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, during diagnostic or 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, portable endoscope used for viewing the adult cervical canal, uterine cavity, or female urinary tract during diagnostic or therapeutic procedures. The device under review (K200038) is a modification of a previously cleared device (K190639), with the primary changes being to indirect patient-contacting materials and additional shielding on the cannula board.

Here's the information regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Assessment Category	Specific Test	Acceptance Criteria (Implicitly "Pass" based on predicate)	Reported Device Performance
Sterilization & Biocompatibility	Sterilization Evaluation (per ISO 11135:2014)	Met ISO 11135:2014 standards for sterilization.	Passed (subject device)
	Bioburden (per ISO 11737-1:2018)	Met ISO 11737-1:2018 standards for bioburden levels.	Passed (subject device)
	Cytotoxicity (per ISO 10993-5:2009)	No unacceptable cytotoxic effects.	Passed (subject device)
	Irritation (per ISO 10993-10:2010)	No unacceptable irritation effects.	Passed (subject device)
	Sensitization (per ISO 10993-10:2010)	No unacceptable sensitization effects.	Passed (subject device)
	EO Residuals (per ISO 10993-7:2008)	Met ISO 10993-7:2008 standards for ethylene oxide residuals.	Passed (leveraged from predicate)
Stability & Shelf Life	Leak Test (on accelerated aged samples)	Maintained integrity and absence of leaks after accelerated aging for 6 months.	Passed (subject device)
	Seal Tensile Strength (on accelerated aged samples)	Maintained seal strength after accelerated aging for 6 months.	Passed (leveraged from predicate)
	Seal Peel (on accelerated aged samples)	Maintained seal integrity after accelerated aging for 6 months.	Passed (leveraged from predicate)
	Performance (Image Quality, Flow Rate, Leak, Bend, Tip Retention, Instrument Access) (on accelerated aged samples)	Maintained specified performance characteristics after accelerated aging for 6 months.	Passed (leveraged from predicate)
Physical & Electrical Performance	Fixed Pattern Noise Test	Met internal requirements for acceptable image noise levels.	Passed (subject device)
	Ship Testing (per ISTA 3A:2008)	Withstood shipping stresses without damage or performance degradation.	Passed (leveraged from predicate)
	Bubble Leak (per ASTM 2096-11)	Absence of bubble leaks.	Passed (leveraged from predicate)
	UL Electrical Safety (per ANSI/AAMI ES 60601-1:2005/(R)2012 and IEC 60601-2-18:2009)	Met electrical safety standards.	Passed (leveraged from predicate)
	UL EMC (per IEC 60601-1-2:2014 and IEC 60601-2-18:2009)	Met electromagnetic compatibility standards.	Passed (leveraged from predicate)
	Optical Distortion Test	Met specifications for optical distortion.	Passed (leveraged from predicate)
	Saline Flow Rate Test	Met specifications for saline flow rate.	Passed (leveraged from predicate)
	90° Bend Test	Withstood specified bending cycles without compromise.	Passed (leveraged from predicate)
	3-Point Bend Test	Withstood specified bending stress without compromise.	Passed (leveraged from predicate)
	LED Temperature Test	Maintained LED temperature within acceptable limits.	Passed (leveraged from predicate)
	Drop Test (per IEC 60601-1-15)	Withstood specified drop conditions without damage or performance degradation.	Passed (leveraged from predicate)
	IPX2 Ingress Test (per IEC 60529:2004)	Met specifications for protection against ingress of water.	Passed (leveraged from predicate)
	System Level Verification	Confirmed overall system functionality and performance.	Passed (leveraged from predicate)
	Software Verification (per IEC 62304:2006)	Met software safety and performance standards.	Passed (leveraged from predicate)
	Cybersecurity/Interoperability Information	Provided as recommended in FDA guidance.	Information provided (leveraged from predicate)
	Wireless Information	Provided as recommended in FDA guidance.	Information provided (leveraged from predicate)
	Design Validation	Confirmed that the design meets user needs and requirements.	Passed (leveraged from predicate)

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the numerical sample size for each specific non-clinical test conducted. However, it indicates tests were performed on "samples accelerated aged to 6-months per ASTM F1980-16." This implies that a sufficient number of devices were tested to draw statistically sound conclusions, in accordance with the specified standard.

