The Endosee System is 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 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 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 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 provided text describes the Endosee® System, a medical device used for diagnostic hysteroscopy and cystoscopy. The document, an FDA 510(k) summary, focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria for performance, a standalone study, or an MRMC study related to AI.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not present in the provided text. The document primarily reports on non-clinical performance testing conducted to ensure safety and equivalence.

Here's a breakdown of the information that can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document doesn't provide a table of acceptance criteria with corresponding performance metrics for diagnostic accuracy or clinical effectiveness. Instead, it lists various non-clinical engineering and safety tests performed. While these tests have internal acceptance criteria, they are not typically clinical performance metrics. The closest general "performance" reported are the specifications that match the predicate device, such as Field of View and Direction of View, which are design specifications rather than clinical performance outcomes.

Test Category	Specific Test (with implicit acceptance criteria of meeting standards)	Reported Device Performance
Sterility	Sterility Testing per ISO 11135-1:2014, EO Residuals per ISO 10993-7:2008, Bioburden per ISO 11737-1:2006 & 11737-2:2009	Not explicitly stated as pass/fail in detail, but the overall conclusion of substantial equivalence implies these tests were met.
Biocompatibility	Cytotoxicity per ISO 10993-5:2009, Sensitization per ISO 10993-10:2010, Irritation per ISO 10993-10:2010	Not explicitly stated as pass/fail in detail, but the overall conclusion of substantial equivalence implies these tests were met.
Shelf Life	Aged to 6-months per ASTM F1980-16. Tested for Seal Tensile Strength, Seal Peel, Functional (Image Quality, Flow Rate, Leak, Bend), and Bubble Leak per ASTM 2096-11 on aged samples.	Cannula Shelf-Life: 6 months (This implies acceptance criteria related to maintaining functionality and integrity for 6 months). For the aged samples, the functional tests (Image Quality, Flow Rate, Leak, Bend) were performed.
Functional Testing	Image Quality Test (Including Resolution), Optical Distortion Test, Saline Flow Rate Test, Leak Test, 90° Bend Test, 3-Point Bend Test, LED Temperature Test, Drop Test per IEC 60601-1-15, IPX2 Ingress Test per IEC 60529:2004, System Level Verification	Not explicitly stated as pass/fail in detail, but the overall conclusion of substantial equivalence implies these tests were met. For basic specifications, the device's Field of View is $100° ± 5°$ and Direction of View is $20° ± 3°$, matching the predicate.
Electrical Standards	UL Electrical Safety per ANSI/AAMI ES 60601-1:2005/(R)2012 and IEC 60601-2-18:2009, UL EMC per IEC 60601-1-2:2014 and IEC 60601-2-18:2009	Not explicitly stated as pass/fail in detail, but the overall conclusion of substantial equivalence implies these tests were met.
Software	Software Verification per IEC 62304:2006 and FDA guidance	Information provided as recommended in FDA guidance.
Cybersecurity/Wireless	Cybersecurity/Intraoperability Information, Wireless information provided as recommended in FDA guidance	Information provided as recommended in FDA guidance.
Design Validation	Performed (no specific criteria or results detailed)	Not detailed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a clinical test set or data provenance in terms of patient data. The "test set" refers to physical samples of the device components (cannulas, display modules) subjected to various engineering and safety tests. For example, for shelf-life testing, samples were "Aged to 6-months" but the number of samples is not specified. There is no information about country of origin for any clinical data as none was presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to the provided document. The "ground truth" in this context would typically refer to diagnostic accuracy established by expert clinicians (e.g., confirming the presence or absence of abnormalities in patient images). The provided document focuses on engineering and safety testing, not clinical diagnostic performance, and thus does not involve human experts establishing a clinical ground truth for a diagnostic test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are used in clinical studies to resolve discrepancies among expert interpretations. The tests described are engineering and safety tests, which do not involve expert adjudication in this manner.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC comparative effectiveness study, nor is there any indication that the Endosee System incorporates AI or is intended for AI-assisted interpretation. The device is a direct visualization tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The Endosee System is a hardware device for direct visualization; it does not feature an algorithm that would operate in a "standalone" mode for diagnostic interpretation.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. As noted above, since no clinical performance study focused on diagnostic accuracy is described, there's no mention of how clinical ground truth would be established. The "ground truth" for the engineering tests would be adherence to the specified technical standards and design requirements.

8. The sample size for the training set

Not applicable. The document does not describe any machine learning or algorithm development that would involve a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set described.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 31, 2019

CooperSurgical, Inc. Roaida Johnson Director. RA New Product Development 95 Corporate Drive Trumbull, Connecticut 06611

Re: K183020

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: October 31, 2018 Received: November 1, 2018

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. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (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 (OS) 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 M. Andrews -S

for 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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Indications for Use

510(k) Number (if known) K183020

Device Name Endosee® System

Indications for Use (Describe)

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)
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K183020 Page 1/5

oper Surgical

510(k) Summary K183020

Submitter Information

Company Name:	CooperSurgical Inc.
Company Address:	95 Corporate DriveTrumbull, CT 06611Telephone: 203-601-5200Fax: 203-601-9870

Contact Person:	Roaida Johnson
Date Prepared:	January 28, 2019

Device Information

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

Predicate Device Information

The subject Endosee System is substantially equivalent to the predicate Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula (K170660).

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

Device Description

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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.

