The Hysteroscope System is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

Note: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery.

Generally recognized indications for diagnostic hysteroscopy include:

Abnormal bleeding
Infertility and pregnancy wastage
Evaluation of abnormal hysterosalpingogram
Intrauterine foreign body
Amenorrhea
Pelvic pain

Generally recognized indications for operative hysteroscopy include:

Directed endometrial biopsy
Polypectomy
Submucous myomectomy
Transection of intrauterine adhesions
Transection of intrauterine septa
Endometrial ablation

Device Description

The Hysteroscope System consists of a sterile single-use disposable Rigid Hysteroscope and video processor for clinical image processing. The Rigid Hysteroscope (available in models GSA01-B, GSB04-B and GSB14-B) are used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. Model GSA01-B is intended for diagnostic hysteroscopy only, and has a rigid shaft without operative channel (injection channel only). Models GSB04-B and GSB14-B are intended for both diagnostic and operative hysteroscopy, and have an operative (insertion) channel. GSB04-B has a rigid shaft, and GSB14-B has a curved tip. The video processor provides power and processes the images from the Rigid Hysteroscopes. Anatomical images are collected via a CMOS chip at the distal end of the hysteroscope and are transmitted through the video processor to a monitor.

AI/ML Overview

The provided text is a 510(k) Summary for a Hysteroscope System. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, it does not include information about acceptance criteria and a study proving that the device meets those criteria in the way typically expected for a clinical performance study involving AI or human readers.

The performance data included in this document focuses on non-clinical testing performed to ensure the device's safety and effectiveness in relation to its physical and functional attributes. This is standard for medical devices like hysteroscopes, which are tools for visualization and surgical procedures, rather than AI-driven diagnostic or interpretative devices.

Therefore, the requested information elements related to AI, human readers, effect size, and specific ground truth establishment (like expert consensus, pathology, or outcomes data for complex diagnostic tasks) are not applicable to the content provided.

Here's the information that can be extracted or inferred from the document regarding acceptance criteria and performance data:

Acceptance Criteria and Device Performance for Shanghai AnQing Medical Instrument CO., Ltd. Hysteroscope System (K181545)

The acceptance criteria for the Hysteroscope System are based on engineering and performance standards relevant to a medical device of its type (a hysteroscope). The "study" proving acceptance criteria is a series of non-clinical tests.

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

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Evaluated per ISO 10993-1:2009 for "Surface – Mucosal Membrane" with "Limited (< 24 hours)" contact.
Cytotoxicity	Device demonstrated to be non-cytotoxic (per ISO 10993-5:2009).
Irritation and Sensitization	Device demonstrated to be non-sensitizing and non-irritating (per ISO 10993-10:2010).
Sterilization	Ethylene oxide sterilization method validated to ISO 11135:2014.
Shelf Life	Demonstrated through a stability study, ensuring devices maintained specifications and packaging maintained sterility after aging.
Electrical Safety and Electromagnetic Compatibility (EMC)	System complies with IEC 60601-1:2005/(R)2012, IEC60601-2-18 Edition 3, and IEC 60601-1-2:2014.
Software Verification and Validation	Conducted and documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for a "moderate" level of concern.
Optical Performance	Optical performance testing was conducted. The system complies with ISO 8600 series and was demonstrated to meet predefined acceptance criteria. (Specific criteria not detailed, but likely include resolution, illumination, field of view, etc., as per ISO 8600).
Mechanical Performance	Mechanical characteristics including leaking, bending, articulating, and irrigation tests were performed. Devices were demonstrated to meet predefined acceptance criteria. (Specific criteria not detailed, but relate to functional integrity and operation).
Physical Specifications	GSA01-B: Straight shape, Φ4.0mm scope diameter, 260mm working length, N/A insertion channel, 0.8mm injection channel diameter. GSB04-B: Straight shape, Φ6.4mm scope diameter, 260mm working length, 2.3mm insertion channel diameter, 1.1mm injection channel diameter. GSB14-B: Curved distal tip (22°±5°, 25mm±1.3mm length), Φ6.4mm scope diameter, 260mm working length, 2.3mm insertion channel diameter, 1.1mm injection channel diameter. (All within specified tolerances).

