Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula

K170660 · CooperSurgical, Inc. · HIH · Jul 13, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K170660
• Device Name: Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula
• Applicant: CooperSurgical, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Jul 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2

Intended 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.

Device Story

Handheld, battery-operated endoscope; consists of reusable monitor and sterile, single-use flexible cannula. Cannula features distal camera and LED light source for illumination and image/video capture. Video signal transfers to handheld LCD touchscreen monitor. Used in outpatient or office settings by clinicians for diagnostic hysteroscopy and cystoscopy. Enables direct visualization of uterine cavity or urinary bladder to evaluate pathology. Benefits include minimally invasive diagnostic access without requiring complex external light/camera systems.

Clinical Evidence

Bench testing only. Design validation performed in a simulated operating room environment using cadaveric specimens to confirm visualization capabilities for cystoscopy. All participants affirmed the cannula enabled visualization of all intended targets in the bladder, meeting acceptance criteria.

Technological Characteristics

Handheld, battery-operated endoscope. Components: reusable monitor, sterile single-use flexible cannula. Cannula materials: glass, stainless steel, nylon, acrylic, adhesive. Illumination: integrated distal LED. Display: 88.9mm diagonal LCD touchscreen. Dimensions: 117.5mm x 29.8mm (monitor), 276mm length, 4.8mm diameter (cannula). Field of view: 100° ± 5°. Direction of view: 20° ± 3°.

Indications for Use

Indicated for adult patients requiring diagnostic visualization of the cervical canal, uterine cavity, or urinary bladder via natural orifices. Indications include abnormal bleeding, infertility, pregnancy wastage, abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain.

Regulatory Classification

Identification

A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

Predicate Devices

• Schoelly Cystoscope/Hysteroscope and Accessories (K150158)
• EndoSee U-Scope 8000 (K123151 & K132384)

Submission Summary (Full Text)

{0}------------------------------------------------

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 [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" (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 [phone] or [phone] 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

{2}------------------------------------------------

#### 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) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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 ●

{5}------------------------------------------------

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.

