Endosee System

K190639 · CooperSurgical, Inc. · HIH · May 15, 2019 · Obstetrics/Gynecology

Device Facts

• Record ID: K190639
• Device Name: Endosee System
• Applicant: CooperSurgical, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: May 15, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Endosee System is used to permit viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic procedures. The types of procedures where the Endosee System could offer visualization include: - Abnormal bleeding - Infertility and pregnancy wastage - Evaluation of abnormal hysterosalpingogram - Intrauterine foreign body - Amenorrhea - Pelvic pain - Directed biopsy - Removal of fibroids and polyps - Transection of intrauterine adhesions - Transection of intrauterine septa The Endosee System 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 and therapeutic procedures.

Device Story

Handheld, battery-operated, portable endoscope; consists of reusable LCD touchscreen display module and sterile, single-use cannula. Cannula features distal light source and camera; captures image/video signals. Signals transferred electronically to display module for real-time visualization. Used in OR, outpatient, or office settings by clinicians. Docking station recharges battery and enables image/video download to external computer. Device facilitates diagnostic and therapeutic hysteroscopy and cystoscopy; provides direct visualization for procedures like biopsy, polyp removal, and adhesion/septa transection. Enables minimally invasive access via natural orifices; improves clinical decision-making through immediate visual feedback.

Clinical Evidence

Bench testing only. Performance verified through design validation and functional testing on 6-month aged samples, including tip retention, instrument access, and EMC/electrical safety re-evaluation per IEC 60601-2-18.

Technological Characteristics

Handheld, battery-operated endoscope. Components: reusable LCD display module, sterile single-use flexible cannula (276mm length, 4.5mm diameter). Light source: LED. Materials: PEEK, ink, glass, adhesive, lens coating, surface black coating. Connectivity: Wi-Fi, USB for data download. Sterilization: Ethylene oxide (SAL 10^-6).

Indications for Use

Indicated for adult patients requiring visualization of the cervical canal, uterine cavity, or urinary bladder for diagnostic and therapeutic procedures, including management of abnormal bleeding, infertility, foreign bodies, amenorrhea, pelvic pain, and tissue removal/biopsy.

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

• Endosee System (K183020)

Submission Summary (Full Text)

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May 15, 2019

CooperSurgical, Inc. Christine Kupchick Regulatory Affairs Associate 95 Corporate Drive Trumbull, CT 06611

Re: K190639

Trade/Device Name: Endosee® System Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope And Accessories Regulatory Class: Class II Product Code: HIH, FAJ Dated: April 12, 2019 Received: April 15, 2019

Dear Christine Kupchick:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Sharon Andrews Assistant Division Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K190639

Device Name Endosee® System

Indications for Use (Describe)

The Endosee System is used to permit viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic procedures. The types of procedures where the Endosee System could offer visualization include:

- · Abnormal bleeding
- · Infertility and pregnancy wastage
- · Evaluation of abnormal hysterosalpingogram
- · Intrauterine foreign body
- · Amenorrhea
- · Pelvic pain
- · Directed biopsy
- · Removal of fibroids and polyps
- · Transection of intrauterine adhesions
- · Transection of intrauterine septa

The Endosee System 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 and therapeutic 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 blue and consists of the words "CooperSurgical" in a stylized font. Below the logo is the tagline "Healthy women, babies, and families™" also in blue.

# 510(k) SUMMARY K190639

#### Submitter Information

| Company Name: | CooperSurgical Inc. |
|------------------|------------------------------------------|
| Company Address: | 95 Corporate Drive<br>Trumbull, CT 06611 |
| | Telephone: [phone] Ext. 3370 |
| | Fax: [phone] |

- Christine Kupchick Contact Person:
- Date Prepared: May 14, 2019

## Device Information

| Trade Names: | Endosee® System |
|--------------------|------------------------------|
| Common Name: | Hysteroscope; Cystoscope |
| Regulation Number: | 21 CFR 884.1690 |
| Regulation Name: | Hysteroscope and Accessories |
| Product Code: | HIH; FAJ |
| Regulatory Class: | Class II |

#### Predicate Device Information

Endosee System (K183020).

The predicate device has not been subject to a design-related recall.

#### Device Description

The Endosee System is a handheld, battery-operated, portable endoscope that consists of a reusable Display Module with an LCD touchscreen monitor and a sterile, single-use cannula. It is intended for use in viewing the adult cervical canal, uterine cavity, or female urinary tract, including the bladder, to perform diagnostic and therapeutic hysteroscopy or cystoscopy procedures in an operating room, outpatient, or office setting. The Cannula has a light source and camera at the distal end, which are used for visualization and to capture image and video of the diagnostic area. The image and video signals are electronically transferred from the Cannula to the Display module via an electrical connector and cable, and the LCD monitor is used for viewing. The Endosee is provided with a Docking Station that recharges the battery in the Display Module and allows the user to download images/video from the internal device memory to an external computer.

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#### Indications for Use

The Endosee System is used to permit viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic procedures. The types of procedures where the Endosee System could offer visualization include:

- Abnormal bleeding
- Infertility and pregnancy wastage
- Evaluation of abnormal hysterosalpingogram
- Intrauterine foreign body
- Amenorrhea
- Pelvic pain
- Directed biopsy
- Removal of fibroids and polyps
- Transection of intrauterine adhesions
- o Transection of intrauterine septa

The Endosee System 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 and therapeutic procedures.

#### Substantial Equivalence Discussion

TABLE 1 provides a comparison of the subject and predicate devices.

| Attribute | Subject Endosee System | Predicate Endosee System (K183020) |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | CooperSurgical, Inc. | Same |
| | The Endosee System is used to permit viewing<br>of the cervical canal and uterine cavity for the<br>purpose of performing diagnostic procedures.<br>Generally recognized indications for diagnostic<br>hysteroscopy include: | The Endosee System is used to permit viewing<br>of the adult cervical canal and uterine cavity for<br>the purpose of performing diagnostic and<br>therapeutic procedures. The types of<br>procedures where the Endosee System could<br>offer visualization include: |
| | • Abnormal bleeding<br>• Infertility and pregnancy wastage<br>• Evaluation of abnormal hysterosalpingogram<br>• Intrauterine foreign body<br>• Amenorrhea and pelvic pain | • Abnormal bleeding<br>• Infertility and pregnancy wastage<br>• Evaluation of abnormal hysterosalpingogram<br>• Intrauterine foreign body<br>• Amenorrhea<br>• Pelvic pain<br>• Directed biopsy |
| Indications for Use | The Endosee System can also be used to permit<br>viewing of the urinary bladder through a<br>minimally invasive approach by utilizing natural<br>orifices for the purpose of performing diagnostic<br>procedures. | • Removal of fibroids and polyps<br>• Transection of intrauterine adhesions<br>• Transection of intrauterine septa<br>The Endosee System can also be used to permit<br>viewing of the adult urinary bladder through a<br>minimally invasive approach by utilizing natural |

#### Table 1: Subject and Predicate Comparison

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| | | orifices for the purpose of performing diagnosti<br>and therapeutic procedures. |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Technology | Handheld, battery-operated endoscope that<br>consists of a reusable, detachable Display<br>Module and sterile, disposable Cannula with a<br>handle; Wi-Fi capability. | Same |
| Cannula Type and<br>Dimensions | Type: Flexible<br>Working Length: 276mm Largest Outer<br>Diameter: 4.5mm | Same |
| Cannula Working<br>Channel | Working channel for fluid infusion and<br>instrument access | Working channel for fluid infusion |
| View | Field of View: 100° ± 5°<br>Direction of View: 20° ± 3° | Same |
| Light Source | LED | Same |
| Image Display | Handheld LCD display module | Same |
| Patient Contacting<br>Materials | PEEK, ink, glass, adhesive, lens coating, surface<br>black coating | Same |
| Number of Uses | Cannula: single-use, disposable<br>Display Module: reusable | Same |
| Cannula Sterilization | Ethylene oxide, SAL 10-6 | Same |
| Cannula Shelf Life | 6 months | Same |
| Packaging | Cannula: Individually pouched or individually<br>pouched with a pipette Display Module: Boxed<br>with Docking Station, power cord, and<br>USB cable | Same |

The subject device and predicate device have different indications for use, however, the inclusion of additional procedures does not represent a new intended use. Therefore, the differences in indications do not raise different questions of safety or effectiveness as compared to the predicate.

The subject device and the predicate device are technologically comparable. The subject device differs from the predicate only in that the working channel in the cannula shaft can be used for both fluid infusion and instrument insertion. This difference does not raise different questions of safety or effectiveness as compared to the predicate.

## Non-Clinical Performance Testing

As part of demonstrating substantial equivalence, the following testing was performed:

- . Design Validation
- Functional Testing (6-month aged samples)
- o Tip Retention
- o Instrument Access
- o EMC/Electrical Safety reevaluated with Essential Performance per IEC 60601-2-18

## Conclusion

The results of the testing described above demonstrate that the subject Endosee System is substantially equivalent to the predicate.