U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA

K132384 · Endosec Corporation · HIH · Jul 2, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K132384
• Device Name: U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA
• Applicant: Endosec Corporation
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Jul 2, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2

Intended Use

The U-Scope 8000 HSC+EMB Cannula 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.

Device Story

Handheld, battery-operated portable hysteroscope; consists of reusable HandTower and sterile, single-use disposable endometrial biopsy cannula. Cannula features miniature CMOS camera, LED illumination, infusion/aspiration channels, and curette for tissue collection. HandTower includes LCD display, video processor, rechargeable battery, and microcontrollers. Used by physicians in hospitals or offices for uterine visualization and biopsy. Physician operates device to view cervical canal/uterine cavity; captures still/video images; adjusts LED brightness; inputs patient ID. Output displayed on integrated LCD; aids cytologic/histologic diagnosis. Benefits include portable, integrated diagnostic and sampling capability in office setting.

Clinical Evidence

Bench testing only. Evaluated per FDA 'Hysteroscopic and Gynecologic Laparoscopes Submission Guidance' (1996). Mechanical testing (bending, pulling, torque, leak, stiffness/force-to-tip deflection); thermal safety (IEC 60601-2-18); field of view/direction of view (ISO 8600-3); image quality (ISO 8600-5); electrical safety/EMC (IEC 60601-1, IEC 60601-1-2, IEC 61000-4-2). Biocompatibility testing (cytotoxicity, sensitization, irritation, acute systemic toxicity) per ISO 10993. Sterilization validation per ISO 11135-1.

Technological Characteristics

Handheld hysteroscope; reusable HandTower with 3.5-inch LCD, 3.7V battery, video processor, firmware. Disposable cannula (4.3mm OD, 27cm length) with CMOS camera, LED illumination, infusion/aspiration channels, curette. Materials compliant with ISO 10993. Sterilization via ethylene oxide (EO). Connectivity: standalone device with integrated display/controls. Electrical safety per IEC 60601-1/2-18.

Indications for Use

Indicated for patients requiring diagnostic hysteroscopy and endometrial biopsy for conditions including abnormal bleeding, infertility, pregnancy wastage, abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain. Used in outpatient or office settings.

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

• U-Scope Model 8000, EndoSee Corporation (K123151)
• Endosampler, MedGyn Products, Inc. (K840383)

Submission Summary (Full Text)

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# 1111 0 2 2014

K132384 Pg. 1 of 5

#### 510(k) Summary

| Sponsor: | EndoSee Corporation |
|-----------------------|------------------------------------|
| Contact Person: | Xiaolong (Bruce) Ou Yang |
| Telephone: | [phone] |
| Fax: | [phone] |
| 510(k) Summary Date: | July 23, 2013 |
| Device Name: | U-Scope 8000 HSC+EMB Cannula |
| Common Name: | Hysteroscope |
| Classification: | |
| Regulatory Class: | II |
| Review Category: | 21 CFR 884.1690 |
| Classification Panel: | Obstetrics and Gynecology |
| Product Code: | HIH (hysteroscope and accessories) |

#### Legally Marketed Predicate Devices

The U-Scope Model 8000, EndoSee Corporation (K123151)

Endosampler, MedGyn Products, Inc. (K840383)

#### Device Description

The U-Scope 8000 HSC+EMB Cannula is a handheld, battery-operated portable hysteroscope. It includes a sterile single use disposable endometrial biopsy cannula (the U-Scope 8000 HSC+EMB cannula) and a reusable HandTower (U-Scope 8000). The disposable U-Scope 8000 HSC+EMB cannula contains a miniature CMOS camera and a light-emitting diode (LED) illumination module at its tip and two channels for infusion of irrigating fluid and aspiration of tissue. Adjacent to the tip of the cannula is a curette that facilitates collection of tissue during the biopsy procedure. The disposable cannula is sterilized and packaged in a sealed pouch. The HandTower is lightweight and ergonomically designed. It has a connector and locking mechanism for attaching and detaching the U-Scope 8000 HSC+EMB cannula. The HandTower contains the remaining electronics, including a power on/off button, a button to adjust the brightness of the LED, a button to allow capture of single images or start/stop a video of the procedure, a video processor, a display unit (LCD display), a rechargeable battery, management electronics, microcontrollers, and firmware.

