject device met all design specifications. The results demonstrated that the subject device is as safe and effective as the predicate device."

Therefore, the "acceptance criteria" for the physical and optical performance of this non-AI medical device are its design specifications, and the "reported device performance" is the statement that it met these specifications through various non-clinical tests.

Parameter (Acceptance Criteria - Design Specification)	Reported Device Performance (Met Specification)
Cannula length	270mm
Outer diameter (RH-2D-01)	4.9mm
Outer diameter (RH-2S-01)	7.8mm
Inner diameter (RH-2D-01: Fluid channel In & out)	1.3mm
Inner diameter (RH-2S-01: Fluid channel In & out)	1.2mm
Inner diameter (RH-2S-01: Accessory channel)	2mm
Handle width	28 mm
Handle height	25 mm
Direction of view	20° ± 5°
Field of view	100° ± 5°
Number of pixels	1280 x 720
Depth of field	5-50mm
Light Source	LED
Operating Voltage	5V DC
Materials	PEBAX® thermoplastic elastomers (Cannula) and polycarbonate (Connector)
Tissue contact duration	≤24 hours
Sterilization state	Sterile
Usage	Single use
Biocompatibility	Non-cytotoxic, non-irritating, non-sensitizing, and not acutely toxic (established via testing of final, finished product)
Interoperability (Software)	Operates with Reedgyn hysteroscope imaging software on Microsoft Windows PC station
Electrical Safety (IEC 60601-1:2005)	Met applicable sections of the standard
Electromagnetic Compatibility (IEC 60601-1-2:2014)	Demonstrated to be electromagnetically compatible in its intended environment of use
Endoscopic Safety (IEC 60601-2-18:2009)	Met the requirements of the standard
General Endoscope Requirements (ISO 8600-1:2015)	Met the requirements of the standard
Field/Direction of View Determination (ISO 8600-3:2003)	Met the requirements of the standard
Maximum Width of Insertion Portion (ISO 8600-4:2014)	Met the requirements of the standard
Optical Resolution (ISO 8600-5:2005)	Met the requirements of the standard
Sterilization Validation (ISO 11135:2014)	In compliance
Packaging (ISO 11607-1:2006)	In compliance
Accelerated Aging (ASTM F1980-16)	In compliance
Tests of Sterility (ISO 11737-2:2009)	In compliance
Leak Determination (ASTM D3078-02(2013))	In compliance
Dye Penetration (ASTM F1929-15)	In compliance
Microbial Barrier Testing (DIN 58953-6:2016)	In compliance
Seal Strength (ASTM F88/F88M-15)	In compliance

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

The document describes non-clinical performance data and compliance with standards. It does not mention a "test set" in the context of patient data or algorithm evaluation. Sample sizes for engineering tests (e.g., sterilization validation, biocompatibility) are not specified. Data provenance regarding country of origin or retrospective/prospective studies is not relevant to the described testing, which appears to be laboratory-based validation.

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

This information is not applicable. The device is a direct viewing instrument, and the testing described is engineering and performance-based, not involving interpretation of images by experts to establish a "ground truth" for diagnostic accuracy of an AI algorithm.

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

Not applicable, as no human expert review or adjudication of a test set for diagnostic performance 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

No MRMC study or evaluation of human reader performance with or without AI assistance was mentioned or conducted, as this is not an AI-powered device.

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

Not applicable, as this is not an AI-powered device.

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

For the engineering and performance testing described, the "ground truth" would be established by the specifications and measurable physical/chemical properties defined by relevant international standards (e.g., ISO, IEC, ASTM) and the device's design. This is not comparable to diagnostic ground truth (e.g., pathology for disease presence).

8. The sample size for the training set

Not applicable, as this is not an AI-powered device. There is no "training set" in the context of machine learning.

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

Not applicable, as this is not an AI-powered device.

Summary

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

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.

November 18, 2019

Reed Medical (Zhejiang) Co., Ltd. % Daniel Qiu Project Manager Shanghai Qisheng Business Consulting Co., Ltd. Room 1301, Bld 46, Jing Gu Zhong Rd. No. 58, Min Hang District, Shanghai, CN Shanghai, Shanghai 200240 CHINA

Re: K190797 Trade/Device Name: Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope And Accessories Regulatory Class: II Product Code: HIH Dated: October 15, 2019 Received: October 15, 2019

Dear Daniel Oiu:

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

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

Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 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 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,

for Sharon Andrews 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

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

Indications for Use

510(k) Number (if known) K190797

Device Name

Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)

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}------------------------------------------------

510(k) Summary

l. Submitter's information

Name: Reed Medical (Zhejiang) Co., Ltd. Address: 8th floor, 10th building, No.988 of Xinxing two road, EDZ of Pinghu, Pinghu, Zhejiang, China Contact person: Lu Zhong Zhong Telephone: +86-573-85135876 Fax: +86-573-85135876 Date prepared: November 17, 2019

II.Device

Device trade name: Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) Classification name: Hysteroscope and Accessories Regulation class: II Regulation number: 21CFR 884.1690 Panel: Obstetrics/Gynecology Product code: HIH

III.Predicative device

K132384, U-scope 8000 System With Hsc+emb Cannula.