{6}------------------------------------------------

## K170660 page 4 of 7

| Property | Subject Device<br>Endosee Hysteroscope | Primary Predicate<br>Schoelly Cystoscopes/<br>Hysteroscopes and<br>Accessories | Additional<br>Predicate<br>Endosee U-Scope<br>Model 8000 | Significant Differences | | Cannula Type | Patient<br>Contacting<br>Materials | Cannula<br>Length | Cannula<br>Largest Outer<br>Diameter | Endoscope<br>Light Source | Endoscope<br>Field of View |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-------------------|--------------------------------------------------------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>Number | Not yet assigned | K150158 | K123151; K132384 | N/A | Flexible | glass, stainless<br>steel, nylon,<br>acrylic, adhesive | 276mm | 4.8mm | LED | $100° ±5°$ | Different. However, the primary<br>predicate and subject devices have types<br>of cannula that are typical for these<br>types of devices, and do not raise any<br>new questions of safety and<br>effectiveness.<br>The cannula type of the subject device is<br>the same as the additional predicate. |
| Indications<br>for Use | The Endosee<br>Hysteroscope and<br>Disposable Diagnostic<br>(Dx) Cannula are used<br>to permit viewing of the<br>cervical canal and<br>uterine cavity for the<br>purpose of performing<br>diagnostic procedures.<br>Generally recognized<br>indications for<br>diagnostic hysteroscopy<br>include: Abnormal<br>bleeding, Infertility and<br>pregnancy wastage,<br>Evaluation of abnormal<br>hystero-salpingogram,<br>Intrauterine foreign<br>body, Amenorrhea,<br>Pelvic Pain<br>The Endosee and<br>Disposable Diagnostic<br>(Dx) Cannula can also<br>be used to permit<br>viewing of the urinary<br>bladder through a<br>minimally invasive<br>approach by utilizing<br>natural orifices for the<br>purpose of performing<br>diagnostic procedures.<br>The target population is<br>all patients for whom a<br>cystourethroscopy<br>would be indicated,<br>either in an office<br>setting or in the<br>operating room. | The Schoelly<br>Cystoscopes/<br>Hysteroscopes and<br>Accessories are indicated<br>to provide the user with<br>the means for endoscopic<br>diagnostic and<br>therapeutic surgical<br>procedures. Examples<br>for the use of the devices<br>include the visualization<br>and manipulation of<br>anatomy as the surgeon<br>deems appropriate. The<br>Schoelly Cystoscopes/<br>Hysteroscopes and<br>Accessories are intended<br>to be used in general<br>urological and<br>gynecological surgery<br>through a minimally<br>invasive approach by<br>utilizing natural orifices<br>to access the surgical<br>site. | The Endosee<br>Hysteroscope and<br>Disposable<br>Diagnostic (Dx)<br>Cannula are used to<br>permit viewing of<br>the cervical canal<br>and uterine cavity<br>for the purpose of<br>performing<br>diagnostic<br>procedures.<br>Generally<br>recognized<br>indications for<br>diagnostic<br>hysteroscopy<br>include: Abnormal<br>bleeding, Infertility<br>and pregnancy<br>wastage, Evaluation<br>of abnormal<br>hystero-<br>salpingogram,<br>Intrauterine foreign<br>body, Amenorrhea,<br>Pelvic Pain | Similar. Although the predicate is<br>also indicated for the use in<br>surgical procedures, the predicate<br>and subject devices have the same<br>intended use in general diagnostic<br>gynecological or diagnostic<br>urological procedures through a<br>minimally invasive approach by<br>utilizing natural orifices to access<br>the diagnostic site. | Rigid | Stainless steel,<br>stainless steel alloy,<br>glass, glass fibers,<br>adhesive, brazing<br>alloy | 300mm - 365mm | 2.9mm;4mm | External, connected<br>via light guide to<br>light guide connector | 70°-85° | Different. However, the primary<br>predicate and subject devices have<br>patient contacting materials that are<br>typical for these types of devices, and<br>do not raise any new questions of safety<br>and effectiveness.<br>The patient contacting materials of the<br>subject device is the same as the<br>additional predicate. |
| Technology<br>Overview | handheld battery-<br>operated hysteroscope,<br>consisting of a reusable<br>handle and a sterile,<br>disposable, diagnostic<br>cannula | rigid reusable<br>cystoscope/ hysteroscope<br>to be used in conjunction<br>with a light guide, light<br>source, video camera,<br>monitor, and printer for<br>diagnostic and<br>therapeutic surgical<br>procedures | handheld battery-<br>operated<br>hysteroscope,<br>consisting of a<br>reusable handle and<br>a sterile, disposable,<br>diagnostic cannula | Different. However, the primary<br>predicate and subject devices have<br>technological characteristics<br>typical for these types of devices,<br>and do not raise any new questions<br>of safety and effectiveness.<br>The technological characteristics of<br>the subject device are the same as<br>the additional predicate. | Flexible | glass, stainless steel,<br>nylon, acrylic,<br>adhesive | 276mm | 4.8mm | LED | $100° ±5°$ | Different. However, the primary<br>predicate and subject devices have<br>cannula lengths that are typical for these<br>types of devices, and do not raise any new questions of safety and<br>effectiveness.<br>The cannula length of the subject device<br>is the same as the additional predicate. |
| | | | | | | Different. However, the primary<br>predicate and subject devices cannula<br>outer diameters that are typical for these<br>types of devices, and do not raise any<br>new questions of safety and<br>effectiveness.<br>The cannula outer diameter of the<br>subject device is the same as the<br>additional predicate. | | | | | |
| | | | | | | Similar. Although the predicate utilizes<br>an external light source and the subject<br>device uses LEDs built into the cannula,<br>both devices are the same in that light is<br>transmitted through the endoscope to<br>enhance visualization of the diagnostic<br>site.<br>The light source of the subject device is<br>the same as the additional predicate. | | | | | |
| | | | | | | Different. However, the primary<br>predicate and subject devices have fields<br>of view that are typical for these types<br>of devices, and do not raise any new<br>questions of safety and effectiveness.<br>The field of view of the subject device<br>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<br>Direction of<br>View | 20 $°$ ± 3 $°$ | 0 $°$ -70 $°$ | 20 $°$ ± 3 $°$ | Different. However, the primary<br>predicate and subject devices have<br>directions of view that are typical for<br>these types of devices, and do not raise<br>any new questions of safety and<br>effectiveness.<br>The direction of view of the subject device is the same as the additional<br>predicate. |
|-----------------------------------|-------------------------------|-----------------------------------------|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Endoscope<br>Image Display | LCD on<br>handheld<br>monitor | Camera/monitor<br>connected to eyepiece | LCD on handheld<br>monitor | Similar. Although, the primary predicate<br>camera/monitor connects to an eyepiece<br>for image display, both devices are the<br>same in that they provide means of video<br>endoscopy by displaying the diagnostic site on an external monitor.<br>The endoscope display image of the<br>subject device is the same as the<br>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.