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#### Intended Use

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The U-Scope 8000 HSC+EMB Cannula 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.

#### Substantial Equivalence

The submission device is substantially equivalent to the U-Scope Model 8000 manufactured by EndoSee Corporation (K123151) in terms of technological characteristics of the hand tower and to the Endosampler manufactured by MedGyn Products, Inc. (K840383) in terms of indication of use and technological characteristics of a biopsy cannula with curette.

| | Subject device | Predicate device | Predicate device |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | U-Scope 8000 HSC+EMB<br>Cannula<br>(this submission) | Endosampler<br>MedGyn Products Inc.<br>(K840383) | U-Scope Model 8000<br>EndoSee Corporation<br>(K123151) |
| Indication for use | To permit viewing of the<br>cervical canal and uterine<br>cavity for the purpose of<br>performing diagnostic<br>procedures and to obtain<br>an endometrial tissue<br>sample (biopsy) in an<br>outpatient or an office<br>setting. The sample is<br>used for cytologic and<br>histologic diagnosis.<br>Generally recognized<br>indications for diagnostic<br>hysteroscopy include:<br>abnormal bleeding,<br>infertility and pregnancy<br>wastage, evaluation of<br>abnormal<br>hysterosalpingogram,<br>intrauterine foreign body, | To obtain clearly<br>differentiated<br>endometrial tissue<br>sample without<br>anesthesia in an<br>outpatient setting or in<br>an office setting. The<br>sample is used for<br>cystologic and<br>histologic diagnosis | To permit viewing of<br>the cervical canal and<br>uterine cavity for the<br>purpose of performing<br>diagnostic procedures.<br>Generally recognized<br>indications for<br>diagnostic<br>hysteroscopy include:<br>abnormal bleeding,<br>infertility and<br>pregnancy wastage,<br>evaluation of abnormal<br>hysterosalpingogram,<br>intrauterine foreign<br>body, amenorrhea, and<br>pelvic pain. |
| | | | |
| | amenorrhea, and pelvic pain. | | |
| Procedures | Uterine diagnostic and endometrial biopsy | Uterine diagnostic uses | Diagnostic hysteroscopy |
| Site of use | Hospitals and physician offices | Hospitals and physician offices | Hospitals and physician offices |
| Device Features | | | |
| Components | (1) image-capturing hand tower; (2) attachable cannula with outflow and inflow ports in which suction can be created and with a curette near its tip | Cannula with outflow port in which suction can be created and with a curette opening near its tip | (1) image-capturing hand tower; (2) attachable cannula with inflow port |
| Cannula Outer Diameter | 4.3 mm | 3 mm | 3.8 x 4.6 mm (oval) |
| Cannula length | 27 cm | 21 cm | 26 cm |
| Illumination light source | LEDs | N/A | LEDs |
| Image transmission | Image transmitted from a video camera to a video monitor on the handle | No image | Image transmitted from a video camera to a video monitor on the handle |
| LCD display size | 3.5 inches (diagonal) | N/A | 3 inches (diagonal) |
| Battery charge indication | Charge indication as an icon on the LCD monitor | N/A | No charge indication on the LCD monitor |
| Battery power | 3.7 V | N/A | 3.3 V |
| Adjust brightness of LEDs | Adjust by depressing a button on the hand tower | N/A | Brightness cannot be adjusted |
| Capture still or video images during procedure | Capture still or video during procedure by depressing a camera button on the hand tower | N/A | Cannot capture still or video during procedure |
| Enter patient ID information prior to procedure | User interface on monitor allows physician to add patient information | N/A | Cannot input patient information via the interface with the monitor |
| Duration of use | ≤ 24 hours | ≤ 24 hours | ≤ 24 hours |
| Sterilization | HandTower is not sterile. The U-Scope 8000 HSC+EMB cannula is sterile following exposure to ethylene oxide (EO) | Exposure to ethylene oxide (EO) | Hand tower is not sterile. Diagnostic cannula sterile following exposure to ethylene oxide (EO) |
| Frequency of use | HandTower is reusable. The U-Scope 8000 HSC+EMB cannula is single patient use | Single patient use | Hand tower is reusable Diagnostic cannula is single patient use |
| Tissue contact materials | Compliant with ISO 10993 | Compliant with ISO 10993 | Compliant with ISO 10993 |

