(160 days)
Olympus K11788, ENDOEYE HD II
Not Found
No
The description focuses on standard video laparoscope functionality and hardware features like high definition imaging, white light/narrow band imaging, and a heater function. There is no mention of AI, ML, or advanced image processing beyond basic video display. The performance studies listed are standard device verification and validation tests, not studies typically associated with AI/ML model performance.
No
The device is described as a rigid video telescope for observation and surgery, not for delivering therapeutic treatment itself. While it aids in surgery, it's a diagnostic and visualization tool.
Yes
The Device Description explicitly states: "The ENDOEYE HD II - High Definition Digital Video Laparoscope is a rigid video telescope used for endoscopic diagnosis, treatment, video observation and surgery..." The word "diagnosis" indicates its use as a diagnostic device.
No
The device description clearly states it is a rigid video telescope and mentions hardware components like a heater function and compatibility with instrument trays for reprocessing, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the instrument is for "endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs." This describes a surgical tool used in vivo (within the living body) for visualization and surgical procedures.
- Device Description: The description reinforces this by stating it's a "rigid video telescope used for endoscopic diagnosis, treatment, video observation and surgery." It's inserted "via a trocar into the patient."
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on bodily specimens.
The device is a surgical endoscope used for visualization and assisting in surgical procedures within the patient's body.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used with a video system center, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.
Product codes (comma separated list FDA assigned to the subject device)
HET, GCJ, NWB
Device Description
The ENDOEYE HD II - High Definition Digital Video Laparoscope is a rigid video telescope used for endoscopic diagnosis, treatment, video observation and surgery within the thoracic and abdominal cavities including female reproductive organs. For laparoscopic applications, the video telescope is inserted via a trocar into the patient.
The ENDOEYE HD II is used with a video system center, light source and monitor to achieve its intended function.
In addition, the ENDOEYE HD II can be inserted in compatible instrument trays for reprocessing.
The ENDOEYE HD II can provide an image with either white light or narrow band imaging and WA50040A and WA50042A include a heater function at the distal tip to reduce fogging of the lens.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and abdominal cavities including the female reproductive organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The following Design verification and validation testing was performed on the subject device:
- Electrical safety as per IEC 60601-1 Edition 3.1 and IEC 60601-2-18 Edition 3.0
- Electromagnetic compatibility (EMC) as per IEC 60601-1-2 Edition 4.0
- Thermal Safety as per IEC 60601-1 Edition 3.1 and IEC 60601-2-18 Edition 3.0
- Mechanical performance testing as per ISO 8600-3 Edition 1, ISO 8600-4 Edition 2 and ISO 8600-5 Edition 1
- Transport and shipping testing as per ASTM D4169-16
- Tests related to the expected service life as per IEC 60601-1 Edition 3.1 and . IEC 60601-2-18 Edition 3.0
- Testing of the illumination system as per IEC 60601-1 Edition 3.1 and IEC 60601-2-18 Edition 3.0
- Software Verification as per IEC 62304 Edition 1.1
- Usability Validation of the Instructions for Use as per FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
Risk analysis was carried out in accordance with established internal acceptance criteria based on ISO 14971:2007.
All samples tested met their predefined acceptance criteria.
The performance data support the safety of the device and demonstrate that the subject devices comply with the recognized standards as specified and support a substantial equivalence determination.
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.
Olympus K11788, ENDOEYE HD II
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
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
August 29, 2019
Olympus Winter & Ibe GmbH Sheri Musgnung Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway Center Valley, PA 18034-061
Re: K190744
Trade/Device Name: ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: HET, GCJ, NWB Dated: July 29, 2019 Received: July 30, 2019
Dear Sheri Musgnung:
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
1
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/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 medical devices and radiation-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,
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) K190744
Device Name ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)
Indications for Use (Describe)
This instrument has been designed to be used with a video system center, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.
| 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 of Safety and Effectiveness
August 26, 2019
General Information 1
| Manufacturer: | Olympus Winter & Ibe GmbH |
|---|---|
| Kuehnstr. 61 | |
| 22045 Hamburg | |
| Germany | |
| Establishment Registration Number: 9610773 |
| Official Correspondent: | Sheri L Musgnung |
|---|---|
| Manager, Regulatory Affairs | |
| Olympus Corporation of the Americas | |
| 3500 Corporate Parkway | |
| Center Valley PA 18034-061 | |
| Phone: 484 896-3147 | |
| Email: sheri.musgnung@olympus.com | |
| Establishment Registration Number: 2429304 |
Device Identification 2
| Proprietary /Trade Name: | ENDOEYE HD II (WA50040A, WA50042A,WA50050A, WA50052A) |
|---|---|
| Classification name: | Laparoscope, Gynecologic and accessories |
| Regulations Number: | 21 CFR 884.1720 |
| Regulatory class: | II |
| Product code: | HET |
| GCJ / NWB | |
| Review Panel: | Obstetrics and Gynecology |
Predicate Device 3
Olympus K11788, ENDOEYE HD II
The predicate has been subject to a design related recall.
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4 Product Description
The ENDOEYE HD II - High Definition Digital Video Laparoscope is a rigid video telescope used for endoscopic diagnosis, treatment, video observation and surgery within the thoracic and abdominal cavities including female reproductive organs. For laparoscopic applications, the video telescope is inserted via a trocar into the patient.
