(30 days)
Not Found
No
The summary describes a standard Xenon light source for endoscopy and makes no mention of AI, ML, image processing, or any related concepts.
No
Explanation: The device is a light source for endoscopic procedures, designed to supply light for diagnostic observation and surgical procedures, not to provide therapy directly.
No
The device is a light source used to illuminate the surgical field for endoscopic diagnostic observation and surgical procedures, but it does not perform any diagnosis itself.
No
The device description explicitly states it is an "electronic light source using a 300/180Watt Xenon lamp," 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 clearly states "for use in endoscopic applications" and "to supply light for endoscopic diagnostic observation and surgical procedures." This describes a device used in vivo (within the body) for visualization during medical procedures.
- Device Description: The description confirms it's an "electronic light source using a 300/180Watt Xenon lamp, to provide light for endoscopic procedures." This further supports its use for illumination during endoscopy.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body), which is the defining characteristic of an IVD.
Therefore, the Model LS 6035/LS 6180 Xenon Light Source is a medical device used for illumination during endoscopic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Model LS 6035/LS 6180 Xenon Light Source is intended for use in endoscopic applications.
The Xenon Light Source Model LS6035 is designed to supply light for endoscopic diagnostic observation and surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
78 GCT
Device Description
The Models LS 6035/LS 6180 is an electronic light source using a 300/180Watt Xenon lamp, to provide light for endoscopic procedures.
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.
K944821, K944607, K954561, K981804
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
982962
CONTEC MEDICAL/Austin & Associates, Inc. 1109 Sturbridge Road Fallston, Maryland 21047 Phone 410/877-3269/Fax 410/877-0544
510(k) SUMMARY
The enclosed is a Summary of our 510(k) Submission of a Xenon Light Source which is substantially equivalent to many current and legally marketed devices.
TRADE NAME: Xenon Light Source Model LS 6035 Xenon Light Source Model LS 6180 CLASSIFICATION NAME: Light Source, Endoscope, Xenon Arc
EQUIVALENCE:
The Xenon Light Source Model LS 6035/6180 is substantially equivalent to current and legally marketed devices. Examples are enclosed and include the Richard Wolf Model 5141(K944821), Model 5135 (K944607), the Karl Storz Model 201315-20 (K954561), the Linvatec Model 8430 (enclosed brochure information) and the CONTEC Model LS6000 (K981804). Each Xenon Light Source is designed the same, meets the same specifications and its indication is the same. The only difference between each model is the Watt of the light source lamp.
DESCRIPTION:
The Models LS 6035/LS 6180 is an electronic light source using a 300/180Watt Xenon lamp, to provide light for endoscopic procedures.
INTENDED USE: The Model LS 6035/LS 6180 Xenon Light Source is intended for use in endoscopic applications.
CHARACTERISTICS:
There is no significant technological characteristics of the Model LS 6035/LS 6180 compared to existing, legally marketed devices of which examples are listed (Equivalence Section above). The lamp utilized with the LS 6035 is a 300 Watt lamp and the LS 6180 is a 180 Watt lamp.
Summary Prepared by:
Summary Prepared On:
8/19/98
Albert Austin Manager/Sales and Quality Assurance CONTEC Medical/Austin & Associates, Inc.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures connected by flowing lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the symbol. The text is in all caps.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 1998
Mr. Albert Austin CONTEC Medical/Austin & Associates, Inc. 1109 Sturbridge Road Fallston, MD 21047
Re: K982962
Xenon Light Source Systems, Models LS-6180 and LS-6035 Dated: August 19, 1998 Received: August 24, 1998 Regulatory Class: II 21 CFR 876.1500/Procode: 78 GCT
Dear Mr. Austin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Xenon Light Source, Model LS6035 Device Name:
Indications For Use:
The Xenon Light Source Model LS6035 is designed to supply light for endoscopic diagnostic observation and surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Bergman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological I
510(k) Number K982962
3
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)