(204 days)
Not Found
No
The device description focuses on the optical and mechanical components of a rigid endoscope and does not mention any software, algorithms, or processing that would indicate the use of AI or ML. The performance studies are related to safety, biocompatibility, and basic functional performance, not algorithmic performance.
No
The device is described as providing the user with the means for "visualizing diagnostic and therapeutic surgical procedures," and its "Description of the training set, sample size, data source, and annotation protocol" section does not contain a study that shows any type of clinical outcome related to the device. This implies it is a visualization tool rather than a therapeutic one itself.
Yes
Explanation: The "Intended Use / Indications for Use" states that the device is "indicated to provide the user with the means for visualizing diagnostic and therapeutic surgical procedures." This explicit mention of "diagnostic" visualization confirms its role in diagnosis.
No
The device description explicitly states it is a rigid endoscope with physical components like rod lenses and optical fibers, and mentions reprocessing and autoclavability, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide the user with the means for visualizing diagnostic and therapeutic surgical procedures." This describes a device used in vivo (within the body) for direct visualization during surgery.
- Device Description: The description details a rigid endoscope with an image relay system and light transmission for illuminating the surgical site. This is consistent with a surgical visualization tool used in vivo.
- Lack of IVD Characteristics: An IVD device is typically 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 interact with or analyze biological specimens outside the body.
The device is a surgical endoscope used for direct visualization during minimally invasive procedures, which falls under the category of surgical instruments or visualization systems, not IVDs.
N/A
Intended Use / Indications for Use
The OES Elite Telescopes are indicated to provide the user with the means for visualizing diagnostic surgical procedures. The device is intended for use in general urological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site.
Product codes
FBP, FGC, HIH
Device Description
The OES ELITE Telescopes are rigid endoscopes. An image relay system of rod lenses transmits the endoscopic image. A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image.
The OES ELITE Telescopes are delivered non-sterile. They are reusable and fully autoclavable. Before first and each subsequent use the device must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use.
The OES ELITE Telescopes will be marketed as individual telescopes.
The OES ELITE Telescopes are available in 4 mm diameters with four different directions of view (0°, 12°, 30°, 70°) each to allow use for various applications in accordance with the intended use as submitted with this 510(k).
The OES ELITE Telescopes will be delivered with a protective tube WA2P400A which is subject to this 510(k) submission
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical
Anatomical Site
General urological and gynecological surgery through natural orifices.
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)
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO-14971:2007.
Performance tests were carried out to ensure that the system functions as intended and meets design specifications. The following performance tests and usability studies were conducted: Biocompatibility testing, Electrical safety and electromagnetic compatibility (EMC), Thermal Safety, and Performance Testing Bench covering optical and mechanical performance testing, shipping tests, tests related to the expected service life and testing of the illumination system. Additionally, design validation/usability tests were conducted.
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
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, arranged in a stacked formation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 24, 2015
Olympus Winter & Ibe GmbH % Daphney Germain-Kolawole Manager, Regulatory Affairs Olympus Corporation of The Americas 3500 Corporate Parkway Center Valley, PA 18034
Re: K151191
Trade/Device Name: OES Elite Telescopes, Protective Tube Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBP, FGC, HIH Dated: October 14, 2015 Received: October 15, 2015
Dear Daphney Germain-Kolawole,
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. 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 801); medical device reporting (reporting of medical device
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151191
Device Name OES ELITE Telescopes, Protective Tube
Indications for Use (Describe)
The OES Elite Telescopes are indicated to provide the user with the means for visualizing diagnostic surgical procedures. The device is intended for use in general urological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site.
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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K151191 Pg. 1 of 4
510(k) Summary of Safety and Effectiveness
November 24, 2015
1. General information
- Manufacturer/Holder Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany
- Establishment Registration No.: 9610773 ■
- Official Correspondent: Daphney Germain-Kolawole Regulatory Affairs & Quality Assurance Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610 Phone: 484-896-5691 FAX: 484-896-7128 Email: daphney.germainkolawole@olympus.com Establishment Registration No.: 2429304
Tube
FBP
FGC, HIH
21 CFR 876.1500
21 CFR 884.1690
Gastroenterology/Urology
Obstetrics/Gynecology
Endoscope and accessories
2. Device identification
- I Device Trade Name: OES ELITE Telescopes, Protective
- 트 Device Classification Name: Telescope, Rigid, Endoscopic
- 트 Regulation Description:
- 트 Product Code:
- 트 Subsequent Product Codes:
- 트 Regulation Number:
- 트
트
■
■
-
Review Panel: ■
- Device Class: 2
4
3. Predicate device
K923982, Olympus OES Laparoscopy System
4. Description of device
The OES ELITE Telescopes are rigid endoscopes. An image relay system of rod lenses transmits the endoscopic image. A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image.
