Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the hardware components and basic video processing, with no mention of AI or ML algorithms for image analysis, diagnosis, or other functions.

Therapeutic

No
The device is described as being used for diagnostic procedures and to obtain tissue samples for diagnosis. It does not provide any therapeutic intervention.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures" and for "cytologic and histologic diagnosis." It also lists "Generally recognized indications for diagnostic hysteroscopy" which include abnormal bleeding, infertility, etc.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components including a handheld, battery-operated portable hysteroscope, a disposable cannula with a camera and LED, and a reusable HandTower containing electronics, a display, and a battery. The performance studies also include mechanical and temperature testing of the physical device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic purposes. This examination is performed in vitro (outside the body).
Device Function: The U-Scope 8000 HSC+EMB Cannula is used to view the cervical canal and uterine cavity and to obtain an endometrial tissue sample. These are procedures performed in vivo (inside the body).
Sample Use: While the sample obtained by the device is used for cytologic and histologic diagnosis (which are in vitro procedures), the device itself is the tool for collecting the sample and visualizing the anatomical site. It does not perform the diagnostic testing on the sample itself.

The device is a surgical/endoscopic instrument used for visualization and tissue collection, not for performing diagnostic tests on a sample outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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, amenorrhea, and pelvic pain.

Product codes (comma separated list FDA assigned to the subject device)

HIH

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Video

Anatomical Site

cervical canal and uterine cavity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

outpatient or office setting

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K123151, K840383

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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K132384 Pg. 1 of 5

510(k) Summary

Sponsor:	EndoSee Corporation
Contact Person:	Xiaolong (Bruce) Ou Yang
Telephone:	(650) 397-5174
Fax:	(888) 388-1420
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.

1

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.

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
Cannula
(this submission)	Endosampler
MedGyn Products Inc.
(K840383)	U-Scope Model 8000
EndoSee Corporation
(K123151)
Indication for use	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 an 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,	To obtain clearly
differentiated
endometrial tissue
sample without
anesthesia in an
outpatient setting or in
an office setting. The
sample is used for
cystologic and
histologic diagnosis	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.

	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

2

.

・ ·

3

Performance Data

:

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.

4

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.

5

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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

6

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Image /page/6/Picture/8 description: The image shows the name "Herbert P. Lerner -S" in a bold, sans-serif font. The text is horizontally oriented and appears to be a title or heading. The background is plain and does not distract from the text.

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

7

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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Attachment 13

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