(63 days)
Not Found
No
The device description focuses on basic endoscopic visualization and image capture, with no mention of AI/ML processing or analysis of the images.
Yes
The device is used for both diagnostic and therapeutic procedures, explicitly stating its use for "performing diagnostic and therapeutic procedures" and listing examples like "Removal of fibroids and polyps," "Transection of intrauterine adhesions," and "Transection of intrauterine septa," which are therapeutic interventions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Endosee System is used "for the purpose of performing diagnostic and therapeutic procedures" and lists several conditions (e.g., Abnormal bleeding, Infertility) for which it provides visualization in diagnostic procedures.
No
The device description explicitly 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 clearly indicates the presence of hardware components beyond just software.
Based on the provided information, the Endosee System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Endosee System Function: The Endosee System is an endoscope used for direct visualization of internal anatomical structures (cervical canal, uterine cavity, bladder) within the body. It is used for diagnostic and therapeutic procedures performed in vivo.
The device's purpose is to provide visual access to internal areas for examination and intervention, not to analyze samples taken from the body.
N/A
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 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.
Product codes (comma separated list FDA assigned to the subject device)
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
Design Validation
Functional Testing (6-month aged samples)
- Tip Retention
- Instrument Access
- EMC/Electrical Safety reevaluated with Essential Performance per IEC 60601-2-18
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Endosee System (K183020)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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)
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.
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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510(k) SUMMARY K190639
Submitter Information
| Company Name: | CooperSurgical Inc. |
|---|---|
| Company Address: | 95 Corporate Drive |
| Trumbull, 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
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.
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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
- o 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.
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 viewing | ||
| of the cervical canal and uterine cavity for the | ||
| purpose of performing diagnostic procedures. | ||
| Generally recognized indications for diagnostic | ||
| hysteroscopy include: | 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 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 permit | |
| viewing of the urinary bladder through a | ||
| minimally invasive approach by utilizing natural | ||
| orifices for the purpose of performing diagnostic | ||
| procedures. | • 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 |
Table 1: Subject and Predicate Comparison
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| | | orifices for the purpose of performing diagnosti
and therapeutic procedures. |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Technology | Handheld, battery-operated endoscope that
consists of a reusable, detachable Display
Module and sterile, disposable Cannula with a
handle; Wi-Fi capability. | Same |
| Cannula Type and
Dimensions | Type: Flexible
Working Length: 276mm Largest Outer
Diameter: 4.5mm | Same |
| Cannula Working
Channel | Working channel for fluid infusion and
instrument 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 Contacting
Materials | PEEK, ink, glass, adhesive, lens coating, surface
black coating | Same |
| Number of Uses | Cannula: single-use, disposable
Display Module: reusable | Same |
| Cannula Sterilization | Ethylene oxide, SAL 10-6 | Same |
| Cannula Shelf Life | 6 months | Same |
| Packaging | Cannula: Individually pouched or individually
pouched with a pipette Display Module: Boxed
with Docking Station, power cord, and
USB 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.