2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for individual tests (e.g., how many hysteroscopes were tested for biocompatibility, optical performance, or mechanical performance). These are typically quality control or design verification tests, not clinical studies with patient data. Data provenance (country of origin, retrospective/prospective) is not applicable as these are laboratory and engineering tests, not patient data studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the type of testing described. Ground truth for these engineering performance tests is established by adherence to recognized national and international standards (e.g., ISO, IEC) and internal design specifications, not by expert medical review of images or diagnoses.

4. Adjudication method for the test set
Not applicable. Adjudication methods like '2+1' or '3+1' are used in clinical studies involving interpretation of data (e.g., radiology images) by multiple experts to establish a consensus ground truth. The testing here is for physical/functional device performance against objective standards.

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 Hysteroscope System, a medical instrument for direct visualization and surgical procedures, not an AI-assisted diagnostic or interpretive system. Therefore, MRMC studies and effect sizes related to AI assistance for human readers are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-based algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance data in this submission is adherence to established engineering, biocompatibility, sterilization, and electrical safety standards (e.g., ISO, IEC). It also includes meeting predefined internal design specifications for mechanical and optical functionality. There is no clinical "ground truth" (like pathology or outcomes data) in the context of diagnostic interpretation, as this device is a viewing and operative tool.

8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established
Not applicable.

Summary

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May 10, 2019

Shanghai AnQing Medical Instrument CO., Ltd. Lina Fei Quality Manager 150 Cailun Road, Zhangjiang High-Tech Park Shanghai, 201210 China

Re: K181545

Trade/Device Name: Hysteroscope System Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: II Product Code: HIH Dated: April 3, 2019 Received: April 10, 2019

Dear Lina Fei:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sharon M. Andrews Assistant Division 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

510(k) Number (if known) K181545

Device Name Hysteroscope System

Indications for Use (Describe)

The Hysteroscope System is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

Note: Hysteroscopes are used as tools to access the uterine cavity and of themselves, a method of surgery.

Generally recognized indications for diagnostic hysteroscopy include:

Abnormal bleeding
· Infertility and pregnancy wastage
· Evaluation of abnormal hysterosalpingogram
· Intrauterine foreign body
· Amenorrhea
· Pelvic pain

Generally recognized indications for operative hysteroscopy include:

· Directed endometrial biopsy
· Polypectomy
Submucous myomectomy
· Transection of intrauterine adhesions
· Transection of intrauterine septa
· Endometrial ablation

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)

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510(k) Summary – K181545

I. Submitter

Device submitter: Shanghai AnQing Medical Instrument CO., Ltd. Room 202, 2nd Floor, No.7 Building & Room 202, 2nd Floor No.4 Building, 150 Cailun Road, Zhangjiang High-Tech Park, 201210, Shanghai, China

Contact person: Wen Shi Quality Manager Phone: +86 135 8580 5802 Fax: +86 21 5019 1132 – 8004 Email: wenshi@innovexmed.com.cn

Date prepared: May 9, 2019

II. Device

Trade Name of Device: Hysteroscope System Common Name: Hysteroscope (And Accessories) Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: II Product Code: HIH Product Code Name: Hysteroscope and Accessories

III. Predicate Devices

Trade name:	LiNA OperaScope
Common name:	Hysteroscope
Classification:	21 CFR 884.1690 Hysteroscope and Accessories
Product Code:	HIH, Hysteroscope and Accessories
Premarket Notification:	K171113

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

IV. Device description

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shaft without operative channel (injection channel only). Models GSB04-B and GSB14-B are intended for both diagnostic and operative hysteroscopy, and have an operative (insertion) channel. GSB04-B has a rigid shaft, and GSB14-B has a curved tip. The specifications for the three models are as follows:

