(275 days)
No
The description focuses on the device's function as a light source for endoscopes and does not mention any AI/ML capabilities or image processing beyond basic illumination.
No
The device provides illumination and visualization, but it does not treat or cure any medical condition.
No
The device provides illumination and visualization, which aids in diagnosis but does not perform the diagnosis itself. Its intended use is to be an accessory to endoscopic devices.
No
The device description explicitly states it is a "lightweight portable lamp" that is "battery-operated and uses LEDs to illuminate the area of interest," indicating it is a hardware device. While software validation is mentioned, it is for "Software Contained in Medical Devices," not a standalone software device.
Based on the provided information, the EndoLED is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide illumination and visualization of optical images" in conjunction with endoscopic devices. This describes a device used for direct observation and imaging within the body, not for testing samples (like blood, urine, or tissue) outside the body to diagnose a condition.
- Device Description: The description focuses on its function as a light source for endoscopes, its portability, battery operation, and different designs and adapters. This aligns with a medical device used for visualization during procedures.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples.
- Providing diagnostic information based on laboratory tests.
- Reagents or assays.
- Any process that involves testing samples in vitro (outside the living organism).
The EndoLED is a medical device used for illumination during endoscopic procedures, which falls under the category of devices used for visualization and intervention within the body, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
The EndoLED is to be used in conjunction with endoscopic devices to provide illumination and visualization of optical images.
Product codes (comma separated list FDA assigned to the subject device)
NTN
Device Description
The EndoLED is a lightweight portable lamp for the use with endoscopes. The device is battery-operated and uses LEDs to illuminate the area of interest. For the users convenience, the EndoLED come in different designs, the straight and the angled one. The accessories comprise adapters for the use of the EndoLED with different types of endoscopes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
Reprocessing validation was carried out in accordance with "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance - April 1996."
The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Minor Level of Concern."
The following standards have been applied to the EndoLED:
ISO 14971
IEC 62366
IEC 60601-1
IEC 60601-1-2
IEC 60601-2-18
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
Image /page/0/Picture/0 description: The image shows handwritten text on a white background. The text at the top appears to be a series of numbers, specifically "K 133311". Below this, the text reads "Page 1 of 2", with the "2" being circled. The handwriting is somewhat stylized, with distinct spacing between the characters.
JUL 30 2014
510(k) Summary of Safety and Effectiveness
1. General information
트
-
Applicant: Olympus Winter & Ibe GmbH Kuehnstrasse 61 22045 Hamburg
Germany -
l Official Correspondent:
-
Sheri L. Musgnung Regulatory Affairs & Quality Assurance Olympus Corporation of the Americas. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610 484-896-5405 Phone: FAX: 484-896-7128 Email: sheri.musqnung@olvmpus.com Establishment Registration No.: 2429304
-
에 Manufacturer: Olympus Winter & Ibe GmbH Kuehnstrasse 61 22045 Hamburg / Germany
Fax:
- 피 Registration number: 9610773
- r Contact person:
2. Device identification
- 할 Proprietary name:
- 루 Common name:
- t Classification name:
- 요 Regulations Number:
- . Regulatory class:
- 트 Product code:
- 트 Device panel:
- Predicate devices
K091829 - PLS Portable Light Source by OPTIM Inc., Sturbridge/MA
4. Description of device
The EndoLED is a lightweight portable lamp for the use with endoscopes. The device is battery-operated and uses LEDs to illuminate the area of interest. For the users convenience, the EndoLED come in different designs, the straight and the angled one. The accessories comprise adapters for the use of the EndoLED with different types of endoscopes.
EndoLED LED Light Source LED Light Source 21 CFR 876.1500 Class II NTN Gastroenterology/Urology
Mr. Jan Schueller-lwersen Phone: +49-66966-2860
+49-66966-2134
Email: jan.schueller-iwersen@olympus-oste.eu
1
Page 2 of ②
K133311
5. Indications of use
The EndoLED is to be used in conjunction with endoscopic devices to provide illumination and visualization of optical images.
6. Comparison of Technological characteristics
The EndoLED shares virtually all specifications and design characteristics of the predicate device. The EndoLED and predicate device are portable detachable light sources for use with rigid and flexible endoscopes. The EndoLED is available in a straight and angled version and the predicate is available in a straight version. The EndoLED utilizes a rechargeable NiMH battery; whereas the predicate device utilizes a rechargeable Lithium lon battery. Both devices offer the users 40 minutes of use at maximum power. The EndoLED device also features a low battery indicator and houses an integrated cooling element.
7. Summary of non-clinical testing
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO-14971:2007.
Reprocessing validation was carried out in accordance with "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance - April 1996."
The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Minor Level of Concern."
The following standards have been applied to the EndoLED:
ISO 14971 IEC 62366 IEC 60601-1 IEC 60601-1-2 IEC 60601-2-18
8 Conclusion
In summary, we believe the EndoLED is substantially equivalent with the predicate device with respect to the general design approach, function, and the indications for use. The EndoLED raises no new concerns of safety or efficacy when compared to the predicate device.
2
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 30, 2014
Olympus Winter & Ibe GmbH Ms. Sheri L. Musgnung Regulatory Affairs & Quality Assurance 3500 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K133311
Trade/Device Name: Endol.ED Model number WA91500A and WA91502A Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class; Class II Product Code: NTN Dated: July 1, 2014 Received: July 2. 2014
Dear Ms. 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. 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 mislcading.
If your device is classified (see above) into cither 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Sheri L. Musgnung
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" (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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K133311
Device Name EndoLED Model number WA91500A and WA91502A
Indications for Use (Describe)
The EndoLED is to be used in conjunction with endoscopic devices to provide illumination and visualization of optical images.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Neil R Ogden -S 2014.07.28 14:20:53 -04'00'
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."