The data provenance for the tests is entirely non-clinical bench testing. There is no mention of human patient data (retrospective or prospective) being used to evaluate the device's performance in this submission, as the submission focuses on demonstrating substantial equivalence through engineering and laboratory testing related to the physical changes.

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

Not applicable. This submission is for a medical device that does not involve algorithmic diagnostic or prognostic capabilities requiring expert interpretation for ground truth establishment. The ground truth for the non-clinical tests is based on established engineering and materials standards (e.g., ISO, ASTM, IEC).

4. Adjudication Method for the Test Set:

Not applicable. No expert adjudication method (e.g., 2+1, 3+1) was used as the evaluation was based on objective, quantifiable non-clinical test results against established engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This device is a physical medical instrument, not an AI or imaging diagnostic tool that would typically involve human readers interpreting cases.

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

Not applicable. The Endosee System is a physical endoscope, not an algorithm. Therefore, "standalone" performance in the context of AI algorithms is not relevant to this submission.

7. The Type of Ground Truth Used:

The ground truth used for proving the device meets the acceptance criteria is established engineering and materials standards, along with internal company specifications for performance. These include:

ISO 11135:2014 (Sterilization)
ISO 11737-1:2018 (Bioburden)
ISO 10993 (Biocompatibility series: -5, -10, -7)
ASTM F1980-16 (Accelerated Aging)
ISTA 3A:2008 (Ship Testing)
ASTM 2096-11 (Bubble Leak)
ANSI/AAMI ES 60601-1:2005/(R)2012 (Electrical Safety)
IEC 60601-2-18:2009 (Electrical Safety for Endoscopes)
IEC 60601-1-2:2014 (EMC)
IEC 60601-1-15 (Drop Test)
IEC 60529:2004 (IPX2 Ingress Test)
IEC 62304:2006 (Software Verification)

8. The Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI or machine learning model. There is no concept of a "training set" for the type of evaluation presented in this submission.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set, there is no ground truth established for it in the context of this device.

Summary

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

February 5, 2020

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

Re: K200038 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: January 7, 2020 Received: January 8, 2020

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 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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jason Roberts, Ph.D. Acting Assistant 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) K200038

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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K200038

Image /page/3/Picture/2 description: The image shows the CooperSurgical logo. The logo is in blue and features the company name in a stylized font. Below the company name is the tagline "Healthy women, babies, and families™".

510(k) SUMMARY

510(k) Submitter

Company Name:	CooperSurgical Inc.
Company Address:	95 Corporate DriveTrumbull CT 06611

Contact

Name:	Christine Kupchick
Telephone:	203-601-5200 Ext. 3370
Fax:	203-601-9870
Email:	christine.kupchick@coopersurgical.com

Date Prepared: January 07, 2020

Device Identification

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:	Class II

Predicate Device Information

The subject Endosee System is substantially equivalent to the predicate Endosee System (K190639).

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

Device Description

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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
Transection of intrauterine septa

Substantial Equivalence Discussion

Attribute	Subject Endosee System	Predicate Endosee System
Manufacturer	CooperSurgical, Inc.	CooperSurgical, Inc.
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, and 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	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, and 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