The ENDOEYE HD II is used with a video system center, light source and monitor to achieve its intended function.
In addition, the ENDOEYE HD II can be inserted in compatible instrument trays for reprocessing.
The ENDOEYE HD II can provide an image with either white light or narrow band imaging and
WA50040A and WA50042A include a heater function at the distal tip to reduce fogging of the lens.
5 Indications for Use
This instrument has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.
The ENDOEYE HD II has the same intended use as the predicate device.
Technological Characteristics 6
The ENDOEYE HD II has the same technological characteristics as the predicate device.
| Device | Subject device | Predicate device |
|---|---|---|
| Device Name | EndoEYE HD II | EndoEYE HD II |
| Model Number | WA50040A, WA50042A | WA50040A, WA50042A |
| WA50050A, WA50052A | WA50050A, WA50052A | |
| 510(k) number | Not yet known | K111788 |
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| Device | Subject device | Predicate device |
|---|---|---|
| Field of view | WA50040A, WA50042A: | |
| 90° $\pm$ 9° (at 16:9 aspect | ||
| ratio) | ||
| WA50050A, WA50052A: | ||
| 80.4° $\pm$ 8° (at 5:4 aspect | ||
| ratio) | WA50040A, WA50042A: | |
| 90° $\pm$ 9° (at 16:9 aspect | ||
| ratio) | ||
| WA50050A, WA50052A: | ||
| 80.4° $\pm$ 8° (at 5:4 aspect | ||
| ratio) | ||
| Depth of field | 21 to 200 mm | 21 to 200 mm |
| Direction of | ||
| viewing (forward) | WA50040A, WA50050A: | |
| 0° $\pm$ 10° | ||
| WA50042A, WA50052A: | ||
| 30° $\pm$ 10° | WA50040A, WA50050A: | |
| 0° $\pm$ 10° | ||
| WA50042A, WA50052A: | ||
| 30° $\pm$ 10° | ||
| Type of CCD chip | Color CCD | Color CCD |
| Number of CCD | ||
| chip | 2 | 2 |
| Outer diameter of | ||
| distal end | Ø 10 mm (WA50040A, | |
| WA50042A) | ||
| Ø 5.4 mm (WA50050A, | ||
| WA50052A) | Ø 10 mm (WA50040A, | |
| WA50042A) | ||
| Ø 5.4 mm (WA50050A, | ||
| WA50052A) | ||
| Outer diameter of | ||
| insertion tube | ||
| maximum | WA50040A: 10.07 mm | |
| WA50042A: 10.2 mm | ||
| WA50050A: 5.45 mm | ||
| WA50052A: 5.45 mm | WA50040A: 10.07 mm | |
| WA50042A: 10.2 mm | ||
| WA50050A: 5.45 mm | ||
| WA50052A: 5.45 mm | ||
| Working length | WA50040A: 325 $\pm$ 5 mm | |
| WA50042A: 330 $\pm$ 1 mm | ||
| WA50050A: 300 $\pm$ 0.5 mm | ||
| WA50052A: 302 $\pm$ 1 mm | WA50040A: 325 $\pm$ 5 mm | |
| WA50042A: 330 $\pm$ 1 mm | ||
| WA50050A: 300 $\pm$ 0.5 mm | ||
| WA50052A: 302 $\pm$ 1 mm | ||
| NBI observation | available | available |
| Heater | ||
| functionality | WA50040A, | |
| WA50042A: Yes | ||
| WA50050A, | ||
| WA50052A: No | WA50040A, | |
| WA50042A: Yes | ||
| WA50050A, | ||
| WA50052A: No | ||
| Autoclavability | yes | yes |
The subject devices have equivalent technology, performance, dimensions and materials. The differences to the predicate device ENDOEYE HD II are:
- . Addition of a printed circuit board (PCB) containing a supervisor circuitry and a second temperature sensor
- Updated Instructions for Use. .
The above described differences in technological characteristics do not raise different questions of safety and effectiveness.
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7 Performance Data
The following Design verification and validation testing was performed on the subject device:
- Electrical safety as per IEC 60601-1 Edition 3.1 and IEC 60601-2-18 Edition 3.0
- Electromagnetic compatibility (EMC) as per IEC 60601-1-2 Edition 4.0
- Thermal Safety as per IEC 60601-1 Edition 3.1 and IEC 60601-2-18 Edition ● 3.0
- Mechanical performance testing as per ISO 8600-3 Edition 1, ISO 8600-4 Edition 2 and ISO 8600-5 Edition 1
- Transport and shipping testing as per ASTM D4169-16 ●
- Tests related to the expected service life as per IEC 60601-1 Edition 3.1 and . IEC 60601-2-18 Edition 3.0
- Testing of the illumination system as per IEC 60601-1 Edition 3.1 and IEC 60601-2-18 Edition 3.0
- Software Verification as per IEC 62304 Edition 1.1 ●
- . Usability Validation of the Instructions for Use as per FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
Risk analysis was carried out in accordance with established internal acceptance criteria based on ISO 14971:2007.
All samples tested met their predefined acceptance criteria.
8 Conclusion
The performance data support the safety of the device and demonstrate that the subject devices comply with the recognized standards as specified and support a substantial equivalence determination.