(273 days)
Not Found
No
The description focuses on standard video processing and optical components (CCDs, lenses, LEDs) to achieve an extended field of view by presenting images side-by-side. There is no mention of AI, ML, or any advanced image analysis techniques beyond basic video processing.
No
The device is described as an endoscope designed for visualization during surgical procedures, not for treatment or therapy.
No
Explanation: The device is described as an endoscope for visualization during surgery, not for diagnosing conditions. It facilitates endoscopic surgery by providing video.
No
The device description clearly outlines physical hardware components like the endoscope body, distal tip with LEDs and CCDs, and lenses. It is a reusable, rigid video endoscope requiring sterilization, indicating a physical device.
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 device is designed for endoscopy and endoscopic surgery within the thoracic and abdominal cavities. This involves direct visualization and surgical procedures within the body.
- Device Description: The description details a video endoscope used for capturing images inside the body. It focuses on the optical and video components for visualization.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is a surgical endoscope used for visualization and potentially facilitating surgical interventions in vivo (inside the body).
N/A
Intended Use / Indications for Use
The WV1 endoscope is a reusable, rigid, video endoscope, 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.
Product codes (comma separated list FDA assigned to the subject device)
HET, GCJ
Device Description
The WV1 System is comprised of two main components:
- WV1 endoscope (Video endoscope)
- FuseBox (Video Processor, cleared under (K132839)
The WV1 endoscope is a reusable, rigid, video endoscope. The device has been designed to be used with a compatible video system, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery. It is a reusable (autoclavable) endoscope and is intended to be used in a sterile environment. It is initially supplied non-sterile to the user and requires the user to process (i.e., clean and sterilize) the device for initial use, as well as after each use. The WV1 endoscope main components are the distal tip, the endoscope body and the endoscope main connector. The required illumination for the endoscope is supplied by integrated LEDs, located on the endoscope's distal tip. The endoscope video system is controlled by the video processor which collects a video signal produced by the CCD (Charge Couple Device). The video assembly that controls the field view and image characteristics, including video resolution and brightness, is located in the endoscope's distal tip. The WV1 Distal Tip is equipped with a color CCD and covers a 90° field of view. The extended field of view is achieved by use of additional 2 lenses located behind the endoscope's distal tip, each attached to a separate CCD. The geometrical location of the lenses allows for image overlap that results in the extended field of view (enabled by operation of the Fusebox). Each view on the distal tip has its own dedicated illumination source (LEDs). The images are presented side by side on a display monitor. The device materials of the WV1 include SS304, plastics, adhesives and glass lenses. The components are part of an external communicating device in direct tissue contact for a duration
§ 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). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
November 1, 2019
270Surgical Ltd. % Janice M. Hogan Partner Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, PA 19103
Re: K190190
Trade/Device Name: WV1 Endoscope Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic Laparoscope and Accessories Regulatory Class: II Product Code: HET Dated: October 3, 2019 Received: October 3, 2019
Dear Janice Hogan:
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,
for Sharon Andrews 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) K190190
Device Name WV1 Endoscope
Indications for Use (Describe)
The WV1 endoscope is a reusable, rigid, video endoscope, 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.
| 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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K190190 510(K) SUMMARY
1. Submitter's Identification
270Surgical Ltd. P.O.B 8414, 4 Arie Regev St. Netanva. Israel. 4250212 Phone: +972-52-8337207 Contact Person: Liat Diamant Porat
Date Prepared: October 31, 2019
2. Device Information
Name of Device: WV1 Endoscope Common or Usual Name: Gynecologic Laparoscope and Accessories Requlatory Class: II Classification number: CFR §884.1720 Product Code: HET Additional Product Code: GCJ per 21 CFR §876.1500 [Endoscope and Accessories]
3. Predicate Device Identification
Predicate: K111788, Olympus, EndoEye HD
The predicate device has been subject to a design-related recall.
4. Device Description
The WV1 System is comprised of two main components:
- · WV1 endoscope (Video endoscope)
- · FuseBox (Video Processor, cleared under (K132839)
The WV1 endoscope is a reusable, rigid, video endoscope.
The device has been designed to be used with a compatible video system, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery.
It is a reusable (autoclavable) endoscope and is intended to be used in a sterile environment. It is initially supplied non-sterile to the user and requires the user to process (i.e., clean and sterilize) the device for initial use, as well as after each use.
