Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the hardware components (display module, cannula, camera, light source) and basic image/video capture and display. There is no mention of any software features that analyze or interpret the images using AI/ML techniques. The performance studies listed are standard non-clinical tests for medical devices, not studies evaluating the performance of an AI/ML algorithm.

Therapeutic

No.
The device is used for diagnostic purposes by permitting viewing of internal anatomical structures, not for treating or alleviating a condition or disease.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the Endosee System is used "for the purpose of performing diagnostic procedures" in viewing the adult cervical canal, uterine cavity, and urinary bladder. Furthermore, the "Device Description" reiterates its purpose to "perform diagnostic hysteroscopy or cystoscopy procedures."

SaMD (Software as a Medical Device)

No

The device description clearly states it is a handheld, battery-operated, portable endoscope consisting of a reusable display module and a sterile, single-use cannula with a light source and camera. This indicates significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Endosee System is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens derived from the human body. The Endosee System is used to directly visualize internal anatomical structures (cervical canal, uterine cavity, bladder) within the patient's body.
The intended use is for diagnostic procedures through direct visualization. The system facilitates viewing for diagnostic purposes, not for analyzing biological samples in a laboratory setting.
The device description focuses on the endoscopic nature of the system. It describes a camera, light source, and display for viewing internal structures.

Therefore, the Endosee System falls under the category of an endoscopic device used for diagnostic visualization, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes

HIH, FAJ

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Endoscopic captured image and video.

Anatomical Site

adult cervical canal, uterine cavity, or female urinary tract, including the bladder.

Indicated Patient Age Range

Adult

Intended User / Care Setting

Operating room, outpatient, or office setting.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Performance Testing:

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
- 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
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

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K170660 (Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

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

1

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)

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.

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 Drive
Trumbull, CT 06611
Telephone: 203-601-5200
Fax: 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

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

4

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

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.

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 for
Use	The Endosee System is used
to permit viewing of the
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	The Endosee Hysteroscope
and Disposable Diagnostic (Dx)
Cannula are used to permit
viewing of the cervical canal
and uterine cavity for the
purpose of performing
diagnostic procedures.
Generally recognized
indications for diagnostic
hysteroscopy include:
Abnormal bleeding, Infertility	Same

	abnormal
hysterosalpingogram,
Intrauterine foreign body,
Amenorrhea, Pelvic Pain

The Endosee System can
also be used to permit
viewing of the urinary
bladder through a minimally
invasive approach by
utilizing natural orifices for
the purpose of performing
diagnostic procedures. | and pregnancy wastage,
Evaluation of abnormal
hysterosalpingogram,
Intrauterine foreign body,
Amenorrhea, Pelvic Pain

Table 1: Subject and Predicate Device Comparison

5

6

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

7

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.