(132 days)
Not Found
No
The summary describes a standard endoscopic system for visualization and image capture, with no mention of AI/ML capabilities, image processing for analysis, or performance metrics typically associated with AI/ML algorithms.
No.
The device is used for diagnostic purposes, specifically for viewing the cervical canal, uterine cavity, and urinary bladder to perform diagnostic procedures and evaluate/diagnose pathologies. It does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used to permit viewing... for the purpose of performing diagnostic procedures" and lists "diagnostic hysteroscopy" and "diagnostic procedures" for the urinary bladder. The "Device Description" also mentions its use for "diagnostic hysteroscopy procedures" and to "enable evaluation and diagnosis of the uterine cavity or the urinary bladder for pathology."
No
The device description clearly outlines hardware components including a reusable Handheld Monitor, a sterile single-use cannula with a camera and LED light source, and an electrical connector.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Endosee Hysteroscope and Disposable Diagnostic (Dx) Cannula are used for direct visualization of internal anatomical structures (cervical canal, uterine cavity, and urinary bladder) using an endoscope. It is a diagnostic tool that allows a healthcare professional to visually inspect these areas.
- Lack of Sample Analysis: The device does not perform any analysis on samples taken from the body. It is a tool for visual examination.
Therefore, while it is a diagnostic device, it falls under the category of an endoscopic device used for direct visualization, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Endosee Hysteroscope and Disposable Diagnostic (Dx) Cannula are used to permit viewing of the adult 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
- · Pelvic Pain
The Endosee Hysteroscope and Disposable (Dx) Cannula can also be used to permit viewing of the adult urinary bladder through a minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic procedures.
Product codes
HIH, FAJ
Device Description
The Endosee system is a handheld, battery-operated endoscope that consists of two components: a reusable Handheld Monitor and a sterile, single use cannula. The Endosee is intended for use in viewing the cervical canal and uterine cavity for the purpose of performing diagnostic hysteroscopy procedures in an outpatient or in an office setting. The Endosee can also be used to permit viewing of the urinary bladder, via the urethra, for the purpose of performing diagnostic cystoscopy procedures in an outpatient or office setting.
The Disposable Diagnostic (Dx) Cannula is inserted through the cervix to view the cervical canal and uterine cavity. The Dx Cannula can also be inserted through the urethra to view the bladder. This enables the evaluation and diagnosis of the uterine cavity or the urinary bladder for pathology. The cannula includes a camera and LED light source at the distal end to illuminate the desired location for better user visualization, as well as to capture image and video of the diagnostic site. The video signal is electronically transferred to the Handheld Monitor of the Endosee Hysteroscope by an electrical connector, and an LCD touchscreen monitor on the reusable Handheld Monitor is used for viewing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical canal, uterine cavity, urinary bladder
Indicated Patient Age Range
adult
Intended User / Care Setting
Outpatient or in an 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
Non-Clinical Performance Testing:
This validation of the subject device was performed on the device design in support of expanding the Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula indications for use to include cystoscopy applications. The purpose of the test was to determine that the subject device enables acceptable visualization of the bladder in a standard urological procedure as it is currently designed. The testing took place in a simulated operating room environment, utilizing cadaveric specimens. The acceptance criteria were that all participants must affirm that the cannula enabled visualization of all intended targets in the bladder. The subject device met all acceptance criteria.
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.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with a triple-line design representing the bodies.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 13, 2017
CooperSurgical, Inc. Roaida Johnson Director. RA. New Product Development 95 Corporate Drive Trumbull, Connecticut 06611
Re: K170660
Trade/Device Name: Endosee® Hysteroscope with Disposable Diagnostic (Dx) Cannula Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: Class II Product Code: HIH, FAJ Dated: June 14, 2017 Received: June 15, 2017
Dear Roaida Johnson:
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. You must comply
1
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 devicerelated 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" (21 CFR 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,
Benjamin R. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K170660
Device Name
Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula
Indications for Use (Describe)
The Endosee Hysteroscope and Disposable Diagnostic (Dx) Cannula are used to permit viewing of the adult 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
- · Pelvic Pain
The Endosee Hysteroscope and Disposable (Dx) Cannula can also be used to permit viewing of the adult urinary bladder through a minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic procedures.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for CooperSurgical. The logo is in black and features a stylized font. The logo is simple and modern.