The WV1 endoscope main components are the distal tip, the endoscope body and the endoscope main connector. The required illumination for the endoscope is supplied by integrated LEDs, located on the endoscope's distal tip.
The endoscope video system is controlled by the video processor which collects a video signal
4
produced by the CCD (Charge Couple Device).
The video assembly that controls the field view and image characteristics, including video resolution and brightness, is located in the endoscope's distal tip. The WV1 Distal Tip is equipped with a color CCD and covers a 90° field of view. The extended field of view is achieved by use of additional 2 lenses located behind the endoscope's distal tip, each attached to a separate CCD. The geometrical location of the lenses allows for image overlap that results in the extended field of view (enabled by operation of the Fusebox).
Each view on the distal tip has its own dedicated illumination source (LEDs). The images are presented side by side on a display monitor.
The device materials of the WV1 include SS304, plastics, adhesives and glass lenses. The components are part of an external communicating device in direct tissue contact for a duration ≤24 hours. Although the materials do not conform to a material standard, their biocompatibility was established via testing of the final, finished product.
Environment of use – hospitals and clinics.
5. Indications for Use
The subject device WV1 and predicate device K111788 have identical intended use and indications for use, specifically:
"The WV1 endoscope is a reusable, rigid, video endoscope, 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."
Both devices are endoscopes designed to be used with a video system to monitor endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs. Both systems also support the use of document, hand instruments, electrosurgical unit, and other ancillary equipment during the same procedures.
6. Summary of Technological Characteristics and Comparison
Like the predicate device, the EndoEye HD, main components of the subject device are the Video endoscope connected to a video processor. Similar to most commercially available laparoscopes, the endoscope itself is constructed of a video and illumination system, the endoscope body and the endoscope main connector. In both devices, the required illumination for the endoscope is located on the endoscope's distal tip, and the video signal is produced by the CCD (Charge Couple Device).
The principles of operation of the WV1 system are similar to those of other current legally marketed endoscopy systems, although the WV1 System features two viewing capabilities: standard and extended. The operator can extend their mode to extended view at any given time, enabled by operation of the Fusebox.
The primary difference between the subject and predicate device is field of view. and light source. The difference in technological characteristics do not raise different questions of safety and effectiveness.
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| Parameter | K190190 – WV1 Endoscopic Device [Proposed Device] | K111788 – Olympus EndoEye HD II (WA50040A, WA50050A) [Predicate] |
|---|---|---|
| Indication for Use | The WV1 endoscope is a reusable, rigid, video endoscope, 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. | 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. |
| Class | II | |
| Regulation | 21 C.F.R. §884.1720 | 21 C.F.R. §884.1720 |
| Code | HET, GCJ | HET |
| Method of Operation | The optical image is transferred from the surgical site to the camera head. | |
| Outer diameter of distal end | The Maximum diameter is 10.7mm and the shaft diameter is 10mm | The Maximum diameter is 10.2mm and the shaft diameter is 10mm |
| Working length | Working length 340 mm | |
| Working channel diameter- N/A. The Endoscope is intended for imaging only. It does not use for other applications that require a working channel. | Working length 325 mm / 330 mm | |
| Working channel diameter- N/A. The Endoscope is intended for imaging only. It does not use for other applications that require a working channel. | ||
| Video Monitor | N/A (device is not supplied with a monitor) | OEV Series HD Monitor |
| Light source | Integrated LED | |
| Power rating -- not applicable. The WV1 system does not use an external light source. | Xenon short-arc lamp | |
| 300W | ||
| External Power Supply | N/A | N/A |
| DOF | 12-175 mm | 12-200 mm |
| Depth Of Field | ||
| Field of View | $90°±10 / 270 °±10$ | $90°$ |
| Direction of view | $0°, -90°, 90°±5%$ | $0°$ |