IV.Device description

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

Parameter	Specification
Cannula length	270mm
Outer diameter	RH-2D-01: 4.9mmRH-2S-01: 7.8mm
Inner diameter	RH-2D-01:-Fluid channel (In & out): 1.3mmRH-2S-01:-Fluid channel (In & out): 1.2mm-Accessory channel: 2mm
Handle width	28 mm
Handle height	25 mm
Direction of view	20° ± 5°
Field of view	100° ± 5°
Number of pixels	1280 x 720
Depth of field	5-50mm
Light Source	LED

The Reedgyn disposable hysteroscope is provided sterilea sealed pouch. It is for single use.

The Reedgyn disposable hysteroscope operates on 5V DC working voltage.

The general type of materials in the device are РЕВАХ® thermoplastic elastomers

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

(Cannula) and polycarbonate (Connector). The The Reedgyn disposable hysteroscope components are part of an external communicating device (Tissue/bone/dentin) in direct tissue contact for a duration ≤24 hours. . The biocompatibility of the Reedgyn disposable hysteroscope was established via testing of the final, finished product (see performance testing section below).

The Reedgyn disposable hysteroscopes are intended to be used in hospitals and physician offices.

V.Indication for use

The Reedgyn disposable hysteroscope RH-2S-01 is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures and to obtain an endometrial tissue sample (biopsy) in an outpatient or office setting. The sample is used for cytologic and histologic diagnosis. Generally recognized indications for diagnostic hysteroscopy include: abnormal bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain.

The indications for use of Reedgyn disposable hysteroscopes are similar to that of predicate device. The indications for the RH-2D-01 falls within the indications of the predicate, but does not include biopsy.

Attribute	Subject device	Predicative deviceU-Scope 8000 Hsc+embCannula
510(k) number	K190797	K132384
Indication for use	The Reedgyn disposable hysteroscope RH-2D-01 isused to permit viewing of the cervical canal anduterine cavity for the purpose of performingdiagnostic procedures in an outpatient or officesetting. Generally recognized indications fordiagnostic hysteroscopy include: abnormalbleeding, infertility and pregnancy wastage,	The predicative device is usedto permit viewing of thecervical canal and uterinecavity for the purpose ofperforming diagnosticprocedures and to obtain anendometrial tissue sample
Attribute	Subject device	Predicative deviceU-Scope 8000 Hsc+embCannula
	evaluation of abnormal hysterosalpingogram,intrauterine foreign body, amenorrhea, and pelvicpain.	(biopsy) in an outpatient oroffice setting. The sample isused for cytologic andhistologic diagnosis. Generallyrecognized indications fordiagnostic hysteroscopyinclude: abnormal bleeding,infertility and pregnancywastage, evaluation of abnormalhysterosalpingogram,intrauterine foreign body,amenorrhea, and pelvic pain.
	The Reedgyn disposable hysteroscope RH-2S-01 isused to permit viewing of the cervical canal anduterine cavity for the purpose of performingdiagnostic procedures and to obtain anendometrial tissue sample (biopsy) in anoutpatient or office setting. The sample is used forcytologic and histologic diagnosis. Generallyrecognized indications for diagnostic hysteroscopyinclude: abnormal bleeding, infertility andpregnancy wastage, evaluation of abnormalhysterosalpingogram, intrauterine foreign body,amenorrhea, and pelvic pain.	diagnostic hysteroscopyinclude: abnormal bleeding,infertility and pregnancywastage, evaluation of abnormalhysterosalpingogram,intrauterine foreign body,amenorrhea, and pelvic pain.
Procedures	Uterine diagnostic for RH-2D-01, Uterinediagnostic and endometrial biopsy for RH-2S-01	Uterine diagnostic andendometrial biopsy
Environment of use	Hospitals and physician offices	Hospitals and physician offices
Intended user	Physicians with adequate training in hysteroscopy	For use only by physicianswith adequate training inhysteroscopy.
Device features:-Components	CMOS camera semi-rigid cannula USB interface electronics USB cable	Image-capturing hand tower; attachable cannula with outflow and inflow portsin which suction can be created and with a curettenear its tip.
-Cannula outerdiameter	RH-2S-01: 7.8 mmRH-2D-01: 4.9 mm	4.3mm
-Accessory channel	RH-2D-01: N/ARH-2S-01: 2mm	N/A
-Cannula	Flexible	Flexible
Attribute	Subject device	Predicative deviceU-Scope 8000 Hsc+embCannula
-Cannula length	270mm	276mm
-Illumination lightsource	LEDs	LEDs
-Hysteroscope fieldof view	$100° ±5°$	$100° ±5°$
-Hysteroscopedirection of view	$20° ±5°$	$20° ±3°$
-Depth of field	5-50mm	4-45mm
-Imagingtransmission	Over USB interface to a viewing station	Image transmitted from avideo camera to a videomonitor on the handle
-Number of pixels	1280 x 720	400*400
-Optical image	Digital CMOS	Digital CMOS technology
Disposable/Reusable	Disposable/ only single usage	Reusable handle and a steriledisposable diagnostic cannula
Battery chargeindication	n/a - no battery	Charge indication as an icon onthe LCD monitor
Batterypower	n/a - no battery	3.7V
Adjustbrightness of LEDs	n/a - brightness is managed by camera exposureand gain	Adjust by depressing a buttonon the hand tower
Capture still or videoimages duringprocedure	Controlled by keyboard and foot switch interfaces	Capture still or video duringprocedure by depressing acamera button on the handtower
Enterpatient IDinformation prior toprocedure	User interface allows physician to add patientinformation	User interface on monitorallows physician to add patientinformation.
Durationof use	$≤$ 2 hours	$≤$ 24 hours
Sterilization	Entire product is sterile following exposure toethylene oxide (EO).	Hand tower is not sterile. TheU-scope 8000 HSC+EMBcannula is sterile followingexposure to ethyleneoxide(EO).
Frequency of use	Disposable for a single usage	Hand tower is reusable. The
Attribute	Subject device	Predicative device
		U-Scope 8000 Hsc+embCannula
		U-scope 8000 HSC+EMBcannula is single patient use.
Tissue contactmaterial	Compliant with ISO 10993	Compliant with ISO 10993