510(k) Summary Endosee® Hysteroscope with Disposable Diagnostic (Dx) Cannula
Submitter Information
| Company Name: | CooperSurgical Inc. |
|---|---|
| Company Address: | 95 Corporate Drive |
| Trumbull, CT 06611 | |
| Telephone: | 203-601-5200 |
| Fax: | 203-601-9870 |
| Contact Person: | Roaida Johnson |
| Date Prepared: | June 14, 2017 |
Device Information
| Trade Names: | Endosee® Hysteroscope with Disposable Diagnostic (Dx) Cannula |
|---|---|
| Common Name: | Hysteroscope, Cystoscope |
| Classification Number: | Class II per 21 CFR 884.1690 |
| Class II per 21 CFR 876.1500 | |
| Classification Name: | Hysteroscope (And Accessories), |
| Cystoscope and Accessories (Flexible/Rigid) | |
| Product Code: | HIH, FAJ |
Predicate Device Information
The Endosee® is substantially equivalent to the following predicates:
| Primary Predicate: | Schoelly Cystoscope/Hysteroscope and Accessories (K150158) |
|---|---|
| Additional Predicate: | EndoSee U-Scope 8000 (K123151 & K132384) |
The predicate devices have not been subject to a design-related recall.
4
Device Description
The Endosee system is a handheld, battery-operated endoscope that consists of two components: a reusable Handheld Monitor and a sterile, single use cannula. The Endosee is intended for use in viewing the cervical canal and uterine cavity for the purpose of performing diagnostic hysteroscopy procedures in an outpatient or in an office setting. The Endosee can also be used to permit viewing of the urinary bladder, via the urethra, for the purpose of performing diagnostic cystoscopy procedures in an outpatient or office setting.
The Disposable Diagnostic (Dx) Cannula is inserted through the cervix to view the cervical canal and uterine cavity. The Dx Cannula can also be inserted through the urethra to view the bladder. This enables the evaluation and diagnosis of the uterine cavity or the urinary bladder for pathology. The cannula includes a camera and LED light source at the distal end to illuminate the desired location for better user visualization, as well as to capture image and video of the diagnostic site. The video signal is electronically transferred to the Handheld Monitor of the Endosee Hysteroscope by an electrical connector, and an LCD touchscreen monitor on the reusable Handheld Monitor is used for viewing.
Product specifications are listed in the tables below:
| Parameter | Specification |
|---|---|
| Length | 117.5mm |
| Diameter | 29.8mm |
| Weight | 90g |
| Diagonal Size of Display Area | 88.9mm |
Handheld Monitor
Disposable Diagnostic (Dx) Cannula
| Parameter | Specification |
|---|---|
| Cannula Type | Flexible |
| Cannula Length | 276mm |
| Cannula Largest Outer Diameter | 4.8mm |
| Field of View | 100° ± 5° |
| Direction of View | 20° ± 3° |
Indications for Use
The Endosee Hysteroscope and Disposable Diagnostic (Dx) Cannula are used to permit viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic procedures.
Generally recognized indications for diagnostic hysteroscopy include:
- o Abnormal bleeding
- Infertility and pregnancy wastage ●
- Evaluation of abnormal hysterosalpingogram ●
- Intrauterine foreign body ●
- Amenorrhea ●
- Pelvic Pain ●
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The Endosee Hysteroscope and Disposable Diagnostic (Dx) Cannula can also be used to permit viewing of the adult urinary bladder through a minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic procedures.
Substantial Equivalence Discussion
The substantial equivalence of the subject device to the predicates is discussed below in Table 1, by similarity in respect to: intended use, indications for use, principals of operation, technological characteristics, materials, and performance.
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K170660 page 4 of 7
| Property | Subject Device
Endosee Hysteroscope | Primary Predicate
Schoelly Cystoscopes/
Hysteroscopes and
Accessories | Additional
Predicate
Endosee U-Scope
Model 8000 | Significant Differences | | Cannula Type | Patient
Contacting
Materials | Cannula
Length | Cannula
Largest Outer
Diameter | Endoscope
Light Source | Endoscope
Field of View |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-------------------|--------------------------------------------------------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | Not yet assigned | K150158 | K123151; K132384 | N/A | Flexible | glass, stainless
steel, nylon,
acrylic, adhesive | 276mm | 4.8mm | LED | $100° ±5°$ | Different. However, the primary
predicate and subject devices have types
of cannula that are typical for these
types of devices, and do not raise any
new questions of safety and
effectiveness.
The cannula type of the subject device is
the same as the additional predicate. |
| Indications
for Use | The Endosee
Hysteroscope and
Disposable Diagnostic
(Dx) Cannula are 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
hystero-salpingogram,
Intrauterine foreign
body, Amenorrhea,
Pelvic Pain
The Endosee and
Disposable Diagnostic
(Dx) Cannula can also
be used to permit
viewing of the urinary
bladder through a
minimally invasive
approach by utilizing
natural orifices for the
purpose of performing
diagnostic procedures.
