(86 days)
Not Found
No
The summary describes a standard LED light source for endoscopy and makes no mention of AI or ML capabilities.
No.
The device is a light source for endoscopic diagnosis, treatment, and observation, but it does not directly perform therapeutic action itself. It is an accessory to therapeutic devices.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the device is "for endoscopic diagnosis, treatment and video observation." This clear mention of "diagnosis" indicates that it is a diagnostic device.
No
The device description explicitly states it is a "desk top device which consists of a LED light source," indicating it is a hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states it's for "endoscopic diagnosis, treatment and video observation" using light with endoscopes and related equipment. This is a procedure performed in vivo (within the living body), not in vitro (outside the living body, typically on biological samples).
- Device Description: The description reinforces its use as a light source for endoscopy, which is an in vivo procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on bodily fluids or tissues, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This light source does not fit that description.
N/A
Intended Use / Indications for Use
This light source has been designed to be used with Olympus-designated endoscopes, camera heads, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
Product codes (comma separated list FDA assigned to the subject device)
NTN, FCW
Device Description
The Olympus CLL-V1 is a desk top device which consists of a LED light source designed and intended to be used with Olympus-designated endoscopes, camera heads, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
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)
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
JUN 1 9 2013
K130819
ATTACHMENT 19
510(k) Summary
1
1
K130819
510(k) Summary of Safety and Effectiveness
1. General information
-
Applicant: 트
Olympus Winter & Ibe GmbH Kuehnstrasse 61 22045 Hamburg Germany -
Official Correspondent: Sheri L. Musgnung 트
Regulatory Affairs & Quality Assurance Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610 Phone: 484-896-5405 FAX: 484-896-7128 Email: Sheri.Musqnung@Olympus.com Establishment Registration No .: 2429304
Olympus Winter & Ibe GmbH 1 Manufacturer: Kuehnstrasse 61 22045 Hamburg / Germany
- Registration number: 9610773 I
- Mr. Jan Schueller-lwersen . Contact person: Phone: +49-66966-2860 +49-66966-2134 Fax: Email: jan.schueller-iwersen@olympus-oste.eu
2. Device identification
- CLL-V1, LED Light Source Proprietary name: 로
- l Common name: LED Light Source
- Requlations Number: 21 CFR 876.1500
- Class II ■ Regulatory class:
- Product code: NTN. FCW
- Gastroenterology/Urology Device panel:
3 Predicate devices
를
l
트
| Device Name: | Stryker L9000 | Storz LED Nova 100 Cold Light Fountain |
|---|---|---|
| Manufacturer: | Stryker | Karl Storz |
| 510(k) No.: | K082813 | K091968 |
2
K130819
4 Description of device
The Olympus CLL-V1 is a desk top device which consists of a LED light source designed and intended to be used with Olympus-designated endoscopes, camera heads, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
5 Indications of use
This light source has been designed to be used with Olympus-designated endoscopes, camera heads, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
6 Comparison of Technological characteristics
LED is the advancing technology therefore the new light source CLL-V1 is based on the latest LED technology. The LED light source features a long lasting LED "bulb" with reduced energy consumption having no need for additional fan cooling therefore being silent in its use. The optimized light intensity allows higher contrast to existing Halogen bulbs resulting in higher brightness.
7 Summary of non-clinical testing
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO-14971:2007.
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 CLL-V1:
ISO 14971:2007 IEC 60601-1:1990 + A1:1993 + A2:1995 + A13:1996 IEC 60601-1-2:2007 IEC 60601-2-18:1996 +A1.2000 IEC 60601-1-6:2006
8 Conclusion
In summary, we believe the CLL-V1 is substantially equivalent with the predicate devices with respect to the general design approach, function, and the indications for use. The CLL-V1 raises no new concerns of safety or efficacy when compared to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the words "Public Health Service" in a bold, sans-serif font. The text is arranged on a single line. The words are black against a white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 ·Silver Spring, MD 20993-002
June 19, 2013
Olympus Winter and Ibe GmbH % Olympus Corporation of the Americas Ms. Sheri L. Musgnung 3500 Corporate Parkway - P.O. Box 610 Center Valley, Pennsylvania 18034-0610
Re: K130819
Trade/Device Name: CLL-VI Light Source Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NTN, FCW Dated: March, 22, 2013 Received: April 01, 2013
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 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
4
Page 2 - Ms. Sheri L. Musgnung
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 forth in the quality systems (OS) 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/ucm1 15809.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/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 Small Manufacturers, International and Consumer Assistance 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
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K130819 510(k) Number (if known):
Device Name: CLL-V1, LED Light Source
Model Numbers: WA97020A
Indications For Use:
This light source has been designed to be used with Olympus-designated endoscopes, camera heads, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
Prescription Use V
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Neil R Ogdens 2013.06.14 11:23:45 -04'00'
(Division Sign-Off) for MXM
Division of Surgical Devices
K130819 510(k) Number
Page 1 of 1
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