VI. Comparison of Technological Characteristics

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

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

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

The subjective device and predicative device have the same intended use. The subject and predicative device have different technological characteristics as evidenced by the table above. The differences in technological characteristics do not raise different questions of safety or effectiveness.

VII.Summary of non-clinical testing

The following performance data were provided to verify that the subject device met all design specifications. The results demonstrated that the subject device is as safe and effective as the predicate device..

Risk Analysis developed in accordance with ISO 14971:2007.
Electrical Safety Testing in accordance with IEC 60601-1:2005 (3rd Edition).
- The subject device was demonstrated to meet applicable sections of the standard.
. Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014.
- The subject device was demonstrated to be electromagnetically compatible । in its intended environment of use.
. Medical electrical equipment - Part 2-18: "Particular requirements for the basic essential performance of of endoscopic safety and a equipment" (IEC60601-2-18:2009).
- -The subject device met the requirements of the standard.
. Biocompatibility Tests in accordance with ISO 10993, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010),irritation (ISO 10993-10:2010) and acute systemic toxicity (ISO 10993-11:2017).
- i The subject device was demonstrated to be non-cytotoxic, non-irritating, non-sensitizing, and not acutely toxic.
Software Validation - Software Life Cycle Processes in accordance with IEC 62304:2015, and Guidance for Industry and FDA staff-Guidance for the content of premarket submissions for software contained in medical devices.Document issued on:May 11,2005.
- -The software of the subject device was demonstrated to function as intended per specification.
Endoscopes-medical endoscopes and endotherapy devices-Part 1:General requirements-(ISO 8600-1:2015).
- The subject device was demonstrated to meet the requirements of the ।

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

standard.

Optics and optical instruments - Medical endoscopes and endoscopic accessories —Part 3: Determination of field of view and direction of view of endoscopes with optics AMENDMENT 1.(ISO 8600-3:2003).
- The subject device was demonstrated to meet the requirements of the । standard.
Endoscopes — Medical endoscopes and endotherapy devices —Part 4: Determination of maximum width of insertion portion.(ISO 8600-4:2014).
- The subject device was demonstrated to meet the requirements of the standard.
Optics and photonics - Medical endoscopes and endotherapy devices -Part 5:Determination of optical resolution of rigid endoscopes with optics.(ISO 8600-5:2005).
- । The subject device was demonstrated to meet the requirements of the standard.

Due to its labeling as sterile, the Reedgyn disposable hysteroscope underwent sterilization validation and shelf life testing to confirm the label shelf life and was found in compliance with the following:

Sterilization of health-care products - Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices. (ISO 11135:2014).
. Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems. (ISO 11607-1:2006).
. Standard guide for accelerated aging of sterile barrier systems for medical devices (ASTM F1980-16).
. Sterilization of medical devices-Microbiological methods-Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process(ISO 11737-2:2009).
Standard test method for determination of leaks in flexible packaging by bubble emission(ASTM D3078-02(2013)).
. Standard test method for detecting seal leaks in porous medical packaging by dye penetration(ASTM F1929-15).
. Sterilization-sterile supply -Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized(DIN 58953-6:2016).
. Standard test method for seal strength of flexible barrier materials(ASTM F88/F88M-15).

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

Results from testing demonstrate assurancethe device is sterile and remains sterile throughout the proposed shelf life.

VIII.Conclusion

The Reedgyn disposable hysteroscopes have similar indications to that of the predicate. The RH-2D-01 indications fall within those of the predicate, and the difference does not alter the intended use. The technological differences between Reedgyn disposable hysteroscopes and the predicate device do not raise different questions of safety and effectiveness. Performance testing as described above has demonstrated that the subject device is as safe and effective as the predicate device. Therefore, the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 884.1690 Hysteroscope and accessories.

(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.