(83 days)
Not Found
No
The summary describes a video endoscope with a new illumination function (NBI) and explicitly states the major difference from the predicate device is only the NBI function. There is no mention of AI, ML, image processing beyond basic illumination switching, or any data sets for training or testing.
Yes
The device is used for both diagnosis and treatment within the abdomen and thoracic cavities, indicating a therapeutic purpose.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "for endoscopic diagnosis and treatment."
No
The device description explicitly states it is a "High Definition Digital Video Laparoscope," which is a hardware component (a video endoscope). It also mentions being used with other hardware like a video system center, light source, monitor, etc.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for "endoscopic diagnosis and treatment within the abdomen and thoracic cavities including the female reproductive organs." This is a description of a surgical or diagnostic procedure performed in vivo (within the living body), not in vitro (outside the living body, typically on biological samples).
- Device Description: The device is described as a "video endoscope used for endoscopy." Endoscopes are instruments used to visualize internal body cavities.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue), or to provide information about a patient's health status based on such analysis.
The device is clearly intended for direct visualization and intervention within the body, which falls under the category of medical devices used for diagnosis and treatment in vivo.
N/A
Intended Use / Indications for Use
HD EndoEYE High Definition Digital Video Laparoscope:
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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, NLM, KOG, NWB EWY NMH/HET
Device Description
The HD EndoEYE - High Definition Digital Video Laparoscope is a video endoscope used for endoscopy The HD Lhoon is "Thigh Dominal cavities which is basically identical to the predicate device, OES Laparo- Thoraco Videoscope, for the same application areas.
The major difference from the predicate device is only the NBI function added to the subject device.
When the CLV-180 and CV-180 or the OTV-S7Pro and CLV-S40Pro are combined with HD EndoEYE, both an endoscopic image by white light illumination and that by NBI illumination can be observed within the thoracic and abdominal cavities. The CV-180 identifies when an NBI-compatible scope is connected, by using the Scope ID function provided with the scopes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and abdominal cavities, 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)
Not Found
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.
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Ko9o980
JUN 2 9 2009
510(k) SUMMARY
HD EndoEYE - High Definition Digital Video Laparoscope
1. General Information
Applicant:
Olympus Winter & Ibe GmbH Kuehnstrasse 61 * 22045 Hamburg * Germany Establishment Registration No: 9610773
Kuehnstrasse 61 * 22045 Hamburg * Germany Establishment Registration No: 9610773
Stacv Abbatiello Kluesner M.S., RAC Official Correspondent: Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway, PO Box 610 Center Valley PA 18034-0610 Phone: (484) 896-5405 Facsimile: (484) 896-7128 Email:Stacy.Kluesner@olympus.com Establishment Registration No: 2429304
Olympus Winter & Ibe GmbH
Manufacturer:
WA50011A/WA50013A/WA50013L/WA50013T/WA50015L
HD EndoEYE - High Definition Digital Video Laparoscope
Common Name:
- Device Identification
Device Name:
HD EndoEYE
==
Class:
Regulation Number / Name:
21 CFR 876.1500 Endoscope and Accessories 21 CFR 874.4720 Mediastinoscope and Accessories 21 CFR 884.1720 Gynecologic Laparoscope and Accessories
Product Code:
GCJ, NLM, KOG, NWB EWY NMH/HET
Classification Panel:
Gastroenterology/ Urology Ear Nose & Throat Obstetrics/Gynecology
OLYMPUS Winter & Ibe GmbH Kuehnstrasse 61 * 22045 Hamburg * Germany TELEPHONE +49-40-66966-2999, TELEFAX +49-40-66966-2109
11 - 2
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Image /page/1/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, black letters. The font is sans-serif and appears to be a standard typeface. The letters are closely spaced, creating a solid block of text. The background is white, providing a strong contrast that makes the word stand out.
A 0909080
Pg 2 of 3
3. Legally Marketed Device to which Substantial Equivalence is claimed
The following table shows the subject and predicate device to which we claim substantial equivalence.
Table 11.1 Subject & Predicate Devices
| Subject Device
(Part of this submission) | Predicate Device | PD's
510(k)No. |
|-------------------------------------------------------------------|--------------------------------------------------------|-------------------|
| HD EndoEYE
WA50011A, WA50013A,
WA50013L, WA50013T, WA50015L | A4941A, A4943A OES Laparo-Thoraco
Videoscope | K955456 |
| | HD EndoEYE Laparo-Thoraco
Videoscope OLYMPUS LTF-VH | K080948 |
4. Device Description
The HD EndoEYE - High Definition Digital Video Laparoscope is a video endoscope used for endoscopy The HD Lhoon is "Thigh Dominal cavities which is basically identical to the predicate device, OES Laparo- Thoraco Videoscope, for the same application areas.
The major difference from the predicate device is only the NBI function added to the subject device.
When the CLV-180 and CV-180 or the OTV-S7Pro and CLV-S40Pro are combined with HD EndoEYE, both an endoscopic image by white light illumination and that by NBI illumination can be observed within the thoracic and abdominal cavities. The CV-180 identifies when an NBI-compatible scope is connected, by using the Scope ID function provided with the scopes.
5. Indications for Use
HD EndoEYE High Definition Digital Video Laparoscope:
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.
6. Comparison of Technological Characteristics
The HD EndoEYE is mainly similar to the predicate devices in specifications without NBI function. Comparison between the subject and predicate devices is shown below.
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Image /page/2/Picture/0 description: The image contains a partial view of the letters 'US' on the left side. To the right of these letters, there is handwritten text that appears to read 'K090980' on the first line. Below this, there is additional handwritten text that seems to say 'Pg 30'.
Table 11.2 Comparison of Specifications
.
| Specifications | Subject Device
HD Endo EYE | Predicate Device
OES | Predicate Device
LTF-VH |
|------------------------------|-------------------------------|-------------------------|----------------------------|
| Field of View | 80° | 70° | 90° |
| Depth of field | 20 to 120 mm | 18 to 100 mm | 15-100mm |
| Direction of View | 0°, 30°, 45° | 0°, 30° | 0° |
| Outer Diameter of Distal End | 10 | 11 | 10mm |
| Optical System | Color | Color | Color |
| Working Length | 250-390mm | 320mm | 370mm |
| Switch for NBI function | Provided | Not provided | Provided |
7. Conclusion
When compared to the predicate devices, the HD EndoEYE does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.
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Image /page/3/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three curved lines that resemble a bird or a symbol representing health and human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JUN 29 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Olympus Winter & Ibe GmbH % Stacy Abbatiello Kluesner, RAC Regulatory Affairs & Quality Assurance Olymous America, Inc. 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610
Re: K090980
Trade/Device Name: HD EndoEYE Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NWB Dated: April 3, 2009 Received: April 14, 2009
Dear Ms. Kluesner:
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. 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.
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 801); medical device reporting (reporting of medical
4
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Danny Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
OLYMPUS
Indications for Use
090980 510(k) Number (if known): Device Name: HD EndoEYE
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 endoscopic diagnosis and treatment within the abdomen and thoracic cavities including the female reproductive organs.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of ー
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(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
ENDOEYE : 86615 :"",""