The target population is
all patients for whom a
cystourethroscopy
would be indicated,
either in an office
setting or in the
operating room. | The Schoelly
Cystoscopes/
Hysteroscopes and
Accessories are indicated
to provide the user with
the means for endoscopic
diagnostic and
therapeutic surgical
procedures. Examples
for the use of the devices
include the visualization
and manipulation of
anatomy as the surgeon
deems appropriate. The
Schoelly Cystoscopes/
Hysteroscopes and
Accessories are intended
to be used in general
urological and
gynecological surgery
through a minimally
invasive approach by
utilizing natural orifices
to access the surgical
site. | The Endosee
Hysteroscope and
Disposable
Diagnostic (Dx)
Cannula are 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
hystero-
salpingogram,
Intrauterine foreign
body, Amenorrhea,
Pelvic Pain | Similar. Although the predicate is
also indicated for the use in
surgical procedures, the predicate
and subject devices have the same
intended use in general diagnostic
gynecological or diagnostic
urological procedures through a
minimally invasive approach by
utilizing natural orifices to access
the diagnostic site. | Rigid | Stainless steel,
stainless steel alloy,
glass, glass fibers,
adhesive, brazing
alloy | 300mm - 365mm | 2.9mm;4mm | External, connected
via light guide to
light guide connector | 70°-85° | Different. However, the primary
predicate and subject devices have
patient contacting materials that are
typical for these types of devices, and
do not raise any new questions of safety
and effectiveness.
The patient contacting materials of the
subject device is the same as the
additional predicate. |
| Technology
Overview | handheld battery-
operated hysteroscope,
consisting of a reusable
handle and a sterile,
disposable, diagnostic
cannula | rigid reusable
cystoscope/ hysteroscope
to be used in conjunction
with a light guide, light
source, video camera,
monitor, and printer for
diagnostic and
therapeutic surgical
procedures | handheld battery-
operated
hysteroscope,
consisting of a
reusable handle and
a sterile, disposable,
diagnostic cannula | Different. However, the primary
predicate and subject devices have
technological characteristics
typical for these types of devices,
and do not raise any new questions
of safety and effectiveness.
The technological characteristics of
the subject device are the same as
the additional predicate. | Flexible | glass, stainless steel,
nylon, acrylic,
adhesive | 276mm | 4.8mm | LED | $100° ±5°$ | Different. However, the primary
predicate and subject devices have
cannula lengths that are typical for these
types of devices, and do not raise any new questions of safety and
effectiveness.
The cannula length of the subject device
is the same as the additional predicate. |
| | | | | | | Different. However, the primary
predicate and subject devices cannula
outer diameters that are typical for these
types of devices, and do not raise any
new questions of safety and
effectiveness.
The cannula outer diameter of the
subject device is the same as the
additional predicate. | | | | | |
| | | | | | | Similar. Although the predicate utilizes
an external light source and the subject
device uses LEDs built into the cannula,
both devices are the same in that light is
transmitted through the endoscope to
enhance visualization of the diagnostic
site.
The light source of the subject device is
the same as the additional predicate. | | | | | |
| | | | | | | Different. However, the primary
predicate and subject devices have fields
of view that are typical for these types
of devices, and do not raise any new
questions of safety and effectiveness.
The field of view of the subject device
is the same as the additional predicate. | | | | | |
Table 1: Comparison of the Endosee to the Predicate Devices
7
K170660
page 5 of 7
8
| Endoscope
Direction of
View | 20 $°$ ± 3 $°$ | 0 $°$ -70 $°$ | 20 $°$ ± 3 $°$ | Different. However, the primary
predicate and subject devices have
directions of view that are typical for
these types of devices, and do not raise
any new questions of safety and
effectiveness.
The direction of view of the subject device is the same as the additional
predicate. |
|-----------------------------------|-------------------------------|-----------------------------------------|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Endoscope
Image Display | LCD on
handheld
monitor | Camera/monitor
connected to eyepiece | LCD on handheld
monitor | Similar. Although, the primary predicate
camera/monitor connects to an eyepiece
for image display, both devices are the
same in that they provide means of video
endoscopy by displaying the diagnostic site on an external monitor.
The endoscope display image of the
subject device is the same as the
additional predicate. |
9
Non-Clinical Performance Testing
As part of demonstrating substantial equivalence to the predicate devices, the following nonclinical performance tests were conducted:
- . Design Validation
- This validation of the subject device was performed on the device design in O support of expanding the Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula indications for use to include cystoscopy applications. The purpose of the test was to determine that the subject device enables acceptable visualization of the bladder in a standard urological procedure as it is currently designed. The testing took place in a simulated operating room environment, utilizing cadaveric specimens. The acceptance criteria were that all participants must affirm that the cannula enabled visualization of all intended targets in the bladder. The subject device met all acceptance criteria.
Conclusion
The results of the testing described above demonstrate that the Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula is substantially equivalent to the predicate.