(28 days)
No
The description focuses on the hardware components (endoscope, display module, cannula) and basic image/video capture and display. There is no mention of AI, ML, or advanced image processing beyond simple visualization.
No
The device is primarily for viewing (visualization) during diagnostic and therapeutic procedures, but it does not directly perform the therapeutic action itself. It provides the means for a clinician to perform therapeutic procedures.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is used "for the purpose of performing diagnostic and therapeutic procedures," and lists several conditions (e.g., abnormal bleeding, infertility, evaluation of abnormal hysterosalpingogram) for which it provides visualization, which are all diagnostic activities. The "Device Description" also mentions its use during "diagnostic or therapeutic hysteroscopy or cystoscopy procedures."
No
The device description explicitly states it is a "handheld, battery-operated, portable endoscope" with a "reusable Display Module" and a "sterile, single-use cannula," clearly indicating it is a hardware device with integrated software.
Based on the provided information, the Endosee System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to obtain information for diagnostic or monitoring purposes.
- Endosee System's Function: The Endosee System is an endoscope used for direct visualization of internal anatomical structures (cervical canal, uterine cavity, urinary bladder). It captures images and video of these structures in situ, not from specimens taken from the body.
- Intended Use: The intended use clearly states it's for "viewing" and performing "diagnostic and therapeutic procedures" by providing visualization of internal anatomy.
- Device Description: The description details a system for capturing and displaying images from within the body using a camera and light source.
The Endosee System is a medical device used for in vivo (within the living body) visualization and procedures, not for analyzing samples in vitro (in a lab setting).
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
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, 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.
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)
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.
● Sterilization Evaluation per ISO 11135:2014
- 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
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
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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
1
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
2
Indications for Use
510(k) Number (if known) K200038
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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3
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 Drive |
| Trumbull 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
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.
4
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.
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
5
| | performing diagnostic and
therapeutic procedures. | performing diagnostic and
therapeutic procedures. |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Handheld, battery-operated
endoscope that consists of a
reusable, detachable Display
Module and sterile, disposable
Cannula with a handle; Wi-Fi
capability. | Handheld, battery-operated
endoscope that consists of a
reusable, detachable Display
Module and sterile, disposable
Cannula with a handle; Wi-Fi
capability. |
| Fundamental
Technology | | |
| Cannula Type
and Dimensions | Type: Flexible
Working Length: 276mm
Largest Outer Diameter: 4.5mm | Type: Flexible
Working Length: 276mm
Largest Outer Diameter: 4.5mm |
| Cannula
Working
Channel | Working channel for fluid infusion
and instrument access | Working channel for fluid infusion
and 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 |
| Cannula
Patient-
Contacting
Materials | 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, disposable
Display Module: reusable | Cannula: single-use, disposable
Display Module: reusable |
| Cannula
Sterilization | 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.
6
● 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
7
- 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.