(315 days)
Not Found
No
The summary describes a light source with intensity control, but there is no mention of AI, ML, image processing, or any learning or adaptive capabilities.
No.
The device's sole function is to provide illumination for observation and manipulation, not to treat a disease or condition.
No
The device is described as a light source for illuminating surgical sites, which aids observation and manipulation, but does not itself provide diagnostic information or measurements. Its purpose is for illumination, not diagnosis.
No
The device description explicitly states it is a "Light Engine" which is a hardware component (LED light source) and mentions controlling it via a PC or USB interface, indicating a physical device with software control, not a software-only device.
Based on the provided information, the Artemis Light Engine is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to "illuminate surgical sites that allow observation or manipulation of body cavities, hollow organs, and canals." This describes a device used during a surgical procedure to provide visualization, not a device used to examine specimens in vitro (outside the body) for diagnostic purposes.
- Device Description: The description focuses on the light source itself, its control, and calibration. There is no mention of analyzing biological samples or performing diagnostic tests.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information about a patient's condition
- Use in a laboratory setting for diagnostic testing
The Artemis Light Engine is a surgical accessory used for illumination during procedures, falling under the category of medical devices used for visualization and access.
N/A
Intended Use / Indications for Use
The Artemis Light Engine is a primary LED light source when used in conjunction with laparoscopes or surgical cameras to illuminated surgical sites that allow observation or manipulation of body cavities, hollow organs, and canals.
Product codes (comma separated list FDA assigned to the subject device)
NTN
Device Description
The Light Engine is a family of light engines that are designed for laboratory and clinical use in applications. The Light Engine provides a light source of which the intensity can be controlled via a PC. The output power of the Light Engine is calibrated as to provide a linear response over the full range of intensity and life-time. The Light Engine can be controlled by an external software device, or directly with the serial port provided by the USB interface (RS232-via-USB).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body cavities, hollow organs, and canals
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)
The performance testing to verify light output of the Artemis Light Engine was done as per the Bench Testing protocol attached. Design Test and Verification demonstrates that the device functions as it is intended and its performance does not raise any issues of safety and effectiveness. Software verification testing was successfully performed and completed.
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, layered on top of each other. The profiles are connected by a curved line that forms the shape of a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 16. 2015
Ouest Medical Imaging Mr. Martin Heuvelmans Quality Assurance Manager Industrieweg 41 1775 PW Middenmeer Netherlands
Re: K141164
Trade/Device Name: Artemis Light Engine Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NTN Dated: February 13, 2015 Received: February 13, 2015
Dear Mr. Heuvelmans:
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
1
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 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/Resourcesfor You/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141164
Device Name
Artemis Light Engine
Indications for Use (Describe)
The Artemis Light Engine is a primary LED light source when used in conjunction with laparoscopes or surgical cameras to illuminated surgical sites that allow observation or manipulation of body cavities, hollow organs, and canals.
| 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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Image /page/3/Picture/0 description: The image shows the logo for Quest Medical Imaging. The logo features a stylized letter "Q" in gray and blue, with the word "Quest" in bold black letters next to it. To the right of "Quest" is a vertical blue line, followed by the words "medical imaging" in a smaller, italicized font.
510(k) Summary (21 CFR 807.92(c))
Administrative information
| Manufacturer Name: | Quest Medical Imaging
Industrieweg 41
1775 PW Middenmeer
Netherlands |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Martin Heuvelmans, QA Manager
Tel: +31 227 604046
Fax: +31 227 604053
E-mail: martin.heuvelmans@quest-
innovations.com |
| Official Correspondent: | Quest Medical Imaging
Martin Heuvelmans, QA Manager
E-mail: martin.heuvelmans@quest-
innovations.com |
FDA Establishment Registration Number: 3010590422
| Date prepared: | March 3, 2014 |
|---|---|
| Name of Device: | |
| Trade Name: | Artemis Light Engine |
| Common Name: | LED light source |
| Classification Name: | 21 CFR 876.1500 |
Identification of Predicate Device(s):
Product Code:
| 510(k)
| Number | Device | Manufacturer |
|---|---|---|
| K130819 | CLLV1, LED Light Source | Olympus Winter & Ibe |
| GmbH | ||
| K123956 | Power LED 175 | Karl Storz GmbH & Co. KG |
NTN
Intended Use Statement
The Artemis Light Engine is a primary LED light source when used in conjunction with laparoscopes or surgical cameras to illuminated surgical sites that allow observation or manipulation of body cavities, hollow organs, and canals.
Device description
The Light Engine is a family of light engines that are designed for laboratory and clinical use in applications. The Light Engine provides a light source of which the
4
intensity can be controlled via a PC. The output power of the Light Engine is calibrated as to provide a linear response over the full range of intensity and life-time. The Light Engine can be controlled by an external software device, or directly with the serial port provided by the USB interface (RS232-via-USB).
Performance Testing
The performance testing to verify light output of the Artemis Light Engine was done as per the Bench Testing protocol attached. Design Test and Verification demonstrates that the device functions as it is intended and its performance does not raise any issues of safety and effectiveness. Software verification testing was successfully performed and completed. The manufacturer complies with the following voluntary standards:
- IEC 60601-1-2 Edition 3: 2007-03 Medical Electrical Equipment Part1-2: ● General Requirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
- . ISO 14971 Second edition 2007-03-01, Medical Devices - Application of Risk Management to Medical Devices.
Predicate Device Comparison
The Artemis Light Engine is substantially equivalent to the above listed 510(k) cleared devices on the market. Wording differences between indications for use of the Artemis Light Engine and those of the above-listed predicate devices do not constitute a new intended use. The characteristics and technology used are comparable with the predicate devices.
Conclusions
The Artemis Light Engine has similar intended use and technical features as the predicate devices listed above. Therefore, the Artemis Light Engine is substantially equivalent to the predicate devices listed above.