The OES ELITE Telescopes are delivered non-sterile. They are reusable and fully autoclavable. Before first and each subsequent use the device must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use.
The OES ELITE Telescopes will be marketed as individual telescopes.
The OES ELITE Telescopes are available in 4 mm diameters with four different directions of view (0°, 12°, 30°, 70°) each to allow use for various applications in accordance with the intended use as submitted with this 510(k).
| Model No. | Model name |
|---|---|
| WA2T400A | OES ELITE Telescope, 4mm, 0° |
| WA2T412A | OES ELITE Telescope, 4mm, 12° |
| WA2T430A | OES ELITE Telescope, 4mm, 30° |
| WA2T470A | OES ELITE Telescope, 4mm, 70° |
| WA2T43WA | OES ELITE Telescope, 4mm, 30° |
The OES ELITE Telescopes will be delivered with a protective tube WA2P400A which is subject to this 510(k) submission
5. Indications of use
The OES Elite Telescopes are indicated to provide the user with the means for visualizing diagnostic and therapeutic surgical procedures. The device is intended for use in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site.
6. Comparison of Technological characteristics
The subject and predicate devices are based on the same technological principle with the same elements:
- I Rigid endoscopes consisting of insertion tube, rod-lens and light-quide system, connector and eyepiece cup.
- . OES ELITE Telescopes are inserted only via natural body orifices. The predicate device additionally permitted surgical access.
5
- A bundle of optical fibers transmits light from an external light source to ■ illuminate the endoscopic image.
- I The image relay system of rod lenses transmits the endoscopic image.
- 트 Outer diameter reduced by 1mm.
- 트 Directions of Views (DOVs) adjusted. Predicate device from 0°, 12°, 45°, Subject device from 0°, 12°, 30°, 70°.
- I The 5mm telescopes of the predicate device had a field of view (FOW) of 70.5°. The Subject device now offers two FOV's 60° and 90°.
- I Maximum working length of the subject device is minimally reduced (10mm)
- I The same materials in patient contact are used in the predicate and subject devices.
7. Performance Data
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO-14971:2007.
Performance tests were carried out to ensure that the system functions as intended and meets design specifications. The following performance tests and usability studies were conducted:
Biocompatibility testing
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995.
The testing included the following tests:
- Biological Safety toxicology: AAMI ANSI ISO 10993-1:2009; Biological . Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process
- . Cytotoxicity: AAMI ANSI ISO 10993-5:2009; Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- . Biological Evaluation in accordance with AAMI ANSI ISO 10993-1: 2009
Electrical safety and electromagnetic compatibility (EMC)
Electrical Safety was tested according to AAMI / ANSI ES60601-1:2005/(R)2012: Medical Electrical Equipment - Part 1.1 General requirements for safety and essential performance.
Electromagnetic compatibility (EMC) is not applicable. The devices are not electrically powered and are just used with light from a light source.
Thermal Safety
Tested according to IEC 60601-2-18:2009. Medical electrical equipment - Part 2-18: IEC 60601-2-18 Edition 3.0 2009-08, medical electrical equipment - part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment as well as in accordance with the guidance document "Hysteroscopes and Gynecology Laparoscopes - Submission Guidance for a 510(k)".
6
Performance Testing Bench
Conducted tests cover optical and mechanical performance testing, shipping tests, tests related to the expected service life and testing of the illumination system. Additionally, design validation/usability tests were conducted.
The following standards have been applied to the OES ELITE Telescopes:
| Rec. No. | Standard |
|---|---|
| 9-61 | IEC 60601-2-18:2009; 3rd Ed. |
| 9-83 | ISO 8600-1:2013 |
| 9-84 | ISO 8600-3:1997 + AM1(2003) |
| 9-94 | ISO 8600-4:2014 |
| 9-39 | ISO 8600-5:2005 |
| 9-40 | ISO 8600-6:2005 |
| 5-40 | ISO 14971:2007 |
| 19-4 | AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,, c1:2009/(r)2012 and |
| a2:2010/(r)2012 (IEC 60601-1:2005, mod). | |
| 5-89 | IEC 60601-1-6:2013 |
| 2-156 | AAMI ANSI ISO 10993-1: 2009 |
| 2-153 | AAMI ANSI ISO 10993-5: 2009 |
| 2-198 | AAMI ANSI ISO 10993-12: 2012 |
| 14-333 | ISO 17665-1:2006 |
8 Conclusions
The performance data support the safety of the device and demonstrate that the subject devices comply with the intended use as specified.
In summary, we believe the OES ELITE Telescopes are substantially equivalent to the predicate devices with respect to the general design approach, function, and the intended use. The OES ELITE Telescopes raise no new concerns of safety or effectiveness compared to the predicate devices.