| Type of CCD chip | Color CCD | Color CCD |
| Number of CCD chip | 3 | 1 |
| Illumination fibers | N/A | Unknown |
| Parameter | K190190 – WV1 Endoscopic Device | |
| [Proposed Device] | K111788 – Olympus EndoEye HD II | |
| (WA50040A, WA50050A) | ||
| [Predicate] | ||
| Imaging System | Electronic | Electronic |
| Eyepiece | N/A | N/A |
| Coupling Lens | N/A | N/A |
| Articulation | No | |
| Autoclave sterilization | Yes | |
| Control Handle | N/A | Buttons on handle |
| Compatible Video System | Fuse Box Processor (K132839) | Olympus OTV-S190, Visera Elite Video System Center included in K111788 |
| Ambient Conditions | Operating conditions | |
| Ambient temperature | 10 to 35 °C (50 to 95 °F) | |
| Relative humidity | 30 to 85 % | |
| Atmospheric | ||
| pressure | 700 to 1060 hPa | |
| Storage conditions | ||
| Temperature | 10 to 40 °C (50 to 104 °F) | |
| Relative humidity | 30 to 75 % | |
| Transport conditions | ||
| Temperature | -47 to 70 °C (-52 to 158 °F) | |
| Relative humidity | 10 to 95 % | |
| Electric Shock Protection | BF | BF (WA50040A) |
| CF (WA50050A) |
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Table VII-1: Comparison Table
7. Summary of Non-Clinical Performance Testing
Bench testing was performed per the following voluntary performance standards or FDA guidance:
Sterilization, Cleaning:
Cleaning, drying and sterilizations were conducted for the WV1 Endoscope, according to AAMI TIR12 and AAMI TIR30. The studies were performed by an independent lab. Reprocessing validation was carried out in accordance with the FDA Guidance. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff (March 17, 2015). These tests demonstrated that the device successfully passed cleaning, drying and sterilization validations according to the instructions in the product Reprocessing Manual.
Biocompatibility Testing:
Biocompatibility studies were performed in accordance with the FDA Guidance document, Use of
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International Standard ISO 10993-1, "Biological evaluation of medical device – Part 1: Evaluation and testing within a risk management process", and ISO 10993-1:2009 as follows:
- i. Cytotoxicity (ISO 10993-5:2009)
- ii. Sensitization (ISO 10993-10:2010)
- iii. Irritation (ISO 10993-10:2010)
- iv. Acute Systemic Toxicity (ISO 10993- 11: 2014)
- v. Material-Mediated Pyrogenicity
Electrical Safety and Electromagnetic Compatibility:
Electrical Safety and Electromagnetic Compatibility testing were conducted according to IEC 60601-1:2005/(R)2012 and A1:2012, (Third Edition + AM1), IEC 60601-1-2: 2014 (Fourth Edition), and IEC 60601-2-18:2009 (Third Edition) that demonstrated the electrical safety and electromagnetic compatibility of the subject device.
Bench Testing:
- System test protocol: 270Surgical Ltd. performed Test Protocol (STP) for the WV1 System . including the Endoscope, FSP-100 Compatible Video System FUSE by EndoChoice with power cable, monitor and cables. STP included core functionality, image settings screen, LED intensity, zoom feature, system default settings, and white balance feature tests. This STP also includes compatibility testing to verify the WV1 endoscope is compatible to the FSP100 FuseBox console.
- Optical Performance Test: 270Surgical Ltd. verified that WV1 Endoscope field of view, depth . of field, direction of view, RMS noise & Signal-noise ratio, non-uniformity, distortion, LED irradiance are according to ISO 8600-1: 2015, ISO 8600-3: 1997; and ISO 8600-5; 2005, IEC 62471: 2006 .
- . Heating Test -The objective of this test was to establish the camera head thermal characteristics (°C) in the WV1 endoscope. The test procedure and acceptance criteria were determined according to "Hysteroscopes and Gynecological Laparoscopes Submission Guidance for 510(k) (March 7, 1996)". The acceptance criteria were met.
- . 270Surgical Ltd. conducted a user evaluation study to demonstrate that the device can be used by the intended users without serious use errors or problems, for the intended uses and under the expected use conditions in accordance with ANM-0035.
All tests met the predefined acceptance criteria.
8. Conclusions
The WV1 Endoscope has the same intended use and similar technological characteristics of the predicate device EndoEye HD. Performance testing, including electrical safety, electromagnetic compatibility, cleaning validation validation, biocompatibility, and bench testing has demonstrated that the WV1 Endoscope is as safe and effective as the predicate. Therefore, the WV1 Endoscope is substantially equivalent to the predicate devices.