Who is the manufacturer of ENDOSEE MODEL 8000 U-SCOPE?

Endosee Corp filed the 510(k) submission for ENDOSEE MODEL 8000 U-SCOPE (K123151).

What is the FDA product code for ENDOSEE MODEL 8000 U-SCOPE?

HIH. It is classified under 21 CFR 884.1690 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for ENDOSEE MODEL 8000 U-SCOPE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ENDOSEE MODEL 8000 U-SCOPE?

Microspan Hysteroscope (K961688); Gyrus ACMI Digital Hysteroscope (K092278).

Who can help prepare an FDA 510(k) submission like ENDOSEE MODEL 8000 U-SCOPE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ENDOSEE MODEL 8000 U-SCOPE

K123151 · Endosee Corp · HIH · Mar 8, 2013 · Obstetrics/Gynecology

Device Facts

Record ID	K123151
Device Name	ENDOSEE MODEL 8000 U-SCOPE
Applicant	Endosee Corp
Product Code	HIH · Obstetrics/Gynecology
Decision Date	Mar 8, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.1690
Device Class	Class 2
Attributes	3rd-Party Reviewed

Indications for Use

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 Story

Handheld, battery-operated portable hysteroscope; consists of reusable handle and sterile, single-use disposable hysteroscopic cannula. Cannula tip contains miniature CMOS camera and LED illumination module; includes channel for irrigating fluid infusion. Handle contains video processor, LCD display, rechargeable battery, and firmware. Operated by trained medical professionals in hospitals or physician offices. Device captures real-time video of cervical canal and uterine cavity; displays images on integrated LCD for direct visualization during diagnostic procedures. Enables physician to perform diagnostic hysteroscopy; provides immediate visual feedback for clinical decision-making. Benefits include portability and disposable cannula to reduce reprocessing requirements.

Clinical Evidence

No clinical data. Bench testing only. Testing included biocompatibility (ISO 10993-1), electrical/EMC safety (ISO 60601-1, ISO 60601-1-2, IEC 60601-2-18), thermal safety, mechanical characteristics, optics performance, image quality, and software verification/validation.

Technological Characteristics

Handheld, battery-operated hysteroscope. Components: reusable handle, sterile single-use disposable cannula. CMOS sensor (approx. 160,000 pixels), LED illumination at distal tip. Oval shaft (3.8mm x 4.6mm). Materials compliant with ISO 10993. Integrated LCD display. Firmware-based video processing. Sterilization: Ethylene oxide (cannula).

Indications for Use

Indicated for diagnostic hysteroscopy in patients presenting with abnormal uterine bleeding, infertility, pregnancy wastage, abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, or pelvic pain.

Regulatory Classification

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.

Predicate Devices

Microspan Hysteroscope (K961688)
Gyrus ACMI Digital Hysteroscope (K092278)

Submission Summary (Full Text)

