(150 days)
Not Found
No
The description focuses on standard video processing, microcontrollers, and firmware, with no mention of AI, ML, or related concepts like deep learning or neural networks. The performance studies also describe standard bench testing and software validation, not AI/ML model training or testing.
No.
The device is used for diagnostic procedures, specifically for viewing the cervical canal and uterine cavity. It does not provide any therapeutic intervention.
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." It then lists several "generally recognized indications for diagnostic hysteroscopy" such as abnormal bleeding and infertility.
No
The device description explicitly states it is a "handheld, battery-operated portable hysteroscope" and includes hardware components such as a disposable cannula with a camera and LED, a reusable handle with electronics, a display, and a battery. The performance studies also detail testing of hardware characteristics like biocompatibility, electrical safety, mechanical characteristics, and sterilization.
Based on the provided information, the U-Scope device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures." This describes a device used for direct visualization within the body, not for examining samples taken from the body (which is the core of IVD).
- Device Description: The description details a hysteroscope, which is an endoscopic device used for internal examination. It involves a camera and light at the tip inserted into the body.
- Anatomical Site: The device is used within the "Cervical canal and uterine cavity," which are internal anatomical sites.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) outside of the body. The diagnostic procedures mentioned are based on direct visual inspection.
In summary, the U-Scope is a medical device used for internal visualization and diagnostic procedures performed directly on the patient, not an in vitro diagnostic device that analyzes samples outside the body.
N/A
Intended Use / 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.
Product codes
HIH
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital CMOS technology
Anatomical Site
Cervical canal and uterine cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained Medical Professionals / Hospitals and Physician Offices
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
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.
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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.
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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
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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 |
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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