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 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.

AI/ML Overview

The Endosee® System is a handheld, battery-operated endoscope used for viewing the adult cervical canal, uterine cavity, or female urinary tract for diagnostic and therapeutic procedures.

Here's an analysis of the provided information regarding its acceptance criteria and supporting studies:

Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state formal "acceptance criteria" with specific thresholds or metrics for the device's performance in a table format. However, it does describe the areas of non-clinical performance testing conducted to demonstrate substantial equivalence to its predicate device (K183020). The conclusion states that the results of the testing demonstrate that the subject Endosee System is substantially equivalent to the predicate. This implies that the device met the performance expectations in these tested areas to be considered substantially equivalent.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Design Validation	Designed to meet intended specifications and uses.	Successfully completed. (Implied by substantial equivalence claim)
Functional Testing	Maintained functionality after aging.	Successfully completed on 6-month aged samples.
* Tip Retention *	Tip securely attached and functional.	Passed. (Implied by substantial equivalence claim)
* Instrument Access *	Working channel allowed for instrument insertion.	Passed. (Specific to this device, the working channel allows for both fluid infusion and instrument insertion.)
EMC/Electrical Safety	Compliance with relevant electrical safety standards.	Reevaluated with Essential Performance per IEC 60601-2-18. (Implied to have met standards)

Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size for the test set in the non-clinical performance testing. It also doesn't mention data provenance such as country of origin or whether the data was retrospective or prospective, as the testing described is non-clinical performance (bench testing) rather than clinical studies on patients.

Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable. The non-clinical performance testing described involved validating the device's design, functional aspects, and safety standards, not comparisons against expert interpretation of medical images or patient outcomes. Therefore, no medical experts were involved in establishing ground truth for this type of testing.

Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data by multiple readers, which is not the type of testing described here.

Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. The submission focuses on non-clinical performance testing to demonstrate substantial equivalence to a predicate device, not on comparing reader performance with and without AI assistance.

Standalone (Algorithm Only) Performance Study:

No standalone (algorithm only) performance study was done. This device is a physical endoscope system, not an AI-powered diagnostic algorithm.

Type of Ground Truth Used:

For the non-clinical performance testing, the "ground truth" would be the engineering specifications, functional requirements, and safety standards (e.g., IEC 60601-2-18) against which the device's performance was measured. It is not expert consensus, pathology, or outcomes data.

Sample Size for the Training Set:

This information is not applicable. There is no mention of a "training set" as this device is not an AI/ML algorithm that requires training data.

How the Ground Truth for the Training Set Was Established:

This information is not applicable, as there is no training set for this device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

· 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

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 DriveTrumbull, CT 06611
	Telephone: 203-601-5200 Ext. 3370
	Fax: 203-601-9870

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

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Indications for Use

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

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 viewingof the cervical canal and uterine cavity for thepurpose of performing diagnostic procedures.Generally recognized indications for diagnostichysteroscopy include:	The Endosee System is used to permit viewingof the adult cervical canal and uterine cavity forthe purpose of performing diagnostic andtherapeutic procedures. The types ofprocedures where the Endosee System couldoffer visualization include:
	• Abnormal bleeding• Infertility and pregnancy wastage• Evaluation of abnormal hysterosalpingogram• Intrauterine foreign body• Amenorrhea and pelvic pain	• Abnormal bleeding• Infertility and pregnancy wastage• Evaluation of abnormal hysterosalpingogram• Intrauterine foreign body• Amenorrhea• Pelvic pain• Directed biopsy
Indications for Use	The Endosee System can also be used to permitviewing of the urinary bladder through aminimally invasive approach by utilizing naturalorifices for the purpose of performing diagnosticprocedures.	• Removal of fibroids and polyps• Transection of intrauterine adhesions• Transection of intrauterine septaThe Endosee System can also be used to permitviewing of the adult urinary bladder through aminimally invasive approach by utilizing natural

Table 1: Subject and Predicate Comparison

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		orifices for the purpose of performing diagnostiand therapeutic procedures.
Technology	Handheld, battery-operated endoscope thatconsists of a reusable, detachable DisplayModule and sterile, disposable Cannula with ahandle; Wi-Fi capability.	Same
Cannula Type andDimensions	Type: FlexibleWorking Length: 276mm Largest OuterDiameter: 4.5mm	Same
Cannula WorkingChannel	Working channel for fluid infusion andinstrument access	Working channel for fluid infusion
View	Field of View: 100° ± 5°Direction of View: 20° ± 3°	Same
Light Source	LED	Same
Image Display	Handheld LCD display module	Same
Patient ContactingMaterials	PEEK, ink, glass, adhesive, lens coating, surfaceblack coating	Same
Number of Uses	Cannula: single-use, disposableDisplay Module: reusable	Same
Cannula Sterilization	Ethylene oxide, SAL 10-6	Same
Cannula Shelf Life	6 months	Same
Packaging	Cannula: Individually pouched or individuallypouched with a pipette Display Module: Boxedwith Docking Station, power cord, andUSB 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.

Regulation Number and Section

§ 884.1690 Hysteroscope and accessories.

(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.