{0}------------------------------------------------ KR23151 Page 1 of 5 ## MAR 0 8 2013 #### 510(k) Summary Prepared February 15, 2013 | Sponsor: | EndoSee Corp. | |----------------------------|-----------------------------------------------------------------------------------| | Contact Person: | Xiaolong (Bruce) Ou Yang 4546 El Camino Real, Suite 215 Los 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: 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. {1}------------------------------------------------ K123151 Page 2 of 5 ## C. Intended Use 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 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 Device U-Scope 8000 | Predicate 1 Imagyn Medical Microspan Hysteroscope (K961688) | Predicate 2 Gyrus ACMI Invisio Digital Hysteroscope System (K092278) | |-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Viewing of cervical canal and uterine cavity | Same | Same | | Indication for use | 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 uterine bleeding, infertility and pregnancy wastage; evaluation of abnormal hysterosalpingogram; intrauterine foreign body; amenorrhea; pelvic pain | The Microspan hysteroscope device is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures | *The Gyrus ACMI Invisio Digital Hysteroscope is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. The Gyrus ACMI Invisio Digital Hysteroscope System: is intended to be used to process the video signal from the Invisio Digital Hysteroscope and ensure brightness, image clarity and color. Diagnostic Hysteroscopy: Abnormal uterine bleeding Infertility & pregnancy wastage 'Evaluation of abnormal hysterosalpingogrm | Table 1 Comparison Table – Intended Use and Indications for Use {2}------------------------------------------------ K123151 Page 3 of 5 | | | | Intrauterine foreign body | |-----------------------------------------------|------------------------------------|------------------------------------------|--------------------------------------------| | | | | Amenorrhea | | | | | Pelvic pain | | | | | Operative Hysteroscopy: | | | | | • Directed biopsy | | | | | • Removal of fibroids and polyps | | | | | • Transection of intrauterine adhesions | | | | | • Transection intrauterine septa | | Intended Users | Trained Medical Professionals | Trained Medical Professionals | Trained Medical Professionals | | Clinical application | Diagnostic hysteroscopy | Diagnostic and operative hysteroscopy | Diagnostic and operative hysteroscopy | | Site of Use | Hospitals and Physician Offices | Hospitals and Physician Offices | Hospitals and Physician Offices | | Class | II | II | II | | Classification Regulation/ Product Code | 21 CFR 884.1690 HIH | 21 CFR 884.1690 HIH | 21 CFR 884.1690 HIH | # Table 2 Comparison Table – Technological Characteristics | Feature | Subject Device U-Scope 8000 | Predicate 1 Imagyn Microspan Hysteroscope (K961688) | Predicate 2 Gyrus ACMI Invisio Digital Hysteroscope System (K092278) | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------| | Components | Design incorporates two separate components (cannula and handle) and incorporates a LCD monitor as an integral part of the handle. | Design incorporates stainless steel shaft, imaging fiber bundle, lens, eyepiece, light source and light cables | Design incorporates handle, semi rigid hysteroscope, digital CMOS sensor, PCBs, LED light source, electrical cords, power supply and cables | | Battery Operated | Yes | No | No | | Optical Image | Digital CMOS technology | Not specified in product labeling | Digital CMOS technology | | Image | The CMOS sensor consists | Not specified in product labeling | The CMOS sensor consists | {3}------------------------------------------------ K123151 Page 4 of 5 | Resolution | of approximately 160,000 pixels. | labeling | of approximately 100,000 pixels | |----------------------------------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | Illumination Light source | LEDs at the distal tip of the cannula | Fiber optic bundle / external OES Xenon light source | Fiber optic bundle /integrated LEDs in the handle | | Image transmission | Transmit images from a video camera to a video monitor | Eyepiece can be connected through an optical coupler to a camera | Transmit images from a video camera to a video monitor | | Inflow and outflow channel for saline instillation | Single channel for inflow | None | In-flow and option for continuous flow with outside sheath | | Sterile | Cannula is provided as sterile single use; Handle is provided non sterile | Provided non-sterile and requires sterilization by the end user | Provided non-sterile and requires sterilization by the end user | | Disposable/ Reusable | Cannula is provided sterile for single use and the handle is reusable. | Reusable device, provided non-sterile which requires sterilization by the end user | Reusable device, provided non-sterile which requires sterilization by the end user | | Shaft diameter and working length | Oval shape (3.8 mm x 4.6 mm ) Working length 287 mm (11.3 in) | Not specified in product labeling | 5.5mm with continuous flow sheath Working length not available | | Contact Materials | Compliant with ISO 10993 | Not specified in product labeling | 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. {4}------------------------------------------------ K123151 Page 5 of 5 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. {5}------------------------------------------------ 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. {6}------------------------------------------------ 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 {7}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K123151 Device Name: U-Scope Model 8000 Indications For Use: 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. 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 Page 1 of _ 1 _ _ (Division Sign-Off) ivision of Reproductive, Gastro-Renal, and

ENDOSEE MODEL 8000 U-SCOPE

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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ENDOSEE MODEL 8000 U-SCOPE

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

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