Model	Shape	Scope diameter	Working length	Minimuminsertionchanneldiameter	InjectionchannelDiameter	Tip Curve	Curved Tiplength
GSA01-B	Straight	Φ4.0mm+0.0/-0.3mm	260mm±8mm	N/A	0.8mm+0.2/-0.0mm	N/A	N/A
GSB04-B	Straight	Φ6.4mm+0.0/-0.3mm	260mm±8mm	2.3mm+0.2/-0.0mm	1.1mm+0.2/-0.0mm	N/A	N/A
GSB14-B	Curveddistal tip	Φ6.4mm+0.0/-0.3mm	260mm±8mm	2.3mm+0.2/-0.0mm	1.1mm+0.2/-0.0mm	22°±5°	25mm±1.3mm

The video processor provides power and processes the images from the Rigid Hysteroscopes. Anatomical images are collected via a CMOS chip at the distal end of the hysteroscope and are transmitted through the video processor to a monitor.

V. Indications for use

The Hysteroscope System is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

Note: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery.

Generally recognized indications for diagnostic hysteroscopy include:

Abnormal bleeding
Infertility and pregnancy wastage
Evaluation of abnormal hysterosalpingogram
Intrauterine foreign body
Amenorrhea
Pelvic pain

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Generally recognized indications for operative hysteroscopy include:

· Directed endometrial biopsy
· Polypectomy
· Submucous myomectomy
Transection of intrauterine adhesions
· Transection of intrauterine septa
Endometrial ablation

VI. Comparison of technological characteristics with the predicate devices

The Hysteroscope System has the same intended use as the predicate device. The Hysteroscope System and the predicate device are designed to provide real-time images to the physician in order to facilitate diagnostic and therapeutic procedures in the cervical canal and uterus. As summarized in the table below, there are differences in technological characteristics between the subject and predicate device. The technological differences between the Hysteroscope System and predicate device do not raise different questions of safety or effectiveness.

Device Feature	HysteroscopeSystem (subjectdevice)	LiNA OperaScopeK171113	Discussion
Indications foruse	The HysteroscopeSystem is intendedto be used to permitviewing of thecervical canal anduterine cavity for thepurpose ofperformingdiagnostic andsurgical procedures.Note: Hysteroscopesare used as tools toaccess the uterinecavity and are not, inand of themselves, amethod of surgery.Generallyrecognizedindications fordiagnostichysteroscopyinclude:• Abnormal bleeding	The LiNA OperaScope isintended for use invisualization of thecervical canal and uterinecavity during diagnosticand therapeuticgynecologicalprocedures. The types ofprocedures where theOperaScope could offervisualization include:• Assessment ofabnormal bleeding, pelvicpain, amenorrhea andabnormal findings fromhysterosalpingogram;• Assessment of Infertilityand pregnancy wastage;• Confirmation of thepresence of intrauterineforeign body;• Assist in locatingsubmucosal fibroids andpolyps targeted for	Similar; the differencein wording of theindications does notalter the intended use.

	• Infertility andpregnancy wastage• Evaluation ofabnormalhysterosalpingogram• Intrauterine foreignbody• Amenorrhea• Pelvic painGenerallyrecognizedindications foroperativehysteroscopyinclude:• Directedendometrial biopsy• Polypectomy• Submucousmyomectomy• Transection ofintrauterineadhesions• Transection ofintrauterine septa• Endometrialablation	removal;• Provide visual guidanceduring directed biopsy,submucosalmyomectomy,transection of intrauterineadhesions and septa.
SystemComponents	The HysteroscopeSystem consists of asterile single-usedisposable RigidHysteroscope andvideo processor forclinical imageprocessing.	Sterile/Single-useHandpiece(Hysteroscope) withCMOS camera, LEDillumination, LCD displayunit, channel for infusionof irrigating fluid, channelfor fluid outflow,microelectronics,firmware and single usebatteries for powering thedevice.Non-Sterile/ReusableRecording Module withsoftware,microelectronics andcontrols for recordingpictures/video, HDMIports (2) for connection to	Similar;the basic systemcomposition isidentical (single usescope with videoprocessor).


Optical Image	CMOS	handpiece(hysteroscope) andexternal monitor andinput port for external 9VDC power supply.	Identical
Image Resolution	100,000 pixels	Digital CMOSTechnologyCMOS camera consistsof approximately 160,000pixels	Different; thedifference does notraise differentquestions of safety oreffectiveness.
IlluminationLight Source	LED	LED at tip of cannula	Identical
Inflow andoutflow channelfor salineinstillation	Inflow and outflowchannels separately	Inflow: Inflow channeland working channelcombined in one channelabove the camera.Outflow: One outflowchannel with twoentrances placed on topand bottom of distal tip.	Different; Thedifference does notraise differentquestions of safety oreffectiveness.
Cannula tipdesign	Angled shaftproximal to tip:Straight: 0°Curved tip:22°	Rounded polymer tip.Angled shaft proximal totip (~ 20°C). Steerable byrotation knob.	Different; thepredicate device issteerable by rotationknob. The differencedoes not raisedifferent questions ofsafety oreffectiveness.
ImageTransmission	Transmits imagesare transmitted tothe user by the videoprocessor with aCMOS chip at thedistal end of theendoscope and theimage showing on amonitor.	Transmits images fromCMOS video camera tolocal LCD display unit onthe handpiece andremote monitor.	Identical
Maximum	4.0 to 6.4mm	4.3 mm	Different; the

InsertionDiameter (Tip)	depending on model		difference in diameterdoes not raisedifferent questions ofsafety oreffectiveness.
Shaft/CannulaLength	260mm	240mm (24cm)	Different; thedifference in lengthdoes not raisedifferent questions ofsafety andeffectiveness.
Energy Source	Hysteroscope: 5VVideo Processor: 5V2A	Handpiece: 3V (2 AAbatteries)Recording Module: 9VDC external poweradapter	Similar;Different outputformats do not raisedifferent safety oreffectiveness.
Sterilization	The RigidHysteroscope isprovided sterilizedby EO. Nore-sterilization ispermitted.Video Processor:Non-Sterile	Handpiece(Hysteroscope):Ethylene Oxide (EO)Handpiece Batteries:Radiation (Gamma)Recording Module:Non-Sterile	Identical

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K181545 Page 6 of 7

VII. Performance data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

Biocompatibility of the Hysteroscope System was evaluated in accordance with ISO 10993-1:2009 for the body contact category of "Surface – Mucosal Membrane" with a contact duration of "Limited (< 24 hours)". The following tests were performed: Cytotoxicity per ISO 10993-5:2009, Irritation and Sensitization per ISO 10993-10:2010. The device was demonstrated to be non-cytotoxic, non-sensitizing and non-irritating.

Sterilization and shelf life testing

The ethylene oxide sterilization method has been validated to ISO 11135:2014. The shelf life of the Rigid Hysteroscope was demonstrated through a stability study which included

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testing of aged devices to ensure devices maintained specifications and that device packaging maintained sterility.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Hysteroscope System. The system complies with the IEC 60601-1:2005/(R)2012, IEC60601-2-18 Edition 3, and IEC 60601-1-2:2014.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for a "moderate" level of concern.

Optical performance testing

Optical performance testing was conducted on the Hysteroscope System. The optical performance of the system complies with ISO 8600 series. The system was demonstrated to meet predefined acceptance criteria.

Mechanical performance testing

Mechanical characteristics including leaking, bending, articulating and irrigation tests were performed. Devices were demonstrated to meet predefined acceptance criteria.

VIII. Conclusion

The subject device has the same intended use as the predicate, and differences in technological characteristics between the subject and predicate devices do not raise different questions of safety or effectiveness. The non-clinical testing demonstrates that the subject device is as safe and as effective as the legally marketed predicate device. Therefore, the subject device is substantially equivalent to the predicate.

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.