Table I. Comparison of the U-Scope 8000 HSC+EMB Cannula to the Predicate Devices

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#### Performance Data

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The U-Scope 8000 HSC+EMB Cannula was subjected to mechanical, temperature, field of view and image quality testing, in accordance with the FDA's "Hysteroscopic and Gynecologic Laparoscopes Submission Guidance" (1996).

Mechanical testing: The device was tested for bending, pulling, torque, and presence of leaks and following testing was found to meet design. The device was also tested for stiffness/force-to-tip deflection in comparison to other cleared endometrial sampling devices. This test served as a surrogate for an assessment of biopsy sampling quality.

Temperature testing: the device was measured for surface temperatures at various points over time and found to meet requirements specified in IEC 60601-2-18.

Field of View and Direction of Viewing testing: The device was tested for field of view accuracy and directions of view accuracy and found to meet requirements specified in ISO 8600-3.

Image Quality testing: The device was tested for image quality and found to meet requirements of ISO 8600-5.

The U-Scope 8000 HSC+EMB Cannula was tested for electrical and safety testing by a certified test laboratory and met the compliance requirements for electrical safety as specified in IEC 60601-1, including provisions for EMC safety in IEC 60601-1-2:2007 and IEC 61000-4-2:2008, as well as testing to IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: "Particular requirements for the basic safety and essential performance of endoscopic equipment," including thermal safety. Mechanical characteristics were also tested with successful results.

A' series of biocompatibility testing, including cytotoxicity, sensitization, irritation, and acute systemic toxicity, demonstrated that the device components that are in contact with the patient are biocompatible.

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Due to its labeling as sterile, the U-Scope 8000 HSC+EMB Cannula underwent sterilization validation and shelf life testing to confirm the label shelf life and was found in' compliance with the following:

- ISO 11135-1:2007 Sterilization of health care products --. Ethylene oxide -Part 1: Requirements for development, validation and routine control of a sterilization process for medical device;
- Packaging for Terminally Sterilized Medical . ISO 11607-1:2006 Devices;
- Designing, testing, and labeling . AAMI TIR12:2010 reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers; and
- . AAMI TIR 30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.

#### Conclusion

U-Scope 8000 HSC+EMB Cannula is substantially equivalent to its proposed predicate devices.

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Public Health Service

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

July 2, 2014

EndoSee Corporation Pin Yu Vice President, Regulatory Affairs 4546 El Camino Road, Suite 215 Los Altos. CA 94022

Re: K132384

Trade/Device Name: U-Scope™ 8000 HSC+EMB Cannula Regulation Number: 21 CFR§ 878.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: Class II Product Code: HIH Dated: June 3, 2014 Received: June 5, 2014

Dear Pin Yu,

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 Codc 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 idvised 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

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Page 2 - Pin Yu

(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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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for

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): K132384

Device Name: U-Scope 8000 HSC+EMB Cannula

#### Indications for Use:

The U-Scope 8000 HSC+EMB Cannula 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, amenorthea, and pelvic pain.

Prescription Use: ____________________________________________________________________________________________________________________________________________________________ X (21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use: · (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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