Indications for Use

Abnormal bleeding
Infertility and pregnancy wastage
Evaluation of abnormal hysterosalpingogram
Intrauterine foreign body
Amenorrhea
Pelvic pain

Substantial Equivalence Discussion

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

Attribute	Subject Endosee System	Predicate Endosee Hysteroscope	Significant Differences
510(k)Number	Not yet assigned	K170660	N/A
Manufacturer	CooperSurgical, Inc.	CooperSurgical, Inc.	N/A
Indications forUse	The Endosee System is usedto permit viewing of thecervical canal and uterinecavity for the purpose ofperforming diagnosticprocedures. Generallyrecognized indications fordiagnostic hysteroscopyinclude: Abnormal bleeding,Infertility and pregnancywastage, Evaluation of	The Endosee Hysteroscopeand Disposable Diagnostic (Dx)Cannula are used to permitviewing of the cervical canaland uterine cavity for thepurpose of performingdiagnostic procedures.Generally recognizedindications for diagnostichysteroscopy include:Abnormal bleeding, Infertility	Same

	abnormalhysterosalpingogram,Intrauterine foreign body,Amenorrhea, Pelvic PainThe Endosee System canalso be used to permitviewing of the urinarybladder through a minimallyinvasive approach byutilizing natural orifices forthe purpose of performingdiagnostic procedures.	and pregnancy wastage,Evaluation of abnormalhysterosalpingogram,Intrauterine foreign body,Amenorrhea, Pelvic PainThe Endosee and DisposableDiagnostic (Dx) Cannula canalso be used to permit viewingof the urinary bladder througha minimally invasive approachby utilizing natural orifices forthe purpose of performingdiagnostic procedures.
Technology	Handheld, battery-operatedendoscope that consists of areusable, detachableDisplay Module and sterile,disposable Cannula with ahandle; Wi-Fi capability	Handheld battery-operatedendoscope that consists of areusable Handheld Monitorand a sterile, disposableCannula	Different. The subjectdevice providesupdated technologyfeatures andcomponentconfigurations.
Cannula Type	Flexible	Flexible	Same
PatientContactingMaterials	PEEK, ink, glass, adhesive,lens coating, surface blackcoating	Glass, stainless steel, nylon,acrylic and adhesive	Different. The subjectdevice contains PEEK,ink, and coatings.
CannulaWorkingLength	276mm	276mm	Same
CannulaLargest OuterDiameter	4.5mm	4.8mm	Different. The subjectcannula largest outerdiameter is smallerthan that of thepredicate.
Light Source	LED	LED	Same
Field of View	$100° ± 5°$	$100° ± 5°$	Same
Direction ofView	$20° ± 3°$	$20° ± 3°$	Same
Image Display	Handheld LCD displaymodule	Handheld LCD display module	Same
CannulaSterilization	Ethylene oxide, SAL⁻⁶	Ethylene oxide, SAL⁻⁶	Same
Number ofUses	Cannula: single-use,disposableDisplay Module: reusable	Cannula: single-use,disposableDisplay Module: reusable	Same
Cannula Shelf-Life	6 months	3 years	Different. The subject
			shelf-life than thepredicate.
Packaging	Cannula: Individuallypouched or individuallypouched with a pipetteDisplay Module: Boxed withDocking Station, powercord, and USB cable	Cannula: Individually pouchedor individually pouched with apipetteDisplay Module: Boxed withDocking Station, power cord,and USB cable	Same

Table 1: Subject and Predicate Device Comparison

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The subject Endosee System has the same indications for use as the predicate device. Both devices have the same method of sterilization, number of uses, and patient contact duration. As described above, there are differences in materials and technology between the subject and predicate device. However, these differences do not raise different questions of safety or efficacy.

Non-Clinical Performance Testing

As part of demonstrating substantial equivalence to the predicate the following non- clinical tests were performed:

● Sterility Testing per ISO 11135-1:2014

EO Residuals per ISO 10993-7:2008 O
Bioburden per ISO 11737-1:2006 & 11737-2:2009 O
Biocompatibility Testing per ISO 10993-1:2009
- Cytotoxicity per ISO 10993-5:2009 o
- Sensitization per ISO 10993-10:2010 O
- Irritation per ISO 10993-10:2010 o
Shelf Life of Cannula ●

●

Aged to 6-months per ASTM F1980-16 o
O The following tests were performed on 6-month accelerated aged samples:
- . Seal Tensile Strength
- . Seal Peel
- Functional (Image Quality, Flow Rate, Leak, Bend)
Ship Testing per ISTA 3A:2008
- Bubble Leak per ASTM 2096-11 O

● Functional Testing

Image Quality Test (Including Resolution) o
Optical Distortion Test o
Saline Flow Rate Test o
O Leak Test
90° Bend Test O
3-Point Bend Test O
LED Temperature Test O
O Drop Test per IEC 60601-1-15
IPX2 Ingress Test per IEC 60529:2004 O
System Level Verification O

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EMC and Electrical Safety .
- o UL Electrical Safety per ANSI/AAMI ES 60601-1:2005/(R)2012 and IEC 60601-2-18:2009
- o UL EMC per IEC 60601-1-2:2014 and IEC 60601-2-18:2009
Software Verification per IEC 62304:2006 and as recommended in the FDA guidance ● "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
Cybersecurity/Intraoperability Information provided as recommended in FDA . guidance, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"
. Wireless information provided as recommended in FDA guidance, "Radio Frequency Wireless Technology in Medical Devices Guidance"
Design Validation

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.