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 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.

AI/ML Overview

The provided text describes non-clinical performance testing for the Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula to support expanding its indications for use to include cystoscopy applications.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Cannula enables acceptable visualization of the bladder in a standard urological procedure.	The subject device met all acceptance criteria. All participants affirmed that the cannula enabled visualization of all intended targets in the bladder.

2. Sample Size and Data Provenance

Test Set Sample Size: Not explicitly stated, but the study utilized "cadaveric specimens."
Data Provenance: Retrospective (cadaveric specimens) from an unspecified country (likely the US, given the FDA submission).

3. Number of Experts and Qualifications

Number of Experts: Not explicitly stated. The text mentions "all participants" in the simulated operating room environment, but their specific qualifications are not detailed beyond being able to "affirm that the cannula enabled visualization." It can be inferred they are likely medical professionals, potentially urologists, given the context of cystoscopy applications and a simulated operating room.

4. Adjudication Method

Adjudication Method: Not explicitly stated. The acceptance criteria indicate that "all participants must affirm" the visualization. This suggests a form of consensus or agreement among the participants, but the specific method (e.g., voting, discussion) is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not explicitly conducted as described in the provided text. The study focused on the standalone performance of the device's visualization capabilities.

6. Standalone Performance Study

Standalone Study: Yes, a standalone performance study was conducted. The purpose was to "determine that the subject device enables acceptable visualization of the bladder in a standard urological procedure as it is currently designed." This refers to the algorithm/device itself (the cannula with its camera and light source) and its ability to provide clear visuals, not its performance in conjunction with human interpretation in a comparative effectiveness study.

7. Type of Ground Truth Used

Ground Truth: Expert consensus based on direct visualization. The ground truth was established by the "participants" in the simulated operating room environment affirming that they could see all intended targets in the bladder using the device.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable/not mentioned. This was a direct performance validation study of a physical device's visualization capabilities, not an AI/algorithm development study.

9. How Ground Truth for the Training Set was Established

Ground Truth for Training Set: Not applicable. As this was not an AI/algorithm development study, there was no separate training set for which ground truth would need to be established by experts for machine learning purposes.

Summary

{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 (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

{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

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

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 DeviceEndosee Hysteroscope	Primary PredicateSchoelly Cystoscopes/Hysteroscopes andAccessories	AdditionalPredicateEndosee U-ScopeModel 8000	Significant Differences		Cannula Type	PatientContactingMaterials	CannulaLength	CannulaLargest OuterDiameter	EndoscopeLight Source	EndoscopeField of View
510(k)Number	Not yet assigned	K150158	K123151; K132384	N/A	Flexible	glass, stainlesssteel, nylon,acrylic, adhesive	276mm	4.8mm	LED	$100° ±5°$	Different. However, the primarypredicate and subject devices have typesof cannula that are typical for thesetypes of devices, and do not raise anynew questions of safety andeffectiveness.The cannula type of the subject device isthe same as the additional predicate.
Indicationsfor Use	The EndoseeHysteroscope andDisposable Diagnostic(Dx) Cannula are usedto permit viewing of thecervical canal anduterine cavity for thepurpose of performingdiagnostic procedures.Generally recognizedindications fordiagnostic hysteroscopyinclude: Abnormalbleeding, Infertility andpregnancy wastage,Evaluation of abnormalhystero-salpingogram,Intrauterine foreignbody, Amenorrhea,Pelvic PainThe Endosee andDisposable Diagnostic(Dx) Cannula can alsobe used to permitviewing of the urinarybladder through aminimally invasiveapproach by utilizingnatural orifices for thepurpose of performingdiagnostic procedures.The target population isall patients for whom acystourethroscopywould be indicated,either in an officesetting or in theoperating room.	The SchoellyCystoscopes/Hysteroscopes andAccessories are indicatedto provide the user withthe means for endoscopicdiagnostic andtherapeutic surgicalprocedures. Examplesfor the use of the devicesinclude the visualizationand manipulation ofanatomy as the surgeondeems appropriate. TheSchoelly Cystoscopes/Hysteroscopes andAccessories are intendedto be used in generalurological andgynecological surgerythrough a minimallyinvasive approach byutilizing natural orificesto access the surgicalsite.	The EndoseeHysteroscope andDisposableDiagnostic (Dx)Cannula are used topermit viewing ofthe cervical canaland uterine cavityfor the purpose ofperformingdiagnosticprocedures.Generallyrecognizedindications fordiagnostichysteroscopyinclude: Abnormalbleeding, Infertilityand pregnancywastage, Evaluationof abnormalhystero-salpingogram,Intrauterine foreignbody, Amenorrhea,Pelvic Pain	Similar. Although the predicate isalso indicated for the use insurgical procedures, the predicateand subject devices have the sameintended use in general diagnosticgynecological or diagnosticurological procedures through aminimally invasive approach byutilizing natural orifices to accessthe diagnostic site.	Rigid	Stainless steel,stainless steel alloy,glass, glass fibers,adhesive, brazingalloy	300mm - 365mm	2.9mm;4mm	External, connectedvia light guide tolight guide connector	70°-85°	Different. However, the primarypredicate and subject devices havepatient contacting materials that aretypical for these types of devices, anddo not raise any new questions of safetyand effectiveness.The patient contacting materials of thesubject device is the same as theadditional predicate.
TechnologyOverview	handheld battery-operated hysteroscope,consisting of a reusablehandle and a sterile,disposable, diagnosticcannula	rigid reusablecystoscope/ hysteroscopeto be used in conjunctionwith a light guide, lightsource, video camera,monitor, and printer fordiagnostic andtherapeutic surgicalprocedures	handheld battery-operatedhysteroscope,consisting of areusable handle anda sterile, disposable,diagnostic cannula	Different. However, the primarypredicate and subject devices havetechnological characteristicstypical for these types of devices,and do not raise any new questionsof safety and effectiveness.The technological characteristics ofthe subject device are the same asthe additional predicate.	Flexible	glass, stainless steel,nylon, acrylic,adhesive	276mm	4.8mm	LED	$100° ±5°$	Different. However, the primarypredicate and subject devices havecannula lengths that are typical for thesetypes of devices, and do not raise any new questions of safety andeffectiveness.The cannula length of the subject deviceis the same as the additional predicate.
						Different. However, the primarypredicate and subject devices cannulaouter diameters that are typical for thesetypes of devices, and do not raise anynew questions of safety andeffectiveness.The cannula outer diameter of thesubject device is the same as theadditional predicate.
						Similar. Although the predicate utilizesan external light source and the subjectdevice uses LEDs built into the cannula,both devices are the same in that light istransmitted through the endoscope toenhance visualization of the diagnosticsite.The light source of the subject device isthe same as the additional predicate.
						Different. However, the primarypredicate and subject devices have fieldsof view that are typical for these typesof devices, and do not raise any newquestions of safety and effectiveness.The field of view of the subject deviceis the same as the additional predicate.

Table 1: Comparison of the Endosee to the Predicate Devices

{7}------------------------------------------------

K170660
page 5 of 7

{8}------------------------------------------------

EndoscopeDirection ofView	20 $°$ ± 3 $°$	0 $°$ -70 $°$	20 $°$ ± 3 $°$	Different. However, the primarypredicate and subject devices havedirections of view that are typical forthese types of devices, and do not raiseany new questions of safety andeffectiveness.The direction of view of the subject device is the same as the additionalpredicate.
EndoscopeImage Display	LCD onhandheldmonitor	Camera/monitorconnected to eyepiece	LCD on handheldmonitor	Similar. Although, the primary predicatecamera/monitor connects to an eyepiecefor image display, both devices are thesame in that they provide means of videoendoscopy by displaying the diagnostic site on an external monitor.The endoscope display image of thesubject device is the same as theadditional 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.

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.