Table 1: Substantial Equivalence Comparison

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	performing diagnostic andtherapeutic procedures.	performing diagnostic andtherapeutic procedures.
	Handheld, battery-operatedendoscope that consists of areusable, detachable DisplayModule and sterile, disposableCannula with a handle; Wi-Ficapability.	Handheld, battery-operatedendoscope that consists of areusable, detachable DisplayModule and sterile, disposableCannula with a handle; Wi-Ficapability.
FundamentalTechnology
Cannula Typeand Dimensions	Type: FlexibleWorking Length: 276mmLargest Outer Diameter: 4.5mm	Type: FlexibleWorking Length: 276mmLargest Outer Diameter: 4.5mm
CannulaWorkingChannel	Working channel for fluid infusionand instrument access	Working channel for fluid infusionand instrument access
View	Field of View: $100° ± 5°$Direction of View: $20° ± 3°$	Field of View: $100° ± 5°$Direction of View: $20° ± 3°$
Light Source	LED	LED
Image Display	Handheld LCD display module	Handheld LCD display module
CannulaPatient-ContactingMaterials	Direct: PEEK, ink, glass, adhesive,lens coating, surface black coating,Indirect: ABS, TPE, polycarbonate,adhesive, ink, silicone, PVC (non-phthalate), copper	Direct: PEEK, ink, glass, adhesive,lens coating, surface black coating,Indirect: ABS, TPE, polycarbonate,adhesive, ink, silicone, PVC, copper
Number of Uses	Cannula: single-use, disposableDisplay Module: reusable	Cannula: single-use, disposableDisplay Module: reusable
CannulaSterilization	Ethylene oxide, SAL-6	Ethylene oxide, SAL-6

The subject and predicate devices have the same intended use.

The subject and predicate devices have the same fundamental technology, cannula type and dimensions, cannula working channel, field and direction of view, light source, image display, number of uses and sterilization. The subject Cannula differs from the predicate in indirect patient-contacting materials and an additional layer of shielding on the Cannula board. These differences do not raise different questions of safety and effectiveness as compared to the predicate.

Non-Clinical Performance

As part of demonstrating substantial equivalence to the predicate, a risk analysis was completed to identify the risks associated with the Endosee Cannula material changes and additional shielding. Verification testing were conducted to evaluate the modifications. The following tests associated with the device modifications were performed on the subject device according to methods and acceptance criteria outlined in the predicate device (K190639). The subject device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence of the subject device.

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● Sterilization Evaluation per ISO 11135:2014

o Bioburden per ISO 11737-1:2018

● Biocompatibility Testing per ISO 10993-1:2009

Cytotoxicity per ISO 10993-5:2009 о
Irritation per ISO 10993-10:2010 o
Sensitization per ISO 10993-10:2010 o

. Stability and Shelf Life of Cannula

The following tests were performed on samples accelerated aged to 6-months per ASTM F1980-16:

o Leak Test

Performance Testing .

o Fixed Pattern Noise Test
The following testing was leveraged from the predicate device (K190639). Test results from the predicate were used to support the subject device because the conditions were identical or the subject device modifications did not introduce a new worst-case configuration or scenario for testing.

● Sterility Testing per ISO 11135-1:2014

o EO Residuals per ISO 10993-7:2008

Stability and Shelf Life of Cannula .

The following tests were performed samples accelerated aged to 6-months per ASTM F1980-16:

o Seal Tensile Strength
Seal Peel o
Performance (Image Quality, Flow Rate, Leak, Bend, Tip Retention, Instrument o Access)

● Ship Testing per ISTA 3A:2008

Bubble Leak per ASTM 2096-11

● EMC and Electrical Safety

UL Electrical Safety per ANSI/AAMI ES 60601-1:2005/(R)2012 and IEC 60601-2 18:2009 with Essential Performance per IEC 60601-2-18
o UL EMC per IEC 60601-1-2:2014 and IEC 60601-2-18:2009 with Essential Performance per IEC 60601-2-18

● Performance Testing

Optical Distortion Test o
Saline Flow Rate Test o
O 90° Bend Test
3-Point Bend Test O
LED Temperature Test o

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Drop Test per IEC 60601-1-15 o
o IPX2 Ingress Test per IEC 60529:2004
System Level Verification
. 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/Interoperability 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 as safe and effective as the predicate and supports a determination of substantial equivalence.

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.