(57 days)
Not Found
No
The description focuses on automatic light control based on video, which is a standard feedback loop mechanism and does not inherently indicate AI/ML. There are no mentions of AI, ML, or related terms.
No
The device provides light for examination, diagnostic and therapeutic applications, but it is a light source for an endoscope, not the therapeutic device itself. The therapeutic application refers to the endoscope's use, not the light projector.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device provides light for "diagnostic and therapeutic applications."
No
The device description explicitly states it uses a "xenon arc lamp" and provides "illumination for an endoscope via a light guide," which are physical hardware components. The device is a light source, not a software-only application.
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 light for examination, diagnostic, and therapeutic applications, particularly in endoscopy. This involves illuminating the inside of the body for visualization and procedures.
- Device Description: The device is a light source that connects to an endoscope via a light guide. It provides illumination for the endoscope.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis on biological specimens.
The device is an accessory used in vivo (within the body) during endoscopic procedures to provide illumination.
N/A
Intended Use / Indications for Use
Light Projector AUTO LP 5123 provides light for examination, diagnostic and therapeutic applications, in particular, in endoscopy.
The Xenon Light Source is classified as Cardiac Floating (CF) which permits its use for cardiac procedures when used in conjunction with the proper instrumentation for entry into the cardiac system.
Product codes (comma separated list FDA assigned to the subject device)
78 GCT
Device Description
Light Projector AUTO LP 5123 uses a xenon arc lamp to provide illumination for an endoscope via a light guide which is connected to the projector's light port. The illumination level is automatically controlled by video.
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)
Independent laboratories tested the Xenon Light Source 5123 according to specified standards IEC601-1 amendment 1 and 2, IEC601-1-1, and IEC601-2-18. The certifications for UL and CE compliance are pending.
No clinical tests performed.
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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353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Phone: 847.913.1113 Fax: 847.913.1488
RICHARD MEDICAL INSTRUMENTS C
510(k) Summary of Safety and Effectiveness
| Submitter | |
|---|---|
| Company / Institution name: | Richard Wolf Medical Instruments Corp. |
| Division name (if applicable): | N.A. |
| Street address: | 353 Corporate Woods Parkway |
| City: | Vernon Hills |
| State/Province: | Illinois |
| Country: | USA |
| ZIP/Postal Code: | 60061 |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |
| Date of Preparation | October 13, 1998 |
| FDA establishment regulation number: | 14 184 79 |
| Phone number (include area code): | (847) 913-1113 |
| FAX number (include area code): | (847) 913-0924 |
| Product Information: | |
| Trade name: | Auto LP 5123 Xenon Light Projector |
| Model number: | 5123.011 |
| Common name: | Xenon Light Source |
| Classification Name: | Xenon Light Source |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---|---|
| 1 K952696 | 1 Xenon Light Source | 1 Richard Wolf M.I.C. |
| 2 | 2 | 2 |
| 3 | 3 | 3 |
1.0 Description
Light Projector AUTO LP 5123 uses a xenon arc lamp to provide illumination for an endoscope via a light guide which is connected to the projector's light port. The illumination level is automatically controlled by video.
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K 983628
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2.0 Intended Use
Light Projector AUTO LP 5123 provides light for examination, diagnostic and therapeutic applications, in particular, in endoscopy.
The Xenon Light Source is classified as Cardiac Floating (CF) which permits its use for cardiac procedures when used in conjunction with the proper instrumentation for entry into the cardiac system.
Technological Characteristics 3.0
The color temperature of the 180 W xenon arc lamp is about 5600 K. The service life is approximately 500 hours and will decline with time due to the number of starts. The light projector is a type CF applied part per IEC601-1.
4.0 Substantial Equivalence
The submitted devices pose the same type of questions about safety and effectiveness as existing devices. The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing 510(k) devices sold by Richard Wolf.
5.0 Performance Data
Independent laboratories tested the Xenon Light Source 5123 according to specified standards IEC601-1 amendment 1 and 2, IEC601-1-1, and IEC601-2-18. The certifications for UL and CE compliance are pending.
6.0 Clinical Tests
No clinical tests performed.
7.0 Conclusions Drawn
These devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manual.
By: Robert J. Casassa
Robert L. Casarsa Quality Assurance Manager
Date: Oct 12 98
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Image /page/2/Picture/0 description: The image shows a logo with a circular border containing the words "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES" in a sans-serif font. Inside the circle is a stylized symbol consisting of three overlapping human profiles or figures, arranged in a way that suggests movement or progression. The symbol is rendered in black, contrasting with the likely white or light background of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 1998
Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K983628 Auto LP 5123 Xenon Light Projector Dated: October 13, 1998 Received: October 15, 1998 Regulatory Class: II 21 CFR 876.1500/Procode: 78 GCT
Dear Mr. Casarsa:
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 II (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 (QS) 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/cdrf/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
ndication
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:__Light Projector AUTO LP 5123
Intended Use:
Light Projector AUTO LP 5123 provides light for examination, diagnostic and therapeutic applications, in particular, in endoscopy.
The Xenon Light Source is classified as Cardiac Floating (CF) which permits its use for cardiac procedures when used in conjunction with the proper instrumentation for entry into the cardiac svstem.
(PI.E.ASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concursence of CDRH Office of Device Evaluation (ODE)
Voriel a. Seymon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _