The U-Scope device is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures. Generally recognized 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 EndoSee U-Scope Model 8000 is a handheld, battery-operated portable hysteroscope. It includes a sterile single use disposable hysteroscopic cannula and a reusable handle. The disposable cannula contains a miniature CMOS camera and a light-emitting diode (LED) illumination module at the tip and a channel for infusion of irrigating fluid. The disposable cannula is sterilized and packaged in a sealed bag. The handle is light weight and ergonomically designed. It has a connector and locking mechanism for attaching and detaching the cannula. The handle contains the remaining electronics including a power on/off button, a video processor, a display unit (LCD display), a rechargeable battery, management electronics, microcontrollers and firmware.

AI/ML Overview

The provided text describes the U-Scope Model 8000 hysteroscope and its substantial equivalence to predicate devices. However, the document primarily focuses on regulatory approval (510(k) submission) and does not contain information about acceptance criteria for an AI/algorithm-based device, nor a study proving general device performance against such criteria, nor any of the specific details requested in points 2-9 for an AI device study.

The "Performance Data" section (Page 4-5) lists various bench tests conducted to ensure compliance with standards for biocompatibility (ISO 10993), electrical safety (ISO 60601-1, ISO 60601-1-2, IEC 60601-2-18), thermal safety, mechanical characteristics, software verification and validation, sterilization validation (ISO 11135-1, ISO 11607, AAMI TIR12:2010), handling reprocessing (AAMI TIR30:2011), battery specifications, durability, and a general mention of optics performance and image quality testing. These are standard performance tests for the physical device, not an AI or algorithm's diagnostic performance.

Therefore, I cannot fulfill the request as the provided text does not contain the necessary information regarding:

Acceptance criteria for an AI/algorithm. The document discusses acceptance criteria for physical components and compliance with medical device standards.
A study proving the device meets AI-specific acceptance criteria. The "Performance Data" describes bench testing for device safety and functionality.
Sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as they pertain to an AI algorithm.

The device described is a physical hysteroscope, not an AI or algorithm-based diagnostic tool.

Summary

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KR23151
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MAR 0 8 2013

510(k) Summary Prepared February 15, 2013

Sponsor:	EndoSee Corp.
Contact Person:	Xiaolong (Bruce) Ou Yang4546 El Camino Real, Suite 215Los Altos, CA 94022
Telephone:	650 397 5174
Fax:	888 388 1420
Device Name:	U-Scope Model 8000
Common Name:	Hysteroscope
Regulatory Class:	II
Classification Regulation:	21 CFR 884.1690
Classification Panel:	Obstetrics and Gynecology

A. Legally Marketed Predicate Devices

The EndoSee device is substantially equivalent to Microspan Hysteroscope manufactured by Imagyn Medical (K961688) and Gyrus ACMI Digital Hysteroscope manufactured by Gyrus ACMI (K092278).

B. Device Description:

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C. Intended Use

Abnormal uterine bleeding, infertility and pregnancy wastage; evaluation of abnormal hysterosalpingogram; intrauterine foreign body; amenorrhea; pelvic pain

D. Substantial Equivalence

The U-Scope 8000 is substantially equivalent to the Microspan Hysteroscope manufactured by Imagyn (K961688 ) and Gyrus ACMI Digital Hysteroscope manufactured by Gyrus ACMI (K092278) with regard to both intended use and technological characteristics as described in the tables below:

Feature	Subject DeviceU-Scope 8000	Predicate 1Imagyn MedicalMicrospan Hysteroscope(K961688)	Predicate 2Gyrus ACMI Invisio DigitalHysteroscope System(K092278)
Intended Use	Viewing of cervical canaland uterine cavity	Same	Same
Indication foruse	The U-Scope device isused to permit viewing ofthe cervical canal anduterine cavity for thepurpose of performingdiagnostic procedures.Generally recognizedindications for diagnostichysteroscopy include:Abnormal uterinebleeding, infertility andpregnancy wastage;evaluation of abnormalhysterosalpingogram;intrauterine foreign body;amenorrhea; pelvic pain	The Microspanhysteroscope device isused to permit viewing ofthe cervical canal anduterine cavity for thepurpose of performingdiagnostic and surgicalprocedures	*The Gyrus ACMI InvisioDigital Hysteroscope isintended to be used to permitviewing of thecervical canal and uterinecavity for the purpose ofperforming diagnostic andsurgical procedures.The Gyrus ACMI InvisioDigital Hysteroscope System:is intended to be used toprocess the video signal fromthe Invisio DigitalHysteroscope and ensurebrightness, image clarity andcolor.Diagnostic Hysteroscopy:Abnormal uterine bleedingInfertility & pregnancywastage'Evaluation of abnormalhysterosalpingogrm

Table 1 Comparison Table – Intended Use and Indications for Use

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			Intrauterine foreign body
			Amenorrhea
			Pelvic pain
			Operative Hysteroscopy:
			• Directed biopsy
			• Removal of fibroidsand polyps
			• Transection ofintrauterine adhesions
			• Transectionintrauterine septa
IntendedUsers	Trained MedicalProfessionals	Trained MedicalProfessionals	Trained MedicalProfessionals
Clinicalapplication	Diagnostic hysteroscopy	Diagnostic and operativehysteroscopy	Diagnostic and operativehysteroscopy
Site of Use	Hospitals and PhysicianOffices	Hospitals and PhysicianOffices	Hospitals and PhysicianOffices
Class	II	II	II
ClassificationRegulation/Product Code	21 CFR 884.1690HIH	21 CFR 884.1690HIH	21 CFR 884.1690HIH

Table 2 Comparison Table – Technological Characteristics

Feature	Subject DeviceU-Scope 8000	Predicate 1Imagyn MicrospanHysteroscope(K961688)	Predicate 2Gyrus ACMI InvisioDigital HysteroscopeSystem (K092278)
Components	Design incorporates twoseparate components(cannula and handle) andincorporates a LCDmonitor as an integral partof the handle.	Design incorporatesstainless steel shaft,imaging fiber bundle, lens,eyepiece, light source andlight cables	Design incorporateshandle, semi rigidhysteroscope, digitalCMOS sensor, PCBs, LEDlight source, electricalcords, power supply andcables
BatteryOperated	Yes	No	No
OpticalImage	Digital CMOS technology	Not specified in productlabeling	Digital CMOS technology
Image	The CMOS sensor consists	Not specified in productlabeling	The CMOS sensor consists

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Resolution	of approximately 160,000pixels.	labeling	of approximately 100,000pixels
IlluminationLight source	LEDs at the distal tip of thecannula	Fiber optic bundle /external OES Xenon lightsource	Fiber optic bundle/integrated LEDs in thehandle
Imagetransmission	Transmit images from avideo camera to a videomonitor	Eyepiece can be connectedthrough an optical couplerto a camera	Transmit images from avideo camera to a videomonitor
Inflow andoutflowchannel forsalineinstillation	Single channel for inflow	None	In-flow and option forcontinuous flow withoutside sheath
Sterile	Cannula is provided assterile single use;Handle is provided nonsterile	Provided non-sterile andrequires sterilization by theend user	Provided non-sterile andrequires sterilization by theend user
Disposable/Reusable	Cannula is provided sterilefor single use and thehandle is reusable.	Reusable device, providednon-sterile which requiressterilization by the end user	Reusable device, providednon-sterile which requiressterilization by the end user
Shaftdiameter andworkinglength	Oval shape (3.8 mm x 4.6mm )Working length 287 mm(11.3 in)	Not specified in productlabeling	5.5mm with continuousflow sheathWorking length notavailable
ContactMaterials	Compliant with ISO 10993	Not specified in productlabeling	Compliant with ISO 10993

E. Performance Data

Bench testing was conducted on the device to verify that it is compliant with biocompatibility requirements for a short duration indwelling device as specified in ISO 10993 - Part 1. It was also tested by a certified test laboratory and met the compliance requirements for electrical safety as specified in ISO 60601-1, including provisions for EMC safety in ISO 60601-1-2 and IEC 60601-2-18 Medical electrical equipment – Part 2-18: "Particular requirements for the basic safety and essential performance of endoscopic equipment", including thermal safety at several points along the cannula. Mechanical characteristics were also tested with successful results. The software test data, including verification and validation results, were submitted as specified in FDA guidance documents related to requirements for software contained in medical devices. Other test data, as specified in FDA guidance documents related to 510(k) hysteroscopic devices included data on optics performance and results of image quality testing.

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Sterilization validation and shelf life testing were conducted to confirm the label shelf life and are in compliance with the following:

ISO 11135-1 Sterilization of health care products -- Ethylene oxide -- Part 1: . Requirements for development, validation and routine control of a sterilization process for medical device
ISO 11607 Packaging for Terminally Sterilized Medical Devices .
AAMI TIR12:2010 -- Designing, testing, and labeling reusable medical devices . for reprocessing in health care facilities: A guide for medical device manufacturers

Handle reprocessing issues were addressed by test methodology described in AAMI TIR30:2011 - A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.

In addition, the following battery and mechanical characteristics bench tests were performed as follows:

testing of battery specifications .
testing of durability of handle .
testing of effects of repeated bending, pulling, and torque .
testing of fluid delivery and controls .

All of these performance verification and validation test results were provided in the submission according to requirements specified in FDA guidance documents.

F. Conclusion

In conclusion, the bench testing performed addressed materials, mechanical and electrical tests related to safety and effectiveness, and successful results demonstrated that the subject device is substantially equivalent to the predicate devices.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with its wings spread, rendered in black. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle, also in black. The logo is simple and conveys a sense of national authority and public service.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 8, 2013

EndoSee Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO MN 55313

Re: K123151

Trade/Device Name: U-Scope Model 8000 Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: February 26, 2013 Received: February 27, 2013

Dear Mr. Job:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin Fisher-S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive. Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K123151

Device Name: U-Scope Model 8000

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin R际库ish 2013.03.08 13.37.06 1

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(Division Sign-Off) ivision of Reproductive, Gastro-Renal, and

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.